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Sample records for research-based pharmaceutical companies

  1. Jordanian pharmaceutical companies: are their marketing efforts paying off?

    PubMed

    Al-Shaikh, Mustafa S; Torres, Ivonne M; Zuniga, Miguel A; Ghunaim, Ayman

    2011-04-01

    The pharmaceuticals industry is one of the main industries in Jordan. Jordanian pharmaceuticals rank third in the export industry of this country. This study aims to examine the strengths that Jordanian pharmaceutical companies have, which, in turn, form their competitiveness base. In addition, this study aims to identify their weaknesses and the effects of marketing their products in the local market. What is the relationship between Jordanian pharmaceutical product quality, price and value, and the competitiveness of pharmaceutical companies in the local market? Our study aims to answer this and other questions. Our results and practical implications are discussed. PMID:21590563

  2. Implementation issues in disease management programs: a pharmaceutical company perspective.

    PubMed

    Browne, R A

    1995-04-01

    Eli Lilly, a pharmaceutical manufacturer, recently established a disease management subsidiary. The author, one of the key forces behind the new venture, provides a how-to based on the company's experiences in developing Integrated Disease Management, Inc. His views, from the pharmaceutical company perspective, may also be applicable to any organization seeking to climb into the red-hot arena of disease management. PMID:10141767

  3. [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

  4. Comparative effectiveness research: the view from a pharmaceutical company.

    PubMed

    Berger, Marc L; Grainger, David

    2010-01-01

    Comparative effectiveness research (CER) represents the next stage in an evolution of research and knowledge development in regard to medical interventions. In this article we describe the challenges currently facing the innovative pharmaceuticals industry and briefly summarize the history of drug development, as context for the current movement to comparative effectiveness. CER should be considered alongside the wider field of health technology assessment (HTA), and we review the status of both CER and HTA internationally and their role in health policy. Limitations as to what can be achieved with HTA and limitations to the availability of evidence of comparative effectiveness at the time of market authorization provide ongoing challenges to all stakeholders. However, embracing CER is regarded as an essential step for the innovative pharmaceutical industry, as companies strive to more clearly demonstrate the effectiveness of their pipeline products with evidence that is compelling to payers and HTA agencies. Examples are given of how these evolving requirements from regulatory and HTA agencies are impacting on drug development efforts and how one company is responding. Finally, there are signs of increasing understanding and alignment across the various partners in drug development, registration and evaluation, and further suggestions are provided for consideration as the field matures and expands. PMID:20831299

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. [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

  20. 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

  1. Patient Organizations Funding from Pharmaceutical Companies: Is Disclosure Clear, Complete and Accessible to the Public? An Italian Survey

    PubMed Central

    Colombo, Cinzia; Mosconi, Paola; Villani, Walter; Garattini, Silvio

    2012-01-01

    Background Many patients and consumers organizations accept drug industry funding to support their activities. As drug companies and patient groups move closer, disclosure become essential for transparency, and the internet could be a useful means of making sponsorship information accessible to the public. This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceutical companies, focusing on their websites. Methodology/Principal Findings Patient and consumer groups were selected from those stated to be sponsored by a group of pharmaceutical companies on their websites. The websites were examined using two forms with principal (name of drug companies providing funds, amount of funding) and secondary indicators of transparency (section where sponsors are disclosed, update of sponsorship). Principal indicators were applied independently by two reviewers to the patient and consumer groups websites. Discordances were solved by discussion. One hundred fifty-seven Italian patient and consumer groups and 17 drug companies were considered. Thirteen drug companies (76%) named at least one group funded, on their Italian websites. Of these, four (31%) indicated the activities sponsored and two (15%) the amount of funding. Of the 157 patient and consumer groups, 46 (29%) named at least one pharmaceutical company as providing funds. Three (6%) reported the amount of funding, 25 (54%) the activities funded, none the proportion of income derived from drug companies. Among the groups naming pharmaceutical company sponsors, 15 (33%) declared them in a dedicated section, five (11%) on the home page, the others in the financial report or other sections. Conclusions/Significance Disclosure of funds is scarce on Italian patient and consumer groups websites. The levels of transparency need to be improved. Disclosure of patient and consumer groups provided with funds is frequent on Italian pharmaceutical companies websites, but information are often not complete. PMID:22590498

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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…

  9. 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

  10. Compliance of scored tablet halves produced by Palestinian Pharmaceutical Companies with the new European Pharmacopoeia requirements.

    PubMed

    Zaid, Abdel Naser; Ghosh, Abeer Abu

    2011-07-01

    The aim of this study was to evaluate the weight uniformity of commonly divided tablets produced by Palestinian Pharmaceutical Companies and to evaluate the importance of both patient- and formulation-related variables on the splitting results. Eighty-four volunteers were enrolled in this study; their age, gender and occupation were documented in order, and the effect of these variables on the tablet splitting results was evaluated. Each volunteer was asked to divide six scored tablets of each product tested and was given clear instructions on how to conduct the splitting process. The split units were individually weighed and the RSD for each product was calculated as instructed in the European Pharmacopoeia (Ph. Eur. 5.5). Only one scored tablet product passed the Ph. Eur. test of mass uniformity, while the remaining 13 products failed; this indicates that the splitting of these tablet products is not a reliable means for the provision of accurate doses to patients. Age, gender and occupation of volunteers were not found to be predictive of any variability noted in the splitting results. The only factors that were suspected to be linked to passing the splitting test, as per the European Pharmacopoeia, were the shape, friability and hardness of the tablets. As a result of this study, we believe that the practice of dividing tablets, which should provide therapeutic and economic benefits for the patient, may potentially cause significant problems, especially in drugs with low therapeutic indices. Tablets produced by Palestinian Pharmaceutical Companies should comply with the new Ph. Eur. splitting regulations to reduce this potential for complications. PMID:21811926

  11. 75 FR 24510 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Sales Representatives at VA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... AFFAIRS 38 CFR Part 1 RIN 2900-AN42 Drug and Drug-Related Supply Promotion by Pharmaceutical Company Sales... control the promotion of drugs and drug-related supplies at VA facilities and the business relationships between VA staff and sales representatives promoting drugs and drug-related supplies. The purposes of...

  12. [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

  13. 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

  14. Attitudes of medical students towards incentives offered by pharmaceutical companies- perspective from a developing nation- a cross sectional study

    PubMed Central

    2014-01-01

    Background A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their incentives. Methods As part of a cross-sectional survey, a validated questionnaire previously used for assessing attitude of medical students towards pharmaceutical industry, was modified, pre-tested and distributed among consenting clinical year students at DUHS and AKU. Questions included acceptability of pharmaceutically sponsored gifts, events and tuition fee, and their impact on future prescription. Responses were graded as agree, disagree or neutral which were then scored according to the AMSA guidelines of ethical conduct. Results Out of a total of 353 targeted students 303 responded, corresponding to a response rate of 85.8%. Responses indicated that 42.7% students believed in no interaction with drug companies during medical school. However, 81% of students favored pharmaceutical sponsorship of student-body events/seminars at medical colleges. More than one-third of the students were comfortable receiving gifts from drug companies. Overall, the results of this study offer an interesting comparison between the students of a private medical school (AKU) and a public medical school (DUHS); AKU students exhibited a greater degree of mistrust towards drug information provided by pharmaceutical companies compared to DUHS students (p?=?0.040). Furthermore, when asked if there was a need to incorporate guidelines in the undergraduate curriculum with regard to interaction with drug companies, 84.2% students at AKU agreed, compared to 54.9% at DUHS. Medical student Attitude Scores are more or less similar to each other independent of their various demographical differences. Conclusion This study highlights that medical students in our population have a high level of acceptability towards incentives offered by pharmaceutical industry and that formal guidance regarding the subject should be incorporated into medical curriculum. PMID:24885167

  15. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    PubMed

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention. PMID:24092398

  16. [A hundred years since the founding of the pharmaceutical company "Salomon, Levin, Elshtein"--the origin of the TEVA Group].

    PubMed

    Michlin, Amnon

    2002-09-01

    The Pharmaceutical trading company "Salomon Levin Elshtein", was founded one hundred years ago. It began in Jerusalem as a small store near the Old City walls, bought by brothers-in-law Haim Salomon (Yoel Moshe Salomon's son) and Moshe Gutel Levin. Among its first customers were the Jewish hospitals and local organizations of the Jewish settlements, who bought drugs for their pharmacies. In those days typical drugs in demand included quinine, for treating malaria and various fevers, and drugs against trachoma. In 1915 Israel Asher Elshtein joined the company, which subsequently changed its name to "Salomon Levin Elshtein" (SLE). Activities expanded and a branch opened in Jaffa. The pioneers of the pharmaceutical industry and various medical products in Israel eventually merged into the Teva Group. PMID:12362494

  17. Arabian nights1001 tales of how pharmaceutical companies cater to the material needs of doctors: case report

    PubMed Central

    Giannakakis, Ioannis A; Ioannidis, John P A

    2000-01-01

    Objective To describe how pharmaceutical companies cater to the material needs of doctors. Design Case report of memoirs. Setting Facilities that have nothing to do with medicine, somewhere in the Arabian peninsula. Patient population Random sample of doctors. Interventions Promotion by the pharmaceutical industry. Main outcome measures Short term outcomes were travel, pleasure, amusement, and gifts, and long term outcomes were the market share of specific companies. Results Short term outcomes were heterogeneous, underlying the diversity of the means employed by the pharmaceutical industry to subvert, divert, and influence medical practice. Overall, 200 doctors were dressed in white gowns, a doctor in preventive medicine quoted Hippocrates in favour of smoking, a senior doctor became a poet, a doctor trying to understand the Methods section of a poster paper wondered whether he should have been sunbathing at the beach instead, and two women doctors were kidnapped by Bedouin warriors. Long term outcomes on the sales of the company drugs are pending but are likely to be most favourable. Conclusions Eat, drink, be merry, and boost prescriptions. PMID:11124175

  18. 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

  19. An Item Response analysis of the Hamilton Depression Rating Scale using shared data from two pharmaceutical companies.

    PubMed

    Evans, Kenneth R; Sills, Terrence; DeBrota, David J; Gelwicks, Steve; Engelhardt, Nina; Santor, Darcy

    2004-01-01

    Although the Hamilton Depression Rating Scale (HAMD) remains the most widely used outcome measure in clinical trials of Major Depressive Disorder, the psychometric properties of the individual HAMD items have not been extensively studied. In the present paper, data from four separate clinical trials conducted independently by two pharmaceutical companies were analyzed to determine the relationship between scores on the individual HAMD items and overall depressive severity in an outpatient population. Option characteristic curves (the probability of scoring a particular option in relation to overall HAMD scores) were generated in order to illustrate the relationship between scoring patterns for each item and the range of total HAMD scores. Results showed that Items 1 (Depressed Mood) and 7 (Work and Activities), and to a lesser degree, Items 2 (Guilt), 10 (Anxiety/Psychic), 11 (Anxiety/Somatic), and 13 (Somatic/General) demonstrated a good relationship between item responses and overall depressive severity. However, other items (e.g. Insight, Hypochondriasis) appeared to be more problematic with regard to their ability to discriminate over the full range of depression severity. The present results illustrate that co-operative data sharing between pharmaceutical companies can be a useful tool for improving clinical methods. PMID:15003433

  20. 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

  1. [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

  2. 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

  3. 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

  4. [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

  5. 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

  6. Patients' awareness of and attitudes toward gifts from pharmaceutical companies to physicians.

    PubMed

    Jastifer, James; Roberts, Sarah

    2009-01-01

    The purpose of this study was to assess patients' awareness of and attitudes toward physicians' receiving gifts from the pharmaceutical industry. The Alger County Community Health Study was a self-report survey targeting rural Alger County, Michigan. The survey (completion rate 10.1%) addressed issues on health, demographics, and patients' awareness of and attitudes toward gifts to physicians. Rates of awareness of gifts were: drug samples, 94 percent; ballpoint pens, 76.2 percent; medical books, 38 percent; conference/travel expenses, 34 percent; dinner out, 36.6 percent; spouse meal at dinner out, 23 percent; golf tournament fees, 19.0 percent. Rates of "approval" of physicians' accepting gifts were: drug samples, 69 percent; ballpoint pens, 54.2 percent; medical books, 49 percent; conference/travel expenses, 14 percent; dinner out, 12.1 percent; spouse meal at dinner out, 7 percent; golf tournament fees, 3.7 percent. Patients' approval of gifts seems to be related to the perceived value of the gift to patients as well as its monetary value. The patient population in the current study seems to be less approving of gifts to physicians than patients surveyed in the 1990s. Patients' opinions should be considered when establishing ethical guidelines and policies regulating physician-industry interaction. PMID:19492632

  7. 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

  8. [(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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 77 FR 12997 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Representatives at VA Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ... commenter suggested that VA exclude medical residents from being considered ``health professional students... it would be inappropriate to allow, as a general rule, drug marketing to target health professional..., and not to educate health professionals about a variety of pharmaceutical products. In addition,...

  16. 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

  17. 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

  18. 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

  19. Silvanus Bevan the 'Quaker FRS' (1691-1765) apothecary with a note on his contribution to the founding of the pharmaceutical company Allen and Hanbury.

    PubMed

    Morris, John S

    2011-02-01

    Silvanus Bevan was born in Swansea, South Wales, moved to London where he trained as an apothecary, and then in 1715 opened a business at Plough Court off Lombard Street in London. As a committed Quaker he was renowned for honesty and fair-trading and consequently he prospered. In the 1730s he took his brother Timothy as a partner. Silvanus Bevan had practised medicine at his Plough Court pharmacy and, with the arrival of his brother became less involved in pharmacy and increasingly interested in medicine. In 1725 he became a Fellow of the Royal Society. Within the family the pharmacy at Plough Court continued to prosper and became the forerunner of the pharmaceutical company Allen and Hanbury. Marriage into other Quaker families linked Silvanus Bevan with the banking firm Barclays. PMID:21350070

  20. [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

  1. 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...

  2. 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

  3. 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

  4. Create a translational medicine knowledge repository--research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?

    PubMed

    Littman, Bruce H; Marincola, Francesco M

    2011-01-01

    Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development. PMID:21569250

  5. GW-1000. GW Pharmaceuticals.

    PubMed

    Smith, Paul F

    2004-07-01

    GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada. PMID:15298072

  6. China: current trends in pharmaceutical drug discovery.

    PubMed

    Luo, Ying

    2008-04-01

    Pharmaceutical discovery and development is expensive and highly risky, even for multinational corporations. As a developing country with limited financial resources, China has been seeking the most cost-effective means to reach the same level of innovation and productivity as Western countries in the pharmaceutical industry sector. After more than 50 years of building up talent and experience, the time for China to become a powerhouse in pharmaceutical innovation is finally approaching. Returnee scientists to China are one of the reasons for the wave of new discovery and commercialization occurring within the country. The consolidation of local Chinese pharmaceutical companies and foreign investment is also providing an agreeable environment for the evolution of a new generation of biotechnology. The opportunity for pharmaceutical innovation is also being expedited by the entry of multinational companies into the Chinese pharmaceutical market, and by the outsourcing of research from these companies to China. PMID:18379963

  7. 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

  8. 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.

