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Sample records for research-based pharmaceutical companies

  1. Changing R&D models in research-based pharmaceutical companies.

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-01-01

    New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2-32.3 billion (2006-2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager. PMID:27118048

  2. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    PubMed

    Lee, Stacey B

    2010-01-01

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections. PMID:20930251

  3. Pharmaceutical company funding and its consequences: a qualitative systematic review.

    PubMed

    Sismondo, Sergio

    2008-03-01

    This article systematically reviews published studies of the association of pharmaceutical industry funding and clinical trial results, as well a few closely related studies. It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests. PMID:17919992

  4. [How to Use Presentations and Leaflets from Pharmaceutical Companies].

    PubMed

    Nango, Eishu

    2015-01-01

    Presentations and leaflets from pharmaceutical companies are still a major source of information for physicians in Japan. Most physicians trust them and base their clinical practice on them. Such products from pharmaceutical companies are just advertising, because they are profit-making enterprises. Gifts from pharmaceutical companies to health care providers introduce bias when prescribing medicine. Thus, it is important that health care providers who receive this information from pharmaceutical companies, interpret it correctly. There are several methods for information supplements used by pharmaceutical companies. The range of the vertical axis on a survival curve may not be the full range, and differences between treatment groups are expanded in graphs. Sometimes the shape of the survival curve is artificial. The treatment effects should be interpreted based on various indicators such as raw incidence, relative risk or the number needed to treat. A composite endpoint is often used in mega-studies because each individual outcome which comprises the composite endpoint has a small event rate that is not enough to reach statistical significance, whether outcomes are important for patients or not. Evidence-based medicine is a formulated method of clinical reasoning from evidence used to make decisions. We should consider not only the evidence, but also a patient's clinical state and circumstances, a patient's preferences and actions, and the clinical expertise of the health care providers. Although pharmaceutical companies seduce health care providers, they have to recognize the true magnitude of the effects of their products and recommend their use for patients carefully. PMID:26721072

  5. Ghost marketing: pharmaceutical companies and ghostwritten journal articles.

    PubMed

    Moffatt, Barton; Elliott, Carl

    2007-01-01

    The use of ghostwriters by industry is subject to increasing public attention and scrutiny. This article addresses the practice and ethics of scientific ghostwriting. We focus on the type of ghostwriting that involves a pharmaceutical company hiring a medical education and communications company to write a paper favorable of their product, who then hires a well-known academic to publish it under his or her name without disclosing the paper's true origins. We argue that this practice is harmful both to the public and to the institutions of science and that it is not justified by an analogy to accepted scientific authorship practices. Finally, we consider ways to discourage the practice. PMID:17259673

  6. Drug and drug-related supply promotion by pharmaceutical company representatives at VA facilities. Final rule.

    PubMed

    2012-03-01

    This final rule amends the Department of Veterans Affairs (VA) regulations regarding access to VA facilities by pharmaceutical company representatives. The purposes of the rule are to reduce or eliminate any potential for disruption in the patient care environment, manage activities and promotions at VA facilities, and provide pharmaceutical company representatives with a consistent standard of permissible business practice at VA facilities. The amendments will facilitate mutually beneficial relationships between VA and pharmaceutical company representatives. PMID:22420057

  7. Doctors’ opinions of information provided by Libyan pharmaceutical company representatives

    PubMed Central

    Alssageer, Mustafa A.; Kowalski, Stefan R.

    2012-01-01

    Objective To examine the opinions of Libyan doctors regarding the quality of drug information provided by pharmaceutical company representatives (PCRs) during detailing visits. Method An anonymous survey was conducted among 1,000 doctors from selected institutes in Tripoli, Benghazi and Sebha. Doctors were asked questions regarding the quality of information provided during drug-detailing visits. Results A questionnaire return rate of 61% (608 returned questionnaires out of 1,000) was achieved. The majority (n=463, 76%) of surveyed participants graded the quality of information provided as average. Approximately, 40% of respondents indicated that contraindications, precautions, interactions and adverse effects of products promoted by PCRs were never or rarely mentioned during promotional visits, and 65% of respondents indicated that an alternative drug to the promoted product was never or rarely mentioned by the representatives. More than 50% of respondents (n=310, 51%) reported that PCRs were not always able to answer all questions about their products. Only seven respondents (1%) believed that PCRs never exaggerated the uniqueness, efficacy or safety of their product. The majority of respondents (n=342, 56%) indicated that verbal information was not always consistent with written information provided. Seven per cent of respondents (n=43) admitted that they did not know whether or not the verbal information provided by PCRs was consistent with written information. Conclusion Doctors believe that the provision of drug information by PCRs in Libya is incomplete and often exaggerated. Pharmaceutical companies should ensure that their representatives are trained to a standard to provide reliable information regarding the products they promote. PMID:23205141

  8. Pharmaceutical company perspectives on current safety risk communications in Japan.

    PubMed

    Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki

    2014-01-01

    In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted. PMID:24555168

  9. Human rights responsibilities of pharmaceutical companies in relation to access to medicines.

    PubMed

    Lee, Joo-Young; Hunt, Paul

    2012-01-01

    Although access to medicines is a vital feature of the right to the highest attainable standard of health ("right to health"), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceutical companies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on Business and Human Rights and places the human rights responsibilities of pharmaceutical companies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for Pharmaceutical Companies consider the specific human rights responsibilities of one sector (pharmaceutical companies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceutical companies, with particular attention to patent-holding pharmaceutical companies. Adopting a right-to-health "lens," the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceutical companies' policies, and provide standards in relation to which pharmaceutical companies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceutical companies and hold them publicly accountable for their human rights responsibilities. PMID:22789042

  10. Trade secrets in life science and pharmaceutical companies.

    PubMed

    Nealey, Tara; Daignault, Ronald M; Cai, Yu

    2015-04-01

    Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through "improper means" is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today's interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees' careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft. PMID:25414378

  11. The Effect of Capital Structure on the Profitability of Pharmaceutical Companies The Case of Iran

    PubMed Central

    Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

    2013-01-01

    Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability. PMID:24250664

  12. Legislative, educational, policy and other interventions targeting physicians’ interaction with pharmaceutical companies: a systematic review

    PubMed Central

    Alkhaled, Lina; Kahale, Lara; Nass, Hala; Brax, Hneine; Fadlallah, Racha; Badr, Kamal; Akl, Elie A

    2014-01-01

    Background Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. Objective The objective of this study was to systematically review the effects of interventions targeting practising physicians’ interactions with pharmaceutical companies. Eligibility criteria We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. Data sources The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. Appraisal and synthesis methods We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Results Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a ‘collaborative approach’ between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. Limitations We identified too few studies to allow strong conclusions. Conclusions Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians’ prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical companies. PMID:24989618

  13. Dynamic Learning Capability and Actionable Knowledge Creation: Clinical R&D in a Pharmaceutical Company.

    ERIC Educational Resources Information Center

    Ingelgard, Anders; Roth, Jonas; Shani, A. B. (Rami); Styhre, Alexander

    2002-01-01

    Interviews with participants in research and development in a pharmaceutical company explored the use of organizational learning mechanisms to create knowledge. Results indicate that dynamic learning capability is embedded in and influenced by company culture, existing skills and competence, capacity for continuous change, and leadership.…

  14. "Insuring" the continued solvency of pharmaceutical companies in the face of product liability class actions.

    PubMed

    Chodock, Rochelle; Yolkut, David; Connolly, Dennis R

    2005-01-01

    Costly product liability lawsuits continue to plague the pharmaceutical industry, and insurance to cover these losses is severely inadequate. Furthermore, questionable regulation of drugs exists once a pharmaceutical has passed FDA approval. This article describes a plan that uses a capitalistic, rather than a governmental, approach to solve both the insurance and the quality control problems. Although the proposed plan has never been used to insure pharmaceutical companies, different permutations of it have been used to insure other litigation-prone industries. Success from the proposed insurance entity results from the combined knowledge of scientists and actuaries to provide both protection from product liability lawsuits for the pharmaceutical industry and enhanced post-market surveillance of pharmaceuticals. PMID:16100814

  15. Dramaturgical study of meetings between general practitioners and representatives of pharmaceutical companies

    PubMed Central

    Somerset, Maggie; Weiss, Marjorie; Fahey, Tom

    2001-01-01

    Objectives To examine the interaction between general practitioners and pharmaceutical company representatives. Design Qualitative study of 13 consecutive meetings between general practitioner and pharmaceutical representatives. A dramaturgical model was used to inform analysis of the transcribed verbal interactions. Setting Practice in south west England. Participants 13 pharmaceutical company representatives and one general practitioner. Results The encounters were acted out in six scenes. Scene 1 was initiated by the pharmaceutical representative, who acknowledged the relative status of the two players. Scene 2 provided the opportunity for the representative to check the general practitioner's knowledge about the product. Scene 3 was used to propose clinical and cost benefits associated with the product. During scene 4, the general practitioner took centre stage and challenged aspects of this information. Scene 5 involved a recovery strategy as the representative fought to regain equilibrium. In the final scene, the representative tried to ensure future contacts. Conclusion Encounters between general practitioners and pharmaceutical representatives follow a consistent format that is implicitly understood by each player. It is naive to suppose that pharmaceutical representatives are passive resources for drug information. General practitioners might benefit from someone who can provide unbiased information about prescribing in a manner that is supportive and sympathetic to the demands of practice. What is already known on this topicPharmaceutical representatives influence physicians' prescribing in ways that are often unacknowledged by the physicians themselvesMeetings with pharmaceutical representatives are associated with increased prescribing costs and less rational prescribingWhat this study addsMeetings between pharmaceutical representatives and general practitioners follow a consistent format that is implicitly understood by each playerGeneral practitioners may cooperate because representatives make them feel valued PMID:11751364

  16. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review

    PubMed Central

    Spurling, Geoffrey K.; Mansfield, Peter R.; Montgomery, Brett D.; Lexchin, Joel; Doust, Jenny; Othman, Noordin; Vitry, Agnes I.

    2010-01-01

    Background Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. Methods and Findings We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review. Conclusions With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies. Please see later in the article for the Editors' Summary PMID:20976098

  17. Attitude and practice of dental surgeons towards pharmaceutical companies' marketing gifts.

    PubMed

    Tahir, Shaila; Rafique, Adeela; Ghafoor, Farkhanda; Saleem, Akif; Khan, Amanullah

    2013-01-01

    Interaction of pharmaceutical companies (PC) with healthcare services has been a reason for concern. In medicine, awareness of the ethical implications of these interactions have been emphasized upon, while this issue has not been highlighted in dentistry. This study undertook a cross-sectional rapid assessment procedure to gather views of dentists in various institutions towards unethical practices in health care and pharmaceutical industry. The purpose of this study was to assess the need for the formulation and implementation of guidelines for the interaction of dentists with the pharmaceutical and device industry in the best interest of patients. A group of 209 dentists of Lahore including faculty members, demonstrators, private practitioners and fresh graduates responded to a questionnaire to assess their attitudes and practices towards pharmaceutical companies' marketing gifts. The study was conducted during 2011 and provided interesting data that showed the pharmaceutical industry is approaching private practitioners more frequently than academicians and fresh graduates. Private practioners accepted the gifts but mostly recognized them as unethical (over 65%). Both groups considered sponsoring of on-campus lectures as acceptable (over 70%). Respondents are not fully aware of the ethical demands which are imperative for all health care industries, and there is a dire need of strict guidelines and code of ethics for the dentist's interaction with the pharmaceutical and device industry so that patient interest is protected. PMID:23967370

  18. Pharmaceutical companies as a source of health information: a pilot study of the effects of source, web site interactivity, and involvement.

    PubMed

    Kim, Hyojin

    2011-01-01

    While pharmaceutical companies provide abundant health and medical information on their Web sites, little is known about consumers' perceptions of pharmaceutical companies as a health information source and the impact of pharmaceutical Web sites on health-related attitudes and behaviors. Findings from this study suggest that a pharmaceutical company can be perceived to be just as credible as a government health agency, and that Web site interactivity and consumer involvement with online health information affect the persuasive effects of the pharmaceutical company's message. Implications for future research and for the role of pharmaceutical companies in health communication are discussed. PMID:21347942

  19. Pharmaceutical companies and Italian Regional Governments: managing relationships in an increasing institutional complexity.

    PubMed

    Compagni, Amelia; Cavalli, Laura; Jommi, Claudio

    2008-09-01

    In Italy, the process of power decentralization to Regional Governments has particularly affected pharmaceutical care policies. Regions are experimenting with various strategies to govern drugs utilization and expenditure, and differentiating their approaches, leading to an ever-changing and complex institutional scenario. Pharmaceutical companies have created new professional roles, the Regional Affairs Managers (RAM), with the mandate to monitor the different regional contexts and measures, and to establish relationships with the public actors in charge of pharmaceutical policies. This analysis shows how public affairs/lobbying actions at regional level and the creation of a solid political competence within companies are still in an early phase. The activities carried out by RAMs remain limited to an exchange of information and only rarely are perceived by Regional public servants (RRs) as giving support to their work or influence decisions. The interaction with RAMs is often seen as little relevant and still too concentrated on products and a marketing/commercial approach rather than on broader issues of interest to RRs who need to manage the pharmaceutical care system at large. The level of acceptance of this type of activity is also variable and RRs' attitudes alternate between diffidence, polite tolerance, and openness to a constructive dialogue about pharmaceuticals and their management in a regional healthcare system. PMID:18384907

  20. Situation analysis of R & d activities: an empirical study in Iranian pharmaceutical companies.

    PubMed

    Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali

    2012-01-01

    As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called "high-tech" industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry's major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceutical companies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts' opinion was designed and delivered to 11 pharmaceutical companies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company. PMID:24250532

  1. Situation Analysis of R & D Activities: An Empirical Study in Iranian Pharmaceutical Companies

    PubMed Central

    Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali

    2012-01-01

    As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called “high-tech” industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry’s major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceutical companies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts’ opinion was designed and delivered to 11 pharmaceutical companies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company. PMID:24250532

  2. What is it like to work for a pharmaceutical company? Interview by Barbara J. Linney.

    PubMed

    Kaufman, E A

    2001-01-01

    Is working for a pharmaceutical company a career option you've thought about pursuing? In this column, Barbara Linney interviews physician executive Edward A. Kaufman, MD, about his 20-year experience working in the pharmaceutical industry. He talks about how he held a series of jobs for SmithKline Beecham's clinical labs business and lived in a number of places. He describes his background and how it made him an attractive candidate for the position, why he sought out the pharmaceutical industry, the nature of the work, and some of the projects that he has been involved in. He gives examples of physicians who have joined the executive ranks at GlaxoSmithKline and what made them such high-caliber candidates for top leadership positions. PMID:11291228

  3. Evaluation of productivity in Iranian pharmaceutical companies: A DEA-based Malmquist approach and panel data analysis

    PubMed Central

    Varmaghani, Mehdi; Meshkini, Amir Hashemi; Farzadfar, Farshad; Yousefi, Mehdi; Yaghoubifard, Saeed; Varahrami, Vida; Darzi, Ehsan Rezaei; Anabi, Majid; Kebriaeezadeh, Abbas; Zekri, Hedieh-Sadat

    2015-01-01

    Objective: In this study, we aimed to assess comparative productivity of 21 pharmaceutical companies in Iran during 2000–2013. Methods: To evaluate the productivity trend of pharmaceutical companies in Iran, we used data envelopment analysis-based Malmquist index. “Total assets” and “capital stock” as inputs and “net sales” and “net profit” as outputs extracted from Tehran stock exchange, were selected to be included in the analysis. This method provides the possibility for analyzing the performance of each company in term of productivity changes over time. We also used an estimation generalized least square panel data model to identify the factors that might affect productivity of pharmaceutical companies in Iran using EViews 7 and Deep 2.1 software. Findings: The mean total productivity during all years of the study was 0.9829, which indicates the improvement in their overall productivity. The results, over the 13-year period, indicated that the range of productivity changes in pharmaceutical companies, that were included in this study, was between 0.884 and 1.098. Panel data model indicated that age of company could positively (t = 4.765978, P < 0.001) and being located in cities other than Tehran (the capital) could negatively (t = −5.369549, P < 0.001) affect the productivity of pharmaceutical companies. The analysis showed the new policy (brand-generic scheme) and also the type of ownership did not have a significant effect on the productivity of pharmaceutical companies. Conclusion: In this study, pharmaceutical productivity trends were fluctuated that could be due to the sub-optimal attention of policy makers and managers of pharmaceutical companies toward long-term strategic planning, focusing on productivity improvement. PMID:25984541

  4. [Anti-counterfeit activities of pharmaceutical companies in Japan: for patient safety].

    PubMed

    Shofuda, Ken-ichi; Aragane, Katsumi; Igari, Yasutaka; Matsumoto, Kinya; Ito, Kazuya

    2014-01-01

    Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceutical companies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceutical companies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceutical companies extend comprehensive measures against counterfeit and illicit trading. PMID:24492224

  5. Challenges of access to medicine and the responsibility of pharmaceutical companies: a legal perspective.

    PubMed

    Ahmadiani, Saeed; Nikfar, Shekoufeh

    2016-01-01

    The right to health as a basic human right- and access to medicine as a part of it- have been a matter of attention for several decades. Also the responsibilities of different parties- particularly pharmaceutical companies- in realization of this right has been emphasized by World Health Organization. This is while many companies find no incentive for research and development of medicines related to rare diseases. Also some legal structures such as "patent agreements" clearly cause huge difficulties for access to medicine in many countries. High prices of brand medicine and no legal production of generics can increase the catastrophic costs- as well as morbidity-mortality of medication in lower income countries. Here we evidently review the current challenges in access to medicine and critically assess its legal roots. How societies/governors can make the pharmaceutical companies responsible is also discussed to have a look on possible future and actions that policy makers- in local or global level- can take. PMID:27141958

  6. Ethics of pharmaceutical company relationships with the nursing profession: no free lunch...and no more pens?

    PubMed

    Crock, Elizabeth

    2009-10-01

    In recent years, nurses have increasingly become recipients of pharmaceutical company gifts, funding and sponsorship. There has been little discussion in the nursing literature, however, of the ethical and professional implications of nurses' acceptance of such sponsorship. This article examines ethical issues related to the issue of nurses' accepting benefits from pharmaceutical companies (and other commercial enterprises). It aims to encourage nurses to look critically at the implications of accepting such gifts/sponsorship, or to enter any form of relationship with commercial companies within the health sector, and to stimulate further discussion of this issue within the profession. PMID:19929164

  7. From generic scheme to brand-generic scheme: Have new policy influenced the efficiency of Iranian pharmaceutical companies?

    PubMed Central

    Hashemi-Meshkini, Amir; Varmaghani, Mehdi; Yousefi, Mehdi; Yaghoubifard, Saeed; Zekri, Hedieh-Sadat; Nikfar, Shekoufeh; Kebriaeezadeh, Abbas

    2014-01-01

    Objective: Brand-generic scheme was implemented in Iran to improve the competition in the pharmaceutical market. In this study, we aim to assess if this policy had any positive effect on efficiency of Iranian pharmaceutical companies. Methods: We used data envelopment analysis to evaluate the relative efficiency of pharmaceutical companies during 1999-2008. The Wilcoxon matched-pairs signed-rank and sign tests were used to assess the difference between mean technical efficiency of companies before and after implementation of the new policy. Findings: Although the Wilcoxon matched-pairs signed-rank tests did not show any significant differences in favor of the new policy in terms of both relative and pure (managerial) technical efficiency for included companies (P = 0.079 and 0.07, respectively), but the one-sided sign test indicated that only relative pure (managerial) efficiency has been improved after this policy (P = 0.031). Conclusion: The “brand-generic scheme” does not seem to be a successful policy to improve efficiency level and prompt competition in pharmaceutical companies in Iran. To achieve this aim, consideration of infrastructural requirements including transparent and non-discriminating laws and regulations to support competition, the competitive pricing policies, the presence of international companies in the market, and full privatization of companies had to be also deeming by policy makers. PMID:25328898

  8. Pharmaceutical companies and global lack of access to medicines: strengthening accountability under the right to health.

    PubMed

    Grover, Anand; Citro, Brian; Mankad, Mihir; Lander, Fiona

    2012-01-01

    Many medicines currently available on the market are simply too expensive for millions around the world to afford. Many medicines available in the developing world are only available to a small percentage of the population due to economic inequities. The profit-seeking behavior of pharmaceutical companies exacerbates this problem. In most cases, the price reductions required to make drugs affordable to a broader class of people in the developing world are not offset by the resultant increase in sales volume. Simply stated, in most of the developing world, it is more profitable to sell drugs to the very wealthy at high prices than it is to sell cheaper drugs to a greater number of people. As a result, medicines remain unaffordable for the vast majority of people in many parts of the world. While this might be an acceptable outcome for certain commodities, such as luxury goods, it is completely unacceptable for life-saving medicines. Therefore, in order to effectively address the global lack of access to medicines, the role pharmaceutical companies play in the international intellectual property regime must be critically examined. PMID:22789043

  9. Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history.

    PubMed

    Nagaich, Upendra; Sadhna, Divya

    2015-01-01

    There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall. PMID:25599028

  10. Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history

    PubMed Central

    Nagaich, Upendra; Sadhna, Divya

    2015-01-01

    There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall. PMID:25599028

  11. Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa

    PubMed Central

    Narsai, Kirti; Williams, Abeda; Mantel-Teeuwisse, Aukje Kaija

    2012-01-01

    Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. Methods: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and efficacy of medicines. The experience of pharmaceutical companies indicated that country specific regulatory requirements are a barrier to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific labeling were cited as key problems. Conclusion: Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI). PMID:23093897

  12. Pharmaceutical Companies and Their Drugs on Social Media: A Content Analysis of Drug Information on Popular Social Media Sites

    PubMed Central

    2015-01-01

    Background Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Objective Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Methods Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. Results From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies’ social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers who interacted with pharmaceutical companies through commenting (23.9%, 177/740). For the drug-specific analysis, we found that the majority of search results contained drug product claims (69.4%, 482/695); more claims mentioned only benefits (44.8%, 216/482) relative to only risks (27.2%, 131/482). Additionally, approximately 25% (150/603) of posts on Twitter and YouTube were presented as personal testimonials. A considerable percentage of content on Facebook contained advertisements for illegal online pharmacies (17%, 16/92). Conclusions Pharmaceutical companies avoid making drug product claims on their social media accounts but frequently post content that is consistent with FDA definitions for help-seeking DTCA. Thousands of people often view content posted by pharmaceutical companies on social media; users also share company postings making both direct and indirect influence possible. Finally, people are likely to be exposed to drug product claims and information about illegal pharmacies when searching for information about popular pharmaceutical drugs on social media. PMID:26032738

  13. An analysis of the attrition of drug candidates from four major pharmaceutical companies.

    PubMed

    Waring, Michael J; Arrowsmith, John; Leach, Andrew R; Leeson, Paul D; Mandrell, Sam; Owen, Robert M; Pairaudeau, Garry; Pennie, William D; Pickett, Stephen D; Wang, Jibo; Wallace, Owen; Weir, Alex

    2015-07-01

    The pharmaceutical industry remains under huge pressure to address the high attrition rates in drug development. Attempts to reduce the number of efficacy- and safety-related failures by analysing possible links to the physicochemical properties of small-molecule drug candidates have been inconclusive because of the limited size of data sets from individual companies. Here, we describe the compilation and analysis of combined data on the attrition of drug candidates from AstraZeneca, Eli Lilly and Company, GlaxoSmithKline and Pfizer. The analysis reaffirms that control of physicochemical properties during compound optimization is beneficial in identifying compounds of candidate drug quality and indicates for the first time a link between the physicochemical properties of compounds and clinical failure due to safety issues. The results also suggest that further control of physicochemical properties is unlikely to have a significant effect on attrition rates and that additional work is required to address safety-related failures. Further cross-company collaborations will be crucial to future progress in this area. PMID:26091267

  14. Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

    ERIC Educational Resources Information Center

    Education Development Center, Inc., Newton, MA.

    The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

  15. Prevalence of low back pain in employees of a pharmaceutical company.

    PubMed

    Rotgoltz, J; Derazne, E; Froom, P; Grushecky, E; Ribak, J

    1992-01-01

    The association of low back pain (LBP) with mechanical factors at the workplace is uncertain. Most of the studies on this subject did not examine multiple levels of symptoms and did not take into account both the type of work and the primary activity during work. We studied the annual prevalence, severity and duration of attacks of LBP recorded on a physician-administered questionnaire in 208 workers in a pharmaceutical factory. Symptoms were then cross-tabulated with job type, location, work requirements, gender, and years at the factory. LBP was reported by 138 (66.3%) of the workers. Although over 75% of jobs in the packing department, laboratories and offices required prolonged sitting, LBP was most prevalent among workers in the packing department, where the chairs were found to be ergonomically unfit (odds ratio 3.7, 95% confidence interval 1.5-9.1, P = 0.003). Logistic regression demonstrated a highly significant and independent association between LBP and work in the packing or production department (odds ratio 2.03), sitting or lifting (odds ratio 1.97) and 6 years seniority (odds ratio 1.64). Gender was not a significant variable. We conclude that among these pharmaceutical company employees, prolonged sitting and work in the packing or production departments were independently associated with LBP. Prospective studies are warranted to substantiate our findings. PMID:1428819

  16. Development and Distribution of Drugs for NTDs: Efforts of One Pharmaceutical Company.

    PubMed

    Asada, Makoto

    2016-01-01

      The Pharmaceutical Industry is expected to play a proactive global role in combatting neglected tropical diseases (NTDs) and other tropical diseases affecting low-income countries. Such a role would include novel medicine R&D, manufacturing and distribution. In order to succeed in this role, several challenges need to be overcome: a) the economic challenge or cost benefit balance for the development of these medicines, and b) sparse in-house experience with these diseases within the Industry. During the last decade, the Product Development Partnership (PDP) model has become an effective strategy to address such challenges. Organizations such as the Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), TB alliance, PATH (formerly the Program for Appropriate Technology in Health), and others have linked pharmaceutical companies, funding organizations, academic researchers and others, and have thus been able to successfully populate treatment pipelines directed at NTDs, Malaria, tuberculosis (TB), and human immunodeficiency virus (HIV)/AIDS. In this paper, our experience working with one of these organizations, DNDi, is described. We have been collaborating with DNDi in evaluating the actions of Eisai's antifungal compound, E1224, in a clinical study for treating Chagas Disease. In addition, other Eisai initiatives directed at NTDs and improving patients' access to medicines are introduced. PMID:26831797

  17. Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities

    PubMed Central

    Gupta, Sandeep Kumar; Nayak, Roopa Prasad

    2014-01-01

    Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceutical companies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceutical companies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine. PMID:24799811

  18. R&D investments for neglected diseases can be sensitive to the economic goal of pharmaceutical companies.

    PubMed

    Dimitri, Nicola

    2012-08-01

    A fundamental problem with neglected diseases is how to induce pharmaceutical companies to invest resources for developing effective treatments. A recent debate focused on the role of economic incentives represented by monetary transfers to the firms. In this article I focus on the economic goals of pharmaceutical companies, as determinants for R&D effort. In particular, within a stylized framework, the work compares expected profit and expected productivity maximization, arguing that the former in general induces higher R&D investments than the latter. Therefore, as it is currently the case, when pharmaceutical firms focus on productivity, appropriate economic incentives might be needed for them to invest in R&D for neglected diseases. PMID:22414544

  19. 38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false On-site activities by pharmaceutical company representatives at VA medical facilities. 1.220 Section 1.220 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS GENERAL PROVISIONS Security and Law Enforcement at Department of Veterans Affairs Facilities...

  20. [The pharmaceutical company Choay: an history linked to research and commercialization of biological products].

    PubMed

    Bonnemain, Bruno

    2015-12-01

    Eugène Choay, when he created his own company in 1911, had already a large experience in pharmaceutical industry obtained with Maison Frère where he discovered the famous Dentol, well known thank to Poulbot's publicity drawings for this product. But, convinced of the future of biological products and Opotherapy, he decided to invest himself in this area with a totally new process for cold desiccation of organs. The success will be there and several pharmacists from Choay family will take care of the company and bring it to the top of its specialty in Opotherapy. At the beginning of the 1970's, Choay in in full development and has the products, the sites and the human resources for the future. In 1975, 4 therapeutic areas are covered by Choay's products: coagulation, inflammation, dermatology and hepatology. After more than 65 years of independence, Choay group will be finally bought partially and then totally by Sanofi. With the support of Sanofi, Choay created, in 1981, their US subsidiary called Choay Laboratories Inc;, after the NDA approval of sub-cutaneous Calciparine by the FDA. In 1985 Fraxiparine, a low molecular weight heparin discovered by Jean Choay's team, is lauched on the market. All these developments represent an outstanding record a longevity which indicates how perceptive was Eugène Choay and his successors when choosing to invest totally in the therapeutic use of hormones and products acting on coagulation factors. PMID:26827552

  1. A survey of pharmaceutical company representative interactions with doctors in Libya

    PubMed Central

    Alssageer, Mustafa A.; Kowalski, Stefan R.

    2012-01-01

    Objectives To examine the frequency of pharmaceutical company representative (PCR) interactions with doctors in Libya and review possible associations between these interactions and the personal and practice setting characteristics of doctors. Method An anonymous survey questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. Results A questionnaire return rate of 61% (608 returned questionnaires) was achieved. Most respondents (94%) reported that they had been visited by PCRs at least ‘once’ in the last year. Fifty per cent of respondents met with PCRs at least once a month, and 20% at least once a week. The following characteristics were significantly associated with meeting with a representative more than once a week: age, gender (male > female), years of practice, being a specialist (other than an anaesthesiologist) or working in private practice. Ninety-one per cent of doctors reported that they had received at least one kind of relationship gift during the last year. Printed materials (79%), simple gifts (73%) and drug samples (69%) were the most common relationship products given to respondents. Reimbursements or sponsored items were reported by 33% of respondents. Physician specialists were more likely to receive drug samples or sponsored items than residents, general practitioners, anaesthesiologists or surgeons (P<0.01). Participants working in private practice alone or in both sectors were more likely to receive printed materials, simple gifts or free samples from PCRs than doctors working in the public sector (P<0.05). Conclusion Libyan doctors are frequently visited by PCRs. Doctors, working in private practice or specialist practice, are especially targeted by promotional activities. An agreed code of conduct for pharmaceutical promotion in Libya between doctors and PCRs should be created. PMID:23002397

  2. R&D implementation in a department of laboratory medicine and pathology: a systematic review based on pharmaceutical companies.

    PubMed

    Feulefack, Joseph; Sergi, Consolato

    2015-01-01

    A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis.  We identified some suggested implementation strategies relevant for marketing to enhance companies' own R&D strategies; such as reliability of companies on "sourcing-in" R&D facilities and "think-tank" events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework. PMID:25946935

  3. R&D Implementation in a Department of Laboratory Medicine and Pathology: A Systematic Review Based on Pharmaceutical Companies

    PubMed Central

    Feulefack, Joseph; Sergi, Consolato

    2015-01-01

    A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis. We identified some suggested implementation strategies relevant for marketing to enhance companies’ own R&D strategies; such as reliability of companies on “sourcing-in” R&D facilities and “think-tank” events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework. PMID:25946935

  4. Reducing systems biology to practice in pharmaceutical company research; selected case studies.

    PubMed

    Benson, N; Cucurull-Sanchez, L; Demin, O; Smirnov, S; van der Graaf, P

    2012-01-01

    Reviews of the productivity of the pharmaceutical industry have concluded that the current business model is unsustainable. Various remedies for this have been proposed, however, arguably these do not directly address the fundamental issue; namely, that it is the knowledge required to enable good decisions in the process of delivering a drug that is largely absent; in turn, this leads to a disconnect between our intuition of what the right drug target is and the reality of pharmacological intervention in a system such as a human disease state. As this system is highly complex, modelling will be required to elucidate emergent properties together with the data necessary to construct such models. Currently, however, both the models and data available are limited. The ultimate solution to the problem of pharmaceutical productivity may be the virtual human, however, it is likely to be many years, if at all, before this goal is realised. The current challenge is, therefore, whether systems modelling can contribute to improving productivity in the pharmaceutical industry in the interim and help to guide the optimal route to the virtual human. In this context, this chapter discusses the emergence of systems pharmacology in drug discovery from the interface of pharmacokinetic-pharmacodynamic modelling and systems biology. Examples of applications to the identification of optimal drug targets in given pathways, selecting drug modalities and defining biomarkers are discussed, together with future directions. PMID:22161355

  5. [Production of autologous keratinocytes for therapeutic purposes within a pharmaceutical company].

    PubMed

    Guillot, F L

    2001-01-01

    Because biotechnologies are growing and are becoming key players in the pharmaceutical industry scene, Genévrier Laboratories inaugurated in January 1998, a new department especially designed for the production of cultured cells as therapeutic agents. Meeting clinician therapeutic needs by providing autologous keratinocytes and chondrocytes in the near future, represents the primary aim of the Biotechnology department. Concrete cell-based products are already being used for the treatment of burns and cutaneous chronic wounds such as the EPIBASE graft, which corresponds to an epidermis sheet composed of cultured autologous keratinocytes. PMID:11530505

  6. An analysis of the relationship between staff qualification and export readiness of pharmaceutical companies: the case of iran.

    PubMed

    Mohammadzadeh, Mehdi

    2012-01-01

    Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceutical companies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them. PMID:24250528

  7. An Analysis of the Relationship Between Staff Qualification and Export Readiness of Pharmaceutical Companies: The Case of Iran

    PubMed Central

    Mohammadzadeh, Mehdi

    2012-01-01

    Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceutical companies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them. PMID:24250528

  8. Menstrual disturbances and hormonal changes in women workers exposed to a mixture of organic solvents in a pharmaceutical company

    PubMed Central

    Hassani, Somayeh; Namvar, Mohamad; Ghoreishvandi, Maryam; Attarchi, Mirsaeed; Golabadi, Majid; Seyedmehdi, Seyed Mohammad; Khodarahmian, Mahshad

    2014-01-01

    Background: Chemicals are among risk factors that can affect women's reproductive system. This study is aimed to investigate the association of occupational exposure to a mixture of organic solvents with menstruation disturbances and hormonal changes among female workers. Methods: Female workers of a pharmaceutical company were divided into three groups of non-exposed, lowexposed and highly-exposed to a mixture of organic solvents (formaldehyde, phenol, N-hexane, and chloroform) based on workplace measurements. Menstrual disturbances (in terms of short cycles, long cycles, irregular cycles, and bleeding or spotting between periods) and mean of hormone levels (including follicle stimulating hormone, luteinizing hormone, thyroid stimulating hormone, prolactin, estrogen and progesterone levels) were compared between these three groups. For investigating associations, logistic regression was performed. Results: Our study showed that mean length of cycles, duration of bleeding, and amount of flow and also prevalence of long cycles, irregular cycles, and bleeding or spotting between periods were higher in exposed groups (p≤0.05). Odds ratio for prevalence of menstrual disturbances in the low exposure group and high exposure group were 9.69 (p=0.001) and 3.40 (p=0.002) respectively compared to the reference group. Estrogen and progesterone levels were not affected (p> 0.05), but other hormones levels were significantly disturbed in the exposed groups compared with the non-exposed group (p=0.001). Conclusion: Occupational exposure to the mixture of organic solvents may be associated with the increase of menstrual disorders and hormonal changes in female workers. Based on our findings, periodic evaluation of reproductive system of female workers in pharmaceutical companies is recommended. PMID:25695014

  9. Characteristics of physicians receiving large payments from pharmaceutical companies and the accuracy of their disclosures in publications: an observational study

    PubMed Central

    2012-01-01

    Background Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors concurrent publications. Methods The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. Results These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. Conclusions With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database. PMID:23013260

  10. [Attractiveness of France for international clinical trials in 2012: 6(th) survey assessed by Leem (French association of pharmaceutical companies)].

    PubMed

    Lassale, Catherine; Sibenaler, Claire; Bhier, Jehan-Michel; Barthlmy, Philippe; Pltan, Yannick; Courcier, Soizic

    2013-01-01

    Since 2002, the Leem (French Association of Pharmaceutical Companies) has conducted a survey every two years to update the attractiveness of France for international clinical trials. Thirty companies (68% of the French market) have participated in this 6(th) survey which involved 79 countries, a greater number of Phases I/II, II and III studies (420 versus 352 in 2010), a relatively stable number of included patients (246,895 versus 249,704 in 2010) and a greater number of centers (32,965 versus 24,337 in 2010). The evolution of time-lines for the go-ahead by French Authorities is heterogeneous (shorter time-lines by the French National Agency of Drug and Health Products Safety [ANSM] but longer time-lines by Research Ethics Comittees [CPP]). The time-lines for first hospital contracts remain stable. France ranks at an average position among European countries in regards to quantitative and qualitative data, and its state-of-art in early stages is still recognized. Its good performance in oncology and orphan diseases are major assets of competitiveness. PMID:23484655

  11. Confessions of a pharmaceutical company: voice, narrative, and gendered dialectics in the case of Gardasil.

    PubMed

    Malkowski, Jennifer

    2014-01-01

    Despite the fact that both men and women carry the human papillomavirus (HPV) and jointly contribute to its status as an epidemic, the promotion of Gardasil, a vaccine that blocks infection from four strains of HPV, has largely been designated as a women's-only health issue. The following case study contributes to ongoing efforts in the field of health communication to identify problematic assumptions informing contemporary health policy and practices. Specifically, I analyze how Merck Pharmaceuticals, the creator of Gardasil, strategically imbues direct-to-consumer advertisements with contradiction to preserve traditional notions of both women and medicine. I found that three gendered dialectics characterize Merck's efforts to invoke complacency among female consumers: public/secret, education/ignorance, and structured/individualist. In the case of the HPV vaccination, the implications of these dialectics are the perpetuation of complacency among female audiences that threatens both the success of this particular technology and the overall status of women and health. In line with conclusions offered by Thompson (2010a), this study extends a call for health and communication scholars to continue to deconstruct dominant medical discourses and presents possibilities for re-storying narratives that mediate women's experiences with health. PMID:23402269

  12. Superparamagnetic iron oxide nanoparticles for MRI: contrast media pharmaceutical company R&D perspective.

    PubMed

    Corot, Claire; Warlin, David

    2013-01-01

    Superparamagnetic iron oxide (SPIO) nanoparticles are a relatively large class of contrast agents for magnetic resonance imaging. According to their biodistribution, distinct classes of SPIO nanoparticles have been investigated for clinical applications either as macrophage imaging agents or blood pool agents. Contrast agents which are pharmaceutics followed the same development rules as therapeutic drugs. Several drawbacks such as clinical development difficulties, organization of market access and imaging technological developments have limited the widespread use of these products. SPIO nanoparticles that are composed of thousands iron atoms providing large T2* effects are particularly suitable for theranostic. Stem cell migration and immune cell trafficking, as well as targeted SPIO nanoparticles for molecular imaging studies are mainly at the stage of proof of concept. A major economic challenge in the development of molecular imaging associated with a therapeutic treatment/procedure is to define innovative business models compatible with the needs of all players taking into account that theranostic solutions are promising to optimize resource allocation and ensure that expensive treatments are prescribed to responding patients. PMID:23633290

  13. [(Mis)information on drugs: the double standard practiced by pharmaceutical companies].

    PubMed

    Barros, J A

    2000-01-01

    Different factors have been identified as influencing drug prescribers. Some studies emphasize the role played by sources of information available to physicians. Reports have been published on the influence of marketing strategies on these health professionals. Such strategies include advertisements in medical journals, sales representatives, free samples, leaflets, distribution of gifts and prizes, etc. The research reported here aimed to identify information provided by a commonly used Brazilian prescription handbook, the Dicionário de Especialidades Farmacêuticas (DEF), in relation to the 44 most frequently sold pharmaceutical products in Brazil, using as parameters the WHO guidelines for information to be included in informative materials offered to physicians. The information was then compared to that included in the PDR (Physicians' Desk Reference) and USP-DI (Drug Information for the Health Care Professional) used by prescribers in the United States. The results showed lack of data in the Brazilian publication (contraindications, side effects, drug interaction), suggesting lack of reliability in prescription quality and thus in the ultimate utilization of drugs. PMID:10883040

  14. A study on the interactions of doctors with medical representatives of pharmaceutical companies in a Tertiary Care Teaching Hospital of South India

    PubMed Central

    Gupta, Sandeep Kumar; Nayak, Roopa P.; Sivaranjani, R.

    2016-01-01

    Background: The promotional activities by medical representatives (MRs) of the pharmaceutical companies can impact the prescribing pattern of doctors. Hence, the interaction between doctors and the pharmaceutical industry is coming under increasing scrutiny. Objective: The primary objective was to assess the attitude of the doctors toward the interaction with the MRs of the pharmaceutical company. The secondary objective was to assess the awareness of the doctors about regulations governing their interaction with the pharmaceutical company. Materials and Methods: This was a cross-sectional study. This study was carried out using a pretested questionnaire containing 10 questions between June and September 2014. The doctors working in the Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur (Tamil Nadu) during the study period was included. Results: A total of 100 pretested questionnaires were distributed, and 81 doctors responded (response rate 81%). 37% doctors responded that they interacted with MR once a week whereas 25.9% told that they interact with MRs twice a month. About 69.1% doctors think that MR exaggerate the benefits of medicines and downplays the risks and contraindications of medicine(P = 0.000). 61.7% doctors think that MR has an impact on their prescribing (P = 0.000). 63% doctors stated that they had received promotional tools such as stationery items, drug sample, textbooks or journal reprints from MR in last 12 months (P = 0.0012). Unfortunately, 70.4% doctors have not read the guidelines about interacting with the pharmaceutical industry or its representative (P = 0.000). Conclusion: Rather than forbidding any connection between doctors and industry, it is better to establish ethical guidelines. The Medical Council of India code is a step in the right direction, but the majority of doctors in this study have not read the guidelines about interacting with the pharmaceutical industry or its representative. PMID:26957869

  15. Evaluating the reliability and accuracy of the promotional brochures for the generic pharmaceutical companies in Iraq using World Health Organization guidelines

    PubMed Central

    Mikhael, Ehab Mudher

    2015-01-01

    Background: Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. Physician targeted promotion through medical representatives is one of the most common tactic for drug promotion by pharmaceutical drug companies. WHO states that medical representatives to work in an ethical way should make available to prescribers and dispensers complete and unbiased information for each product discussed; therefore this study aimed to evaluate the ethics in the medical brochures of generic pharmaceutical companies that are given through medical representatives to physicians in Iraq. Materials and Methods: An observational, cross-sectional study was conducted in Iraq – Baghdad from February to April 2014. Promotional drug brochures were collected mainly from pharmaceutical exhibition during attendance of medical conferences that were sponsored by generic pharmaceutical companies. Evaluation of each brochure was based primarily on WHO criteria for ethical medicinal drug promotion. The availability of emotional pictures in each brochure was also examined. Furthermore, references were checked to find their retrievability, source, and authenticity of presentations. Results: Most medical brochures were for antibiotics, and drugs for cardiovascular diseases. All brochures mention drug name, with its active ingredient and indication, but there is a significant absence for drug interaction, while drug side effects and contraindications if present were written in a small font. Emotional picture presented in 70% of brochures. Reference citation was present in 72% of brochures, however only 75% of references in these brochures were correct. Conclusions: The information that is provided in medical brochures is biased and mainly persuasive since it is mainly focusing on the positive aspect of drug therapy. PMID:25709340

  16. Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

    PubMed

    Beran, Roy G

    2004-01-01

    Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal obligations were addressed in a fashion which allowed the conduct of a trial adopting a proven methodology but novel infrastructure such that it was a totally independent study with regards conduct and reporting of final data, irrespective of the results being either positive or negative. This may represent a more acceptable way to ensure that future clinical trials are devoid of undue influence from the pharmaceutical industry which may still fund the study. PMID:15685926

  17. Public administration and R&D localisation by pharmaceutical and biotech companies: a theoretical framework and the Italian case-study.

    PubMed

    Jommi, Claudio; Paruzzolo, Silvia

    2007-04-01

    This article has two objectives. It firstly provides a general framework for variables that influence R&D (Research and Development) localisation by pharmaceutical and biotech companies. The analysis of R&D localization includes both in-house R&D and contracted R&D. Following a systematic literature search, these variables were classified into four distinct categories: regulatory environment, institutional framework, national systems of innovation and local development and specialisation. The authors highlight that some of these factors directly depend on the action of public administrations (e.g., patent protection, price regulation, public investments in research, and incentives to private companies); others are indirectly influenced by public policies (e.g., GDP growth rate, infrastructures). This theoretical framework was used to analyse the Italian case-study. Pros and cons of the Italian context were investigated from the point of view of multinational pharmaceutical companies and the Italian Association of Biotech Companies. Interviews were chosen as the most appropriate data gathering technique given the exploratory nature of the study of the Italian context. The paper is divided into five parts. A brief introduction provides figures showing that Europe has been loosing positions compared with other Continents and the same has occurred in Italy compared with other EU countries. The second one illustrates the methodology. The third one is focused on variables affecting R&D localisation. In the fourth section the Italian case-study is discussed. Theoretical and empirical findings are summarised and discussed in the conclusions. PMID:16824641

  18. Developing a suitable model for supplier selection based on supply chain risks: an empirical study from Iranian pharmaceutical companies.

