Science.gov

Sample records for agencies pharmaceutical companies

  1. Indigenous and multinational pharmaceutical companies.

    PubMed

    Lilja, J

    1983-01-01

    There is a set of complex relationships between governments and the pharmaceutical companies. These relationships can be analysed in many different ways. In the following article the drug system of each country will be the unit of analysis. The drug system includes all the decision processes, formal as well as informal, from the production or importation of drugs to the intake of the drug by the patient. The aim of this paper is to discuss how environmental factors, the strategies of the drug companies and the national policies, will effect the drug system of a country. Satisfying solutions to the economical and health goals of the country will be searched for. If we want a more rational discussion in this area, professionally and politically, we need more empirical knowledge about the multinational drug companies and their effects on society. This does not mean that we shall sit waiting for this new knowledge. We have to make decisions using todays knowledge. However, in the long run rational decision strategy must include ways to collect important empirical data about the phenomenom under investigation. The aim of this survey is to indicate areas where we already have quite good knowledge and indicate other areas where this data is missing. PMID:6623122

  2. Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.

    PubMed

    Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan

    2014-03-01

    Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma. PMID:24291787

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

    PubMed

    Lee, Stacey B

    2010-01-01

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

  4. 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

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

    PubMed

    Sismondo, Sergio

    2008-03-01

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

  6. Exposing nursing students to the marketing methods of pharmaceutical companies.

    PubMed

    Civaner, Murat; Sarikaya, Ozlem; Alici, Sevim Ulupinar; Bozkurt, Gulcin

    2008-05-01

    There is a strong association between reliance on the promotional activities of pharmaceutical companies and a generally less appropriate use of prescription drugs. Pharmaceutical companies direct some of their promotion towards health workers who do not have the authority to prescribe medicines, such as nurses in certain countries. The aim of this study was to determine the impact that exposure to the marketing methods of pharmaceutical companies has on judgments made by nursing students about health worker-pharmaceutical company relationships. A cross-sectional survey was carried out with 442 nursing students in Istanbul, Turkey. The exposure of students to the marketing methods of pharmaceutical companies, whether it be indirectly through observation or directly by first-hand experience, increases the probability that students will adopt rationales that underlie affirmative judgments of health worker-pharmaceutical company relationships. Based on the pervasiveness and ability of drug promotion to influence the perceptions of students, it is imperative that attempts be made to reduce its negative impact. PMID:18388173

  7. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media. PMID:27220801

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

    PubMed

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

    2014-01-01

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

  9. Value of services provided by pharmaceutical companies: perceptions of physicians and pharmaceutical sales representatives.

    PubMed

    Gaedeke, R M; Tootelian, D H; Sanders, E E

    1999-01-01

    Pharmaceutical sales representatives (PSRs) are a key component of pharmaceutical companies' marketing strategies in that they are the link between the pharmaceutical company and the physician. PSRs provide various services in order to increase the physician's prescribing activity of their companies' products. Given the high cost of recruiting, training, and supporting a PSR, it is important for PSRs to understand the relative significance physicians ascribe to services provided. This study examined whether there is a gap in the perceptions of physicians and PSRs regarding the value of specific services provided by PSRs. Physicians and PSRs who attended medical meetings were surveyed. Results of the study indicated that there were significant differences in the perceived value between PSRs and physicians. Services which were perceived to be less important to physicians than to PSRs were new product detailing, old product detailing, providing product studies and research findings, PSRs serving as expert consultants, and recruiting physicians to participate in FDA approval drug studies. Services for which there were no significant differences of perceived value between the groups included free product samples and promotional luncheons and dinners. PMID:11066720

  10. Financial ties and conflicts of interest between pharmaceutical and tobacco companies.

    PubMed

    Shamasunder, Bhavna; Bero, Lisa

    2002-08-14

    Corporate diversification allows for well-hidden financial ties between pharmaceutical and tobacco companies, which can cause a conflict of interest in the development and marketing of pharmaceutical products. In our investigation of tobacco company documents released and posted on the Internet as a result of the Master Settlement Agreement, we have found that these financial ties have fostered both competition and collaboration between the tobacco and pharmaceutical industries. We present 3 case studies. One shows how tobacco companies pressured pharmaceutical companies to scale back their smoking cessation educational materials that accompanied Nicorette. The second shows how they restricted to whom the pharmaceutical company could market its transdermal nicotine patch. In the third case, we show how subsidiary tobacco and pharmaceutical companies of a parent company collaborated in the production of a nicotine-release gum. Thus, because tobacco cessation product marketing has been altered as a result of these financial conflicts, disclosure would serve the interest of public health. PMID:12169078

  11. Solar process steam for a pharmaceutical company in Jordan

    NASA Astrophysics Data System (ADS)

    Berger, M.; Mokhtar, M.; Zahler, C.; Al-Najami, M. M. R.; Krüger, D.; Hennecke, K.

    2016-05-01

    This paper presents details of the recent installation of a linear Fresnel collector to provide saturated steam for process heat usage through Direct Steam Generation (DSG) for industrial use in the Jordanian pharmaceuticals manufacturing company RAM Pharma, where first solar steam has been provided in March 2015. This commercial DSG project also represents the first solar DSG plant in MENA. During sunshine, the system achieves a solar fraction of 100 %, and the conventional steam boiler is not needed. In the evening the fossil fired backup takes over automatically and replaces the solar collector in operation. Operational experience, details of the control strategy, and measurement data are presented in the paper.

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

    PubMed

    Moffatt, Barton; Elliott, Carl

    2007-01-01

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

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

    PubMed

    2012-03-01

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

  14. Teaching statistics to clinical research staff in a pharmaceutical company.

    PubMed

    Dhar, Sunil K; Kianifard, Farid

    2006-01-01

    Education of clinical research staff in understanding statistical concepts is an area of importance for pharmaceutical companies. This understanding is needed to help them communicate with statisticians using a common language, in designing clinical trials and interpretation of clinical trial results. Such staff has little time for a one-semester or even a one-week continuing education course in statistics. Faced with this reality, we developed a 3-module course,for a total of 1.5 days, which was taught over a period of one month that addresses the needs of this audience. We describe the format and content of the course and provide references that can serve as a resource for teaching such a course. PMID:17080755

  15. 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

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

    PubMed

    Lee, Joo-Young; Hunt, Paul

    2012-01-01

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

  17. 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

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

    PubMed Central

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

    2013-01-01

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

  19. 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.…

  20. Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

    PubMed

    Batt, Sharon

    2016-07-01

    A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. PMID:27417863

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

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-01-01

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

  2. 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

  3. 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

  4. Environmental impact assessment and control of pharmaceuticals: the role of environmental agencies.

    PubMed

    Adler, N E; Koschorreck, J; Rechenberg, B

    2008-01-01

    In 2005, the new legislation for pharmaceuticals came into effect. Since then environmental risk assessments are required for all new marketing authorisation applications. The German Federal Environment Agency has been assessing the environmental impact of 136 veterinary and 134 human pharmaceuticals. The authorisation of pharmaceuticals has shown that the authorisation of some groups of substances have to be combined with risk mitigation measures. Environmental risks may also arise from those pharmaceuticals which were authorised before the environmental risk assessment was added to the requirements of authorisation. Four examples of "existing" pharmaceuticals, i.e. diclofenac, ethinyl estradiol, ivermectin, and florfenicol are highlighted in this article. Risk management options for veterinary and human pharmaceuticals are discussed. PMID:18192745

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. [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

  11. Trust and transparency: patient perceptions of physicians' financial relationships with pharmaceutical companies.

    PubMed

    Perry, Joshua E; Cox, Dena; Cox, Anthony D

    2014-01-01

    Financial ties between physicians and pharmaceutical companies are pervasive and controversial. However, little is known about how patients perceive such ties. This paper describes an experiment examining how a national sample of U.S. adults perceived a variety of financial relationships between physicians and drug companies. Each respondent read a single scenario about a hypothetical physician and his financial ties to the pharmaceutical industry; scenarios varied in terms of payment type of (e.g., payment for meals vs. consulting fees) and amount. Respondents then evaluated the physician on several dimensions (e.g., expertise, trustworthiness, knowledge of new treatments, moral character, focus on patients' interests). Findings revealed that perceptions of the physician were more strongly influenced by payment type than by payment amount. Specifically, respondents were quite critical of doctors who owned drug company stock or received industry payments for meals and lodging, but were more forgiving of physicians who received free drug samples (which were perceived as benefiting patients) or consulting fees (which were seen as signaling physician expertise). Interestingly, physicians who received no payments, while seen as honest, were also viewed by some respondents as inexperienced or uninformed about new treatments. Implications for public policy and future research are discussed. PMID:25565614

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

    PubMed

    Ahmadiani, Saeed; Nikfar, Shekoufeh

    2016-01-01

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

  13. 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

  14. Cardiovascular Drug Discovery: A Perspective from a Research-Based Pharmaceutical Company

    PubMed Central

    Gromo, G.; Mann, J.; Fitzgerald, J.D.

    2014-01-01

    The theme of this review is to summarize the evolving processes in cardiovascular drug discovery and development within a large pharmaceutical company. Emphasis is placed on the contrast between the academic and industrial research operating environments, which can influence the effectiveness of research collaboration between the two constituencies, but which plays such an important role in drug innovation. The strategic challenges that research directors face are also emphasized. The need for improved therapy in many cardiovascular indications remains high, but the feasibility in making progress, despite the advances in molecular biology and genomics, is also assessed. PMID:24890831

  15. 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

  16. A Collaborative Assessment Among 11 Pharmaceutical Companies of Misinformation in Commonly Used Online Drug Information Compendia

    PubMed Central

    Randhawa, Amarita S.; Babalola, Olakiitan; Henney, Zachary; Miller, Michele; Nelson, Tanya; Oza, Meerat; Patel, Chandni; Randhawa, Anupma S.; Riley, Joyce; Snyder, Scott; So, Sherri

    2016-01-01

    Background: Online drug information compendia (ODIC) are valuable tools that health care professionals (HCPs) and consumers use to educate themselves on pharmaceutical products. Research suggests that these resources, although informative and easily accessible, may contain misinformation, posing risk for product misuse and patient harm. Objective: Evaluate drug summaries within ODIC for accuracy and completeness and identify product-specific misinformation. Methods: Between August 2014 and January 2015, medical information (MI) specialists from 11 pharmaceutical/biotechnology companies systematically evaluated 270 drug summaries within 5 commonly used ODIC for misinformation. Using a standardized approach, errors were identified; classified as inaccurate, incomplete, or omitted; and categorized per sections of the Full Prescribing Information (FPI). On review of each drug summary, content-correction requests were proposed and supported by the respective product’s FPI. Results: Across the 270 drug summaries reviewed within the 5 compendia, the median of the total number of errors identified was 782, with the greatest number of errors occurring in the categories of Dosage and Administration, Patient Education, and Warnings and Precautions. The majority of errors were classified as incomplete, followed by inaccurate and omitted. Conclusion: This analysis demonstrates that ODIC may contain misinformation. HCPs and consumers should be aware of the potential for misinformation and consider more than 1 drug information resource, including the FPI and Medication Guide as well as pharmaceutical/biotechnology companies’ MI departments, to obtain unbiased, accurate, and complete product-specific drug information to help support the safe and effective use of prescription drug products. PMID:26917822

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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…

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

    PubMed

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

    1992-01-01

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

  3. [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

  4. An Instructional Design Model for Developing a Computer Curriculum To Increase Employee Productivity in a Pharmaceutical Company.

    ERIC Educational Resources Information Center

    Stumpf, Mark R.

    This report presents an instructional design model that was developed for use by the End-Users Computing department of a large pharmaceutical company in developing effective--but not lengthy--microcomputer training seminars to train office workers and executives in the proper use of computers and thus increase their productivity. The 14 steps of…

  5. [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

  6. 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

  7. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug. PMID:26183623

  8. 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

  9. Impact of pharmaceutical company representatives on internal medicine residency programs. A survey of residency program directors.

    PubMed

    Lichstein, P R; Turner, R C; O'Brien, K

    1992-05-01

    To survey internal medicine residency program directors regarding interactions between their residents and pharmaceutical company (PC) representatives (PCRs) a questionnaire was sent to the directors of all Accreditation Council for Graduate Medical Education-approved internal medicine residency programs. The survey included 444 program directors, of whom 272 (61.16%) responded. The majority of program directors, 228 (83.8%), allowed PCRs to meet with residents during working hours and 241 (88.6%) permitted PC sponsorship of conferences. About half of the program directors were "moderately" or "very" concerned about the potential adverse effects of PC marketing on resident attitudes and prescribing practices. Seventy percent "agreed" or "strongly agreed" that the benefits of PC sponsorship outweigh the adverse effects and 41.5% believed that refusal to allow PCRs to meet with residents would jeopardize PC funding of other departmental activities. Most program directors reported that alternate funds for conferences were available if PC support was withdrawn. "Unethical" marketing activities were observed by 14.3% of program directors and 37.5% reported that residents had participated in PC-sponsored trips during the 3 years prior to the survey. At the time of this survey, only 35.3% of programs had developed formal policies regulating PCR activities and 25.7% provided residents with formal instruction on marketing issues. Knowledge of the current extent of PCR interactions with residents may be helpful to program directors in developing policies regulating PC-marketing activities. PMID:1580704

  10. 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

  11. 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

  12. The Effects of Technology Entrepreneurship on Customers and Society: A Case Study of a Spanish Pharmaceutical Distribution Company.

    PubMed

    Muñoz, Rosa M; Sánchez de Pablo, Jesús D; Peña, Isidro; Salinero, Yolanda

    2016-01-01

    The main purpose of this paper is to provide an understanding, within the field of corporate entrepreneurship, of the various factors that enable technology entrepreneurship in established firms and its principal effects on customers and society. The paper reports on a case study regarding technology entrepreneurship in a Spanish company whose activity is pharmaceutical distribution. This company has been able to overcome the consequences of the worldwide crisis and start an innovative process which includes the installation of new information technology (IT) and an investment of 6 million Euros. It is, in this respect, a model to imitate and the objective of this paper is therefore to discover the managers' entrepreneurial orientation (EO) characteristics which have made this possible, along with the organizational and social effects resulting from the process. We verify that EO is present in this company and that the development of new IT has important effects on customers and the population. PMID:27445938

  13. The Effects of Technology Entrepreneurship on Customers and Society: A Case Study of a Spanish Pharmaceutical Distribution Company

    PubMed Central

    Muñoz, Rosa M.; Sánchez de Pablo, Jesús D.; Peña, Isidro; Salinero, Yolanda

    2016-01-01

    The main purpose of this paper is to provide an understanding, within the field of corporate entrepreneurship, of the various factors that enable technology entrepreneurship in established firms and its principal effects on customers and society. The paper reports on a case study regarding technology entrepreneurship in a Spanish company whose activity is pharmaceutical distribution. This company has been able to overcome the consequences of the worldwide crisis and start an innovative process which includes the installation of new information technology (IT) and an investment of 6 million Euros. It is, in this respect, a model to imitate and the objective of this paper is therefore to discover the managers’ entrepreneurial orientation (EO) characteristics which have made this possible, along with the organizational and social effects resulting from the process. We verify that EO is present in this company and that the development of new IT has important effects on customers and the population. PMID:27445938

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

    PubMed Central

    Feulefack, Joseph; Sergi, Consolato

    2015-01-01

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

  15. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    PubMed Central

    2013-01-01

    Background The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration

  16. Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

    PubMed

    Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

    2012-01-01

    This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. PMID:22789039

  17. The Use of In Silico Models Within a Large Pharmaceutical Company.

    PubMed

    Brigo, Alessandro; Muster, Wolfgang

    2016-01-01

    The present contribution describes how in silico models are applied at different stages of the drug discovery process in the pharmaceutical industry. A thorough description of the most relevant computational methods and tools is given along with an in-depth evaluation of their performance in the context of potential genotoxic impurities assessment.The challenges of predicting the outcome of highly complex studies are discussed followed by considerations on how novel ways to manage, store, share and analyze data may advance knowledge and facilitate modeling efforts. PMID:27311478

  18. 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

  19. 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

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

    PubMed Central

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

    2014-01-01

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

  1. 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

  2. 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

  3. [Sponsoring of medical conferences, workshops and symposia by pharmaceutical companies. Physicians must be wary of this!].