  9. Recognizing misleading pharmaceutical marketing online.

    PubMed

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

    2014-01-01

    In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. PMID:24986349

  10. NCI: SBIR & STTR - Investor Forum - Presenting Companies

    Cancer.gov

    The 14 chosen companies were pre-screened by an independent panel of experts from venture capital firms, bio-pharmaceutical, and medical device companies, based on their strength of research, impact on cancer, product development and market potential.

  11. Mergers and innovation in the pharmaceutical industry.

    PubMed

    Comanor, William S; Scherer, F M

    2013-01-01

    Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? PMID:23220457

  12. 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

  13. [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

  14. 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

  15. 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

  16. Pharmacovigilance in pharmaceutical companies: An overview

    PubMed Central

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

    2013-01-01

    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

  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. 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)

  19. 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.

  20. Mitochondrial pharmaceutics.

    PubMed

    Weissig, Volkmar; Cheng, Shing-Ming; D'Souza, Gerard G M

    2004-03-01

    Since the end of the 1980s, key discoveries have been made which have significantly revived the scientific interest in a cell organelle, which has been studied continuously and with steady success for the last 100 years. It has become increasingly evident that mitochondrial dysfunction contributes to a variety of human disorders, ranging from neurodegenerative and neuromuscular diseases, obesity, and diabetes to ischemia-reperfusion injury and cancer. Moreover, since the middle of the 1990s, mitochondria, the 'power house' of the cell, have also become accepted as the cell's 'arsenals' reflecting their increasingly acknowledged key role during apoptosis. Based on these recent developments in mitochondrial research, increased pharmacological and pharmaceutical efforts have lead to the emergence of 'Mitochondrial Medicine' as a whole new field of biomedical research. Targeting of biologically active molecules to mitochondria in living cells will open up avenues for manipulating mitochondrial functions, which may result in the selective protection, repair or eradication of cells. This review gives a brief synopsis over current strategies of mitochondrial targeting and their possible therapeutic applications. PMID:16120357

  1. Animal health pharmaceutical industry.

    PubMed

    Carnevale, Richard A; Shryock, Thomas R

    2006-02-24

    The animal health pharmaceutical industry has proactively reported on the volumes of member company antimicrobial active ingredients sold in the U.S. At the individual company level, reporting of finished product distribution data to the FDA is a regulatory requirement, with applications to surveillance and pharmacovigilance. An accounting of product manufactured is done for purposes of good business practices, as well as marketing analyses. Additional applications of antimicrobial usage data might include use in risk assessments, such as for the FDA's Center for Veterinary Medicine Guidance for Industry #152 for the evaluation of the microbiological safety of antimicrobials intended for use in food animals. Compilation of national usage data will be a complex undertaking, hindered by issues such as confidentiality, auditing, field use practice variations, population dynamics (e.g. disease incidence, market conditions for poultry and livestock production), and generic usage. The amounts or volumes in pounds should be considered relative to the large number of animals under husbandry in the United States. Large volumes might seem impressive unless put into proper context. Until such time as a clearly defined application of national usage data is agreed, it is recommended that local usage programs will provide more useful information to perpetuate prudent antimicrobial use in animals. PMID:16266763

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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 consumers thoughts and tailor specific marketing messages. PMID:23346245

  10. 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

  11. [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

  12. 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.

  13. [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

  14. 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

  15. NCI: SBIR & STTR - Investor Forum - Presenting Companies

    Cancer.gov

    The chosen companies were selected from a highly competitive field of applicants by an independent panel of experts from venture capital firms, bio-pharmaceutical and medical device companies, based on their strength of research, impact on cancer, product development, and market potential.

  16. [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

  17. 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.

  18. Microbiological research for the Hungarian pharmaceutical industry.

    PubMed

    Ambrus, G

    2001-10-01

    A 50-year historical survey is presented on the R & D activities of the Institute for Drug Research, Budapest, in the areas of antibiotics, enzyme inhibitors and immunosuppressants of microbial origin as well as in the field of the microbial bioconversion of steroids. Research projects that have led to the elaboration of industrial processes applied by Hungarian pharmaceutical companies have mainly been selected. PMID:11686089

  19. 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

  20. 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

  1. 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

  2. Pharmaceutical Education in Poland

    ERIC Educational Resources Information Center

    Furmanowa, Miroslawa; Borke, Mitchell L.

    1978-01-01

    The content and organization of Poland's system of pharmaceutical education is described. Tables are presented of the subjects of the basic studies curriculum and the following areas of specialization: applied pharmacy, pharmaceutical analysis, clinical analysis, drug technology, herbal pharmacy, and bioanalysis and environmental studies. (SW)

  3. 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

  4. Obtaining, challenging and enforcing pharmaceutical patents under the America Invents Act.

    PubMed

    Genieser, Lars H; McCann, Clifton E

    2012-09-01

    The America Invents Act (AIA) will affect how intellectual property rights for pharmaceutical innovations are obtained, challenged and enforced. For example, the AIA allows pharmaceutical companies to take a more uniform approach in seeking patent protection worldwide. Post-grant and inter partes review procedures in the USPTO will allow patents to be challenged by pharmaceutical interests at a lower cost than that of litigation in US courts, and should improve the quality of patents as a whole. Provisions in the AIA incentivize pharmaceutical companies to monitor the published applications and patents of competitors, and to make prompt challenges to patentability where appropriate, promoting the integrity of the intellectual property landscape. PMID:24236880

  5. Case histories in pharmaceutical risk management.

    PubMed

    McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

    2009-12-01

    The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS). PMID:19767156

  6. [The pharmaceutical cost of elderly people in private health insurance].

    PubMed

    Wild, F

    2009-12-01

    In this paper the author analyses the prescription of pharmaceuticals for elderly private insured persons. Data from eight firms form the basis of the survey. The main focus lies in the analysis of the expenditure per capita and the distribution of the pharmaceuticals costs. It will illustrate that costs for elderly private insured persons will have a great impact on the expenditure for the private health insurance companies in the coming years. PMID:20052826

  7. [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

  8. 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

  9. 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

  10. Smart Companies.

    ERIC Educational Resources Information Center

    Galagan, Patricia A.

    1997-01-01

    Capturing and leveraging knowledge is an important new management trend that is as yet undefined. Some companies are accounting for their intellectual capital and applying it to the company balance sheets. (JOW)

  11. 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

  12. 78 FR 33441 - Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ..., 78 FR 12101, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey... Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans to...

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

    PubMed

    Burkhart, M; Wermelinger, J; Setz, W; Mller, 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

  14. 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

  15. Exporting Exploitation: The Dumping of U.S. Banned Pharmaceuticals in LDC's.

    PubMed

    Friedman, J A; Alkhateeb, W

    1981-01-01

    United States pharmaceutical companies are marketing or manufacturing drugs in less developed countries which add hazards to the diseases they are intended to control. For many pharmaceutical companies the financial benefits outweigh any possible risks. In many cases U.S. export laws and other nations' import laws are not enforced and people are denied their right to be provided with full unbiased disclosure of all medications they are considering consenting to. PMID:20841092

  16. 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

  17. 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

  18. 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

  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. 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

  1. The impact of mergers on pharmaceutical R&D.

    PubMed

    LaMattina, John L

    2011-08-01

    Mergers and acquisitions in the pharmaceutical industry have substantially reduced the number of major companies over the past 15 years. The short-term business rationale for this extensive consolidation might have been reasonable, but at what cost to research and development productivity? PMID:21804580

  2. 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

  3. 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

  4. 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

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

    PubMed

    Nozal, Ral Rodrquez

    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 'Cmara Nacional de Industrias Qumicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organizacin Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unin Nacional de Laboratorios Qumico-Farmacuticos', 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 'Unin Farmacutica Nacional'. PMID:22372007

  6. Financial Times Global Pharmaceutical & Biotechnology Conference 2009.

    PubMed

    Scattereggia, Jennifer

    2010-01-01

    The Financial Times Global Pharmaceutical & Biotechnology conference, held in London, included topics covering the current and future challenges confronting the pharma and biotech industry, and presented possible solutions to those challenges. This conference report highlights selected presentations on the industry challenges for big pharma companies, diversification as a solution to industry problems, overcoming challenges with collaborations and M&As, and the role of emerging markets in the pharma industry. Other subjects discussed included the expected impact of personalized medicine on the industry, the entry of big pharma into the generics market and the problems that are confronting the small pharma and biotech industry. PMID:20024844

  7. 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

  8. 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

  9. [Chapter 5. The internationalization of the Japanese pharmaceutical industry (1980-2010)].

    PubMed

    Yongue, Julia S

    2014-01-01

    The Japanese pharmaceutical industry experienced a period of rapid and economic growth following the introduction of the national healthcare system in 1961. Triggered by a major revision in Japanese legislation from process to substance patents, leading Japanese pharmaceutical companies began to invest in research and development (R&D). By the mid-1980s, some had managed to develop their first internationally marketable drugs, many of which were antibiotics. The emergence of novel drugs gave companies the impetus to engage in progressively more appreciable investments in Asia, Europe and the United States. In the 1980s, internationalization was mainly inwardly focused so as to limit firms' exposure to risk. However, as profits increased in the 1990s from the sale of new drugs, Japanese pharmaceutical companies were able to engage in even more sizeable, outwardly focused investments. By 2010, Japan's leading pharmaceutical enterprises had succeeded in putting place three types of global operations: manufacturing, marketing and R&D. PMID:25272639

  10. [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

  11. 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

  12. 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

  13. 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

  14. Models for open innovation in the pharmaceutical industry.

    PubMed

    Schuhmacher, Alexander; Germann, Paul-Georg; Trill, Henning; Gassmann, Oliver

    2013-12-01

    The nature of the pharmaceutical industry is such that the main driver for its growth is innovation. In view of the vast challenges that the industry has been facing for several years and, in particular, how to manage stagnating research and development (R&D) productivity, pharmaceutical companies have opened their R&D organizations to external innovation. Here, we identify and characterize four new types of open innovator, which we call 'knowledge creator', 'knowledge integrator', 'knowledge translator' and 'knowledge leverager', and which describe current open R&D models. PMID:23892183

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

    PubMed

    Granja, Mnica

    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 Mdicas 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

  16. Developing and delivering clinical pharmacology in pharmaceutical companies

    PubMed Central

    Richards, Duncan

    2012-01-01

    The challenges of developing new medicines are well known. Effective application of clinical pharmacology expertise is vital to the successful evaluation of potential new medicines. In drug development, this depends on effective integration of diverse skills. Many of these are currently in short supply, but through innovative partnerships between industry and academia there is an opportunity to reinvigorate the discipline by nurturing these key skills to the benefit of both partners. Specific areas of focus should be experimental medicine, modelling and simulation, and translational skills. PMID:22360674

  17. 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

  18. [Increases in pharmaceutical expenditures of PHI by monoclonal antibodies].

    PubMed

    Wild, F

    2013-06-01

    The dynamics of one of the most innovative segments of health care and its impact on pharmaceutical expenditure of private health insurance (PHI) is examined on the basis of drug prescription data from private health insurance companies. The study shows that the increase in pharmaceutical expenditure can be explained partly by the new treatment possibilities available with monoclonal antibodies. The per capita expenditure on drugs with monoclonal antibodies increased by 255% from 2006 to 2010 in private health insurance, while the corresponding expenditure of all pharmaceuticals has risen by only 19% in the same period. In the coming years, growth on this scale will be a challenge for all payers in the health system. PMID:23926705

  19. Measuring US pharmaceutical industry R&D spending.

    PubMed

    Golec, Joseph; Vernon, John

    2008-01-01

    Government policy debates on pharmaceutical pricing often turn on whether higher drug prices fund greater company-financed R&D spending. In the US, debate breaks down because each side uses a different measure of R&D spending, and the measures are far apart. Government agencies, Congress and consumer groups use government-generated survey data from the National Science Foundation (NSF), and the pharmaceutical industry uses survey data from the Pharmaceutical Research and Manufacturers of America (PhRMA). This issue is also relevant to academic work because some studies use NSF data, and others use PhRMA data. This article illustrates the pros and cons of these survey data series, and offers a more reliable, comprehensive and replicable alternative series, based on Compustat data. PMID:19014202

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. Pharmaceutical study of Yashadabhasma

    PubMed Central

    Bhojashettar, Santhosh; Jadar, P. G.; Rao, V. Nageswara

    2012-01-01

    Background: Rasashastra is a branch which deals with the pharmaceutics of Rasaoushadhis. Bhasmas are one among such Rasaoushadhis which are known for their low doses and fast action. A verse from Rasaratnasamuchchaya says that the bhasma prepared by using Mercury as media is of best quality. Materials and Methods: Following this principle, Yashadabhasma (Zinc calx) was prepared by subjecting it to Samanya shodhana (general purification method for all metals), Vishesha shodhana (specific putification method for Zinc), Jarana (roasting) and Marana (incineration) with Parada(Mercury) as a media under Gajaputa (classical heating system with 1000 cowdung cakes). Results and Conclusion: Yellow colored Yashadabhasma which passed all the classical bhasmaparikshas (tests for properly prepared calx) was obtained after two putas. The bhasma did not pass Nishchandratva(free from shining particles) test after 1stputa but was passed after giving it 2ndputa. PMID:23284213

  6. Pharmaceutical considerations of nitroglycerin

    SciTech Connect

    Yacobi, A.; Amann, A.H.; Baaske, D.M.

    1983-04-01

    During the past few years, there have been rapid changes in the pharmaceutical uses of nitroglycerin. New dosage forms and new delivery systems have become available, which have resulted in potential confusion to all concerned with the proper use of these systems. The goal of this review is to prevent confusion and to bring all the relevant information together. The various analytical techniques available for quality control of the dosage forms and for the study of the pharmacokinetics are reviewed, with the intent of enabling the reader to identify pertinent references rapidly. The interaction of nitroglycerin with packaging and plastic delivery devices is also reviewed so that the reader can make informed choices. Finally, the clinical pharmacy and pharmacokinetics are reviewed so as to bring the reader up to date in that area. After reading this article, the areas of nitroglycerin research that still need to be explored should be apparent.

  7. 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

  8. 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

  9. 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

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

    PubMed

    Grevsen, Jrgen 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

  11. 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.