    PubMed

    Mehralian, Gholamhossein; Rajabzadeh Gatari, Ali; Morakabati, Mohadese; Vatanpour, Hossein

    2012-01-01

    The supply chain represents the critical link between the development of new product and the market in pharmaceutical industry. Over the years, improvements made in supply chain operations have focused largely on ways to reduce cost and gain efficiencies in scale. In addition, powerful regulatory and market forces have provided new incentives for pharmaceutical firms to basically rethink the way they produce and distribute products, and also to re-imagine the role of the supply chain in driving strategic growth, brand differentiation and economic value in the health continuum. The purpose of this paper is to formulate basic factors involved in risk analysis of pharmaceutical industry, and also determine the effective factors involved in suppliers selection and their priorities. This paper is based on the results of literature review, experts' opinion acquisition, statistical analysis and also using MADM models on data gathered from distributed questionnaires. The model consists of the following steps and components: first factors involved in to supply chain risks are determined. Based on them a framework is considered. According the result of statistical analysis and MADM models the risk factors are formulated. The paper determines the main components and influenceial factors involving in the supply chain risks. Results showed that delivery risk can make an important contribution to mitigate the risk of pharmaceutical industry. PMID:24250442

  19. Developing a Suitable Model for Supplier Selection Based on Supply Chain Risks: An Empirical Study from Iranian Pharmaceutical Companies

    PubMed Central

    Mehralian, Gholamhossein; Rajabzadeh Gatari, Ali; Morakabati, Mohadese; Vatanpour, Hossein

    2012-01-01

    The supply chain represents the critical link between the development of new product and the market in pharmaceutical industry. Over the years, improvements made in supply chain operations have focused largely on ways to reduce cost and gain efficiencies in scale. In addition, powerful regulatory and market forces have provided new incentives for pharmaceutical firms to basically rethink the way they produce and distribute products, and also to re-imagine the role of the supply chain in driving strategic growth, brand differentiation and economic value in the health continuum. The purpose of this paper is to formulate basic factors involved in risk analysis of pharmaceutical industry, and also determine the effective factors involved in suppliers selection and their priorities. This paper is based on the results of literature review, experts’ opinion acquisition, statistical analysis and also using MADM models on data gathered from distributed questionnaires. The model consists of the following steps and components: first factors involved in to supply chain risks are determined. Based on them a framework is considered. According the result of statistical analysis and MADM models the risk factors are formulated. The paper determines the main components and influenceial factors involving in the supply chain risks. Results showed that delivery risk can make an important contribution to mitigate the risk of pharmaceutical industry. PMID:24250442

  20. Ecotoxicity of raw and treated effluents generated by a veterinary pharmaceutical company: a comparison of the sensitivities of different standardized tests.

    PubMed

    Maselli, Bianca de S; Luna, Luis A V; Palmeira, Joice de O; Tavares, Karla P; Barbosa, Sandro; Beijo, Luiz A; Umbuzeiro, Gisela A; Kummrow, Fábio

    2015-05-01

    Pharmaceutical effluents have recently been recognized as an important contamination source to aquatic environments and the toxicity related to the presence of antibiotics in effluents has attracted great attention. Conventionally, these effluents have been treated using physico-chemical and aerobic biological processes, usually with low rates of pharmaceuticals removal. Due to the complexity of effluents, it is impossible to determine all pharmaceuticals and their degradation products using analytical methods. Ecotoxicity tests with different organisms may be used to determine the effect level of effluents and thus their environmental impacts. The objective of this work was to compare the sensitivities of five ecotoxicity tests using aquatic and terrestrial organisms to evaluate the toxicity of effluents from the production of veterinary medicines before and after treatment. Raw and chemically treated effluent samples were highly toxic to aquatic organisms, achieving 100,000 toxic units, but only few of those samples presented phytotoxicity. We observed a reduction in the toxicity in the biologically treated effluent samples, which were previously chemically pre-treated, however the toxicity was not eliminated. The rank of test organisms' reactions levels was: Daphnia similis > Raphidocelis subcapitata > Aliivibrio fischeri > Allium cepa ~ Lactuca sativa. Effluent treatment employed by the evaluated company was only partially efficient at removing the effluent toxicity, suggesting potential risks to biota. The acute toxicity test with D. similis proved to be the most sensitive for both raw and treated effluents and is a suitable option for further characterization and monitoring of pharmaceutical effluents. PMID:25682103

  1. [Findings from a questionnaire survey on new guidelines for preparing Drug Guide for Patients and a perspective from a pharmaceutical company as the information provider].

    PubMed

    Asada, Kazuhiro

    2015-01-01

    Draft versions of two products of based on a "Drug Guide for Patients" have been prepared the guidelines proposed in "Research on risk communication between patients and healthcare professionals regarding information on safety measures for drugs, etc." by Health and Labour Sciences Research Grants. We conducted a questionnaire survey on the draft to identify issues regarding the contents and their preparation from the viewpoint of pharmaceutical companies as authors. The questionnaire results indicated that, the segments of the contents of the "Drug Guide for Patients" based on the new guidelines are generally acceptable. In this paper, the author offers proposals to address issues regarding the preparation of easy-to-read contents for patients and strategies to promote the overall understanding recognition of Drug Guide for Patients. Drug Guide for Patients are expected to be utilized as materials providing information to be used for routine risk minimization activities of the Risk Management Plan in the future. PMID:25747228

  2. Ovation Pharmaceuticals, Inc.

    PubMed

    Deutsch, Barry

    2002-11-01

    Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceutical company in August 2002. PMID:12437486

  3. Herbicide and pharmaceutical relationships

    Technology Transfer Automated Retrieval System (TEKTRAN)

    For many years, virtually all pharmaceutical companies had an agrochemical division. This was partly to maximize the benefits of expensive chemical synthesis efforts by searching for many types of useful biological activities. Leads for pharmaceuticals and pesticides often overlap, in some cases l...

  4. Effect of mergers and acquisitions on drug discovery: perspective from a case study of a Japanese pharmaceutical company.

    PubMed

    Shibayama, Sotaro; Tanikawa, Kunihiro; Fujimoto, Ryuhei; Kimura, Hiromichi

    2008-01-01

    The pharmaceutical industry has experienced intermittent waves of mergers and acquisitions (M&As) since the 1980s and recently appeared to be in yet another wave. Previous studies indicated rather negative impacts of consolidation on research and development, suggesting that they do not necessarily lead to long-term reinforcement of research capabilities, although they may enrich the drug pipeline in the short term. However, recent studies have implied a positive side in terms of knowledge-base transfer. Further micro-organizational studies suggested that scientists learned new knowledge and approaches from partner scientists and improved their performance and innovation. These findings imply that measures for the scientist-level integration after M&As would reinforce fundamental research capabilities in the long term. PMID:18190869

  5. Planning and analysis of repeated measures at key time-points in clinical trials sponsored by pharmaceutical companies.

    PubMed

    Shih, W J; Quan, H

    1999-04-30

    In this paper we explore the possible reasons why medical papers reporting clinical trials sponsored by the pharmaceutical industry often analyse repeated measures data at certain key time-points instead of employing sophisticated models of repeated measures proposed by many statisticians. A survey indicated that the priority reason in the industry for having repeated measures in clinical trials is to monitor the trial and to utilize the early results for strategic decision making. We discuss what the common statistical methods do and do not offer for analysis of repeated measures in such clinical trials. We advocate the need to improve the understanding of the medical interest in conducting longitudinal trials in the industry, and to plan and analyse the repeated measures accordingly. We address the medical interest by formulating the problem and give illustrative examples for both phases II and III trials. PMID:10363334

  6. Application of chiral technology in a pharmaceutical company. Enantiomeric separation and spectroscopic studies of key asymmetric intermediates using a combination of techniques. Phenylglycidols.

    PubMed

    McConnell, Oliver; He, Yanan; Nogle, Lisa; Sarkahian, Ani

    2007-09-01

    Phenylglycidols substituted in the 2-, 3-, and 4- positions with fluorine, chlorine, and trifluoromethyl, and with methoxy in the 3- position, were synthesized from the corresponding E-cinnamic acids and separated into their (R,R)- and (S,S)- enantiomers using subcritical fluid chromatography with mixtures of MeOH in CO(2), on either a Chiralpak AD or AS chiral stationary phase. These compounds and commercially-available (R,R)- and (S,S)-phenylglycidol were analyzed for their vibrational circular dichroism (VCD), electronic circular dichroism (ECD), and optical rotation (OR) properties to exemplify a strategy whereby the absolute stereochemistry of common and key chiral intermediates is established early in the structure-activity and structure-property relationship phase of a drug discovery program in a pharmaceutical company. From this study, substituents in the phenyl group of the synthesized molecules were found not to grossly alter spectroscopic features, and therefore, diagnostic absorption bands in the respective VCD spectra, and the sign and shape of the measured ECD curves could be used to determine and track the absolute stereochemistry of analogs without necessarily requiring time-consuming ab initio calculations of all low energy conformers for all compounds. VCD, OR, and ECD calculations for the determination of absolute configuration carried out at the DFT level with the hybrid B3PW91 functional and the TZVP basis set were found to be especially useful in this study. PMID:17323324

  7. What drives success for specialty pharmaceuticals?

    PubMed

    Gudiksen, Mark; Fleming, Edd; Furstenthal, Laura; Ma, Philip

    2008-07-01

    Specialty pharmaceuticals have become increasingly important in the global pharmaceutical landscape. Numerous large pharmaceutical companies are moving towards developing therapies for specialty markets, which are attractive owing to factors including the established commercial track record and lower commercial infrastructure costs. In this article, we analyse the key drivers of commercial success and failure for specialty pharmaceuticals. PMID:18535582

  8. India's pharmaceutical industry: hype or high tech take-off?

    PubMed

    Malhotra, Prabodh; Lofgren, Hans

    2004-11-01

    India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fully-fledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets. PMID:15527398

  9. Sulfite-containing Canadian pharmaceutical products available in 1991.

    PubMed Central

    Miyata, M; Schuster, B; Schellenberg, R

    1992-01-01

    OBJECTIVE: To compile an inclusive list of Canadian pharmaceutical products available in 1991 that contained sulfites. DATA SOURCES: Written and oral responses from 94 pharmaceutical companies selected from the 1989 Compendium of Pharmaceuticals and Specialties. RESULTS: A list of sulfite-containing pharmaceutical products was compiled from data supplied by the 90 responding companies. Companies whose products contained no sulfites were separately identified. CONCLUSIONS: Sulfites are present in many pharmaceutical products and are one of many excipients and additives that have been reported to cause severe adverse reactions. The provided list should be a useful aid for health care practitioners when prescribing pharmaceutical products for sulfite-sensitive patients. PMID:1483237

  10. Doctors and pharmaceutical industry.

    PubMed

    Beran, Roy G

    2009-09-01

    The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine. PMID:20157968

  11. Reducing pharmaceutical risk.

    PubMed

    Spilker, B

    1998-08-01

    This article describes several types of risk encountered in drug discovery, development and marketing, as well as the overall business risks in the pharmaceutical industry. Discovery risk refers to the risk companies face if they are partly or totally dependent on discovering new drugs; many avenues are presented for companies to pursue in order to decrease discovery risk. Development risk is defined as the risk that drug discoveries that enter development will not reach the market and become commercially viable drugs. To decrease development risk, it is possible to pursue one or more of the approaches presented. Significant marketing risks for a company include that the sales forecasts will not be met, the positioning of a drug may not be correct or optimal and the sales force is not performing adequately. At the corporate level there are numerous major risks involved in pursuing the specific mission, objectives, strategies and tactics of the overall company as well as those in the functional areas. Many aspects of the company's business can be adjusted or changed to decrease corporate risk. Selected issues concerning risk include venture capital funds, the appetite for risk within a company and the influence of senior and middle level managers' personalities on risk. PMID:15616620

  12. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  13. Pharmaceutical new product development: the increasing role of in-licensing.

    PubMed

    Edwards, Nancy V

    2008-12-01

    Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician. PMID:19041620

  14. Vulnerabilities to misinformation in online pharmaceutical marketing

    PubMed Central

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2013-01-01

    Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

  15. [The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

    PubMed

    Sihn, Kyu-Hwan

    2015-12-01

    After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for vitamins and health tonics showed particularly explosive growth. As Korean industrial workers worked night and day to increase exports in the 1960s, they needed vitamins and health tonics for recovery from fatigue and to support vitality. The expansion of the general pharmaceuticals market was accompanied by increases in numbers of pharmaceutical companies. Competition intensified between pharmaceutical companies, leading some companies to search for new survival plans. The pharmaceutical industry underwent structural reform in 1960s, replacing imported medical substances with local products and inventing the new market of general pharmaceuticals. The market for vitamins and health tonics was increased, and a successful product could support a pharmaceutical company. On the contrary, a general pharmaceutical could affect the very existence of the company: if a company chased a popular product and the imitation bubble burst, then the company have lost its competitiveness in the world market. PMID:26819439

  16. The undiscovered Argentine pharmaceutical market.

    PubMed

    Felix, P F; Thomas, R K; Pol, L G

    2001-01-01

    The Argentine health care system is more highly developed than most systems in Latin America and gives most of its citizens access to a reasonable level of care. Now after 50 years of government control the system is becoming privatized, which provides new possibilities for health care marketers. One company developed an innovative approach to pharmaceutical marketing in Argentina that, while perhaps not appropriate for the U.S. market, may reap rewards in certain cultures and provide lessons for others. PMID:11763647

  17. Pharmacovigilance in pharmaceutical companies: An overview.

    PubMed

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-12-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs). PMID:24347978

  18. Managing pharmaceutical sales activities in an academic anesthesiology department.

    PubMed

    Johnstone, R E; Valenzuela, R C; Sullivan, D

    1995-09-01

    To contain costs, departments of anesthesiology must control the use of new, expensive drugs. Conflicts with pharmaceutical companies can arise when they promote drug sales. Pharmaceutical company sales represent anesthesiology department expenses. Anesthesiologists hold diverse opinions on this clash of interests, on the proper roles of pharmaceutical sales representatives in anesthesiology departments, and on the ethics of accepting industry gifts. Our department has managed pharmaceutical sales activities by encouraging discussion of the ethics and legal limits of industry gifts, by banning sales representatives from bringing food into the department, and by adopting The American Medical Association Guidelines on Gifts. PMID:8534476

  19. Internet pharmaceutical sales: attributes, concerns, and future forecast.

    PubMed

    Bruckel, Katy; Capozzoli, Ernest A

    2003-01-01

    Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters. PMID:15683019

  20. Pharmaceutical Analysis as a Branch of Pharmaceutics

    ERIC Educational Resources Information Center

    Connors, Kenneth A.

    1977-01-01

    Pharmaceutical analysis is incorporated into the pharmaceutics component of the undergraduate curriculum at the University of Wisconsin. Many collaborative demonstrations, lectures, and laboratory experiments can illustrate the close relationship between analysis and modern pharmacy practice. (Author/LBH)

  1. Pharmaceutical industry scoping study. Final report

    SciTech Connect

    1998-06-01

    This scoping study provides a worldwide overview of the pharmaceutical industry with emphasis on the US, which dominates the market. It is a comprehensive reference developed to help utilities and energy service providers focus their efforts on good business opportunities in this very profitable industry. The objectives were to characterize the pharmaceutical industry and the ideal technologies that specifically target this market segment; and to enable well-equipped utility or energy service account managers to recognize and respond to opportunities and determine which strategies may best suite their company`s marketing objectives.

  2. 77 FR 30028 - Manufacturer of Controlled Substances; Notice of Registration; Cedarburg Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ..., 77 FR 2324, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, made... (8333).. II Fentanyl (9801) II The company plans to manufacture the listed controlled substances in...

  3. The Utilization of Project Management in the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Krusko, Diane; Cangemi, Robert R.

    1987-01-01

    A survey of 99 pharmaceutical companies concerning their organization and use of project management techniques for research and development found that the industry is using project management increasingly in a variety of ways for better business planning and operations. (MSE)

  4. Pharmaceutical supply chain risks: a systematic review

    PubMed Central

    2013-01-01

    Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

  5. Pharmaceutical strategy and innovation: an academics perspective.

    PubMed

    Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

    2007-06-01

    The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences. PMID:17458911

  6. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  7. Information flow in the pharmaceutical supply chain.

    PubMed

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

  8. Information flow in the pharmaceutical supply chain

    PubMed Central

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

  9. Pharmaceutical technology management--profitable business avenue.

    PubMed

    Puthli, Shivanand P

    2010-01-01

    Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business. PMID:20017657

  10. RFID in the pharmaceutical industry: addressing counterfeits with technology.

    PubMed

    Taylor, Douglas

    2014-11-01

    The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity. PMID:25308613

  11. Exposure of Medical Students to Pharmaceutical Marketing in Primary Care Settings: Frequent and Influential

    ERIC Educational Resources Information Center

    Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

    2009-01-01

    It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts.…

  12. Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research.

    PubMed

    Orzan, G; Zara, I A; Purcarea, V L

    2012-12-15

    Recent years have seen an "explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer's thoughts and tailor specific marketing messages. PMID:23346245

  13. [E-commerce of pharmaceuticals].

    PubMed

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications. PMID:12803063

  14. The Development of a Generic Pharmaceutical Training Institute.

    ERIC Educational Resources Information Center

    Lindeman, Lynn William; Boerner, Hank

    The manufacture of generic drugs is a growing industry, generally composed of small companies that are more dependent than brand-name companies on hiring entry-level workers. To provide standardized training for employees in the generic drug manufacturing field, the Generic Pharmaceutical Training Institute (GPTI) was established by a partnership…

  15. A new e-beam application in the pharmaceutical industry

    NASA Astrophysics Data System (ADS)

    Sadat, Theo; Malcolm, Fiona

    2005-10-01

    The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a "miniature" low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned.

  16. [The aspects of pricing policy in Azerbaijan pharmaceutical sector].

    PubMed

    Dzhalilova, K I; Alieva, K Ia

    2012-01-01

    The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers. PMID:22392783

  17. GMK (Progenics Pharmaceuticals).

    PubMed

    Knutson, Keith L

    2002-01-01

    Progenics Pharmaceuticals is developing GMK vaccine (a ganglioside conjugate vaccine coupled to keyhole limpet hemocyanin and formulated with the adjuvant QS-21), licensed from the Memorial Sloan-Kettering Cancer Center, for the potential treatment of melanoma and other cancers [194258], [325284]. It was previously under co-development with Bristol-Myers Squibb, but in May 2001, all rights to the GMK vaccine were returned to Progenics [409168]. It was the first of a new class of ganglioside conjugate vaccine evaluated by Progenics [194258]. GMK vaccination induces antibodies against GM2 ganglioside capable of specifically killing melanoma cells. Melanoma patients with antibodies against GM2 ganglioside have significantly improved disease-free and overall survival compared to antibody-negative subjects. The vaccine is undergoing two phase III trials, the first comparing GMK to high-dose IFNalpha in melanoma patients with more serious disease and at a high risk of relapse, and the second, in collaboration with the European Organization for Research and Treatment of Cancer, comparing GMK (14 doses of GMK over three years) to no treatment other than close monitoring of malignant melanoma patients at immediate risk of relapse [409168]. In February 1999, Lehman Brothers predicted that the vaccine had a 50% probability of reaching market, with an estimated first launch date in 2002. The analysts predicted potential peak sales in 2008 of $150 million in the US and $100 million in the rest of the world at that time [319225]. In January 2000, Lehman Brothers expected that an NDA filing would take place in 2002, with possible launch of the vaccine in 2003. In addition, Lehman Brothers estimated potential peak sales at $500 million [357788]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of GMK and PRO-542 in 2002 [390063]. In July 2001, Ladenburg Thalmann predicted a $257 million market potential for GMK in the US, with the non-US market equivalent to the US market. A launch date of 2005 in the US, with a worldwide launch in 2006, was estimated [433347]. PMID:12054067

  18. Biological and Pharmaceutical Nanomaterials

    NASA Astrophysics Data System (ADS)

    Kumar, Challa S. S. R.

    2006-01-01

    This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.

  19. [Healthy pharmaceutical policy].

    PubMed

    Gonzlez Pier, Eduardo

    2008-01-01

    Today, the pharmaceutical industry is experiencing a profound transition. Globalization and technological advancement represent the principal pressures for change in the market, where it is increasingly more difficult for this type of industry to efficiently recoup the growing cost of innovation. Mexico needs to analyze the policy implications of these change factors and promote, in the pharmaceutical market, policies that maximize health gains on invested resources. Pharmaceutical policy offers a rare example for a complementary approach between a sound health policy and an efficient economic policy; that is, a "healthy pharmaceutical policy." PMID:19082260

  20. Microcap pharmaceutical firms: linking drug pipelines to market value.

    PubMed

    Beach, Robert

    2012-01-01

    This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms. PMID:23971143

  1. Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

    PubMed

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

    This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient. PMID:17970244

  2. Institutional mistrust in the organization of pharmaceutical clinical trials

    PubMed Central

    2010-01-01

    In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. PMID:18633728

  3. Radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

    Dám, A. M.; Gazsó, L. G.; Kaewpila, S.; Maschek, I.

    1996-03-01

    Product specific doses were calculated for pharmaceuticals to be radiation treated. Radio-pasteurization dose were determined for some heat sensitive pharmaceutical basic materials (pancreaton, neopancreatin, neopancreatin USP, duodenum extract). Using the new recommendation (ISO standards, Method 1) dose calculations were performed and radiation sterilization doses were determined for aprotinine and heparine Na.

  4. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale. PMID:26027494

  5. District cooling and thermal storage in pharmaceutical applications

    SciTech Connect

    Strause, R.; Morgan, T.

    1995-12-31

    Many of the guidelines for designing a central or district cooling plant can be applied to the pharmaceutical industry. Most pharmaceutical companies with central cooling plants have operated these plants very inefficiently for many years and these problems are now being addressed by the industry. The Clean Air Act and new tax guidelines have forced the pharmaceutical industry to address their utility costs. This paper will address some of the common problems faced by the industry and describe measures the industry has taken to correct them.

  6. Health reform accelerates changes in the pharmaceutical industry.

    PubMed

    Spatz, Ian D

    2010-07-01

    The Patient Protection and Affordable Care Act makes major changes to the Medicare prescription drug benefit, reducing drug costs for many seniors and increasing rebates and other costs for industry. Although these changes will affect prescription drug costs and pharmaceutical companies' profits, they are unlikely to alter the trends already reshaping the pharmaceutical industry. By participating in crafting health care reform, instead of opposing reform as it did in 1993, the pharmaceutical industry avoided some potential threats to revenues and made accommodations that limited the overall federal costs of reform. PMID:20606183

  7. How pharmaceutical industry funding affects trial outcomes: causal structures and responses.

    PubMed

    Sismondo, Sergio

    2008-05-01

    Three recent systematic reviews have shown that pharmaceutical industry funding of clinical trials is strongly associated with pro-industry results. This article builds on those analyses, situating funding's effects in the context of the ghost-management of research and publication by pharmaceutical companies, and the creation of social ties between those companies and researchers. There are multiple demonstrated causes of the association of funding and results, ranging from trial design bias to publication bias; these are all rooted in close contact between pharmaceutical companies and much clinical research. Given these points, most proposed measures to respond to this bias are too piecemeal to be adequate. PMID:18299169

  8. [Conflict of interest regarding clinical physicians' relationship with pharmaceutical industry and medical education].

    PubMed

    Miyata, Yasushi

    2010-01-01

    The relationship between clinical physicians and the pharmaceutical industry is becoming an important social issue. Many lawsuits against drug companies in the area of psychiatric medicine have been heavily covered by the mass media in the U.S., and the injustices of drug companies and clinical physicians have been revealed in court. Although there are few such large social issues in Japan, the relationship between clinical physicians and the pharmaceutical industry in Japan appears inappropriate. A study on the relationship between Japanese clinical physicians and the pharmaceutical industry revealed that many physicians received "gifts" from pharmaceutical companies. This is one form of evidence for the inappropriate relationship between Japanese physicians and pharmaceutical industries. Recently, many recommendations to realize an appropriate relationship between physicians and the pharmaceutical industry have been published in the U.S. However, discussion concerning the relationship between clinical physicians and pharmaceutical companies in Japan is not active. We have received a lot of financial support for continuing medical education from pharmaceutical industries. Without such support, we may not be able to maintain the same level of medical education. Understanding such present conditions, we need to discuss what is an appropriate relationship between clinical physicians and the pharmaceutical industry. PMID:21226250

  9. [Global health--the ethical responsibility of the pharmaceutical industry].

    PubMed

    Lassen, Lars Christian; Thomsen, Mads Krogsgaard

    2006-09-01

    Health is a global concern and all stakeholders in society--including the pharmaceutical industry--have an ethical responsibility to contribute to promote health. At Novo Nordisk, we have decided to focus on defeating diabetes since this is the area where the company can make the biggest difference. Financial viability goes hand in hand with environmental and social responsibility, not only in the external stakeholder dialogue, but also in the quest for attraction and retention of the best possible staff. Examples of the ethical obligations of a pharmaceutical company are presented, as are classical dilemmas faced by the industry. PMID:16999884

  10. Effective executive management in the pharmaceutical industry.

    PubMed

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

    Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they need vision as well as commitment regarding the unique requirements of the industry. PMID:18972973

  11. Pharmaceutical Industry in Syria

    PubMed Central

    2010-01-01

    The aim of this article is to present the development of the pharmaceutical industry in Syria using national and international public data sources. At the end of the 80ies, the pharmaceutical industry in Syria was very poor, covering 6% of the national needs. In less than 20 years, with the government support in terms of legal frame and strategic political engagement, the Syrian pharmaceutical industry finally covered almost 90% of the national needs, in terms of drugs, and exported drugs in around 52 Arabian countries. Beyond covering the local market, the main added values of this huge development consisted in exporting drugs in amount of 150 million dollars per year and providing jobs for 17000 Syrian people, out of which around 85% are women. Strong and weak points of the pharmaceutical sector are taken into consideration in the article and further interventions to support a sustainable development are proposed by the author. PMID:20945828

  12. Development of an Integrated Performance Measurement (PM) Model for Pharmaceutical Industry

    PubMed Central

    Shabaninejad, Hosein; Mirsalehian, Mohammad Hossein; Mehralian, Gholamhossein

    2014-01-01

    With respect to special characteristics of pharmaceutical industry and lack of reported performance measure, this study tries to design an integrated PM model for pharmaceutical companies. For generating this model; we first identified the key performance indicators (KPIs) and the key result indicators (KRIs) of a typical pharmaceutical company. Then, based on experts᾽ opinions, the identified indicators were ranked with respect to their importance, and the most important of them were selected to be used in the proposed model; In this model, we identified 25 KPIs and 12 KRIs. Although, this model is mostly appropriate to measure the performances of pharmaceutical companies, it can be also used to measure the performances of other industries with some modifications. We strongly recommend pharmaceutical managers to link these indicators with their payment and reward system, which can dramatically affect the performance of employees, and consequently their organization`s success. PMID:24711848

  13. Development of an integrated performance measurement (PM) model for pharmaceutical industry.

    PubMed

    Shabaninejad, Hosein; Mirsalehian, Mohammad Hossein; Mehralian, Gholamhossein

    2014-01-01

    With respect to special characteristics of pharmaceutical industry and lack of reported performance measure, this study tries to design an integrated PM model for pharmaceutical companies. For generating this model; we first identified the key performance indicators (KPIs) and the key result indicators (KRIs) of a typical pharmaceutical company. Then, based on experts᾽ opinions, the identified indicators were ranked with respect to their importance, and the most important of them were selected to be used in the proposed model; In this model, we identified 25 KPIs and 12 KRIs. Although, this model is mostly appropriate to measure the performances of pharmaceutical companies, it can be also used to measure the performances of other industries with some modifications. We strongly recommend pharmaceutical managers to link these indicators with their payment and reward system, which can dramatically affect the performance of employees, and consequently their organization`s success. PMID:24711848

  14. Suitability of polyvinylidene fluoride (PVDF) piping in pharmaceutical ultrapure water applications.

    PubMed

    Burkhart, M; Wermelinger, J; Setz, W; Müller, D

    1996-01-01

    This paper discusses polyvinylidene fluoride (PVDF) as an alternative to stainless steel in pharmaceutical ultrapure water piping systems. Two leading Swiss companies, a piping systems supplier and a pharmaceutical manufacturer, teamed together to jointly carryout the research. Issues addressed are metallic contamination, microbial concerns, piping system functionally and ozone resistance. Comparisons between PVDF and stainless steel are made when necessary. PMID:8810840

  15. Psychiatric Training Program Engagement with the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One

    ERIC Educational Resources Information Center

    Mohl, Paul C.

    2005-01-01

    OBJECTIVE: To analyze the educational and ethical issues involved in interactions between departments of psychiatry and the pharmaceutical industry. METHODS: The author analyzes the history of attitudes toward pharmaceutical companies, various conflicting ethical principles that apply, and areas of confluence and conflict of interest between…

  16. The Joys of Clinical Trials: A Case Study of a Multicenter Pharmaceutical Trial.

    ERIC Educational Resources Information Center

    Soronson, Bryan M.; Shaw, Diana V.

    1994-01-01

    A discussion of clinical trials in the pharmaceutical industry describes typical processes and administrative issues, then presents a case in which a foreign pharmaceutical company negotiated with a university for sponsorship of a multicenter clinical trial of a new drug therapy. Problems and important considerations in clinical trials are…

  17. 76 FR 78258 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ....S.C. Sec. 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. 45, in the market for tretinoin... rights to two pharmaceutical products, Refissa, a branded tretinoin emollient cream, and a generic tretinoin emollient cream, to Spear Pharmaceuticals (``Spear''), the company that owns both products....

  18. Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

    PubMed

    Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

    2013-03-01

    In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. PMID:23339876

  19. Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

    PubMed

    Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

    2014-01-01

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

  20. Racing to define pharmaceutical R&D external innovation models.

    PubMed

    Wang, Liangsu; Plump, Andrew; Ringel, Michael

    2015-03-01

    The pharmaceutical industry continues to face fundamental challenges because of issues with research and development (R&D) productivity and rising customer expectations. To lower R&D costs, move beyond me-too therapies, and create more transformative portfolios, pharmaceutical companies are actively capitalizing on external innovation through precompetitive collaboration with academia, cultivation of biotech start-ups, and proactive licensing and acquisitions. Here, we review the varying innovation strategies used by pharmaceutical companies, compare and contrast these models, and identify the trends in external innovation. We also discuss factors that influence these external innovation models and propose a preliminary set of metrics that could be used as leading indicators of success. PMID:25448753

  1. Ethical pharmaceutical promotion and communications worldwide: codes and regulations

    PubMed Central

    2014-01-01

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

  2. Legal considerations for social media marketing by pharmaceutical industry.

    PubMed

    Yang, Y Tony; Chen, Brian

    2014-01-01

    Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction. PMID:24772685

  3. Intellectual Property and the Pharmaceutical Scientist: An Industry Perspective.

    ERIC Educational Resources Information Center

    Reilly, William J., Jr.

    1989-01-01

    Three issues are discussed: (1) conflict between the pharmaceutical industry and academe; (2) how and why some companies contract their research efforts to colleges; and (3) how colleges can increase their percentage of industry monies available for contract research. (Author/MSE)

  4. Generics market in Greece: the pharmaceutical industry's beliefs.

    PubMed

    Geitona, Mary; Zavras, Dimitrios; Hatzikou, Magda; Kyriopoulos, John

    2006-11-01

    The aim of this study was to investigate the beliefs and perspectives of the pharmaceutical industry on generic medication in Greece. Questionnaires were mailed to all 58 members of the Hellenic Association of Pharmaceutical Companies from November 2002 to February 2003. The response rate was 52%, namely 30 questionnaires were completed and returned. The questionnaire requested information on companies' involvement in generics, their opinion on generics' characteristics and on public policies affecting the demand and supply of generic medication. A descriptive analysis of the outcomes, that is percentage comparison through binomial tests and Fisher tests, was performed. According to our findings, 43% of the respondents were involved in the production and distribution of generics and the mean period of their involvement was 12 years. The majority of the respondents were in favor of their companies' involvement in generics, despite the relatively small market share of generics in Greece; 9.7% of total pharmaceutical market in 2003. Bearing in mind that in Greece the promotion of generics is not encouraged, pharmaceutical companies believe that the mandatory introduction of bioequivalence studies is an indirect promotional strategy towards generics. Additionally, the majority declared that their main competitive advantages are their safety, efficacy and effectiveness as well as their economic benefit to the society. Finally, the respondents expressed their preference for the introduction of pharmacoeconomic submissions for drugs' reimbursement by social insurance funds. PMID:16386326

  5. Impacts of international sanctions on Iranian pharmaceutical market

    PubMed Central

    2013-01-01

    Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients. PMID:23902642

  6. Do cost-sharing and entry deregulation curb pharmaceutical innovation?

    PubMed

    Grossmann, Volker

    2013-09-01

    This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceutical companies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity. PMID:23896384

  7. Impacts of international sanctions on Iranian pharmaceutical market.

    PubMed

    Cheraghali, Abdol Majid

    2013-01-01

    Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients. PMID:23902642

  8. Ethics and pharmaceutical medicine -- the full report of the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK.

    PubMed

    Bickerstaffe, R; Brock, P; Husson, J-M; Rubin, I; Bragman, K; Paterson, K; Sommerville, A

    2006-02-01

    The practice of pharmaceutical medicine brings with it ethical challenges and dilemmas often very different from those encountered in the practice of clinical medicine. Having established a framework of guiding ethical principles, this report aims to look in some detail at specific areas of possible ethical concern to pharmaceutical physicians, offering practical advice and guidance on good practice. The report covers issues related to pharmaceutical research, including dissemination of research findings, communication with other health professionals and patients and involvement of pharmaceutical physicians and companies in the provision of patient services. The primacy of the interests of patients and the wider public is emphasised, and the possible impact of new developments in pharmaceutical technology is explored. It is hoped that the report will help those working in pharmaceutical medicine and act as a stimulus for wider discussion and debate. PMID:16451302

  9. Customer relationship management in the contract pharmaceutical industry: an exploratory study for measuring success.

    PubMed

    Kros, John F; Nadler, Scott; Molis, Justin

    2007-01-01

    Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative. PMID:18048307

  10. Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research

    PubMed Central

    Orzan, G; Zara, IA; Purcarea, VL

    2012-01-01

    Recent years have seen an “explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer’s thoughts and tailor specific marketing messages. PMID:23346245

  11. The Role of Entrepreneurial Activities in Academic Pharmaceutical Science Research

    PubMed Central

    Stinchcomb, Audra L.

    2010-01-01

    Academic pharmaceutical science research is expanding further and further from the University setting to encompass the for-profit private company setting. This parallels the National Institutes of Health momentum to include multiple funding opportunities for University and private company collaboration. It has been recognized that the non-profit and for-profit combination research model can accelerate the commercialization of pharmaceutical products, and therefore more efficiently improve human health. Entrepreneurial activities require unique considerations in the University environment, but can be modeled after the commercialization expansion of the academic healthcare enterprise. Challenges and barriers exist to starting a company as an entrepreneurial faculty member, but the rewards to one's personal and professional lives are incomparable. PMID:20017206

  12. A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran

    PubMed Central

    Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

    2015-01-01

    Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184

  13. EU pharmaceutical expenditure forecast

    PubMed Central

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and Objectives With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Method In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012–2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. Results According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (−€9,367 million), France (−€5,589 million), and, far behind them, Germany (−€831 million), Greece (−€808 million), Portugal (−€243 million), and Hungary (−€84 million). The main source of savings came from the cardiovascular, central nervous system, and respiratory areas and from biosimilar entries. Oncology, immunology, and inflammation, in contrast, lead to additional expenditure. The model was particularly sensitive to the time to market of branded products, generic prices, generic penetration, and the distribution of biosimilars. Conclusions The results of this forecast suggested a decrease in pharmaceutical expenditure in the studied period. The model was sensitive to pharmaceutical policy decisions.

  14. [AIDS and social justice: pharmaceutical industry and economics].

    PubMed

    López Guzmán, José

    2008-01-01

    This article takes a broad look at the complicated framework of relationships between the third world and pharmaceutical companies. In the first part of the work reference is made to the poverty of these countries, their lack of education in terms of health, the scarcity of basic hygiene, and their greatly limited access to medicines, especially those for treating AIDS. The article then proceeds to the issue of the pharmaceutical companies' degree of responsibility for the reduced availability of medicines in certain areas of the world. One of the factors that most limits access to medicines is their price, and many sectors of society propose taking action on the patents of drugs (rescinding or limiting them) in order to lower their price. However, the problem of patent exemption is more complicated than it seems at first glance, and comes with its own risks. If, for lack of funds or the uncertainty concerning a return on the capital invested, pharmaceutical companies discontinue research and development of new drugs, AIDS therapy would worsen. It is imperative and urgent to develop new drugs against the AIDS because of its resistance to the drugs currently available. The article concludes with the pharmaceutical industry's effort to look for possible forms of collaboration with developing countries. PMID:19166259

  15. Systems Medicine in Pharmaceutical Research and Development.

    PubMed

    Kuepfer, Lars; Schuppert, Andreas

    2016-01-01

    The development of new drug therapies requires substantial and ever increasing investments from the pharmaceutical company. Ten years ago, the average time from early target identification and optimization until initial market authorization of a new drug compound took more than 10 years and involved costs in the order of one billion US dollars. Recent studies indicate even a significant growth of costs in the meanwhile, mainly driven by the increasing complexity of diseases addressed by pharmaceutical research.Modeling and simulation are proven approaches to handle highly complex systems; hence, systems medicine is expected to control the spiral of complexity of diseases and increasing costs. Today, the main focus of systems medicine applications in industry is on mechanistic modeling. Biological mechanisms are represented by explicit equations enabling insight into the cooperation of all relevant mechanisms. Mechanistic modeling is widely accepted in pharmacokinetics, but prediction from cell behavior to patients is rarely possible due to lacks in our understanding of the controlling mechanisms. Data-driven modeling aims to compensate these lacks by the use of advanced statistical and machine learning methods. Future progress in pharmaceutical research and development will require integrated hybrid modeling technologies allowing realization of the benefits of both mechanistic and data-driven modeling. In this chapter, we sketch typical industrial application areas for both modeling techniques and derive the requirements for future technology development. PMID:26677181

  16. [Historical sketch of modern pharmaceutical science and technology (Part 4). Post World War II 50 years].

    PubMed

    Yamakawa, K

    1995-01-01

    A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceutical companies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans. PMID:11613536

  17. Vitrase ISTA Pharmaceuticals.

    PubMed

    Czajka, Marcin; Fekrat, Sharon

    2002-04-01

    Vitrase is under development by ISTA Pharmaceuticals Inc (formerly Advanced Corneal Systems, ACS) and Otsuka Pharmaceutical (in Japan) for the potential treatment of vitreous hemorrhage and diabetic retinopathy. In November 1998, it was approved in Mexico for the clearing of vitreous hemorrhage [305542]. In October 1998, Vitrase was designated a Fast-Track product for the vitreous hemorrhage indication by the FDA [303024], [307576]. The initial section of an NDA was filed in January 2002, which comprised the non-clinical pharmacology and toxicology sections [434925]. In April 2002, following discussions with the FDA, ISTA reported that it would be proceeding with the preparation and submission of the clinical and other required sections of the NDA for Vitrase for the treatment of vitreous hemorrhage [447148]. In February 2002, analysts at CIBC World Markets Corp predicted Vitrase would be launched in early 2003, with worldwide sales reaching 200 million dollars within 5 years [444945]. PMID:15565518

  18. [The pharmaceutical record].

    PubMed

    Adenot, I

    2007-09-01

    With a view to improving healthcare quality, an Act of Parliament passed on 13 August 2004 provides for a "Personal Medical Record" (Dossier Médical Personnel, or DMP) for every person in France by 2007. The purposes and interest of this coordination tool are widely understood and accepted. However, its implementation proves highly complex, due to its many legal, human and organisational aspects. Community pharmacists, being totally conversant with IT resources, propose actively to contribute to the DMP by supplying it immediately with pharmaceutical data, through a "Pharmaceutical Record" (Dossier pharmaceutique, or DP). This professional tool, which the National Council of Pharmacists is currently developing, aims to centralise data on all medicines dispensed to each patient, and, subject to strict confidentiality conditions, to make it accessible from any pharmacy. The DP should allow pharmacists soon to meet the objectives set by the law: fighting drug induced accidents and redundant healthcare. By making dispensation more secure and better suited to the individual patient, it should allow medicine traceability right to the patient (another important objective for public health), and support the future evolution of the pharmacist's role. In short, the pharmaceutical record should become an asset for community pharmacist's practice to live up to the demands of healthcare in our time. PMID:17982380

  19. Trade, TRIPS, and pharmaceuticals.

    PubMed

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus. PMID:19167054

  20. Evolving role of pharmaceutical physicians in the industry: Indian perspective.

    PubMed

    Patil, Anant; Rajadhyaksha, Viraj

    2012-01-01

    The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceutical companies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning. PMID:22347701

  1. Evolving role of pharmaceutical physicians in the industry: Indian perspective

    PubMed Central

    Patil, Anant; Rajadhyaksha, Viraj

    2012-01-01

    The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceutical companies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning. PMID:22347701

  2. Impact of antibiotic restrictions: the pharmaceutical perspective.

    PubMed

    Power, E

    2006-08-01

    The development of new antibiotics is dependent on their performance in economic models that favour products with large markets, high levels of potential sales and low development risks. There is a trend toward more severe and more widespread market restrictions for the use of antibiotics, ostensibly to control resistance, though they may be enacted through the control of drug budgets. The restrictions reduce the potential earnings of new antibiotics. In addition, more stringent regulatory procedures increase development costs and risk. As a consequence, compared with drugs for other diseases, particularly chronic diseases, antibiotics perform poorly in economic decision models and are therefore less likely to be selected by pharmaceutical companies for continued development. Overall, this creates a conflict between the twin objectives of controlling resistance through antibiotic restriction and addressing resistance clinically through the introduction of new agents. Ultimately, this may lead to the accelerated loss of efficacy for currently available agents, as we become more dependent on them. Moreover, the new agents that we need to maintain our current levels of health will be lacking in pharmaceutical pipelines. Antibiotic resistance is inevitable; the development of new antibiotics is, however, under threat. Unless the market conditions can be economically rebalanced to encourage innovation and investment, or new models of pharmaceutical development can be applied to this area, the number of companies with active antibiotic research programmes will continue to fall. Just as we should not be complacent regarding the development of resistance, we should not be complacent in assuming that the antibiotics of tomorrow will be there when we need them. PMID:16827822

  3. [Dangerous liaisons--physicians and pharmaceutical sales representatives].

    PubMed

    Granja, Mónica

    2005-01-01

    Interactions between physicians and detailers (even when legitimate ones) raise scientific and ethical questions. In Portugal little thinking and discussion has been done on the subject and the blames for bribery have monopolized the media. This work intended to review what has been said in medical literature about these interactions. How do physicians see themselves when interacting with pharmaceutical companies and their representatives? Do these companies in fact change their prescriptive behaviour, and, if so, how do they change it? How can physicians interact with detailers and still keep their best practice? A Medline research, from 1966 till 2002, was performed using the key-words as follows. A database similar to Medline but concerning medical journals published in Portugal, Index das Revistas Médicas Portuguesas, was also researched from 1992 to 2002. Pharmaceutical companies are profit bound and they allot promoting activities, and detailing in particular, huge amounts of money. Most physicians hold firmly to the belief that they are able to resist and not be influenced by drug companies promotion activities. Nevertheless, all previous works on literature tell us the opposite. Market research also indicates that detailers effectively promote drug sales. Various works also suggest that the information detailers provide to physicians may be largely incorrect, even comparing it to the written information provided by the pharmaceutical companies they work for. The frequency at which portuguese physicians (especially family physicians) contact with pharmaceutical sales representatives is higher than the frequency reported in countries where the available studies come from (namely, Canada and the United States of America). This may put portuguese physicians at a higher risk, making it imperative that work and wide debate are initiated among the class. PMID:16202335

  4. A national survey on the effect of pharmaceutical promotion on medical students.

    PubMed

    Vainiomäki, Maija; Helve, Otto; Vuorenkoski, Lauri

    2004-11-01

    The pharmaceutical industry affects physicians' clinical decision-making, especially their prescribing behaviour. However, little is known of the interactions between medical students and the pharmaceutical industry. The purpose of the present study was to examine the extent and perceived influence of pharmaceutical promotion on Finnish medical students and students' attitudes towards such promotion. Altogether 952 students (34%) responded to an anonymous questionnaire that was distributed to all Finnish medical students at varying levels of study. Students reported that they attended presentations by pharmaceutical company representatives on a frequent basis. A total of 44% attended at least twice a month. Students regarded the pharmaceutical industry as one of their most important sources of pharmaceutical information. The importance attached to pharmaceutical promotion as a source of pharmaceutical information and the intensity of pharmaceutical marketing increased over the course of medical studies. Although most students were not in favour of reducing promotion, the students largely believed that such activities would affect their future prescribing behaviour, and the awareness of this influence increased over the course of studies. The fact that medical students are commonly exposed to pharmaceutical promotion should be addressed in medical education. PMID:15763854

  5. Bolaamphiphiles: A Pharmaceutical Review

    PubMed Central

    Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.