    PubMed

    Warntjen, M

    2009-12-01

    The longstanding conventional forms of cooperation between medical organizations and physicians on the one hand and the pharmaceutical industry and manufacturers of medical products on the other hand nowadays hold the risk of coming into conflict with the public prosecutor. Typical circumstances which are taken up by the investigating authorities are financial supports of medical conferences, workshops and symposia. To understand the problem under criminal law it is important to become acquainted with the protective aim of the statutory offences of the acceptance of benefits according to section sign 331 of the Penal Code (Strafgesetzbuch, StGB) and of corruption according to section sign 332 of the Penal Code. The "trust of the general public in the objectivity of governmental decisions" must be protected and the "evil appearance of the corruptibility of official acts" must be counteracted. A basic differentiation is made between physicians with and without office-bearing functions. By paying attention to the recommendations and basic principles of cooperation between the medical profession and the healthcare industry presented in this article (transparency principle, equivalence principle, documentation principle and separation principle) the emergence of any suspicious factors can be effectively avoided. PMID:20012247

  4. 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

  5. The changing world of oncology drug development-A global pharmaceutical company's perspective.

    PubMed

    Galbraith, Susan

    2014-06-01

    Recent approvals for oncology drugs have seen an increasing proportion directed to specific genetic targets identified with an associated companion diagnostic test. In addition, there is a wave of drugs directed against immune 'checkpoints' which promise to transform the way cancer is treated in the next decade. We can increase the probability of success in drug development based on a thorough mechanistic understanding of how a target drug affects cancer biology and the specific biological and genotypic context in which it operates. This article compares and contrasts the discovery and development of gefitinib-the first EGFR tyrosine kinase inhibitor and AZD9291, an irreversible inhibitor of both sensitizing and resistant mutated EGFR. This demonstrates how the better understanding we now have of the genetic changes driving the cancer growth and the biochemical structure and function of the mutated proteins, has led to a much faster developmental path with higher likelihood of success in pivotal trials. An emerging trend in response to the challenge of the increasing segmentation of cancers based on their genetic makeup is the development of 'basket' studies which include one or more screening tests for multiple genetic aberrations and the direction of patients to one of several arms of a clinical trial based on the specific aberration in their tumor. In the face of both the wealth of genetic information about cancer and the challenges of drug development, collaboration across academia and industry is vital. There is great potential to benefit from more 'open innovation' to address some of these challenges and opportunities. Far from there being a decline in innovation in pharmaceutical development, I see that we are in one of the most exciting times in cancer drug development with innovation in every aspect of how we discover and develop new therapies. PMID:25841416

  6. Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies

    PubMed Central

    Xu, Wei; Boehm, Garth; Zheng, Qiang

    2015-01-01

    Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically available.This is justified as the article is only concerned with inherent product quality risks. After establishing a link between Chinese essential medicines and those available in the US, we examine US recall data to separate product specific recalls. We conclude that, in addition to existing manufacturing based risks, there are two other product specific risks that stand out from all others, degradation and dissolution failure. Methodology for relative product risk for degradation is needed to be developed and further work is required to better understand dissolution failures which largely occur with modified-release solid oral products. We conclude that a product specific quality risk profile would be enhanced by including a risk assessment for degradation for all products, and in the case of solid oral products, dissolution. PMID:26904402

  7. 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

  8. 41 CFR 302-12.6 - What expenses will my agency pay if I use a relocation services company to ship household goods...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... agency pay if I use a relocation services company to ship household goods in excess of the maximum weight... relocation services company to ship household goods in excess of the maximum weight allowance? If you use a relocation services company to ship HHG in excess of the maximum weight allowance, your agency will pay...

  9. 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

  10. 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

  11. 76 FR 77024 - In the Matter of Carolina Power & Light Company North Carolina Eastern, Municipal Power Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-09

    ... Register on August 30, 2011 (76 FR 53970). No comments or hearing requests were received. Pursuant to 10... Company (CP&L, the licensee) and North Carolina Eastern Municipal Power Agency are the owners of Brunswick... and an ISFSI located in Brunswick County, North Carolina. The facility operating licenses authorize...

  12. 76 FR 77021 - In the Matter of Carolina Power & Light Company, North Carolina Eastern Municipal Power Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-09

    ... Hearing,'' was published in the Federal Register on August 30, 2011 (76 FR 53967). No comments or hearing... Carolina Power & Light Company (CP&L, the licensee) and North Carolina Eastern Municipal Power Agency are... Carolina. The facility operating license authorizes CP&L to possess, use, and operate the Harris...

  13. ICH: an exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world.

    PubMed

    2010-08-01

    Under the pretext of harmonising regulatory requirements for marketing authorisation of new drugs, the drug regulatory agencies of the world's wealthiest countries and three pharmaceutical industry trade associations, joined together since 1990 in the ICH, are promoting their own interests by imposing their criteria for evaluating drugs on the whole world. The toxicity standards advocated by ICH sometimes promote faster, cheaper drug development over patient protection. The drug quality standards advocated by ICH sometimes increase manufacturing costs without providing any public health benefit. It would be preferable if the World Health Organization were in charge of setting standards for drug development, focusing on patients' interests. PMID:20939460

  14. 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

  15. 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

  16. 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

    ... control the promotion of drugs and drug-related supplies at VA facilities and the business relationships... standard of permissible business practice at VA facilities. It would also facilitate mutually beneficial... terms to be inclusive of all items typically promoted by pharmaceutical sales representatives....

  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. Pharmaceutical regulation in the single European market.

    PubMed

    Matthews, D; Wilson, C

    1998-01-01

    This paper assesses the impact of new EU-wide drug authorisation procedures. The paper examines various attempts to introduce harmonised market authorisation routes for pharmaceuticals including the establishment of the multi-state, concentration, decentralised and centralised procedures. The paper considers the current role of the European Medicines Evaluation Agency and the likelihood that its powers will be increased in the future. Finally, the paper assesses whether EU regulation has created beneficial market conditions for pharmaceutical companies operating in the single European market. PMID:9922630

  19. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

    PubMed

    Enzmann, Harald; Broich, Karl

    2013-01-01

    For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate

  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. 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

  2. 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...

  3. Genaissance pharmaceuticals, inc.

    PubMed

    Oestreicher, Paul

    2002-03-01

    Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC) is the world leader in the discovery and use of gene variation for the development of personalized medicines. In addition, the company has established partnerships with some of the world's top biopharmaceutical companies. The company has initiated the development of its own pipeline of products -- HAP Clozapine for schizophrenia and HAP Statin for cholesterol management -- utilizing its proprietary genetic markers. The company also markets its technology and clinical development skills to the pharmaceutical industry as a complete solution for improving the development, marketing and prescribing of drugs. PMID:11972448

  4. 78 FR 67218 - Agency Information Collection Activities: Company-Run Annual Stress Test Reporting Template and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ...The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a revision to this information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid......

  5. Bacterial mutagenicity screening in the pharmaceutical industry.

    PubMed

    Escobar, P A; Kemper, R A; Tarca, J; Nicolette, J; Kenyon, M; Glowienke, S; Sawant, S G; Christensen, J; Johnson, T E; McKnight, C; Ward, G; Galloway, S M; Custer, L; Gocke, E; O'Donovan, M R; Braun, K; Snyder, R D; Mahadevan, B

    2013-01-01

    Genetic toxicity testing is used as an early surrogate for carcinogenicity testing. Genetic toxicity testing is also required by regulatory agencies to be conducted prior to initiation of first in human clinical trials and subsequent marketing for most small molecule pharmaceutical compounds. To reduce the chances of advancing mutagenic pharmaceutical candidates through the drug discovery and development processes, companies have focused on developing testing strategies to maximize hazard identification while minimizing resource expenditure due to late stage attrition. With a large number of testing options, consensus has not been reached on the best mutagenicity platform to use or on the best time to use a specific test to aid in the selection of drug candidates for development. Most companies use a process in which compounds are initially screened for mutagenicity early in drug development using tests that require only a few milligrams of compound and then follow those studies up with a more robust mutagenicity test prior to selecting a compound for full development. This review summarizes the current applications of bacterial mutagenicity assays utilized by pharmaceutical companies in early and late discovery programs. The initial impetus for this review was derived from a workshop on bacterial mutagenicity screening in the pharmaceutical industry presented at the 40th Annual Environmental Mutagen Society Meeting held in St. Louis, MO in October, 2009. However, included in this review are succinct summaries of use and interpretation of genetic toxicity assays, several mutagenicity assays that were not presented at the meeting, and updates to testing strategies resulting in current state-of the art description of best practices. In addition, here we discuss the advantages and liabilities of many broadly used mutagenicity screening platforms and strategies used by pharmaceutical companies. The sensitivity and specificity of these early mutagenicity screening

  6. 41 CFR 302-12.7 - What expenses will my agency pay if I use a relocation services company to ship household goods...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 4 2012-07-01 2012-07-01 false What expenses will my agency pay if I use a relocation services company to ship household goods in excess of the maximum weight allowance? 302-12.7 Section 302-12.7 Public Contracts and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES...

  7. 41 CFR 302-12.6 - What expenses will my agency pay if I use a relocation services company to ship household goods...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 41 Public Contracts and Property Management 4 2011-07-01 2011-07-01 false What expenses will my agency pay if I use a relocation services company to ship household goods in excess of the maximum weight allowance? 302-12.6 Section 302-12.6 Public Contracts and Property Management Federal Travel...

  8. 41 CFR 302-12.7 - What expenses will my agency pay if I use a relocation services company to ship household goods...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 41 Public Contracts and Property Management 4 2014-07-01 2014-07-01 false What expenses will my agency pay if I use a relocation services company to ship household goods in excess of the maximum weight allowance? 302-12.7 Section 302-12.7 Public Contracts and Property Management Federal Travel...

  9. 41 CFR 302-12.7 - What expenses will my agency pay if I use a relocation services company to ship household goods...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 4 2013-07-01 2012-07-01 true What expenses will my agency pay if I use a relocation services company to ship household goods in excess of the maximum weight allowance? 302-12.7 Section 302-12.7 Public Contracts and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES...

  10. 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...

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

    PubMed Central

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

    2014-01-01

    This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities. PMID:27226834

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

    PubMed Central

    Miyata, M; Schuster, B; Schellenberg, R

    1992-01-01

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

  13. Regulatory review: How do agencies ensure the quality of decision making?

    PubMed

    Liberti, L; McAuslane, N; Patel, P; Breckenridge, A; Eichler, H G; Peterson, R

    2013-09-01

    The Centre for Innovation in Regulatory Science (CIRS) Workshop on Regulatory Review brought together international regulators and multinational pharmaceutical company representatives to focus on best practices that underlie regulatory decision making, thereby facilitating the transparent, timely, procedurally predictable, and good-quality evaluation of new medicines. Participants investigated frameworks used by agencies, discussed challenges for regulatory agencies in making quality decisions, investigated the role of other stakeholders, and made recommendations of activities and processes that agencies and companies can consider to enable quality decision making. PMID:23963218

  14. 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.

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

    PubMed

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

    2014-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The

  16. Agreements at the Pharmaceutical/University Interface.

    ERIC Educational Resources Information Center

    Ku, Katherine

    1987-01-01

    Specific agreements that arise at the interface between universities and pharmaceutical companies are described including sponsored research agreements, license agreements, clinical study agreements, material transfer agreements, and patient consent forms with respect to commercialization rights. (Author/MLW)

  17. 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

  18. Pharmaceutical published literature databases: a survey.

    PubMed

    Hull, P

    1996-01-01

    Pharmaceutical companies often maintain a bibliographic database of published articles on their products. Although such databases share the common purpose of providing the company with a centralized source of published information, the databases themselves vary in scope, uses, and technologies. In order to explore the current status of these databases, a survey was conducted in early 1995. This article provides an overview of pharmaceutical product literature databases and the results from that survey. PMID:10157847

  19. 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.

  20. European pharmacovigilance: increasingly outsourced to drug companies.

    PubMed

    2014-12-01

    New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator (benfluorex) disaster. The European Commission's original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations. Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers. The role of the new European Pharmacovigilance Risk Assessment Committee (PRAC) has been strengthened. Patients in every Member State have the right to report adverse drug effects directly to health authorities. EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved. However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest. Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies. Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are based on data preanalysed by the drug companies. In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments. In 2012, following France's Mediator disaster, several modest

  1. 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

  2. [Drug patents and other ways to protect pharmaceutical research].

    PubMed

    Ohana, Patrick; Tardieu, Sophie; Blin, Olivier; Tassy, Sébastien; Sambuc, Roland

    2004-01-01

    Pharmaceutical research constitutes a significant cost for pharmaceutical companies. Because of the importance of the financial investment in research projects, companies must protect their discoveries. There are multiple ways to do this. First, the legal avenue can be divided into three parts: a pharmaceutical company can protect a new drug by a patent, then an additional patent or a secondary patent; moreover, since 1992 in Europe, the pharmaceutical industry has been able to extend a patent by the "Supplementary Protection Certificate" (le Certificat Complémentaire de Protection [CCP]). The nonjuridical way is to use the chiral "switch", which can extend patents close to expiring, thus enhancing profitability. PMID:15359623

  3. 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

  4. 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

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

    PubMed

    Sihn, Kyu-Hwan

    2015-12-01

    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

  6. Vulnerabilities to misinformation in online pharmaceutical marketing

    PubMed Central

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

    2013-01-01

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

  7. Vulnerabilities to misinformation in online pharmaceutical marketing.

    PubMed

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

    2013-05-01

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

  8. Reprivatizing pharmaceutical supplies in Africa.

    PubMed

    Turshen, M

    2001-01-01

    Perhaps no part of the health system is as imperiled by neoliberal economic reforms as the public drug sector. The national bill for pharmaceuticals can claim one-third of a developing country's annual health budget. This article describes the essential drugs program created by WHO in the 1980s to protect financially reduced ministries of health from the high prices charged by multinational pharmaceutical companies. It describes the backlash from the World Bank and UNICEF, which launched the Bamako Initiative and other community financing schemes and revolving drug plans in which individuals, families or community groups buy drugs above the wholesale purchase price; clinics use the proceeds to maintain drug supplies and subsidize other health services. When this plan failed, the Bank proposed outright privatization of drug purchase and supply, returning power to the multinational suppliers. The article ends with a consideration of patents and the new intellectual property rights as they pertain to pharmaceutical production in Africa. PMID:11469153

  9. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    PubMed

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision. PMID:19519381

  10. 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

  11. Paying for On-Patent Pharmaceuticals

    PubMed Central

    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

  12. Lessons from 60 years of pharmaceutical innovation.

    PubMed

    Munos, Bernard

    2009-12-01

    Despite unprecedented investment in pharmaceutical research and development (R&D), the number of new drugs approved by the US Food and Drug Administration (FDA) remains low. To help understand this conundrum, this article investigates the record of pharmaceutical innovation by analysing data on the companies that introduced the approximately 1,200 new drugs that have been approved by the FDA since 1950. This analysis shows that the new-drug output from pharmaceutical companies in this period has essentially been constant, and remains so despite the attempts to increase it. This suggests that, contrary to common perception, the new-drug output is not depressed, but may simply reflect the limitations of the current R&D model. The implications of these findings and options to achieve sustainability for the pharmaceutical industry are discussed. PMID:19949401

  13. 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

  14. 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

  15. The changing environment for US pharmaceuticals.

    PubMed

    Meyer, P R

    1994-01-01

    Health reform is currently the predominant health policy issue in the US. It carries profound implications for the pharmaceutical field, including the possibility of price controls that could stifle pharmaceutical research. While policy makers are contemplating alternative approaches to reform, the marketplace for pharmaceuticals has changed dramatically. For example, price increases have lessened, price discounting has increased, and new drugs are typically launched at prices lower than those of the leading product in the therapeutic class. These changes are driven in part by the growth of managed care. Further evidence of change in the industry is the number of job reductions announced and the decline in market valuation of pharmaceutical companies. Policy makers need to take the changed marketplace into consideration as they proceed with health reform, to avoid layering additional policy impediments on top of an increasingly harsh and unforgiving market. Such an approach could seriously compromise incentives for pharmaceutical research. PMID:10155590

  16. The economics of pharmaceutical supply in Tanzania.

    PubMed

    Yudkin, J S

    1980-01-01

    This paper analyzes the patterns of purchasing, distribution, and utilization of pharmaceuticals currently found in Tanzania, an underdeveloped country in Africa. Like other nations in the Third World, Tanzania offers the prospect of a rapidly expanding market for the multinational pharmaceutical industry. However, this market has been to a large extent developed by the intense promotional activities of the drug companies themselves. In addition to normal marketing methods, these companies indulge in techniques which would be neither acceptable nor legal in developed countries. As a result, expensive proprietary drugs are overpurchased and overprescribed, mainly in the large urban hospitals, with consequent deprivation of other health care facilities, particularly those for the rural peasants who form the majority of the population. The activities of the multinational pharmaceutical companies in the Third World are therefore an important component in the continuing underdevelopment of health in these nations. PMID:7419314

  17. 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)

  18. 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

  19. 75 FR 13147 - Integrity Life Insurance Company, et al.;

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-18

    ... COMMISSION Integrity Life Insurance Company, et al.; Notice of Application March 10, 2010. AGENCY: Securities...: Integrity Life Insurance Company (``Integrity''), Separate Account I of Integrity Life Insurance Company (``Integrity Separate Account I''), Separate Account II of Integrity Life Insurance Company...