  12. 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

  13. 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

  14. [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

  15. The pharmaceutical industry as an informant.

    PubMed

    Collier, Joe; Iheanacho, Ike

    2002-11-01

    The pharmaceutical industry spends more time and resources on generation, collation, and dissemination of medical information than it does on production of medicines. This information is essential as a resource for development of medicines, but is also needed to satisfy licensing requirements, protect patents, promote sales, and advise patients, prescribers, and dispensers. Such information is of great commercial value, and most of it is confidential, protected by regulations about intellectual property rights. Through their generation and dissemination of information, transnational companies can greatly influence clinical practice. Sometimes, their commercially determined goals represent genuine advances in health-care provision, but most often they are implicated in excessive and costly production of information that is largely kept secret, often duplicated, and can risk undermining the best interests of patients and society. PMID:12424005

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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…

  1. Drug companies, UNAIDS make drugs available.

    PubMed

    1998-01-01

    The United Nations AIDS (UNAIDS) initiative is working with several drug companies and four countries on a pilot program to build a health infrastructure that provides affordable drugs to insure that combination therapies are used appropriately. The countries involved in the program are Uganda, Chile, Vietnam and Cote d'Ivoire, and the drug companies are Glaxo Wellcome, Hoffmann-La Roche, and Virco NV. Each country agreed to form national HIV/AIDS drug advisory boards, and non-profit companies will act as clearinghouses. Financing will come from the pharmaceutical companies, local health ministries, and a $1 million grant from UNAIDS. The program will be evaluated in terms of improvements to overall health care delivery, number of people treated, the impact on emergency care, and the rate of illness and death. PMID:11364863

  2. 76 FR 75939 - ZipGlobal Holdings, Inc., Symbollon Pharmaceuticals, Inc., Microholdings US, Inc., ComCam...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... available information about the company. 7. 1st Global Financial, Corp. has its principal place of business... COMMISSION ZipGlobal Holdings, Inc., Symbollon Pharmaceuticals, Inc., Microholdings US, Inc., ComCam International, Inc., Outfront Companies, Augrid Global Holdings Corp., 1st Global Financial, Corp.; Order...

  3. 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...

  4. Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.

    PubMed

    Schuck, Edgar; Bohnert, Tonika; Chakravarty, Arijit; Damian-Iordache, Valeriu; Gibson, Christopher; Hsu, Cheng-Pang; Heimbach, Tycho; Krishnatry, Anu Shilpa; Liederer, Bianca M; Lin, Jing; Maurer, Tristan; Mettetal, Jerome T; Mudra, Daniel R; Nijsen, Marjoleen Jma; Raybon, Joseph; Schroeder, Patricia; Schuck, Virna; Suryawanshi, Satyendra; Su, Yaming; Trapa, Patrick; Tsai, Alice; Vakilynejad, Majid; Wang, Shining; Wong, Harvey

    2015-03-01

    The application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its broad application. An important goal of preclinical PK/PD analysis in all pharmaceutical companies is for the selection/optimization of doses and/or dose regimens, including prediction of human efficacious doses. Oncology was the therapeutic area with the most PK/PD analysis support and where it showed the most impact. Consistent use of more complex systems pharmacology models and hybrid physiologically based pharmacokinetic models with PK/PD components was less common compared to traditional PK/PD models. Preclinical PK/PD analysis is increasingly being included in regulatory submissions with ~73% of companies including these data to some degree. Most companies (~86%) have seen impact of preclinical PK/PD analyses in drug development. Finally, ~59% of pharmaceutical companies have plans to expand their PK/PD modeling groups over the next 2years indicating continued growth. The growth of preclinical PK/PD modeling groups in pharmaceutical industry is necessary to establish required resources and skills to further expand use of preclinical PK/PD modeling in a meaningful and impactful manner. PMID:25630504

  5. 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. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:4197-4206, 2015. PMID:26398581

  6. [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

  7. [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

  8. [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

  9. [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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. Pharmaco-economic impact of demographic change on pharmaceutical expenses in Germany and France

    PubMed Central

    2012-01-01

    Background Most European health care systems are suffering from the impact of demographic change. In short, aging of society is leading to higher costs of treatment per capita, while reproduction rates below 2.1 children per woman lead to a reduced number of younger people to provide for the necessary contributions into the health insurance system. This research paper addresses the questions what impact the demographic development will have on one particular spending area, what are pharmaceutical expenditure in two of Europes largest health care systems, Germany and France, and what the implications are for pharmaceutical companies. Methods The research is based on publicly available data from German and French health ministries, the OECD, and institutes which focus on projection of demographic development in those countries. In a first step, data was clustered into age groups, and average spending on pharmaceuticals was allocated to that. In the second step, these figures were extrapolated, based on the projected change in the demographic structure of the countries from 2004 until 2050. This leads to a deeper understanding of demand for pharmaceutical products in the future due to the demographic development as a single driving factor. Results Pharmaceutical expenses per head (patient) will grow only slightly until 2050 (0.5% p.a. in both countries). Demographic change alone only provides for a slowly growing market for pharmaceutical companies both in Germany and in France, but for a relevant change in the consumption mix of pharmaceutical products, based on a shift of relevance of different age groups. Conclusions Despite demographic changes pharmaceutical expenses per head (patient) and the overall pharmaceutical markets will grow only slightly until 2050 in Germany as well as in France. Nevertheless, the aging of society implies different challenges for pharmaceutical companies and also for the health care system. Companies have to cope with the shift of relevance of different age groups and within the health care system new options for financing the slowly growing expenses have to be found. PMID:23092314

  16. Guides to pollution prevention: The pharmaceutical industry. Final report

    SciTech Connect

    Not Available

    1991-10-01

    Pharmaceutical manufacturers generate a variety of wastes during manufacturing, maintenance, and housekeeping operations which can be reduced or minimized through source reduction and recycling. The typical waste streams are spent fermentation broths, process liquors, solvents, equipment wash water, spilled materials, off-spec products, and used processing aids. Suggestions include improvements to operational practices, solvent recycling and implementing good materials management and housekeeping practices. To help companies in the industry identify opportunities for waste reduction at their own facilities, the guide includes a set of worksheets which take the user step-by-step through an analysis of the on-site waste generating operations and the possibilities for minimizing each waste. The guide and its worksheets would also be instructive to consultants serving the pharmaceutical manufacturing industry and government agencies who regulate waste streams generated from these firms.

  17. 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

  18. 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.

  19. 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...

  20. 78 FR 3030 - Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ...'s notice of determination was published in the Federal Register on January 24, 2012 (77 FR 3501..., 2012 (77 FR 28901) and October 29, 2012 (77 FR 65581) respectively. At the request of a company... Employment and Training Administration Novartis Pharmaceuticals Corporation, Primary Care Business...

  1. 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

  2. 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…

  3. 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

  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. 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

  6. 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

  7. The epiphany of data warehousing technologies in the pharmaceutical industry.

    PubMed

    Barrett, J S; Koprowski, S P

    2002-03-01

    The highly competitive pharmaceutical industry has seen many external changes to its landscape as companies consume each other increasing their pipelines while removing redundant functions and processes. Internally, companies have sought to streamline the discovery and development phases in an attempt to improve candidate selection and reduce the time to regulatory filing. In conjunction with efforts to screen and develop more compounds faster and more efficiently, database management systems (DBMS) have been developed for numerous groups supporting various R&D efforts. An outgrowth of DBMS evolution has been the birth of data warehousing. Often confused with DBMS, data warehousing provides a conduit for data residing across platforms, networks, and in different data structures. Through the use of metadata, the warehouse establishes connectivity of varied data stores (operational detail data, ODD) and permits identification of data ownership, location and transaction history. This evolution has closely mirrored and in some ways been driven by the electronic submission (formerly CANDA). The integration of the electronic submissions and document management with R&D data warehousing initiatives should provide a platform by which companies can address compliance with 21 CFR Part 11. Now more than ever "corporate memory" is being extended to the data itself. The when, why and how of successes and failures are constantly being probed by R&D management teams. The volume of information being generated by today's pharmaceutical companies requires mining of historical data on a routine basis. Data warehousing represents a core technology to assist in this endeavor. New initiatives in this field address the necessity of data portals through which warehouse data can be web-enabled and exploited by diverse data customers both internal and external to the company. The epiphany of data warehousing technologies within the pharmaceutical industry has begun and promises to change the way in which companies process and provide data to regulatory agencies. The improvements in drug discovery and reduction in development timelines remain to be seen but would seem to be rational if such technology is fully exploited. PMID:11911607

  8. 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...

  9. 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......

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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…

  15. 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

  16. 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

  17. 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…

  18. 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

  19. 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

  20. 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…

  1. 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

  2. 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…

  3. 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

  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. 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.…

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Interactions between physicians and the pharmaceutical industry: what does the literature say?

    PubMed Central

    Lexchin, J

    1993-01-01

    OBJECTIVE: To determine the effect of three types of interaction between physicians and the pharmaceutical industry--company-funded clinical trials, company-sponsored continuing medical education (CME) and information for physicians supplied by pharmaceutical detailers--on orientation and quality of clinical trials, content of CME courses and physicians' prescribing behaviour. DATA SOURCES: MEDLINE and HEALTH searches for English-language articles published from 1978 to 1993, supplemented by material from the author's personal collection. STUDY SELECTION: A total of 227 papers from the MEDLINE and HEALTH searches and about 2000 items from the author's library were initially reviewed. The following selection criteria were used: studies conducted in Australia, Canada, New Zealand, Britain and the United States; studies conducted after 1977; quantitative surveys containing details of the survey methods; studies on the orientation and quality of company-funded clinical trials and on the content of CME courses giving explicit criteria used in the evaluation; and reports on the outcome of interactions stating how the outcomes were assessed. Thirty-six studies met these criteria. DATA EXTRACTION: Information was extracted on five topics: physicians' attitudes toward drug industry interactions, frequency with which physicians participate in the interactions, orientation and quality of company-funded clinical trials, content of company-sponsored CME courses and changes in physicians' prescribing behaviour as a result of an interaction. DATA SYNTHESIS: Although most physicians participate only occasionally in company-sponsored clinical trials, most see detailers and attend company-sponsored CME courses. However, physicians do not have a very high opinion of the information from detailers or of company-sponsored CME events. Many doctors regard pharmaceutical companies as an important source of funding for clinical trials, but they also have concerns about accepting money from this source. Company funding of clinical trials may affect the quality of the trials and the types of research that physicians undertake. Company-sponsored CME courses may have a commercial bias even if conducted under guidelines designed to ensure the independence of the event. All three types of interactions affect physicians' prescribing behaviour and, in the case of obtaining information from detailers, physicians' prescribing practices are less appropriate as a result of the interaction. CONCLUSIONS: Physicians are affected by their interactions with the pharmaceutical industry. Further research needs to be done in most cases to determine whether such interactions lead to more or less appropriate prescribing practices. The CMA's guidelines on this topic should be evaluated to see whether they are effective in controlling physician-industry interactions. Further measures may be necessary if the guidelines fail to prevent negative effects on prescribing practices. PMID:8221424

  12. 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

  13. How much cash does your company need?

    PubMed

    Passov, Richard

    2003-11-01

    In late 2001, the directors of Pfizer asked that very question. And with good reason. After its 2000 merger with rival Warner-Lambert, the New York-based pharmaceutical giant found itself sitting on a net cash position of $8 billion, which seemed extraordinarily conservative for a company whose products generated $30 billion in revenues. Most large companies with revenues that healthy would increase leverage, thereby unlocking tremendous value for shareholders. But knowledge-intensive companies like Pfizer, this author argues, are in a class apart. Because their largely intangible assets (like R&D) are highly volatile and cannot easily be valued, they are more vulnerable to financial distress than are firms with a preponderance of tangible assets. To insure against that risk, they need to maintain large positive cash balances. These companies' decisions to run large cash balances is one of the key reasons their shares sustain consistent premiums. Only by investing in their intangible assets can knowledge-based companies hope to preserve the value of those assets. A company that finds itself unable to do so because unfavorable market conditions reduce its operating cash flows will see its share price suffer almost as much as if it were to default on its debts. By the same token, with the right balance sheet, knowledge companies can profitably insure against the risk of failing to sustain value-added investments in difficult times. An optimal capital structure that calls for significant cash balances is certainly at odds with the results of a traditional capital structure analysis, the author demonstrates, but it explains the financial policies of many well-run companies, from Pfizer to Intel to ChevronTexaco. PMID:14619157

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

    PubMed Central

    Montastruc, Franois; Moulis, Guillaume; Palmaro, Aurore; Gardette, Virginie; Durrieu, Genevive; 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% [0.050.61]), 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% [1.074.22]). 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

  15. Regulatory constraints as seen from the pharmaceutical industry.

    PubMed

    Galligani, G; David-Andersen, I; Fossum, B

    2005-01-01

    In Chile, Canada, Europe, Japan, and the USA, which are the main geographical areas for fish farming of high value fish such as salmonids, sea bass, sea bream, yellowtail and catfish, vaccination has been established as an important method for the prevention of infectious diseases. To make new vaccines available to the fish farming industry, pharmaceutical companies must comply with the regulatory framework for licensing of fish vaccines, which in recent years has become more regulated. Considerable scientific and regulatory skills are thus required to develop, document and license vaccines in accordance with the requirements in the different geographical areas. International co-operation to harmonise requirements for the licensing documentation is ongoing. Even though there are obvious benefits to the pharmaceutical industry from the harmonisation process, it may sometimes impose unreasonable requirements. The regulatory framework for fish vaccines clearly has an impact on the time for bringing a new fish vaccine to the market. Several hurdles need to be passed to complete the regulatory process, i.e. obtain a licence. Fulfilment of the rather detailed and extensive requirements for documentation of the production and controls, as well as safety and efficacy of the vaccine, represent a challenge to the pharmaceutical industry, as do the different national and regional licensing procedures. This paper describes regulatory constraints related to the documentation, the licensing process, the site of production and the continuing international harmonisation work, with emphasis on inactivated conventional fish vaccines. PMID:15962486

  16. [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

  17. 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

  18. 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

  19. Public Policy and Pharmaceutical Innovation

    PubMed Central

    Grabowski, Henry G.

    1982-01-01

    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

  20. 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

  1. Biosafe nanoscale pharmaceutical adjuvant materials.

    PubMed

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

    2014-09-01

    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

  2. Economic analysis and pharmaceutical policy.

    PubMed

    Rovira, J

    1995-10-01

    Economic evaluation, a comparative analysis of alternative actions in terms of costs and consequences, allows rational decisions to be made concerning the deployment of resources (people, time, equipment, facilities and knowledge). Pharmaceutical policy reflects the various objectives of the many social groups, some of which are conflicting. While new methodologies for evaluation of health care programmes still need to gain wider acceptance, resource limitations for both care providers and decision makers make economic analysis an increasingly important tool. PMID:7485919

  3. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

    Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

  4. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovsk, Kate?ina; K?eslek, Vojt?ch

    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.