    2014-01-01

    The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179

  6. Pharmaceutical spray freeze drying.

    PubMed

    Wanning, Stefan; Süverkrüp, Richard; Lamprecht, Alf

    2015-07-01

    Pharmaceutical spray-freeze drying (SFD) includes a heterogeneous set of technologies with primary applications in apparent solubility enhancement, pulmonary drug delivery, intradermal ballistic administration and delivery of vaccines to the nasal mucosa. The methods comprise of three steps: droplet generation, freezing and sublimation drying, which can be matched to the requirements given by the dosage form and route of administration. The objectives, various methods and physicochemical and pharmacological outcomes have been reviewed with a scope including related fields of science and technology. PMID:25900097

  7. Taste masking technologies in oral pharmaceuticals: recent developments and approaches.

    PubMed

    Sohi, Harmik; Sultana, Yasmin; Khar, Roop K

    2004-05-01

    Taste is one of the most important parameters governing patient compliance. Undesirable taste is one of several important formulation problems that are encountered with certain drugs. Oral administration of bitter drugs with an acceptable degree of palatability is a key issue for health care providers, especially for pediatric patients. Several oral pharmaceuticals, numerous food and beverage products, and bulking agents have unpleasant, bitter-tasting components. So, any pharmaceutical formulation with a pleasing taste would definitely be preferred over a competitor's product and would translate into better compliance and therapeutic value for the patient and more business and profits for the company. The desire of improved palatability in these products has prompted the development of numerous formulations with improved performance and acceptability. This article reviews the earlier applications and methodologies of taste masking and discusses the most recent developments and approaches of bitterness reduction and inhibition for oral pharmaceuticals. PMID:15244079

  8. Dangerous liaisons: doctors-in-training and the pharmaceutical industry.

    PubMed

    Pokorny, A M J; Gittins, C B

    2015-10-01

    Interaction between doctors and the pharmaceutical industry is long-standing and ingrained in modern practice. Doctors-in-training are at a vulnerable stage of their careers, both in requiring knowledge and forming lasting relationships. There is evidence that limiting contact between industry and junior doctors has a positive effect on subsequent clinical behaviour. Currently in Australia, there is no limitation on pharmaceutical representatives approaching doctors-in-training, and the majority of education sessions are sponsored by pharmaceutical companies. This purposefully creates a sense of reciprocity, which may have adverse long-term consequences on attitudes, behaviours and patient care. Several guidelines exist that may assist junior doctors in navigating these potential interactions, most notably the Royal Australasian College of Physicians' own Guidelines for Ethical Relationships between Physicians and Industry. Despite this, there is no reflection of its importance or necessity within subspecialty curricula. This should be rectified, to the benefit of both the profession and public. PMID:26429220

  9. Mechanochemistry of ibuprofen pharmaceutical.

    PubMed

    Andini, Salvatore; Bolognese, Adele; Formisano, Domenico; Manfra, Michele; Montagnaro, Fabio; Santoro, Luciano

    2012-07-01

    In this paper mechanochemistry has been studied in view of possible application to detoxification of expired pharmaceuticals. The experiments have been carried out with a commercial medication containing ibuprofen ((RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid) which has been submitted to prolonged milling up to 40h. When Al(OH)(3) is used as co-reagent, the first degradation step induced by the mechanochemical treatment is an acid-base reaction with the ibuprofen carboxylic acid group. The subsequent degradation follows a complex pathway leading to 1-(4-isobutylphenyl)ethanone, 1-isobutyl-4-vinylbenzene and 2-(4-(3-methylbutan-2-yl)phenyl)propan-1-ol after 10h milling and, in addition, 1-(4-acetylphenyl)-2-methylpropan-1-one, 1-(4-(1-hydroxy-2-methylpropyl)phenyl)ethanone and 1-(4-(2-hydroxy-2-methylpropyl)phenyl)ethanone after 40h milling. The degradation reaction path and products have been identified by means of FT-IR spectroscopy, thin layer chromatography, NMR spectroscopy, mass spectroscopy and elemental analysis. The observed ibuprofen decarboxylation makes the drug simultaneously lose both its pharmaceutical activity and toxicity. PMID:22472100

  10. The Pharmaceutical Commons

    PubMed Central

    Lezaun, Javier

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. PMID:25866425

  11. Deliquescence of pharmaceutical systems.

    PubMed

    Mauer, Lisa J; Taylor, Lynne S

    2010-12-01

    Deliquescence is a first order phase transition from solid to solution that occurs at a relative humidity (RH) that is characteristic to the crystalline compound. Such dissolution of active pharmaceutical ingredients and excipients can lead to detrimental physical and chemical instabilities. Furthermore, in systems containing more than one deliquescent component, the RH of the solid-solution transition will be lowered, leading to some level of dissolution at unexpectedly low RH conditions. Deliquescence lowering is independent of the ratio of the deliquescent components and therefore is of concern for any formulation containing two or more deliquescent compounds. Because chemical reactions occur much more readily in solution, deliquescence will enhance the degradation of labile APIs. RH fluctuations will lead to cycles of deliquescence and efflorescence (crystallization), which will contribute to particle agglomeration and caking. This review will address the phenomenon of deliquescence, the significance of deliquescence to pharmaceutical systems, measurement techniques, the kinetics and thermodynamics of deliquescence, the behavior of mixtures of deliquescent compounds (including phase diagrams and thermodynamics of binary systems), and consequences of deliquescence on chemical and physical stability. PMID:19895256

  12. Report raises questions about drug companies advertising budgets.

    PubMed

    1999-08-01

    A report by AIDS Action cites that data, indicates the pharmaceutical industry is spending more resources on marketing and advertising than on research and development (R&D). The pharmaceutical industry blames the high cost of AIDS drugs on R&D information compiled from annual reports and industry publications show excessive marketing as the source. A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) disputes the information in the AIDS Action report as misleading. According to PhRMA, research spending has been steadily increasing, and at a greater rate than any other industry. In addition, PhRMA noted that pharmaceutical companies have already dedicated money to fund initiatives in developing countries. Solutions proposed by AIDS Action include lowering drug prices or transferring funds from marketing to research, and reestablishing the "reasonable pricing clause" between National Institutes of Health and those companies seeking tax breaks for R&D. PMID:11366996

  13. Influence of pharmaceutical marketing on prescription practices of physicians.

    PubMed

    Narendran, Roshni; Narendranathan, M

    2013-01-01

    In India same drug molecules are sold under different brand names by different pharmaceuticals. To persuade the physicians to prescribe their brands pharmaceuticals engage in marketing techniques like giving samples, gifts, sponsoring travel etc. Many countries are striving to reduce the impact of incentives on prescription behaviour. This study explores the influence of pharmaceutical marketing on the prescription practices of doctors in India. There were 103 study subjects - 50 doctors and 53 sales personnel. Data collection was done by a self administered questionnaire. Data were collected on 36 variables which were supposed to influence prescription. The effectiveness of the promotional strategies on prescription behaviour was marked in a seven point Likert scale ranging from "not at all effective" (score=1) to "extremely effective" (score=7). Open ended questions were used to collect qualitative data. Good rapport with the doctor, launch meetings, reputation of the company, quality of the drug and brand names significantly influenced prescription behaviour, while direct mailers, advertisements in journals and giving letter pads and other brand reminders were less effective. Commonly used method of giving samples was not among the twenty most effective methods influencing prescription. Product quality and good company are still factors that influence prescription. Pharmaceutical marketing influences the choice of brands by a physician. The more expensive strategies involved in public relations are more effective. Sending mails and journal advertisements are less effective strategies. How expensive marketing strategies affect cost of the medicines has to be explored further. PMID:24000508

  14. Facing the next challenge of pharmaceutical care: patient noncompliance.

    PubMed

    Bloom, D L

    1996-11-01

    Medication misusage is a costly problem. Fixing the matter will not be easy because it means reshaping pharmaceutical care. Yet, the business reasons for undertaking such an action are compelling. Not only would MCOs and payers reduce expenditures, but drug companies, pharmacists, and pharmacy benefit managers could vitalize their positions in the marketplace. This article proposes how an integrated program might overcome noncompliance. PMID:10162562

  15. Challenges for pharmaceutical industry: new partnerships for sustainable human health.

    PubMed

    Hunter, Jackie

    2011-05-13

    The healthcare burden is increasing in both the developed and the developing world and there is widespread acceptance that the historical pharmaceutical business model is not sustainable. In order to meet the healthcare challenge, companies and academia need to develop new business models to increase the probability of success and decrease the cost of failure. New partnerships have already emerged in the area of neglected diseases and other models for diseases of the developed world are emerging. PMID:21464073

  16. Listening to Lyrica: contested illnesses and pharmaceutical determinism.

    PubMed

    Barker, Kristin K

    2011-09-01

    Fibromyalgia syndrome is a debilitating pain disorder of unknown origins and a paradigmatic contested illness. As with other contested illnesses, the reality of fibromyalgia is disputed by many physicians. Thus, millions of individuals who are diagnosed with fibromyalgia must cope with chronic symptoms as well as medical and public skepticism. In this context, the U.S. Federal Drug Administration's approval of Lyrica, the first prescription medication specifically for the management of fibromyalgia, is of considerable interest. In this paper I examine the cultural logic whereby the existence (and marketing) of an officially approved prescription medication for a condition lends support to the biomedical existence of the condition itself. I label this logic pharmaceutical determinism and argue that it represents an important new phase in the proliferation of contested illness diagnoses. Using the case of Lyrica, I describe the role that pharmaceutical companies and pharmaceuticals themselves play in promoting and legitimating contested diagnoses and validating those who are so diagnosed. Through a narrative analysis of the Lyrica direct-to-consumer advertising campaign and the responses of fibromyalgia sufferers to the introduction and marketing of Lyrica, I demonstrate the symbiotic relationship between the interests of the pharmaceutical industry, contested illness legitimization, and medicalization. I also provide a gender analysis of this relationship, foregrounding how contested illnesses continue to be shaped by their feminization in a cultural context that equates women with irrationality. Finally, I address the consequences and limitations of relying on the pharmaceutical industry for illness validation. PMID:21840638

  17. Pharmaceutical market access in emerging markets: concepts, components, and future

    PubMed Central

    Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

    2014-01-01

    This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

  18. Pharmaceutical sales representatives and the doctor/patient relationship.

    PubMed

    Wall, L Lewis; Brown, Douglas

    2002-09-01

    As marketing efforts by drug companies become more aggressive, physicians are being asked to provide clinical "preceptorships" to pharmaceutical sales representatives. During a "preceptorship" of this type, the company representative spends a day with the physician seeing patients "as an educational experience," and the physician receives an "honorarium" from the drug company in return. We explore the implications of this practice. First, we examine the nature of the doctor/patient relationship and the fiduciary obligations incumbent upon physicians in their role as healers. Second, we examine four interlocking ethical principles-nonmaleficence, beneficence, respect for patient autonomy, and justice-that should govern doctor/patient encounters. Third, we critique several hypothetical scenarios involving individuals who might put forth a claim to enter the doctor/patient relationship (ie, a pharmacist, a social scientist, the husband of the patient, and a pharmaceutical sales representative). We conclude that the practice of providing clinical "preceptorships" to pharmaceutical sales representatives is unjustifiable, is unethical, and should not be permitted. PMID:12220784

  19. Creating knowledge structures in the pharmaceutical industry: the increasing significance of virtual organisation.

    PubMed

    Salazar, A; Howells, J

    2000-01-01

    This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceutical companies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceutical companies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceutical companies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly. PMID:11214458

  20. [Early achievements of the Danish pharmaceutical industry-6 Pharmacia].

    PubMed

    Grevsen, Jørgen V; Kruse, Edith; Kruse, Poul R

    2014-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The Upjohn Company under the name of Pharmacia & Upjohn. In 2000 this company was merged with the chemical group Monsanto under a new name, Pharmacia Corporation. Pharmacia Corporation was taken over by Pfizer in 2003. The early activities of A/S Pharmacia included not only the import of raw materials and ready-made articles, such as medicinal products, but also the manufacture of own medicinal products. This is not surprising considering the founder Edward Jacobsen's pharmaceutical career. Pharmacia's early manufacture of own medicinal products consisted mainly of generics, however, not only the expensive foreign medicinal products, but also any available Danish generics such as easily manufactured pharmacopeia products. It is thus worth mentioning that Pharmacia's own technological production capacity at that time was limited and required a cooperation with other (Danish) pharmaceutical companies. Pharmacia was able to produce tablet cores, but the sugarcoating had to be made by external business partners. Pharmacia was able to produce digitalis preparations, but the standardization of these had to be effected elsewhere. The total production of one of Pharmacia's products took place at an external business partner. Pharmacia was established at a time where the increasing use of industrially manufactured medicinal products, both Danish and foreign ones, had resulted in a considerable decrease in sales of pharmacy produced medicinal products. This had for a long time worried The Danish Association of Pharmacies, and this resulted in a reaction from the association, namely the DAK-products which by nature were produced in Denmark and thus became the most essential element in the fight against the industrially manufactured products--a fight which according to the association had to be fought with all legal means. Therefore The Danish Association of Pharmacies obviously reacted precipitated when in 1926 the association in writing stated that Pharmacia's products were not manufactured in Denmark in spite of the fact that they were labelled as such according to agreement with Landsforeningen Dansk Arbejde, i.e., The National Association Danish Work, which in 1925 allowed Pharmacia to use the labels of the association. The unemployment was high in the 1920'ies and increasing so when Pharmacia subsequently took legal action against the Association of Pharmacies and claimed that the statement was unjustified and might harm Pharmacia, it may indicate that the public of that time looked positively upon the manufacture and the use of Danish manufactured products. The Danish Association of Pharmacies lost the case as the claim according to the court was unjustified and thus unlawful. The suspicions of the association were not supported by facts, however, they were not either completely groundless. Following this The National Association Danish Work gave notice to terminate the contract with Pharmacia concerning the right to use the labels of the association. By expanding the cooperation and later on by merging with the Swedish Pharmacia AB the Danish A/S Pharmacia succeeded in continuing and developing a company where research, development and production of innovative medicinal products as well as of generics could take place in Denmark. PMID:25816560

  1. Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 1: Executive summary

    NASA Technical Reports Server (NTRS)

    1978-01-01

    The feasibility of the commercial manufacturing of pharmaceuticals in space is examined. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is presented. Antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon were studied. Production mass balances for antihemophilic factor, beta cells, and erythropoietin were compared for space verus ground operation.

  2. Lets Do Lunch? The ethics of accepting gifts from the pharmaceutical industry.

    PubMed

    Hagen, Brad; Pijl-Zieber, Em M; Souveny, Krystal; Lacroix, Allison

    2008-04-01

    When nurses think of ethical issues, debates on assisted suicide or maternal versus fetal rights often come to mind. A less obvious but undoubtedly more common ethical issue is whether or not sponsored lunches, educational events and other forms of gift giving should be accepted from pharmaceutical companies. The authors review the nature of pharmaceutical marketing and gift giving and examine some of the potential ethical issues that arise when nurses accept these gifts. PMID:18488765

  3. Challenges in pediatric drug development: a pharmaceutical industry perspective.

    PubMed

    Rose, Klaus

    2009-01-01

    A paradigm change is taking place from protecting children against clinical research to protecting them through research. It is based on a better scientific understanding of the child's physiology, on the increasing potential of biomedical interventions, and on an evolving conviction of children's right to benefit from scientific and pharmaceutical progress. The WHO campaign 'Make medicines child size' is contributing to expand this to a global vision of the health of all children. Research-based pharmaceutical industry develops innovative new medicines for serious and life-threatening diseases. It has built up competency in pediatric drug development and has welcomed US and EU pediatric legislation as well as the WHO campaign. More diseases without effective therapy in the past will become treatable conditions. Eventually these advances will also be reflected in the medical care in developing countries. Research-based pharmaceutical industry can support specific pediatric aspects of drug development in neglected diseases by sharing its learning. The way forward will be a constructive dialog among the key stakeholders to ensure continuing improvement in worldwide child healthcare. PMID:19127957

  4. Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.

    PubMed

    Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

    2009-12-01

    It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised. PMID:19184498

  5. Pharmaceutical representatives' beliefs and practices about their professional practice: a study in Sudan.

    PubMed

    Idris, K M; Mustafa, A F; Yousif, M A

    2012-08-01

    Pharmaceutical representatives are an important promotional tool for pharmaceutical companies. This cross-sectional, exploratory study aimed to determine pharmaceutical representatives' beliefs and practices about their professional practice in Sudan. A random sample of 160 pharmaceutical representatives were interviewed using a pretested questionnaire. The majority were male (84.4%) and had received training in professional sales skills (86.3%) and about the products being promoted (82.5%). Only 65.6% agreed that they provided full and balanced information about products. Not providing balanced information was attributed by 23.1% to doctors' lack of time. However, 28.1% confessed they sometimes felt like hiding unfavourable information, 21.9% were sometimes or always inclined to give untrue information to make sales and 66.9% considered free gifts as ethically acceptable. More attention is needed to dissemination of ethical codes of conduct and training about the ethics of drug promotion for pharmaceutical representatives in Sudan. PMID:23057370

  6. Alcohol medications development: advantages and caveats of government/academia collaborating with the pharmaceutical industry.

    PubMed

    Litten, Raye Z; Ryan, Megan; Falk, Daniel; Fertig, Joanne

    2014-05-01

    The process of developing pharmacological treatments for alcohol use disorder is notoriously complex and challenging. The path to market is long, costly, and inefficient. One way of expediting and reducing the drug development process is through collaborations-building partnerships among government, academia, pharmaceutical and biotechnology companies, healthcare organizations and advocacy groups, and the patients (end consumers) themselves. By forging collaborations, particularly with pharmaceutical companies, the alcohol treatment field stands to reap benefits in generating new medications for use in mainstream treatment settings. At the same time, there are certain caveats that should be considered, particularly by academic researchers, before entering into such partnerships. This commentary examines the advantages and caveats of government and academia collaborations with pharmaceutical companies. PMID:24689461

  7. [Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

    PubMed

    Dzhalilova, K I

    2009-11-01

    Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery. PMID:19996506

  8. The pharmaceutical industry as a medicines provider.

    PubMed

    Henry, David; Lexchin, Joel

    2002-11-16

    Rising prices of medicines are putting them beyond the reach of many people, even in rich countries. In less-developed countries, millions of individuals do not have access to essential drugs. Drug development is failing to address the major health needs of these countries. The prices of patented medicines usually far exceed the marginal costs of their production; the industry maintains that high prices and patent protection are necessary to compensate for high development costs of innovative products. There is controversy over these claims. Concerns about the harmful effects of the international system of intellectual property rights have led the World Trade Organization to relax the demands placed on least developed countries, and to advocate differential pricing of essential drugs. How these actions will help countries that lack domestic production capacity is unclear. Better access to essential drugs may be achieved through voluntary licensing arrangements between international pharmaceutical companies and manufacturers in developing countries. PMID:12443614

  9. Pharmaceutical promotion and GP prescription behaviour.

    PubMed

    Windmeijer, Frank; de Laat, Eric; Douven, Rudy; Mot, Esther

    2006-01-01

    The aim of this paper is to empirically analyse the responses by general practitioners to promotional activities for ethical drugs by pharmaceutical companies. Promotion can be beneficial as a means of providing information, but it can also be harmful in the sense that it lowers price sensitivity of doctors and it merely is a means of maintaining market share, even when cheaper, therapeutically equivalent drugs are available. A model is estimated that includes interactions of promotion expenditures and prices and that explicitly exploits the panel structure of the data, allowing for drug specific effects and dynamic adjustments, or habit persistence. The data used are aggregate monthly GP prescriptions per drug together with monthly outlays on drug promotion for the period 1994-1999 for 11 therapeutic markets, covering more than half of the total prescription drug market in the Netherlands. Identification of price effects is aided by the introduction of the Pharmaceutical Prices Act, which established that Dutch drugs prices became a weighted average of the prices in surrounding countries after June 1996. We conclude that GP drug price sensitivity is small, but adversely affected by promotion. Ltd. PMID:15945041

  10. [Chapter 4. Transitions in pharmaceutical market, production and sales in Japan (1980-2010)].

    PubMed

    Yoshioka, Ryuzo; Matsumoto, Kazuo

    2014-01-01

    In this paper, the writers reviewed in detail the pharmaceutical market and the shifts in manufacturing and sales including the trade balance in Japan over a thirty-year period from 1980 to 2010. From the 1980s to the 1990s, many innovative pharmaceutical products were developed and launched in the Japanese market. During the same period, some Japanese companies managed to develop their first internationally marketable drugs, which were antibiotics and effective remedies for the digestive and circulatory organs. During this period, Japanese pharmaceutical companies were also able to launch some of blockbuster drugs. For two decades, the pharmaceutical market grew rapidly. For this reason, it can be called "The Growth Period for Pharmaceutical Products" in Japan. After that period, drug development and sales slowed down due to a lack of expertise in genetic engineering and biotechnologies. This situation caused a large deficit in the trade balance for Japanese pharmaceutical products. However, with regard to the trade balance (including technical royalties) for pharmaceutical product technologies, Japan remains in the black even today. PMID:25272638

  11. Technology evaluation: PRO-542, Progenics Pharmaceuticals inc.

    PubMed

    Mukhtar, M; Parveen, Z; Pomerantz, R J

    2000-12-01

    Progenics's rCD4-IgG2 (PRO-542) is a recombinant fusion protein, which has been developed using the company's Universal Antiviral Binding (UnAB) technology, and is in phase I/II clinical trials for the treatment of human immunodeficiency virus type I (HIV-1) infection [273391]. At the beginning of 1997, Progenics received a Phase II Small Business Innovation Research Program (SBIR) grant from the National Institute of Allergy and Infectious diseases (NIAID) to fund the development of PRO-542 [236048]. A further grant of $2.7 million was awarded in August 1998 for the clinical evaluation of PRO-542 and other anti-HIV therapies [294200]. Progenics is collaborating with the Aaron Diamond AIDS Research Center (ADARC) in New York and the Center for Disease Control and Prevention in Atlanta [178410]. In February 2000, Progenics and Genzyme Transgenics Corp signed an agreement to continue the development of a transgenic source of PRO-542. Genzyme will develop transgenic goats that produce PRO-542 in their milk in exchange for undisclosed fees and milestone payments. Genzyme will supply PRO-542 to Progenics for clinical trials with a possibility for eventual commercial supply [357291]. Following on from this, in October 2000, Progenics received an SBIR grant to fund a two-year project with Genzyme Transgenics into the development of cost-effective methods for the manufacture of PRO-542, by optimization of the production of the drug in the milk of transgenic dairy animals [385982]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of PRO-542 and GMK (Progenics Pharmaceuticals) in 2002 [390063]. PMID:11249748

  12. How pharmaceutical industry employees manage competing commitments in the face of public criticism.

    PubMed

    Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

    2013-10-01

    The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. PMID:23744524

  13. OSI-774 OSI Pharmaceuticals.

    PubMed

    Norman, P

    2001-02-01

    OSI-774 (formerly CP-358774), a quinazoline derivative, is an orally active epidermal growth factor receptor (EGFR) inhibitor which was originally under joint development by Pfizer and OSI Pharmaceuticals (formerly Oncogene Science) for the potential treatment of cancer (eg, ovarian, non-small cell lung cancer (NSCLC) and head and neck). It is being evaluated in phase II trials [304305], [372201]. On 8 January 2001, OSI announced that it had signed an agreement with Roche and Genentech for the global co-development and marketing of OSI-774. The agreement with Genentech covers the United States, that with Roche the rest of the world [395371], [395526]. In June 2000, OSI gained all development and marketing rights for OSI-774 following Pfizer's merger with Warner-Lambert [371439]. In September 2000, Pfizer transferred the IND dossierfor OSI-774 to OSI ahead of the timeline agreed in the June 2000 development and marketing rights agreement [383786]. The phase II trials will assess OSI-774 both as a single agent and in combination with existing chemotherapy regimens [347783]. Phase III trials are expected to be initiated in 2001 [347783]. In October 2000, Lehman Brothers predicted that OSI-774 would move into pivotal trials in thefirst half of 2001 and that the drug would be launched in 2003. The analysts also estimated worldwide sales of US $66 million, $285 million and $461 million in 2003, 2004 and 2005, respectively, and peak sales in excess of US $500 million [395189]. PMID:11816847

  14. Curriculum Research: Toward a Framework for "Research-based Curricula"

    ERIC Educational Resources Information Center

    Clements, Douglas H.

    2007-01-01

    Government agencies and members of the educational research community have petitioned for research-based curricula. The ambiguity of the phrase "research-based", however, undermines attempts to create a shared research foundation for the development of, and informed choices about, classroom curricula. This article presents a framework for the…

  15. Guiding Students through the Jungle of Research-Based Literature

    ERIC Educational Resources Information Center

    Williams, Sherie

    2005-01-01

    Undergraduate students of today often lack the ability to effectively process research-based literature. In order to offer education students the most up-to-date methods, research-based literature must be considered. Hence a dilemma is born as to whether professors should discontinue requiring the processing of this type of information or teach…

  16. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

    Oral presentation at SETAC North America 32nd annual meeting, describing our prioritization of active pharmaceutical ingredients (APIs), based on estimates of risks posed by API residues originating from municipal wastewater. Goals of this project include prioritization of APIs f...

  17. 'Get with the Program!': pharmaceutical marketing, symptom checklists and self-diagnosis.

    PubMed

    Ebeling, Mary

    2011-09-01

    During more than a decade of direct-to-consumer advertising (DTC) of pharmaceuticals in the United States, several highly controversial and contested disease states have been promoted to affect diagnostic and prescribing outcomes that are favorable to a company's branded drug. Influencing medical diagnosis is essential to the branding of a disease, which helps to protect pharmaceutical intellectual property and assures higher profits for drug companies. Enormous marketing as well as medical resources are deployed to ensure that new diagnoses of disease states are recognized. While much work has been done investigating the marketing processes necessary to shape and define diagnoses for many of these new disease states, such as Premenstrual Dysphoric Disorder (PMDD), the promotion of self-diagnosis within pharmaceutical marketing campaigns garner little sociological attention. This article reviews and analyzes branded disease awareness campaigns sponsored by pharmaceutical companies that employ self-diagnostic "tools". By using the example of one specific disease state, PMDD, I illustrate how the marketing of self-diagnosis transforms the patient into a consumer in order to achieve the aims of a drug company. This example is contextualized within the larger theoretical framework on the sociology of diagnosis. Consideration is given to how the marketing of self-diagnosis goes beyond Jutel's (2009) description of diagnosis as being the "classification tool of medicine" and becomes a marketing tool to construct a well-educated consumer who will demand medical diagnoses inline with a drug company's objectives. PMID:21835526

  18. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

    Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

    2015-12-01

    Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter <232> and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. PMID:26398581

  19. Assessing the Factors Associated With Iran’s Intra-Industry Trade in Pharmaceuticals

    PubMed Central

    Yusefzadeh, Hassan; Hadian, Mohammad; Gorji, Hassan Abolghasem; Ghaderi, Hossein

    2015-01-01

    Background: Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran’s intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. Methods: This study assessed the factors associated with Iran’s intra-industry trade in pharmaceuticals with the rest of the world during the 2001–2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran’s IIT in pharmaceuticals. Results: The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran’s intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn’t have the expected signs. In addition, we found that Iran’s IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. Conclusions: In order to get more prepared for integration into the global economy, the development of Iran’s IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade. PMID:26156931

  20. Aripiprazole (Otsuka Pharmaceutical Co).

    PubMed

    Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih

    2002-01-01

    Otsuka Pharmaceuticals in collaboration with Bristol-Myers Squibb is developing aripiprazole, a dual dopamine autoreceptor agonist and postsynaptic D2 receptor antagonist, for the potential treatment of psychoses including schizophrenia [281327], [340364]. A regulatory filing for schizophrenia in the US was submitted at the end of 2001 [340364]. The compound entered phase III trials in Japan in 1995 [192966]. Although presynaptic dopamine autoreceptor agonists may be efficacious in the treatment of schizophrenia, they may also potentially increase the risk for exacerbation of psychosis through stimulation of postsynaptic dopaminergic receptors [245791], [350478], [350479]. However, earlier neuropharmacology studies have shown that aripiprazole can act as a presynaptic D2 agonist while displaying an antagonistic effect at the postsynaptic D2 receptors [281327], [337126], [350479], [424587], [424588]. In animal models, aripiprazole inhibits the apomorphine-induced stereotypy, without causing catalepsy [281327], [337126]. Moreover, in contrast to classical antipsychotics that produce disabling movement disorders, aripiprazole does not cause an upregulation of D2 receptors or an increase in expression of the c-fos mRNA in the striatum, in agreement with the low risk for extrapyramidal side effects (EPS) during aripiprazole treatment [245781], [262096], [350481], [350483]. Collectively, aripiprazole is an important atypical antipsychotic candidate with a favorable safety profile. Moreover, the mechanism of action of aripiprazole differentiates it from both typical and atypical antipsychotics and hence, may provide important leads for pharmacotherapy of schizophrenia and other psychotic disorders. In January 2000, Lehman Brothers predicted peak sales of aripiprazole could reach US $500 million [357788]. In February 2001, Credit Suisse First Boston predicted sales of US $403 million in 2005 [399484]. PMID:12054061

  1. [Clinical researchers and the pharmaceutic industry. The research contract is not an addendum].

    PubMed

    Cohen, A F

    1999-06-26

    The relation between a pharmaceutical company and a clinical investigator combines a certain form of entrepreneurship with scientific endeavour. Both parties are concerned with the content of the clinical study as well as with its business aspects. A good contract is essential for the project to succeed. In three cases based on actual experience the contract failed. In the first case, dosage miscalculation in the hospital pharmacy led to side effects in patients as a consequence of which the study was stopped. The pharmaceutical company sued the investigator. In the second case the investigator published data in a congress abstract, which prevented a patent by the company. In the third case scientific information was published by the company with the principal investigator featuring in the acknowledgement section of the article only. Investigators should have their own standard contract ready, and they should invest time and energy in understanding the contracts of the research they are carrying out. PMID:10416489

  2. [An analysis of the pharmaceuticals market in Vietnam].

    PubMed

    Simonet, D

    2001-01-01

    This article sheds a light on the Vietnamese pharmaceutical market. The progress that has been made in the recent years following the opening of the Vietnamese regime to the western world, although not easy, brought a certain number of opportunities for domestic firms and foreign investors. The pharmaceutical Vietnamese industry started to emerge at the beginning of the 1990s. Although, the consumption of drugs is low, it does reach the sum of $ 5.5 per capita. As the majority of these products are imported, foreign companies tend to dominate the market both in volume and in diversity. The state has always played an important role with the implementation of a strict price control strategy and most national drug companies remain state-owned. The production and consumption of drugs were also largely influenced by state policies as the latter also control hospitals. In the second half of the eighties, the progressive liberalisation of the country allowed private drug pharmacies to appear and advertisement campaigns became legal. Because the lack of specific products like antibiotics was clear, the government increased the flow of imports, including private imports by citizens. Sources of imports have become more diverse, although France remains an important source of supply. Fournier, Lipha and Pierre Fabre are among the French drug manufacturers located in Vietnam. Other foreign companies include from India, South Korea, Thailand and Germany. Joint ventures were also created with French and Japanese companies. The import of medical materials is subjected to authorisations from the Ministry of Health and the Ministry of Foreign Trade as it is necessary to obtain a licence to do so. Licences are issued on the basis of the production of drugs that do not currently exist on the local market. But Vietnam also exports pharmaceutical products to Laos, Cambodia, and Cuba. Local resources constitute an important source of new products and have stirred a strong interest among pharmaceutical researchers. A strong decentralisation process characterises the pharmaceutical sector, with pharmacies in the provinces and districts while wholesalers remain located in Hanoi and Saigon. The presence of many middlemen has contributed to an increase in prices. Today, a concentration of pharmacies is still noted in inner cities while the suburbs and the villages still have difficulties supplying drugs for inhabitants. Solutions have been implemented such as the opening of new pharmacies and additional professional training for pharmacists. Prices were lowered while the quality of the supply chain was improved. Local production is encouraged as hospitals are prompted to prescribe Vietnamese products. The modernisation of the Vietnamese pharmaceutical industry is also visible through the importation of medical materials and an increase in the number of private hospitals financed with both the help of local and foreign investors, mainly through joint-ventures, most often in Saigon and Hanoi. The renovation of local hospitals was also possible with the help of France and Japan. Columbia Gia Dinh International, located in Saigon, is one of the very few US/Vietnamese medical institutions created with a local partner, the Gia Dinh hospital. The recovery of the economy will accelerate the creation of new projects designed to improve local medical infrastructures. Other private companies, some of which are based in Singapore, have been specifically designed to deliver care to expatriates working in Vietnam. Insurance coverage has been provided in Vietnam since in 1992. Other improvements concern the implementation of "Good Manufacturing Practices" (GMP) and "Good Laboratory Practices" and "Good Storage Practices". Most norms were implemented at the end of the 90s in joint companies linking foreign investors and local partners or in independent foreign drug manufacturers based in Vietnam. Special areas were created to receive high tech investments in the medical and pharmaceutical field. Prices should diminish as competition on the market increases and new products are placed on the market to achieve economies of scale. But investment in medical research is still strongly needed. PMID:11641078

  3. The pharmaceutical industry and research in 2002 and beyond.

    PubMed

    Dutta, Anand S; Garner, Andrew

    2003-12-01

    The success of the pharmaceutical industry will continue to depend on its ability to satisfy the clinical needs of established market economies. The number and quality of new drugs emerging from development pipelines seems likely to rise due to increased research and development budgets of the merged pharmaceutical companies, efficiencies across all facets of the development process, increasing use of new technologies and availability of new targets from the ongoing work on the role of human genes in disease pathways. In addition to the traditional small-molecule drugs, the market for protein products, including monoclonal antibodies and therapeutic vaccines, is likely to expand as advances in recombinant and formulation technologies are made. Current work on relatively newer fields of pharmaceutical research, such as novel G-protein-coupled receptors, chemokines/cytokines, integrins and control of cell cycle regulation and signal transduction pathways (kinases, phosphatases and transcription factors) will lead to new drugs over the next decade. It is tempting to argue that a progressive fall in the number of new drugs in the last decade of the 20th century reflects the end of an era as companies struggle to identify any remaining quality products using old-style drug hunting practices. PMID:14747843

  4. [Pharmaceutical industry and "New German Medicine" ("Neue Deutsche Heilkunde")].

    PubMed

    Meyer, Ulrich

    2004-01-01

    THe so-called "New German Medicine", initially propagated in the health policy of the National Socialist Party, promoted greater use of phytotherapeutic and homeopathic drugs by the medical community. In response, the "Reichsfachschaft der pharmazeutischen Industrie e. V." (Association of Pharmaceutical Industry of the Reich") was obliged to pursue a carefully chosen double strategy, given that the members of the Association were both manufacturers of natural remedies and manufacturers of allopathic drugs.However, the fact that I.G. Farben completely ignored the "New German Medicine" suggests that the large chemical-pharmaceutical manufacturers did not take this policy very seriously. The only documents pertaining to increased research in the area of natural remedies stem from the medium-sized manufacturers Knoll and Schering. In the case of both companies it is noteworthy that they worked towards obtaining a scientific foundation for the developed preparates, and that they employed conventional methods of chemical analysis and proof of activity. THe growth of the classical manufacturers of natural remedies, such as the company Willmar Schwabe was, as far as any growth at all could be observed, significantly smaller than had been theoretically postulated. There is no casual relationship between any commercial success during the period in which the Nazis were in power and today's commercial prosperity.Moreover, from the viewpoint of the pharmaceutical industry, the "New German Medicine" seems to have passed its zenith before 1936, when the 4-year plan for war preparation entered into force. PMID:16025629

  5. [The pharmaceutical industry in France: the turning point of 1915].

    PubMed

    Bonnemain, Bruno

    2015-12-01

    For several convergent reasons, 1915 was a key period for the pharmaceutical industry in France. The overall realization that France was dependent on Germany for chemical and pharmaceutical products came from shortages of key drugs but also from massive use of poison gas for which France was not able to face this unexpected event. France's shortage for chemists properly trained to answer the needs of industry, the weak relationship between industry and faculty, the uncomfortable situation of specialty drugs, the regulations on patents and trademarks were many subjects of controversies which will contribute to the analysis of the source of this French dependence to Germany. It will be at the origin of new orientations after the war for the pharmaceutical industry and the French society. The objective was to be independent for drugs and consequently to resolve the identified issues, as well as to have a dynamic industrial research. The creation and development of several pharmaceutical companies after the war was a more or less direct benefit from the considerations starting in 1915. PMID:26827550

  6. Differential pricing of new pharmaceuticals in lower income European countries.

    PubMed

    Kaló, Zoltán; Annemans, Lieven; Garrison, Louis P

    2013-12-01

    Pharmaceutical companies adjust the pricing strategy of innovative medicines to the imperatives of their major markets. The ability of payers to influence the ex-factory price of new drugs depends on country population size and income per capita, among other factors. Differential pricing based on Ramsey principles is a 'second-best' solution to correct the imperfections of the global market for innovative pharmaceuticals, and it is also consistent with standard norms of equity. This analysis summarizes the boundaries of differential pharmaceutical pricing for policymakers, payers and other stakeholders in lower-income countries, with special focus on Central-Eastern Europe, and describes the feasibility and implications of potential solutions to ensure lower pharmaceutical prices as compared to higher-income countries. European stakeholders, especially in Central-Eastern Europe and at the EU level, should understand the implications of increased transparency of pricing and should develop solutions to prevent the limited accessibility of new medicines in lower-income countries. PMID:24219049

  7. Advances in knowledge management for pharmaceutical research and development.

    PubMed

    Torr-Brown, Sheryl

    2005-05-01

    There are two assumptions that are taken for granted in the pharmaceutical industry today. Firstly, that we can generate an unprecedented amount of drug-related information along the research and development (R&D) pipeline, and secondly, that researchers are more connected to each other than they have ever been, owing to the internet revolution of the past 15 years or so. Both of these aspects of the modern pharmaceutical company have brought many benefits to the business. However, the pharmaceutical industry is currently under fire due to allegations of decreased productivity despite significant investments in R&D, which if left to continue at the present pace, will reach almost US 60 billion dollars by 2006. This article explores the role of knowledge in the industry and reviews recent developments and emerging opportunities in the field of knowledge management (KM) as it applies to pharmaceutical R&D. It is argued that systematic KM will be increasingly necessary to optimize the value of preceding advances in high-throughput approaches to R&D, and to fully realize the anticipated increase in productivity. The application of KM principles and practices to the business can highlight opportunities for balancing the current reliance on blockbuster drugs with a more patient-centric focus on human health, which is now becoming possible. PMID:15892246

  8. Multiscale mechanistic modeling in pharmaceutical research and development.

    PubMed

    Kuepfer, Lars; Lippert, Jrg; Eissing, Thomas

    2012-01-01

    Discontinuation of drug development projects due to lack of efficacy or adverse events is one of the main cost drivers in pharmaceutical research and development (R&D). Investments have to be written-off and contribute to the total costs of a successful drug candidate receiving marketing authorization and allowing return on invest. A vital risk for pharmaceutical innovator companies is late stage clinical failure since costs for individual clinical trials may exceed the one billion Euro threshold. To guide investment decisions and to safeguard maximum medical benefit and safety for patients recruited in clinical trials, it is therefore essential to understand the clinical consequences of all information and data generated. The complexity of the physiological and pathophysiological processes and the sheer amount of information available overcharge the mental capacity of any human being and prevent a prediction of the success in clinical development. A rigorous integration of knowledge, assumption, and experimental data into computational models promises a significant improvement of the rationalization of decision making in pharmaceutical industry. We here give an overview of the current status of modeling and simulation in pharmaceutical R&D and outline the perspectives of more recent developments in mechanistic modeling. Specific modeling approaches for different biological scales ranging from intracellular processes to whole organism physiology are introduced and an example for integrative multiscale modeling of therapeutic efficiency in clinical oncology trials is showcased. PMID:22161351

  9. Use and practice of achiral and chiral supercritical fluid chromatography in pharmaceutical analysis and purification.

    PubMed

    Lemasson, Elise; Bertin, Sophie; West, Caroline

    2016-01-01

    The interest of pharmaceutical companies for complementary high-performance chromatographic tools to assess a product's purity or enhance this purity is on the rise. The high-throughput capability and economic benefits of supercritical fluid chromatography, but also the "green" aspect of CO2 as the principal solvent, render supercritical fluid chromatography very attractive for a wide range of pharmaceutical applications. The recent reintroduction of new robust instruments dedicated to supercritical fluid chromatography and the progress in stationary phase technology have also greatly benefited supercritical fluid chromatography. Additionally, it was shown several times that supercritical fluid chromatography could be orthogonal to reversed-phase high-performance liquid chromatography and could efficiently compete with it. Supercritical fluid chromatography is an adequate tool for small molecules of pharmaceutical interest: synthetic intermediates, active pharmaceutical ingredients, impurities, or degradation products. In this review, we first discuss about general chromatographic conditions for supercritical fluid chromatography analysis to better suit compounds of pharmaceutical interest. We also discuss about the use of achiral and chiral supercritical fluid chromatography for analytical purposes and the recent applications in these areas. The use of preparative supercritical fluid chromatography by pharmaceutical companies is also covered. PMID:26643850

  10. Perceptions and Attitudes of Egyptian Health Professionals and Policy-Makers towards Pharmaceutical Sales Representatives and Other Promotional Activities

    PubMed Central

    Kamal, Susan; Holmberg, Christine; Russell, Jean; Bochenek, Tomasz; Tobiasz-Adamczyk, Beata; Fischer, Christiane; Tinnemann, Peter

    2015-01-01

    Background Pharmaceutical promotion activities in low and middle-income countries are often neither regulated nor monitored. While Egypt has the highest population and per capita use of medicines in the Arab world, we know very little about pharmaceutical companies promotional activities in the country. Aim To explore and analyze the perceptions of physicians towards promotional and marketing activities of pharmaceutical companies among physicians and pharmacists in Egypt. Methodology Perspectives of different healthcare system stakeholders were explored through semi-structured, in-depth interviews conducted in 2014 in Cairo, Egypt. Interviewees were chosen via purposive sampling and snowball technique. Each interview was recorded and transcribed. Then qualitative, thematic analysis was conducted with the help of NVIVO software. Findings The majority of physicians and pharmacists acknowledged exposure to pharmaceutical promotion. It was commonly believed that interaction with the pharmaceutical industry is necessary and both associated risks and benefits were acknowledged. The interviewed physicians considered themselves competent enough to minimize risks and maximize benefits to their prescribing habits. Views diverged on the extent and magnitude of the risks and benefits of pharmaceutical promotion, especially in regard to the influence on patients’ health. Conclusions Pharmaceutical promotion in Egypt is intensely directed at prescribers and dispensers. Physicians, pharmacists and policymakers expressed little skepticism to the influence of promotion towards their individual prescribing. Raising awareness of the pitfalls of pharmaceutical promotion is necessary, especially among the less experienced physicians. PMID:26473484

  11. [The pharmaceutical industry in the industrial chemical group: the National Union of Chemical-Pharmaceutical Laboratories (1919-1936)].

    PubMed

    Nozal, Raúl Rodríquez

    2011-01-01

    The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'. PMID:22372007

  12. Anaerobic pretreatment of pharmaceutical wastewaters

    SciTech Connect

    Not Available

    1990-10-01

    The US Department of Energy's (DOE) Office of Industrial Technologies (OIT) sponsors research and development (R D) to improve the energy efficiency of American industry and to provide for fuel flexibility. The pharmaceutical industry generates considerable amounts of wastewater that require extensive treatment before they are released. A common method of disposal is aerobic biological treatment, but this method is energy intensive and expensive. An alternative process--anaerobic digestion--costs less, saves energy, generates less sludge requiring disposal, and produces a usable fuel--methane. OIT and HydroQual, Inc., with Merck Co. recently completed a joint project that demonstrated the anaerobic biological treatment of wastewaters generated by the pharmaceutical industry. The objectives of the project were to demonstrate how the anaerobic biological process and the resulting energy savings can apply to the pharmaceutical industry and how effective and beneficial the process is to sludge management operations at pharmaceutical plants. This technical case study provides an overview of the DOE-HydroQual-Merck R D project and highlights the field tests done on pilot-scale anaerobic wastewater treatment units at a pharmaceutical plant. This document makes field test and data analysis results available to other researchers and private industry. It discusses project status; summarizes field-test efforts; and reviews potential technology impacts in terms of commercial applications, benefits, and full-scale system economics. 5 figs., 1 tab.

  13. Considering the Future of Pharmaceutical Promotions in Social Media

    PubMed Central

    Carpentier, Francesca Renee Dillman

    2016-01-01

    This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media.