  20. Pharmaceutical strategy and innovation: an academics perspective.

    PubMed

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

    2007-06-01

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

  1. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

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

  2. 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

  3. 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

  4. The role of pharmaceuticals in the total health care of developing countries.

    PubMed

    Hoekenga, M T

    1983-05-01

    Following an overview of the less developed countries (LDCs) and their health problems, attention is directed to what pharmaceutical companies have been doing to develop tropical disease medicinals: past and current programs for the development of pharmaceuticals; the relationship of pharmaceuticals to other health problems; criticisms of the pharmaceutical industry; problems and constraints in developing drugs by pharmaceutical firms, particularly for tropical diseases; and strengthening incentives to pursue tropical medicine research in the future. There are 31 countries in the less developed category and they have 4 things in common: poverty; a high birthrate; a young population, and a low life expectancy. At the top of the list of the major health problems in developing countries are malaria, diarrheal diseases, and malnutrition. For malaria, there is a need for something new for chloroquine resistant infections, but research looks promising. Meanwhile, the use of presently available medications in much of the world would go far towards alleviating suffering and death from this disease. For diarrheal diseases and malnutrition the principal problems lie elsewhere than with development of new pharmaceuticals. For tuberculosis and leprosy, the 4th and 5th major health problems, therapy has improved markedly in recent years, yet there is room for improvement. Of the sexually transmitted diseases, only for sexually transmitted herpes is the industry missing a solution. On balance, it seems clear that the need for new pharmaceuticals, although important, is not as critical as some of the other needs of the LDCs. If this individual is correct in maintaining that the most important problems in the LDCs are pure water, adequate food, basic sanitation, and a distribution system for already available pharmaceuticals, then the question is why is the drug industry singled out for so much criticism. The principal charges, which are discussed in detail, are as follows

  5. Characteristics of Information Agencies (Libraries) and Information Agents (Librarians) in Highly Productive Computer Software and Services Companies: The Key to Growth and Survival?

    ERIC Educational Resources Information Center

    Carroll, Margaret Aby; Chandler, Yvonne J.

    This study examines whether an analysis of characteristics of libraries or information centers and librarians in highly productive companies yields operational models and standards that can improve their efficiency and effectiveness and their parent organization's productivity. Data was collected using an e-mail survey instrument sent to 500 large…

  6. 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

  7. 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.…

  8. 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

  9. 75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... HUMAN SERVICES Food and Drug Administration Pharmaceutical Supply Chain; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain...

  10. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ... Pharmaceutical Engineering Co-Sponsorship Educational Workshop: Redefining the `C' in CGMP (Current Good Manufacturing Practices): Creating, Implementing, and Sustaining a Culture of Quality AGENCY: Food and...

  11. The Development of a Generic Pharmaceutical Training Institute.

    ERIC Educational Resources Information Center

    Lindeman, Lynn William; Boerner, Hank

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

  12. [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

  13. 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.

  14. Vendor qualification for pharmaceutical excipients--GMP requirements and approach.

    PubMed

    Patel, K T; Chotal, N P

    2010-11-01

    Excipients are, in the large majority of cases, not made specifically for pharmaceutical use. Most pharmaceutical excipient manufacturers supply less than 10% of the total production of that particular material for pharmaceutical use. Excipient product portfolio consists of hundreds of products differing in chemistry, origin and functionality and they are used in many different applications. The days of treating excipients like commodities and buying them without fully qualifying the source and the entire distribution chain have gone by as GMP regulations demands to ensure quality of other materials used in the manufacturing process. The paradigm that exists in some pharmaceutical companies today where excipients are sourced from distributors without knowing the actual manufacturer, manufacturing site and full distribution lifecycle chain to be changed. The present contribution gives an overview about the current moves on GMP requirements for pharmaceutical excipient and approach for qualification of pharmaceutical excipient manufacturers. PMID:21155382

  15. The view of the pharmaceutical industry.

    PubMed

    Roche, G; Helenport, J P

    1994-06-01

    Rhône-Poulenc Rorer has committed itself to the development of artemether because we believe the drug will be of considerable benefit to sufferers from severe falciparum malaria, and because it is a stable, effective and economical compound that can be given by intramuscular injection. The quality of the pharmaceutical product meets international regulatory standards. Artemether is unlikely to yield big profits, but we believe that major pharmaceutical companies have a responsibility to develop such much-needed products. To develop this project further, we will need the assistance of academic institutions, research organizations and international bodies. PMID:8053031

  16. Pharmaceutical expenditure in Sweden.

    PubMed

    Henriksson, F; Hjortsberg, C; Rehnberg, C

    1999-05-01

    Recently, the responsibility for prescribed pharmaceuticals in Sweden was transferred from national level to the regional health authorities (county councils). The purpose was that a closer integration and balance between pharmaceuticals and other factors of production in health care should produce better opportunities for a cost-effective use of the total health care resources. The purpose of this paper is to present a deeper analysis of pharmaceuticals as a production factor in Sweden, mainly during the 1990s, and to discuss the future development and future policy decisions in Sweden. Pharmaceuticals have increased their share of total health care expenditure in Sweden, from about 9% in 1990 to about 14% in 1995. The Swedish pharmaceutical market can be divided into sub-markets, where the prescription sub-market accounts for the greater part of pharmaceutical expenditure. Further, a few disease categories account for a larger fraction of the cost of prescribed pharmaceuticals. The importance of pharmaceuticals as a production factor also differs between different age groups. Several factors are expected to contribute to a future increase in Swedish pharmaceutical expenditure, for instance an ageing population and the rapid introduction of expensive new pharmaceuticals. PMID:10538288

  17. 75 FR 71417 - 2010 Company Organization Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... Bureau of the Census 2010 Company Organization Survey AGENCY: Bureau of the Census, Commerce. ACTION... Organization Survey. The survey's data are needed, in part, to update the multilocation companies in the... companies may be selected if an organizational change within the company is indicated, or if they have...

  18. 78 FR 66785 - Luminant Generation Company, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Luminant Generation Company, LLC AGENCY: Nuclear Regulatory Commission. ACTION: Notice of receipt... consecutive weeks of ] a combined license (COL) application from Luminant Generation Company, LLC....

  19. 78 FR 68100 - Luminant Generation Company, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Luminant Generation Company, LLC AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION... consecutive weeks of a combined license (COL) application from Luminant Generation Company, LLC....

  20. 78 FR 69710 - Luminant Generation Company, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Luminant Generation Company, LLC AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION... consecutive weeks of a combined license (COL) application from Luminant Generation Company, LLC....

  1. 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.

  2. 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

  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. 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.

  5. 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

  6. 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

  7. 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

  8. 76 FR 35245 - Country Investors Life Assurance Company, et al.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-16

    ... COMMISSION Country Investors Life Assurance Company, et al. June 9, 2011. AGENCY: Securities and Exchange... securities. Applicants: COUNTRY Investors Life Assurance Company (the ``Company''), COUNTRY Investors Variable Life Account (the ``Life Account'') and COUNTRY Investors Variable Annuity Account (the...

  9. Basic principles of pharmaceutical science in Ayurvĕda.

    PubMed

    Subhose, Varanasi; Srinivas, Pitta; Narayana, Ala

    2005-01-01

    Pharmaceutical is one of the allied branches of science, which is closely associated with Medical science. Today pharmaceutical chemistry and pharmacognosy are playing important role in treatment for a disease and its prevention. Herbal medicines are being used by about 80% of the world population mostly in the developing countries in the primary health care. There has been an upsurge in demand for the Phyto-pharmaceutical products of Ayurvĕda in western nations, because of the fact that the synthetic drugs are considered to be unsafe. Due to this many national and multinational pharmaceutical companies are now concentrating on manufacturing of Ayurvĕdic Phyto-pharmaceutical products. Ayurvĕda is the Indian traditional system of medicine, which also deals about pharmaceutical science. The Ayurvĕdic knowledge of the pharmaceutical science is scattered in Ayurvĕdic classical texts. Săranghadhara Samhita, which is written by Săranghadhara, explain systematically about the information of the Ayurvĕdic pharmaceutical science and also updated it. Industrialized manufacturing of Ayurvĕdic dosage forms has brought in new challenges like deviation from basic concepts of medicine preparation. Săranghadhara Samrhită the devout text on pharmaceutics in Ayurvĕda comes handy to solve such problems, as the methods described are very lucid and easy to follow. PMID:17333665

  10. 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)

  11. Radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

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

    1996-03-01

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

  12. [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

  13. The UK pharmaceutical market. An overview.

    PubMed

    Towse, A

    1996-01-01

    The National Health Service (NHS) accounts for more than 98% of the UK prescription medicines market, which is the sixth largest pharmaceutical market in the world. Most of this market is driven by the UK's approximately 35,000 general practitioners (GPs). It is an open market, with most leading foreign pharmaceutical companies having a strong presence. While the growth rate of this market has been decelerating, it remains one of the fastest growing components of NHS expenditure. The NHS does not operate any kind of national reimbursement list, but the UK government has adopted several means to keep medicines expenditure under control. These include cash incentives and constraints for GPs relating to expenditure on medicines, individual quarterly updates on GP prescribing, the publication of a list of medicines that cannot be prescribed by GPs, the switching of some prescription-only medicines to over-the-counter medicines, and a co-payment system. The main form of economic regulation in the UK, however, remains the Pharmaceutical Price Regulation Scheme (PPRS). This limits the rate-of-return on capital attributable to medicines sales to the NHS, with the intended rate-of-return being equal to that of UK industry overall. The pharmaceutical industry has generally performed relatively well in the UK market, managing to preserve incentives to innovation. This reflects the fact that UK GPs have been able to maintain their clinical freedom, as well as government recognition of the economic contribution made by the pharmaceutical industry. Current issues of interest in the UK pharmaceutical market context include the future of the PPRS, the debates over the imposition of a national formulary and generic substitution, and over parallel trade, the potential impact of managed-care protocols and computer-based prescribing on pharmaceutical expenditures, and possible political changes. PMID:10163432

  14. 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

  15. [Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

    PubMed

    Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

    2014-07-01

    Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations. PMID:25272516

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

    PubMed

    Sismondo, Sergio

    2008-05-01

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

  17. 77 FR 8956 - Surety Companies Acceptable on Federal Bonds: Integrity Mutual Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... Supplement No. 9 to the Treasury Department Circular 570, 2011 Revision, published July 1, 2011, at 76 FR... Fiscal Service Surety Companies Acceptable on Federal Bonds: Integrity Mutual Insurance Company AGENCY.... 9305 to the following company: Integrity Mutual Insurance Company (NAIC 14303). Business Address:...

  18. 77 FR 25536 - Surety Companies Acceptable On Federal Bonds: Endurance American Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-30

    ... Supplement No. 17 to the Treasury Department Circular 570, 2011 Revision, published July 1, 2011, at 76 FR... Fiscal Service Surety Companies Acceptable On Federal Bonds: Endurance American Insurance Company AGENCY.... 9305 to the following company: Endurance American Insurance Company (NAIC 10641). Business Address:...

  19. 75 FR 22689 - Surety Companies Acceptable on Federal Bonds: Regent Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... No. 11 to the Treasury Department Circular 570, 2009 Revision, published July 1, 2009, at 74 FR 31536... Fiscal Service Surety Companies Acceptable on Federal Bonds: Regent Insurance Company AGENCY: Financial... following company: Regent Insurance Company (NAIC 24449) Business Address: One General Drive, Sun...

  20. 78 FR 15123 - Surety Companies Acceptable On Federal Bonds: Atlantic Specialty Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... Supplement No. 5 to the Treasury Department Circular 570, 2012 Revision, published July 2, 2012, at 77 FR... Fiscal Service Surety Companies Acceptable On Federal Bonds: Atlantic Specialty Insurance Company AGENCY.... 9305 to the following company: Atlantic Specialty Insurance Company (NAIC 27154). BUSINESS ADDRESS:...

  1. 77 FR 25535 - Surety Companies Acceptable On Federal Bonds: Pacific Employers Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-30

    ... Supplement No. 18 to the Treasury Department Circular 570, 2011 Revision, published July 1, 2011, at 76 FR... Fiscal Service Surety Companies Acceptable On Federal Bonds: Pacific Employers Insurance Company AGENCY....C. 9305 to the following company: Pacific Employers Insurance Company (NAIC 22748). Business...

  2. 77 FR 8956 - Surety Companies Acceptable on Federal Bonds: Grange Mutual Casualty Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... Supplement No. 7 to the Treasury Department Circular 570, 2011 Revision, published July 1, 2011, at 76 FR... Fiscal Service Surety Companies Acceptable on Federal Bonds: Grange Mutual Casualty Company AGENCY.... 9305 to the following company: Grange Mutual Casualty Company (NAIC 14060). Business Address: 671...

  3. 76 FR 77591 - Surety Companies Acceptable on Federal Bonds: Aspen American Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... Supplement No. 3 to the Treasury Department Circular 570, 2011 Revision, published July 1, 2011, at 76 FR... Fiscal Service Surety Companies Acceptable on Federal Bonds: Aspen American Insurance Company AGENCY.... 9305 to the following company: Aspen American Insurance Company (NAIC 43460). Business Address:...

  4. 75 FR 61246 - Surety Companies Acceptable on Federal Bonds: Darwin National Assurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

    ... Supplement No. 4 to the Treasury Department Circular 570, 2010 Revision, published July 1, 2010, at 75 FR... Fiscal Service Surety Companies Acceptable on Federal Bonds: Darwin National Assurance Company AGENCY.... 9305 to the following company: Darwin National Assurance Company (NAIC 16624). Business Address: 9...

  5. 75 FR 60865 - Surety Companies Acceptable on Federal Bonds: Allied World Reinsurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... Supplement No. 3 to the Treasury Department Circular 570, 2010 Revision, published July 1, 2010, at 75 FR... Fiscal Service Surety Companies Acceptable on Federal Bonds: Allied World Reinsurance Company AGENCY.... 9305 to the following company: Allied World Reinsurance Company (NAIC 22730). Business Address:...

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

    PubMed

    Lassen, Lars Christian; Thomsen, Mads Krogsgaard

    2006-09-01

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

  7. 75 FR 42432 - Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... Transmission Company, LLC, Transcontinental Gas Pipe Line Company, LLC, and Enterprise Field Services, LLC..., LLC, and Enterprise Field Services, LLC, collectively referred to as the Applicants, in Refugio County... scoping process the Commission will use to gather input from the public and interested agencies on...