  5. Pharmaceutical study of Lauha Bhasma.

    PubMed

    Singh, Neetu; Reddy, K R C

    2010-07-01

    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 800C was maintained whereas in Batch II, a temperature of 600C 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 600C, 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 800C, 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

  6. 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 800C was maintained whereas in Batch II, a temperature of 600C 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 600C, 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 800C, 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

  7. 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

  8. Water clusters in amorphous pharmaceuticals.

    PubMed

    Authelin, Jean-Rene; MacKenzie, Alan P; Rasmussen, Don H; Shalaev, Evgenyi Y

    2014-09-01

    Amorphous materials, although lacking the long-range translational and rotational order of crystalline and liquid crystalline materials, possess certain local (short-range) structure. This paper reviews the distribution of one particular component present in all amorphous pharmaceuticals, that is, water. Based on the current understanding of the structure of water, water molecules can exist in either unclustered form or as aggregates (clusters) of different sizes and geometries. Water clusters are reported in a range of amorphous systems including carbohydrates and their aqueous solutions, synthetic polymers, and proteins. Evidence of water clustering is obtained by various methods that include neutron and X-ray scattering, molecular dynamics simulation, water sorption isotherm, concentration dependence of the calorimetric Tg , dielectric relaxation, and nuclear magnetic resonance. A review of the published data suggests that clustering depends on water concentration, with unclustered water molecules existing at low water contents, whereas clusters form at intermediate water contents. The transition from water clusters to unclustered water molecules can be expected to change water dependence of pharmaceutical properties, such as rates of degradation. We conclude that a mechanistic understanding of the impact of water on the stability of amorphous pharmaceuticals would require systematic studies of water distribution and clustering, while such investigations are lacking. PMID:24824578

  9. 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

  10. 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

  11. 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.

  12. 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

  13. 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

  14. 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

  15. Hospital-based training for pharmaceutical manufacturers' representatives.

    PubMed

    Phillips, D J; Smith, J E

    1983-10-01

    A hospital-based training program for pharmaceutical manufacturers' representatives is described. The pharmacy department of a large teaching institution established a training program for new sales representatives of a major pharmaceutical company. Goals were outlined by the sales training manager and the pharmacy department. The sales training personnel, department of pharmacy, and the cooperating departments of medicine, surgery, and nursing worked together to formulate objectives for the sessions, and teaching responsibilities were delegated to members of all these departments. The program length varied from one to five days. A formal contract was developed specifying content, program dates, and reimbursement. The institution is reimbursed for the use of the facility, materials, and administrative overhead. The program's success has led to the development of similar programs with several other companies. The extra income has enabled the pharmacy to create a new division within the department. Evaluations from more than 500 sales representatives who have participated in the programs have been consistently positive. The pharmacy department in a teaching institution has the resources to provide a training program for sales representatives that can be an additional source of income. PMID:6638029

  16. 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.

  17. 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.

  18. [The legal regulation of life cycle of orphan pharmaceuticals].

    PubMed

    Gildeyeva, G N; Kartavtsova, T V

    2014-01-01

    The legislation of the USA, countries of EU and Japan is analyzed concerning orphan diseases and pharmaceuticals developed for their treatment (orphan pharmaceuticals). The main characteristics and stages of registration of orphan pharmaceuticals in the USA, countries of EU and Japan are considered. Thee peculiarities of orphan pharmaceuticals and pharmaceutical market of orphan pharmaceuticals in the Russian Federation are discussed. The legislative regulation of turnover of orphan pharmaceuticals in the Russian Federation and corresponding obstacles and perspectives are considered. PMID:25219041

  19. 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

  20. Pharmaceutical Compounds Studied Using NEXAFS

    SciTech Connect

    Murray Booth, A.; Braun, Simon; Lonsbourough, Tom; Schroeder, Sven L. M.; Purton, John; Patel, Sunil

    2007-02-02

    Total Electron Yield (TEY) oxygen K-edge NEXAFS detects the presence of strongly adsorbed water molecules on poloxamer-coated pharmaceutical actives, which provides a useful spectroscopic indicator for bioavailability. The results are supported by complementary XPS measurements. Carbon K-edge spectra obtained in a high-pressure NEXAFS cell were used in situ to establish how a polymer coating spread on a drug surface by using humidity induced dispersion of the coating. Finally, we demonstrate how combined Carbon and Oxygen K-edge measurements can be used to characterize amorphous surface layers on micronised crystals of a drug compound.

  1. 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.

  2. [Expectations for the education of graduate school of pharmaceutical sciences from the viewpoint of discovery and development of new drugs].

    PubMed

    Ohmori, Kenji

    2011-01-01

    For the purpose of the development of new drugs for incurable diseases, many students enter graduate school of pharmaceutical sciences every year. At first, I expect education to let it develop more and spread without forgetting this will. Recently, withdrawals from Japan of the research institutes of the foreign-affiliated pharmaceutical companies have occurred successively. It is pointed out that there is it for the study about the biomedical research that is the next step of fundamental researches having been weak. I expect the immediate construction of the cluster, which consists of pharmaceutical companies and graduate schools of pharmaceutical sciences. Time of ten several years and a cost of one hundred billion yen are necessary for the research and development of new drug. The success probability is low, besides. Many trials are accomplished to raise the success probability. The one is introduction of the project system. The best members are gathered from the fields such as medicinal chemistry, molecular biology, biochemistry, pharmacology, pharmacokinetics, pharmaceutics and toxicological sciences, etc. The project system is a system enforcing go or stop by own judgment, an authority and the responsibility of the purpose are given. It is necessary for the project leader to have great knowledge and the abilities to hold lively discussion. It is a researcher from graduate school of pharmaceutical sciences that is the most suited to be as a project leader. I expect to upbring education from the time when a leader is young. PMID:21628982

  3. 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...

  4. 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

  5. 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

  6. Toward a definition of pharmaceutical innovation

    PubMed Central

    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

  7. A research-based narrative assignment for global health education.

    PubMed

    Lencucha, Raphael

    2014-03-01

    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 the results from an evaluation of this assignment with undergraduate public health students, including its strengths and limitations. The research-based narrative assignment was implemented during an introductory global health course for third and fourth year undergraduate public health students. The students (n=20) completed the assignment and then wrote a two-page reflection about their experience. The author analyzed these student reflections using open coding and thematic analysis. Four salient themes were identified from the written reflections including (1) the challenge of representing persons, (2) the opportunity to develop an engaged understanding of the chosen issue, (3) seeing the bigger picture or integrating the various determinants into a coherence story, and finally (4) the struggle to create a compelling story that was based on accurate information. The analysis of the students' reflections provides important insights into their experience conducting this assignment, particularly in highlighting key strengths and challenges of this approach. These strengths and challenges are discussed. PMID:23377611

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. [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

  18. 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

  19. 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

  20. 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

  1. 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…

  2. 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

  3. 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

  4. Pharmaceutical experiment aboard STS-67 mission

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Astronaut William G. Gregory, pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour during the STS-67 mission. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical, but also biotechnology, cell biology, fluids, and crystal growth investigation

  5. 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

  6. 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

  7. 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 industrys 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

  8. 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

  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. 75 FR 5075 - Coalinga Cogeneration Company, Kern River Cogeneration Company, Mid-Set Cogeneration Company...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ...-612-000; ER10-611-000] Coalinga Cogeneration Company, Kern River Cogeneration Company, Mid-Set Cogeneration Company, Salinas River Cogeneration Company, Sargent Canyon Cogeneration Company, Sycamore Cogeneration Company; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for...

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  1. 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

  2. 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

  3. 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

  4. Revisiting flow-chemiluminescence techniques: pharmaceutical analysis.

    PubMed

    Iranifam, Mortaza

    2013-01-01

    The state of the art in flow-chemiluminescence (flow-CL) technique for automated pharmaceutical analysis is reviewed. Flow-CL approaches have become powerful and promising tools for pharmaceutical screening in recent years due to their simplicity, low cost and high sensitivity. Because of these advantages, these methods have been widely used for pharmaceutical analysis in recent years. The literature reviewed covers papers of analytical interest that appeared between 2007 and mid-2012 and have been divided into several sections based on fundamental types of CL systems employed. Furthermore, entries have been summarized alphabetically in tabular form giving details of analytical figures of merit of the methods. PMID:23124900

  5. [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

  6. The mortality of companies.

    PubMed

    Daepp, Madeleine I G; Hamilton, Marcus J; West, Geoffrey B; Bettencourt, Lus 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. 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

  9. 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 ...

  10. 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 ...

  11. Citywide pharmaceutical preparation for bioterrorism.

    PubMed

    Terriff, C M; Tee, A M

    2001-02-01

    One community's efforts to become pharmaceutically prepared for an attack with biological agents is described. In response to recent bioterrorist activities, including a local scare in 1999 involving anthrax, the pharmacy department at Deaconess Medical Center in Spokane, Washington, was asked to develop a plan for bioterrorism preparedness. A literature search was conducted, and resources, such as the Centers for Disease Control and Prevention, were contacted. For each biological agent, information was compiled about symptom onset, treatment, postexposure prophylaxis, patient isolation precautions, and the availability of antidotes at local hospitals. A procedure was developed for obtaining antidotes that might not be available or stocked in sufficient quantities. After being reviewed by appropriate authorities, the information was presented to area hospitals and trauma centers, drug wholesalers, hospital risk-management personnel, and emergency management personnel. In May 2000 dozens of emergency and medical personnel attended a day-long program on domestic preparedness. Citywide cooperation was obtained on how to respond to a mass exposure to a bioterrorism agent. The job of a pharmacist during a bioterrorism strike is to rapidly disseminate antidotes and information, provide dosage and vaccination schedules for both treatment and prophylaxis, and counsel patients. Medical facilities in Spokane have cooperated to make the community more prepared for a bioterrorist attack. PMID:11217178

  12. 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

  13. 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

  14. 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

  15. 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

  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. 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

  18. 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...

  19. Assessing the assessments: Pharmaceuticals in the environment

    SciTech Connect

    Enick, O.V. Moore, M.M.

    2007-11-15

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development.

  20. 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...

  1. 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

  2. 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 ...

  3. 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.

  4. Pharmaceutical Formulation Facilities as Sources of Opioids and Other Pharmaceuticals to Wastewater Treatment Plant Effluents

    PubMed Central

    2010-01-01

    Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally <1 ?g/L. Four pharmaceuticals (methadone, oxycodone, butalbital, and metaxalone) in samples of NY3 effluent had median concentrations ranging from 3.4 to >400 ?g/L. Maximum concentrations of oxycodone (1700 ?g/L) and metaxalone (3800 ?g/L) in samples from NY3 effluent exceeded 1000 ?g/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 ?g/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847

  5. Public pharmaceutical expenditure: identification of spatial effects

    NASA Astrophysics Data System (ADS)

    Lauridsen, Jorgen; Snchez, Mariluz Mat; Bech, Mickael

    2010-06-01

    The aim of the present study is to analyse the spatio-temporal dynamics underlying Spanish pharmaceutical expenditure increases. We suggest alternative ways to resolve the problem of identifying exogenous and endogenous spatial spillover in a seemingly unrelated regression framework, while parametric instability is captured using linear time trends in the coefficients. The results highlight the need of considering these dynamic aspects in the pharmaceutical expenditure analysis.

  6. Production of Plasmid DNA as Pharmaceutical.

    PubMed

    Schmeer, Marco; Schleef, Martin

    2015-01-01

    Pharmaceutical applications of plasmid DNA require certain quality standards, depending on the intended use of the plasmids. That is, for direct gene transfer into human, GMP Grade is mandatory, however, for GMP production of for example viral vectors (AAV or mRNA etc.), the plasmid DNA used has not to be produced under GMP necessarily. Here we summarize important features of producing plasmid DNA, ensuring the required quality for the intended (pharmaceutical) application. PMID:26072414

  7. Historic overview of powerhouse, company houses, and company hotel, after ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    Historic overview of powerhouse, company houses, and company hotel, after snowfall; looking west. (photographer unknown, ca. 1910.) - Nooksack Falls Hydroelectric Plant, Route 542, Glacier, Whatcom County, WA

  8. 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

  9. 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

  10. 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

  11. [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

  12. 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.

  13. 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

  14. 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

  15. 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

  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. 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

  18. 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

  19. 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

  20. 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

  1. 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...

  2. [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

  3. 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

  4. '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

  5. Integrating internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio.

    PubMed

    Summerfield, Scott G; Evans, Christopher; Spooner, Neil; Dunn, John A; Szapacs, Matthew E; Yang, Eric

    2014-05-01

    The portfolios of pharmaceutical companies have diversified substantially over recent years in recognition that monotherapies and/or small molecules are less suitable for modulating many complex disease etiologies. Furthermore, there has been increased pressure on drug-development budgets over this same period. This has placed new challenges in the path of bioanalytical scientists, both within the industry and with contract research organizations (CROs). Large pharmaceutical, biotechnology and small-medium healthcare enterprises have had to make important decisions on what internal capabilities they wish to retain and where CROs offers a significant strategic benefit to their business model. Our journey has involved asking where we believe an internal bioanalytical facility offers the greatest benefit to progressing drug candidates through the drug-development cycle and where externalization can help free up internal resources, adding flexibility to our organization in order to deal with the inevitable peaks and troughs in workload. PMID:24958115

  6. 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

  7. Ethical dilemma of mandated contraception in pharmaceutical research at catholic medical institutions.

    PubMed

    Casey, Murray Joseph; O'Brien, Richard; Rendell, Marc; Salzman, Todd

    2012-01-01

    The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance. PMID:22694032

  8. 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.

  9. [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

  10. Globalization and the pharmaceutical industry revisited.

    PubMed

    Busfield, Joan

    2003-01-01

    This survey of the pharmaceutical industry at the beginning of the 21st century updates some of the information provided in Claudio Tarabusi and Graham Vickery's survey, "Globalization in the Pharmaceutical Industry," published in the International Journal of Health Services in 1998, which was largely based on data up to 1993. However, the purpose of the present article differs from that of Tarabusi and Vickery, which covered a wide range of aspects of the industry relevant to globalization but did not explicitly address the question of the extent to which the industry could be described as globalized. After looking at the industry in some detail, the author directly confronts the question of the appropriateness of the use of the term "globalization" for characterizing the directions in which the pharmaceutical industry has been moving. PMID:14582874

  11. 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

  12. Obesity, the Endocannabinoid System, and Bias Arising from Pharmaceutical Sponsorship

    PubMed Central

    McPartland, John M.