  14. The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

    PubMed

    Kelleher, Finnuala

    2004-01-01

    Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions. PMID:16755695

  15. Characteristics of physicians targeted by the pharmaceutical industry to participate in e-detailing.

    PubMed

    Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David

    2009-01-01

    Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing. PMID:19408179

  16. Marketing the use of the space environment for the processing of biological and pharmaceutical materials

    NASA Technical Reports Server (NTRS)

    1984-01-01

    The perceptions of U.S. biotechnology and pharmaceutical companies concerning the potential use of the space environment for the processing of biological substances was examined. Physical phenomena that may be important in space-base processing of biological materials are identified and discussed in the context of past and current experiment programs. The capabilities of NASA to support future research and development, and to engage in cooperative risk sharing programs with industry are discussed. Meetings were held with several biotechnology and pharmaceutical companies to provide data for an analysis of the attitudes and perceptions of these industries toward the use of the space environment. Recommendations are made for actions that might be taken by NASA to facilitate the marketing of the use of the space environment, and in particular the Space Shuttle, to the biotechnology and pharmaceutical industries.

  17. Manufacturing Menopause: An Analysis of the Portrayal of Menopause and Information Content on Pharmaceutical Web Sites

    ERIC Educational Resources Information Center

    Charbonneau, Deborah Hile

    2010-01-01

    Consumer-targeted prescription drug advertising serves as an interesting lens through which we can examine the portrayal of menopause in online drug advertisements. The aim of this study was to explore the portrayal of menopause on web sites sponsored by pharmaceutical companies for hormone therapies (HT). To unravel this question, a qualitative

  18. Is Industry-University Interaction Promoting Innovation in the Brazilian Pharmaceutical Industry?

    ERIC Educational Resources Information Center

    Paranhos, Julia; Hasenclever, Lia

    2011-01-01

    This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment…

  19. Is Industry-University Interaction Promoting Innovation in the Brazilian Pharmaceutical Industry?

    ERIC Educational Resources Information Center

    Paranhos, Julia; Hasenclever, Lia

    2011-01-01

    This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment

  20. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... Q10 Pharmaceutical Quality System: A Practical Approach to Effective Life- Cycle Implementation of...) Conference: A Practical Approach to Effective Life- Cycle Implementation of Systems and Processes for... product life cycle according to the ICH Q10 model. These companies are reaping the benefits that come...

  1. Manufacturing Menopause: An Analysis of the Portrayal of Menopause and Information Content on Pharmaceutical Web Sites

    ERIC Educational Resources Information Center

    Charbonneau, Deborah Hile

    2010-01-01

    Consumer-targeted prescription drug advertising serves as an interesting lens through which we can examine the portrayal of menopause in online drug advertisements. The aim of this study was to explore the portrayal of menopause on web sites sponsored by pharmaceutical companies for hormone therapies (HT). To unravel this question, a qualitative…

  2. Immunotoxicology assessment in the pharmaceutical industry.

    PubMed

    Dean, J H; Hincks, J R; Remandet, B

    1998-12-28

    Through several inter-laboratory evaluation studies, selected methods were optimized and evaluated using reference compounds in rodents, to determine their predictive value for detecting toxicity to the immune system. These provide the basis for the OECD, EPA and pending FDA Guidelines. To describe the status of immunotoxicity evaluation using these methods in the pharmaceutical industry, a survey was conducted, and is reported, of ongoing activities among the major pharmaceutical companies. The results describe which assays are performed, how compounds are selected for evaluation; and when, during the drug development process, an evaluation is performed. Finally, the strategy at Sanofi, for the evaluation and application of immunotoxicity methods during the preclinical development of new molecular entities (NMEs) is described. During the past 8 years, Sanofi has evaluated more than 27 NMEs from multiple therapeutic classes as well as four reference compounds (azathioprine, dexamethasone, cyclophosphamide and cyclosporin A). Our experience with multiple animal species (rat, dog and monkey) and immunotoxicity assays selected from the recommended tiers as well as the outcome from the evaluation of our NMEs and reference standards, is described. This experience has led us to believe that immunotoxicology parameters represent an important adjunct for the safety assessment of NMEs. In addition, these methods were easily integrated into the drug development process and yielded an unexpectedly low frequency of positive results. In summary, immunotoxicity can be evaluated on a case-by-case basis driven by pathology or clinical hematology findings, by the drug's indication, the chemical class or indication of the NME evaluated (for example, anti-viral agents), or systematically performed. PMID:10022261

  3. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing. PMID:9800720

  4. [Advertising and Zeitgeist. The advertising of Schwabe Pharmaceuticals].

    PubMed

    Hofmann, Cornelia; Riha, Ortrun

    2015-01-01

    This contribution explores the advertisements for homeopathic products in magazines in the first half of the twentieth century, focusing on the period between 1933 and 1945 and based on the example of the pharmaceutical company Dr Willmar Schwabe. In the first half of the twentieth century, Schwabe Pharmaceuticals was market leader for homeopathic and other complementary medical products (phytotherapy, biochemicals). The example chosen as well as the time frame complement the existing research. We searched three German publications (the homeopathy journal Leipziger Populäre Zeitschrift für Homöopathie, the medical weekly Münchner Medizinische Wochenschrift and the pharma magazine Pharmazeutische Zeitung) and collected target-group-specific results for laypersons, physicians and pharmacists. Analysis of the images and texts in the selected advertisements often reflected the historical background and the respective health policies (wartime requirements, times of need, "Neue Deutsche Heilkunde"). The history of this traditional company was seen as an important point in advertising, as were the recognisability of the brand through the company logo, the emphasis on the high quality of their products and the reference to the company's own research activities. We furthermore found the kind of argumentation that is typical of natural medicine (naturalness, the power of the sun, prominent representatives). Schwabe met the expectations of its clients, who were interested in complementary medicine, whilst pursuing an approach to homeopathy that was compatible with natural science, and it presented itself as a modern, scientifically oriented enterprise. The company did not lose credibility as a result, but increased its clientele by expanding to include the whole naturopathic market. PMID:26137649

  5. 75 FR 73071 - Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Energy Regulatory Commission Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC, Transcontinental Gas Pipe Line Company, LLC, Enterprise Field Services, LLC; Notice... Abandonment Project proposed by Northern Natural Gas Company, Southern Natural Gas Company, Florida...

  6. Risk Communication and the Pharmaceutical Industry: what is the reality?

    PubMed

    Edwards, Brian; Chakraborty, Sweta

    2012-11-01

    Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company's risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are used globally, we are not aware of any research into their effectiveness outside the ICH regions. What listed companies can communicate about benefits and risks is strongly influenced by the obligations of companies to the market and investors. There needs to be internal coordination for simultaneous release. Internal communications about significant issues should be restricted to those who know how to manage the risk of insider dealing from internal communications that may later be made public. Unfortunately, there is evidence that some companies do not have a cohesive strategy for communicating risk which should take into account all forms of promotional material and company-sponsored information sources on the Internet. A pharmaceutical company is not the only stakeholder responsible for communicating risks on their products. However, the relative roles and responsibilities of all relevant stakeholders are not defined and are often unclear. This means it is difficult to evaluate whether a company's actions might be duplicative or inefficient. We recommend that companies have a dedicated communications group whose role is to coordinate the company's communications strategy mapped to objectives that have been agreed with key stakeholders apart from just regulatory agencies. This same group can assess effectiveness of the communications, monitor audience reaction and adjust the communication strategy accordingly. PMID:23061779

  7. Code of ethics for the national pharmaceutical system: Codifying and compilation

    PubMed Central

    Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin

    2013-01-01

    Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended. PMID:24174954

  8. Paying for On-Patent Pharmaceuticals: Limit Prices and the Emerging Role of a Pay for Outcomes Approach.

    PubMed

    Fuller, Richard L; Goldfield, Norbert

    2016-01-01

    In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

  9. Endocrine-Active Pharmaceuticals: An Environmental Concern?

    EPA Science Inventory

    Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

  10. Marketing to the consumer: perspectives from the pharmaceutical industry.

    PubMed

    David, C

    2001-01-01

    Individualized health management is one of the most exciting challenges facing health care marketing today. Greater access to health information has empowered consumers to take more control of their health needs, creating a whole new landscape for marketers, manufacturers, and service providers. Customization is the key to creating marketing campaigns that successfully target today's health-conscious consumers. Drawing on individualized market intelligence and available genetic information, pharmaceutical companies are learning to tailor products to meet the needs of this growing market. PMID:11291513

  11. Antibiotics: the changing regulatory and pharmaceutical industry paradigm.

    PubMed

    Bax, Richard; Green, Samantha

    2015-05-01

    Drug licensing is changing. Previously, regulators prioritized the licensing of innovative drugs that fulfilled a high unmet medical need for a small number of patients, including orphan, cancer and HIV medicines. Alternatives to large and costly prospective, randomized, double-blind clinical trials have led to a more bespoke development, such as adaptive design studies. Regulators have recently agreed to include much-needed narrow-spectrum antibiotics, active against certain MDR bacteria, in this paradigm. The background to why big pharmaceutical companies have largely deserted the antibacterial research arena, and the proposals that are hoped to reinvigorate their interest, are presented. PMID:25634991

  12. Pharmaceutical reform in South Korea and the lessons it provides.

    PubMed

    Kim, Hak-Ju; Ruger, Jennifer Prah

    2008-01-01

    Through implementation of its 2000 pharmaceutical reform, the South Korean government expected to reduce the cost of medications and improve service levels, medical appropriateness of care, and drug effectiveness. However, despite the reform's lofty goals, unintended consequences have distorted the supply of medical services and spending. These consequences have included increasing the use of uninsured services, prescribing high-price drugs, and a growing market share for multinational drug companies. Further reforms are needed to reduce the measure's adverse effects. This paper examines the Korean mandatory prescription system and offers an analysis of Korea's reforms. PMID:18508813

  13. Occupational hygiene measurement strategy in the pharmaceutical industry.

    PubMed

    Rackham, M; McHattie, G V; Teasdale, E L

    1989-01-01

    In an industry which handles materials which are biologically active it is necessary to limit the exposure of workers engaged in both research and production to these materials. Part of the control procedure is to be able to demonstrate that whatever system is put in place is effective and remains so. This may require a programme of environmental monitoring. To be effective any monitoring programme must be properly planned and executed. This paper sets out the philosophy and practice of one multinational pharmaceutical company which may stimulate debate in the industry. PMID:2716294

  14. Career pathways in research: pharmaceutical.

    PubMed

    Kenkre, J E; Foxcroft, D R

    The pharmaceutical pathway is the final article in this series on career pathways and highlights opportunities for nurses within associated industries. This pathway shows that nurses can use their nursing qualifications, combined with their knowledge, skills and expertise, to develop a career within another sphere of employment. PMID:11974783

  15. Price regulation, industry structure and innovation: an international comparison of pharmaceutical industries.

    PubMed

    Thomas, L G

    1992-01-01

    The home competitive environment has a powerful effect on companies -- shaping skills, strategies, and performance outside the home environment. Government industrial policies, such as pharmaceutical pricing regulations, affect companies primarily through shaping the nature of the home environment. Successful competitive environments (such as the UK) exhibit higher average drug prices and an internal structure of prices that favour significant innovators, discourage minor products, and provide a shield against foreign competitors. Poor competitive environments (such as France) exhibit low average prices and an internal price structure that favours weak local companies producing imitative or minor products. PMID:10146925

  16. The art and science of risk management: a US research-based industry perspective.

    PubMed

    Bush, Janice K; Dai, Wanju S; Dieck, Gretchen S; Hostelley, Linda S; Hassall, Thomas

    2005-01-01

    The research-based pharmaceutical industry in the US strongly supports the concepts of risk management and sees formal risk management as playing a major role in the development of safe medicines for the public, as well as providing a mechanism to ensure that decisions concerning individual drug benefit and risk are made based on scientific evidence. Safe medicines refer to those drugs whose benefits have been found to outweigh their risks when they are used according to the approved labelling. Risk management is the comprehensive and proactive application of scientifically based methodologies to identify, assess, communicate and minimise risk throughout the life cycle of a drug so as to establish and maintain a favourable benefit-risk balance in patients. Although there are certainly a number of global risk management initiatives in place or being undertaken, harmonisation has yet to be achieved. Industry is faced with a variety of different risk management approaches and tools. There is a need to move the focus of risk management from the post-approval arena to earlier in the development process and tools need to be developed to support risk management throughout the lifecycle of a drug. The focus in the US on risk minimalisation strategies will also be an area for methodological development. A key factor in the success of overall risk management is the dialogue between industry and regulators throughout the development, review and marketing of the product. It is through such dialogue that appropriate, efficient and effective risk management strategies will be developed and implemented and the best decisions regarding the safe use of pharmaceutical products will be made. PMID:15649102

  17. The performance and problems of the Turkish pharmaceutical industry: is there a need to develop a national drug policy?

    PubMed

    Kisa, A

    2001-10-01

    Turkey has a big pharmaceutical industry-of the drugs consumed there, 90% are manufactured domestically. Eighty percent of this manufacturing is run by foreign companies. In this study, the performance of the Turkish pharmaceutical industry in terms of the technology and production is examined and compared with that of some other countries, and the importance of the essential drugs list and national drug policy is discussed. At the end of the study, strategies are suggested toward meeting the main current challenges in the Turkish pharmaceutical industry. PMID:11508904

  18. The pathologist and toxicologist in pharmaceutical product discovery.

    PubMed

    Alden, C L; Sagartz, J E; Smith, P F; Wilson, A G; Bunch, R T; Morris, D L

    1999-01-01

    Significant change is occurring in the drug discovery paradigm; many companies are utilizing dedicated groups from the toxicology/ pathology disciplines to support early stage activities. The goal is to improve the efficiency of the discovery process for selecting a successful clinical candidate. Toxicity can be predicted by leveraging molecular techniques via rapid high-throughput, low-resource in vitro and in vivo test systems. Several important activities help create a platform to support rapid development of a new molecular entity. The proceedings of this symposium provide excellent examples of these applied concepts in pharmaceutical research and development. Leading biopharmaceutical companies recognize that a competitive advantage can be maintained via rapid characterization of animal models, the cellular identification of therapeutic targets, and improved sensitivity of efficacy assessment. The participation of the molecular pathologist in this quest is evolving rapidly, as evidenced by the growing number of pathologists that interact with drug discovery organizations. PMID:10367682

  19. Pharmaceutical promotion in Canada: convince them or confuse them.

    PubMed

    Lexchin, J

    1987-01-01

    Currently, drug companies are spending in excess of $200 million annually on promoting their products to Canadian physicians. Although the industry has adopted a voluntary code of advertising practice, this has not prevented gross excesses in all forms of pharmaceutical promotion: drug-company sponsored continuing medical education, and promotion through the public media, detailers, direct mail, sampling, and journal advertising. Not only does advertising add to the cost of drugs, but physicians' reliance on information conveyed through advertising leads to poor prescribing and consequently to significant adverse health effects for patients. Reforms of promotional practices are possible, but the initiative is unlikely to come from either the medical profession or the government. Pressure applied through an emerging grass-roots movement is the best hope for change. PMID:3557776

  20. Pharmaceuticals: pharmaceutical cost controls--2005. End of Year Issue Brief.

    PubMed

    Seay, Melicia; Varma, Priya

    2005-12-31

    The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization and 2005 legislative activity surrounding the most commonly used and emerging pharmaceutical cost control measures. PMID:16708455

  1. Fosamprenavir. Vertex Pharmaceuticals/GlaxoSmithKline.

    PubMed

    Corbett, Amanda H; Kashuba, Angela D M

    2002-03-01

    Fosamprenavir, a Vertex Pharmaceuticals phosphate ester prodrug of the HIV protease inhibitor amprenavir, is under development by GlaxoSmithKline (GSK; formerly Glaxo Wellcome) for the potential treatment of HIV infection in adults and children. By November 2000, it was in phase III trials; a third phase III trial was initiated in April 2001. In October 2001, GSK expected filing in both the EU and US in 2002. In January 2002, Vertex anticipated an NDA filing during the second half of 2002. Fast-track status for fosamprenavir was received by Glaxo Wellcome in December 1999. As of January 2002, enrollment was complete for two of the three phase III trials, and an NDA was expected to be filed during 2002. Fosamprenavir was first synthesized at Vertex as part of a collaboration with Glaxo Wellcome and by 1999, it was being developed by Glaxo Wellcome as part of an ongoing agreement between the two companies. In September 2000 and January 2001, Merrill Lynch predicted a 2002 launch, with sales of pounds sterling 50 million in 2002, rising to pounds sterling 150 million in 2004. PMID:12054084

  2. Innovation strategies for generic drug companies: moving into supergenerics.

    PubMed

    Ross, Malcolm S F

    2010-04-01

    Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies. PMID:20373253

  3. Interactions between Medical Residents and Drug Companies: A National Survey after the Mediator® Affair

    PubMed Central

    Montastruc, François; Moulis, Guillaume; Palmaro, Aurore; Gardette, Virginie; Durrieu, Geneviève; Montastruc, Jean-Louis

    2014-01-01

    Background The present study aimed to describe exposure and attitudes of French medical residents towards pharmaceutical industry. The study was performed shortly after the Mediator affair which revealed several serious conflicts of interest inside the French health system. Methods and Findings A cross-sectional study was implemented among residents from 6 French medical faculties. Independent education in pharmacology, attitudes towards the practices of pharmaceutical sales representatives, opinions concerning the pharmaceutical industry, quality of information provided by the pharmaceutical industry, and opinions about pharmaceutical company sponsorship were investigated through a web-based questionnaire. We also assessed potential changes in resident attitudes following the Mediator affair. The mean value of exposure to drug companies was 1.9 times per month. Global opinions towards drug company information were negative for 42.7% of the residents and positive for only 8.2%. Surprisingly, 81.6% of residents claimed that they had not changed their practices regarding drug information since the Mediator affair. Multivariate analyses found that residents in anesthesiology were less likely to be exposed than others (OR = 0.17 CI95% [0.05–0.61]), exposure was significantly higher at the beginning of residence (p<0.001) and residents who had a more positive opinion were more frequently exposed to drug companies (OR = 2.12 CI95% [1.07–4.22]). Conclusions Resident exposure to drug companies is around 1 contact every 2 weeks. Global opinion towards drug information provided by pharmaceutical companies was negative for around 1 out of 2 residents. In contrast, residents tend to consider the influences of the Mediator affair on their practice as relatively low. This survey enabled us to identify profiles of residents who are obviously less exposed to pharmaceutical industry. Current regulatory provisions are not sufficient, indicating that further efforts are necessary to develop a culture of disclosure of conflict of interest and of transparency in residents. PMID:25279555

  4. A Research-Based Development Economics Course for Undergraduates

    ERIC Educational Resources Information Center

    Singh, Prakarsh; Guo, Hongye; Morales, Alvaro

    2015-01-01

    The authors present details of a research-based course in development economics taught at a private liberal arts college. There were three key elements in this class: teaching of applied econometrics, group presentations reviewing published and working papers in development economics, and using concepts taught in class to write an original

  5. Research-Based Teaching Unit on the Tides. Research Report

    ERIC Educational Resources Information Center

    Viiri, Jouni; Saari, Heikki

    2004-01-01

    The aim of this study was to develop a new research-based learning unit for tides to be used in lower secondary schools. The learning unit was based on the scientific theory of tides, textbooks, and also an analysis of students' conceptions. Descriptions are included of the content and the teaching-learning activities of the unit. The teacher talk

  6. Toward a Common Understanding of Research-Based Instructional Strategies

    ERIC Educational Resources Information Center

    Goodwin, Deborah; Webb, Mary Ann

    2014-01-01

    A review of available books, articles and on-line resources which deal with "Research-Based Instructional Strategies" will produce a plethora of materials which promote the effectiveness of these strategies on student achievement. Also, a perusal of classroom instruction and teacher evaluation instruments will reveal that many of the…

  7. A Research-Based Development Economics Course for Undergraduates

    ERIC Educational Resources Information Center

    Singh, Prakarsh; Guo, Hongye; Morales, Alvaro

    2015-01-01

    The authors present details of a research-based course in development economics taught at a private liberal arts college. There were three key elements in this class: teaching of applied econometrics, group presentations reviewing published and working papers in development economics, and using concepts taught in class to write an original…

  8. What Successful Science Teachers Do: 75 Research-Based Strategies

    ERIC Educational Resources Information Center

    Glasgow, Neal A.; Cheyne, Michele; Yerrick, Randy K.

    2010-01-01

    The experience and science expertise of these award-winning authors makes this easy-to-use guide a teacher's treasure trove. This latest edition to the popular What Successful Teachers Do series describes 75 research-based strategies and outlines best practices for inquiry-oriented science. Each strategy includes a brief description of the

  9. What Successful Science Teachers Do: 75 Research-Based Strategies

    ERIC Educational Resources Information Center

    Glasgow, Neal A.; Cheyne, Michele; Yerrick, Randy K.

    2010-01-01

    The experience and science expertise of these award-winning authors makes this easy-to-use guide a teacher's treasure trove. This latest edition to the popular What Successful Teachers Do series describes 75 research-based strategies and outlines best practices for inquiry-oriented science. Each strategy includes a brief description of the…

  10. Research-Based Learning: Teaching Development through Fieldschools

    ERIC Educational Resources Information Center

    Guinness, Patrick

    2012-01-01

    The challenge of bringing research-based learning to undergraduate development studies and anthropology students has led to convening a fieldschool in Indonesia. The fieldschool has been vital in introducing students to fieldwork methodology and in developing a deeper understanding of the relation of research data to development theory. In…

  11. Integrating Interdisciplinary Research-Based Experiences in Biotechnology Laboratories

    ERIC Educational Resources Information Center

    Iyer, Rupa S.; Wales, Melinda E.

    2012-01-01

    The increasingly interdisciplinary nature of today's scientific research is leading to the transformation of undergraduate education. In addressing these needs, the University of Houston's College of Technology has developed a new interdisciplinary research-based biotechnology laboratory curriculum. Using the pesticide degrading bacterium,…

  12. Principles of Assessment for Project and Research Based Learning

    ERIC Educational Resources Information Center

    Hunaiti, Ziad; Grimaldi, Silvia; Goven, Dharmendra; Mootanah, Rajshree; Martin, Louise

    2010-01-01

    Purpose: The purpose of this paper is to provide assessment guidelines which help to implement research-based education in science and technology areas, which would benefit from the quality of this type of education within this subject area. Design/methodology/approach: This paper is a reflection on, and analysis of, different aspects of…

  13. Research-Based Learning: Teaching Development through Fieldschools

    ERIC Educational Resources Information Center

    Guinness, Patrick

    2012-01-01

    The challenge of bringing research-based learning to undergraduate development studies and anthropology students has led to convening a fieldschool in Indonesia. The fieldschool has been vital in introducing students to fieldwork methodology and in developing a deeper understanding of the relation of research data to development theory. In

  14. Promoting Professionalism in Master's Level Teachers through Research Based Writing

    ERIC Educational Resources Information Center

    McMillen, Paula S.; Garcia, Jesus; Bolin, David A.

    2010-01-01

    Three perspectives on the redesign and implementation of a master's level social studies seminar are offered. Research-based writing was used to build information literacy skills and foster teachers' professionalism. Assessments indicate that students improved research and writing skills, increased their sense of teaching efficacy, and enhanced…

  15. Principles of Assessment for Project and Research Based Learning

    ERIC Educational Resources Information Center

    Hunaiti, Ziad; Grimaldi, Silvia; Goven, Dharmendra; Mootanah, Rajshree; Martin, Louise

    2010-01-01

    Purpose: The purpose of this paper is to provide assessment guidelines which help to implement research-based education in science and technology areas, which would benefit from the quality of this type of education within this subject area. Design/methodology/approach: This paper is a reflection on, and analysis of, different aspects of

  16. After the Crash: Research-Based Theater for Knowledge Transfer

    ERIC Educational Resources Information Center

    Colantonio, Angela; Kontos, Pia C.; Gilbert, Julie E.; Rossiter, Kate; Gray, Julia; Keightley, Michelle L.

    2008-01-01

    Introduction: The aim of this project was to develop and evaluate a research-based dramatic production for the purpose of transferring knowledge about traumatic brain injury (TBI) to health care professionals, managers, and decision makers. Methods: Using results drawn from six focus group discussions with key stakeholders (consumers, informal…

  17. A Research-Based Narrative Assignment for Global Health Education

    ERIC Educational Resources Information Center

    Lencucha, Raphael

    2014-01-01

    There is a paucity of research on novel approaches to classroom-based global health education despite the growing popularity of this topic in health professional curricula. The purpose of the following paper is to (1) describe the rationale underlying the use of a research-based narrative assignment for global health education, and (2) describe

  18. Principals Use Research-Based Techniques for Facilitating School Effectiveness.

    ERIC Educational Resources Information Center

    Hord, Shirley M.; Hall, Gene E.

    Research shows that principals with strong leadership qualities are a critical factor in effective schools. This paper describes three research based techniques that principals can use when making decisions about how to help teachers develop their skills. The Concerns Based Adoption Model (CBAM) is an empirically based conceptual framework that…

  19. Technology Integration: A Research-Based Professional Development Program

    ERIC Educational Resources Information Center

    Faulder, Tori Rose

    2011-01-01

    This research-based thesis project explains the governmental acts and policies, investors, and other stakeholders who have worked to promote, question, and explore the use of information and communication technologies (ICT) in the classroom. Research suggests that best-practice ICT integration requires using ICT alongside constructivist pedagogy.…

  20. Web Design for Instruction: Research-based Guidelines.

    ERIC Educational Resources Information Center

    Skaalid, Bonnie

    2001-01-01

    Describes a Web site that introduces novice Web users to principles of design and navigation of instructional Web sites. Discusses the process involved in designing the site, lessons learned while developing it, and recommendations for further research. Includes a list of research-based guidelines derived from the literature in the areas of screen…

  1. Research-Based Teaching Unit on the Tides. Research Report

    ERIC Educational Resources Information Center

    Viiri, Jouni; Saari, Heikki

    2004-01-01

    The aim of this study was to develop a new research-based learning unit for tides to be used in lower secondary schools. The learning unit was based on the scientific theory of tides, textbooks, and also an analysis of students' conceptions. Descriptions are included of the content and the teaching-learning activities of the unit. The teacher talk…

  2. A Research-Based Narrative Assignment for Global Health Education

    ERIC Educational Resources Information Center

    Lencucha, Raphael

    2014-01-01

    There is a paucity of research on novel approaches to classroom-based global health education despite the growing popularity of this topic in health professional curricula. The purpose of the following paper is to (1) describe the rationale underlying the use of a research-based narrative assignment for global health education, and (2) describe…

  3. A Research-Based Laboratory Course in Organic Chemistry

    ERIC Educational Resources Information Center

    Newton, Thomas A.; Tracy, Henry J.; Prudente, Caryn

    2006-01-01

    The development, implementation, evolution, and evaluation of a research-based laboratory course which was created as an alternative to more traditional laboratory instruction is described. The course was able to engage the students in devising and executing their own experiments, the satisfaction of determining the outcomes of those experiments,…

  4. Improving Reading Instruction through Research-Based Instructional Strategies

    ERIC Educational Resources Information Center

    Nash, Vickie Lynn

    2010-01-01

    The diverse population of students in grades 1- 3 at a suburban elementary school has created a challenge for teachers when differentiating instruction in reading. The purpose of this doctoral project study was to explore the lived experiences of these teachers as they have acquired research-based instructional strategies in reading that support…

  5. Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.

    PubMed

    Yadav, Vikramaditya G; Stephanopoulos, Gregory

    2014-07-01

    Research and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from R&D in favor of manufacturing. It is estimated that transitioning to continuous manufacturing could enable companies to compete for a share in emerging markets. Accordingly, the model for continuous manufacturing that has emerged commences with the conversion of late-stage intermediates into the active pharmaceutical ingredient (API) in a series of continuous flow reactors, followed by continuous solid processing to form finished tablets. The use of flow reactions for API synthesis will certainly generate purer products at higher yields in shorter times compared to equivalent batch reactions. However, transitioning from batch to flow configuration simply alleviates transport limitations within the reaction milieu. As the catalogue of reactions used in flow syntheses is a subset of batch-based chemistries, molecules such as natural products will continue to evade drug prospectors. Also, it is uncertain whether flow synthesis can deliver improvements in the atom and energy economies of API production at the scales that would achieve the levels of revenue growth targeted by companies. Instead, it is argued that implementing metabolic engineering for the production of oxidized scaffolds as gateway molecules for flow-based addition of electrophiles is a more effective and scalable strategy for accessing natural product chemical space. This new paradigm for manufacturing, with metabolic engineering as its engine, would also permit rapid optimization of production variables and allow facile scale-up from gram to ton scale to meet material requirements for clinical trials, thus recasting manufacturing as a tool for discovery. PMID:24719301

  6. The pharmaceutical corporation and the 'good work' of managing women's bodies.

    PubMed

    Padamsee, Tasleem Juana

    2011-04-01

    Pharmaceutical companies are intricately intertwined with every aspect of contemporary medical reality, and they increasingly drive the social process of medicalization in order to establish and dominate markets for their drugs and devices. In addition to funding the majority of clinical research, organizing it to generate an evidence base that favors their innovations, and influencing the regulation of pharmaceutical drugs and devices, companies still spend substantial resources on direct attempts to shape the attitudes, dispositions, and prescribing behavior of physicians. This article sheds new light on our picture of the relationship between the pharmaceutical industry and physicians by examining a novel form of physician-directed communication produced by one prominent corporation. An interpretive, thematic analysis of ORGYN - the unique, full-length magazine published by the Organon Corporation between 1990 and 2003 - reveals two overarching messages it communicated to physicians during that period. First, it offered a compelling picture of the "good work" obstetricians and gynecologists do, which involves enabling women of reproductive age to control their fertility through contraception and infertility treatment, and providing symptom relief and preventive benefits to older women by increasing compliance with hormone therapy regimes. Second, it included pharmaceutical technology in every aspect of the doctor's work, portraying pharmaceutical corporations as the physician's "natural partner", and women patients as passive, disempowered objects of medical practice. Through these consistent messages, the print magazine ORGYN represented one important set of mechanisms by which a pharmaceutical corporation helped drive and sustain medicalization. The article ends with a consideration of the implications of ORGYN's messages for companies, doctors, women patients, and the study of medicalization. PMID:21435768

  7. [Pharmaceutical and parapharmaceutical advertising of Annales vertes in 1927].

    PubMed

    Bonnemain, Bruno

    2007-10-01

    The journal Les Annales, under the direction of Adolphe Brisson, was deeply modified by Pierre (Adolphe's son) who decided to publish in 1927 the first issue of Les Annales with a green cover, so called Les Annales vertes. This journal contained a lot of pharmaceutical as well as parapharmaceutical advertising. It is the useful to make an analysis of it at a period which is just preceding the 1929 financial krasch and which is characterized by large advertising budgets in the pharmaceutical industry. Directed toward the general population, advertising was mainly targeting women and patients suffering from anaemia, intestinal transit diseases, or corn. It is also an opportunity to observe the dynamism of some pharmaceutical companies, most of which have disappeared since then. This very large amount of advertising, indeed in excess, will drive ultimately to change the law a few years later in order to control more and more tightly this activity of advertising that targeted the general population as well as medical doctors and pharmacists. PMID:18348495

  8. Recent patents and patented technology platforms for pharmaceutical taste masking.

    PubMed

    Kaushik, Deepak; Dureja, Harish

    2014-04-01

    Taste masking is an important factor in the development of oral dosage forms containing bitter active pharmaceutical ingredients. Currently numerous techniques are being applied to overcome this problem. Realizing this, several researchers and pharmaceutical companies are now engaged in developing novel techniques to address the problem of taste masking evident by numerous patents filed in this area in recent times. In this review the most recent patents for taste masking are discussed and how these patents overcome the limitations of conventional approaches of taste masking is also highlighted. Novel techniques based on some recent patents such as nanohybrid, melt extrusion, non-complex cyclodextrin compositions and off taste masking are providing new realms to taste masking of bitter drugs. The present article also provides an overview of various patented platform technologies based on different techniques/mechanisms employed for taste masking. The unique features and principles of taste-masking approaches used in various patented technologies are also discussed. A better understanding of these new patents and patented technologies will help researchers and pharmaceutical industries to select the appropriate platform, or to develop innovative products with improved taste masking properties. PMID:24499438

  9. Public policy and pharmaceutical innovation.

    PubMed

    Grabowski, H G

    1982-09-01

    Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures. PMID:10309721

  10. Biosafe Nanoscale Pharmaceutical Adjuvant Materials

    PubMed Central

    Jin, Shubin; Li, Shengliang; Wang, Chongxi; Liu, Juan; Yang, Xiaolong; Wang, Paul C.; Zhang, Xin; Liang, Xing-Jie

    2014-01-01

    Thanks to developments in the field of nanotechnology over the past decades, more and more biosafe nanoscale materials have become available for use as pharmaceutical adjuvants in medical research. Nanomaterials possess unique properties which could be employed to develop drug carriers with longer circulation time, higher loading capacity, better stability in physiological conditions, controlled drug release, and targeted drug delivery. In this review article, we will review recent progress in the application of representative organic, inorganic and hybrid biosafe nanoscale materials in pharmaceutical research, especially focusing on nanomaterial-based novel drug delivery systems. In addition, we briefly discuss the advantages and notable functions that make these nanomaterials suitable for the design of new medicines; the biosafety of each material discussed in this article is also highlighted to provide a comprehensive understanding of their adjuvant attributes. PMID:25429253

  11. Are pharmaceutics really going supercritical?

    PubMed

    Pasquali, Irene; Bettini, Ruggero

    2008-12-01

    The present work focuses on some applications of supercritical fluids in the pharmaceutical field, provides a critical review of the most recent advances and aims to give a vision on the future of this technology. In particular, processes such as particle and crystal engineering, formation of cyclodextrin complexes, coating, foaming and tissue engineering, extrusion, production of liposomes, formulation of biotechnological compounds, sterilization and solvent removal are described and discussed. PMID:18597957

  12. A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey

    PubMed Central

    Van Campen, Luann E.; Allen, Albert J.; Watson, Susan B.; Therasse, Donald G.

    2015-01-01

    Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. PMID:26740962

  13. Health risks of counterfeit pharmaceuticals.

    PubMed

    ten Ham, Martijn

    2003-01-01

    Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate. PMID:14583061

  14. Pharmaceutical study of Lauha Bhasma

    PubMed Central

    Singh, Neetu; Reddy, K. R. C.

    2010-01-01

    In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like “pakwa jambu phala varna,” varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta. PMID:22131745

  15. Understanding pharmaceutical quality by design.

    PubMed

    Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet

    2014-07-01

    This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review. PMID:24854893

  16. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovská, Kateřina; Křesálek, Vojtěch

    2015-10-01

    Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.

  17. The CTSA Pharmaceutical Assets Portal – a public–private partnership model for drug repositioning

    PubMed Central

    Marusina, Kate; Welsch, Dean J.; Rose, Lynn; Brock, Doug; Bahr, Nathan

    2011-01-01

    The Pharmaceutical Assets Portal aims to facilitate industry-academic collaborations for discovery of new indications for compounds no longer being developed by pharmaceutical companies, through eliminating barriers to access such compounds. The Portal’s enabling infrastructure includes a national investigator database; a Foci-of-Expertise browser; a material transfer agreement template; and a funding partner. Whereas the goal of creating a shared compound repository remains to be achieved, the Portal has established a mechanism to facilitate future drug repositioning opportunities. PMID:22768020

  18. Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 2: Technical analysis

    NASA Technical Reports Server (NTRS)

    1978-01-01

    A technical analysis on the feasibility of commercial manufacturing of pharmaceuticals in space is presented. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is described. The candidate products are antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon. Production mass balances for antihemophelic factor, beta cells, and erythropoietin were compared for space versus ground operation. A conceptual description of a multiproduct processing system for space operation is discussed. Production requirements for epidermal growth factor of alpha-1-antitrypsin and interferon are presented.

  19. The ethics of pharmaceutical research funding: a social organization approach.

    PubMed

    Gray, Garry C

    2013-01-01

    This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical-company-sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates three significant ways that institutional corruption can occur in the research process. First, conflicts of norms between pharmaceutical companies, universities, and affiliated teaching hospitals can result in compromises and self-censorship. Second, normal behavior is shaped through routine interactions. Unethical behaviors can be (or can become) normal behaviors when they are produced and reproduced through a network of social interactions. Third, funding arrangements can create networks of dependency that structurally distort the independence of the academic researcher in favor of the funder's interests. More broadly, the case study demonstrates how the social organization approach deepens our understanding of the practice of ethics. PMID:24088153

  20. The productivity crisis in pharmaceutical R&D.

    PubMed

    Pammolli, Fabio; Magazzini, Laura; Riccaboni, Massimo

    2011-06-01

    Advances in the understanding of the molecular basis of diseases have expanded the number of plausible therapeutic targets for the development of innovative agents in recent decades. However, although investment in pharmaceutical research and development (R&D) has increased substantially in this time, the lack of a corresponding increase in the output in terms of new drugs being approved indicates that therapeutic innovation has become more challenging. Here, using a large database that contains information on R&D projects for more than 28,000 compounds investigated since 1990, we examine the decline of R&D productivity in pharmaceuticals in the past two decades and its determinants. We show that this decline is associated with an increasing concentration of R&D investments in areas in which the risk of failure is high, which correspond to unmet therapeutic needs and unexploited biological mechanisms. We also investigate the potential variations in productivity with regard to the regional location of companies and find that although companies based in the United States and Europe differ in the composition of their R&D portfolios, there is no evidence of any productivity gap. PMID:21629293

  1. International pharmaceutical social risk regulation: An ethical perspective.

    PubMed

    Gordon, Cameron

    2011-03-01

    Pharmaceutical production and distribution constitute big business. For the companies the rewards can be substantial. Rates of return on drug company investments tend to be higher than many other manufacturing enterprises. But reward is only one side of the story. There is also the issue of social risk, the focus of this article. Social risk for pharmaceutical production is especially pronounced. An ineffective or, worse, dangerous drug, can have dire consequences for the population at large. For this reason, there is elaborate government regulation and oversight of drug safety and risk. These systems, especially in the US and Europe, will be the main focus of this paper. The two systems will be described, and then compared and contrasted in terms of their framing of social risk and actions governments take to limit it. Systems elsewhere, especially in the developing world, are increasing in relative importance and these will be briefly discussed as well. Ethical issues that have arisen in these various systems will be surfaced and analysed. The paper will close with some conclusions and suggestions for further research. PMID:21406340

  2. Respirator leakage in the pharmaceutical industry of northwest England.

    PubMed

    Burgess, G L; Mashingaidze, M T

    1999-11-01

    Field qualitative fit tests were conducted at 10 separate companies in the Northwest of England to determine the proportion of leaking respirators in a cross-section of pharmaceutical manufacturing industries. The 3 M FT-10 Qualitative Fit Test Apparatus was used to test a total of 211 half-face particulate respirator wearers. Participants wore their own respirators and were asked to don them as they would normally. In all cases, no specific intervention had occurred prior to testing. Results indicated a failure rate of 69% (of the 211 subjects tested, 145 respirators were leaking). Successful results were not associated with the frequency of use (p = 0.71) or years of experience wearing respirators (p = 0.59). Similarly, successful results were not associated with respirator training in the current job (p = 0.38) or training in previous jobs (p = 0.49). Leakage was not consistent across the 10 companies, with two companies exhibiting a 100% failure rate while another company had 26 successful tests in 50 wearers (52% pass rate). Only 35 of the 211 participants performed a negative pressure test. Of these, 80% successfully passed the test, which was significantly greater than the 22% pass rate among those who had not performed the pressure test (p < 0.001). PMID:10616324

  3. “Does Organizational Culture Influence the Ethical Behavior in the Pharmaceutical Industry?”

    PubMed Central

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-01-01

    Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer’s V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India. PMID:24826027

  4. Using Collaborative Environments in Research-Based Science Education

    NASA Astrophysics Data System (ADS)

    Fortson, L.; Subbarao, M.; Greenberg, G.

    2008-06-01

    With the advent of the Internet, the World Wide Web and social networking systems, a number of collaborative environments have been developed that support efforts in online science education. This paper examines the basic aspects of online collaboration, describes two differing types of collaborative environments currently used, and discusses the elements of successful collaborative environments for online projects that enable research-based science education.

  5. Global gene mining and the pharmaceutical industry

    SciTech Connect

    Knudsen, Lisbeth E.

    2005-09-01

    Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring independence and legal competence. Good decision making, assuring legality of protocols and assessment of data protection is suggested to be part of any evaluation of protocols.

  6. Adapting Project Management Practices to Research-Based Projects

    NASA Technical Reports Server (NTRS)

    Bahr, P.; Baker, T.; Corbin, B.; Keith, L.; Loerch, L.; Mullenax, C.; Myers, R.; Rhodes, B.; Skytland, N.

    2007-01-01

    From dealing with the inherent uncertainties in outcomes of scientific research to the lack of applicability of current NASA Procedural Requirements guidance documentation, research-based projects present challenges that require unique application of classical project management techniques. If additionally challenged by the creation of a new program transitioning from basic to applied research in a technical environment often unfamiliar with the cost and schedule constraints addressed by project management practices, such projects can find themselves struggling throughout their life cycles. Finally, supplying deliverables to a prime vehicle customer, also in the formative stage, adds further complexity to the development and management of research-based projects. The Biomedical Research and Countermeasures Projects Branch at NASA Johnson Space Center encompasses several diverse applied research-based or research-enabling projects within the newly-formed Human Research Program. This presentation will provide a brief overview of the organizational structure and environment in which these projects operate and how the projects coordinate to address and manage technical requirements. We will identify several of the challenges (cost, technical, schedule, and personnel) encountered by projects across the Branch, present case reports of actions taken and techniques implemented to deal with these challenges, and then close the session with an open forum discussion of remaining challenges and potential mitigations.

  7. Section 1: Company directory

    SciTech Connect

    Not Available

    1991-12-01

    This is a 1992 directory of those companies doing business in all areas of the independent power producers industry. The listing includes the company name, address, telephone and FAX numbers, and the name of a company contact. The listing is international in scope.

  8. Introduction: Institutional corruption and the pharmaceutical policy.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. PMID:24088143

  9. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

    EPA Science Inventory

    Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

  10. Pharmaceutical Cocrystals and Their Physicochemical Properties

    PubMed Central

    2009-01-01

    Over the last 20 years, the number of publications outlining the advances in design strategies, growing techniques, and characterization of cocrystals has continued to increase significantly within the crystal engineering field. However, only within the last decade have cocrystals found their place in pharmaceuticals, primarily due to their ability to alter physicochemical properties without compromising the structural integrity of the active pharmaceutical ingredient (API) and thus, possibly, the bioactivity. This review article will highlight and discuss the advances made over the last 10 years pertaining to physical and chemical property improvements through pharmaceutical cocrystalline materials and, hopefully, draw closer the fields of crystal engineering and pharmaceutical sciences. PMID:19503732

  11. Toward a definition of pharmaceutical innovation.

    PubMed

    Morgan, Steven; Lopert, Ruth; Greyson, Devon

    2008-01-01

    ONGOING DEBATES IN THE PHARMACEUTICAL SECTOR ABOUT INTELLECTUAL PROPERTY, PRICING AND REIMBURSEMENT, AND PUBLIC RESEARCH INVESTMENTS HAVE A COMMON DENOMINATOR: the pursuit of innovation. However, there is little clarity about what constitutes a true pharmaceutical innovation, and as a result there is confusion about what kind of new products should be pursued, protected and encouraged through health policy and clinical practice. If the concept of pharmaceutical innovation can be clarified, then it may become easier for health policy-makers and practitioners to evaluate, adopt and procure products in ways that appropriately recognize, encourage and give priority to truly valuable pharmaceutical innovations. PMID:21602949

  12. Pharmaceutical Injury Insurance in the Nordic countries - an alternative to the traditional law of tort.

    PubMed

    Persson, L; Westerhäll, L

    1997-01-01

    The problem of litigation brought against physicians, pharmaceutical companies and pharmacies for alleged injury as a result of drug treatment is an increasing one throughout the world. The shortcomings of litigation as a means of solving conflicts and providing remedies are evident; it is slow, complex, extremely costly, and sometimes unfair. An alternative approach is offered by the various "pharmaceutical insurance" schemes which exists in the Nordic countries, that in Sweden having been operative for the longest period. This critical account of the Nordic systems of compensation may provide a starting point for developing non-litigious approaches to the problem of drug-induced injury elsewhere. In particular, one may note the manner in which Product Liability Legislation according to the E.C. model and "pharmaceutical insurance" schemes according to the Nordic model can usefully complement one another. PMID:23511368

  13. Oxymoron no more: the potential of nonprofit drug companies to deliver on the promise of medicines for the developing world.