  8. 76 FR 21426 - Union Pacific Railroad Company-Temporary Trackage Rights Exemption-BNSF Railway Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ... Surface Transportation Board Union Pacific Railroad Company--Temporary Trackage Rights Exemption--BNSF Railway Company AGENCY: Surface Transportation Board, DOT. ACTION: Partial Revocation of Exemption... protective conditions set forth in Oregon Short Line Railroad--Abandonment Portion Goshen Branch...

  9. 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

  10. External referencing and pharmaceutical price negotiation.

    PubMed

    Garcia Mariñoso, Begoña; Jelovac, Izabela; Olivella, Pau

    2011-06-01

    External referencing (ER) imposes a price cap for pharmaceuticals, based on prices of identical or comparable products in foreign countries. Suppose a foreign country (F) negotiates prices with a pharmaceutical firm, whereas a home country (H) can either negotiate prices independently or implement ER, based on the foreign price. We show that country H prefers ER if copayments in H are relatively high. This preference is reinforced when H's population is small. Irrespective of relative country sizes, ER by country H harms country F. Our model is inspired by the wide European experience with this cost-containment policy. Namely, in Europe, drug authorization and price negotiations are carried out by separate agencies. We confirm our main results in two extensions. The first one allows for therapeutic competition between drugs. In the second one, drug authorization and price negotiation take place in a single agency. PMID:20577969

  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. Are pharmaceuticals potent environmental pollutants? Part I: environmental risk assessments of selected active pharmaceutical ingredients.

    PubMed

    Carlsson, Carina; Johansson, Anna-Karin; Alvan, Gunnar; Bergman, Kerstin; Kühler, Thomas

    2006-07-01

    As part of achieving national environmental goals, the Swedish Government commissioned an official report from the Swedish Medical Products Agency on environmental effects of pharmaceuticals. Considering half-lives/biodegradability, environmental occurrence, and Swedish sales statistics, 27 active pharmaceutical ingredients were selected for environmental hazard and risk assessments. Although there were large data gaps for many of the compounds, nine ingredients were identified as dangerous for the aquatic environment. Only the sex hormones oestradiol and ethinyloestradiol were considered to be associated with possible aquatic environmental risks. We conclude that risk for acute toxic effects in the environment with the current use of active pharmaceutical ingredients is unlikely. Chronic environmental toxic effects, however, cannot be excluded due to lack of chronic ecotoxicity data. Measures to reduce potential environmental impact posed by pharmaceutical products must be based on knowledge on chronic ecotoxic effects of both active pharmaceutical ingredients as well as excipients. We believe that the impact pharmaceuticals have on the environment should be further studied and be given greater attention such that informed assessments of hazards as well as risks can be done. PMID:16257037

  13. 78 FR 54691 - American General Life Insurance Company, et al.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... COMMISSION American General Life Insurance Company, et al. August 29, 2013, AGENCY: The Securities and... Life Insurance Company (``American General''), The United States Life Insurance Company in the City of New York (``US Life'') (each, an ``Insurance Company'' and together, the ``Insurance Companies''),...

  14. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2014-01-01

    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, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part. PMID:24964711

  15. Patents or patients? Global access to pharmaceuticals and social justice.

    PubMed

    de Wildt, Gilles; Khoon, Chan Chee

    2008-01-01

    Innovation, vaccine development, and world-wide equitable access to necessary pharmaceuticals are hindered by current patenting arrangements and the orientation of pharmaceutical research. Plausible alternatives exist, including instituting the right of national or international agencies to act in the public interest and to buy patents selectively with a view to innovation and equitable access. Alternatives could partly or wholly finance themselves and lower pharmaceutical prices globally. Countries, individuals or groups of patients could help promote alternatives by calling into question the current emphasis on commercialization and profit, and by demanding globally equitable arrangements when sharing data that are important for research or when individuals or communities volunteer as research participants. PMID:18771195

  16. 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…

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

    ERIC Educational Resources Information Center

    Soronson, Bryan M.; Shaw, Diana V.

    1994-01-01

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

  18. 78 FR 64911 - 2013 Company Organization Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... Bureau of the Census 2013 Company Organization Survey AGENCY: Bureau of the Census, Commerce. ACTION... Organization Survey. The survey's data are needed, in part, to update the multilocation companies in the... organizational change within the company is indicated, or if they have been selected through the...

  19. 76 FR 62759 - 2011 Company Organization Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... Bureau of the Census 2011 Company Organization Survey AGENCY: Bureau of the Census, Commerce. ACTION... Organization Survey. The survey's data are needed, in part, to update the multilocation companies in the... organizational change within the company is indicated, or if they have been selected through the...

  20. 76 FR 20458 - Mutual Holding Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    ... Office of Thrift Supervision Mutual Holding Company AGENCY: Office of Thrift Supervision (OTS), Treasury... collection. Title of Proposal: Mutual Holding Company. OMB Number: 1550-0072. Form Numbers: MHC-1 (OTS Form... whether the applicant meets the statutory and regulatory criteria to form a mutual holding company...

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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

    PubMed

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

    2006-11-01

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

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

    ERIC Educational Resources Information Center

    Reilly, William J., Jr.

    1989-01-01

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

  9. 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

  10. [Early achievements of the Danish pharmaceutical industry--3. Alfred Benzon].

    PubMed

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

    2011-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 3 deals with products from the company founded by Alfred Benzon in 1849. Alfred Nicolai Benzon owned the Swan Pharmacy in Copenhagen. In 1863 he started an independent company manufacturing branded pharmaceuticals, thus combining the pharmacy's activities with the wholesale business. The family owned the company until 1952, when it was converted into a foundation. After several restructuring rounds, the medicine production business continued as Benzon Pharma A/S until 1990, when Nycomed Pharma A/S bought up all the branded pharmaceuticals. As the first pharmaceutical company in Denmark, Alfred Benzon was an industrial frontrunner in the country at the time, supplying not only the domestic market but foreign markets as well. Alfred Benzon was the first Danish company to produce ether for anesthesia, and malt extract, a dietetic preparation. The high quality of both products made them valuable export articles. In the early 1890s, Alfred Benzon became the first Danish company to start the research-based production of extract of thyroid glands from slaughtered cattle. This was the beginning of a long-standing specialization in producing organotherapeutic substances from animal organs originating from Danish animal husbandry. In 1932 the company had 26 preparations of this type in its range, many of them on the market for several years. These medicine substances included iron preparations and effervescent salts followed by sulfonamides, synthetic hormones and a substance to counteract motion sickness. PMID:21879529

  11. Is the pharmaceutical market in Bulgaria innovative?

    PubMed

    Stoimenova, A; Stankova, M; Samev, K; Petrova, G

    2003-09-01

    After the turn to market oriented economy a lot of drugs were authorized for sale in the East European countries. Because of the limited resources of these countries, mainly generic or brand generic products were licensed. The number of the patented drugs on the market could be used as measure of the market attractiveness to the R&D producers. The study shows the analysis of the innovativeness of the Bulgarian drug market comparing the registration and the patient activity of the producers. The number of the authorized products for five years period (1990-2000) and share of the patented products were investigated. During the observed period the number of newly authorized pharmaceuticals increased almost seven times from 800 (650 INN) to 6000 (2000 INN) dosage forms. The prevailing part of the newly registered drugs was found to be brand generics and possess only trade name protection. The share of drugs that are patented is less than five percent of all newly registered medicines, and among the fifty most commonly prescribed and sold medicines between 1996-2000, only 0.5 percent of drugs were patented. Obviously the Bulgarian pharmaceutical market is very competitive but not that attractive for most of the R&D producers. In general the registration of the patent protected products is increasing during the years and especially after harmonization of the related legislation with the EU requirements. The patent activity of the pharmaceutical companies regarding newly authorized drugs is influenced by the structure of morbidity and population. During the last two years the patent activity is increasing and is oriented mainly towards the protection of newly authorized drugs or pharmaceutical forms and obligatory registration of trademarks for the privatized Bulgarian pharmaceutical manufacturers. PMID:14677267

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

    PubMed Central

    Orzan, G; Zara, IA; Purcarea, VL

    2012-01-01

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

  13. 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

  14. Free trade in pharmaceuticals.

    PubMed

    Outterson, M Kevin

    2004-09-01

    Provisions in the Australia-United States Free Trade Agreement (AUSFTA) may threaten the Australian Pharmaceutical Benefits Scheme (PBS), the "gold standard" of such programs worldwide. If Australia postpones passing of the US Free Trade Agreement Implementation Bill in the Senate, there will be opportunity for broader interests in both the United States and Australia to carefully study the agreement. The provisions of AUSFTA relating to the PBS are supposed to promote transparency, but the pharmaceutical manufacturers themselves (who are demanding transparency) do not reveal the content of their submissions to the Pharmaceutical Benefits Advisory Committee, or disclose all their financial relationships with researchers and policymakers. In AUSFTA, the "public health" language of affordable prescription drugs is missing and is replaced by language supporting "pharmaceutical innovation". Debate as to whether AUSFTA will force significant changes to the PBS, including higher drug prices, is currently under way in Australia. Perhaps the appropriate target of reforms should be the excessive US drug prices, and not the economically efficient Australian drug prices. PMID:15347274

  15. Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation.

    PubMed

    Davis, Courtney; Abraham, John

    2011-07-01

    Government regulators have increasingly accelerated new cancer drugs on to the market by granting them approval based on less clinical data supporting drug efficacy than permitted under standard regulations. With more lenient regulatory standards, pharmaceutical companies have keenly sought to develop cancer drugs. Focusing on the US, this article examines how the emergence and implementation of such accelerated approvals should be understood, particularly in relation to corporate bias and disease-politics theories. Drawing on longitudinal and case study data analysis, it is argued that the emergence of accelerated approval regulations for cancer drugs should be regarded primarily as part of a deregulatory regime driven by the interests of the pharmaceutical industry in partnership with all major aspects of the state, rather than as a response to patient activism in the aftermath of AIDS. Furthermore, even in cases when some patients successfully demand accelerated marketing approval of cancer drugs, such approval by regulators, while in manufacturers' interests, may not be in the interests of patients' health because the political culture of the regulatory agency is reluctant to uphold its own techno-regulatory standards of public-health protection when that would challenge the agenda-setting influence of manufacturers, including industry collaborations with patients and the medical profession. PMID:21314687

  16. [The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America].

    PubMed

    Iñesta, Antonio; Oteo, Luis Angel

    2011-06-01

    The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society. PMID:21709969

  17. The role of entrepreneurial activities in academic pharmaceutical science research.

    PubMed

    Stinchcomb, Audra L

    2010-06-01

    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 nonprofit 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

  18. 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

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

    PubMed Central

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

    2015-01-01

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

  20. 76 FR 30397 - Faribault Woolen Mill Company, Faribault, MN; Faribo Woolens, Inc., a Related Company of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ..., 2010 (75 FR 3930). At the request of the State agency, the Department reviewed the certification for... Related Company of Faribault Woolen Mill Company, Faribault, MN; Amended Certification Regarding..., Faribault Woolen Mill Company. Accordingly, the Department is amending the certification to include...

  1. 77 FR 64185 - BNSF Railway Company-Acquisition and Operation Exemption-Nebraska Northeastern Railway Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-18

    ... Surface Transportation Board BNSF Railway Company--Acquisition and Operation Exemption-- Nebraska Northeastern Railway Company AGENCY: Surface Transportation Board. ACTION: Notice of exemption. SUMMARY: The.... 11323-25 for BNSF Railway Company (BNSF), a Class I rail carrier, to acquire and operate a 120.4-...

  2. 75 FR 12329 - Union Pacific Railroad Company-Temporary Trackage Rights Exemption-BNSF Railway Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... Surface Transportation Board Union Pacific Railroad Company--Temporary Trackage Rights Exemption--BNSF Railway Company AGENCY: Surface Transportation Board, DOT. ACTION: Partial revocation of exemption... Railway Company (BNSF) to extend to December 18, 2010, the expiration date of the local trackage...

  3. Pharmaceutical patent challenges--time for reassessment?

    PubMed

    Glass, Gregory

    2004-12-01

    For nearly 15 years after the passage of the Hatch-Waxman Act in 1984, generics drug companies took little advantage of its provisions, which provided financial incentives to them for challenging the patents of branded pharmaceutical products. However, during the past 3-5 years, generics manufacturers have dramatically increased the number of patent challenges. Although these challenges can certainly benefit consumers and payers, the number of challenges puts many innovator companies at risk, which they argue is detrimental to future R&D spending. If many of the challenges are successful, then the increase in challenges could in turn be detrimental to generics, and the system itself might therefore be due for a re-balance. PMID:15573104

  4. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... of the classification. On December 2, 2011 (76 FR 75551), FDA announced the availability of the draft... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new...

  5. Maintaining the Quality of Pharmaceutical Education during Difficult Times. The 1982 Argus Commission Report.

    ERIC Educational Resources Information Center

    Goyan, Jere E.; And Others

    1982-01-01

    Forces influencing the quality of pharmaceutical education are examined, including: development of school leadership; changing composition of faculty; faculty development and reward; student quality and mix; school extramural activities related to research funding, accreditation agencies, the pharmaceutical industry, and foundations; and…

  6. Challenges in Providing e-Learning Solutions in the Regulated Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Vesper, James L.

    Regulatory agencies around the world require that those involved in producing pharmaceutical products be adequately trained. E-learning can accomplish this, providing consistent delivery and learner assessment. However, there are some unique expectations that regulators and the pharmaceutical industry have of e-learning solutions. These include…

  7. Natural gas annual 1993 supplement: Company profiles

    SciTech Connect

    Not Available

    1995-02-01

    The Natural Gas Annual provides information on the supply and disposition of natural gas to a wide audience including industry, consumers, Federal and State agencies, and educational institutions. This report, the Natural Gas Annual 1993 Supplement: Company Profiles, presents a detailed profile of 45 selected companies in the natural gas industry. The purpose of this report is to show the movement of natural gas through the various States served by the companies profiled. The companies in this report are interstate pipeline companies or local distribution companies (LDC`s). Interstate pipeline companies acquire gas supplies from company owned production, purchases from producers, and receipts for transportation for account of others. Pipeline systems, service area maps, company supply and disposition data are presented.

  8. 76 FR 23342 - Russell Investment Management Company, et al.;

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-26

    ... COMMISSION Russell Investment Management Company, et al.; Notice of Application April 20, 2011. AGENCY... section 6(c) of the Investment Company Act of 1940 (the ``Act'') for an exemption from sections 2(a)(32... companies as the series to acquire Shares. Applicants: Russell Investment Management Company...

  9. 75 FR 60833 - Jackson National Life Insurance Company, et al.;

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... COMMISSION Jackson National Life Insurance Company, et al.; Notice of Application September 27, 2010. AGENCY... National Life Insurance Company (``Jackson''), Jackson National Life Insurance Company of New York... Companies and serve as the underlying investment vehicles for the variable life insurance contracts...

  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. 77 FR 16262 - Importer of Controlled Substances, Notice of Registration; Johnson Matthey, Inc., Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ...) II The company plans to import the listed controlled substances as raw materials, to be used in the..., 2011, 76 FR 77253, Johnson Matthey, Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford... raw material, the company plans to import gram amounts to be used as reference standards for sale...

  12. EU pharmaceutical expenditure forecast

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Yamakawa, K

    1995-01-01

    A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of

  14. 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

  15. The Disposable Author: How Pharmaceutical Marketing Is Embraced within Medicine's Scholarly Literature.

    PubMed

    Matheson, Alastair

    2016-07-01

    The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine's relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical area of scholarly interest, the medical journal publication. Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians' qualified colleagues, including "key opinion leaders," are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and "ghost management," vices condemned as "dirty little secrets" perpetrated from "behind the scenes" with the connivance of academic "shills" or "guest authors," in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine's editorial standards assist rather than impede the workings of commerce. PMID

  16. 78 FR 59991 - Advisory Committee on Small and Emerging Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... COMMISSION Advisory Committee on Small and Emerging Companies AGENCY: Securities and Exchange Commission... on Small and Emerging Companies. FOR FURTHER INFORMATION CONTACT: Johanna Losert, Special Counsel, Office of Small Business Policy, Securities and Exchange Commission, 100 F Street, NE., Washington...