    2009-01-01

    Background Previous research has shown that academic physicians conflicted by funding from the pharmaceutical industry have corrupted evidence based medicine and helped enlarge the market for drugs. Physicians made pharmaceutical-friendly statements, engaged in disease mongering, and signed biased review articles ghost-authored by corporate employees. This paper tested the hypothesis that bias affects review articles regarding rimonabant, an anti-obesity drug that blocks the central cannabinoid receptor. Methods/Principal Findings A MEDLINE search was performed for rimonabant review articles, limited to articles authored by USA physicians who served as consultants for the company that manufactures rimonabant. Extracted articles were examined for industry-friendly bias, identified by three methods: analysis with a validated instrument for monitoring bias in continuing medical education (CME); analysis for bias defined as statements that ran contrary to external evidence; and a tally of misrepresentations about the endocannabinoid system. Eight review articles were identified, but only three disclosed authors' financial conflicts of interest, despite easily accessible information to the contrary. The Takhar CME bias instrument demonstrated statistically significant bias in all the review articles. Biased statements that were nearly identical reappeared in the articles, including disease mongering, exaggerating rimonabant's efficacy and safety, lack of criticisms regarding rimonabant clinical trials, and speculations about surrogate markers stated as facts. Distinctive and identical misrepresentations regarding the endocannabinoid system also reappeared in articles by different authors. Conclusions The findings are characteristic of bias that arises from financial conflicts of interest, and suggestive of ghostwriting by a common author. Resolutions for this scenario are proposed. PMID:19333392

  13. 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

  14. Pharmaceutical policy and the lay public.

    PubMed

    Traulsen, Janine M; Almarsdttir, Anna Birna

    2005-08-01

    Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry. The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation; patients and professionals have different rationalities with regard to their views on medicine. Because the lay public and medicine users are not one entity, one of the many challenges facing policy makers today is to identify, incorporate and prioritise the many diverse needs. The authors recommend research which includes studies that look at: lay attitudes towards pharmaceutical policy; lay experiences of drug therapy and how it affects their daily lives; the problem of identifying lay representatives; the relationship between industry and the consumers; the effect of the media on medicine users and on pharmaceutical policy itself. The authors acknowledge that although lay involvement in policy is still in its infancy, some patient organisations have been successful and there are developments towards increased lay involvement in pharmaceutical policymaking. PMID:16228621

  15. 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

  16. 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

  17. 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

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

    PubMed Central

    Abud, Mara Jos; 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

  19. An empirical analysis of primary and secondary pharmaceutical patents in Chile.

    PubMed

    Abud, Mara Jos; 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

  20. 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.

  1. Capillary zone electrophoresis in pharmaceutical analysis.

    PubMed

    Fanali, S; Cristalli, M; Nardi, A; Ossicini, L; Shukla, S K

    1990-06-01

    The paper presents a brief characterization of capillary zone electrophoresis, a modern analytical separation method with high expediency for practical applications, especially in pharmaceutical analysis. Basic theoretical considerations are presented and discussed to explain the effects of the operational parameters upon the separation efficiency and resolution of species. Descriptions of simple instrumentation and of the analytical procedure itself are given. Experimental examples are given of the separation of mixtures of pharmaceutically important compounds and of the effects of operational parameters, especially pH of BGE and voltage applied. Lastly, the practical application of CZE for analysis of isoxsuprine in commercial preparations is shown. PMID:2205222

  2. Radiostability of pharmaceuticals under different irradiation conditions

    NASA Astrophysics Data System (ADS)

    Crucq, Anne-Sophie; Deridder, Vronique; 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.

  3. [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

  4. 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

  5. TRIPS and the global pharmaceutical market.

    PubMed

    Barton, John H

    2004-01-01

    This paper reviews the international controversy over patents and access to drugs in developing countries and explores the implications of the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, the 2001 Doha Declaration, and the 2003 agreement preceding the Cancun meeting. These agreements do not resolve the important funding issues that developing countries confront as they seek access to drugs. Also, the international debate and its resolution will complicate the importing of foreign pharmaceuticals into the United States and strengthen pressures both for expanding public support of U.S. drug purchases and, in the long run, for political control of U.S. pharmaceutical pricing. PMID:15160812

  6. 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

  7. An energy alliance company

    SciTech Connect

    Bernhardt, T.

    1991-10-01

    San Diego Gas Electric has been through tough times including the high fuel-cost era of the early '80s, which contributed to high rates, and a two-and-one-half-year merger attempt with Southern California Edison Co., recently rejected by the California Public Utility Commission (CPUC) - but has emerged a strong and vital company, tested and ready for the challenges of the future. This paper reports on San Diego Gas and Electric's ability to flourish as a company despite problems involving dwindling natural resources and regulations (environmental and otherwise) that style growth.

  8. 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... Michigan Public Service Commission. DTE Gas filed (1) in Docket No. PR13-29-000 a new baseline filing...

  9. 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...

  10. 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

  11. 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…

  12. 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

  13. 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.

  14. 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...

  15. 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...

  16. 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 ...

  17. 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)

  18. 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

  19. 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…

  20. 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…

  1. Healthy children as subjects in pharmaceutical research.

    PubMed

    Koren, Gideon

    2003-01-01

    Recruitment of healthy children for drug research has emerged due in part to several new American laws and policies that have led to a surge in pharmaceutical research involving children-subjects. In this paper, I review the ethical and scientific issues and the arguments in favor and against this new practice. PMID:12943269

  2. 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...

  3. 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.

  4. 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)

  5. 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;

  6. Multifunctional and stimuli-sensitive pharmaceutical nanocarriers.

    PubMed

    Torchilin, Vladimir

    2009-03-01

    Currently used pharmaceutical nanocarriers, such as liposomes, micelles, and polymeric nanoparticles, demonstrate a broad variety of useful properties, such as longevity in the body; specific targeting to certain disease sites; enhanced intracellular penetration; contrast properties allowing for direct carrier visualization in vivo; stimuli-sensitivity, and others. Some of those pharmaceutical carriers have already made their way into clinic, while others are still under preclinical development. In certain cases, the pharmaceutical nanocarriers combine several of the listed properties. Long-circulating immunoliposomes capable of prolonged residence in the blood and specific target recognition represent one of the examples of this kind. The engineering of multifunctional pharmaceutical nanocarriers combining several useful properties in one particle can significantly enhance the efficacy of many therapeutic and diagnostic protocols. This paper considers the current status and possible future directions in the emerging area of multifunctional nanocarriers with primary attention on the combination of such properties as longevity, targetability, intracellular penetration, contrast loading, and stimuli-sensitivity. PMID:18977297

  7. 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

  8. 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

  9. 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

  10. 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

  11. Communicating pharmaceutical outcomes to hospital administration.

    PubMed

    Mountzuris, J

    1995-10-01

    The contributions of a pharmaceutical outcomes approach to therapeutic decision-making and the budgetary process are explored. In the new health care climate, pharmacists can no longer look at a pharmaceutical product or service strictly on the basis of clinical outcomes but must consider the economic and humanistic outcomes as well. Today, pharmacists as effective outcomes managers must ask, Will the drug therapy work? What will be the overall cost? What effect will the treatment have on the patient's quality of life? Some newly developed agents, while they may have a high acquisition cost, can reduce suffering and bottom-line costs by avoiding unnecessary hospitalizations. There needs to be a movement from individual departmental budgets to shared budgets. Another approach to the budgetary system is cost shifting among the various patient care settings. Reimbursement strategies should be in place to ensure recovery of costs. Hospital decision-makers should have a comprehensive knowledge of institutional payer mix, pharmaceutical, formulary decisions, financial planning, and the availability of indigent care programs. Pharmaceutical outcomes must become an important factor in therapeutic decisions. Pharmacy directors must present a strategic financial plan to hospital administration that positions the pharmacy as a solution to cost issues. PMID:8846245

  12. [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

  13. 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...

  14. 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

  15. Company profile: Sistemic Ltd.

    PubMed

    Reid, Jim

    2013-09-01

    Founded in 2009 and headquartered in Glasgow, Scotland, UK, Sistemic Ltd has developed from a thought in the minds of four scientists into a company working globally to play its part in delivering the exciting opportunities for improvements in human health presented by cell therapies and regenerative medicine products (jointly referred to as the CT industry). Sistemic is now working in all corners of the world with some of the industry's leading companies to ensure that the products that they are developing, which will undoubtedly change the way we treat some of the major diseases and conditions currently placing a large burden on healthcare systems, including diabetes, dementia and cardiovascular disease, are as safe and efficacious as possible. Sistemic is also working to ensure that these products can be produced at a cost that will not lead to potentially transformational treatments being an additional financial burden on our already overburdened healthcare systems. Sistemic is using its revolutionary and IP-protected SistemQC (UK) technology to enhance understanding of characterization, process optimization and potency of CT products. The company is using the diagnostic power of miRNAs, a set of approximately 2000 ncRNAs that regulate a large percentage of the total gene expression of a cell. miRNAs are often present in a cell- and tissue-specific way that, at least in some cases, accounts for the phenotypic differences between cell types. These differences in miRNA expression can be interpreted by the miRNA profile and it is interpreting the instructive power of these profiles that underpin Sistemic's knowledge bases, giving CT companies a more comprehensive understanding of their cell populations with respect to their identity and functional capabilities. This knowledge is being used by companies to characterize, process, optimize and assess the efficacy of cell products. PMID:23998750

  16. 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.

  17. 78 FR 17763 - Housatonic Railroad Company, Inc., Maybrook Railroad Company, and Housatonic Transportation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... Surface Transportation Board Housatonic Railroad Company, Inc., Maybrook Railroad Company, and Housatonic Transportation Company--Intra-Corporate Family Transaction Exemption Housatonic Railroad Company, Inc. (HRRC), Maybrook Railroad Company (MRC), and Housatonic Transportation Company (HTC) (collectively,...

  18. [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

  19. 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

  20. 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

  1. 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

  2. Integrating Research-Based and Practice-Based Knowledge through Workplace Reflection

    ERIC Educational Resources Information Center

    Nilsen, Per; Nordstrom, Gunilla; Ellstrom, Per-Erik

    2012-01-01

    Purpose: This paper seeks to present a theoretical framework with the aim of contributing to improved understanding of how reflection can provide a mechanism to integrate research-based knowledge with the pre-existing practice-based knowledge. Design/methodology/approach: The paper begins with an explanation of important concepts: research-based

  3. Preservice Teachers' Thinking within a Research-Based Framework: What Informs Decisions?

    ERIC Educational Resources Information Center

    Olson, Joanne K.

    2007-01-01

    A research-based framework for teaching science is a heuristic tool used to help preservice teachers conceptualize many complexities of teaching while making explicit the strategy to use a research-based body of professional knowledge to inform instructional decision-making (Clough, 2003, Paper presented at the annual meeting of the Association

  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. 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

  6. Historic overview of newly completed powerhouse, company houses, and company ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    Historic overview of newly completed powerhouse, company houses, and company hotel, after snowfall; looking west. (photographer unknown, ca. 1906 - Nooksack Falls Hydroelectric Plant, Route 542, Glacier, Whatcom County, WA

  7. A pharmaceutical care challenge: recruiting, training, and retaining pharmaceutical care practitioners.

    PubMed

    Hatwig, C A; Crane, V S; Hayman, J N

    1993-10-01

    We do not claim to have all the answers when it comes to implementing an ideal pharmaceutical care model. We are not even sure what all the characteristics of such a model should be. We have recognized, based on our interpretation of the model, that meeting the demands of pharmaceutical care will require changes and advanced skills in our staff. We continue to work in creating an environment where the concept of pharmaceutical care can flourish. Our department has focused on defining and then providing pharmaceutical care through individual practitioners and patient care teams. More employee empowerment with less management control was the key to facilitating initial phases in our pharmaceutical care model. A successful orientation process has further enhanced our abilities to hire new graduates and/or experienced practitioners for our open positions. We believe we have taken some significant first steps toward recruiting, training, and developing our staff to become competent and satisfied with their newly developing role as pharmaceutical care practitioners. PMID:10129979

  8. 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; ?2 = 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

  9. 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

  10. 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

  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. 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

  14. 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

  15. [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

  16. 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

  17. 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).

  18. Company Profile: Intramagnetics General Corporation

    SciTech Connect

    1992-09-01

    Intramagnetics General Corporation was founded in 1971 as a spin-off from the General Electric Company (GE). IGC is a world leader in superconductivity technology and applications. The US Department of Energy called IGC the United States` top commercial source of low-temperature superconducting wire, and also noted the company`s superior performance in high-temperature superconducting wire. This article discusses the products of the company and its present/future plans. Organizational and commercial information is also presented.

  19. 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....

  20. 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

  1. 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

  2. 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…

  3. 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

  4. 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

  5. [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 contrle 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

  6. 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

  7. 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

  8. 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 doctorpatient 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

  9. Proteomics in pharmaceutical research and development.

    PubMed

    Cutler, Paul; Voshol, Hans

    2015-08-01

    In the 20 years since its inception, the evolution of proteomics in pharmaceutical industry has mirrored the developments within academia and indeed other industries. From initial enthusiasm and subsequent disappointment in global protein expression profiling, pharma research saw the biggest impact when relating to more focused approaches, such as those exploring the interaction between proteins and drugs. Nowadays, proteomics technologies have been integrated in many areas of pharmaceutical R&D, ranging from the analysis of therapeutic proteins to the monitoring of clinical trials. Here, we review the development of proteomics in the drug discovery process, placing it in a historical context as well as reviewing the current status in light of the contributions to this special issue, which reflect some of the diverse demands of the drug and biomarker pipelines. PMID:25763573

  10. External referencing and pharmaceutical price negotiation.

    PubMed

    Garcia Marioso, Begoa; 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

  11. Controlling Pharmaceutical Crystallization with Designed Polymeric Heteronuclei

    PubMed Central

    2015-01-01

    To investigate the hypothesis that molecules acting as crystallization inhibitors in solution could be transformed into crystallization promoters, additives were synthesized that mimic the pharmaceuticals acetaminophen and mefenamic acid and also possess polymerizable functionality. It was found that, in solution, these additives face-selectively inhibit crystal growth and lead to overall slower crystal appearance. In contrast, when the tailor-made additives were incorporated into an insoluble polymer, the induction time for the onset of crystal formation for both pharmaceuticals was substantially decreased. This approach now allows for the synthesis of tailor-made polymers that decrease the induction time for crystal appearance and may find application in compounds that are resistant to crystallization or in improving the fidelity of heteronucleation approaches to solid form discovery. PMID:25521054

  12. Pharmaceutical salts of ciprofloxacin with dicarboxylic acids.

    PubMed

    Surov, Artem O; Manin, Alex N; Voronin, Alexander P; Drozd, Ksenia V; Simagina, Anna A; Churakov, Andrei V; Perlovich, German L

    2015-09-18

    New salts of antibiotic drug ciprofloxacin (CIP) with pharmaceutically acceptable maleic (Mlt), fumaric (Fum) and adipic (Adp) acids were obtained and their crystal structures were determined. The crystal lattices of the fumarate and adipate salts were found to accommodate the water molecules, while the maleate salt was anhydrous. The dehydration and melting processes were analyzed by means of differential scanning calorimetry and thermogravimetric analysis. Solubility and intrinsic dissolution rates of the salts were measured in pharmaceutically relevant buffer solutions with pH 1.2 and pH 6.8. Under acidic conditions, the salts were found to be less soluble than the parent form of drug, while the [CIP+Fum+H2O] and [CIP+Mlt] solids showed enhanced dissolution rate when compared to a commercially available ciprofloxacin hydrochloride hydrate. In the pH 6.8 solution, all the salts demonstrated solubility improvement and faster dissolution rate with respect to pure CIP. PMID:26066411