    PubMed

    Hale, Victoria G; Woo, Katherine; Lipton, Helene Levens

    2005-01-01

    Although some pharmaceutical company efforts to develop and distribute drugs in developing countries have been successful, many fall short of meeting needs in resource-poor nations. In the context of public-private partnerships, we discuss the concept of a nonprofit pharmaceutical company dedicated to developing and distributing drugs for diseases endemic in developing countries. Using the experience of the Institute for OneWorld Health, we present the vision, core elements of the product development model, and challenges confronting this model. Despite limitations, early successes raise hopes that a nonprofit drug company can exist successfully both as a global health organization and as a business. PMID:16012146

  14. Microbial factories for recombinant pharmaceuticals

    PubMed Central

    Ferrer-Miralles, Neus; Domingo-Espín, Joan; Corchero, José Luis; Vázquez, Esther; Villaverde, Antonio

    2009-01-01

    Most of the hosts used to produce the 151 recombinant pharmaceuticals so far approved for human use by the Food and Drug Administration (FDA) and/or by the European Medicines Agency (EMEA) are microbial cells, either bacteria or yeast. This fact indicates that despite the diverse bottlenecks and obstacles that microbial systems pose to the efficient production of functional mammalian proteins, namely lack or unconventional post-translational modifications, proteolytic instability, poor solubility and activation of cell stress responses, among others, they represent convenient and powerful tools for recombinant protein production. The entering into the market of a progressively increasing number of protein drugs produced in non-microbial systems has not impaired the development of products obtained in microbial cells, proving the robustness of the microbial set of cellular systems (so far Escherichia coli and Saccharomyces cerevisae) developed for protein drug production. We summarize here the nature, properties and applications of all those pharmaceuticals and the relevant features of the current and potential producing hosts, in a comparative way. PMID:19317892

  15. Microbial factories for recombinant pharmaceuticals.

    PubMed

    Ferrer-Miralles, Neus; Domingo-Espn, Joan; Corchero, Jos Luis; Vzquez, Esther; Villaverde, Antonio

    2009-01-01

    Most of the hosts used to produce the 151 recombinant pharmaceuticals so far approved for human use by the Food and Drug Administration (FDA) and/or by the European Medicines Agency (EMEA) are microbial cells, either bacteria or yeast. This fact indicates that despite the diverse bottlenecks and obstacles that microbial systems pose to the efficient production of functional mammalian proteins, namely lack or unconventional post-translational modifications, proteolytic instability, poor solubility and activation of cell stress responses, among others, they represent convenient and powerful tools for recombinant protein production. The entering into the market of a progressively increasing number of protein drugs produced in non-microbial systems has not impaired the development of products obtained in microbial cells, proving the robustness of the microbial set of cellular systems (so far Escherichia coli and Saccharomyces cerevisae) developed for protein drug production. We summarize here the nature, properties and applications of all those pharmaceuticals and the relevant features of the current and potential producing hosts, in a comparative way. PMID:19317892

  16. Plant cells as pharmaceutical factories.

    PubMed

    Rischer, Heiko; Häkkinen, Suvi T; Ritala, Anneli; Seppänen-Laakso, Tuulikki; Miralpeix, Bruna; Capell, Teresa; Christou, Paul; Oksman-Caldentey, Kirsi-Marja

    2013-01-01

    Molecules derived from plants make up a sizeable proportion of the drugs currently available on the market. These include a number of secondary metabolite compounds the monetary value of which is very high. New pharmaceuticals often originate in nature. Approximately 50% of new drug entities against cancer or microbial infections are derived from plants or micro-organisms. However, these compounds are structurally often too complex to be economically manufactured by chemical synthesis, and frequently isolation from naturally grown or cultivated plants is not a sustainable option. Therefore the biotechnological production of high-value plant secondary metabolites in cultivated cells is potentially an attractive alternative. Compared to microbial systems eukaryotic organisms such as plants are far more complex, and our understanding of the metabolic pathways in plants and their regulation at the systems level has been rather poor until recently. However, metabolic engineering including advanced multigene transformation techniques and state-of-art metabolomics platforms has given us entirely new tools to exploit plants as Green Factories. Single step engineering may be successful on occasion but in complex pathways, intermediate gene interventions most often do not affect the end product accumulation. In this review we discuss recent developments towards elucidation of complex plant biosynthetic pathways and the production of a number of highvalue pharmaceuticals including paclitaxel, tropane, morphine and terpenoid indole alkaloids in plants and cell cultures. PMID:23394561

  17. Prevalence and Determinants of Physician Participation in Conducting Pharmaceutical-sponsored Clinical Trials and Lectures

    PubMed Central

    Ashar, Bimal H; Miller, Redonda G; Getz, Kelly J; Powe, Nell R

    2004-01-01

    BACKGROUND The relationship between physicians and the pharmaceutical industry is controversial because of the potential for conflicts of interest. However, little empirical evidence exists on the extent of physician participation in activities sponsored by pharmaceutical companies. OBJECTIVES To determine the prevalence of participation of internal medicine physicians in clinical trials and lectures sponsored by pharmaceutical companies and to describe factors that are associated with such participation. DESIGN, SETTING, AND PARTICIPANTS We conducted a cross-sectional regional survey of 1,000 Maryland internal medicine physicians between February 2000 and January 2001 in order to measure the prevalence of physician participation in pharmaceutical-sponsored clinical trials and lectures. We also collected economic and demographic information to examine potential associations between physician characteristics and engagement in such activities. RESULTS Of 835 eligible physicians 444 (53%) responded, of whom 37% reported engaging in pharmaceutical-sponsored clinical trials and/or lectures to supplement their incomes. In our multivariable analysis, subspecialists versus generalist physicians (odds ratio [OR], 1.85; 95% confidence interval [CI], 1.14 to 2.99), physicians in private group-single specialty and academic practice versus physicians in solo practice (OR, 2.30; 95% CI, 1.19 to 4.44 and OR, 2.56; 95% CI, 1.17 to 5.61, respectively), and physicians with higher versus lower annual incomes (OR, 1.22; 95% CI, 1.04 to 1.44) had a greater odds of participation in these activities. Additionally, physicians dissatisfied with their income had a 140% greater odds of participation (OR, 2.36; 95% CI, 1.45 to 3.83) than those who were satisfied with their income. CONCLUSIONS A substantial number of internists engage in pharmaceutical industry-sponsored clinical trials and/or lectures in an effort to supplement their incomes. Physician dissatisfaction with income appears to partially explain such participation. PMID:15566444

  18. Actor modelling and its contribution to the development of integrative strategies for management of pharmaceuticals in drinking water.

    PubMed

    Titz, Alexandra; Döll, Petra

    2009-02-01

    Widespread presence of human pharmaceuticals in water resources across the globe is documented. While some, but certainly not enough, research on the occurrence, fate and effect of pharmaceuticals in water resources has been carried out, a holistic risk management strategy is missing. The transdisciplinary research project "start" aimed to develop an integrative strategy by the participation of experts representing key actors in the problem field "pharmaceuticals in drinking water". In this paper, we describe a novel modelling method, actor modelling with the semi-quantitative software DANA (Dynamic Actor Network Analysis), and its application in support of identifying an integrative risk management strategy. Based on the individual perceptions of different actors, the approach allows the identification of optimal strategies. Actors' perceptions were elicited by participatory model building and interviews, and were then modelled in perception graphs. Actor modelling indicated that an integrative strategy that targets environmentally-responsible prescription, therapy, and disposal of pharmaceuticals on one hand, and the development of environmentally-friendly pharmaceuticals on the other hand, will likely be most effective for reducing the occurrence of pharmaceuticals in drinking water (at least in Germany where the study was performed). However, unlike most other actors, the pharmaceutical industry itself does not perceive that the production of environmentally-friendly pharmaceuticals is an action that helps to achieve its goals, but contends that continued development of highly active pharmaceutical ingredients will help to reduce the occurrence of pharmaceuticals in the water cycle. Investment in advanced waste or drinking water treatment is opposed by both the wastewater treatment company and the drinking water supplier, and is not mentioned as appropriate by the other actors. According to our experience, actor modelling is a useful method to suggest effective and realisable integrative risk management strategies in complex problem fields that involve many societal actors. PMID:19110360

  19. Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.

    PubMed

    Hecker, Sandra J; Preston, Christopher; Foote, MaryAnn

    2003-01-01

    Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed. PMID:14650931

  20. An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)

    PubMed Central

    Mohammadzadeh, Mehdi; Aryanpour, Narges

    2013-01-01

    Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires. PMID:24250597

  1. An export-marketing model for pharmaceutical firms (the case of iran).

    PubMed

    Mohammadzadeh, Mehdi; Aryanpour, Narges

    2013-01-01

    Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires. PMID:24250597

  2. Drug discovery market exclusivity after KSR: the challenge to pharmaceutical scientists and the US congress.

    PubMed

    Wolff, Manfred E

    2011-08-01

    The Hatch-Waxman Act provides 180 days of market exclusivity to encourage generic companies to challenge the validity of pharmaceutical patents issued to innovator pharmaceutical companies. The consequent patent losses have been exacerbated owing to the application of holdings of the 2007 Supreme Court KSR decision to questions of pharmaceutical patentability by the judiciary and the US Patent Office. The resulting negative effect on support for new drug and formulation discovery by pharmaceutical scientists is discussed. To counteract the societal detriment of this negative effect, the adoption of a 12-year US Food and Drug Administration (FDA) market exclusivity paradigm for all approved new chemical entities including prodrugs is proposed. Such market exclusivities have already been enacted in the United States for follow-on biologicals and are in substantial harmony with those of the European Union, Japan, and Canada. An extension of the existing 3-year FDA market exclusivity for new formulations under 21 U.S.C. (United States Code) §505(b)(2) to 5 years should also be considered. PMID:21472728

  3. Using health outcomes data to inform decision-making: a pharmaceutical industry perspective.

    PubMed

    Keech, M

    2001-01-01

    Within the pharmaceutical industry, there is increasing interest in collecting health outcomes data in order to inform decision-making, both internally and externally. The overall aim of generating the health outcomes information is to determine the value of the product, from the perspective of all the stakeholders. In addition to studies carried out during phase II and III of clinical development, pharmaceutical companies have recently begun to collect health outcomes information earlier, with the expected requirements for reimbursement and market access considered during the preclinical and phase I stages. However, there are a number of challenges to the demonstration of product value during drug development, particularly relating to the limitations of clinical trials. One way that pharmaceutical companies are addressing these challenges is through the use of economic modelling, to provide a framework to test assumptions and assess uncertainty, and examine the budget impact of treatments. Although different countries may use the information differently, health outcomes evidence generated by the pharmaceutical industry is generally used to inform decision-making about pricing, reimbursement, treatment guidelines and inclusion of drugs on formularies. A wide variety of health outcomes information is produced by the industry in order to provide data on product value that are appropriate for the different perspectives of the stakeholders in the healthcare system. PMID:11700786

  4. Curing the disobedient patient: medication adherence programs as pharmaceutical marketing tools.

    PubMed

    Lamkin, Matt; Elliott, Carl

    2014-01-01

    Pharmaceutical companies have long focused their marketing strategies on getting doctors to write more prescriptions. But they lose billions in potential sales when patients do not take their prescribed drugs. Getting patients to "adhere" to drug therapies that have unpleasant side effects and questionable efficacy requires more than mere ad campaigns urging patients to talk to their doctors. It requires changing patients' beliefs and attitudes about their medications through repeated contact from people patients trust. Since patients do not trust drug companies, these companies are delivering their marketing messages through nurses, pharmacists, and even other patients--leveraging patients' trust in these intermediaries to persuade them to consume more brand name drugs. Armed with the premise that better adherence improves patients' health, drug companies justify manipulating patients by reframing reasonable decisions to decline therapy as pathological, and promote brand loyalty in the guise of offering medical care. PMID:25565615

  5. Research-Based Implementation of Peer Instruction: A Literature Review

    PubMed Central

    Vickrey, Trisha; Rosploch, Kaitlyn; Rahmanian, Reihaneh; Pilarz, Matthew; Stains, Marilyne

    2015-01-01

    Current instructional reforms in undergraduate science, technology, engineering, and mathematics (STEM) courses have focused on enhancing adoption of evidence-based instructional practices among STEM faculty members. These practices have been empirically demonstrated to enhance student learning and attitudes. However, research indicates that instructors often adapt rather than adopt practices, unknowingly compromising their effectiveness. Thus, there is a need to raise awareness of the research-based implementation of these practices, develop fidelity of implementation protocols to understand adaptations being made, and ultimately characterize the true impact of reform efforts based on these practices. Peer instruction (PI) is an example of an evidence-based instructional practice that consists of asking students conceptual questions during class time and collecting their answers via clickers or response cards. Extensive research has been conducted by physics and biology education researchers to evaluate the effectiveness of this practice and to better understand the intricacies of its implementation. PI has also been investigated in other disciplines, such as chemistry and computer science. This article reviews and summarizes these various bodies of research and provides instructors and researchers with a research-based model for the effective implementation of PI. Limitations of current studies and recommendations for future empirical inquiries are also provided. PMID:25713095

  6. Research-based implementation of peer instruction: a literature review.

    PubMed

    Vickrey, Trisha; Rosploch, Kaitlyn; Rahmanian, Reihaneh; Pilarz, Matthew; Stains, Marilyne

    2015-03-01

    Current instructional reforms in undergraduate science, technology, engineering, and mathematics (STEM) courses have focused on enhancing adoption of evidence-based instructional practices among STEM faculty members. These practices have been empirically demonstrated to enhance student learning and attitudes. However, research indicates that instructors often adapt rather than adopt practices, unknowingly compromising their effectiveness. Thus, there is a need to raise awareness of the research-based implementation of these practices, develop fidelity of implementation protocols to understand adaptations being made, and ultimately characterize the true impact of reform efforts based on these practices. Peer instruction (PI) is an example of an evidence-based instructional practice that consists of asking students conceptual questions during class time and collecting their answers via clickers or response cards. Extensive research has been conducted by physics and biology education researchers to evaluate the effectiveness of this practice and to better understand the intricacies of its implementation. PI has also been investigated in other disciplines, such as chemistry and computer science. This article reviews and summarizes these various bodies of research and provides instructors and researchers with a research-based model for the effective implementation of PI. Limitations of current studies and recommendations for future empirical inquiries are also provided. PMID:25713095

  7. [Early achievements of the Danish pharmaceutical industry-7].

    PubMed

    Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

    2014-01-01

    A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board of Health was, however, at that time of the opinion that there were no serious problems with organotherapeutics from those companies marketing such products. It requires studies in the unprinted journals of the Ministry of Health and the National Board of Health to find the background for and the causes of the request from the Ministry at this point concerning the control of the organotherapeutic products of the pharmaceutical industry. Neither were GEA's barbiturates innovative products. The "Gad Andresen Case" is interesting for two reasons. Firstly, it illustrates that the development of generics at this stage could not always take place exclusively in a pharmaceutical-chemical laboratory, but also required a certain minimum of clinical trials including human beings. Secondly, it shows that the industrial products had now slowly, but surely gained market shares and displaced the pharmacy-produced medicinal products to such an extent that it did not only worry the pharmacy owners and their trade orga- nization. Now this concern had also resulted in a counteract so that the pharmacies in the manufacture of their products had to copy the industrial products, however, in certain cases with a dubious result. Gealgica tablets and especially their content of fenacetine is not only a model example of how the opinion of the positive and negative properties of a medicinal product changes over time. It also shows how long time could pass before the health authorities took measures against a substance with problematic side effects in spite of the fact that less damaging substances had been available for a long time, in this case paracetamol. Medicinal products containing fenacetine were on the market for almost 100 years. On the contrary meprobamat is a model example of a drug substance where the opinion of its positive and negative properties changed essentially over a relatively short period. In spite of this it remained on the market for a little less than 40 years. Restenil and Trihistan are mentioned on Knud & Dagny Gad Andresen's homepage (in 2014) as new medicinal products developed by GEA. This is not quite correct. Both drug substances in these preparations had been developed in the USA. In Denmark GEA had the possibility to market these substances under GEA's own brand names along with corresponding foreign brand names. It can be concluded that GEA's own research on the whole was confined to the development of own patentable syntheses of already known drug substances. During the later marketing of generics GEA appealed to the national feeling of the Danish population in the same way as a.o. Pharmacia did in the 1920s. From the very start GEA specialized in the manufacture of generics, and GEA was able to follow this way with commercial success--as a Danish alternative--for almost 90 years. PMID:25816561

  8. Pharmaceutical marketing in a new age. Effective campaigns still need to focus on what customers want.

    PubMed

    Rao, Sanjay K

    2002-01-01

    The pharmaceutical industry has focused heavily on marketers' ability to market new products more efficiently. However, a more streamlined marketing approach can help address customers' needs and ease the pressure on drug companies to discover new drugs with blockbuster appeal. Through discussion and a detailed example, this article describes a stream-lined approach to creating more effective marketing and sales force strategies. PMID:11881547

  9. 76 FR 29744 - Monongahela Power Company, West Penn Power Company, The Potomac Edison Company, PJM...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... Edison Company, PJM Interconnection, L.L.C.; Notice of Filing Take notice that on May 13, 2011, Monongahela Power Company, West Penn Power Company, The Potomac Edison Company (collectively, the...

  10. Synthetic biology advances for pharmaceutical production.

    PubMed

    Breitling, Rainer; Takano, Eriko

    2015-12-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

  11. The Impact of Biotechnology on Pharmaceutics.

    ERIC Educational Resources Information Center

    Block, Lawrence H.

    1990-01-01

    The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

  12. Biotech pharmaceuticals and biotherapy: an overview.

    PubMed

    Steinberg, F M; Raso, J

    1998-01-01

    Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals. PMID:10945918

  13. Nanostructured materials in electroanalysis of pharmaceuticals.

    PubMed

    Rahi, A; Karimian, K; Heli, H

    2016-03-15

    Basic strategies and recent developments for the enhancement of the sensory performance of nanostructures in the electroanalysis of pharmaceuticals are reviewed. A discussion of the properties of nanostructures and their application as modified electrodes for drug assays is presented. The electrocatalytic effect of nanostructured materials and their application in determining low levels of drugs in pharmaceutical forms and biofluids are discussed. PMID:26751130

  14. Synthetic biology advances for pharmaceutical production

    PubMed Central

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

  15. Financial Aspects and the Future of the Pharmaceutical Industry in the United States of America

    PubMed Central

    Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

    2013-01-01

    Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. Purpose: The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. Methodology: This paper represents a thorough literature review of the multifaceted sources including: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). Discussion: In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or – at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Conclusion: Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and eliminating a major source of the industry’s profits. Still, there is plenty of room for improvement in the medications people take while there is no shortage of human suffering to alleviate. It is doubtful whether big pharmaceutical firms will be able to pursue these goals within the old model of developing exclusive new drugs that can be sold further in the future. In the past, medicines for the ailments that were never before addressed, like anti-cholesterol or anti-depression drugs were developed. Currently, and in the future, it is expected that only blockbuster modifications will be developed. This phenomenon is expected to create market saturation, which will significantly reduce profits. The business model that drove the major drug makers’ success is not working anymore. Pharmaceutical companies must create new ways and to bring new ideas. The survivors will be those that market strategies supported by innovative approaches and winning capabilities. PMID:24511277

  16. Pharmaceutical counterfeiting and the RFID technology intervention.

    PubMed

    Coustasse, Alberto; Arvidson, Cody; Rutsohn, Phil

    2010-07-01

    Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of the counterfeit drug problem. Recommendations for how the pharmaceutical industry may sooner adopt the RFID model are made. PMID:20582850

  17. What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study

    PubMed Central

    Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Warner, Kay; Wever, Kim

    2016-01-01

    Objectives To explore European-based pharmaceutical industry professionals’ beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Setting Pharmaceutical companies in the UK, Poland and Spain. Participants 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Method Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. Results 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Conclusions Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. PMID:26743701

  18. Developing a pharmaceutical purchasing strategy.

    PubMed

    Hynniman, C E

    1992-09-01

    The process commonly used by group purchasing organizations to contract for multisource pharmaceuticals and a strategic approach for the director of pharmacy in working with the purchasing group and the P & T Committee is described. The pharmacist should be knowledgeable concerning the group's contract commitment requirements, product specifications, terms and conditions and procedures for vendor selection, product award, contract implementation, and performance monitoring. To ensure results that meet the needs of the medical staff, it is important that the P & T Committee actively participate. The P & T Committee should understand the reasons for selecting a particular purchasing group, understand the necessary steps in obtaining the most favorable economic advantage, review products with potential brand interchange concerns, recommend product specifications, and reaffirm formulary procedures regarding the principle of current consent. PMID:10171225

  19. Models for financing the regulation of pharmaceutical promotion.

    PubMed

    Lexchin, Joel

    2012-01-01

    Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs. PMID:22784944

  20. Causality assessment: A brief insight into practices in pharmaceutical industry.

    PubMed

    Naidu, R Purushotham

    2013-10-01

    Healthcare industry is flooded with multitude of drugs, and the list is increasing day by day. Consumption of medications has enormously increased due to life style changes, having safer drugs is the need of the hour. Regulators and other authorities to have a check have put in stringent regulations and pharmacovigilance system in place. Eventhough there has been increase in adverse drug reactions (ADR) reporting in the last decade, causality assessment has been the greater challenge for academicians and even industry. Causality is crucial for risk benefit assessment, particularly when it involves post marketing safety signals. Pharmaceutical companies have put in efforts to have a standardized approach for causality assessment. This article will provide some insight into the approaches for causality assessment from a pharma industry perspective. PMID:24312892

  1. Anti-counterfeit technologies: a pharmaceutical industry perspective.

    PubMed

    Bansal, Dipika; Malla, Swathi; Gudala, Kapil; Tiwari, Pramil

    2013-03-01

    Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence like overt, covert, and track and trace technologies. This review emphasises ideal technological characteristics, existing anti-counterfeit technologies, and their adoption in different countries. Developed countries like the USA have implemented RFID while the European trend is towards 2D barcodes. The Indian government is getting sensitised about the extent of the problem and has formulated rules mandating barcodes. Even the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain. PMID:23641326

  2. The pharmaceutical industry and oncology in central and eastern Europe.

    PubMed

    Ben-Am, M; Gemperli, B; Covelli, A; Burke, G

    1999-01-01

    Major opportunities exist for patients, investigators and the pharmaceutical industry in oncology drug development in Central and Eastern Europe. Novel therapeutics may be offered for investigational use in selected centres capable of adherence to Good Clinical Practice (GCP). Requirements for participation in oncology clinical trials include the availability of experienced qualified investigators highly motivated to conform with the principles of GCP (International Harmonization (ICH) guidelines); availability of appropriate Institutional Review Board for Human Subjects (IRB), access to appropriate patient populations, access to individual patient data, acceptance of possible audit by sponsoring companies and the Food and Drug Administration (FDA), and a willingness to participate in the generation of new knowledge. Patients gain through access to novel therapeutics. We have had success in performing clinical trials to international standards in Central and Eastern Europe. This experience will be described. PMID:10676548

  3. Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective

    PubMed Central

    Bansal, Dipika; Malla, Swathi; Gudala, Kapil; Tiwari, Pramil

    2013-01-01

    Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence like overt, covert, and track and trace technologies. This review emphasises ideal technological characteristics, existing anti-counterfeit technologies, and their adoption in different countries. Developed countries like the USA have implemented RFID while the European trend is towards 2D barcodes. The Indian government is getting sensitised about the extent of the problem and has formulated rules mandating barcodes. Even the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain. PMID:23641326

  4. Models for financing the regulation of pharmaceutical promotion

    PubMed Central

    2012-01-01

    Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs. PMID:22784944

  5. Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association.

    PubMed Central

    1994-01-01

    The history of health care delivery in Canada has been marked by close collaboration between physicians and the pharmaceutical and health supply industries, this collaboration extending to research as well as to education. Since medicine is a self-governing profession physicians have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their duties toward their patients and society. The following guidelines have been developed by the CMA to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents and interns as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA considers that the same principles apply to the relationship between its members and manufacturers of medical devices, infant formulas and similar products, and health care products and service suppliers in general. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada. PMID:8287348

  6. The mortality of companies.

    PubMed

    Daepp, Madeleine I G; Hamilton, Marcus J; West, Geoffrey B; Bettencourt, Luís M A

    2015-05-01

    The firm is a fundamental economic unit of contemporary human societies. Studies on the general quantitative and statistical character of firms have produced mixed results regarding their lifespans and mortality. We examine a comprehensive database of more than 25 000 publicly traded North American companies, from 1950 to 2009, to derive the statistics of firm lifespans. Based on detailed survival analysis, we show that the mortality of publicly traded companies manifests an approximately constant hazard rate over long periods of observation. This regularity indicates that mortality rates are independent of a company's age. We show that the typical half-life of a publicly traded company is about a decade, regardless of business sector. Our results shed new light on the dynamics of births and deaths of publicly traded companies and identify some of the necessary ingredients of a general theory of firms. PMID:25833247

  7. The mortality of companies

    PubMed Central

    Daepp, Madeleine I. G.; Hamilton, Marcus J.; West, Geoffrey B.; Bettencourt, Luís M. A.

    2015-01-01

    The firm is a fundamental economic unit of contemporary human societies. Studies on the general quantitative and statistical character of firms have produced mixed results regarding their lifespans and mortality. We examine a comprehensive database of more than 25 000 publicly traded North American companies, from 1950 to 2009, to derive the statistics of firm lifespans. Based on detailed survival analysis, we show that the mortality of publicly traded companies manifests an approximately constant hazard rate over long periods of observation. This regularity indicates that mortality rates are independent of a company's age. We show that the typical half-life of a publicly traded company is about a decade, regardless of business sector. Our results shed new light on the dynamics of births and deaths of publicly traded companies and identify some of the necessary ingredients of a general theory of firms. PMID:25833247

  8. Who Has Used Internal Company Documents for Biomedical and Public Health Research and Where Did They Find Them?

    PubMed Central

    Wieland, L. Susan; Rutkow, Lainie; Vedula, S. Swaroop; Kaufmann, Christopher N.; Rosman, Lori M.; Twose, Claire; Mahendraratnam, Nirosha; Dickersin, Kay

    2014-01-01

    Objective To describe the sources of internal company documents used in public health and healthcare research. Methods We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. Results Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceutical companies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. Conclusions Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for research, indicating a need for funding for this type of research and well-indexed and curated repositories to provide researchers with ready access to the documents. PMID:24800999

  9. Evolution of Plant-Made Pharmaceuticals

    PubMed Central

    Thomas, David R.; Penney, Claire A.; Majumder, Amrita; Walmsley, Amanda M.

    2011-01-01

    The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual difficulties of pharmaceutical development, pharmaceuticals made by plants have achieved pertinent milestones albeit slowly compared to other pharmaceutical production systems and are now at the cusp of reaching the consumer. Though the current economic climate begs for cautious investment as opposed to trail blazing, it is perhaps a good time to look to the future of plant-made pharmaceutical technology to assist in planning for future developments in order not to slow this technology’s momentum. To encourage continued progress, we highlight the advances made so far by this technology, particularly the change in paradigms, comparing developmental timelines, and summarizing the current status and future possibilities of plant-made pharmaceuticals. PMID:21686181

  10. [Future challenges and prospects for drug companies].

    PubMed

    Lajoux, Christian

    2008-04-01

    The challenge for drug companies is to work with healthcare professionals and public-sector stakeholders in order to ensure therapeutic progress and better healthcare. Faced with major scientific and economic upheavals, the industry's model of innovation is being totally revisited. France has always been an important home for the drugs industry. Indeed, this country has numerous advantages (human resources, top-flight research, production tools, etc.) and a vibrant professional pharmaceutical syndicate. Yet France is falling further and further behind in the international race. Competition no longer takes place solely between economic players, but now also between geographic zones. Will companies operating in France be able to meet the challenges of collaborative public-private research and changes in the means of production, the two key levers for future success? The main priority now is to ensure coherence between national healthcare policy and industrial policy, if France is to become a world leader in the life sciences and healthcare. Only efficient cooperation between the authorities, stakeholders and companies, will enable us to achieve this goal. PMID:19024935

  11. Another development in pharmaceuticals: an introduction.

    PubMed

    Streky, G

    1985-01-01

    The provision of appropriate medicines of the right kind, quality and quantity, and at reasonable prices is a central concern for any government. Simultaneously, there is increasing recognition of the serious problems inherent in the existing systems of pharmaceutical development, promotion, marketing, distribution and use in all countries and particularly in the 3rd World. The vast majority of people in most 3rd World countries have little or no access to effective and safe medicines. The Dag Hammarskjold Foundation organized a consultation on Another Development in Pharmaceuticals in June 1985. It was based on some papers commissioned for that occasion with a view to developing new approaches to fundamental problems in this field and involving both national and international actors and institutions. The basic concern of these papers was to place the debate on pharmaceuticals in its proper historical, contemporary and future context. The 5 major areas discussed were: 1) man and medicines: a historical perspective; 2) towards a healthy use of pharmaceuticals; 3) towards a healthy pharmaceutical industry by the year 2000; 4) 1st principles for the prescription, promotion and use of pharmaceuticals: towards a code of conduct; and 5) monitoring Another Development in Pharmaceuticals. 90% of the world's production of pharmaceuticals originates in the industrialized countries, which also accounts for 80% of the consumption. 3rd World countries have been supplied with a very inappropriate assortment of products by the pharmaceutical industry. There is a growing demand for improved practices that are conducive to health development. An international harmonization of regulatory standards is needed. PMID:12341048

  12. Managing the cost of specialty pharmaceuticals.

    PubMed

    Kernich, Catherine A; Creighton, Frederick A

    2004-01-01

    The cost of specialty pharmaceuticals is a significant driver of increased costs in the delivery of ambulatory care. This expense is expected to increase disproportionately as an increased number of specialty pharmaceuticals available to treat rare, complex, or chronic diseases enter the market. Ambulatory practice managers must plan for these increased expenditures in a fiscally sound manner. The department of medicine at University Hospitals of Cleveland has developed a comprehensive system of checks and balances for managing specialty pharmaceuticals. This system includes working closely with providers and payers, underpinned with sound business planning techniques. PMID:15586478

  13. Quality evaluation of pharmaceutical formulations containing hydrochlorothiazide.

    PubMed

    de Oliveira, Marcelo Antonio; Yoshida, Maria Irene; Silva, Daphne Carina Gonçalves Monteiro da

    2014-01-01

    Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations. PMID:25335110

  14. The 32nd Annual J.P. Morgan Healthcare Conference (January 13-16, 2014 - San Francisco, California, USA): Auxilium Pharmaceuticals.

    PubMed

    Watt, J

    2014-03-01

    CEO and President Adrian Adams described Auxilium Pharmaceuticals as "the same as a Big Pharma company, only smaller." This 'specialty biopharmaceutical company' has transformed itself in the last 6 to 9 months to become the "leading men's healthcare franchise with a broad and diverse product portfolio." All of this has led to a very busy 2013, which began with the USD 600 million acquisition (Q2) and integration of Actient Pharmaceuticals, the licensing of avanafil (Stendra™) for erectile dysfunction and ended with the approval of collagenase Clostridium histolyticum (Xiaflex®) in Peyronie's disease. From a portfolio of 2 products at the beginning of 2013, Auxilium ended the year with 12. PMID:24696871

  15. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers

    PubMed Central

    2010-01-01

    Background There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes. Methods Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes. Results and discussion A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals. Conclusion We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes. PMID:20529296

  16. Corporate social responsibility in countries with mature and emerging pharmaceutical sectors

    PubMed Central

    Volodina, Anna; Sax, Sylvia; Anderson, Stuart

    2009-01-01

    In recent decades the concept of Corporate Social Responsibility (CSR) has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry. Objective: To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany) and developing (Russia) markets. Methods: A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. Results: Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. The reputation of the pharmaceutical industry was generally poor: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany) socially irresponsible behavior by companies has a significant negative impact. Conclusions: This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the extent of irresponsible actions and the variation between them. PMID:25136398

  17. Ability grouping and science education reform: Policy and research base

    NASA Astrophysics Data System (ADS)

    Lynch, Sharon

    This article reviews current policy trends concerning the practice of ability grouping in K-12 science education. Relevant statements of key policy-making, policy-influencing organizations such as the NSTA, AAAS, NSF, the National Research Council, the U.S. Office of Education Department of Civil Rights, NAACP, the National Governors' Association, programs related to the Jacob Javits Grants for the Gifted and Talented, and others are summarized. The author's interpretation of the various positions are presented herein. The article also explores the research base supporting the various policies on grouping by examining selected general research literature on grouping, followed by research that is science education specific. Methodological issues color the research findings. The ethical and pragmatic implications of developing research and policy are discussed. The conclusions are that there is a dearth of recent empirical research specifically related to ability grouping in science, and that the time is ripe for the concerted development of a research agenda by key players in science education reform. Moreover, as controversial and value-laden as the topic is, it should be noted that grouping practices alone are unlikely to influence science education reform unless considered in the context of comprehensive restructuring efforts at the local school level.Received: 10 April 1993; Revised: 26 August 1993;

  18. Development of a research-based hospital model in Korea.

    PubMed

    Kim, Ganglip

    2012-05-01

    Noting the increasing public attention on healthcare, Korean society has shown greater attention to the significance of the health technology (HT) development. In order to promote HT competitiveness, the role of research-based hospitals (RBHs), in producing new ideas as well as utilizing final outcomes, has grown increasingly significant. Despite high quality healthcare professionals, state-of-the-art equipment, and well-developed information technology, few hospitals in Korea are successful leaders in HT development. In order to understand HT research and development (R&D) programs in Korea as well as hospital-based R&D investment performance, this paper has analyzed a recent three-year R&D investment of the Korean government. In addition, a survey on how to promote RBHs in Korea has been proceeded through adopting the Delphi method. Several model cases of RBHs abroad have also been studied to understand key success factors in formulating a development model of RBHs in Korea. This paper proposes suggestions for the promotion of RBHs in Korea: systematic reform related to the hospitals, reinforcement of the infrastructure of the hospitals, empowering human resources and policy framework to support the hospitals. PMID:22661874

  19. Research-based active-learning instruction in physics

    NASA Astrophysics Data System (ADS)

    Meltzer, David E.; Thornton, Ronald K.

    2013-04-01

    The development of research-based active-learning instructional methods in physics has significantly altered the landscape of U.S. physics education during the past 20 years. Based on a recent review [D.E. Meltzer and R.K. Thornton, Am. J. Phys. 80, 478 (2012)], we define these methods as those (1) explicitly based on research in the learning and teaching of physics, (2) that incorporate classroom and/or laboratory activities that require students to express their thinking through speaking, writing, or other actions that go beyond listening and the copying of notes, or execution of prescribed procedures, and (3) that have been tested repeatedly in actual classroom settings and have yielded objective evidence of improved student learning. We describe some key features common to methods in current use. These features focus on (a) recognizing and addressing students' physics ideas, and (b) guiding students to solve problems in realistic physical settings, in novel and diverse contexts, and to justify or explain the reasoning they have used.

  20. Solid state amorphization of pharmaceuticals.

    PubMed

    Willart, J F; Descamps, M

    2008-01-01

    Amorphous solids are conventionally formed by supercooling liquids or by concentrating noncrystallizing solutes (spray-drying and freeze-drying). However, a lot of pharmaceutical processes may also directly convert compounds from crystal to noncrystal which may have desired or undesired consequences for their stability. The purpose of this short review paper is (i) to illustrate the possibility to amorphize one compound by several different routes (supercooling, dehydration of hydrate, milling, annealing of metastable crystalline forms), (ii) to examine factors that favor crystal to glass rather than crystal to crystal transformations, (iii) to discuss the role of possible amorphous intermediates in solid-solid conversions induced by milling, (iv) to address the issue of chemical stability in the course of solid state amorphization, (v) to discuss the nature of the amorphous state obtained by the nonconventional routes, (vi) to show the effect of milling conditions on glasses properties, and (vii) to attempt to rationalize the observed transformations using the concepts of effective temperature introduced in nonequilibrium physics. PMID:18954076

  1. Animal-derived pharmaceutical proteins.

    PubMed

    Redwan, el-Rashdy M

    2009-01-01

    Livestock animals have made a significant contribution to human health and well-being throughout humankind's history. A significant contribution of farm animals to human health are the longstanding use of bovine and porcine for production of insulin (for treatment of diabetes), gelatin (for pharmaceutical and other purposes), as well as horse and sheep antibody against natural venoms, toxins, drugs and microbial peptides. Gelatin being the biggest animal protein consumed in human health, follows with antibodies fragments. The chronic problem of animal-derived therapeutics, especially those of high molecular weight, is the immunogenicity induction in addition to their biosafety. However, the invertebrates and lower vertebrates donate the human being a several crucial emergency saving life small-peptides or their analogs such as Refludan, Prialt, Exendin. Not only, but the farm animals are enormously using as models for novel surgical strategies, testing of biodegradable implants and sources of tissue replacements, such as skin and heart valves. Recently, they are being harnessing as bioreactor for production of biopharmaceutical related products through gene farming with efficiency far greater than any conventional microbial or cell-culture production systems. Only 16 transgenic cows would be covering the worldwide needs from human growth hormone. The transgenic, especially animal, technology would be solving a several biopharmaceutical products disadvantages, such as cost, biosafety, immunogenicity and the availability dimensions. PMID:19591041

  2. Pharmaceutical standardization of Apamarga kshara

    PubMed Central

    Jadav, Hasmukh R.; Galib, R.; Prajapati, Pradeep Kumar

    2015-01-01

    Standardization of herbal drugs is essential to certify their quality and purity. Kshara (alkaline substance) of Apamarga (Achyranthes aspera Linn.) is an important constituent in many Ayurvedic formulations, but its standard manufacturing process (SMP) is not attempted till date. This study is aimed to establish SMP for Apamarga kshara. In pharmaceutical process; generally the sediments of ash obtained at the end of washes will be discarded. However, in the study, we attempted to wash the sediments repeatedly by adding water to extract more Kshara. Apamarga was collected from the local area and authenticated. Kshara was prepared by following standard methods and the preliminary physicochemical profile was developed. It is observed that the ash yields Kshara even in the consecutive washes. First wash yielded 21.23% w/w Kshara, while the second and third washes yielded 9.38% w/w and 4.76% w/w, respectively. Repeated washes yield more Kshara. Hence, it is advocated to wash the ashes repeatedly. As the findings are encouraging, similar experiments can be extended to all other Kshara preparations. PMID:26834430

  3. Pharmaceutical standardization of Apamarga kshara.

    PubMed

    Jadav, Hasmukh R; Galib, R; Prajapati, Pradeep Kumar

    2015-01-01

    Standardization of herbal drugs is essential to certify their quality and purity. Kshara (alkaline substance) of Apamarga (Achyranthes aspera Linn.) is an important constituent in many Ayurvedic formulations, but its standard manufacturing process (SMP) is not attempted till date. This study is aimed to establish SMP for Apamarga kshara. In pharmaceutical process; generally the sediments of ash obtained at the end of washes will be discarded. However, in the study, we attempted to wash the sediments repeatedly by adding water to extract more Kshara. Apamarga was collected from the local area and authenticated. Kshara was prepared by following standard methods and the preliminary physicochemical profile was developed. It is observed that the ash yields Kshara even in the consecutive washes. First wash yielded 21.23% w/w Kshara, while the second and third washes yielded 9.38% w/w and 4.76% w/w, respectively. Repeated washes yield more Kshara. Hence, it is advocated to wash the ashes repeatedly. As the findings are encouraging, similar experiments can be extended to all other Kshara preparations. PMID:26834430

  4. The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures

    PubMed Central

    Lee, Munjae; Choi, Mankyu

    2015-01-01

    Objectives This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. Results The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. Conclusion It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties. PMID:26730355

  5. Pharmaceutical marketing research and the prescribing physician.

    PubMed

    Greene, Jeremy A

    2007-05-15

    Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue. PMID:17502635

  6. Active Pharmaceutical Ingredients and Aquatic Organisms

    EPA Science Inventory

    The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...

  7. GUIDES TO POLLUTION PREVENTION: THE PHARMACEUTICAL INDUSTRY

    EPA Science Inventory

    Pharmaceutical manufacturers generate a variety of wastes during manufacturing, maintenance, and housekeeping operations which can be reduced or minimized through source reductIon and recycling. he typical waste streams are spent fermentation broths, process liquors, solvents, eq...

  8. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

    EPA Science Inventory

    The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environme...

  9. 78 FR 11638 - Michigan Consolidated Gas Company, DTE Gas Company, DTE Gas Company; Notice of Petition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Energy Regulatory Commission Michigan Consolidated Gas Company, DTE Gas Company, DTE Gas Company; Notice... Docket Nos. PR13-29-000, and PR13-30-000 (not consolidated), Michigan Consolidated Gas Company (MichCon) and DTE Gas Company (DTE Gas) filed to institute a name change to both itself from MichCon to DTE...

  10. Companies commit to emergency contraception -- have you?

    PubMed

    1999-12-01

    Despite the efforts of the medical community, as well as promotional efforts by pharmaceutical companies, relatively few women in the US have heard of emergency contraceptives (ECs). Gynetics, marketer of Preven, plans to file a new drug application for a levonorgestrel EC by the end of 1999, with an anticipated approval in the second half of 2000. Women's Capital Corp., marketer of Plan B, is also aiming for a national commercial launch of its product. According to a recently published acceptability study, women will use ECs when they are made available. A survey among 235 women at 13 Kaiser Permanente medical offices in San Diego, California, regarding their experiences with ECs showed that 91% were satisfied with ECs, and 97% said they would use ECs for emergencies only--dispelling fears that women would forego use of ongoing contraception. About 70% of the women who participated in the study were using a contraceptive method when they requested ECs. PMID:12295558

  11. Of doctor conventions and drug companies.

    PubMed

    Standridge, John B

    2006-01-01

    Pharmaceutical companies provide the majority of financial support for staging the American Academy of Family Physicians (AAFP) Annual Scientific Assembly. In return they are allowed to dominate the physical and mental environment. The assembly is opulent and entertaining, but undoubtedly much of the expense is passed to the health care consumer in the form of high-priced brand-name prescription drugs. Additionally, public perception of such spectacles threatens the image that the AAFP has been careful to nurture--that family physicians are the ultimate advocates for our patients and, by extension, the health care-consuming public. Family physicians and our representative AAFP must recognize our complicity with and vulnerability to media forces. We must further adjust our role, not only to avoid the appearance of impropriety but to rededicate ourselves to our science, our intellectual basis, and ultimately our patients. PMID:16823679

  12. Genomics. University company to exploit heart data.

    PubMed

    Lawler, A

    2000-06-30

    This month, Boston University, which directs the Framingham Heart Study, a massive government effort begun in 1948 to monitor the cardiovascular health of more than 10,000 residents of this suburb of Boston, announced plans to form a bioinformatics company that will mine the data. The university will own 20% of Framingham Genomic Medicine Inc., which hopes to raise $21 million to begin modernizing the immense database and packaging it in a format that will be valuable to the pharmaceutical industry. The plan raises a host of difficult ethical issues, including patient privacy, academic conflicts of interest, and reciprocal value to the Framingham residents whose medical data will form the basis for the new enterprise. PMID:10917821

  13. THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications

    NASA Astrophysics Data System (ADS)

    Wu, Huiquan; Khan, Mansoor

    2012-08-01

    As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.

  14. Miscellaneous Pharmaceutical Agents in Interventional Radiology

    PubMed Central

    Oppenheimer, Jason; Ray, Charles E.; Kondo, Kimi L.

    2010-01-01

    Interventional radiologists employ a wide variety of drugs on a daily basis to improve patient experiences and outcomes during interventional procedures. The expectation is for the interventionalist to be well-versed in all pharmaceuticals used in the interventional suite. In this article, the authors review the following classes of common miscellaneous pharmaceutical agents used in interventional radiology: vasodilators, vasoconstrictors, antiemetics, bowel antiperistalsis agents, and prothrombotics. PMID:22550384

  15. Principles of Adolescent Substance Use Disorder Treatment: A Research-Based Guide

    MedlinePlus

    ... Treatment: A Research-Based Guide Acknowledgements Principles of Adolescent Substance Use Disorder Treatment: A Research-Based Guide ... Contents Acknowledgements From the Director Introduction Principles of Adolescent Substance Use Disorder Treatment Frequently Asked Questions Treatment ...

  16. Principles of Adolescent Substance Use Disorder Treatment: A Research-Based Guide

    MedlinePlus

    ... Treatment: A Research-Based Guide » Acknowledgements Principles of Adolescent Substance Use Disorder Treatment: A Research-Based Guide ... Contents Acknowledgements From the Director Introduction Principles of Adolescent Substance Use Disorder Treatment Frequently Asked Questions Treatment ...

  17. How should we teach faculty about research-based teaching?

    NASA Astrophysics Data System (ADS)

    Olmstead, Alice; Turpen, Chandra; Prather, Edward E.

    2015-01-01

    Faculty professional development (PD) workshops are the primary mechanism used to increase the adoption and adaptation of research-based instructional strategies (RBIS). PD workshops draw in large numbers of physics and astronomy instructors and can serve a critical role in changing instructional practices within our community. Our research focuses on two of the largest and longest-running PD workshops accessible to faculty: the New Physics and Astronomy Faculty Workshop and the Center for Astronomy Education Tier I Teaching Excellence Workshop. We seek to reveal opportunities to improve these workshops through increased awareness of instructors' experiences and prior knowledge, and increased awareness of how these workshops are designed and implemented.Other studies often assume that instructors have coherent theories of teaching and learning, and conclude that many have wrong ideas that need to be confronted or 'fixed'. Our approach is to first investigate the ideas that instructors have about teaching and learning, and identify what we call their 'potentially productive resources'. This approach is better suited to inform respectful PD efforts that build on instructors' intuitions, and we have analyzed interviews with several young astronomy/physics faculty members who were about to attend these PD workshops to demonstrate how this approach can be applied. The primary findings of our first study are: 1) instructors are trying out practices that show some alignment with common RBIS; 2) instructors' values show alignment with common discipline-based education research goals; and 3) instructors often experience dissatisfaction with specific aspects of their instruction. Taken together our findings are poised to inform changes to existing PD efforts.Our ongoing research focuses on the development of a real-time observation tool to document what happens during workshops and what learning opportunities these PD practices create for participants. We will show the preliminary results of this work.