  17. 76 FR 19150 - Jackson National Life Insurance Company, et al.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... Special Counsel, at (202) 551-6795, Office of Insurance Products, Division of Investment Management... COMMISSION Jackson National Life Insurance Company, et al. March 31, 2011. AGENCY: The Securities and... contracts. Applicants: Jackson National Life Insurance Company (``Jackson''), Jackson National...

  18. 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

  19. 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

  20. Writing Technical Documents for the Global Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Bonk, Robert J.

    1998-01-01

    States that technical writers in the global pharmaceutical industry write for two audiences: regulatory agencies and healthcare practitioners. Contends that information products that address these audiences must balance the competing forces of business interests, market penetration, and the cultural variables of products so tied to people's…

  1. 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

  2. Impact of antibiotic restrictions: the pharmaceutical perspective.

    PubMed

    Power, E

    2006-08-01

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

  3. Pharmaceutical policy regarding generic drugs in Belgium.

    PubMed

    Simoens, Steven; De Bruyn, Kristien; Bogaert, Marc; Laekeman, Gert

    2005-01-01

    Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian drug market has evolved following initiation of the RP scheme. The market share held by generic drugs increased following implementation of the RP scheme. Focusing on volume, average market share (by semester) for generic drugs amounted to 2.05% of the total pharmaceutical market from January 1998 to June 2001, compared with 6.11% from July 2001 to December 2003. As new generic drugs are introduced, their market share tends to increase in the first couple of months, after which it levels off. Faced with increasing generic competition, some manufacturers have launched new variants of their original drug, thereby effectively extending the period of patent protection. Strategies consisting of price reductions in return for the abolition of prescribing conditions and the launch of new dosages or formulations appear to have been successful in maintaining the market share of original drugs. Nevertheless, the introduction of the RP scheme was associated with savings amounting to 1.8% of pharmaceutical expenditure by the third-party payer in 2001 and 2.1% in 2002. The findings of this paper indicate that the RP scheme has stimulated the Belgian generic drug market. However, existing policy has largely failed to take into account the role that physicians and pharmacists can play in stimulating generic drug use. Therefore, further development of the Belgian generic drug market seems to hinge on the creation of appropriate incentives for physicians to prescribe, and for pharmacists to

  4. Pharmaceuticals in the environment: scientific evidence of risks and its regulation

    PubMed Central

    Küster, Anette; Adler, Nicole

    2014-01-01

    During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk–benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data. PMID:25405974

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

    PubMed

    Granja, Mónica

    2005-01-01

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

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

    PubMed

    Vainiomäki, Maija; Helve, Otto; Vuorenkoski, Lauri

    2004-11-01

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

  7. 77 FR 27760 - Appalachian Power Company; Notice of Application for Amendment of License and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... Energy Regulatory Commission Appalachian Power Company; Notice of Application for Amendment of License..., 2012. d. Applicant: Appalachian Power Company. e. Name of Project: Claytor Hydroelectric Project. f... that resource agency. k. Description of Application: Appalachian Power Company (licensee)...

  8. Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.

    PubMed

    Light, Donald W; Lexchin, Joel; Darrow, Jonathan J

    2013-01-01

    Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. PMID:24088149

  9. 78 FR 70964 - Luminant Generation Company, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Luminant Generation Company, LLC AGENCY: Nuclear Regulatory Commission. ACTION: Combined license... for four consecutive weeks of a combined license (COL) application from Luminant Generation...

  10. Classification of dermal sensitizers in pharmaceutical manufacturing.

    PubMed

    Winkler, Gian C; Perino, Christopher; Araya, Selene H; Bechter, Rudolf; Kuster, Martin; Lovsin Barle, Ester

    2015-08-01

    Workers in development and manufacturing of pharmaceuticals are at risk for occupational contact dermatitis (OCD) of irritative (ICD) or allergic (ACD) origin, due to contacts with reactive intermediates (IM) and drug substances (DS). We examined, if alternative methods could replace presently used animal tests for identification of ACD in pharmaceutical development and manufacturing, without apparent loss of worker health, in line with regulations. The status of alternative methods for regulatory toxicology for consumer products has recently been reviewed by the Organisation for Economic Co-operation and Development (OECD) and the European Commission's Joint Research Center (JRC) for the European Chemicals Agency (ECHA). They concluded that prediction of skin sensitization potential, extent and quality by in vitro methods, for regulatory assessments, will depend on the regulatory purpose and level of confidence required. Some alternative methods are currently in validation. Current Globally Harmonized System (GHS) regulations on classification, labeling and packaging of substances and mixtures depend on human and animal data, whereas alternative methods may provide supportive evidence. Since the levels of workplace skin exposure to DS and IM in manufacturing of pharmaceuticals are usually not known, it is not possible to conduct quantitative risk assessments based on threshold calculations for contact sensitizers. PMID:26028366

  11. Should ANVISA be permitted to reject pharmaceutical patent applications in Brazil?

    PubMed

    Mueller, Lisa L; Taketsuma Costa, Silvia Moreira

    2014-01-01

    Pharmaceutical manufacturers who seek new markets for expansion are particularly attracted to Brazil given its potential for growth and the expectation that it will be the fifth largest drug market by 2015. Given the significance of Brazil in the marketplace, strong patent protection for pharmaceutical products and processes is critical. In April 2013, a new workflow came into effect in Brazil which allows the National Sanitary Vigilance Agency (ANVISA), a government agency whose function is to protect public health, to examine and reject any patent application that claims a pharmaceutical product or process before any examination of the application by the Brazilian Patent Office. If a patent application is rejected by ANVISA, the application is returned to the Brazilian Patent Office and filed away, without any further examination, for an unknown period of time. Therefore, the examination of pharmaceutical product and process applications under this new workflow is problematic for local and global pharmaceutical manufacturers for multiple reasons. PMID:24206261

  12. Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medications.

    PubMed

    Lexchin, Joel

    2012-06-01

    Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of "seeding" trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it's not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. PMID:21327723

  13. [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

  14. 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

  15. 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

  16. Report raises questions about drug companies advertising budgets.

    PubMed

    1999-08-01

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

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

    PubMed

    Malhotra, Prabodh; Lofgren, Hans

    2004-11-01

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

  18. 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

  19. Mechanochemistry of ibuprofen pharmaceutical.

    PubMed

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

    2012-07-01

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

  20. Practicing Research Ethics: Private-Sector Physicians & Pharmaceutical Clinical Trials

    PubMed Central

    2008-01-01

    This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians’ relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities. PMID:18353515

  1. 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

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

    PubMed

    Hunter, Jackie

    2011-05-13

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

  3. Your business in court and at Federal agencies: 2011-2012.

    PubMed

    Reiss, John B; Crowder, Dawn; McCabe, Brittany; DeFeo, Marisa; Rifin, Marta; Talbot, Meghan

    2013-01-01

    FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws. PMID:24640636

  4. 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

  5. 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.

  6. 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

  7. 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

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

    PubMed

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

    2014-05-01

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

  9. 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.

  10. 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

  11. 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

  12. Government initiatives in the development of a pharmaceutical industry in Australia.

    PubMed

    Hirst, C A

    1992-01-01

    Government policy recognizes that the purchasing power of the government, through the Pharmaceutical Benefits Scheme, has suppressed prices and returns to the pharmaceutical industry in Australia, and that research, development and export activities have been low. The factor (f) scheme is designed to provide some pricing relief to those companies willing and able to undertake particular industry development activities. This scheme, together with the other changes implemented by the government, will result in the restructuring and development of the pharmaceutical industry in Australia. PMID:1623637

  13. Discovery pharmaceutics--challenges and opportunities.

    PubMed

    Chen, Xue-Qing; Antman, Melissa D; Gesenberg, Christoph; Gudmundsson, Olafur S

    2006-01-01

    Most pharmaceutical companies are now evaluating compounds for druglike properties early in the discovery process. The data generated at these early stages allow upfront identification of potential development challenges and thus selection of the best candidates for lead nomination. Most often, lead nomination candidates are selected based on pharmacological and toxicological data. However, many drugs in development suffer from poor biopharmaceutical properties due to suboptimal physiochemical parameters. The poor biopharmaceutical properties often lead to extended timelines and a higher cost of developing the compounds. To avoid these problems and choose the best compounds from a biopharmaceutical perspective, physicochemical parameters such as solubility, lipophilicity, and stability need to be evaluated as early as possible. Furthermore, the preformulation approaches used to evaluate the compounds for their pharmacokinetic and toxicological properties need to be optimized. This minireview summarizes some of the parameters and approaches that can be used to evaluate compounds in the early stages of drug discovery. PMID:16796392

  14. 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

  15. Feasibility Study of Economics and Performance of Solar Photovoltaics at the Former Chicago, Milwaukee, and St. Paul Rail Yard Company Site in Perry, Iowa. A Study Prepared in Partnership with the Environmental Protection Agency for the RE-Powering America's Land Initiative: Siting Renewable Energy on Potentially Contaminated Land and Mine Sites

    SciTech Connect

    Salasovich, J.; Geiger, J.; Healey, V.; Mosey, G.

    2013-03-01

    The U.S. Environmental Protection Agency (EPA), in accordance with the RE-Powering America's Land initiative, selected the Former Chicago, Milwaukee & St. Paul Rail Yard Company site in Perry, Iowa, for a feasibility study of renewable energy production. The National Renewable Energy Laboratory (NREL) provided technical assistance for this project. The purpose of this report is to assess the site for a photovoltaic (PV) system installation and estimate the cost, performance, and site impacts of different PV options. In addition, the report recommends financing options that could assist in the implementation of a PV system at the site. This study did not assess environmental conditions at the site.

  16. Occupational contact dermatitis in the pharmaceutical industry.

    PubMed

    Goossens, An; Hulst, Kim Vander

    2011-01-01

    Occupation-induced skin reactions are not infrequently observed in the pharmaceutical industry. Workers may come in contact with irritant substances and also with chemically reactive intermediates or drugs that may be potential sensitizers. The skin lesions can be located at the site of contact, usually the hands, although airborne reactions on exposed and even nonexposed areas (eg, by particles trapped under clothing) are not uncommon. Generalized reactions may occur due to inhalation or transcutaneous absorption. An accidental exposure to a highly allergenic compound may cause a chemical burn, followed by primary sensitization and allergic contact dermatitis. The pharmaceutical contact allergens belong to many different pharmacologic classes. If several cases of contact dermatitis occur in multiple individuals in the same company, then the working conditions are implicated and should be changed to prevent their recurrence. Measures to be taken include dust control, installation of closed filter equipment, and keeping the workers informed about the potential risks associated with the manipulation of the chemicals. PMID:22014988

  17. 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

  18. Rho Chi lecture. Pharmaceutical sciences in the next millennium.

    PubMed

    Triggle, D J

    1999-02-01

    Even a cursory survey of this article suggests that the pharmaceutical sciences are being rapidly transformed under the influence of both the new technologies and sciences and the economic imperatives. Of particular importance are scientific and technological advances that may greatly accelerate the critical process of discovery. The possibility of a drug discovery process built around the principles of directed diversity, self-reproduction, evolution, and self-targeting suggests a new paradigm of lead discovery, one based quite directly on the paradigms of molecular biology. Coupled with the principles of nanotechnology, we may contemplate miniature molecular machines containing directed drug factories, circulating the body and capable of self-targeting against defective cells and pathways -- the ultimate "drug delivery machine." However, science and technology are not the only factors that will transform the pharmaceutical sciences in the next century. The necessary reductions in the costs of drug discovery brought about by the rapidly increasing costs of the current drug discovery paradigms means that efforts to decrease the discovery phase and to make drug development part of drug discovery will become increasingly important. This is likely to involve increasing numbers of "alliances," as well as the creation of pharmaceutical research cells -- highly mobile and entrepreneurial groups within or outside of a pharmaceutical company that are formed to carry out specific discovery processes. Some of these will be in the biotechnology industry, but an increasing number will be in universities. The linear process from basic science to applied technology that has been the Western model since Vannevar Bush's Science: The Endless Frontier has probably never been particularly linear and, in any event, is likely to be rapidly supplanted by models where science, scientific development, and technology are more intimately linked. The pharmaceutical sciences have always been

  19. 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

  20. 76 FR 63679 - Advisory Committee on Small and Emerging Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-13

    ... COMMISSION Advisory Committee on Small and Emerging Companies AGENCY: Securities and Exchange Commission. ACTION: Notice of meeting of SEC Advisory Committee on Small and Emerging Companies. SUMMARY: The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing...

  1. 76 FR 79230 - Advisory Committee on Small and Emerging Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... COMMISSION Advisory Committee on Small and Emerging Companies AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of SEC Advisory Committee on Small and Emerging Companies. SUMMARY: The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing...

  2. 77 FR 2102 - Advisory Committee on Small and Emerging Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ... COMMISSION Advisory Committee on Small and Emerging Companies AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of SEC Advisory Committee on Small and Emerging Companies. SUMMARY: The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing...

  3. 78 FR 38413 - American Family Life Insurance Company, et al.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... COMMISSION American Family Life Insurance Company, et al. June 20, 2013. AGENCY: Securities and Exchange...''). Applicants: American Family Life Insurance Company (the ``Company''), American Family Variable Account I (the ``Life Account''), and American Family Variable Account II (the ``Annuity Account'') (together,...

  4. 76 FR 35085 - Savings and Loan Holding Company Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Office of Thrift Supervision Savings and Loan Holding Company Application AGENCY: Office of Thrift... following information collection. Title of Proposal: Savings Loan Holding Company Application. OMB Number... savings and loan holding company, or any individual who owns, controls, or holds with power to vote...

  5. When School Management Companies Fail: Righting Educational Wrongs.

    ERIC Educational Resources Information Center

    Conn, Kathleen

    2002-01-01

    Reviews public school system of education; describes school management companies (nonprofit, for profit) and their fiduciary duties; discusses monitoring the performance of school management companies; describes legal mechanisms and remedies (tort, contract, agency, and constitutional law) for holding school management companies accountable.…

  6. 77 FR 65419 - Virginia Electric and Power Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-26

    ... and Power Company AGENCY: Nuclear Regulatory Commission. ACTION: Partial Director's Decision; issuance... Power Station, Units 1 and 2 (North Anna 1 and 2), by the Virginia Electric and Power Company (VEPCO or... August 23, 2011, Virginia Electric and Power Company (the licensee) should be required to obtain...