  13. Supercritical fluid chromatography in pharmaceutical analysis.

    PubMed

    Desfontaine, Vincent; Guillarme, Davy; Francotte, Eric; Novkov, Lucie

    2015-09-10

    In the last few years, there has been a resurgence of supercritical fluid chromatography (SFC), which has been stimulated by the introduction of a new generation of instruments and columns from the main providers of chromatographic instrumentation, that are strongly committed to advancing the technology. The known limitations of SFC, such as weak UV sensitivity, limited reliability and poor quantitative performance have been mostly tackled with these advanced instruments. In addition, due to the obvious benefits of SFC in terms of kinetic performance and its complementarity to LC, advanced packed-column SFC represents today an additional strategy in the toolbox of the analytical scientist, which may be particularly interesting in pharmaceutical analysis. In the present review, the instrumentation and experimental conditions (i.e. stationary phase chemistry and dimensions, mobile phase nature, pressure and temperature) to perform "advanced SFC" are discussed. The applicability of SFC in pharmaceutical analysis, including the determination of drugs in formulations and biofluids is critically discussed. PMID:25818887

  14. Controlling pharmaceutical crystallization with designed polymeric heteronuclei.

    PubMed

    Pfund, Laura Y; Price, Christopher P; Frick, Jessica J; Matzger, Adam J

    2015-01-21

    To investigate the hypothesis that molecules acting as crystallization inhibitors in solution could be transformed into crystallization promoters, additives were synthesized that mimic the pharmaceuticals acetaminophen and mefenamic acid and also possess polymerizable functionality. It was found that, in solution, these additives face-selectively inhibit crystal growth and lead to overall slower crystal appearance. In contrast, when the tailor-made additives were incorporated into an insoluble polymer, the induction time for the onset of crystal formation for both pharmaceuticals was substantially decreased. This approach now allows for the synthesis of tailor-made polymers that decrease the induction time for crystal appearance and may find application in compounds that are resistant to crystallization or in improving the fidelity of heteronucleation approaches to solid form discovery. PMID:25521054

  15. Metabolomics in pharmaceutical research and development.

    PubMed

    Puchades-Carrasco, Leonor; Pineda-Lucena, Antonio

    2015-12-01

    Metabolomics has significant potential in pharmaceutical and clinical research, including the identification of new targets, the elucidation of the mechanism of action of new drugs, the characterization of safety and efficacy profiles, as well as the discovery of biomarkers for early disease diagnosis, prognosis, patient stratification, and treatment response monitorization. Metabolomics involves the analysis of small molecules and can lead to an improved understanding of drug candidate actions and to a better selection of targets. Although the application of metabolomics in the pharmaceutical industry is still at its infancy, this experimental approach has the possibility to transform our knowledge of drug action through the examination of drug-induced metabolic pathways associated to both drug efficacy and adverse drug reactions. PMID:25900094

  16. 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

  17. Effects of Pharmaceutical Medications on Male Fertility

    PubMed Central

    Brezina, Paul R.; Yunus, Fahd N.; Zhao, Yulian

    2012-01-01

    The number of couples seeking consultation for infertility problems has steadily increased over the past decade, affecting 10%?15% of the sexually active population. Abnormal semen production, a male factor infertility (MFI), is thought to be the cause of up to 50% of all infertilities in developed countries. There are potentially many different causes of male infertility, including hormonal, anatomical, and secondary to exposure to exogenous substances. In many cases of MFI, a definitive cause for abnormalities is never identified. Recently, the research community has given greater attention to identifying causes of MFI ranging from genetic Y chromosome microdeletions to mechanisms of environmental damage on sperm production. Still evolving, is a clear understanding of how many pharmaceutical medications may cause MFI, which is often treatable and reversible. In this review we will outline the data regarding various pharmaceutical medications that have been investigated as possible causes of MFI. PMID:23926519

  18. 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.

  19. 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.

  20. Pharmaceutical Composition for Improving Physical Working Capacity.

    PubMed

    Baulin, S I; Rogacheva, S M; Afanaseva, S V; Zabanova, E V; Karagaycheva, Yu V

    2015-11-01

    For development of a pharmaceutical composition improving physical performance, effects of various drugs and their combinations on forced swimming test performance were studied on laboratory rats. Maximum increase in animal performance was produced by a 3-component composition asparcam+mildronate+metaprote in proportion of 5.0, 10.7, and 14.3 mg/kg, respectively. No changes in blood serum biochemistry and morphological composition of the peripheral blood were detected after single intragastric administration of the composition. PMID:26601841

  1. 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

  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. 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

  4. 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

  5. Photo-pharmaceutical therapy: features and prospects

    NASA Astrophysics Data System (ADS)

    Zharov, Vladimir P.; Potapenko, Alexander Y.; Minenkov, Alexander A.

    2001-07-01

    This article is an attempt to analyze the concept, distinguishing features and possible application of photo- pharmaceutical therapy (PPT). Besides photopheresis, PUVA, and photodynamic therapy, PPT also embraces a broad spectrum of various combinations of light and drugs. PPT techniques can be classified according to the role of light in drug therapy into several groups: 1) Light activation of drugs before, during or after their administration, 2) light activation of cells of biotissue to potentiate the pharmaceutical effect of drugs, 3) light assisted drug delivery, 4) optical sensing of drug action at cellular and subcellular levels, and 5) selective photochemistry of drugs during their manufacturing. PPT seeks to describe the mechanisms of light-drug interaction, to time and sequence light-drug action, and to verify their synergetic effect. This article yields the results of developing new PPT modifications created in collaboration with some Russian scientific institutes and medical centers. The developed modifications are as follows: 1) drug pre-administration photoactivation, 2) antibody-photoconformation photoimmunotherapy, 3) photophonophoresis with a blend of photosensitizers and antibiotics, 4) photoelectrophoresis, 5) drug effect enhancement due to laser-induced blood circulation activation, 6) photoimmunization with alpha- fetoprotein, 7) photo-pharmaceutical dosimetry, and 8) a rapid drug toxicity photoassay.

  6. Pharmaceutical services in the United States Army.

    PubMed

    Williams, R F; Moran, E L; Bottaro, S D; Dydek, G J; Caouette, M L; Thomas, J D; Echevarria, R

    1997-04-01

    The status of pharmaceutical services in the United States Army is described. The Army Medical Department (AMEDD) has 157 commissioned pharmacy officers and 399 civilian pharmacists working in the United States and overseas. Pharmaceutical services are provided from fixed medical treatment facilities on Army installations and, during war and other field operations, field hospitals. Reductions in personnel and facility closures have helped align the AMEDD with the size of the Army's activeduty force, but there has been only a 15% reduction in the number of eligible beneficiaries. Measures such as the interservice TRICARE program have been implemented to help meet the continued high demand for pharmaceutical services cost-effectively. Army pharmacy is similar to civilian pharmacy, except that Army hospitals often include high-volume outpatient pharmacies not usually found in civilian institutions. Pharmacists are being given direct patient care roles on multidisciplinary teams. Army pharmacists participate in field exercises so that they will be prepared to provide services under combat conditions. The AMEDD trains its own pharmacy technicians in a highly structured 18-week course. A triservice Pharmacoeconomic Center (PEC) has been established with the goal of providing prescribers with the tools for making cost-effective decisions about drug therapy, including a formulary. Army pharmacy officers have broad opportunities to further their education and training. In preparing for the next century, Army pharmacists need to continue to prove their value to the AMEDD, the Army, and the Department of Defense. PMID:9099343

  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. 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

  9. 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

  10. 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

  11. The return of the pharmaceutical industry to the market of contraception.

    PubMed

    Johansson, E D

    2000-01-01

    In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives. PMID:11108881

  12. 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

  13. 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

  14. 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

  15. HIC@RE and its relevance for a company like RIEMSER

    PubMed Central

    Mller, Berno; Becker, Jrgen

    2011-01-01

    The increased incidence of infections caused by methicillin-resistant strains of Staphylococcus aureus (MRSA) burdens the healthcare systems with significant additional costs. Simple measures such as active MRSA screening can lead to a reduction of infectious events and massive savings. To establish an effective and comprehensive strategy for prevention and eradication of MRSA, the cooperation and networking of all stakeholders in the health care system is necessary. Pharmaceutical companies are part of the health care system; they therefore have a vital and ethical interest that care within the health system will be further optimized and thus continue to remain affordable. The targets of the HIC@RE project demonstrate the interests of the pharmaceutical and health-care research company RIEMSER Arzneimittel AG, so that a sufficient rationale is given for cooperation in this project. PMID:22242103

  16. 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

  17. 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

  18. 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

  19. 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)

  20. 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

  1. 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

  2. The moral economy of the drug company-medical scientist collaboration in interwar America.

    PubMed

    Rasmussen, Nicolas

    2004-04-01

    This paper explores the exchange relationships underlying collaborations between pharmaceutical companies and preclinical (laboratory-based) researchers, in universities and similar contexts, during the interwar period. It also examines the arguments advanced to justify such collaborations in particular contexts as a way of investigating the perceived costs and benefits, especially among the academic parties in these collaborations, and the way these collaborations were regarded in the US biomedical research community. PMID:15295826

  3. After slow start, project to channel drug company funds to universities builds steam.

    PubMed Central

    Berkowitz, P

    1996-01-01

    Drug companies appear to have been listening when researchers began complaining about their lack of participation in the MRC/PMAC Health Program, for the 30-month-old project appears to have taken on new life. It is designed to increase collaboration between university and pharmaceutical industry researchers by directing more of the industry's growing investment in Canada through the MRC's peer-review process. By mid-May, program commitments stood at $60 million. Images p319-a PMID:8705914

  4. [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

  5. 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

  6. 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

  7. 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 topdown 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. [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

  15. The pharmaceutical sector inquiry: 'Hamlet' in a nutshell.

    PubMed

    den Exter, Andr

    2010-03-01

    In July 2009, the European Commission (DG Competition) published a Communication on the pharmaceutical sector. This inquiry was launched because there were some indications that competition in the pharmaceutical market in the European Union might not be working well. The report examines the reasons for the observed delay. This article analyses the outcomes from a critical standpoint, arguing in favour of enhanced 'soft law' accountability mechanisms in the pharmaceutical sector, defending conditional patenting and the introduction of a Community patent. PMID:20443440

  16. Health care reform and the pharmaceutical industry.

    PubMed

    Mossinghoff, G J

    1994-08-01

    Consumer choice among competing private plans should be strengthened, rather than lending support to the mandate for a government single-payer plan. A major theme running through this position paper is that drugs are not only the most cost-effective form of medical treatment, but they represent only a small share of the national health care expenditures. In this article, the author focuses on defending three guiding principles for reform: (1) all Americans should have prescription-drug coverage; (2) competition can and must be relied on to control costs; and (3) the discovery of new cures must be actively encouraged through adequate incentives for the pharmaceutical industry. PMID:10152353

  17. 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.

  18. Globalization in the pharmaceutical industry, Part I.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

    This report on the pharmaceutical industry will be published in two parts. Part I begins with a summary of the study and its conclusions. The authors then provide an overview of the characteristics of the industry and current trends in its growth and structure: production and consumption, employment, research and development, capital investment, firm and product concentration and product competition, and pricing. A discussion of international trade follows, covering intra- and inter-regional, intra-firm, and intra-industry trade. The report will continue in the next issue of the Journal (Part II) with a look at foreign direct investment, inter-firm networks, and governmental policies. PMID:9493754

  19. Globalization in the pharmaceutical industry, Part II.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

    This is the second of a two-part report on the pharmaceutical industry. Part II begins with a discussion of foreign direct investment and inter-firm networks, which covers international mergers, acquisitions, and minority participation; market shares of foreign-controlled firms; international collaboration agreements (with a special note on agreements in biotechnology); and licensing agreements. The final section of the report covers governmental policies on health and safety regulation, price regulation, industry and technology, trade, foreign investment, protection of intellectual property, and competition. PMID:9595345

  20. In silico toxicology for the pharmaceutical sciences.

    PubMed

    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. PMID:19716836

  1. Defining the pharmaceutical system to support proactive drug safety.

    PubMed

    Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret

    2013-02-01

    The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement. PMID:23656445

  2. Essential drugs and registration of pharmaceuticals: the Sri Lankan experience.

    PubMed Central

    Weerasuriya, K.

    1993-01-01

    Many factors influence the regulation of pharmaceuticals in a country. The essential drugs concept, formulated by the World Health Organization to assist developing countries in selecting appropriate drugs, also provides a basis for regulation. Sri Lanka has long regulated pharmaceuticals as part of its health policy. Over 70% of 3436 pharmaceutical product registrations were found to be drugs (or alternatives) named in the country's essential drugs list. This is despite the fact that product registrations are mainly for the private health care sector, and the list is for the state sector. The essential drugs concept therefore appears to have influenced the pharmaceuticals registered in Sri Lanka. PMID:8490987

  3. Pharmaceuticals Exposed to the Space Environment: Problems and Prospects

    NASA Technical Reports Server (NTRS)

    Jaworske, Donald A.; Myers, Jerry G.

    2016-01-01

    The NASA Human Research Program (HRP) Health Countermeasures Element maintains ongoing efforts to inform detailed risks, gaps, and further questions associated with the use of pharmaceuticals in space. Most recently, the Pharmacology Risk Report, released in 2010, illustrates the problems associated with maintaining pharmaceutical efficacy. Since the report, one key publication includes evaluation of pharmaceutical products stored on the International Space Station (ISS). This study shows that selected pharmaceuticals on ISS have a shorter shelf-life in space than corresponding terrestrial controls. The HRP Human Research Roadmap for planetary exploration identifies the risk of ineffective or toxic medications due to long-term storage during missions to Mars. The roadmap also identifies the need to understand and predict how pharmaceuticals will behave when exposed to radiation for long durations. Terrestrial studies of returned samples offer a start for predictive modeling. This paper shows that pharmaceuticals returned to Earth for post-flight analyses are amenable to a Weibull distribution analysis in order to support probabilistic risk assessment modeling. The paper also considers the prospect of passive payloads of key pharmaceuticals on sample return missions outside of Earth's magnetic field to gather additional statistics. Ongoing work in radiation chemistry suggests possible mitigation strategies where future work could be done at cryogenic temperatures to explore methods for preserving the strength of pharmaceuticals in the space radiation environment, perhaps one day leading to an architecture where pharmaceuticals are cached on the Martian surface and preserved cryogenically.