  18. [Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

    PubMed

    Curcio, Pasqualina Curcio

    2008-10-01

    The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions. PMID:18949238

  19. Marketing norm perception among medical representatives in Indian pharmaceutical industry.

    PubMed

    Nagashekhara, Molugulu; Agil, Syed Omar Syed; Ramasamy, Ravindran

    2012-03-01

    Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company's medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field. PMID:24826035

  20. Harmonization, regulation, and trade: interactions in the pharmaceutical field.

    PubMed

    Timmermans, Karin

    2004-01-01

    This article aims to draw attention to the process of harmonization of requirements for drug registration (the so-called ICH process) and to examine how it may affect access to medicines in developing countries. The ICH process, especially when seen in conjunction with the World Trade Organization's Agreement on Technical Barriers to Trade, may create additional barriers to would-be entrants on the global pharmaceutical market, notably large generic manufacturers in developing countries-the very companies that can create credible price competition for the innovative industry and, thus, increase access to medicines. These barriers could help maintain the status quo by insulating well-established companies from competition, thereby forming a further obstacle to lower drug prices and to access to medicines, especially in developing countries. Developing countries should therefore carefully consider the implications of the positioning of ICH standards as global standards, and be vigilant with regard to their possible incorporation, whether explicitly or not, in international trade agreements. PMID:15560428

  1. Pharmaceutical reversal of insulin resistance.

    PubMed

    Lautt, W Wayne; Macedo, M Paula; Sadri, Parissa; Legare, Dallas J; Reid, Maria A G; Guarino, Maria P

    2004-01-01

    Insulin action is approximately doubled following a meal. The mechanism of postprandial insulin sensitization is dependent on hepatic parasympathetic nerves regulated by the prandial status. The nerves provide a permissive signal to the liver that allows insulin to cause the release of a putative hepatic insulin sensitizing substance (HISS) that selectively stimulates glucose uptake into skeletal muscle but not liver or adipose tissue. The parasympathetic signal has several steps identified in the regulatory pathway; acetylcholine acts on muscarinic receptors leading to activation of nitric oxide synthase and generation of HISS. The meal-induced insulin (MIS) sensitization requires hepatic GSH, which decreases with fasting and several disease states. Interfering with the MIS process results in severe insulin resistance with the response to insulin being reduced by approximately 50% to levels seen in the fasted state. A wide range of conditions have been shown to be associated with insulin resistance attributed to lack of the MIS process including insulin resistance; in chronic liver disease produced by chemical damage or bile duct ligation, hepatic denervation, sucrose fed rats, aging, spontaneously hypertensive rats, fetal alcohol exposed adult offspring, spontaneously insulin resistant rats, animals with pharmacological blockade of hepatic muscarinic receptors, NO synthase, cyclooxygenase, hepatic cGMP, and hepatic GSH levels. Pharmaceutical reversal of insulin resistance has been shown in several models using a variety of approaches including mimicking or potentiating the parasympathetic signal using cholinergic agonists, NO donors, cholinesterase antagonists, phosphodiesterase antagonists, and replenishment of hepatic GSH levels. These compounds are being evaluated for therapeutic application by our international academic/industry collaborative team. The MIS process has now been demonstrated in mice, rats, guinea pigs, cats, dogs, and humans, and has been demonstrated by independent laboratories. PMID:15633605

  2. A lesson from Japan: research and development efficiency is a key element of pharmaceutical industry consolidation process.

    PubMed

    Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

    2014-02-01

    Scholarly attention to pharmaceutical companies' ability to sustain research and development (R&D) productivity has increased as they increasingly handle business challenges. Furthermore, the deterioration of R&D productivity has long been considered a major cause of mergers and acquisitions (M&As). This study attempts to investigate quantitatively the possible causes of the deterioration and the relationship between the deterioration and M&As by examining the Japanese pharmaceutical industry. Japan from 1980 to 1997 is an ideal case because of the availability of official data, but more importantly the significant changes in its business environment at the time. Using the Malmquist Index and data envelopment analysis, we measured the deterioration of R&D productivity from 1980 to 1997 based on a sample of 15 Japanese companies. Two lessons can be learned from Japan's case. First, to sustain R&D productivity over the long term, companies should use licensing activities and focus on the dominant therapeutic franchises. Second, if a company fails significantly to catch up with the benchmark, it is likely to pursue an M&A or seek an alternative way to improve R&D productivity. These findings appear similar to the current situation of the global pharmaceutical industry, although Japan pursued more licensing activities than M&A to improve R&D productivity. PMID:24647159

  3. Mastering the value chain. An interview with Mark Levin of Millennium Pharmaceuticals. Interview by David Champion.

    PubMed

    Levin, M

    2001-06-01

    As today's business leaders are all too aware, a new scientific or technological break-through can quickly transform an industry's competitive landscape. The upheaval is often traumatic for the companies involved, forcing them to rethink their strategies and redefine their boundaries. But an industry in flux also creates vast opportunities. To seize them, companies must see how the current upheavals will affect the future distribution of profits--and then reinvent themselves to capitalize on the new sources of value. In this interview with HBR senior editor David Champion, Mark Levin, the founder and CEO of Millennium Pharmaceuticals, describes his vision of the future of the pharmaceutical industry in the wake of the genetics revolution and new technologies that have altered the economics of drug development. No company, he argues, will create serious long-term value by staying in just one or two stages of the value of chain. That's why Millennium, which started out doing basis research into genes and proteins and selling its findings to pharmaceutical giants, has moved downstream - toward the patients who actually use and pay for the drugs. He explains why the research end has become less lucrative than the more mechanical tasks of identifying, testing, and manufacturing molecules. Levin talks about the changes Millennium has undergone since its inception in 1993-from 30 workers to more than 1,000, and from one end of the value chain to the other. He discusses the company's cultural transformations as well as the partnerships and acquisitions that have helped millennium become involved in every stage of the chain-from gene to patient. Levin's vigorous approach to balancing long-term strategy with short-term tactics offers important lessons to any executive facing an industry upheaval. PMID:11408971

  4. Impact of pharmaceutical promotion on prescribing decisions of general practitioners in Eastern Turkey

    PubMed Central

    Vancelik, Serhat; Beyhun, Nazim E; Acemoglu, Hamit; Calikoglu, Oksan

    2007-01-01

    Background Commercial sources of information are known to have greater influence than scientific sources on general practitioners' (GPs) prescribing behavior in under developed and developing countries. The study aimed to determine the self-reported impact of pharmaceutical promotion on the decision-making process of prescription of GPs in Eastern Turkey. Methods A cross-sectional, exploratory survey was performed among 152 GPs working in the primary health centers and hospitals in Erzurum province of Eastern Turkey in 2006. A self-administered structured questionnaire was used. The questionnaire included questions regarding sociodemographics, number of patients per day, time per patient, frequency of sales representative visits to GPs, participation of GPs in training courses on prescribing (in-service training, drug companies), factors affecting prescribing decision, reference sources concerning prescribing and self-reported and self-rated effect of the activities of sales representatives on GPs prescribing decisions. Results Of 152 subjects, 53.3% were male and 65.8% were working at primary health care centers, respectively. Mean patient per day was 58.3 ± 28.8 patients per GP. For majority of the GPs (73.7%), the most frequent resource used in case of any problems in prescribing process was drug guides of pharmaceutical companies. According to self-report of the GPs, their prescribing decisions were affected by participation in any training activity of drug companies, frequent visits by sales representatives, high number of patient examinations per day and low year of practice (p < 0.05 for all). Conclusion The results of this study suggest that for the majority of the GPs, primary reference sources concerning prescribing was commercial information provided by sales representatives of pharmaceutical companies, which were reported to be highly influential on their decision-making process of prescribing by GPs. Since this study was based on self-report, the influence reported by the GPs may have been underestimated. PMID:17592644

  5. Southern Company`s standby generator program

    SciTech Connect

    Swartz, S.

    1995-12-01

    Alabama Power Company (APCO) continues to look for ways to improve customer satisfaction and enact demand-side management programs. The decision was made to evaluate the availability of customer-owned generators in order to meet these objectives. The idea was to utilize customer-owed standby generators (SG) as we would a peaking plant and to pay the customer credits based on the cost of the construction of peaking capacity plants. It was felt that if APCO could utilize this capacity to offset the construction of peaking capacity, then these costs would be passed on to our customers.

  6. The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school

    PubMed Central

    Stanley, A G; Jackson, D; Barnett, D B

    2005-01-01

    Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK. PMID:15801942

  7. The superefficient company.

    PubMed

    Hammer, M

    2001-09-01

    Most companies do a great job promoting efficiency within their own walls, streamlining internal processes wherever possible. But they have less success coordinating cross-company business interactions. When data pass between companies, inconsistencies, errors, and misunderstandings routinely arise, leading to wasted work--for instance, the same sales, order entry, and customer data may be entered repeatedly into different systems. Typically, scores of employees at each company manage these cumbersome interactions. The costs of such inefficiencies are very real and very large. In this article, Michael Hammer outlines the activities and goals used in streamlining cross-company processes. He breaks down the approach into four stages: scoping--identifying the business process for redesign and selecting a partner; organizing--establishing a joint committee to oversee the redesign and convening a design team to implement it; redesigning--taking apart and reassembling the process, with performance goals in mind; and implementing--rolling out the new process and communicating it across the collaborating companies. The author describes how several companies have streamlined their supply-chain and product development processes. Plastics compounder Geon integrated its forecasting and fulfillment processes with those of its main supplier after watching inventories, working capital, and shipping times creep up. General Mills coordinated the delivery of its yogurt with Land O'Lakes; butter and yogurt travel cost effectively in the same trucks to the same stores. Hammer says this new kind of collaboration promises to change the traditional vocabulary of corporate relationships. What if you and I sell different products to the same customer? We're not competitors, but what are we? In the past, we didn't care. Now, we should, the author says. PMID:11550633

  8. Evaluation of the accuracy and consistency of the Swedish environmental classification and information system for pharmaceuticals.

    PubMed

    Agerstrand, Marlene; Rudn, Christina

    2010-05-01

    The Swedish environmental and classification system for pharmaceuticals is a voluntary, industry-owned system with the purpose to provide environmental information about active pharmaceutical ingredients in the Swedish market. In this paper we report the results from a detailed evaluation of the accuracy and consistency of the risk assessments conducted within this system. The evaluation focused on the following three aspects: 1) comparison of the companies' risk assessments with the classification system's own guidance document, 2) how the risk assessments are affected if additional effect data is used, and 3) the consistency of different risk assessments for the same pharmaceutical substance. The analyses show that the system's guidance gives no criteria for when to consider a study "long-term" or "short-term", and that this confusion affected the outcome of the risk assessments in some cases. Furthermore, when the system's guidance document is followed and the risk assessment was supplemented with effect data from the open scientific literature, then the risk classification for a substantial number of the evaluated substances was altered. Our analyses also revealed that in some cases risk assessors disagree on the outcome of the assessment for the same active pharmaceutical ingredient. Finally we list some recommendations to improve the classification system. The recommendations include clarifying concepts and instructions in the guidance document, introduction of a standardized way of reporting data to the website, and promotion of use of non-standard test data when considered the most relevant. PMID:20206966

  9. The pharmaceutical sales rep/physician relationship in Turkey: ethical issues in an international context.

    PubMed

    Tengilimoglu, Dilaver; Kisa, Adnan; Ekiyor, Aykut

    2004-01-01

    In many developed countries, the physician/pharmaceutical sales representative relationship has increasingly become the focus of ethical questions. Given this context, the purpose of the present study was to determine the ethical dilemmas faced by pharmaceutical sales representatives in Turkey in their relations with physicians, and to identify possible solutions. Through an investigator-designed questionnaire, the ethical problems perceived by 215 pharmaceutical sales representatives were quantitatively analyzed. Nearly all of the participants (96.7%) reported that they had faced ethical dilemmas in marketing drugs to physicians. The most commonly reported problems included paramedical requests (for free lab test kits, etc.) and the necessity of bargaining with physicians over the use of their firm's drugs by offering gifts and sponsorships. The participants in the study felt that physicians were the primary source of ethical problems in the marketing of drugs, and the participants' most highly ranked potential solution to these ethical problems was a better understanding, on the part of physicians, of the role of pharmaceutical sales representatives. At the end of this study, suggestions are given with a view to helping health policy makers understand and address the current controversies involving drug company representatives and physicians. PMID:15914382

  10. Peering into the Pharmaceutical “Pipeline”: Investigational Drugs, Clinical Trials, and Industry Priorities

    PubMed Central

    Cottingham, Marci D.; Kalbaugh, Corey A.

    2014-01-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. PMID:25159693

  11. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

    PubMed

    Edwards, Brian

    2004-01-01

    The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose. PMID:15154832

  12. Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

    PubMed

    Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

    2015-04-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. PMID:25159693

  13. Sociology of pharmaceuticals development and regulation: a realist empirical research programme.

    PubMed

    Abraham, John

    2008-09-01

    A realist conceptualization of interests is proposed in opposition to the fashionable view that interests, objectivity and reality are merely social constructs, and that sociological analyses should be confined to discourse, actor-networks and micro-contextual practices. The objective interests of pharmaceutical companies in profit-maximization, and of patients/public health in the optimisation of drugs' benefit-risk ratios, can be empirically validated. The relationship between those interests and pharmaceutical regulation is best characterised by 'neo-liberal corporate bias' at the macro- and meso-levels. How such bias manifests itself at the micro-social level of science-based pharmaceutical testing and regulatory decision making is examined using a realist sociology of scientific knowledge, which appreciates that assessment of the validity of techno-scientific knowledge claims is essential for their sociological explanation. Commercial interests are shown to have biased science away from the interests of public health, in favour of industry. International comparisons of drug regulation demonstrate that drug injuries are not necessarily an inevitable by-product of pharmaceutical progress because some countries have fewer drug safety problems than others. Similarly, the lowering of techno-scientific standards for drug safety testing is not an inevitable cost of faster development of therapeutically valuable medicines, but a consequence of the internationalization of neo-liberal corporate bias. PMID:18761508

  14. Environmental management practices in the Lebanese pharmaceutical industries: implementation strategies and challenges.

    PubMed

    Massoud, May A; Makarem, N; Ramadan, W; Nakkash, R

    2015-03-01

    This research attempts to provide an understanding of the Lebanese pharmaceutical industries' environmental management strategies, priorities, and perceptions as well as drivers, barriers, and incentives regarding the implementation of the voluntary ISO 14001 Environmental Management System. Accordingly, a semistructured in-depth interview was conducted with the pharmaceutical industries. The findings revealed a significant lack of knowledge about the standard among the industries. The main perceived drivers for adopting the ISO 14001 are improving the companies' image and overcoming international trade. The main perceived barriers for acquiring the standard are the lack of government support and the fact that ISO 14001 is not being legally required or enforced by the government. Moreover, results revealed that adopting the ISO 14001 standard is not perceived as a priority for the Lebanese pharmaceutical industries. Although the cost of certification was not considered as a barrier for the implementation of ISO 14001, the majority of the pharmaceutical industries are neither interested nor willing to adopt the Standard if they are not exposed to any regulatory pressure or external demand. They are more concerned with quality and safety issues with the most adopted international standard among the industries being the ISO 9001 quality management system. This study highlights the aspect that financial barriers are not always the hurdles for implementing environmental management strategies in developing countries and underscores the need for regulatory frameworks and enforcement. PMID:25673269

  15. The SUPER Program: A Research-based Undergraduate Experience

    NASA Astrophysics Data System (ADS)

    Ernakovich, J. G.; Boone, R. B.; Boot, C. M.; Denef, K.; Lavallee, J. M.; Moore, J. C.; Wallenstein, M. D.

    2014-12-01

    Producing undergraduates capable of broad, independent thinking is one of the grand challenges in science education. Experience-based learning, specifically hands-on research, is one mechanism for increasing students' ability to think critically. With this in mind, we created a two-semester long research program called SUPER (Skills for Undergraduate Participation in Ecological Research) aimed at teaching students to think like scientists and enhancing the student research experience through instruction and active-learning about the scientific method. Our aim was for students to gain knowledge, skills, and experience, and to conduct their own research. In the first semester, we hosted active-learning workshops on "Forming Hypotheses", "Experimental Design", "Collecting and Managing Data", "Analysis of Data", "Communicating to a Scientific Audience", "Reading Literature Effectively", and "Ethical Approaches". Each lesson was taught by different scientists from one of many ecological disciplines so that students were exposed to the variation in approach that scientists have. In the second semester, students paired with a scientific mentor and began doing research. To ensure the continued growth of the undergraduate researcher, we continued the active-learning workshops and the students attended meetings with their mentors. Thus, the students gained technical and cognitive skills in parallel, enabling them to understand both "the how" and "the why" of what they were doing in their research. The program culminated with a research poster session presented by the students. The interest in the program has grown beyond our expectations, and we have now run the program successfully for two years. Many of the students have gone on to campus research jobs, internships and graduate school, and have attributed part of their success in obtaining their positions to their experience with the SUPER program. Although common in other sciences, undergraduate research experiences are rare in ecology. We feel that development and implementation of these types of active-learning, research based programs can help universities to produce undergraduate researchers capable of contributing meaningfully to research, and to greater societal issues by enhancing their problem solving and critical thinking skills.

  16. Water and stability of pharmaceutical solids

    NASA Astrophysics Data System (ADS)

    Shalaev, Evgenyi

    2007-03-01

    Solid pharmaceuticals are multi-component systems consisting of an active pharmaceutical ingredient (API) and inactive ingredients (excipients). Excipients may include inorganic salts (e.g., NaCl), carbohydrates (e.g., lactose), and polymers, to name a few, whereas APIs range from relatively simple molecules (e.g., aspirin) to proteins and olygonucleotides. Pharmaceutical solids could exist either as single-phase or heterophase systems. They also may have different extent of order, such as highly ordered crystalline phases, amorphous solids that are thermodynamically unstable but might be kinetically stable under the time frame of observation, and crystalline mesophases including liquid crystals. With all this diversity, there are common features for such systems, and two of them will be discussed in the presentation. (i) Requirements for chemical stability of pharmaceuticals are very strict. A very limited (e.g., less than 0.1%) extent of conversion is allowed in these materials over the shelf life, i.e., during several years of storage at ambient and (sometimes) not fully controlled (e.g., a medicine cabinet in one's bathroom) conditions. (ii) All pharmaceutical solids contain some water, although its amount and physical state are highly variable and may change during manufacturing and shelf life. There are many challenging questions and issues associated with the ``Water and stability of pharmaceutical solids'' subject; some of them will be considered in the presentation: (i) What are the features of chemical reactivity of crystalline vs disordered systems? (ii) What is the role of water in solid state chemical reactivity of amorphous solids, e.g., water as plasticizer vs reactant vs reaction media? (iii) How homogeneous are pharmaceutical amorphous solid solutions, e.g., carbohydrate-water systems? (iv) What is the optimal water content? With water being the most common destabilizing factor, is ``the drier - the better'' always the case?

  17. [Early achievements of the Danish pharmaceutical industry--1 Novo Nordisk].

    PubMed

    Kruse, Edith

    2008-01-01

    The article series provides an account in words and pictures of the Danish pharmaceutical industry's products from the earliest times until about 1950. Part 1 deals with products from Nordisk Insulinlaboratorium, founded in 1923, and Novo Terapeutisk Laboratorium, founded in 1925. The two companies were competitors for many years and became two of the world's leading insulin producers. In 1989 they joined forces, merging to become Novo Nordisk A/S, today one of the world's leading biotech companies. The article chronicles the earliest decades of development and progress in insulin production, illustrated with photos of several types of consumer packaging. In 1923 Nordisk Insulinlaboratorium marketed Insulin "Leo" tablets, from which patients had to make their own sterile solution for injection two to three times a day, because the solution was unstable. Ready-to-use solutions gradually came on the market, and formulations with prolonged duration, so-called protamin-insulins, were developed in the 1930s. Insulin "Leo" Retard was marketed in 1936, and its basic properties were maintained and further developed in step with research breakthroughs well into the 1980s. Novo Terapeutisk Laboratorium's first insulin was Insulin Novo in 1925, and at the same time one of the company founders developed Novo-sprøjten (the Novo Syringe) for individual dosage from a special ampoule. The syringe was further developed over the years and was the prototype for the NovoPen launched in 1985 as well as for later advanced dosage systems. Starting in 1938 Novo Terapeutisk Laboratorium marketed Zink-Protamin-Insulin Novo and products based on other insulin derivatives in the 1940s. The era concludes with Insulin Novo Lente from 1952 as well as suspensions of amorphous and crystalline zinc-insulin. Ever since, insulin treatments for diabetes have been the focus of intensive development throughout the global marketplace and continue to be so. PMID:18548941

  18. Estrogenic activity of pharmaceuticals and pharmaceutical mixtures in a yeast reporter gene system.

    PubMed

    Fent, Karl; Escher, Claudia; Caminada, Daniel

    2006-08-01

    Pharmaceuticals enter aquatic environments in unchanged form or as metabolites. Little is known about their potential hormonal activity, which is of particular interest due to potential long-term effects on fertility and reproduction in aquatic organisms. Moreover, there is a need to assess the combined activity of pharmaceutical mixtures. In this study, 37 pharmaceuticals have been analysed in vitro for estrogenic activity using a recombinant yeast system expressing the human estrogen receptor alpha. Six pharmaceuticals belonging to different therapeutic classes, cimetidine, fenofibrate, furosemide, paracetamol, phenazone and tamoxifen, exhibited weak estrogenic activity. Furosemide showed an almost full concentration-response curve, whereas the other compounds showed low efficacy. The half-maximal activities of the pharmaceuticals were in the range of 0.66-25.53 mM. Furthermore, binary mixtures of furosemide and 17beta-estradiol (E2), and furosemide and phenazone, and mixtures of up to five active pharmaceuticals were assessed for their combinatory activity at different equipotent concentrations. The estrogenic activity of binary mixtures of furosemide with E2 and phenazone, respectively, followed the model of concentration addition (CA). Mixtures of other pharmaceuticals often deviated from the CA model, because extrapolations become inaccurate with only partial and non-parallel concentration-response curves having low efficacy. This demonstrates that full and parallel concentration-response curves are a prerequisite for accurate predictions of mixture activity. Our study demonstrates for the first time weak estrogenic activity in vitro of some common pharmaceuticals and their mixtures. PMID:16781844

  19. AN INFORMATIC APPROACH TO ESTIMATING ECOLOGICAL RISKS POSED BY PHARMACEUTICAL USE: HUMAN PRESCRIPTION PHARMACEUTICALS

    EPA Science Inventory

    Pharmaceuticals are often excreted from patients as the parent compound or as active metabolites. Some of these compounds have been found in the environment. However, the environmental concentrations of the majority of pharmaceuticals and their metabolites are not known. The re...

  20. Selected aspects of europeization of pharmaceutical law.

    PubMed

    Zimmermann, Agnieszka; Wengler, Lubomira; Paw?owski, Leszek

    2010-01-01

    As one of its aspects, the process of European integration has an influence on the legal orders of the Member States, which is often referred to in the literature as the europeization of law. Upon Poland's accession to the structures of the European Union, there have also been radical changes to the Polish legal system. According to the concept of the sources of law in the Polish Constitution and to the judicial decisions of the European Court of Justice, Community law now takes priority over national law, even over acts of parliament. Pharmaceutical law represents one of the areas where the harmonization process has been taking place. It shapes the principles and the manner according to which medicinal products are approved for marketing, the conditions of clinical trials, as well as the conditions of drug manufacture and advertisement. It also determines the rules of trading in medicinal products, the running of pharmaceutical wholesalers and pharmacies, as well as the duties and rights of the Pharmaceutical Inspectorate. This paper provides a summary of research on the impact of Community law on Polish pharmaceutical law, i.e. on the europeization process, and on the consequences of this process for the Polish pharmaceutical market and for research and development. PMID:20369799

  1. 'Linkage' pharmaceutical evergreening in Canada and Australia

    PubMed Central

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

  2. Captive insurance companies.

    PubMed

    Strauss, Peter

    2014-01-01

    The landscape of the business world is changing; and now, more than ever, business owners are recognizing that life is filled with risks: known risk, calculated risk, and unexpected risk. Every day, businesses thrive or fail based on understanding the risk of owning and operating their business, and business owners are recognizing that there are alternative risk financing mechanisms other than simply taking out a basket of standard coverage as recommended by your friendly neighborhood agent. A captive insurance company is an insurance company established to provide a broad range of risk management capabilities to affiliated companies. The captive is owned by the business owner and can provide insurance to the business for potential future losses, whether or not the losses are already covered by a commercial carrier or are "self-insured." The premiums paid by your business are tax deductible. Meanwhile, the premiums that your captive collects are tax-free up to $1.2 million annually. PMID:25807627

  3. Growth of the Asian health-care market: global implications for the pharmaceutical industry.

    PubMed

    Epstein, Richard J

    2007-10-01

    The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceutical companies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets. PMID:17853900

  4. Thermal properties of food and pharmaceutical powders

    NASA Astrophysics Data System (ADS)

    Abiad, Mohamad Ghassan

    Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.

  5. [Applications of phosphorimetry in pharmaceutical analysis].

    PubMed

    Li, Wei; Cao, Ling-xian; Li, Gai-ru; Jin, Wei-jun

    2002-06-01

    Applications of phosphorimetry including solid substrate phosphorescence, liquid medium phosphorescence, low temperature phosphorescence and phosphorescence sensors were reviewed in pharmaceutical analysis. The drugs involved here included the varieties of alkaloid, Chinese traditional medicine, tetracyclines, quinolone, riboflavin, anticancer medicine, naphazoline, naproxen, nafronyl dipyridamole and so on. Solid surface phosphorimetry is characterized by sample volume of microliter grade, simple and fast operation procedures in pharmaceutical analysis. The combination of liquid phosphorescence with flow injection analysis and chemosensing technique has good advantages in fast, continuous and on-line monitoring of medicines. Modified low temperature phosphorimetry still remains its high sensitivity and overcomes some disadvantages in the procedures. Phosphorimetry will be more widely applied to pharmaceutical analysis as the development of sensitive and quenching, energy transfer, derivative and immunization luminescence. PMID:12938353

  6. 75 FR 42432 - Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC, Transcontinental Gas Pipe Line Company, LLC, and Enterprise Field Services, LLC; Notice of Intent To Prepare...

  7. 75 FR 13524 - Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... Energy Regulatory Commission Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC, Transcontinental Gas Pipe Line Company, LLC, Enterprise Field Services, LLC; Notice of Application March 16, 2010. Take notice that on March 5, 2010, Northern Natural Gas...

  8. Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain.

    PubMed

    Erices, Rainer; Frewer, Andreas; Gumz, Antje

    2015-07-01

    Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and objective account of these trials is lacking. The aim of this study was to describe and evaluate the clinical trials performed in the German Democratic Republic (GDR) based on archival material from the health system and the secret service. We found documents relating to 220 trials involving more than 14,000 patients and 68 Western companies. However, no record of patient information forms or systematic documentation regarding the provision of patient consent was discovered. There was no evidence to suggest that the trials systematically and intentionally damaged patients. The trials were conducted without the knowledge of the public. GDR legislation stipulated that patients must consent to the trials, but no evidence was found to suggest that patients were systematically informed. Documents suggest that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. The GDR agreed to the trials due to impending bankruptcy and Western pharmaceutical companies capitalised on this situation. PMID:25341732

  9. Acquiring Pharmaceutical Industry Assets in the UK: 1 + 1 = 1?

    PubMed

    Kanavos, Panos; Angelis, Aris

    2014-01-01

    The recent AstraZeneca takeover bid from Pfizer puts pharmaceutical R&D once again on the public agenda. Three pertinent questions are (a) what can be expected from this acquisition, (b) what are the implications for the UK economy and science base, and (c) whether such a deal should go ahead. Although the key driver behind this acquisition would be an improvement in company performance and shareholder value, past evidence suggests that mergers and acquisitions (M&A) of large pharmaceutical companies imply a neutral net effect on productivity, if not a decline, with employment decreasing and R&D spend following a similar trend. Similarities between the two companies include dropping sales; however, relative to its size, AstraZeneca has a more promising R&D pipeline, especially in therapeutic areas where Pfizer's strength is currently limited (e.g. oncology). Ensuring a portfolio diversification would make Pfizer's takeover proposal a knight's one, but history points towards a knave-like behavior. PMID:25346596

  10. An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile

    PubMed Central

    Abud, María José; Hall, Bronwyn; Helmers, Christian

    2015-01-01

    We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between “primary” (active ingredient) and “secondary” patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate “older” therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents. PMID:25915050

  11. Early drug discovery and the rise of pharmaceutical chemistry.

    PubMed

    Jones, Alan Wayne

    2011-06-01

    Studies in the field of forensic pharmacology and toxicology would not be complete without some knowledge of the history of drug discovery, the various personalities involved, and the events leading to the development and introduction of new therapeutic agents. The first medicinal drugs came from natural sources and existed in the form of herbs, plants, roots, vines and fungi. Until the mid-nineteenth century nature's pharmaceuticals were all that were available to relieve man's pain and suffering. The first synthetic drug, chloral hydrate, was discovered in 1869 and introduced as a sedative-hypnotic; it is still available today in some countries. The first pharmaceutical companies were spin-offs from the textiles and synthetic dye industry and owe much to the rich source of organic chemicals derived from the distillation of coal (coal-tar). The first analgesics and antipyretics, exemplified by phenacetin and acetanilide, were simple chemical derivatives of aniline and p-nitrophenol, both of which were byproducts from coal-tar. An extract from the bark of the white willow tree had been used for centuries to treat various fevers and inflammation. The active principle in white willow, salicin or salicylic acid, had a bitter taste and irritated the gastric mucosa, but a simple chemical modification was much more palatable. This was acetylsalicylic acid, better known as Aspirin®, the first blockbuster drug. At the start of the twentieth century, the first of the barbiturate family of drugs entered the pharmacopoeia and the rest, as they say, is history. PMID:21698778

  12. WHO Expert Committee on specifications for pharmaceutical preparations.

    PubMed

    2010-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file. PMID:20560300

  13. The Clinical Development of Molecularly Targeted Agents in Combination With Radiation Therapy: A Pharmaceutical Perspective

    SciTech Connect

    Ataman, Ozlem U.; Sambrook, Sally J.; Wilks, Chris; Lloyd, Andrew; Taylor, Amanda E.; Wedge, Stephen R.

    2012-11-15

    Summary: This paper explores historical and current roles of pharmaceutical industry sponsorship of clinical trials testing radiation therapy combinations with molecularly targeted agents and attempts to identify potential solutions to expediting further combination studies. An analysis of clinical trials involving a combination of radiation therapy and novel cancer therapies was performed. Ongoing and completed trials were identified by searching the (clinicaltrials.gov) Web site, in the first instance, with published trials of drugs of interest identified through American Society of Clinical Oncology, European CanCer Organisation/European Society for Medical Oncology, American Society for Radiation Oncology/European Society for Therapeutic Radiology and Oncology, and PubMed databases and then cross-correlated with (clinicaltrials.gov) protocols. We examined combination trials involving radiation therapy with novel agents and determined their distribution by tumor type, predominant molecular mechanisms examined in combination to date, timing of initiation of trials relative to a novel agent's primary development, and source of sponsorship of such trials. A total of 564 studies of targeted agents in combination with radiation therapy were identified with or without concomitant chemotherapy. Most studies were in phase I/II development, with only 36 trials in phase III. The tumor site most frequently studied was head and neck (26%), followed by non-small cell lung cancer. Pharmaceutical companies were the sponsors of 33% of studies overall and provided support for only 16% of phase III studies. In terms of pharmaceutical sponsorship, Genentech was the most active sponsor of radiation therapy combinations (22%), followed by AstraZeneca (14%). Most radiation therapy combination trials do not appear to be initiated until after drug approval. In phase III studies, the most common (58%) primary endpoint was overall survival. Collectively, this analysis suggests that such trials are not given priority by pharmaceutical companies. The potential reasons for this and some challenges and possible solutions are discussed.

  14. Quality of Pharmaceutical Care in Surgical Patients

    PubMed Central

    de Boer, Monica; Ramrattan, Maya A.; Boeker, Eveline B.; Kuks, Paul F. M.; Boermeester, Marja A.; Lie-A-Huen, Loraine

    2014-01-01

    Background Surgical patients are at risk for preventable adverse drug events (ADEs) during hospitalization. Usually, preventable ADEs are measured as an outcome parameter of quality of pharmaceutical care. However, process measures such as QIs are more efficient to assess the quality of care and provide more information about potential quality improvements. Objective To assess the quality of pharmaceutical care of medication-related processes in surgical wards with quality indicators, in order to detect targets for quality improvements. Methods For this observational cohort study, quality indicators were composed, validated, tested, and applied on a surgical cohort. Three surgical wards of an academic hospital in the Netherlands (Academic Medical Centre, Amsterdam) participated. Consecutive elective surgical patients with a hospital stay longer than 48 hours were included from April until June 2009. To assess the quality of pharmaceutical care, the set of quality indicators was applied to 252 medical records of surgical patients. Results Thirty-four quality indicators were composed and tested on acceptability and content- and face-validity. The selected 28 candidate quality indicators were tested for feasibility and sensitivity to change. This resulted in a final set of 27 quality indicators, of which inter-rater agreements were calculated (kappa 0.92 for eligibility, 0.74 for pass-rate). The quality of pharmaceutical care was assessed in 252 surgical patients. Nearly half of the surgical patients passed the quality indicators for pharmaceutical care (overall pass rate 49.8%). Improvements should be predominantly targeted to medication care related processes in surgical patients with gastro-intestinal problems (domain pass rate 29.4%). Conclusions This quality indicator set can be used to measure quality of pharmaceutical care and detect targets for quality improvements. With these results medication safety in surgical patients can be enhanced. PMID:25006676

  15. Pharmaceutical challenges in veterinary product development.

    PubMed

    Ahmed, Imran; Kasraian, Kasra

    2002-10-01

    There are many similarities between the human health and animal health industries. Both industries are research driven, have global presence, are highly regulated, and have to profit in a competitive business environment. However, there are also notable differences. This review highlights and discusses those differences as they relate to the pharmaceutical challenges in veterinary product development. This paper provides a brief review of the animal health pharmaceutical product landscape, segmentation, and market evolution; highlights challenges and special considerations in veterinary drug delivery; and identifies unmet needs in animal health along with recent advances. PMID:12363436

  16. [Major milestones for European pharmaceutical policy].

    PubMed

    Sauer, Fernand

    2014-01-01

    Under the 1985 White Paper on the completion of the single market, several pharmaceutical harmonisation measures were unanimously adopted, in favor of biotech products and on pricing transparency, legal status of prescription, wholesale distribution and advertising. The European pharmaceutical harmonisation was extended to Norway and Iceland, to new accession member states and through major international conferences with the US and Japan (ICH). Starting in 1995, the European medicines agency has produced an efficient marketing authorisation system for new human and veterinary medicines. The system was extended to pediatric medicines and advanced therapies. The monitoring of drug adverse effects (pharmacovigilance) has been gradually strengthened. PMID:25668913

  17. Pharmaceutical analysis using micellar electrokinetic capillary chromatography.

    PubMed

    Swaile, D F; Burton, D E; Balchunas, A T; Sepaniak, M J

    1988-08-01

    The potential utility in pharmaceutical analysis of a capillary electrokinetic separation technique that employs a micellar "pseudo-stationary phase" is discussed and illustrated. Chromatograms of separations of vitamin metabolites and derivatized amino acids are presented to illustrate the high efficiency of the technique and the ability to simultaneously separate the charged and neutral components of pharmaceutical samples. The analytical characteristics of the technique and the importance of optimizing experimental parameters, such as surfactant concentration and capillary column diameter, are discussed and demonstrated with the aid of chromatograms. PMID:3215989

  18. Radiostability of pharmaceuticals under different irradiation conditions

    NASA Astrophysics Data System (ADS)

    Crucq, Anne-Sophie; Deridder, Véronique; Tilquin, Bernard

    2005-02-01

    In this paper, the products studied are cefazolin, glucagon and dobutamine HCl. The radioresistance of pharmaceuticals may depend on the conditions of irradiation. The best is to irradiate the drugs in solid state and the chemical transformations can be reduced also by lowering the temperature of the liquid. In solid state, the dose rate has no influence on the decomposition for the selected molecules and it should be noted that drug excipients selected for bioavailability reasons are not always radioprotectors. These results are important from a technical point of view in pharmaceutical industry.

  19. The Electric Company.

    ERIC Educational Resources Information Center

    Children's Television Workshop, New York, NY.

    This book is intended as an introduction to the television program, "The Electric Company," designed to help teach reading to children in grades 2-4 who are experiencing difficulty. Contents include: Sidney P. Marland, Jr.'s preface, "A Significant New Teaching Tool"; Joan Ganz Cooney's "Television and the Teaching of Reading"; and Barbara…

  20. Company Town Shutdown.

    ERIC Educational Resources Information Center

    Turnage, Martha A.

    Saltville, Virginia, is a former company town whose main employer, a soda ash plant, shut down on July 1, 1971. The closure of the chemical plant displaced 700 workers, and created a crisis that threatened not only the existence of the town, but of the entire region. In response, Virginia Highlands Community College (VHCC), in cooperation with the…

  1. The living company.

    PubMed

    de Geus, A

    1997-01-01

    What can explain the longevity gap between a company that survives for centuries--the Swedish company Stora, for example, which is more than 700 years old--and the average corporation, which does not last 20 years? A team at Royal Dutch/Shell Group explored that question. Arie de Geus, a retired Shell executive, writes about the team's findings and describes what he calls living companies-organizations that have beaten the high mortality rate of the average corporation. Many companies die young, de Geus argues, because their policies and practices are based too heavily on the thinking and language of economics. Their managers focus on producing goods and services and forget that the organization is a community of human beings that is in business--any business--to stay alive. In contrast, managers of living companies consider themselves to be stewards of a long-standing enterprise. Their priorities reflect their commitment to the organization's long-term survival in an unpredictable world. Like careful gardeners, they encourage growth and renewal without endangering the plant they are tending. They value profits the same way most people value oxygen: as necessary for life but not the purpose of it. They scuttle assets when necessary to make a dramatic change in the business portfolio. And they constantly search for new ideas. These managers also focus on developing people. They create opportunities for employees to learn from one another. Such organizations are suited for survival in a world in which success depends on the ability to learn, to adapt, and to evolve. PMID:10165449

  2. Pharmacist, the pharmaceutical industry and pharmacy education in Saudi Arabia: A questionnaire-based study

    PubMed Central

    Bin Saleh, Ghada; Rezk, Naser L.; Laika, Laila; Ali, Anna; El-Metwally, Ashraf

    2015-01-01

    Background: In Saudi Arabia there is an estimated need of more than 100,000 pharmacy graduates to cover all present sectors. The shortage of pharmacists has affected many of these sectors especially the pharmaceutical industry. The contribution of Saudi pharmacists to local pharmaceuticals industry would be extremely beneficial and important for shaping the future of the drug industry within the Kingdom. It is not clear whether future Saudi pharmacists are willing to contribute to local pharmaco-industrial fields. Methods: A cross-sectional, questionnaire-based survey was conducted on all final-year pharmacy students in King Saud University (KSU), Riyadh, Kingdom of Saudi Arabia (KSA). Results: Out of a total of 130 students registered in the final-year of the pharmacy program in KSU, 122 (93.8%) were able to complete the questionnaire. The results showed that the majority (83%) of Saudi pharmacy students indicated that they had not received practical training in the pharmaceutical companies, while only 17.2% of the students felt that they had the knowledge and the skills to work in the pharmaceutical industry after graduation. The majority of the students (66.7%) chose clinical pharmacy as their future career field while only 10.9% indicated willingness to work in a pharmaceutical industry career. Only 8.2% selected working in the pharmaceutical industry. The significant predictor of possibly choosing a career in the local drug industry is a student with a bachelor’s degree (compared to Pharm D degree) in pharmacy (OR = 2.7 [95% CI 1.1–6.3]). Conclusion: Pharmacy students who are enrolled in the capital city of Riyadh are not properly trained to play an influential role in local drug companies. As a result, their level of willingness to have a career in such important business is not promising (more among Pharm D program). Future research in other pharmacy colleges within Saudi Arabia is needed to confirm such results. PMID:26594125

  3. 99M-technetium labeled macroaggregated human serum albumin pharmaceutical

    DOEpatents

    Winchell, Harry S.; Barak, Morton; Van Fleet, III, Parmer

    1977-05-17

    A reagent comprising macroaggregated human serum albumin having dispersed therein particles of stannous tin and a method for instantly making a labeled pharmaceutical therefrom, are disclosed. The labeled pharmaceutical is utilized in organ imaging.

  4. Teaching Pharmaceutical Biotechnology at the University of Illinois at Chicago.

    ERIC Educational Resources Information Center

    Groves, Michael J.; Klegerman, Melvin E.

    1988-01-01

    The Department of Pharmaceutics at the University of Illinois at Chicago has been carrying out research in pharmaceutical biotechnology that has allowed unique student involvement and promises further interdisciplinary research and instructional activities. (MSE)

  5. NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS

    EPA Science Inventory

    Quantitation of human and veterinary pharmaceuticals in environmental matrices has resulted in pharmaceuticals in the environment receiving unprecedented attention from the scientific community. Aquatic hazard assessments often use quantitative structure activity relationships an...

  6. Predicting variability of aquatic concentrations of human pharmaceuticals

    EPA Science Inventory

    Potential exposure to active pharmaceutical ingredients (APIs) in the aquatic environment is a subject of ongoing concern. We recently estimated maximum likely potency-normalized exposure rates at the national level for several hundred commonly used human prescription pharmaceut...

  7. Risks to aquatic organisms posed by human pharmaceutical use

    EPA Science Inventory

    In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...

  8. Incentives for Starting Small Companies Focused on Rare and Neglected Diseases.

    PubMed

    Ekins, Sean; Wood, Jill

    2016-04-01

    Starting biotech or pharmaceutical companies is traditionally thought to be based around a scientist, their technology platform or a clinical candidate spun out from another company. Between us we have taken a different approach and formed two small early stage companies after initially leveraging the perspective of a parent with a child with a life-threatening rare disease. Phoenix Nest ( http://www.phoenixnestbiotech.com/ ) was co-founded to work on treatments for Sanfilippo syndrome a devastating neurodegenerative lysosomal storage disorder. In the space of just over 3 years we have built up collaborations with leading scientists in academia and industry and been awarded multiple NIH small business grants. The second company, Collaborations Pharmaceuticals Inc. ( http://www.collaborationspharma.com/ ) was founded to address some of the other 7000 or so rare diseases as well as neglected infectious diseases. The Rare Pediatric Disease Priority Review Voucher is likely the most important incentive for companies working on rare diseases with very small populations. This may also be partially responsible for the recent acquisitions of rare disease companies with late stage candidates. Lessons learned in the process of starting our companies are that rare disease parents or patients can readily partner with a scientist and fund research through NIH grants rather than venture capital or angel investors initially. This process may be slow so patience and perseverance is key. We would encourage other pharmaceutical scientists to meet rare disease parents, patients or advocates and work with them to further the science on their diseases and create a source of future drugs. PMID:26666772

  9. Deep pharma: psychiatry, anthropology, and pharmaceutical detox.

    PubMed

    Oldani, Michael

    2014-06-01

    Psychiatric medication, or psychotropics, are increasingly prescribed for people of all ages by both psychiatry and primary care doctors for a multitude of mental health and/or behavioral disorders, creating a sharp rise in polypharmacy (i.e., multiple medications). This paper explores the clinical reality of modern psychotropy at the level of the prescribing doctor and clinical exchanges with patients. Part I, Geographies of High Prescribing, documents the types of factors (pharmaceutical-promotional, historical, cultural, etc.) that can shape specific psychotropic landscapes. Ethnographic attention is focused on high prescribing in Japan in the 1990s and more recently in the Upper Peninsula of Michigan, in the US. These examples help to identify factors that have converged over time to produce specific kinds of branded psychotropic profiles in specific locales. Part II, Pharmaceutical Detox, explores a new kind of clinical work being carried out by pharmaceutically conscious doctors, which reduces the number of medications being prescribed to patients while re-diagnosing their mental illnesses. A high-prescribing psychiatrist in southeast Wisconsin is highlighted to illustrate a kind of med-checking taking place at the level of individual patients. These various examples and cases call for a renewed emphasis by anthropology to critically examine the "total efficacies" of modern pharmaceuticals and to continue to disaggregate mental illness categories in the Boasian tradition. This type of detox will require a holistic approach, incorporating emergent fields such as neuroanthropology and other kinds of creative collaborations. PMID:24700144

  10. The Pharmaceutical Care Movement: Opportunities for Collaboration.

    ERIC Educational Resources Information Center

    Temple, Thomas R.