  7. How might the Trans-Pacific Partnership impact on the pharmaceutical sector in Vietnam?

    PubMed

    Binh, Nguyen Hoa; Anh, Pham Ngoc Kieu; Phuong, Nguyen Minh

    2016-07-01

    Ratification of the Trans-Pacific Partnership (TPP) will attract a large number of foreign drug companies in the coming years to Vietnam. It is anticipated to bring investment to Vietnam's pharmaceutical industries, lead to increased infrastructure and enable the use of more sophisticated technologies for the discovery, development and manufacture of drugs. However, with respect to pharmaceutical companies, which are producing generic drugs primarily, the availability of biologic will be reduced. Thus, the consequence is, an increase in drug cost resulting in difficulties for patients wishing to procure these drugs. This will be particularly detrimental for developing countries, such as Vietnam and Malaysia. PMID:27346326

  8. PBT assessment and prioritization of contaminants of emerging concern: Pharmaceuticals.

    PubMed

    Sangion, Alessandro; Gramatica, Paola

    2016-05-01

    The strong and widespread use of pharmaceuticals, together with incorrect disposal procedures, has recently made these products contaminants of emerging concern (CEC). Unfortunately, little is known about pharmaceuticals' environmental behaviour and ecotoxicity, so that EMEA (European Medicines Agency) released guidelines for the pharmaceuticals' environmental risk assessment. In particular, there is a severe lack of information about persistence, bioaccumulation and toxicity (PBT) of the majority of the thousands of substances on the market. Computational tools, like QSAR (Quantitative Structure Activity Relationship) models, are the only way to screen large sets of chemicals in short time, with the aim of ranking, highlighting and prioritizing the most environmentally hazardous for focusing further experimental studies. In this work we propose a screening method to assess the potential persistence, bioaccumulation and toxicity of more than 1200 pharmaceutical ingredients, based on the application of two different QSAR models. We applied the Insubria-PBT Index, a MLR (Multiple Linear Regression) QSAR model based on four simple molecular descriptors, implemented in QSARINS software, and able to synthesize the PBT potential in a unique cumulative value and the US-EPA PBT Profiler that assesses the PBT behaviour evaluating separately P, B and T. Particular attention was given to the study of Applicability Domain in order to provide reliable predictions. An agreement of 86% was found between the two models and a priority list of 35 pharmaceuticals, highlighted as potential PBTs by consensus, was proposed for further experimental validation. Moreover, the results of this computational screening are in agreement with preliminary experimental data in the literature. This study shows how in silico models can be applied in the hazard assessment to perform preliminary screening and prioritization of chemicals, and how the identification of the structural features, mainly

  9. WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

    PubMed

    2006-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies. PMID:16836287

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

    PubMed

    Ebeling, Mary

    2011-09-01

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

  11. Production of pharmaceutical proteins by transgenic animals.

    PubMed

    Houdebine, Louis-Marie

    2009-03-01

    Proteins started being used as pharmaceuticals in the 1920s with insulin extracted from pig pancreas. In the early 1980s, human insulin was prepared in recombinant bacteria and it is now used by all patients suffering from diabetes. Several other proteins and particularly human growth hormone are also prepared from bacteria. This success was limited by the fact that bacteria cannot synthesize complex proteins such as monoclonal antibodies or coagulation blood factors which must be matured by post-translational modifications to be active or stable in vivo. These modifications include mainly folding, cleavage, subunit association, gamma-carboxylation and glycosylation. They can be fully achieved only in mammalian cells which can be cultured in fermentors at an industrial scale or used in living animals. Several transgenic animal species can produce recombinant proteins but presently two systems started being implemented. The first is milk from farm transgenic mammals which has been studied for 20 years and which allowed a protein, human antithrombin III, to receive the agreement from EMEA (European Agency for the Evaluation of Medicinal Products) to be put on the market in 2006. The second system is chicken egg white which recently became more attractive after essential improvement of the methods used to generate transgenic birds. Two monoclonal antibodies and human interferon-beta 1a could be recovered from chicken egg white. A broad variety of recombinant proteins were produced experimentally by these systems and a few others. This includes monoclonal antibodies, vaccines, blood factors, hormones, growth factors, cytokines, enzymes, milk proteins, collagen, fibrinogen and others. Although these tools have not yet been optimized and are still being improved, a new era in the production of recombinant pharmaceutical proteins was initiated in 1987 and became a reality in 2006. In the present review, the efficiency of the different animal systems to produce

  12. Biricodar. Vertex Pharmaceuticals.

    PubMed

    Dey, Saibal

    2002-05-01

    Vertex is developing biricodar as a chemosensitizing agent designed to restore the effectiveness of chemotherapeutic agents in tumor multidrug resistance. By November 1998, phase II trials had commenced for biricodar, in combination with chemotherapy, for five common cancer indications: breast, ovarian, soft-tissue sarcomas, small cell lung cancer and prostate cancer. Phase II trials were ongoing in January 2002. By March 2000, Vertex was the sole developer of biricodar, as an agreement made in 1996 with BioChem Pharma (now Shire Pharmaceuticals), for the development and marketing of biricodar in Canada was terminated. Biricodar is the free base compound, which also has a citrate salt analog known as VX-710-3. Vertex has published three patents, WO-09615101, WO-09636630 and WO-09736869, disclosing derivatives of biricodar that are claimed for the treatment of multidrug resistant protein and P-glycoprotein-mediated multidrug resistant tumors. In January 2002, a Banc of America analyst report forecast that biricodar had a 30% chance of reaching the market with a launch date in the second half of 2005, with peak sales estimated at $250 million. PMID:12090559

  13. 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...

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

    PubMed Central

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

    2015-01-01

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

  15. Global health: the ethical responsibility of the pharmaceutical industry.

    PubMed

    Lassen, Lars Christian; Thomsen, Mads Krogsgaard

    2007-02-01

    Health as a global issue concerns all and clearly manifests global inequality. All stakeholders of the healthcare systems and disease treatment--including the pharmaceutical industry--have an ethical obligation to contribute to promoting global health. At Novo Nordisk we primarily focus on providing our contribution to global health through defeating diabetes. At the same time we stand by being a private company required to deliver a financial profit, which is why we must create positive results on the financial, the environmental and the social bottom lines. In this article we attempt to provide a brief overview of some of the initiatives that we think business companies can take--and therefore are also obliged to in promoting global health. Further, we have pointed out a number of dilemmas within research and development as well as business ethics that all companies face when they convert the ethical principles to daily practice globally. PMID:17349219

  16. 75 FR 59721 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... the major species, for example, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some... pharmaceutical companies that sponsor new animal drugs. In the Federal Register of July 20, 2010 (75 FR...

  17. [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

  18. Aripiprazole (Otsuka Pharmaceutical Co).

    PubMed

    Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih

    2002-01-01

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

  19. [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

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

    PubMed

    Dutta, Anand S; Garner, Andrew

    2003-12-01

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

  1. Rasagiline. Teva Pharmaceutical.

    PubMed

    Kupsch, Andreas

    2002-05-01

    Rasagiline is a selective and potent irreversible MAO(B) inhibitor which is under development by Teva for the treatment of neurological diseases. Rasagiline is in phase III trials in the US, Canada and Europe for Parkinson's disease (PD) and has completed phase II trials in Israel and Hungary. Teva planned to submit a filing in 2002 and expected to launch rasagiline in 2003. Lundbeck acquired European development and commercialization rights to rasagiline in November 1999 and, in September 2001, the company reported that it planned to file an NDA in 2003. In March 2002, analysts at Morgan Stanley Dean Witter predicted that H Lundbeck would make sales of rasagiline of DKr 100 million in 2003, rising to DKr 300 million in 2008. In the same month, launch was predicted in 2004/2005 for the PD indication, and 2005/2006 for the AD indication, by analysts at Deutsche Banc Alex Brown. PMID:12090555

  2. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  3. 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

  4. Multiscale mechanistic modeling in pharmaceutical research and development.

    PubMed

    Kuepfer, Lars; Lippert, Jörg; 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

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

    PubMed

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

    2013-12-01

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

  6. 76 FR 44912 - Landia Chemical Company Site; Lakeland, Polk County, FL; Notice of Settlement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... AGENCY Landia Chemical Company Site; Lakeland, Polk County, FL; Notice of Settlement AGENCY... Landia Chemical Company Superfund Site located in Lakeland, Polk County, Florida for publication. DATES... by Site name Landia Chemical Company Superfund Site by one of the following methods:...

  7. 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

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

    PubMed

    Nozal, Raúl Rodríquez

    2011-01-01

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

  9. 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 Europe’s 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

  10. Considering the Future of Pharmaceutical Promotions in Social Media

    PubMed Central

    Carpentier, Francesca Renee Dillman

    2016-01-01

    This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. PMID:27239874

  11. Early benefit assessment for pharmaceuticals in Germany: lessons for policymakers.

    PubMed

    Schlette, Sophia; Hess, Rainer

    2013-10-01

    Since 2011, Germany's Pharmaceutical Market Restructuring Act has mandated that all newly introduced drugs are subject to an assessment of their benefits in relation to a comparator, typically the current standard treatment. For drugs found to have some additional benefit, the manufacturer and the statutory health insurers negotiate a price. For drugs found to have no additional benefit, their price is set in reference to the price of the comparator. This new system is intended to reduce spending on expensive new drugs that are no more effective than existing treatments, while encouraging pharmaceutical companies to invest in innovative drugs that improve health outcomes. The German experience provides lessons for the United States, where comparative effectiveness research is publicly funded but public insurance programs are limited in their ability to use its findings to make coverage or pricing decisions. PMID:24171232

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

    PubMed

    Kelleher, Finnuala

    2004-01-01

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

  13. 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

  14. 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.

  15. 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…

  16. 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…

  17. Current trends in the pharmaceutical industry--a case study approach.

    PubMed

    Rusu, Alexandru; Kuokkanen, Katja; Heier, Annabelle

    2011-10-01

    This commentary offers an overview of some current trends of the pharmaceutical industry drawing on examples taken from the analysis of four companies (Pfizer, Merck, Novo Nordisk, Crucell). The very brief analysis looks at diversification paths, pipeline management strategies, generic competition as well as corporate social responsibility policies. PMID:21782941

  18. 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...

  19. 76 FR 71968 - Proposed Agency Information Collection Activities; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... expenditures; and All other loans and all lease financing receivables. Currently, the FR Y-9C report does not... by FR Y-9C by any of the following methods: Agency Web site: http://www.federalreserve.gov . Follow... Company Only Financial Statements for Large Bank Holding Companies (FR Y-9LP), the Parent Company...

  20. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

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

  1. Regulatory beneficiaries and informal agency policymaking.

    PubMed

    Mendelson, Nina A

    2007-03-01

    Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to- consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise low-level employees and supply valuable information to regulated entities regarding how an agency will implement a program. Thus far, however, the debate has largely ignored the distinct and substantial interests of regulatory beneficiaries--those who expect to benefit from government regulation of others. Regulatory beneficiaries include, among others, pharmaceutical consumers, environmental users, and workers seeking safe workplaces. When agencies make policy informally, regulatory beneficiaries suffer distinctive losses to their ability to participate in the agency's decision and to invoke judicial review. This Article argues that considering the interests of regulatory beneficiaries strengthens the case for procedural reform. The Article then assesses some possible solutions. PMID:17410678

  2. [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

  3. 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

  4. 75 FR 36452 - Pruco Life Insurance Company, et al.; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... COMMISSION Pruco Life Insurance Company, et al.; Notice of Application June 18, 2010. AGENCY: Securities and.... Applicants: Pruco Life Insurance Company (``Pruco Life''), Pruco Life Insurance Company of New Jersey (``PLNJ,'' and collectively with Pruco Life, the ``Insurance Companies''), Pruco Life Flexible Premium......

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2013-05-01

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

  7. Guidelines for Analysis of Pharmaceutical Supply System Planning in Developing Countries. Volume 7: Pharmaceutical Supply System Planning. International Health Planning Methods Series.

    ERIC Educational Resources Information Center

    Schaumann, Leif; And Others

    Intended to assist Agency for International Development (AID) officers, advisors, and health officials in incorporating health planning into national plans for economic development, this seventh of ten manuals in the Interational Health Planning Methods Series deals with pharmaceutical supply systems planning in developing countries. Following an…

  8. Recent advances in trace analysis of pharmaceutical genotoxic impurities.

    PubMed

    Liu, David Q; Sun, Mingjiang; Kord, Alireza S

    2010-04-01

    Genotoxic impurities (GTIs) in pharmaceuticals at trace levels are of increasing concerns to both pharmaceutical industries and regulatory agencies due to their potentials for human carcinogenesis. Determination of these impurities at ppm levels requires highly sensitive analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical R&D. Practical guidance with respect to the analytical determination of diverse classes of GTIs is currently lacking in the literature. This article provides an industrial perspective with regard to the analysis of various structural classes of GTIs that are commonly encountered during chemical development. The recent literatures will be reviewed, and several practical approaches for enhancing analyte detectability developed in recent years will be highlighted. As such, this article is organized into the following main sections: (1) trace analysis toolbox including sample introduction, separation, and detection techniques, as well as several 'general' approaches for enhancing detectability; (2) method development: chemical structure and property-based approaches; (3) method validation considerations; and (4) testing and control strategies in process chemistry. The general approaches for enhancing detection sensitivity to be discussed include chemical derivatization, 'matrix deactivation', and 'coordination ion spray-mass spectrometry'. Leveraging the use of these general approaches in method development greatly facilitates the analysis of poorly detectable or unstable/reactive GTIs. It is the authors' intent to provide a contemporary perspective on method development and validation that can guide analytical scientists in the pharmaceutical industries. PMID:20022442

  9. The occurrence of selected human pharmaceutical compounds in UK estuaries.

    PubMed

    Thomas, Kevin V; Hilton, Martin J

    2004-09-01

    This report describes a scoping study conducted in order to establish whether pharmaceutical compounds may be present in UK estuaries. Surface water samples collected from five UK estuaries were analysed for the presence of 14 pharmaceutical compounds selected from the priority lists of the UK Environment Agency and the Oslo and Paris Commission (OSPAR). The pharmaceutical compounds/metabolites clofibric acid, clotrimazole, dextropropoxyphene, diclofenac, ibuprofen, mefenamic acid, propranolol, tamoxifen and trimethoprim were detected at measurable concentrations in the samples collected. The concentrations of erythromycin, lofepramine, paracetamol, sulfamethoxazole and acetyl-sulfamethoxazole were all below the limits of detection of the methods used (between 4 and 20 ng l(-1)). The anti-fungal agent clotrimazole was the most frequently detected at a maximal concentration of 22 ng l(-1) and a median concentration of 7 ng l(-1). The analgesic compound ibuprofen was detected at a maximal concentration of approximately 930 ng l(-1) and a median concentration of 48 ng l(-1), whilst the other pharmaceutical compounds were detected between the limits of detection of the method used and 570 ng l(-1). PMID:15325211

  10. Recent trends in the impurity profile of pharmaceuticals

    PubMed Central

    Pilaniya, Kavita; Chandrawanshi, Harish K.; Pilaniya, Urmila; Manchandani, Pooja; Jain, Pratishtha; Singh, Nitin

    2010-01-01

    Various regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug administration (FDA), and the Canadian Drug and Health Agency (CDHA) are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs). The various sources of impurity in pharmaceutical products are — reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \\ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas–liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid–liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR) spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research. PMID:22247862

  11. Pharmaceuticals in Australia: developments in regulation and governance.

    PubMed

    Lofgren, Hans; Boer, Rebecca de

    2004-06-01

    The pharmaceutical domain represents a type of internationalised policy network theorised in recent writings on neo-liberalism, neo-corporatism and governance. This article presents an analysis of developments in prescription drug regulation in Australia. A relatively stable, state-managed pattern of interaction has been superseded by less closed exchange, and the government itself has fragmented into agencies pursuing different objectives. Developments in the three core regulatory areas are described: safety and efficacy controls, social policy (access and equity), and state support for industry (economic) development. Consensus-building occurs within the context of the National Medicines Policy. The pharmaceutical industry, represented by Medicines Australia, has a stake in all aspects of pharmaceutical policy and regulation, and draws upon unique resources (expertise and lobbying capacity). The context for the developments described is Australia's abandonment of a protectionist version of the Keynesian welfare national state in favour of the model of the competition state, which is oriented towards support for the growth of high technology industries such as pharmaceuticals, premised on partnerships with business. PMID:15081192

  12. “Good Publication Practice for Pharmaceutical Companies”: Where Are We Now?