  4. The potential for research-based information in public health: Identifying unrecognised information needs

    PubMed Central

    Forsetlund, Louise; Bjrndal, Arild

    2001-01-01

    Objective To explore whether there is a potential for greater use of research-based information in public health practice in a local setting. Secondly, if research-based information is relevant, to explore the extent to which this generates questioning behaviour. Design Qualitative study using focus group discussions, observation and interviews. Setting Public health practices in Norway. Participants 52 public health practitioners. Results In general, the public health practitioners had a positive attitude towards research-based information, but believed that they had few cases requiring this type of information. They did say, however, that there might be a potential for greater use. During five focus groups and six observation days we identified 28 questions/cases where it would have been appropriate to seek out research evidence according to our definition. Three of the public health practitioners identified three of these 28 cases as questions for which research-based information could have been relevant. This gap is interpreted as representing unrecognised information needs. Conclusions There is an unrealised potential in public health practice for more frequent and extensive use of research-based information. The practitioners did not appear to reflect on the need for scientific information when faced with new cases and few questions of this type were generated. PMID:11208260

  5. The spotlight on PBMs: federal enforcement of the anti-kickback statute on the pharmaceutical benefit management industry.

    PubMed

    Radinsky, Greg

    2003-01-01

    Pharmaceutical benefit management companies (PBMs) act as intermediaries between pharmaceutical manufacturers and third-party payors to administer prescription drug benefits. While PBMs have increased in importance in recent years, they have simultaneously become the target of critics, including United States Attorneys and the Federal Trade Commission. This Article gives a brief overview of the federal enforcement environment in which PBMs are conducting business and discusses how PBMs' rebates are negotiated. It then discusses the applicability of the federal Anti-Kickback Statute, which is the likeliest enforcement tool for prosecutors to use against PBMs. The Article concludes by discussing the steps PBMs can take to minimize their liability and provides insight into how effective the federal government will be in building fraud cases against PBMs' current business practices. PMID:12940677

  6. Metaphors and myths in pharmaceutical advertising.

    PubMed

    Delbaere, Marjorie

    2013-04-01

    It should come as no surprise that the ancient Greek word for drug, pharmakon, meant remedy. But this same word also meant poison as well as magical charm. We speak of heart attacks and of a long road to recovery. These meanings and phrases are reflective of how society conceives of illness and medical therapies. Metaphors and myths of magic, sports and journey are prevalent in medical terminology and they permeate pharmaceutical advertising. This research investigates the conceptual metaphors that are present in advertisements for pharmaceuticals, both those directed to consumers as well as those directed to physicians, for a broad range of drugs and medical conditions. This research employed a content analysis of advertisements appearing in popular consumer magazines as well as in physician journals and an analysis of online consumer drug reviews. The research concludes with a discussion of the similarities and differences among the conceptual metaphors in consumer versus physician ads, across different medical conditions, and the impact of specific metaphors on consumers' understanding of illness and drug therapies. PMID:23453313

  7. Old Yet New--Pharmaceuticals from Plants

    NASA Astrophysics Data System (ADS)

    Houghton, Peter J.

    2001-02-01

    Plants or their crude extracts have been used since prehistory to treat human ailments. Plants are still used in this way in many parts of the world, but Western scientific medicine has tended to isolate active compounds, or make derivatives of them, for use as drugs. Compounds produced by the plant have been important pharmaceuticals since the isolation of morphine almost two hundred years ago and new naturally occurring compounds such as paclitaxel are continually being introduced commercially. Bioactive molecules may also be produced from chemicals found in plants by chemical modification using synthetic chemistry or microorganisms (as in the production of steroids). A third major contribution of plant chemicals to drugs is their utilization as templates for the design of new compounds made by synthesis (e.g. the discovery of aspirin and related compounds from substances in willow bark). New pharmaceuticals from plants are being discovered by examining traditional medicines and by large-scale bioassay screening processes. In addition, the chemical survival systems of plants that exist in hostile environments are receiving increasing attention as leads to discover active compounds. The knowledge of botanical relationships helps find new sources of known compounds of interest and novel compounds with similar structures from related species. Future prospects for the discovery of new compounds from plants are broadened by the new technologies of gene manipulation, tissue culture, and combinatorial chemistry, so it is very likely that natural products from plants will continue to play an important role in the fight against disease.

  8. Pharmaceutical Applications of Ion-Exchange Resins

    NASA Astrophysics Data System (ADS)

    Elder, David P.

    2005-04-01

    The historical uses of ion-exchange resins and a summary of the basic chemical principles involved in the ion-exchange process are discussed. Specific applications of ion-exchange resins are provided. The utility of these agents to stabilize drugs are evaluated. Commonly occurring chemical and physical incompatibilities are reviewed. Ion-exchange resins have found applicability as inactive pharmaceutical constituents, particularly as disintegrants (inactive tablet ingredient whose function is to rapidly disrupt the tablet matrix on contact with gastric fluid). One of the more elegant approaches to improving palatability of ionizable drugs is the use of ion-exchange resins as taste-masking agents. The selection, optimization of drug:resin ratio and particle size, together with a review of scaleup of typical manufacturing processes for taste-masked products are provided. Ion-exchange resins have been extensively utilized in oral sustained-release products. The selection, optimization of drug:resin ratio and particle size, together with a summary of commonly occurring commercial sustained-release products are discussed. Ion-exchange resins have also been used in topical products for local application to the skin, including those where drug flux is controlled by a differential electrical current (ionotophoretic delivery). General applicability of ion-exchange resins, including ophthalmic delivery, nasal delivery, use as drugs in their own right (e.g., colestyramine, formerly referred to as cholestyramine), as well as measuring gastrointestinal transit times, are discussed. Finally, pharmaceutical monographs for ion-exchange resins are reviewed.

  9. Towards a healthy use of pharmaceuticals.

    PubMed

    Laporte, J R

    1985-01-01

    This paper examines 4 factors which determine the kind and the quantity of medicines used in a community: drug promotion, the disease pattern, the pharmaceutical supply, and the structure and priorities of the health system. The use of drugs is a method whereby manufacturers exert pressure to ensure a constant expansion of the market, rather than trying to fulfill a real need. Drug promotion is an obvious determinant of irrational and unhealthy use of drugs. The pharmaceutical industry spends between 15 and 25% of its total budget on promotional activities, and this proportion is even higher in 3rd World countries. The general assumption that the prescription of a medicine has some relationship with the disease the patient is suffering from is unsupported by the evidence. It has never been proven that an infinite number of drugs provides any greater benefits for public heaath than a more limited number of products. The existence of a large number of drugs may result in confusion at all levels of the therapeutic chain, and represent a waste of manpower and money. The economic and human resources allocated to health systems are the main determinants of drug consumption. Drug utilization, as defined by the WHO, involves 3 elements: the drug supply; the use of the drug in the health system; and the use of the drug beyond the health system. PMID:12341047

  10. [Amorphous form in pharmaceutical technological research].

    PubMed

    Mrtha, Csaba; Jjrtn, Laczkovich Orsolya; Szabn, Rvsz Piroska

    2011-01-01

    Detecting and analysing of the amorphous phase are increasingly important in pharmaceutical technology. The amorphous or glassy state has a several advantages and disadvantages. The amorphous form can be applied in deliberate amorphization, when active pharmaceutical ingredient (API) is formulated in glassy state, or this form can appear accidentally during formulation or storage. The aim of this study was to characterize glass-forming properties of 13 different materials. Differential Scanning Calorimetry (DSC) was used as an analytical technique and T(g) and T(m) values were determined. The equation of T(g)/T(m) (K/K) was applied to determine the glass-forming tendencies. We made 2 groups of investigated substances. The first group was that we could not amorphized: tenoxicam, mannitol, niflumic acid, theophyllin and lidocain. The second group contains materials, which could be prepared in glassy form. This group can be divided into 2 sub-groups: poor-glass formers and good-glass formers. Poor-glass formers are following: meloxicam, ibuprofen and piroxicam. Good-glass formers are lacidipine, gemfibrosil, sorbitol, loratadine, chlorhexidine and clopidogrel hydrogensulfate. PMID:21595304

  11. 76 FR 9348 - Southern California Edison Company, Pacific Gas and Electric Company, San Diego Gas & Electric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... Energy Regulatory Commission Southern California Edison Company, Pacific Gas and Electric Company, San... Edison Company (SCE), Pacific Gas and Electric Company (PG&E), and San Diego Gas & Electric Company (SDG..., Joint Petition of Pacific Gas and Electric Company, Southern California Edison Company, and San...

  12. Methods for the comparative evaluation of pharmaceuticals

    PubMed Central

    Zentner, Annette; Velasco-Garrido, Marcial; Busse, Reinhard

    2005-01-01

    Political background As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut fr Qualitt und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement. The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG) is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established. Research questions and methods This health technology assessment (HTA) report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI). It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs? Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines) were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables. Results and discussion Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many countries made post-licensing evaluation of pharmaceuticals a requirement for reimbursement or pricing decisions. Typically an explicitly designated drug review body is involved. In all eleven countries included (Austria, Australia, Canada, Switzerland, Finland, France, the Netherlands, Norway, New Zealand, Sweden, and the United Kingdom) a drug's therapeutic benefit in comparison to treatment alternatives is leading the evaluation. A medicine is classified as a therapeutic improvement if it demonstrates an improved benefit-/risk-profile compared to treatment alternatives. However, evidence of superiority to a relevant degree is requested. Health related quality of life is considered as the most appropriate criterion for a drug's added value from patients' perspective. Review bodies in Australia, New Zealand, and the United Kingdom have committed themselves to include this outcome measure whenever possible. Pharmacological or innovative characteristics (e.g. administration route, dosage regime, new acting principle) and other advantages (e.g. taste, appearance) are considered in about half of the countries. However, in most cases these aspects rank as second line criteria for a drug's added value. All countries except France and Switzerland perform a comparative pharmacoeconomic evaluation to analyse costs caused by a drug intervention in relation to its benefit (preferably by cost utility analysis). However, the question if a medicine is cost effective in relation to treatment alternatives is answered in a political and social context. A range of remarkably varying criteria are considered. Countries agree that randomised controlled head-to-head trials (head-to-head RCT) with a high degree of internal and external validity provide the most reliable and least biased evidence of a drug's relative treatment effects (as do systematic reviews and meta-analyses of these RCT). Final outcome parameters reflecting long-term treatment objectives (mortality, morbidity, quality of life) are preferred to surrogate parameters. Following the concept of community effectiveness, drug re

  13. Adequacy of pharmacological information provided in pharmaceutical drug advertisements in African medical journals

    PubMed Central

    Oshikoya, Kazeem A.; Senbanjo, Idowu O.; Soipe, Ayo

    2008-01-01

    Pharmaceutical advertisement of drugs is a means of advocating drug use and their selling but not a substitute for drug formulary to guide physicians in safe prescribing. Objectives: To evaluate drug advertisements in Nigerian and other African medical journals for their adequacy of pharmacological information. Methods: Twenty four issues from each of West African Journal of Medicine (WAJM), East African Medical Journal (EAMJ), South African Medical Journal (SAMJ), Nigerian Medical Practitioner (NMP), Nigerian Quarterly Journal of Hospital Medicine (NQJHM) and Nigerian Postgraduate Medical Journal (NPMJ) were reviewed. While EAMJ, SAMJ and NMP are published monthly, the WAJM, NQJHM and NPMJ are published quarterly. The monthly journals were reviewed between January 2005 and December 2006, and the quarterly journals between January 2001 and December 2006. The drug information with regards to brand/non-proprietary name, pharmacological data, clinical information, pharmaceutical information and legal aspects was evaluated as per World Health Organisation (WHO) criteria. Counts in all categories were collated for each advertiser. Results: Forty one pharmaceutical companies made 192 advertisements. 112 (58.3%) of these advertisements were made in the African medical journals. Pfizer (20.3%) and Swipha (12.5%) topped the list of the advertising companies. Four (2.1%) adverts mentioned generic names only, 157 (81.8%) mentioned clinical indications. Adults and children dosage (39.6%), use in special situations such as pregnancy and renal or liver problems (36.5%), adverse effects (30.2%), average duration of treatment (26.0%), and potential for interaction with other drugs (18.7%) were less discussed. Pharmaceutical information such as available dosage forms and product and package information {summary of the generic and proprietary names, the formulation strength, active ingredient, route of administration, batch number, manufactured and expiry dates, and the manufacturer on both the container and pack of the drug} were mentioned in 65.6% and 50% adverts, respectively. The product and package descriptions were provided in 57 (72.2%) Nigerian medical journals, which was significantly higher than in other African medical journals 39 (37.9%) (P<0.001). Conclusions: None of the drug advertisements in the journals adequately provided the basic information required by the WHO for appropriate prescribing. More guidance and regulation is needed to ensure adequate information is provided. PMID:25152785

  14. Pharmaceutical care education in Kuwait: pharmacy students perspectives

    PubMed Central

    Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.

    2014-01-01

    Background Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective To investigate pharmacy students attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists physical separation from patient care areas (82.6%). Conclusion Pharmacy students attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also recognizing the barriers to its widespread adoption. The education and training provided at Kuwait University Faculty of Pharmacy is designed to develop students to be the change agents who can advance pharmacist-provided direct patient care. PMID:25243027

  15. Opportunities for Electronic Health Record Data to Support Business Functions in the Pharmaceutical IndustryA Case Study from Pfizer, Inc.

    PubMed Central

    Kim, Daijin; Labkoff, Steven; Holliday, Samuel H.

    2008-01-01

    The Pfizer Healthcare Informatics team conducted a series of guided interviews with 35 Pfizer senior leaders to elicit their understanding, desires, and expectations of how Electronic Health Records (EHR) might be used in the pharmaceutical industry today and/or in the future. The interviews yielded fourteen use case categories comprising 42 specific use cases. The highest priority use cases were Drug Safety & Surveillance, Clinical Trial Recruitment, and Support Regulatory Approval. Fifteen EHR companies were surveyed to assess their functionality against the specified use cases. Self-reported responses from the EHR companies were highest for Virtual Phase IV Trials and Document Management for Clinical Trials. This research identifies preliminary opportunities for EHR products to provide aggregate, blinded data to address the interests of the pharmaceutical industry. However, further collaboration between the stakeholders will be necessary to ensure the full realization of the opportunities for data re-use. PMID:18579836

  16. Opportunities for electronic health record data to support business functions in the pharmaceutical industry--a case study from Pfizer, Inc.

    PubMed

    Kim, Daijin; Labkoff, Steven; Holliday, Samuel H

    2008-01-01

    The Pfizer Healthcare Informatics team conducted a series of guided interviews with 35 Pfizer senior leaders to elicit their understanding, desires, and expectations of how Electronic Health Records (EHR) might be used in the pharmaceutical industry today and/or in the future. The interviews yielded fourteen use case categories comprising 42 specific use cases. The highest priority use cases were "Drug Safety & Surveillance," "Clinical Trial Recruitment," and "Support Regulatory Approval." Fifteen EHR companies were surveyed to assess their functionality against the specified use cases. Self-reported responses from the EHR companies were highest for "Virtual Phase IV Trials" and "Document Management for Clinical Trials." This research identifies preliminary opportunities for EHR products to provide aggregate, blinded data to address the interests of the pharmaceutical industry. However, further collaboration between the stakeholders will be necessary to ensure the full realization of the opportunities for data re-use. PMID:18579836

  17. IRRIGATION FOR VACCINE PRODUCTION IN PHARMACEUTICAL TOBACCO

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Biotechnology companies in North America and Europe have engineered plants to produce recombinant proteins for therapeutic drugs and vaccines. Chlorogen, Inc. located in St. Louis, Missouri, inserted the protective antigen (PA) gene from Bacillus anthracis into tobacco (Nicotiana tabacum cv LAMD 60...