    1996-01-01

    Areas in which pharmacy educators and practitioners can collaborate to hasten pharmacy curriculum development are outlined, including: state and regional centers for operationalizing the pharmaceutical care concept; training, formal resource programs for pharmacists; research advisory boards; public education; links with medical community;…

  11. Developing Closer Ties with the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Reid, Gregor; Hoddinott, Susan

    1991-01-01

    The need for research administrators to understand and appreciate the pharmaceutical industry's research and development environment is discussed, using examples from Canada. The research administrator's role in the technology transfer process and implications for faculty are examined. Ways to build closer school-industry ties are discussed. (MSE)

  12. Pollution prevention in the pharmaceutical industry

    SciTech Connect

    Venkataramani, E.S.

    1995-09-01

    A clear understanding of the process, reaction pathways, process equipment, operational requirements, and waste stream characteristics are critical for the evaluation, selection, and implementation of pollution prevention in the pharmaceutical industry. Although pollution prevention opportunities are always preferred over treatment and disposal techniques, consideration of a full range of options--including at-source treatments and disposal--is a practical necessity to ensure protection of the environment using best available technology. General housekeeping can also play a major role in waste minimization. Waste minimization and pollution prevention are not new concepts for the pharmaceutical industry. But the confidential and highly competitive nature of the business stands in the way of disseminating information regarding specific activities in this area. The pharmaceutical industry could probably do much better in this respect. Successful implementation of waste minimization in the pharmaceutical industry requires that a process modification not have a negative impact on product quality. Recovered and recycled materials must meet quality specifications that are similar to those for virgin raw materials.

  13. Pharmaceutical Applications of Ion-Exchange Resins

    ERIC Educational Resources Information Center

    Elder, David

    2005-01-01

    The historical uses of ion-exchanged resins and a summary of the basic chemical principles involved in the ion-exchanged process are discussed. Specific applications of ion-exchange are provided that include drug stabilization, pharmaceutical excipients, taste-masking agents, oral sustained-release products, topical products for local application…

  14. Who Dispenses Pharmaceuticals to Children at School?

    ERIC Educational Resources Information Center

    Francis, Elaine Esielionis; And Others

    1996-01-01

    This study examined how pharmaceuticals were dispensed in one Florida county's public elementary, middle, and high schools and in six private schools. Surveys indicated that of 28,134 children surveyed, 1,016 received 5,411 doses of medication from school personnel, who were not necessarily health care personnel. Methylphenidate was the most…

  15. Halal pharmaceutical industry: opportunities and challenges.

    PubMed

    Nor Norazmi, Mohd; Lim, Li Sze

    2015-08-01

    The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, well-regulated, and harmonized accreditation and halal management system. PMID:26187623

  16. NUTRACEUTICAL AND PHARMACEUTICAL USES OF LEGUMES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The legume family Fabaceae has numerous taxa with tremendous potential for nutraceuticals and pharmaceuticals that have only recently started to be investigated. This family is the third largest family of flowering plants with approximately 650 genera and nearly 20,000 species. Species in this fam...

  17. The Pharmaceutical Care Movement: Opportunities for Collaboration.

    ERIC Educational Resources Information Center

    Temple, Thomas R.

    1996-01-01

    Areas in which pharmacy educators and practitioners can collaborate to hasten pharmacy curriculum development are outlined, including: state and regional centers for operationalizing the pharmaceutical care concept; training, formal resource programs for pharmacists; research advisory boards; public education; links with medical community;

  18. Pharmaceutical drugs chatter on Online Social Networks.

    PubMed

    Wiley, Matthew T; Jin, Canghong; Hristidis, Vagelis; Esterling, Kevin M

    2014-06-01

    The ubiquity of Online Social Networks (OSNs) is creating new sources for healthcare information, particularly in the context of pharmaceutical drugs. We aimed to examine the impact of a given OSN's characteristics on the content of pharmaceutical drug discussions from that OSN. We compared the effect of four distinguishing characteristics from ten different OSNs on the content of their pharmaceutical drug discussions: (1) General versus Health OSN; (2) OSN moderation; (3) OSN registration requirements; and (4) OSNs with a question and answer format. The effects of these characteristics were measured both quantitatively and qualitatively. Our results show that an OSN's characteristics indeed affect the content of its discussions. Based on their information needs, healthcare providers may use our findings to pick the right OSNs or to advise patients regarding their needs. Our results may also guide the creation of new and more effective domain-specific health OSNs. Further, future researchers of online healthcare content in OSNs may find our results informative while choosing OSNs as data sources. We reported several findings about the impact of OSN characteristics on the content of pharmaceutical drug discussion, and synthesized these findings into actionable items for both healthcare providers and future researchers of healthcare discussions on OSNs. Future research on the impact of OSN characteristics could include user demographics, quality and safety of information, and efficacy of OSN usage. PMID:24637141

  19. An Interdisciplinary Course in Pharmaceutical Advertising.

    ERIC Educational Resources Information Center

    Grieshaber, Larry D.; And Others

    1980-01-01

    A course in pharmaceutical product merchandising offered at the St. Louis College of Pharmacy incorporated as its three major components the development of a one-page print advertisement, a recorded radio commercial, and a videotape commercial series. Student evaluations were based on performance rather than effort. (MSE)

  20. New pharmaceuticals in inflammatory bowel disease

    PubMed Central

    Łodyga, Michał; Eder, Piotr; Bartnik, Witold; Gonciarz, Maciej; Kłopocka, Maria; Linke, Krzysztof; Małecka-Panas, Ewa; Radwan, Piotr

    2015-01-01

    This paper complements the previously published Guidelines of the Working Group of the Polish Society of Gastroenterology and former National Consultant in Gastroenterology regarding the management of patients with Crohn's disease and ulcerative colitis. Attention was focused on the new pharmaceutical recently registered for inflammatory bowel disease treatment. PMID:26557934

  1. An Innovative Pharmaceutical Care Practical Course

    ERIC Educational Resources Information Center

    Bulatova, N. R.; Aburuz, S.; Yousef, A. M.

    2007-01-01

    The innovative practical course was developed to improve the students' ability to acquire pharmaceutical care skills. The primary components of the course were in-school training using small group discussions and hospital experience including identification, analysis, prevention and resolution of drug-therapy problems, patient counseling on their…

  2. Pharmaceutical technology, biopharmaceutics and drug delivery.

    PubMed

    Youn, Yu Seok; Lee, Beom-Jin

    2011-03-01

    The 40th annual international conference of the Korean Society of Pharmaceutical Sciences and Technology on Pharmaceutical Technology, Biopharmaceutics and Drug Delivery was held on 2-3 December 2010 in Jeju Special Self-Governing Providence, Korea, to celebrate its 40th anniversary. A comprehensive review of a wide spectrum of recent topics on pharmaceutical technology, biopharmaceutics and drug delivery was presented. Invited lectures and poster presentations over 2 days were divided into six parallel sessions covering areas such as biotechnology, biopharmaceutics, drug delivery, formulation/manufacture, regulatory science and frontier science. Among these, there were two sessions related to regulatory science and biopharmaceutics that were co-sponsored by the Korea Food and Drug Administration. In fact, this conference provided an opportunity for many investigators to discuss their research, collect new information and to promote the advancement of knowledge in each pharmaceutical area. This conference report summarizes the keynote podium presentations provided by many distinguished speakers, including Gordon L Amidon of the University of Michigan. PMID:22833999

  3. Roles for Educational Psychologists in Pharmaceutical Education.

    ERIC Educational Resources Information Center

    Speedie, Stuart M.

    Functions of educational specialists, including educational psychologists, in the field of pharmaceutical education are discussed. The functions considered range from a general educational consultant to evaluator of an innovative program. Requirements for functioning effectively within a pharmacy school are also examined. The compensation…

  4. Pharmaceuticals and Hormones in the Environment

    EPA Science Inventory

    Some of the earliest initial reports from Europe and the United States demonstrated that a variety of pharmaceuticals and hormones could be found in surface waters, source waters, drinking water, and influents and effluents from wastewater treatment plants (WWTPs). It is unknown...

  5. [Archeology of the radio pharmaceutical advertisement].

    PubMed

    Lefebvre, Thierry

    2002-01-01

    After Second World War, a debate sets in France the partisans and the detractors of the radio advertisement, in particular pharmaceutical advertisement. In this article, the author revises campaigns led, during the thirties, by Robert Desnos for Armand Salacrou. PMID:12731488

  6. Pharmaceuticals as Groundwater Tracers - Applications and Limitations

    NASA Astrophysics Data System (ADS)

    Scheytt, T. J.; Mersmann, P.; Heberer, T.

    2003-12-01

    Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments show that clofibric acid exhibits no degradation and almost no retardation (Rf = 1.1) whereas ibuprofen is biodegraded (> 90 %) under aerobic conditions. Carbamazepine shows no degradation in the soil column experiments but significant retardation under the prevailing conditions. We conclude that clofibric acid will show the transport behavior of a conservative tracer, whereas ibuprofen may be used to characterize the biodegradation potential in the aerobic zone.

  7. Pharmaceutical care: past, present and future.

    PubMed

    Berenguer, B; La Casa, C; de la Matta, M J; Martín-Calero, M J

    2004-01-01

    Since the concept of Pharmaceutical Care was introduced from United States about twenty years ago, this initiative has become a dominant form of practice for thousands of pharmacists around the world. Currently, pharmaceutical care is understood as the pharmacists' compromise to obtain the maximum benefit from the pharmacological treatments of the patients, being therefore responsible of monitoring their pharmacotherapy. As the profession has moved from a product orientation (dispensing medications) to a patient focus, clinical training requirements have expanded. This is a slow but ongoing process, which started from a philosophical point of view, in order to transform the concept of Pharmacy from commodity-based, mercantile operations into a clinical profession in the community pharmacies. Since its introduction, there has been an ample debate on the definition of pharmaceutical care due to differences in Pharmacy systems and in health care structure among the different countries. Moreover, several implementation barriers exist, which are attributable to problems in education, skills, resources and environment. Indeed, an awareness of the problem resulting from the use of medicines exists and numerous studies reflect that drug use control is necessary since there is an important relationship between morbidity / mortality and pharmacotherapy. Thus, it is possible to evaluate the benefits of pharmaceutical care on patients' health and ultimately on society. Many studies have been conducted, which show that the provision of pharmaceutical care has its value in common pathologies such as diabetes, hypertension, asthma, hyperlipidemia, chronic pain, rheumatic diseases or psychiatric disorders, as well as in polymedicated patients. A large amount of data is currently being published in biomedical journals, in an effort to establish the clinical, economic and humanistic viability of pharmaceutical care. Thus, the aim of this review is to study the evolution of this practice from its beginning until nowadays. Furthermore, we have analyzed a number of implementation programs performed in countries of Europe, the United States and Latin America, focusing on clinical, economical and humanistic outcomes, and also, on the current concept of drug therapy problems (DTP) considered as failures in drug therapy. We conclude that the positive outcomes obtained with different programs of pharmaceutical care are making a beneficial change in patients' health but still more research projects should be conducted to support this change. PMID:15579081

  8. Continuous processes for the production of pharmaceutical intermediates and active pharmaceutical ingredients.

    PubMed

    LaPorte, Thomas L; Wang, Chenchi

    2007-11-01

    Continuous processing can be applied to the production of pharmaceutical intermediates and active pharmaceutical ingredients. Relatively small, well-designed continuous reactors offer enhanced heat and mass transfer rates, shorter inventories of hazardous materials and precise control of reaction and quench times compared with batch processing. These factors have a significant impact on the safety, quality and economics of a process. Continuous processing, a mainstay of the chemical industry, remains a novelty within the pharmaceutical industry; however, there has been renewed interest in the application of continuous processing to organic synthesis in the pharmaceutical industry in recent years, and this review discusses the opportunities for reaction engineering of low-molecular-weight compounds. PMID:17987525

  9. [Key points in clinical pharmaceutical education and research, as seen from pharmaceutical consultation clinics].

    PubMed

    Ooi, Kazuya

    2015-01-01

    Pharmaceutical education was expanded to a 6-year system in 2006, in an efforts to enhance clinical pharmaceutical research and education. Since that time, pharmacists have attempted to participate in medical all aspects of medical care, but an environment in which they can master direct pharmaceutical techniques for patients has not yet been sufficiently developed. This is because pharmaceutical education emphasizes the acquisition of knowledge and has not reached the point where it cultivates minds that can adapt to the multitude of situations that are envisaged in medical settings. By incorporating physical assessment in pharmaceutical settings, it is believed that a mind-set of treating patients can be formed in students, leading to the development of pharmacists skilled in the implementation of their area of treatment. We feel that, by shifting to clinical pharmaceutical education and research we will realize an integrated ability in pharmacists to treat patients, which will earn multifaceted appreciation from both patients themselves and medical practitioners. The pharmaceutical consultation clinic established at Mie University offers second opinions by pharmacists, but patients' opinions of pharmacists are tepid and the letter sometimes became the target of acerbic comments. This is a reflection of the current state in which pharmacists have not made their role in medicine clear. Ultimately, efforts must be made to resolve anxiety with respect to the things patients want to hear, without evading this responsibility even when under pressure. Pharmaceutical science should always be cognizant of what the pharmacists' contribution to medicine, should be, and research a means to help that individual acquire the ability to make quick though careful judgments while gathering needed findings. PMID:25747209

  10. Smart customers, dumb companies.

    PubMed

    Locke, C

    2000-01-01

    Customers today are being bombarded with an overwhelming array of choices. To alleviate customer frustration, say Steven Cristol and Peter Sealey in Simplicity Marketing, companies should stop creating new brands and product extensions. Better to consolidate product and service functions by following a four R approach: replace, repackage, reposition, and replenish. That's an outmoded, dictatorial view of markets, says Christopher Locke. Far from being stymied by choices, customers are rapidly becoming smarter than the companies that pretend to serve them. In this networked economy, people are talking among themselves, and that changes everything. Locke predicts we'll see a growing number of well-defined micromarkets--groups of customers converging in real time around entertaining and knowledgeable voices--such as NPR's car guys and the Motley Fool investment site. "Micromedia" Web sites will replace traditional advertising because they'll provide credible user-supplied news about products and services. Locke contends that an open exchange of information solves the "problem" of choice much better than manipulative strategies like simplicity or even permission marketing. Companies can participate in micromarkets through what Locke dubs "gonzo marketing." If Ford, for example, discovers that a subset of its employees are organic gardeners, it may offer support to a big independent organic-gardening Web site with donations and employee volunteers. This marketing effort would be driven not by advertising managers but by people with genuine interest in each micromarket, so it would have credibility with customers. With gonzo marketing, both companies and their markets will benefit. PMID:11184973

  11. Bioremediation companies engineer new consortia

    SciTech Connect

    Johnson, E.

    1996-07-01

    Bioremediation companies face technical and legal hurdles, which may result in the amalgamation of smaller remedial action companies. New breakthroughs in genetic engineering promise to counteract the specificity problems of microbial consortia.

  12. Eli Lilly and Company's bioethics framework for human biomedical research.

    PubMed

    Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

    2015-11-01

    Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action - to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values. PMID:26325585

  13. 12 CFR 583.15 - Parent company.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Parent company. 583.15 Section 583.15 Banks and... SAVINGS AND LOAN HOLDING COMPANIES 583.15 Parent company. The term parent company means any company which directly or indirectly controls any other company or companies....

  14. Providing System Compliance Training to Accountants of a Global Pharmaceutical Company: The Switzerland Case

    ERIC Educational Resources Information Center

    Leschinsky, Maribeth; Messemer, Jonathan E.

    2010-01-01

    On July 30, 2002, President George W. Bush signed the Sarbanes-Oxley Act of 2002 into law. The legislation was crafted by the United States Congress to address issues related to accounting improprieties which came to light during the Enron scandal. The specific purpose of the legislation was "To protect investors by improving the accuracy and…

  15. Electronic processing of informed consents in a global pharmaceutical company environment.

    PubMed

    Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

    2014-01-01

    We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail. PMID:25160337

  16. Pharmaceutical company sponsored disease management programs: an alternative for tax-exempt MCOs and hospitals.

    PubMed

    Jedrey, Christopher M; Chaurette, Katherine A; Winn, Lara Beth

    2002-01-01

    On April 25, 2002, the Internal Revenue Service finalized the proposed Corporate Sponsorship regulations. The changes made in the final regulations pertain to the proposed $79 ceiling on disregarded benefits, the 2 percent threshold for disregarded benefits, the scope of disregarded benefits, Web site hyperlinks, the inclusion of certain electronic publications in the definition of periodicals, the valuation date for substantial return benefits, and the scope of use or acknowledgement. The proposed regulations were discussed in the Winter 2002 issue of Managed Care Quarterly in an article titled the same as this one. This article is based on the final IRS regulations and therefore supersedes the original article published in the Winter 2002 issue. PMID:12476660

  17. Providing System Compliance Training to Accountants of a Global Pharmaceutical Company: The Switzerland Case

    ERIC Educational Resources Information Center

    Leschinsky, Maribeth; Messemer, Jonathan E.

    2010-01-01

    On July 30, 2002, President George W. Bush signed the Sarbanes-Oxley Act of 2002 into law. The legislation was crafted by the United States Congress to address issues related to accounting improprieties which came to light during the Enron scandal. The specific purpose of the legislation was "To protect investors by improving the accuracy and

  18. International best practices for negotiating 'reimbursement contracts' with price rebates from pharmaceutical companies.

    PubMed

    Morgan, Steven; Daw, Jamie; Thomson, Paige

    2013-04-01

    Reimbursement contracts, in which health insurers receive rebates from drug manufacturers instead of paying the transparent list price, are becoming increasingly common worldwide. Through interviews with policy makers in nine high-income countries, we describe the use of these contracts around the globe and identify related policy challenges and best practices. Of the nine countries surveyed, the majority routinely use confidential reimbursement contracts. This alternative to drug coverage at list prices offers benefits but is not without challenges. Payers face increased administrative costs, difficulties enforcing contracts, and reduced information about prices paid by others. Among the best practices identified, policy makers recommend establishing clear and consistent processes for negotiating contracts with relatively simple rebate structures and transparency to the public about the existence, purpose, and type of reimbursement contracts in place. Policy makers should also work to address undesirable price disparities within their countries and internationally, which may occur as a result of this new pricing paradigm. PMID:23569058

  19. Multilingualism in Companies: An Introduction

    ERIC Educational Resources Information Center

    Sherman, Tamah; Strubell, Miquel

    2013-01-01

    This thematic collection of four papers explores a number of perspectives on companies in which multiple languages are used. The "organisational" perspective concerns the question of how the presence of or demand for multiple languages in the company is managed--how companies are guided by national and other policies in regard to the use…

  20. Prevalence and Implementation Fidelity of Research-Based Prevention Programs in Public Schools. Final Report

    ERIC Educational Resources Information Center

    Crosse, Scott; Williams, Barbara; Hagen, Carol A.; Harmon, Michele; Ristow, Liam; DiGaetano, Ralph; Broene, Pamela; Alexander, Debbie; Tseng, Margaret; Derzon, James H.

    2011-01-01

    This report presents descriptive information about the prevalence and quality of implementation of research-based programs from the Study of the Implementation of Research-Based Programs to Prevent Youth Substance Abuse and School Crime. The study found that, while schools reported implementing a large number of prevention programs during the…

  1. Examining the Process of Developing a Research-Based Mathematics Curriculum and Its Policy Implications

    ERIC Educational Resources Information Center

    Superfine, Alison Castro; Kelso, Catherine Randall; Beal, Susan

    2010-01-01

    The implementation of "research-based" mathematics curricula is increasingly becoming a central element of mathematics education reform policies. Given the recent focus on grounding mathematics curriculum policies in research, it is important to understand precisely what it means for a curriculum to be research-based. Using the Curriculum Research

  2. Research-Based Assessment Affordances and Constraints: Perceptions of Physics Faculty

    ERIC Educational Resources Information Center

    Madsen, Adrian; McKagan, Sarah B.; Martinuk, Mathew Sandy; Bell, Alexander; Sayre, Eleanor C.

    2016-01-01

    To help faculty use research-based materials in a more significant way, we learn about their perceived needs and desires and use this information to suggest ways for the physics education research community to address these needs. When research-based resources are well aligned with the perceived needs of faculty, faculty members will more readily

  3. Developing Understanding of Research-Based Pedagogy with Preservice Teachers: An Instrumental Case Study

    ERIC Educational Resources Information Center

    Laframboise, Kathryn L.; Shea, Kim

    2009-01-01

    Preservice teachers have difficulty incorporating research-based instructional strategies and often revert to those observed during their own school years. This study describes how preservice teachers used a framework of planning, implementation, feedback, and reflection to try research-based teaching practices from their methods courses and…

  4. Research-Based Assessment Affordances and Constraints: Perceptions of Physics Faculty

    ERIC Educational Resources Information Center

    Madsen, Adrian; McKagan, Sarah B.; Martinuk, Mathew Sandy; Bell, Alexander; Sayre, Eleanor C.

    2016-01-01

    To help faculty use research-based materials in a more significant way, we learn about their perceived needs and desires and use this information to suggest ways for the physics education research community to address these needs. When research-based resources are well aligned with the perceived needs of faculty, faculty members will more readily…

  5. No more pens: what the 2009 Pharmaceutical Research and Manufacturer's Association code changes really mean.

    PubMed

    Meffert, Jeffrey J

    2009-01-01

    In 2002, new guidelines for interactions with the pharmaceutical industry and physicians were published as an official code of conduct. Adherence to the guidelines was voluntary, and there were no provisions for discipline to companies who did not subscribe to the code or who subscribed but did not comply. Many of the code standards are routinely violated, sometimes egregiously, with many violations on easy display at national professional meetings. In response to further problems and complaints, tougher code standards-now famous for the specific ban on logo pens and coffee cups-were adopted in 2009. Subscription to the new code is voluntary, and there are no provisions for discipline or punishment for those companies who chose not to subscribe or who may violate its standards. PMID:19539160

  6. Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals

    PubMed Central

    Bubela, Tania; Boon, Heather; Caulfield, Timothy

    2008-01-01

    Background This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles. Results Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64%) and herbal remedy (53%) clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; χ2 = 7.8129; degrees of freedom = 2). Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies. Conclusion Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most published research based primarily on anecdotal accounts. Our results highlight how media coverage is not providing the public with the information necessary to make informed decisions about medical treatments. Most concerning is the lack of disclosure of trial funding and conflicts of interest that could influence the outcome or reporting of trial results. This lack of reporting may impact the medical research community, which has the most to lose by way of public trust and respect. PMID:19036123

  7. The Trans-Pacific Partnership and pharmaceutical innovation.

    PubMed

    Freeman, Robert A

    2016-01-01

    Trade agreements are an overlooked area of research and policy analysis that affect market access, pricing and reimbursement decisions by pharmaceutical manufacturers, and research and development decisions in the long term. The Trans-Pacific Partnership (TPP) is the most recent multi-national agreement under considerations that may have profound implications in developed and developing countries in the Pacific Rim. As in the case of other trade arrangements, the TPP negotiations are not transparent, but a major leak of the most recent draft has been published in WikiLeaks. The leaked document has raised a number of concerns about intellectual property rights (IPR) and regulatory data protection (RDP) that have implications for public health and economic policy throughout the region. In particular, IPR and RDP go beyond the minimum standards set under the World Trade Organization (WTO) and may affect drug access negatively by delaying generic drug and biosimilar product availability and by raising prices by removing national regulations dealing with drug pricing and reimbursement. Of particular concern is the establishment of a litigation process where multi-national companies can sue individual countries before a panel of private attorneys who are appointed by the World Bank or United Nations. This paper addresses these concerns along with a commentary on the likelihood of occurring and the need for future research. PMID:26803645

  8. A framework for pharmaceutical value-based innovations.

    PubMed

    Salimi, Tehseen; Lehner, Jean-Pierre; Epstein, Robert S; Tunis, Sean R

    2012-01-01

    The rapidity of change and increasing complexity of today's healthcare environment dictates that pharmaceutical companies refine their drug development process to ensure that products provide maximal value to consumers. Innovation should receive the support and encouragement it deserves but the balance between cost of therapy and enhanced benefits to the end users, the patients, must not be compromised. The health or quality-of-life outcomes that therapies are likely to achieve need to be clearly stated for patients so they know what to expect before beginning treatment. A drug development program that incorporates principles of 'patient-centered medicine' early on can help define the true value of a health technology. This demands not only demonstrating value as measured by actual patient experience and patient-reported outcomes, but understanding the unmet needs of multiple stakeholders: what is their perception of what represents value? What factors impact healthcare coverage decisions? In this paper, we describe an illustrative framework designed to weave 'patient-centric' medical and real-world evidence into the phases of research and development. This evidence and value development framework works iteratively, providing useful insights parallel to product development from early phase to life-cycle management while forming a progressive evidence chain throughout the phases of research and development. This in turn leads to the creation of value-based innovation with robust foundational evidence for clinical decisions, postlaunch coverage and reimbursement evaluations. PMID:24237316

  9. [Patents in pharmaceutical industry: between ethics and property rights].

    PubMed

    Martínez Cárdenas, Edgar E

    2003-01-01

    The article presents a reflection on one of the greater challenges which the contemporary State is confronted with, related to guaranteeing the effective application of the fundamental rights, besides having to solve the conflicts that arise due to the rivalry between either fundamental rights or between some of these and others known as second or third generation rights. The conflict between the protection to the intellectual property rights, as in the case of the patents of the pharmaceutical multinationals, and the fundamental right to life is considered. It is observed that the interests of these companies have prevailed, as if the fundamental value to protect was the profit of these multinationals, or their efficiency, and not the right to health of the individuals which bears a direct relation with the right to the life. This situation is aggravated still more when the State, instead of being on the side of the weaker and offering him protection, safeguards the stronger who abuse of their dominant position, exerting the monopoly on the production of many essential medicines. PMID:14658364

  10. [The pharmaceutical industry and the adverse effects of the drugs].

    PubMed

    Lamarque, V; Pltan, Y

    2007-09-01

    New drug development is a long, expensive and hazardous process especially regarding the final outcome. During the first non-clinical steps, molecules identified as potential candidates are screened for their toxicological profile, which allows to eliminate some but also to identify possible "target" organs. Then clinical trials are conducted, where tolerance profile knowledge is increased through the development with the detection of the most frequent adverse effects (between 1% and 1 per thousand). At marketing authorization, because of the limited number and of the selectivity of patients enrolled in clinical trials, the drug safety profile is based on the more frequent adverse effects. In Europe, since November 2005, a new regulation - the Risk Management system - has been added to Pharmacovigilance. These are designed to better anticipate and even minimize important identified or potential risks or to better inform on populations not studied during the clinical trials. This concept is based on risk reduction throughout drug's life cycle with specific strategic actions in addition to the product information, in order to optimise the drug benefit/risk ratio. Pharmaceutical companies will therefore invest significantly in post-marketing, allowing proper and safety use of their products. As they played a major role in the clinical development few years ago, they could from now on, be recognised as the key player towards this new paradigm defined as the post-approval development. PMID:17982378

  11. Understanding pharmaceutical research manipulation in the context of accounting manipulation.

    PubMed

    Brown, Abigail

    2013-01-01

    The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied - though by no means solved - in financial accounting than in medicine. This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information. PMID:24088151

  12. Drug nanocrystals in the commercial pharmaceutical development process.

    PubMed

    Möschwitzer, Jan P

    2013-08-30

    Nanosizing is one of the most important drug delivery platform approaches for the commercial development of poorly soluble drug molecules. The research efforts of many industrial and academic groups have resulted in various particle size reduction techniques. From an industrial point of view, the two most advanced top-down processes used at the commercial scale are wet ball milling and high pressure homogenization. Initial issues such as abrasion, long milling times and other downstream-processing challenges have been solved. With the better understanding of the biopharmaceutical aspects of poorly water-soluble drugs, the in vivo success rate for drug nanocrystals has become more apparent. The clinical effectiveness of nanocrystals is proven by the fact that there are currently six FDA approved nanocrystal products on the market. Alternative approaches such as bottom-up processes or combination technologies have also gained considerable interest. Due to the versatility of nanosizing technology at the milligram scale up to production scale, nanosuspensions are currently used at all stages of commercial drug development, Today, all major pharmaceutical companies have realized the potential of drug nanocrystals and included this universal formulation approach into their decision trees. PMID:23000841

  13. Which Pharmaceutical Sales Representatives’ Features do Slovenian Family Physicians Value?

    PubMed Central

    Klemenc-Ketis, Zalika; Kersnik, Janko

    2013-01-01

    Introduction: One of the key strategies for marketing new drugs to physicians is personal selling by pharmaceutical sales representatives (PSRs). Goal: The aim of this study was to determine which features of PSR’s are most valued by Slovenian family physicians (FPs). Methods: We performed a cross-sectional observational postal survey in FPs. We sent the invitation for cooperation in the study to all Slovenian FPs working in family practices at the primary level of care (N = 895). Data was collected using a validated PSRs’ assessment scale. It consists of 12 questions on PSRs’ assessment that could be answered on a seven-point Likert scale. Results: The response rate was 27.6%. There were 174 (70.4%) of female physicians among the respondents. Average age of the respondents was 48.3 ± 9.0 years. Highly assessed PSRs’ characteristics were “Provides objective product information”, “Does not mislead”, and “Shows good knowledge on the subject promoted”. Worst rated PSRs’ characteristics were “Possesses knowledge on health care system”, “Same person for the product of company for a longer period of time”, and “Acts friendly”. Conclusions: Slovenian FPs value PSRs’ selling and communication skills and trustworthiness highly. FPs and PSRs develop a personal relationship which reflects in different perceptions of various PSRs’ characteristics by FPs. PMID:24554801

  14. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  15. Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem

    NASA Astrophysics Data System (ADS)

    Kodesova, Radka; Klement, Ales; Kocarek, Martin; Fer, Miroslav; Golovko, Oksana; Grabic, Roman; Jaksik, Ondrej

    2014-05-01

    It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from Čáslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with decreasing adsorption. In all cases (including non contaminated soil sample) biological activity initially increased (1 and 2 day after the pharmaceutical application) and then dropped down on 5th day (Trimetoprim, Clindamycin, Atenolol, Sulfamethoxazol) or 23rd day (Clarithromycin, Metoprolol, Carbamazepin) of soil sample incubation. A closer correlation between the numbers of colony forming unites and degradation rates were not revealed. Acknowledgement: Authors acknowledge the financial support of the Czech Science Foundation (Project No. 13-12477S).

  16. Organizational performance, Marketing strategy, and Financial strategic alignment: an empirical study on Iranian pharmaceutical firms

    PubMed Central

    2013-01-01

    Background Strategic Functional-level planning should be aligned with business level and other functional strategies of a company. It is presumed that assimilating the strategies could have positive contribution to business performance, in this regard alignment between marketing strategy and financial strategy seems to be the most important strategies being studied. An empirical work in generic pharmaceutical manufacturing companies for evaluating effect of alignment between these two functions on organizational performance was developed in this paper. Methods All Iranian pharmaceutical generic manufactures listed in Tehran stock market have been tested for period of five years between 2006–2010 and their marketing strategies were determined by using Slater and Olson taxonomy and their financial strategies have been developed by calculating total risk and total return of sample companies for five years based on rate of risk and return in the frame of a 2 × 2 matrix. For the business performance three profitability indices including Q-Tubin (Rate of market value to net asset value), ROA (Return on Asset), ROE (Return on Equity) have been tested. For analysis, a series of one-way ANOVAs as a collection of statistical models within marketing strategies considering financial strategy as independent variable and the three performance measures as dependent variables was used. Results Results show strategic alignment between financial and marketing has significant impact on profitability of company resulting in arise of all three profitability indices. Q tubing’s rate were 2.33,2.09,2.29,2.58 and rate of ROA were 0.21,0.194,0.25,0.22 and rate of ROE were 0.44,0.46,0.45,0.42 for matched strategy types, respectively the rates shown here are more than average meaning that specific type of marketing strategy is fitted with specific type of financial strategy. Conclusion Managers should not consider decisions regarding marketing strategy independently of their financial strategy. PMID:23915467

  17. Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market

    PubMed Central

    2014-01-01

    Background Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies’ competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). Results The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. Conclusion This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets’ needs. PMID:24708770

  18. General public knowledge, perceptions and practice towards pharmaceutical drug advertisements in the Western region of KSA

    PubMed Central

    Al-Haddad, Mahmoud S.; Hamam, Fayez; AL-Shakhshir, Sami M.

    2013-01-01

    This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor–patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceutical companies and drug suppliers. PMID:24648823

  19. [Relationship between pharmaceutical industry and the French government during the last two centuries].

    PubMed

    Bonnemain, Henri; Bonnemain, Bruno

    2002-01-01

    Between the law of germinal an XI and the 1941 law, the relationship between the pharmaceutical industry and the French government were driven by the official practice of pharmacy. The State trues pharmacist who has to contrôle financially and deontologically his company. After 1941, the State will more and more regulate and control all the activities of the pharmaceutical products industry due to the major financial impact of these products on Health Care and Social Security budgets. French State will be progressively concerned with medical information and good practices (good manufacturing practices, good laboratory practices...) It will also regulate the pricing of new drugs, the development process and will encourage the marketing of innovative products. These rules, on the basis of the European directive of 1965, will be more or less harmonized for all European countries. Since 1989, this harmonization process is looking for an expansion outside of Europe, at least for the marketing authorization, in order to facilitate the registration of innovative products in all countries. One can then observe on a period of two centuries the evolution from freedom of the pharmaceutical industry more and more to a strict controlled freedom. PMID:12378715

  20. Dropwise additive manufacturing of pharmaceutical products for solvent-based dosage forms.

    PubMed

    Hirshfield, Laura; Giridhar, Arun; Taylor, Lynne S; Harris, Michael T; Reklaitis, Gintaras V

    2014-02-01

    In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms. PMID:24311373

  1. Pharmaceutical marketing practices: balancing public health and law enforcement interests; moving beyond regulation-through-litigation.

    PubMed

    Zalesky, Christopher D

    2006-01-01

    Fraudulent or abusive sales and marketing practices by pharmaceutical companies can result in costly overutilization of products that are increasingly paid for by government healthcare programs and may result in adverse health and safety consequences to the patient-beneficiaries of those programs. Federal enforcement efforts in this area are largely modeled on those used to combat white-collar crime, with cases taking years to reach conclusion. This approach overlooks the impact on patients who receive unnecessary care or are denied access to appropriate care during the course of the investigation. Many states are beginning to regulate certain pharmaceutical sales and marketing practices, but state-by-state regulation ignores the importance of a uniform federal regulatory and enforcement approach in an area already occupied by federal law. This Article explores current federal and state efforts to limit overutilization, fraud, and abuse in the sale and marketing of prescription drugs, and illustrates the merits of an expanded role for the U.S. Food and Drug Administration (FDA) to regulate pharmaceutical sales and marketing practices. This approach borrows lessons learned from the FDA's efficient and effective regulatory and enforcement methods and maintains a careful balance between the interests of patient-beneficiaries, the government and industry. PMID:17002233

  2. Patent indicators: a window to pharmaceutical market success.

    PubMed

    Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

    2013-07-01

    Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market. PMID:23611022

  3. Rosmarinic Acid - Pharmaceutical and Clinical Aspects.

    PubMed

    Amoah, Solomon K S; Sandjo, Louis P; Kratz, Jadel M; Biavatti, Maique W

    2016-03-01

    The biosynthesis and biotechnological production of Rosmarinic acid, a phenolic ester that is widespread in the plant kingdom, has been widely investigated. This compound has shown many remarkable biological and pharmacological activities, which have led to its pharmaceutical and analytical development, as well as clinical studies, which are summarized and analyzed here for the first time. This review compiles data from the Pubmed, Scopus, Scifinder, Web Of Science, and Science Direct databases published between 1990 and 2015, restricting the search to works with the keywords "Rosmarinic acid" in the title. The initial search identified more than 800 articles; after an initial screening and removal of duplicate works, the search was further refined, resulting in approximately 300 articles that were scrutinized and comprise this review. The articles were organized to describe extraction and isolation, analytical methods, pharmaceutical development, and biological and pharmacological activities [divided into nonclinical (in vitro, in vivo) and clinical studies], pharmacokinetic studies, and stability studies. PMID:26845712

  4. Fate of selected pharmaceuticals in river waters.

    PubMed

    Calza, P; Medana, C; Padovano, E; Giancotti, V; Minero, C

    2013-04-01

    The aqueous environmental fate of two antibiotics, lincomycin and clarithromycin, and an antiepileptic drug, carbamazepine, was investigated by monitoring drugs decomposition and identifying intermediates in Po river water (North Italy). Initially, control experiments in the dark and under illumination were performed on river water spiked with drugs to simulate all possible transformation processes occurring in the aquatic system. Under illumination, these pharmaceuticals were degraded and transformed into numerous organic intermediate compounds. Several species were formed and characterised by analysing MS and MS(n) spectra and by comparison with parent molecule fragmentation pathways. River water was sampled at three sampling points in an urban area. The selected pharmaceuticals were detected in all samples. Eight transformation products identified in the laboratory simulation were found in natural river water from carbamazepine degradation, three from clarithromycin and two from lincomycin. Their transformation occurring in aquatic system mainly involved mono- and poly-hydroxylation followed by oxidation of the hydroxyl groups. PMID:22851223

  5. Chitosan modification and pharmaceutical/biomedical applications.

    PubMed

    Zhang, Jiali; Xia, Wenshui; Liu, Ping; Cheng, Qinyuan; Tahirou, Talba; Gu, Wenxiu; Li, Bo

    2010-01-01

    Chitosan has received much attention as a functional biopolymer for diverse applications, especially in pharmaceutics and medicine. Our recent efforts focused on the chemical and biological modification of chitosan in order to increase its solubility in aqueous solutions and absorbability in the in vivo system, thus for a better use of chitosan. This review summarizes chitosan modification and its pharmaceutical/biomedical applications based on our achievements as well as the domestic and overseas developments: (1) enzymatic preparation of low molecular weight chitosans/chitooligosaccharides with their hypocholesterolemic and immuno-modulating effects; (2) the effects of chitin, chitosan and their derivatives on blood hemostasis; and (3) synthesis of a non-toxic ion ligand--D-Glucosaminic acid from oxidation of D-Glucosamine for cancer and diabetes therapy. PMID:20714418

  6. External referencing and pharmaceutical price negotiation.

    PubMed

    Garcia Mariñoso, Begoña; Jelovac, Izabela; Olivella, Pau

    2011-06-01

    External referencing (ER) imposes a price cap for pharmaceuticals, based on prices of identical or comparable products in foreign countries. Suppose a foreign country (F) negotiates prices with a pharmaceutical firm, whereas a home country (H) can either negotiate prices independently or implement ER, based on the foreign price. We show that country H prefers ER if copayments in H are relatively high. This preference is reinforced when H's population is small. Irrespective of relative country sizes, ER by country H harms country F. Our model is inspired by the wide European experience with this cost-containment policy. Namely, in Europe, drug authorization and price negotiations are carried out by separate agencies. We confirm our main results in two extensions. The first one allows for therapeutic competition between drugs. In the second one, drug authorization and price negotiation take place in a single agency. PMID:20577969

  7. Confocal Raman Microscopy in Pharmaceutical Development

    NASA Astrophysics Data System (ADS)

    Haefele, Thomas F.; Paulus, Kurt

    There is a wide range of applications of confocal Raman microscopy in pharmaceutical development. It is a powerful tool to probe the distribution of components within a formulation, to characterize homogeneity of pharmaceutical samples, to determine solid state of drug substances and excipients and to characterize contaminations and foreign particulates. The information obtained by confocal Raman microscopy is extremely useful, sometimes even crucial, for drug substance design, for the development of solid and liquid formulations, as a tool for process analytics and for patent infringements and counterfeit analysis. In this chapter, those aspects and applications will be presented, focusing on solid drug formulations. This chapter will also reveal the advantages and demonstrate the synergies of Raman mapping as compared to similar imaging methods such as SEM/EDX, NIR and MIR imaging.

  8. Health technology assessment. The pharmaceutical industry perspective.

    PubMed

    Schubert, Francois

    2002-01-01

    Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations. PMID:12053418

  9. Chitosan Modification and Pharmaceutical/Biomedical Applications

    PubMed Central

    Zhang, Jiali; Xia, Wenshui; Liu, Ping; Cheng, Qinyuan; Tahirou, Talba; Gu, Wenxiu; Li, Bo

    2010-01-01

    Chitosan has received much attention as a functional biopolymer for diverse applications, especially in pharmaceutics and medicine. Our recent efforts focused on the chemical and biological modification of chitosan in order to increase its solubility in aqueous solutions and absorbability in the in vivo system, thus for a better use of chitosan. This review summarizes chitosan modification and its pharmaceutical/biomedical applications based on our achievements as well as the domestic and overseas developments: (1) enzymatic preparation of low molecular weight chitosans/chitooligosaccharides with their hypocholesterolemic and immuno-modulating effects; (2) the effects of chitin, chitosan and their derivatives on blood hemostasis; and (3) synthesis of a non-toxic ion ligand—D-Glucosaminic acid from Oxidation of D-Glucosamine for cancer and diabetes therapy. PMID:20714418

  10. Overview of genotoxic impurities in pharmaceutical development.

    PubMed

    Bercu, Joel P; Dobo, Krista L; Gocke, Elmar; McGovern, Timothy J

    2009-01-01

    This symposium focuses on the management of genotoxic impurities in the synthesis of pharmaceuticals. Recent developments in both Europe and United States require sponsors of new drug applications to develop processes to control the risks of potential genotoxic impurities. Genotoxic impurities represent a special case relative to the International Conference on Harmonisation Q3A/Q3B guidances, because genotoxicity tests used to qualify the drug substance may not be sufficient to demonstrate safety of a potentially genotoxic impurity. The default risk management approach for a genotoxic impurity is the threshold of toxicological concern unless a more specific risk characterization is appropriate. The symposium includes descriptions of industry examples where impurities are introduced and managed in the synthesis of a pharmaceutical. It includes recent regulatory developments such as the "staged threshold of toxicological concern" when administration is of short duration (eg, during clinical trials). PMID:19966139

  11. Do Spin-Offs Make the Academics' Heads Spin? The Impacts of Spin-Off Companies on Their Parent Research Organisation

    ERIC Educational Resources Information Center

    Zomer, Arend H.; Jongbloed, Ben W. A.; Enders, Jurgen

    2010-01-01

    As public research organisations are increasingly driven by their national and regional governments to engage in knowledge transfer, they have started to support the creation of companies. These research based spin-off companies (RBSOs) often keep contacts with the research institutes they originate from. In this paper we present the results of a

  12. Do Spin-Offs Make the Academics' Heads Spin? The Impacts of Spin-Off Companies on Their Parent Research Organisation

    ERIC Educational Resources Information Center

    Zomer, Arend H.; Jongbloed, Ben W. A.; Enders, Jurgen

    2010-01-01

    As public research organisations are increasingly driven by their national and regional governments to engage in knowledge transfer, they have started to support the creation of companies. These research based spin-off companies (RBSOs) often keep contacts with the research institutes they originate from. In this paper we present the results of a…

  13. Development of an orphan drug by a start-up company. MetroGel for rosacea.

    PubMed

    Borgman, R J

    1992-01-01

    The Orphan Drug Act of 1983, along with the discovery of a new use for a known drug and an investor willing to assume the necessary risk, brought about the formation of a start-up pharmaceutical company. The primary incentive of the Orphan Drug Act of seven years of marketing exclusivity provided the protection from competition necessary for recovery of the significant research and development and marketing costs. The orphan product, MetroGel, for the treatment of rosacea, required approximately five years of development before it was approved for marketing by the Food and Drug Administration. MetroGel has become the number one drug in the United States for the treatment of rosacea. It currently is marketed in other countries through a licensing agreement with a major pharmaceutical company. PMID:1464478

  14. Bioceramics and pharmaceuticals: A remarkable synergy

    NASA Astrophysics Data System (ADS)

    Vallet-Regí, María; Balas, Francisco; Colilla, Montserrat; Manzano, Miguel

    2007-09-01

    The research on controlled drug delivery systems using bioceramics as host matrices presents two distinct sides; one route aims at embedding pharmaceuticals in biomaterials designed for the reconstruction or regeneration of living tissues, in order to counteract inflammatory responses, infections, bone carcinomas and so forth, while the other route deals with the more traditional drug introduction systems, i.e. oral administration. The incorporation of pharmaceuticals to bioceramic matrices could be very interesting in clinical practice. It is rather common in these days for an orthopedic surgeon working in bone reconstruction to use bioceramics. An added value to the production of these ceramics would be the optional addition of pharmaceuticals such as antibiotics, anti-inflammatories, anti-carcinogens, etc. In this sense, if we take into account the infections statistics at hip joint prostheses, the incidence varies between 2 and 4%, reaching up to a 45% in bolts used as external fixation. One of the main problems in these situations is the access to the infected area of the bone, in order to deliver the adequate antibiotic. If the pharmaceutical could be included within the implant itself, the added value would be straightforward. And if the bioceramic is bioactive, and therefore precursor of new bone tissue, the capability to introduce peptides, proteins or growth factors at its pores could accelerate the bone regeneration processes. We are facing a fine example of multidisciplinary research, where the so-called transversal supply of knowledge from and between the domains of materials science, biology and medicine will empower the know-how and applications that shall, undoubtedly, give rise to new advances in science and technology.