    PubMed Central

    Wager, Elizabeth

    2005-01-01

    Abstract and Introduction Abstract Eighteen months on from the publication of “Good Publication Practice for Pharmaceutical Companies,” one member of the working group that developed these guidelines reflects on what they have achieved and what has changed since they were first developed. Introduction Pharmaceutical company publication practices have recently attracted the attention of journal editors, the mass media, and even been the subject of legal proceedings. The issue of the nonpublication of trial results moved from being a largely academic concern to the subject of newspaper headlines when GlaxoSmithKline was sued by the New York Attorney General.[1] The settlement included a commitment to make summaries of trial results available on the company Web site. At around the same time, other companies, such as Eli Lilly, announced similar policies.[2] Companies may have also been examining their publication policies in the light of the case against Pfizer-Warner-Lambert, which resulted in the company being fined $240 million and ordered to pay $152 million in damages for promoting the off-label use of gabapentin (Neurontin).[3] Evidence brought against the company included having “A ‘publication strategy’ that subsidized the production and dissemination of anecdotal reports favorable to off-label use of Neurontin,” which were “of no scientific value.” Some news items also mentioned the use of ghostwriters. It is tempting to believe that a great deal of time, effort, and even money might have been saved if companies had paid more attention to their publication practices. A set of guidelines on Good Publication Practice (GPP) for pharmaceutical companies were published in mid-2003.[4] This article reviews the history of the guidelines in light of the recent developments. PMID:16369385

  13. Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers

    PubMed Central

    Garuba, Habibat A; Kohler, Jillian C; Huisman, Anna M

    2009-01-01

    Background Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries [1]. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals [2]. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution. Methods Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. Results The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. Conclusion Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of

  14. 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

  15. 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

  16. 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...

  17. Pharmaceutical care in smoking cessation.

    PubMed

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

  18. Electron microscopy of pharmaceutical systems.

    PubMed

    Klang, Victoria; Valenta, Claudia; Matsko, Nadejda B

    2013-01-01

    During the last decades, the focus of research in pharmaceutical technology has steadily shifted towards the development and optimisation of nano-scale drug delivery systems. As a result, electron microscopic methods are increasingly employed for the characterisation of pharmaceutical systems such as nanoparticles and microparticles, nanoemulsions, microemulsions, solid lipid nanoparticles, different types of vesicles, nanofibres and many more. Knowledge of the basic properties of these systems is essential for an adequate microscopic analysis. Classical transmission and scanning electron microscopic techniques frequently have to be adapted for an accurate analysis of formulation morphology, especially in case of hydrated colloidal systems. Specific techniques such as environmental scanning microscopy or cryo preparation are required for their investigation. Analytical electron microscopic techniques such as electron energy-loss spectroscopy or energy-dispersive X-ray spectroscopy are additional assets to determine the elemental composition of the systems, but are not yet standard tools in pharmaceutical research. This review provides an overview of pharmaceutical systems of interest in current research and strategies for their successful electron microscopic analysis. Advantages and limitations of the different methodological approaches are discussed and recent findings of interest are presented. PMID:22921788

  19. Pharmaceutical crystallization with nanocellulose organogels.

    PubMed

    Ruiz-Palomero, Celia; Kennedy, Stuart R; Soriano, M Laura; Jones, Christopher D; Valcárcel, Miguel; Steed, Jonathan W

    2016-06-14

    Carboxylated nanocellulose forms organogels at 0.3 wt% in the presence of a cationic surfactant. The resulting gels can be used as novel crystallization media for pharmaceutical solid form control, resulting in isolation a new sulfapyridine solvate, morphology modification and crystallization of an octadecylammonium salt of sulfamethoxazole. PMID:27168091

  20. [The development of modern Japanese pharmaceutical industry (Part 3): from 1886 to 1906, coinciding with the era between the institution and issue of Japanese Pharmacopoeia first edition with third edition (JP I-JP III)].

    PubMed

    Yamada, H

    1992-01-01

    The history of the developmental outline of the pharmaceutical industry during the Meiji era, is introduced. The main topics or events in the development are as follows: 1. The establishment of Osaka Pharmaceutical Products, Examination Company; 2. National Institute of Hygiene which was originated from Drug Ruling Institute ("Shiyakujo"); 3. Development of the pharmaceutical industries, especially in East and West Japan ("Kanto and Kansai"); 4. The influences of two big wars (Sino-Japanese War and Russo-Japanese War) on the private pharmaceutical business. And each of them is considered in order to explain the background of the pharmaceutical business during the middle Meiji era. PMID:11639711

  1. Pharmaceutical websites and the communication of risk information.

    PubMed

    Davis, Joel J; Cross, Emily; Crowley, John

    2007-01-01

    This study examines the pharmaceutical websites of 44 leading direct-to-consumer (DTC) advertised drugs to determine the extent to which risk information was completely communicated. Three operational definitions of "completeness" were used: communication of the single highest incidence side effect, communication of top three highest incidence side effects, and communication of side effects with incidence of >or= 10% (all measured in terms of absolute percentage). Results indicated that regardless of the measures used, pharmaceutical websites are unlikely to completely communicate risk information. About two thirds of all sites communicated the single highest incidence side effect or all top three side effects. For drugs with side effects at >or= 10% incidence, only about half of their websites fully reported all effects at this level of incidence. Implications for advertisers and regulatory agencies are presented. PMID:17365347

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

    PubMed

    Ross, Malcolm S F

    2010-04-01

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

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

    PubMed Central

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

    2014-01-01

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

  4. 76 FR 57769 - Advisory Committee on Small and Emerging Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... COMMISSION Advisory Committee on Small and Emerging Companies AGENCY: Securities and Exchange Commission... Commission intends to establish the Securities and Exchange Commission Advisory Committee on Small and... Chief, Office of ] Small Business Policy, Securities and Exchange Commission, 100 F Street,...

  5. 15. Photocopy of original drawing, Bethlehem Steel Company (Bethlehem, PA) ...

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

    15. Photocopy of original drawing, Bethlehem Steel Company (Bethlehem, PA) 1928 (Source: Vermont Agency of Transportation) DETAILS OF PORTALS AND TOP LATERALS - Jeffersonville Bridge, Spanning Lamoille River on Vermont Route 15, Cambridge, Lamoille County, VT

  6. Making history: lessons from the great moments series of pharmaceutical advertisements.

    PubMed

    Metzl, Jonathan M; Howell, Joel D

    2004-11-01

    The authors shed light on present-day pharmaceutical advertisements by looking back to an important early chapter in pharmaceutical company-sponsored promotion: the Great Moments in Medicine and Great Moments in Pharmacy, a series of commercial paintings produced by Parke, Davis & Company between 1948 and 1964. Beginning in the early 1950s, Parke-Davis delivered reproductions of the Great Moments images to physicians and pharmacies throughout the United States and Canada and funded monthly pullout facsimiles in key national magazines. The images also appeared in calendars, popular magazines, and "educational" brochures. By the mid-1960s, articles in both the popular and the medical press lauded the Great Moments for "changing the face of the American doctor's office" while describing the painter, Robert Thom, as the "Norman Rockwell" of medicine. The authors' brief analysis uses source material including popular articles about the Great Moments, existing scholarship, previously unexamined artist's notes, and, ultimately, the images themselves to explain why these seemingly kitschy paintings attained such widespread acclaim. They show how the Great Moments tapped into a 1950s medical climate when doctors were thought of as powerfully independent practitioners, pharmaceutical companies begged the doctor's good graces, and HMOs and health plans were nowhere to be seen. The authors conclude by suggesting that the images offer important lessons for thinking about the many pharmaceutical advertisements that confront present-day doctors, patients, and other consumers. PMID:15504766

  7. 76 FR 36625 - Mutual Holding Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Office of Thrift Supervision Mutual Holding Company AGENCY: Office of Thrift Supervision (OTS), Treasury... Thrift Supervision, 1700 G Street, NW., Washington, DC 20552, by fax to (202) 906-6518, or by e-mail to...'s Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552....

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

    PubMed

    Padamsee, Tasleem Juana

    2011-04-01

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

  9. Mega-mergers in the pharmaceutical industry. In whose interests?

    PubMed

    Po, A L

    1998-10-01

    Companies merge to achieve economies of scale. In an industry such as the pharmaceutical industry which relies on a high level of investment in research and development, such mergers appear rational. However, it is not at all obvious that a higher level of investment by a smaller number of firms will necessarily lead to an increased rate of genuine innovations. There is a risk that conflicts of interest and the pursuit of short term gains may encourage more mergers than is optimal for the industry. The impact of mega-mergers in the pharmaceutical industry on research output, employees, shareholders, financial advisers, managers and patients is discussed. A healthy pharmaceutical industry, able to invest the necessary resources in the development of innovative medicines is in the interest of patients and shareholders alike. Over-concentration may interfere with innovative activity and lead to monopolistic power. Close scrutiny of merger activity is important but in a deregulated world, governments may have little power to act. In any case, a drug-specific monopolistic industry may be beneficial to some countries which may therefore be reluctant to act in the interest of the world as a single community in search of more effective medicines. PMID:10344903

  10. 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

  11. 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

  12. [Transition from Ancient Medicine Materials Traders to Pharmaceutical Manufacturers-- Cases of Gisaburo Shiono Junior and Chobei Takeda the Fifth].

    PubMed

    Yasushi, Shoichiro

    2015-01-01

    The pharmaceutical industry, which developed through the Meiji and Taisho eras, is apparently one of the most important technological industries. However, only a few papers have been published regarding the entrepreneurships of the industry early on. It is crucial to research this subject in order to explore the process of how highly technical companies progressed in the early stage of modern industrialization in Japan. This paper focuses on two distinguished entrepreneurs, Gisaburo Shiono Jr. and Chobei Takeda the Fifth, who were both from the Dosho district of Osaka City. Gisaburo Shiono Jr. founded Shionogi & Co., Ltd. and Chobei Takeda the Fifth founded Takeda Pharmaceutical Company Limited; both of which are currently outstanding companies in the Japanese pharmaceutical market. The paper reveals that the two entrepreneurs started out by importing chemical materials from western Europe and North America, and then expanded their activities into manufacturing pharmaceutical materials in their own firms. Finally, they succeeded in developing their own new medicine products. Their lifetime histories, surveyed along with management activities, are described to clarify the process of each company's development through a few wartime experiences including World War I. Their achievements were quite similar, but the processes used were different. The case of Gisaburo Shiono Jr. shows his risk management skills, which filled his lack of technological leadership. The case of Chobei Takeda the Fifth shows his ability to gradually adapt the company to change throughout a long history of changing environment. PMID:27149784

  13. 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.

  14. 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

  15. Volatile hydrocarbons in pharmaceutical solutions

    SciTech Connect

    Kroneld, R. )

    1991-07-01

    Volatile pollutants such as hydrocarbons have, during many years, been analysed in small concentrations in air, water, food, pharmaceutical solutions, and human blood and tissues. It has also been shown that such substances have unexpected consequences for cell cultures and scientific experiments. These substances also accumulate in patients receiving haemodialysis and these patients are exposed to quite high concentrations. The knowledge of the toxicity of such compounds has led to the development of maximum limit concentrations with the aim to decrease the exposure of humans. This paper discusses the problems of human exposure in general and especially through pharmaceutical solutions, and the possibilities of eliminating such compounds with the aim of decreasing the exposure as a hygienic challenge.

  16. 78 FR 58315 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  17. 76 FR 38188 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  18. 76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  19. 75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  20. 75 FR 11551 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  1. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ...The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced......

  2. 76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  3. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  4. 77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  5. 76 FR 25353 - Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment AGENCY... unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations... comment--including your name and your state--will be placed on the public record of this...

  6. 78 FR 58314 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  7. Pharmaceutical cocrystals: walking the talk.

    PubMed

    Bolla, Geetha; Nangia, Ashwini

    2016-06-28

    Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future. PMID:27278109

  8. 76 FR 59590 - Airworthiness Directives; The Boeing Company Airplanes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... 28, 2005 (70 FR 12119, March 11, 2005). Applicability (c) This AD applies to The Boeing Company Model... Directives; The Boeing Company Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice... FR 10917, March 9, 2004), for certain Model 767-200 and -300 series airplanes. That AD...

  9. 75 FR 18908 - Jackson National Life Insurance Company, et al.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... Eisenstein, Branch Chief, at (202) 551-6795, Office of Insurance Products, Division of Investment Management... COMMISSION Jackson National Life Insurance Company, et al. April 7, 2010. AGENCY: The Securities and Exchange... National Life Insurance Company (``Jackson National''), Jackson National Separate Account--I (the...

  10. 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

  11. 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

  12. 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

  13. Attitude and practice of dental surgeons towards pharmaceutical companies’ marketing gifts

    PubMed Central

    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

  14. Nanotechnology and pharmaceutical inhalation aerosols.

    PubMed

    Patel, A R; Vavia, P R

    2007-02-01

    Pharmaceutical inhalation aerosols have been playing a crucial role in the health and well being of millions of people throughout the world for many years. The technology's continual advancement, the ease of use and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years. But administration of drugs by the pulmonary route is technically challenging because oral deposition can be high, and variations in inhalation technique can affect the quantity of drug delivered to the lungs. Recent advances in nanotechnology, particularly drug delivery field have encouraged formulation scientists to expand their reach in solving tricky problems related to drug delivery. Moreover, application of nanotechnology to aerosol science has opened up a new category of pharmaceutical aerosols (collectively known as nanoenabled-aerosols) with added advantages and effectiveness. In this review, some of the latest approaches of nano-enabled aerosol drug delivery system (including nano-suspension, trojan particles, bioadhesive nanoparticles and smart particle aerosols) that can be employed successfully to overcome problems of conventional aerosol systems have been introduced. PMID:17375556

  15. 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.

  16. Pharmaceutical study of Lauha Bhasma

    PubMed Central

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

    2010-01-01

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

  17. 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 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like "pakwa jambu phala varna," varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta. PMID:22131745

  18. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovská, Kateřina; Křesálek, Vojtěch

    2015-10-01

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

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

    PubMed

    Burgess, G L; Mashingaidze, M T

    1999-11-01

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

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

    PubMed Central

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-01-01

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

  1. "Does organizational culture influence the ethical behavior in the pharmaceutical industry?".

    PubMed

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-12-01

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

  2. In Silico Models for Ecotoxicity of Pharmaceuticals.

    PubMed

    Roy, Kunal; Kar, Supratik

    2016-01-01

    Pharmaceuticals and their active metabolites are one of the significantly emerging environmental toxicants. The major routes of entry of pharmaceuticals into the environment are industries, hospitals, or direct disposal of unwanted or expired drugs made by the patient. The most important and distinct features of pharmaceuticals are that they are deliberately designed to have an explicit mode of action and designed to exert an effect on humans and other living systems. This distinctive feature makes pharmaceuticals and their metabolites different from other chemicals, and this necessitates the evaluation of the direct effects of pharmaceuticals in various environmental compartments as well as to living systems. In this background, the alarming situation of ecotoxicity of diverse pharmaceuticals have forced government and nongovernment regulatory authorities to recommend the application of in silico methods to provide quick information about the risk assessment and fate properties of pharmaceuticals as well as their ecological and indirect human health effects. This chapter aims to offer information regarding occurrence of pharmaceuticals in the environment, their persistence, environmental fate, and toxicity as well as application of in silico methods to provide information about the basic risk management and fate prediction of pharmaceuticals in the environment. Brief ideas about toxicity endpoints, available ecotoxicity databases, and expert systems employed for rapid toxicity predictions of ecotoxicity of pharmaceuticals are also discussed. PMID:27311470

  3. 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.

  4. 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

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

    PubMed

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

    2005-01-01

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

  6. [Innovation in pharmaceutical and health biotechnology industries: challenges for a virtuous agenda].

    PubMed

    Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José

    2012-12-01

    Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil. PMID:23532311

  7. 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...

  8. New strategies for pharmaceutical design.

    PubMed

    Gillmor, S A; Cohen, F E

    1993-01-01

    Parallel synthesis and testing procedures are being investigated to shorten the drug design and discovery process. These procedures have focused on peptides and nucleotides, although these compounds are unlikely to be useful therapeutics because of their low bioavailability and sensitivity to enzymatic degradation. More recently, the use of other modular systems with distinct linking chemistries have been explored. Structural data combined with computational screens of compound databases provides an alternative method to identify novel nonpeptide pharmaceuticals. When structural information is not available, homology-based models have proved to be sufficient to identify nonpeptide inhibitors active at low micromolar concentrations against important enzymes in parasite life cycles. PMID:8167566

  9. Posttraumatic stress disorder, drug companies, and the Internet.

    PubMed

    Mansell, Penny; Read, John

    2009-01-01

    The public increasingly acquires information about the causes of, and treatments for, mental health problems from the Internet. This study investigated the top 54 websites about posttraumatic stress disorder (PTSD) in Google and Yahoo! to assess differences in the content of websites funded and not funded by drug companies. In all, 42% of the websites received drug company funding. There was no relationship found between the causes stated and whether the website was drug company funded. Drug company-funded websites, however, gave significantly more emphasis to medication in the treatment of PTSD. This study confirms an earlier study indicating that the pervasive influence of the pharmaceutical industry in the mental health field, designed to maximize product sales, now includes information available to the public via the Internet. PMID:19197709

  10. 76 FR 69752 - Agency Information Collection Activities: Proposed Collection; Comment Request, Write Your Own...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-09

    ..., mechanical, or other technological collection techniques or other forms of information technology, e.g... Your Own (WYO) Company Participation Criteria; New Applicant. Type of Information Collection: Extension... SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Proposed...