  18. Assessing Your Company's Training Needs.

    ERIC Educational Resources Information Center

    Food, Drink and Tobacco Industry Training Board, Croydon (England).

    This book was designed to serve as a guide for the small and medium-sized firm establishing a systematic training pattern for the first time, and to the larger company for whom it will act as a useful check list. The guide examines the kind of information required and the ways in which actual companies have arrived at their training requirements

  19. Company Town: Beyond the Legacy.

    ERIC Educational Resources Information Center

    Bedics, Bonnie C.; Doelker, Richard E., Jr.

    1992-01-01

    Research indicates that living in company towns created a population lacking in initiative and self-determination. In one community that was a company town until the mid-1950s, key-informant interviews indicated high levels of dropping out, illiteracy, teen pregnancy, poverty, and dependency. However, a survey of high school students revealed no

  20. Boycott threat forces French company to abandon RU486.

    PubMed

    Dorozynski, A

    1997-04-19

    Threatened boycotts by American anti-abortion groups have forced the French pharmaceutical company Roussel-Uclaf, a subsidiary of the German company Hoechst, to stop production and distribution of mifepristone (RU-486), which the protesters call "the abortion pill." All patent rights have been transferred, without charge, to Dr. Edouard Sarkiz, one of the pill's developers. Hoechst, which had acquired Marion Pharmaceuticals to form a new group, Hoechst-Marion-Roussel, had increased its share of the US pharmaceutical market from 1% to 4% in doing so and could not tolerate a boycott. RU-486, which was discovered by Professor Etienne Baulieu, was introduced in France in 1987 as an alternative to surgical abortion. Although Hoechst, then a majority stockholder of Roussel-Uclaf, had asked the French firm to interrupt production of the pill in 1988, the French minister of health and social affairs at that time, Claude Evin, ordered production to be continued. Approximately 25% of French women seeking abortion use RU-486; it is also used in Britain, Sweden, and China (women in China must pay for the drug, while surgical abortion is free). All American firms have refused to buy the drug from Roussel-Uclaf. An offer to the World Health Organization was ignored. The American Population Council obtained the right to use RU-486 in 1993. Dr. Sarkiz has formed Exelgyn, a small nonprofit company, to produce and distribute RU-486; research into other uses for the drug will also be conducted. There has been limited research into its use as an emergency contraceptive and as a treatment for endometriosis, uterine fibroma, and breast cancer. According to Professor Baulieu, the drug could be used in treating wounds and burns because of its antiglucocorticoid and immunosuppressive properties; preliminary research by the professor indicates the drug could also possibly be used as a reversible male contraceptive because of its action on the membranes of spermatozoa. The drug's use in abortion is due to its effect on the uterine mucus membrane. PMID:9146386

  1. The politics and strategy of industry self-regulation: the pharmaceutical industry's principles for ethical direct-to-consumer advertising as a deceptive blocking strategy.

    PubMed

    Arnold, Denis G; Oakley, James L

    2013-06-01

    As the pharmaceutical industry lobbies European regulators to permit direct-to-consumer advertising (DTCA) of prescription drugs in the European Union, we found that five leading companies violated industry-developed and -promulgated standards for ethical advertising in the United States. Utilizing multiple data sources and methods, we demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry's guiding principles for ethical DTCA over a four-year period despite pledges of compliance by company leaders. Noncompliance resulted in children being exposed to sexually themed promotional messages more than 100 billion times. We argue that the guidelines are a coordinated effort by the industry to prevent unwanted federal regulation, and we introduce the concept of a blocking strategy to explain company behavior and to advance theoretical understanding of firms' public affairs strategies. We recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education. PMID:23418365

  2. Global risk of pharmaceutical contamination from highly populated developing countries.

    PubMed

    Rehman, Muhammad Saif Ur; Rashid, Naim; Ashfaq, Muhammad; Saif, Ameena; Ahmad, Nasir; Han, Jong-In

    2015-11-01

    Global pharmaceutical industry has relocated from the west to Asian countries to ensure competitive advantage. This industrial relocation has posed serious threats to the environment. The present study was carried out to assess the possible pharmaceutical contamination in the environment of emerging pharmaceutical manufacturing countries (Bangladesh, China, India and Pakistan). Although these countries have made tremendous progress in the pharmaceutical sector but most of their industrial units discharge wastewater into domestic sewage network without any treatment. The application of untreated wastewater (industrial and domestic) and biosolids (sewage sludge and manure) in agriculture causes the contamination of surface water, soil, groundwater, and the entire food web with pharmaceutical compounds (PCs), their metabolites and transformed products (TPs), and multidrug resistant microbes. This pharmaceutical contamination in Asian countries poses global risks via product export and international traveling. Several prospective research hypotheses including the development of new analytical methods to monitor these PCs/TPs and their metabolites, highly resistant microbial strains, and mixture toxicity as a consequence of pharmaceutical contamination in these emerging pharmaceutical exporters have also been proposed based on the available literature. PMID:23535471

  3. The Third Wave in Pharmaceutical Education: The Clinical Movement.

    ERIC Educational Resources Information Center

    Hepler, Charles D.

    1987-01-01

    Pharmaceutical education and pharmaceutical practice began to diverge in the early twentieth century for socioeconomic reasons and have since grown along separate paths. The movement toward clinical pharmacy, emerging about 1970, may reunite the two but it first faces new challenges. (MSE)

  4. Pharmaceutical Concern and Prioritization Framework for Aquatic Life Effects

    EPA Science Inventory

    Human pharmaceuticals and veterinary drugs are being developed and used at an increasing rate world-wide. This, and increasingly sensitive analytical techniques, have lead to recurrent detection of pharmaceuticals as environmental pollutants. The goal of the present work was to d...

  5. Pharmaceutical Sociology: Issues in Research, Education and Service.

    ERIC Educational Resources Information Center

    Svarstad, Bonnie L.

    1979-01-01

    Discusses need for social scientific research, clinical social scientists in pharmacy, and specialists in pharmaceutical sociology and the other social sciences. To illustrate, patient noncompliance with drug regimens and the use of sociology to analyze the problem are examined. Includes a sample program in pharmaceutical sociology, course

  6. Astronaut William Gregory works with pharmaceutical experiments on middeck

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Astronaut William G. Gregory, STS-67 pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical but also biotechnology, cell biology, fluids and crystal growth investigations.

  7. 75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ...The Food and Drug Administration (FDA) is announcing a public workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain Workshop-- Enough Talk: Let's Find and Implement Solutions.'' The workshop, cosponsored with the Parenteral Drug Association (PDA), will focus on solutions to reduce the risk to product quality in the pharmaceutical supply chain. Date and Time: The conference will be held......

  8. Pharmacists' Perceptions of the Economic Value of Compounded Pharmaceuticals: A Comparison of Compounded and Commercial Pharmaceuticals in Select Disease States.

    PubMed

    Lobb, William B; Wilkin, Noel E; Holmes, Erin R

    2015-01-01

    Studies have been conducted to assess patient satisfaction with compounded pharmaceuticals and to directly compare compounded pharmaceuticals with their comparable commercial pharmaceuticals. Yet, the economic value of or potential for economic value derived from compounded pharmaceuticals relative to commercial pharmaceuticals is still not known. Therefore, the purpose of this study was to assess and compare compounding and non-compounding pharmacists' perceptions of the economic value of compounded preparations relative to commercial products. In-depth interviews with 10 compounding pharmacists and physicians who prescribe compounded prescription pharmaceutical preparations were conducted to help develop a self-administered questionnaire distributed to 50 compounding and 50 non-compounding pharmacists. Compounding and non-compounding pharmacists' perceptions differed most often in the context of compounded pharmaceuticals for pediatric patients. However, both groups responded with moderate agreement that compounded prescription treatments are more profitable for the pharmacy than commercial prescription treatments in most therapeutic areas. This research sought to understand the perception of pharmacists of areas for potential direct and indirect economic cost savings as a result of compounding. For all items whereby compounding and non-compounding pharmacists' ratings were significantly different, compounding pharmacists more strongly believed that compounding pharmaceuticals offered benefit and vice versa. The differences in ratings that were most common were those that directly compared the economic value of compounding and commercial pharmaceuticals, with compounding pharmacists more strongly agreeing with the potential cost savings associated with compounded pharmaceuticals. Based on these findings, prescription compounds are believed to have a benefit to the health system by those who provide them. Future research should proactively explore the economic benefit of compounded preparations compared to conventionally manufactured products to determine the economic value of compounded pharmaceuticals for patients, pharmacies, physicians, and the healthcare system. PMID:26891565

  9. Analysis on Time-Lag Effect of Research and Development Investment in the Pharmaceutical Industry in Korea

    PubMed Central

    Lee, Munjae; Choi, Mankyu

    2015-01-01

    Objectives The aim of this study is to analyze the influence of the research and development (R&D) investment of pharmaceutical companies on enterprise value. Methods The period of the empirical analysis is from 2000 to 2012, considering the period after the influence of the financial crisis. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association, and data related to stock price were extracted from KISVALUE-III of National Information and Credit Evaluation Information Service Co., Ltd. STATA 12.0 was used as the statistical package for panel analysis. Results In the pharmaceutical firms, the influence of the R&D intensity with regard to Tobin's q was found to be positive. However, only the R&D expenditure intensities of previous years 2 and 5 (t–2 and t–5, respectively) were statistically significant (p < 0.1), whereas those of previous years 1, 3, and 4 years (t–1, t–3, and t–4, respectively) were not statistically significant. Conclusion R&D investment not only affects the enterprise value but is also evaluated as an investment activity that raises the long-term enterprise value. The research findings will serve as valuable data to understand the enterprise value of the Korea pharmaceutical industry and to strengthen reform measures. Not only should new drug development be made, but also investment and support should be provided according to the specific factors suitable to improve the competitiveness of each company, such as generic, incrementally modified drugs, and biosimilar products. PMID:26473091

  10. Regulatory scientific advice in drug development: does company size make a difference?

    PubMed Central

    Putzeist, Michelle; Gispen-De Wied, Christine C.; Hoes, Arno W.; Leufkens, Hubert G.

    2010-01-01

    Purpose To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. Methodology A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 20062008. Definition of company size was based on ranking by total revenues (Scrips Pharmaceutical Company League Tables2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). Results In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P?companies (P?=?0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P?Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development. PMID:21049297

  11. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made... Enforcement Administration Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical... determined that the registration of Halo Pharmaceutical Inc. to manufacture the listed basic classes...

  12. 75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... AGENCY Best Management Practices for Unused Pharmaceuticals at Health Care Facilities AGENCY... guidance document entitled, Best Management Practices for Unused Pharmaceuticals at Health Care Facilities... been studying unused pharmaceutical disposal practices at health care facilities, prompted by...

  13. 78 FR 46371 - Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... FR 12101, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523, made application... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals... 952(a), and determined that the registration of Meda Pharmaceuticals Inc., to import the basic...

  14. Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters

    PubMed Central

    de Cazes, Matthias; Abejón, Ricardo; Belleville, Marie-Pierre; Sanchez-Marcano, José

    2014-01-01

    The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW) containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds. PMID:25295629

  15. Prioritizing veterinary pharmaceuticals for aquatic environment in Korea.

    PubMed

    Kim, Younghee; Jung, Jinyong; Kim, Myunghyun; Park, Jeongim; Boxall, Alistair B A; Choi, Kyungho

    2008-09-01

    Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the environment, and toxicological hazard. Twenty compounds were identified in the top priority class, most of which were antibiotics. Among these compounds, 8 were identified as deserving more immediate attention: amoxicillin, enramycin, fenbendazole, florfenicol, ivermectin, oxytetracycline, tylosin, and virginiamycin. A limitation of this study is that we initially screened veterinary pharmaceuticals by sales tonnage for veterinary use only. However, this is the first attempt to prioritize veterinary pharmaceuticals in Korea, and it provides important concepts for developing environmental risk management plans for such contaminants in aquatic systems. PMID:21783906

  16. Strategic of Applying Free Chemical Usage In Purified Water System For Pharmaceutical Industry Toward CPOB (Cara Pembuatan Obat yang Baik) Indonesia To Reducing Environmental Pollution

    NASA Astrophysics Data System (ADS)

    Kartono, R.; Basuki, Y. T.

    2014-03-01

    The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM) regulation in order to achieve "Cara Pembuatan Obat yang Baik" (CPOB) of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO) membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI) as final polisher for controlling conductivity, and finally Ultra Violet (UV) disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.

  17. How Faculty Learn about and Implement Research-Based Instructional Strategies: The Case of Peer Instruction

    ERIC Educational Resources Information Center

    Dancy, Melissa; Henderson, Charles; Turpen, Chandra

    2016-01-01

    The lack of knowledge about how to effectively spread and sustain the use of research-based instructional strategies is currently a significant barrier to the improvement of undergraduate physics education. In this paper we address this lack of knowledge by reporting on an interview study of 35 physics faculty, of varying institution types, who…

  18. Lift, Squeeze, Stretch, and Twist: Research-Based Inquiry Physics Experiences (RIPE) of Energy for Kindergartners

    ERIC Educational Resources Information Center

    Van Hook, Stephen J.; Huziak-Clark, Tracy L.

    2008-01-01

    This study examines changes in kindergarten students' understanding of energy after participating in a series of lessons developed using an inquiry-based early childhood science teaching model: Research-based Inquiry Physics Experiences (RIPE). The lessons addressed where objects get their energy and what they use their energy to do, and how…

  19. Island Explorations: Discovering Effects of Environmental Research-Based Lab Activities on Analytical Chemistry Students

    ERIC Educational Resources Information Center

    Tomasik, Janice Hall; LeCaptain, Dale; Murphy, Sarah; Martin, Mary; Knight, Rachel M.; Harke, Maureen A.; Burke, Ryan; Beck, Kara; Acevedo-Polakovich, I. David

    2014-01-01

    Motivating students in analytical chemistry can be challenging, in part because of the complexity and breadth of topics involved. Some methods that help encourage students and convey real-world relevancy of the material include incorporating environmental issues, research-based lab experiments, and service learning projects. In this paper, we…

  20. Cooperative Learning and the Academically Talented Student. Research-Based Decision Making Series.

    ERIC Educational Resources Information Center

    Robinson, Ann

    The research base on cooperative learning was examined for its applicability to academically talented students. Common types of cooperative learning are described with highlights of the model characteristics as they apply to academically talented students. The models include: Teams-Games-Tournament (TGT); Student Teams Achievement Divisions…