  15. Cubanes: Super explosives and potential pharmaceutical intermediates

    NASA Technical Reports Server (NTRS)

    Bashir-Hashemi, A.

    1994-01-01

    The cubane molecule, in which eight carbon atoms are locked in a cubic framework, shows great potential for both military and pharmaceutical applications. Octanitrocubane, with a predicted density of 2.1 g/cc and strain energy of more than 165 kcal/mol, is considered to be the 'super-explosive', while cubane derivatives submitted to the National Institutes of Health for preliminary biological activity screening have displayed promising anti-cancer and anti-HIV activity.

  16. Pharmaceutical policy and the pharmacy profession.

    PubMed

    Traulsen, Janine M; Almarsdóttir, Anna Birna

    2005-10-01

    In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy as a health care profession, as well as what it means when we view pharmaceutical policy in the context of the health sector labour market, is discussed. The authors also discuss how factors external to the profession are affecting its purpose and realm of practice, including the current trend in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental in developing new and expanding roles for the profession, sometimes inspired by external events, but often as a result of their own prerogative. The pharmacy profession is encouraged to take a leading role in forming and contributing to policy, in this way making visible its contribution to society in general and public health in particular. If not, the profession will forever be reacting to policy and will remain at the mercy of policymakers and other strong actors in society. PMID:16341741

  17. Paying for pharmaceutical registration in developing countries.

    PubMed

    Kaplan, Warren A; Laing, Richard

    2003-09-01

    Fees charged by drug regulatory authorities (DRAs) may be used as a policy instrument to speed up regulatory approval, to encourage retention of quality staff and to stimulate introduction of generics versus new chemical entities. Often, the cost recovery function of these registration fees is not related to the true cost of the pharmaceutical regulatory process. In this paper, we scaled new drug registration fees of various DRAs to indices of economic development - the GNP per capita and the total government health expenditure per capita. Based on our analyses of 34 countries, most DRA registration fees for new drug applications for developing/non-OECD countries are less than the current GNP/capita of that country or are about US dollars 5000 for each US dollars 1000 spent per capita on healthcare. At present, each US dollars 1000 new drug registration fee for the developing/non-OECD countries analyzed corresponds to a total pharmaceutical market share of about US dollars 85 million. Our analyses further suggest little relationship between DRA registration fees and drug approval times in developing countries. The situation is complex, however, as policy tradeoffs are important to consider. Differential registration fees, presumably designed to encourage locally produced versus imported products, may violate international trade regulations. Moreover, certain DRA registration fees may provide perverse incentives for the pharmaceutical industry. Developing countries should require that DRA registration fees be based on accurate accounting of the cost of services provided. At present levels, these fees could be increased without disincentive to the pharmaceutical industry. For new drug registration fees, our analyses suggest that developing countries could charge between 1-5 times their GNP per capita or between US dollars 17000 and US dollars 80000 for each US dollars 1000 spent per capita on healthcare. PMID:12917265

  18. Comparisons between in vitro whole cell imaging and in vivo zebrafish-based approaches for identifying potential human hepatotoxicants earlier in pharmaceutical development.

    PubMed

    Hill, Adrian; Mesens, Natalie; Steemans, Margino; Xu, Jinghai James; Aleo, Michael D

    2012-02-01

    Drug-induced liver injury (DILI) is a major cause of attrition during both the early and later stages of the drug development and marketing process. Reducing or eliminating drug-induced severe liver injury, especially those that lead to liver transplants or death, would be tremendously beneficial for patients. Therefore, developing new pharmaceuticals that have the highest margins and attributes of hepatic safety would be a great accomplishment. Given the current low productivity of pharmaceutical companies and the high costs of bringing new medicines to market, any early screening assay(s) to identify and eliminate pharmaceuticals with the potential to cause severe liver injury in humans would be of economic value as well. The present review discusses the background, proof-of-concept, and validation studies associated with high-content screening (HCS) by two major pharmaceutical companies (Pfizer Inc and Jansen Pharmaceutical Companies of Johnson & Johnson) for detecting compounds with the potential to cause human DILI. These HCS assays use fluorescent-based markers of cell injury in either human hepatocytes or HepG2 cells. In collaboration with Evotec, an independent contract lab, these two companies also independently evaluated larval zebrafish as an early-stage in vivo screen for hepatotoxicity in independently conducted, blinded assessments. Details about this model species, the need for bioanalysis, and, specifically, the outcome of the phenotypic-based zebrafish screens are presented. Comparing outcomes in zebrafish against both HCS assays suggests an enhanced detection for hepatotoxicants of most DILI concern when used in combination with each other, based on the U.S. Food and Drug Administration DILI classification list. PMID:22242931

  19. Classification of dermal sensitizers in pharmaceutical manufacturing.

    PubMed

    Winkler, Gian C; Perino, Christopher; Araya, Selene H; Bechter, Rudolf; Kuster, Martin; Lovsin Barle, Ester

    2015-08-01

    Workers in development and manufacturing of pharmaceuticals are at risk for occupational contact dermatitis (OCD) of irritative (ICD) or allergic (ACD) origin, due to contacts with reactive intermediates (IM) and drug substances (DS). We examined, if alternative methods could replace presently used animal tests for identification of ACD in pharmaceutical development and manufacturing, without apparent loss of worker health, in line with regulations. The status of alternative methods for regulatory toxicology for consumer products has recently been reviewed by the Organisation for Economic Co-operation and Development (OECD) and the European Commission's Joint Research Center (JRC) for the European Chemicals Agency (ECHA). They concluded that prediction of skin sensitization potential, extent and quality by in vitro methods, for regulatory assessments, will depend on the regulatory purpose and level of confidence required. Some alternative methods are currently in validation. Current Globally Harmonized System (GHS) regulations on classification, labeling and packaging of substances and mixtures depend on human and animal data, whereas alternative methods may provide supportive evidence. Since the levels of workplace skin exposure to DS and IM in manufacturing of pharmaceuticals are usually not known, it is not possible to conduct quantitative risk assessments based on threshold calculations for contact sensitizers. PMID:26028366

  20. New Medium for Pharmaceutical Grade Arthrospira.

    PubMed

    Amara, Amro A; Steinbüchel, Alexander

    2013-01-01

    The aim of this study is to produce a pharmaceutical grade single cell product of Arthrospira from a mixed culture. We have designed a medium derived from a combination between George's and Zarrouk's media. Our new medium has the ability to inhibit different forms of cyanobacterium and microalgae except the Chlorella. The medium and the cultivation conditions have been investigated to map the points where only Arthrospira could survive. For that, a mixed culture of pure Chlorella and Arthrospira (~90 : 10) has been used to develop the best medium composition that can lead to the enrichment of the Arthrospira growth and the inhibition of the Chlorella growth. To enable better control and to study its growth, an 80 l photobioreactor has been used. We have used high saline (2xA-St) medium which has been followed by in fermentor reducing its concentration to 1.5x. The investigation proves that Chlorella has completely disappeared. A method and a new saline medium have been established using a photobioreactor for in fermentor production of single cell Arthrospira. Such method enables the production of pure pharmaceutical grade Arthrospira for medicinal and pharmaceutical applications or as a single cell protein. PMID:26904724

  1. Solventless pharmaceutical coating processes: a review.

    PubMed

    Bose, Sagarika; Bogner, Robin H

    2007-01-01

    Coatings are an essential part in the formulation of pharmaceutical dosage form to achieve superior aesthetic quality (e.g., color, texture, mouth feel, and taste masking), physical and chemical protection for the drugs in the dosage forms, and modification of drug release characteristics. Most film coatings are applied as aqueous- or organic-based polymer solutions. Both organic and aqueous film coating bring their own disadvantages. Solventless coating technologies can overcome many of the disadvantages associated with the use of solvents (e.g., solvent exposure, solvent disposal, and residual solvent in product) in pharmaceutical coating. Solventless processing reduces the overall cost by eliminating the tedious and expensive processes of solvent disposal/treatment. In addition, it can significantly reduce the processing time because there is no drying/evaporation step. These environment-friendly processes are performed without any heat in most cases (except hot-melt coating) and thus can provide an alternative technology to coat temperature-sensitive drugs. This review discusses and compares six solventless coating methods - compression coating, hot-melt coating, supercritical fluid spray coating, electrostatic coating, dry powder coating, and photocurable coating - that can be used to coat the pharmaceutical dosage forms. PMID:17510883

  2. New Medium for Pharmaceutical Grade Arthrospira

    PubMed Central

    Amara, Amro A.; Steinbüchel, Alexander

    2013-01-01

    The aim of this study is to produce a pharmaceutical grade single cell product of Arthrospira from a mixed culture. We have designed a medium derived from a combination between George's and Zarrouk's media. Our new medium has the ability to inhibit different forms of cyanobacterium and microalgae except the Chlorella. The medium and the cultivation conditions have been investigated to map the points where only Arthrospira could survive. For that, a mixed culture of pure Chlorella and Arthrospira (~90 : 10) has been used to develop the best medium composition that can lead to the enrichment of the Arthrospira growth and the inhibition of the Chlorella growth. To enable better control and to study its growth, an 80 l photobioreactor has been used. We have used high saline (2xA-St) medium which has been followed by in fermentor reducing its concentration to 1.5x. The investigation proves that Chlorella has completely disappeared. A method and a new saline medium have been established using a photobioreactor for in fermentor production of single cell Arthrospira. Such method enables the production of pure pharmaceutical grade Arthrospira for medicinal and pharmaceutical applications or as a single cell protein. PMID:26904724

  3. Pharmaceuticals that contain polycyclic hydrocarbon scaffolds.

    PubMed

    Stockdale, Tegan P; Williams, Craig M

    2015-11-01

    Numerous variations on structural motifs exist within pharmaceutical compounds that have entered the clinic. These variations have amounted over many decades based on years of drug development associated with screening natural products and de novo synthetic systems. Caged (or bridged) bicyclic structural elements offer a variety of diverse features, encompassing three-dimensional shape, and assorted pharmacokinetic properties. This review highlights approximately 20 all carbon cage containing pharmaceuticals, ranging in structure from bicyclo[2.2.1] through to adamantane, including some in the top-selling pharmaceutical bracket. Although, a wide variety of human diseases, illnesses and conditions are treated with drugs containing the bicyclic motif, a common feature is that many of these lipophilic systems display CNS and/or neurological activity. In addition, to an extensive overview of the history and biology associated with each drug, a survey of synthetic methods used to construct these entities is presented. An analysis section compares natural products to synthetics in drug discovery, and entertains the classical caged hydrocarbon systems potentially missing from the clinic. Lastly, this unprecedented review is highly pertinent at a time when big pharma is desperately trying to escape flatland drugs. PMID:26171466

  4. Prioritizing Environmental Risk of Prescription Pharmaceuticals

    PubMed Central

    Dong, Zhao; Senn, David B.; Moran, Rebecca E.

    2015-01-01

    Low levels of pharmaceutical compounds have been detected in aquatic environments worldwide, but their human and ecological health risks associated with low dose environmental exposure is largely unknown due to the large number of these compounds and a lack of information. Therefore prioritization and ranking methods are needed for screening target compounds for research and risk assessment. Previous efforts to rank pharmaceutical compounds have often focused on occurrence data and have paid less attention to removal mechanisms such as human metabolism. This study proposes a simple prioritization approach based on number of prescriptions and toxicity information, accounting for metabolism and wastewater treatment removal, and can be applied to unmeasured compounds. The approach was performed on the 200 most-prescribed drugs in the U.S. in 2009. Our results showed that under-studied compounds such as levothyroxine and montelukast sodium received the highest scores, suggesting the importance of removal mechanisms in influencing the ranking, and the need for future environmental research to include other less-studied but potentially harmful pharmaceutical compounds. PMID:22813724

  5. Pharmaceutical policy reform in the Russian Federation.

    PubMed

    Rudisill, Caroline; Vandoros, Sotiris; Antoun, Joseph George

    2014-06-01

    Of Russia's 142 million citizens, fewer than 20 million are enrolled in outpatient drug coverage plans. The current government aims to establish universal health insurance including outpatient medicines. Based on the current political and regulatory environment, this report explores pharmaceutical pricing options for Russia that balance greater access to medicines with achieving government plans of boosting local pharmaceutical production. To match innovative medicine prices with their health benefits, in the long run, we suggest that Russia consider adopting value-based pricing, and in the short term, that it introduce direct price negotiations and price drugs according to reference countries that use health technology assessment. Although generic market shares are high, generic medicine prices are higher than they should be. We propose tenders at the manufacturer level for the pricing of high-selling generics, and free pricing for products with sufficient market competition. These policy recommendations are a jumping-off point for further discussion about how pharmaceutical policy could aid this major economy to achieve its population health and health service goals. PMID:24603082

  6. Pharmaceutical applications of graphene-based nanosheets.

    PubMed

    Kim, Mi-Gyeong; Park, Joo Y; Shon, Yuna; Shim, Gayong; Oh, Yu-Kyoung

    2014-01-01

    Graphene-based nanosheets (GNS) are atomic-thickness monolayers of hexagonally arranged, graphite-derived carbon atoms that may be composed of graphene, graphene oxide, or reduced graphene oxide. They have attracted tremendous interest for their potential in pharmaceutical applications, due to their unique physical, chemical, and mechanical properties GNS exhibit highly uniform surface areas and may have hydroxyl (-OH), epoxide (-O-), and carboxyl functional groups at their basal surfaces and plane edges, depending on their oxidized and reduced surface properties. GNS show high-level optical absorption of near infrared (NIR) light and elevate the temperature of nearby environments. Furthermore, they can be loaded with anticancer drugs via hydrophobic interactions, π-π stacking, or electrostatic binding. Given these properties, GNS can be used in chemotherapy, photodynamic therapy, photothermal therapy, and theranostics. However, although GNS appear to have far-reaching potential in the field of biomedical research, their widespread pharmaceutical application has been limited by issues such as poor stability in physiological buffers, undefined mechanisms of cellular uptake, toxicity problems, and a lack of standard preparation methods. Here, we review the current pharmaceutical applications of GNS, focusing on chemotherapy, phototherapy, combo therapy and theranostic applications with challenging issues. PMID:24433501

  7. Probiotics: from functional foods to pharmaceutical products.

    PubMed

    Bansal, Tripta; Garg, Sanjay

    2008-08-01

    The concept of probiotics now has been around for more than a century, with its consumption increasing exponentially; owing to exciting scientific and clinical findings, limiting side effects of existing pharmaceutical agents and increased consumer demand for natural products. But, the evidence for their safety and efficacy has largely been anecdotal, lacking an integrated scientific basis. Clinical studies conducted with probiotics were of inadequate design and resulted in unreliable data. That is the reason why despite having innumerable potential therapeutic uses probiotics are not being universally accepted. The purpose of present article is to amalgamate various branches of research which would help in development of "better", "commercial" and "pharmaceutical" probiotic products with defined strength, mechanism of action and indication. Probiotics have been classified into oral and vaginal in accordance to their route of administration, describing the health benefits. The article summarizes the research on significance of strain selection, interactions with co-administered agents and appropriate clinical studies uncovering the safety issues. There is a special emphasis on pharmaceutical issues including probiotic delivery systems, technological challenges during formulation, regulatory concerns, quality control and market potential. Developments in the techniques for in vitro evaluation have also been discussed. PMID:18691088

  8. Analysis of the World Bank's pharmaceutical lending.

    PubMed

    Rodríguez-Monguió, Rosa; Rovira, Joan; Seoane-Vázquez, Enrique

    2007-04-01

    This article analyzes the World Bank's lending activity on pharmaceuticals and medical products (PMP) during the fiscal years (FY) 1999-2001 by regions, borrower and supplier country, and procurement method. Data for the study derived from the World Bank Project and the Business Warehouse databases. The information included all Bank projects approved during the study period. Information for the PMP procurement contracts was extracted for the health sector components of all sector projects awarded. Contract dollar amount was aggregated by borrower and supplier countries. A total of 365 contracts of PMP for a value of US$ 364.5 million (2001 prices) were awarded. International competitive bidding was the most common procurement method used representing 46.0% of the total PMP contracts amount. Domestic providers supplied 52.5% of the PMP contracts managed by the borrower countries. Twenty-two countries accounted for 97.0% of the total PMP purchased during the period of analysis. Only a small fraction of the Bank activity was directed to the pharmaceutical sector. There is a need for more involvement of the World Bank to increase accessibility, affordability and rational use of pharmaceuticals and medical products. An evaluation of the different procurement methods and their implications on drug quality and prices should be performed. PMID:16824640

  9. An insight into the emerging role of regional medical advisor in the pharmaceutical industry.

    PubMed

    Gupta, Sandeep Kumar; Nayak, Roopa P

    2013-07-01

    The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines. PMID:24010061

  10. Pharmaceutical speakers' bureaus, academic freedom, and the management of promotional speaking at academic medical centers.

    PubMed

    Boumil, Marcia M; Cutrell, Emily S; Lowney, Kathleen E; Berman, Harris A

    2012-01-01

    Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver "educational" talks to groups of physicians in the community to help market the company's brand-name drugs. Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most academic medical centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking. PMID:22789048

  11. An insight into the emerging role of regional medical advisor in the pharmaceutical industry

    PubMed Central

    Gupta, Sandeep Kumar; Nayak, Roopa P.

    2013-01-01

    The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines. PMID:24010061

  12. But it's doctor recommended and I read the fine print: antecedents to drug companies' perceived credibility.

    PubMed

    Park, Jin Seong; Hoy, Mariea Grubbs

    2013-01-01

    Using 2009 National Consumer Survey data from Experian Simmons, the authors found that dependence on doctor recommendations to assess the integrity of advertised drugs and the extent of reading small print in direct-to-consumer prescription drug advertising positively related to consumers' perceived credibility of health information from pharmaceutical companies, which in turn positively influenced willingness to ask their doctor for a specific medicine they saw or heard advertised. The potential effect of small print reading on willingness to request prescription was partially mediated by perceived credibility of information from drug companies. The findings are discussed in light of their practical implications. PMID:23458482

  13. Silo Effect a Prominence Factor to Decrease Efficiency of Pharmaceutical Industry

    PubMed Central

    Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

    2013-01-01

    To be sure, all the industries try to be involved in globalization with a constant trend to find out ways to increase productivity across different functions within an organization to maintain competitive advantage world. Pharmaceutical industries are not exceptional and further are based on fragmentation. So these kind of companies need to cope with several barriers such as silo mentality that may affect efficiency of their business activity. Due to eliminate a part of resources such as raw materials, new molecule developed, financial and human resources and so on, companies can gradually loss their competitive potentials in the market and increase their expenses. Furthermore, to avoid any business disturbances in financially connected companies due to silo effect, they should arrange their management to integrated organization form. Otherwise, actions taken by one business member of the chain can influence the profitability of all the other members in the chain. That is why recently supply chain has generated much interest in many business units. In this paper, it has been tried to investigate the different aspects of silo effect which can affect integrate supply chain. Finally, a fluent communication, high level of information exchange, fragmentation management, cross-functional control in a supply chain management format are needed to reduce or control silo effect within entire chain of the holding company by Supply chain management. PMID:24250690

  14. Silo effect a prominence factor to decrease efficiency of pharmaceutical industry.

    PubMed

    Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

    2013-01-01

    To be sure, all the industries try to be involved in globalization with a constant trend to find out ways to increase productivity across different functions within an organization to maintain competitive advantage world. Pharmaceutical industries are not exceptional and further are based on fragmentation. So these kind of companies need to cope with several barriers such as silo mentality that may affect efficiency of their business activity. Due to eliminate a part of resources such as raw materials, new molecule developed, financial and human resources and so on, companies can gradually loss their competitive potentials in the market and increase their expenses. Furthermore, to avoid any business disturbances in financially connected companies due to silo effect, they should arrange their management to integrated organization form. Otherwise, actions taken by one business member of the chain can influence the profitability of all the other members in the chain. That is why recently supply chain has generated much interest in many business units. In this paper, it has been tried to investigate the different aspects of silo effect which can affect integrate supply chain. Finally, a fluent communication, high level of information exchange, fragmentation management, cross-functional control in a supply chain management format are needed to reduce or control silo effect within entire chain of the holding company by Supply chain management. PMID:24250690

  15. Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea

    PubMed Central

    Lee, Munjae

    2015-01-01

    Objectives The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). Results The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p < 0.05). No statistical significance was found in the shareholding ratio of institutional investors and the ratio of outside directors. Conclusion The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits. PMID:26473092

  16. Influence of drug company authorship and sponsorship on drug trial outcomes.

    PubMed

    Tungaraza, Tongeji; Poole, Rob

    2007-07-01

    Studies of drug treatments are more likely to report favourable outcomes when they are funded by the pharmaceutical industry. We compared drug trials reported in three major psychiatric journals to investigate these influences. Independent studies were more likely to report negative findings than industry-funded studies. However, the involvement of a drug company employee had a much greater effect on study outcome than financial sponsorship alone. PMID:17602130

  17. Novel methodology for pharmaceutical expenditure forecast

    PubMed Central

    Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and objective The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical expenditure forecast’; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. Results This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and discount price, distribution chains, and the time to reach peak sales for new drugs; 2) estimating the statistical distribution of the budget impact; and 3) testing different pricing and reimbursement policy decisions on health expenditures. Conclusions This methodology was independent of historical data and appeared to be highly flexible and adapted to test robustness and provide probabilistic analysis to support policy decision making.

  18. Reference-based pricing schemes: effect on pharmaceutical expenditure, resource utilisation and health outcomes.

    PubMed

    Ioannides-Demos, Lisa L; Ibrahim, Joseph E; McNeil, John J

    2002-01-01

    Pharmaceutical expenditure is rising more rapidly than the general inflation rate in most advanced countries. One strategy that has been introduced to control pharmaceutical costs is reference-based pricing (RBP). Its potential is restricted to those specific segments of the drug market where several drugs (and/or their generic forms) exist without substantial evidence that any particular agent is superior. Three broad approaches have been adopted. These involve the aggregation of drugs into generic groups, related drug groups (e.g. ACE inhibitors) or drugs grouped by therapeutic indication (e.g. antihypertensives). For each drug group, a single reimbursement level or reference price is set. Drugs above the reference price require part or total payment by the patient. The experience with RBP ranges from over 10 years in Germany (involving all levels of RBP) to the more recent implementation of RBP for related drug groups in Australia. This review summarises the current state of knowledge on RBP from the published experiences in the countries where RBP has been adopted. The published systematic reviews of RBP from the countries that have implemented it suggest that RBP has been successful at temporarily capping drug prices for the RBP drug groups and achieving short term cost savings. However, other factors influencing total pharmaceutical expenditure have often occurred simultaneously and make it difficult to isolate specific effects of RBP. Further investigation is required before any valid conclusions can be drawn about the net effect of RBP on healthcare costs. RBP has withstood the initial legal challenges of pharmaceutical companies and the criticisms of some clinicians. Where the reference price is based on the lowest priced drug(s) in the group, RBP appears to be one of the few strategies likely to be effective at encouraging doctors to use the least expensive agents as first-line therapy and utilise more expensive agents in those who experience side effects or poor efficacy. PMID:12141886

  19. Trust and the regulation of pharmaceuticals: South Asia in a globalised world

    PubMed Central

    2011-01-01

    Background Building appropriate levels of trust in pharmaceuticals is a painstaking and challenging task, involving participants from different spheres of life, including producers, distributors, retailers, prescribers, patients and the mass media. Increasingly, however, trust is not just a national matter, but involves cross-border flows of knowledge, threats and promises. Methods Data for this paper comes from the project 'Tracing Pharmaceuticals in South Asia', which used ethnographic fieldwork and qualitative interviews to compared the trajectories of three pharmaceuticals (Rifampicin, Oxytocin and Fluoxetine) from producer to patient in three sites (north India, West Bengal and Nepal) between 2005-08. Results We argue that issues of trust are crucial in reducing the likelihood of appropriate use of medicines. Unlike earlier discussions of trust, we suggest that trust contexts beyond the patient-practitioner relationship are important. We illustrate these arguments through three case studies: (i) a conflict over ethics in Nepal, involving a suggested revised ethical code for retailers, medical representatives, producers and prescribers; (ii) disputes over counterfeit, fake, substandard and spurious medicines, and quality standards in Indian generic companies, looking particularly at the role played by the US FDA; and (iii) the implications of lack of trust in the DOTS programmes in India and Nepal for the relationships among patients, government and the private sector. Conclusions We conclude that the building of trust is a necessary but always vulnerable and contingent process. While it might be desirable to outline steps that can be taken to build trust, the range of conflicting interests in the pharmaceutical field make feasible solutions hard to implement. PMID:21529358

  20. Ongoing pharmaceutical reforms in France: implications for key stakeholder groups.

    PubMed

    Sermet, Catherine; Andrieu, Veronique; Godman, Brian; Van Ganse, Eric; Haycox, Alan; Reynier, Jean-Pierre

    2010-01-01

    The rapid rise in pharmaceutical costs in France has been driven by new technologies and the growing prevalence of chronic diseases as well as considerable prescribing freedom and choice of physician among patients. This has led to the introduction of a number of reforms and initiatives in an attempt to moderate expenditure whilst ensuring universal coverage and rewarding innovation. These reforms include accelerating access to and granting average European prices for new innovative drugs, delisting drugs where there are concerns over their value and instigating rebates for excessive prescribing. Alongside this, ongoing initiatives to improve the quality and efficiency of prescribing include programmes to enhance generic prescribing and dispensing as well as to reduce antibacterial and anxiolytic/hypnotic prescribing. However, there have been few publications documenting the impact of specific reforms on the overall costs and quality of care, which have been exacerbated by compartmentalization of budgets. Estimates suggest savings of over 27 million euro/year by decreasing antibacterial prescribing, 450 million euro/year by not reimbursing ineffective drugs, 670 million euro/year from pharmaceutical company rebates and approximately 1 billion euro/year from increased prescribing and dispensing of generics (year 2003-7 values). Additional savings of at least 1.5 billion euro/year are seen as being possible from increased use of generics such as generic proton pump inhibitors, statins (HMG-CoA reductase inhibitors) and ACE inhibitors instead of current branded products such as angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]). Delisting drugs when there are concerns about their value provides an example to other countries with currently limited demand-side measures. Other possible examples include price : volume agreements and multifaceted campaigns to enhance generic prescribing and dispensing and reduce antibacterial prescribing. Possible future initiatives could include adopting more stringent criteria for categorizing new drugs as innovative as well as further reductions in the prices of generics. Other initiatives could include further enhancement of the quality and efficiency of prescribing, including formal auditing of physician prescribing, as well as increasing efforts to monitor the risk : benefit ratio of new drugs post-launch in real-world practice. PMID:20038190

  1. [Impact Reimbursement Act on the pharmaceutical market in Poland].

    PubMed

    Giermaziak, Wojciech

    2014-04-01

    According to 12 may 2011 Reimbursement Act, the new regulations were introduced related to changes in so far in force rules on refunds of official prices and margins for drugs, foodstuffs of special purpose and medical products. After year of functioning of this regulation, in evaluation of the government, law gave measurable financial effects for public payer, sometimes through drastic actions, connected the of reduction of existing profits of manufacturers sector and importers drugs, as well wholesale and retail, both in treatment open and closed. Parallel to research and analysis of effects introduction in life act refund, conducted by government, to target current regulation possible negative phenomena can to be after-effects to regulation, systematically there are conducted analogous study to reputable companies specialized in evaluation and updating market Polish pharmaceutical, such as IMS Health Polska, Pharma Expert, Kamsoft, WHO and European a law firm. In their opinion to reimbursement act is the most serious regulation control system to introduced into Polish order legal, and first time for many years on such a large scale. Thoroughly changed policy of drugs State have important influence for all participants Polish pharmaceutical market, both those directly related to the drug trade, as the functioning doctors and health condition and financial Polish patient. Change in the way prices of drugs is determined as flexible to price formation mechanism, combining drugs similar profile pharmacological in so group limits and dependence of the level of refunds from application drug accordingly characteristics medicinal product, adaptation solutions to new law refund to the existing law about health services, gave measurable financial effect for the public payer. Rationalization expenses to NFZ, as main premise introduction refund act, created to broader than so far possibility to use new molecules of drugs, and the latest medical technology, even if in the revised or new drug programs. Important implications for even Polish image in Europe, especially from the point of view of cohesion policy and application to directive transparency EU have introduction refund act in context to introduction clear, transparent and verifiable procedures used with creating drug pricing mechanisms, foodstuffs of special purpose and medical product. PMID:24868902

  2. Design and Evaluation of a Research-Based Teaching Sequence: The Superposition of Electric Field.

    ERIC Educational Resources Information Center

    Viennot, L.; Rainson, S.

    1999-01-01

    Illustrates an approach to research-based teaching strategies and their evaluation. Addresses a teaching sequence on the superposition of electric fields implemented at the college level in an institutional framework subject to severe constraints. Contains 28 references. (DDR)

  3. A forward looking company

    SciTech Connect

    Christian, David A.

    2004-06-01

    The article is an excerpt of an interview with David A. Christian, Senior Vice President-Nuclear and Chief Nuclear Officer, Dominion Generation conducted at NEI's Nuclear Energy Assembly in New Orleans, Louisiana on 13 May 2004. It highlights the company's energy diversity, and in particular, activities related to early-site permits and possible future plans for nuclear power plant development in the U.S. The interview touches on questions related to the Consortium (composed of Dominion, AECL Technologies, the U.S. subsidiary of AECL, Hatachi America and Bechtel Power Corp.) and the DOE financial support involved (approximately 50%) along with comments related to job impacts, energy security and climate change impacts, human resource issues (particularly about getting high school students interested in jobs related to the nuclear industry) and public policy. The interview ends with a discussion of investment interest and the state of standardization in the industry.

  4. Company profile: Aviir, Inc.

    PubMed

    Beggs, Michael; Biggs, William H; French, Cynthia

    2013-02-01

    Aviir, Inc. is a venture-funded biotechnology company developing and commercializing laboratory tests to provide personalized information to physicians and patients, with the goal of preventing cardiovascular disease and metabolic syndromes. Leveraging advanced research, Aviir developed and launched MIRISK VP™, a risk assessment test to better identify individuals at risk of a heart attack. Aviir also offers an extensive menu of other cardiovascular and metabolic tests through its Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Efforts are likewise focused on expanding genomics testing capability to address sudden cardiac death attributed to inherited cardiovascular diseases. This completes their integrated precision diagnostics approach that combines biomarker immunoassays with genomic and transcription analysis, along with core clinical chemistry to deliver a comprehensive personal health solution. PMID:23394387

  5. Places of pharmaceutical knowledge-making: global health, postcolonial science, and hope in South African drug discovery.

    PubMed

    Pollock, Anne

    2014-12-01

    This article draws on ethnographic research at iThemba Pharmaceuticals, a small South African startup pharmaceutical company with an elite international scientific board. The word 'iThemba' is Zulu for 'hope', and so far drug discovery at the company has been essentially aspirational rather than actual. Yet this particular place provides an entry point for exploring how the location of the scientific knowledge component of pharmaceuticals--rather than their production, licensing, or distribution--matters. The article explores why it matters for those interested in global health and postcolonial science, and why it matters for the scientists themselves. Consideration of this case illuminates limitations of global health frameworks that implicitly posit rich countries as the unique site of knowledge production, and thus as the source of unidirectional knowledge flows. It also provides a concrete example for consideration of the contexts and practices of postcolonial science, its constraints, and its promise. Although the world is not easily bifurcated, it still matters who makes knowledge and where. PMID:25608441

  6. Pharmacy benefit management companies.

    PubMed

    Taniguchi, R

    1995-09-01

    The principal services offered by pharmacy benefit management companies (PBMs) are described. A PBM contracts with employers, insurers, and others to provide accessible and cost-effective benefits to those groups' members. PBMs vary in their organization and services because they originate from different types of businesses. Many PBMs have been formed by publicly traded companies that have combined traditional ways of controlling cost and use, such as formularies, with new elements to form organizations whose primary function is managing the pharmacy benefit. Often, the PBM is paid a fixed amount for which it must provide all contracted services. PBMs may provide pharmacy services themselves (e.g., mail order prescription service is offered by Medco, one of the largest PBMs); more often, they subcontract with others to provide certain services. Full-service PBMs have the following functions: establishing networks of pharmacies for use by plan members; processing claims electronically at the time a prescription is filled and thus maintaining a database on drug use and cost; using these data to generate various reports; encouraging the use of generic products; managing existing formularies, helping to establish customized formularies, or providing a national formulary; providing information to support formulary guidelines (counter-detailing); offering programs in which prescriptions for maintenance medications are filled less frequently with larger amounts, often by mail order; negotiating volume-based rebates from manufacturers; performing drug-use review; developing disease management programs based on clinical practice guidelines and measurements of patient outcome; and evaluating outcomes by combining data on drug therapy with information about other parts of the patient's care.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8528857

  7. [Collaboration between academia and companies].

    PubMed

    Ueda, Minoru

    2008-05-01

    Recently the collaboration between academia and company has been recommended by the government and more than 1,000 venture companies have established since 2001. Indeed this situation caused the researchers active, on the other side many undesirable troubles has been increasing among researches in the university. In this paper the cause of these troubles related to the collaboration between academia and company has been analyzed and proposed the possible solutions for the problems. PMID:18464523

  8. 76 FR 1666 - Susquehanna Union Railroad Company-Control Exemption-North Shore Railroad Company, Nittany & Bald...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... Company, Nittany & Bald Eagle Railroad Company, Shamokin Valley Railroad Company, Juniata Valley Railroad... Class III railroads: North Shore Railroad Company, Nittany & Bald Eagle Railroad Company,...

  9. [Impact of demographic chance on pharmaceutical expenses in private health insurance--a scenario-based analysis].

    PubMed

    Böcking, W; Tidelski, O; Skuras, B; Bäumler, A; Kitzmann, F

    2012-08-01

    Health Insurance costs in Germany have grown constantly over the last years. This increase of costs is not only observable in the total consideration but also in all single items. An outstanding growth rate exists in the field of pharmaceutical expenses. Detailed analyses of distribution and development of these costs, separated by age and indication groups, are currently only sporadically available and mostly focusing on the Statutory Health Insurance system in Germany. This research article is based on an initial data analysis and focuses on the question how pharmaceutical expenses in a German private health insurance company will develop until the year 2050, if the observed trend of the past years continues in the same way. This analysis focuses on different age groups. The objective is the demonstration of several scenarios, which illustrate the level of influence of different parameters (demographic changes, developments of prices for pharmaceuticals). Based on the cognition of certain effects measures for handling the growing challenge of financing the health system can be deduced. As a result, both demographic changes and price effects have an significant impact on the future development of per capita pharmaceutical expenses. Whereas older age groups will still cause the highest costs, the middle-aged people will show the highest growth rates. This strong cost increase is not sustainable for the German health insurance system. In addition to previous measures of a regulatory health policy (especially improved cost-benefit-assessments) the article shows new approaches for an intensified prevention and health promotion. PMID:22872541

  10. Cure for empire: the 'Conquer-Russia-Pill', pharmaceutical manufacturers, and the making of patriotic Japanese, 1904-45.

    PubMed

    Kim, Hoi-Eun

    2013-04-01

    Seirogan, a popular anti-diarrhoeal pill, is arguably one of the most successful pharmaceutical products of modern Japan. What is less known is that the Japanese army initially developed Seirogan during the Russo-Japanese War as the ‘Conquer-Russia-Pill’, which was later marketed to the public by private manufacturers. Previous scholars have emphasised the top–down governmental method of mobilising private sectors to manipulate public opinion for the cause of external imperialist expansion and domestic stability during wartime Japan. But the matrix that the Conquer-Russia-Pill allows us to glimpse is an inverted power relation among the state, commercial sectors, and imperial citizens. While the Japanese government remained indifferent if not hostile to jingoistic pharmaceutical manufacturers who could easily disrupt international relations, pharmaceutical companies quickly recognised and exploited the opportunities that the Conquer-Russia-Pill and its symbolism provided under the banner of the empire. In turn, Japanese consumers reacted to commercial sermons carefully anchored in patriotic and militaristic discourses and images by opening their wallets. In other words, the popularity of the Conquer-Russia-Pill was a culmination of the convergence of a governmental initiative to enhance military capabilities, the commercial ingenuity of pharmaceutical manufacturers, and a consumer response to patriotic exhortations. PMID:24070348

  11. The impact of TRIPS on innovation and exports: a case study of the pharmaceutical industry in India.

    PubMed

    Malhotra, Prabodh

    2008-01-01

    Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India. PMID:18624153

  12. Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era.

    PubMed

    Ferreira, Ana P; Tobyn, Mike

    2015-01-01

    In the pharmaceutical industry, chemometrics is rapidly establishing itself as a tool that can be used at every step of product development and beyond: from early development to commercialization. This set of multivariate analysis methods allows the extraction of information contained in large, complex data sets thus contributing to increase product and process understanding which is at the core of the Food and Drug Administration's Process Analytical Tools (PAT) Guidance for Industry and the International Conference on Harmonisation's Pharmaceutical Development guideline (Q8). This review is aimed at providing pharmaceutical industry professionals an introduction to multivariate analysis and how it is being adopted and implemented by companies in the transition from "quality-by-testing" to "quality-by-design". It starts with an introduction to multivariate analysis and the two methods most commonly used: principal component analysis and partial least squares regression, their advantages, common pitfalls and requirements for their effective use. That is followed with an overview of the diverse areas of application of multivariate analysis in the pharmaceutical industry: from the development of real-time analytical methods to definition of the design space and control strategy, from formulation optimization during development to the application of quality-by-design principles to improve manufacture of existing commercial products. PMID:24641280

  13. Occurrence of Pharmaceuticals in Calgary's Wastewater and Related Surface Water.

    PubMed

    Chen, M; Cooper, V I; Deng, J; Amatya, P L; Ambrus, D; Dong, S; Stalker, N; Nadeau-Bonilla, C; Patel, J

    2015-05-01

    The influents/effluents from Calgary's water resource recovery facilities and the surface water were analyzed for pharmaceuticals in the present study. The median concentrations in the effluents for the 15 targeted pharmaceuticals were within the range of 0.006 to 3.32 ppb. Although the wastewater treatment facilities were not designed to remove pharmaceuticals, this study indicates that the wastewater treatment processes are effective in removing some of the pharmaceuticals from the aqueous phase. The removal rate estimated can be 99.5% for caffeine, whereas little or no removal was observed for carbamazepine. Biodegradation, chemical degradation, and sorption could be some of the mechanisms responsible for the removal of pharmaceuticals. The drug residues in downstream surface water could be associated with incomplete removal of pharmaceuticals during the treatment process and may lead to concerns in terms of potential impacts on the aquatic ecosystem. However, this study does not indicate any immediate risks to the downstream aquatic environment. PMID:26460461

  14. Pharmaceutical industry exposure in our hospitals: the final frontier.

    PubMed

    Dean, Jessica; Loh, Erwin; Coleman, Justin J

    2016-01-18

    Despite recent changes in attitudes, most hospitals continue to experience pharmaceutical industry presence. Pharmaceutical industry presence may be necessary and beneficial in the context of sponsorship of clinical trials with appropriate governance. Doctors continue to hold positive attitudes towards market-oriented activities of the pharmaceutical and medical device industries. Despite evidence to the contrary, doctors believe they are able to effectively manage pharmaceutical sales representative interactions such that their own prescribing is not adversely impacted. Doctors also share a belief that small gifts and benefits are harmless. There may be significant financial burden associated with divestment of such sponsorship by hospitals. Change requires education and effective policies to manage pharmaceutical industry relationships and conflicts of interest. We discuss case studies involving students and public hospital doctors to show that divestment is possible without significant financial detriment. Health services need to be proactive in transitioning financial and cultural reliance on pharmaceutical industry sponsorship to other potentially less harmful sources. PMID:26763810

  15. Interactions of doctors with the pharmaceutical industry

    PubMed Central

    Morgan, M A; Dana, J; Loewenstein, G; Zinberg, S; Schulkin, J

    2006-01-01

    Objective To assess the opinions and practice patterns of obstetrician‐gynaecologists on acceptance and use of free drug samples and other incentive items from pharmaceutical representatives. Methods A questionnaire was mailed in March 2003 to 397 members of the American College of Obstetricians and Gynecologists who participate in the Collaborative Ambulatory Research Network. Results The response rate was 55%. Most respondents thought it proper to accept drug samples (92%), an informational lunch (77%), an anatomical model (75%) or a well‐paid consultantship (53%) from pharmaceutical representatives. A third (33%) of the respondents thought that their own decision to prescribe a drug would probably be influenced by accepting drug samples. Respondents were more likely to think the average doctor's prescribing would be influenced by acceptance of the items than theirs would be (p<0.002). Respondents who distributed drug samples to patients indicated doing so because of patients' financial need (94%) and for their convenience (76%) and less so as a result of knowledge of the efficacy of the sample product (63%). A third (34%) of respondents agreed that interactions with industry should be more strictly regulated. Conclusion Obstetrician‐gynaecologists largely indicated that they would act in accordance with what they think is proper regarding accepting incentive items from pharmaceutical representatives. Although accepting free drug samples was considered to be appropriate more often than any other item, samples were most commonly judged to be influential on prescribing practices. The widely accepted practice of receiving and distributing free drug samples needs to be examined more carefully. PMID:17012493

  16. Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations

    NASA Astrophysics Data System (ADS)

    Ulu, Sevgi Tatar

    2009-02-01

    Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL -1 for ciprofloxacin, 28.5-700 ng mL -1 for enoxacin, 29.5-800 ng mL -1 for norfloxacin and 33.5-1000 ng mL -1 for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL -1 for ciprofloxacin, 8.5 ng mL -1 for enoxacin, 9.2 ng mL -1 for norfloxacin and 9.98 ng mL -1 for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method.

  17. Salt forms of the pharmaceutical amide dihydrocarbamazepine.

    PubMed

    Buist, Amanda R; Kennedy, Alan R

    2016-02-01

    Carbamazepine (CBZ) is well known as a model active pharmaceutical ingredient used in the study of polymorphism and the generation and comparison of cocrystal forms. The pharmaceutical amide dihydrocarbamazepine (DCBZ) is a less well known material and is largely of interest here as a structural congener of CBZ. Reaction of DCBZ with strong acids results in protonation of the amide functionality at the O atom and gives the salt forms dihydrocarbamazepine hydrochloride {systematic name: [(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)(hydroxy)methylidene]azanium chloride, C15H15N2O(+)·Cl(-)}, dihydrocarbamazepine hydrochloride monohydrate {systematic name: [(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)(hydroxy)methylidene]azanium chloride monohydrate, C15H15N2O(+)·Cl(-)·H2O} and dihydrocarbamazepine hydrobromide monohydrate {systematic name: [(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)(hydroxy)methylidene]azanium bromide monohydrate, C15H15N2O(+)·Br(-)·H2O}. The anhydrous hydrochloride has a structure with two crystallographically independent ion pairs (Z' = 2), wherein both cations adopt syn conformations, whilst the two hydrated species are mutually isostructural and have cations with anti conformations. Compared to neutral dihydrocarbamazepine structures, protonation of the amide group is shown to cause changes to both the molecular (C=O bond lengthening and C-N bond shortening) and the supramolecular structures. The amide-to-amide and dimeric hydrogen-bonding motifs seen for neutral polymorphs and cocrystalline species are replaced here by one-dimensional polymeric constructs with no direct amide-to-amide bonds. The structures are also compared with, and shown to be closely related to, those of the salt forms of the structurally similar pharmaceutical carbamazepine. PMID:26846502

  18. Microbiological investigations for radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

    Dám, A.; Gazsó, L. G.; Grigorova, P.

    Several antibiotics, excipients were investigated in dry state to estimate the safety sterilization dose as well as herbs extract powders to reduce the microbial count by radiation treatment. The sterilization dose of pharmaceuticals were calculated individually for each product based on the bioburden, the radiosensitivity of contaminating microflora and the required sterility assurance level. According to our results all of the materials investigated can be sterilized by less than 10 kGy. For herbs extract 1 kGy was enough to reduce the initial count close to the acceptable level.

  19. New areas of plant-made pharmaceuticals.

    PubMed

    Hassan, Syed Waqas; Waheed, Mohammad Tahir; Lössl, Andreas G

    2011-02-01

    On October 15 2010 the meeting 'Recombinant Pharmaceutical Manufacturing from Plants - The Future of Molecular Farming' hosted by EuroScicon was held at BioPark Hertfordshire, Welwyn Garden city, UK. The scientific program of this very eventful meeting was wide ranging and covered diverse aspects of biopharming. The highlights presented included: safety issues in biopharming; coexpression of multiple proteins; steps towards vaccine generation; and engineering of secondary metabolites and medicinal plants. This article summarizes the stimulating scientific presentations and fruitful panel discussions that subsequently arose during and after this event. PMID:21332263

  20. In silico toxicology for the pharmaceutical sciences

    SciTech Connect

    Valerio, Luis G.

    2009-12-15

    The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy of in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical prediction of human drug metabolism, mechanisms of action for pharmaceuticals, and newer models for predicting human adverse effects. How accurate are these approaches is both a statistical issue and challenge in toxicology. In this review, fundamental concepts and the current capabilities and limitations of this technology will be critically addressed.