  11. Entrepreneurial patent management in pharmaceutical startups.

    PubMed

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

    Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. PMID:26948802

  12. Specialty pharmaceuticals: developing a management plan.

    PubMed

    Willcutts, Dave

    2002-01-01

    This is the first in a series of articles that address the complex issues associated with specialty pharmaceuticals in the development of a successful specialty pharmaceutical program, a critical component of managing this high-cost and highly fragmented sector. This article focuses on how to define specialty pharmaceuticals. Other articles in this series will explore such topics as the mechanics of developing and managing a specialty pharmaceutical program, how and when to establish clinical protocols and authorizations, the importance of data management, and the benefits from automated processes. PMID:12561391

  13. The use of natural and synthetic phospholipids as pharmaceutical excipients*

    PubMed Central

    van Hoogevest, Peter; Wendel, Armin

    2014-01-01

    In pharmaceutical formulations, phospholipids obtained from plant or animal sources and synthetic phospholipids are used. Natural phospholipids are purified from, e.g., soybeans or egg yolk using non-toxic solvent extraction and chromatographic procedures with low consumption of energy and minimum possible waste. Because of the use of validated purification procedures and sourcing of raw materials with consistent quality, the resulting products differing in phosphatidylcholine content possess an excellent batch to batch reproducibility with respect to phospholipid and fatty acid composition. The natural phospholipids are described in pharmacopeias and relevant regulatory guidance documentation of the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Synthetic phospholipids with specific polar head group, fatty acid composition can be manufactured using various synthesis routes. Synthetic phospholipids with the natural stereochemical configuration are preferably synthesized from glycerophosphocholine (GPC), which is obtained from natural phospholipids, using acylation and enzyme catalyzed reactions. Synthetic phospholipids play compared to natural phospholipid (including hydrogenated phospholipids), as derived from the number of drug products containing synthetic phospholipids, a minor role. Only in a few pharmaceutical products synthetic phospholipids are used. Natural phospholipids are used in oral, dermal, and parenteral products including liposomes. Natural phospholipids instead of synthetic phospholipids should be selected as phospholipid excipients for formulation development, whenever possible, because natural phospholipids are derived from renewable sources and produced with more ecologically friendly processes and are available in larger scale at relatively low costs compared to synthetic phospholipids. Practical applications: For selection of phospholipid excipients for pharmaceutical formulations, natural phospholipids are preferred

  14. 76 FR 14970 - National Starch and Chemical Company, Salisbury, Rowan County, NC; Notice of Settlement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-18

    ... AGENCY National Starch and Chemical Company, Salisbury, Rowan County, NC; Notice of Settlement AGENCY... National Starch and Chemical Company Site located in Mobile, Mobile County, Alabama for publication. DATES..., identified by Docket ID No. EPA-RO4- SFUND-2011-0278 or Site name National Starch and Chemical...

  15. 77 FR 47840 - American Drum and Pallet Company Site; Memphis, Shelby County, Tennessee; Notice of settlement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-10

    ... AGENCY American Drum and Pallet Company Site; Memphis, Shelby County, Tennessee; Notice of settlement... Agency has entered into a settlement for past response costs concerning the American Drum and Pallet... Drum and Pallet Company Site by one of the following methods:...

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

    PubMed Central

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

    2004-01-01

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

  17. [Eprus, an agency to respond to health emergencies].

    PubMed

    de Bort, Clara

    2015-01-01

    The Health Emergency Preparedness and Response Agency (Eprus) was created by the French ministry in charge of the health. It manages on behalf of the state, human, pharmaceutical and logistical resources which can be used in the event of exceptional health situations, in France and abroad. PMID:26145996

  18. The 2002 PhRMA Code and Pharmaceutical Marketing: did anybody bother to ask the reps?

    PubMed

    Sillup, George P; Trombetta, Bill; Klimberg, Ronald

    2010-10-01

    After marketing tactics resulted in $1.2 billion fines, the 2002 PhRMA Code attempted to standardize marketing and sales practices. Self-regulation had varied success by other industries and by pharmaceutical industries in other countries. Similarly, the Code addressed negative responses about pharmaceutical's practices but had no provisions for monitoring violations. Representative's (reps) perspectives were assessed using an 18-item instrument with 72 reps from 25 companies. Analyses indicated that reps from bigger companies, PhRMA and non-PhRMA, adhered better. The way reps adhered was split between adhering reluctantly and following faithfully. Two thirds felt it was more difficult to do their jobs, resulting from prior entertainment-based relationships with physicians. PMID:21058100

  19. 77 FR 553 - Surety Companies Acceptable on Federal Bonds: Amendment-Evergreen National Indemnity Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-05

    ..., 2011, at 76 FR 38892. FOR FURTHER INFORMATION CONTACT: Surety Bond Branch at (202) 874-6850... 20782. Dated: December 20, 2011. Laura Carrico, Director, Financial Accounting and Services Division... Company AGENCY: Financial Management Service, Fiscal Service, Department of the Treasury. ACTION:...

  20. 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

  1. 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

  2. Your business in court and at federal agencies: 2010 - 2011.

    PubMed

    Reiss, John B; Crowder, Dawn; Simons, Brian; Pleskov, Igor; Davis, Tiffany; Nugent, Patrick

    2012-01-01

    This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA). In addition, the government pursued actions against individual executives under the Responsible Corporate Officer Doctrine ("RCO Doctrine") because it does not believe sanctions against the companies provide sufficient deterrence to inappropriate behavior. Companies need to focus on implementing effective compliance programs in order to prevent the occurrence of allegedly improper activity. It should be noted that the existence of an effective program will not protect executives from liability under the RCO Doctrine if improper behavior takes place. The Food and Drug Administration's (FDA's) has undertaken a number of initiatives during the past year in an attempt to counter claims that its review processes for domestic products is driving the development of drugs and devices to overseas markets. The Agency also has improved its capacity to review products imported from overseas by undertaking initiatives with foreign agencies and stationing more FDA employees in foreign countries. The FDA increased the number of warning letters and other enforcement actions. The FDA added two new topics of enhanced authority during the year. One was an expansion of its regulatory authority over foods, and the second was new authority to regulate certain tobacco products. The former is being subjected to some review by the courts, and the scope of its authority over tobacco is the subject of ongoing major litigation. The Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) are unlikely to experience significant change regarding their regulation of Manufacturers. The FTC, as it has for many years, continues to try to prevent "reverse" payments to generic drug manufacturers by Innovator Manufacturers to diminish generic drug competition, and proposed legislation is

  3. 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

  4. 76 FR 37194 - Surety Companies Acceptable on Federal Bonds; Change in State of Incorportation, Business Address...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Revision published July 1, 2010 at 75 FR 38192. FOR FURTHER INFORMATION CONTACT: Surety Bond Branch at (202.... Paul Mercury Insurance Company AGENCY: Financial Management Service, Fiscal Service, Department of the... Company (24767), St. Paul Guardian Insurance Company (24775) and St. Paul Mercury Insurance (24791)...

  5. 78 FR 30941 - Frank Russell Company, et al.; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... COMMISSION Frank Russell Company, et al.; Notice of Application May 17, 2013. AGENCY: Securities and Exchange Commission (``Commission''). ACTION: Notice of an application under section 6(c) of the Investment Company... relief from certain disclosure requirements. Applicants: Frank Russell Company (``Russell''),...

  6. 77 FR 38619 - Idaho Power Company; Notice of Application for Amendment of License and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-28

    ... Energy Regulatory Commission Idaho Power Company; Notice of Application for Amendment of License and...: Idaho Power Company. e. Name of Project: Bliss Hydroelectric Project. f. Location: The project is... agency. k. Description of the Application: Idaho Power Company, licensee of the Bliss...

  7. 77 FR 38618 - Idaho Power Company; Notice of Application for Amendment of License and Soliciting Comments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-28

    ... Energy Regulatory Commission Idaho Power Company; Notice of Application for Amendment of License and...: Idaho Power Company. e. Name of Project: Lower Salmon Falls Hydroelectric Project. f. Location: The... agency. k. Description of the Application: Idaho Power Company, licensee of the Lower Salmon...

  8. 78 FR 75581 - Minnesota Life Insurance Company, et al.; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... COMMISSION Minnesota Life Insurance Company, et al.; Notice of Application December 6, 2013. AGENCY: The.... Applicants: Minnesota Life Insurance Company (``Minnesota Life'' or ``Insurance Company''), Variable Annuity...., Washington, D.C. 20549- 1090. Applicants, c/o Daniel P. Preiner, Counsel, Minnesota Life Insurance...

  9. 75 FR 27377 - Jackson National Life Insurance Company of New York, et al.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ... COMMISSION Jackson National Life Insurance Company of New York, et al. May 10, 2010. AGENCY: The Securities.... Applicants: Jackson National Life Insurance Company of New York (``JNL New York''), JNLNY Separate Account I... Jackson National Life Insurance Company of New York, 1 Corporate Way, Lansing, Michigan 48951,...

  10. 78 FR 5841 - Symetra Life Insurance Company, et al.; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-28

    ... COMMISSION Symetra Life Insurance Company, et al.; Notice of Application January 22, 2013. AGENCY: Securities... rule 12d1-2 under the Act to invest in certain financial instruments. Applicants: Symetra Life Insurance Company (``Symetra''), First Symetra National Life Insurance Company of New York (``First...

  11. 78 FR 24249 - Lincoln National Life Insurance Company, et al; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... Account; or (ii) in the judgment of the Insurance Company's management, further investment in such... COMMISSION Lincoln National Life Insurance Company, et al; Notice of Application April 18, 2013 AGENCY... the Act from Section 17(a) of the Act. APPLICANTS: Lincoln National Life Insurance Company...

  12. 78 FR 62716 - Pacific Life Insurance Company, et al; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-22

    ... COMMISSION Pacific Life Insurance Company, et al; Notice of Application October 17, 2013. AGENCY: Securities... 1940, as amended (the ``1940 Act''). Applicants: Pacific Life Insurance Company (``Pacific Life... Street NE., Washington, DC 20549-1090. Applicants: Pacific Life Insurance Company, Separate Account A...

  13. 77 FR 9708 - Pacific Life Insurance Company, et al.; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... COMMISSION Pacific Life Insurance Company, et al.; Notice of Application February 13, 2012. AGENCY... rule 12d1-2 under the Act to invest in certain financial instruments. Applicants: Pacific Life Insurance Company (``Pacific Life''), Pacific Life & Annuity Company (``PL&A,'' and collectively...

  14. 75 FR 39589 - Nationwide Life Insurance Company,et al.; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... COMMISSION Nationwide Life Insurance Company, et al.; Notice of Application July 2, 2010. AGENCY: The... thereunder. Applicants: Nationwide Life Insurance Company (``NWL''); Nationwide Variable Account-II (the... life insurance company organized under the laws of the State of Ohio.\\1\\ NWL offers traditional...

  15. 78 FR 8601 - AXA Equitable Life Insurance Company, et al; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... COMMISSION AXA Equitable Life Insurance Company, et al; Notice of Application January 31, 2013. AGENCY... the Act from Section 17(a) of the Act. Applicants: AXA Equitable Life Insurance Company (``AXA... Equitable Life Insurance Company, 1290 Avenue of Americas, New York, New York 10104; Patricia Louie,...

  16. [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

  17. 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

  18. Cannabis-based medicines--GW pharmaceuticals: high CBD, high THC, medicinal cannabis--GW pharmaceuticals, THC:CBD.

    PubMed

    2003-01-01

    GW Pharmaceuticals is undertaking a major research programme in the UK to develop and market distinct cannabis-based prescription medicines [THC:CBD, High THC, High CBD] in a range of medical conditions. The cannabis for this programme is grown in a secret location in the UK. It is expected that the product will be marketed in the US in late 2003. GW's cannabis-based products include selected phytocannabinoids from cannabis plants, including D9 tetrahydrocannabinol (THC) and cannabidiol (CBD). The company is investigating their use in three delivery systems, including sublingual spray, sublingual tablet and inhaled (but not smoked) dosage forms. The technology is protected by patent applications. Four different formulations are currently being investigated, including High THC, THC:CBD (narrow ratio), THC:CBD (broad ratio) and High CBD. GW is also developing a specialist security technology that will be incorporated in all its drug delivery systems. This technology allows for the recording and remote monitoring of patient usage to prevent any potential abuse of its cannabis-based medicines. GW plans to enter into agreements with other companies following phase III development, to secure the best commercialisation terms for its cannabis-based medicines. In June 2003, GW announced that exclusive commercialisation rights for the drug in the UK had been licensed to Bayer AG. The drug will be marketed under the Sativex brand name. This agreement also provides Bayer with an option to expand their license to include the European Union and certain world markets. GW was granted a clinical trial exemption certificate by the Medicines Control Agency to conduct clinical studies with cannabis-based medicines in the UK. The exemption includes investigations in the relief of pain of neurological origin and defects of neurological function in the following indications: multiple sclerosis (MS), spinal cord injury, peripheral nerve injury, central nervous system damage, neuroinvasive

  19. 78 FR 48871 - Proposed Agency Information Collection Activities; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-12

    ... FR Y-9, by any of the following methods: Agency Web site: http://www.federalreserve.gov . Follow the... the proper performance of the Federal Reserve's functions; including whether the information has... not being revised: the Parent Company Only Financial Statements for Large Bank Holding Companies (FR...

  20. 78 FR 16502 - Proposed Agency Information Collection Activities; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-15

    ... covered companies), which was published in the Federal Register on October 12, 2012 (77 FR 62396) (12 CFR...: Comments must be submitted on or before May 14, 2013. ADDRESSES: You may submit comments, identified by FR...: Annual Company-Run Stress Test Projections. Agency form number: FR Y-16. OMB control number: 7100-to...

  1. 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

  2. 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

  3. 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

  4. 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…

  5. 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

  6. 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

  7. 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

  8. Developing a pharmaceutical purchasing strategy.

    PubMed

    Hynniman, C E

    1992-09-01

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

  9. The secret things belong unto the Lord our God: secrecy in the pharmaceutical arena.

    PubMed

    Lexchin, Joel

    2007-09-01

    Secrecy in the pharmaceutical arena has taken on more importance in the recent past as the pharmaceutical industry has assumed greater prominence in the funding of clinical research and has also become a funder of the agencies that are charged with regulating it. Governments have adopted a neo-liberal agenda that prioritizes private profit over public health and are therefore willing to let industry set the research agenda. As a result, secrecy, to protect intellectual property rights, is a major feature of clinical research. Secrecy also leads to biases in the published literature that conceal significant safety problems. Because regulators are now partially dependent on the pharmaceutical industry for their existence regulators are unwilling to challenge industry. By treating data on efficacy and safety as commercially confidential information they effectively collude with industry in denying health professionals and the public access to essential information to be able to use drugs appropriately. PMID:17970243

  10. The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation.

    PubMed

    Pignatti, Francesco; Gravanis, Iordanis; Herold, Ralf; Vamvakas, Spiros; Jonsson, Bertil; Marty, Michel

    2011-08-15

    The European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union (EU). Since 2005, the agency has become responsible for the approval of all new oncology drugs in the EU. In this article we describe the mission, role, and responsibilities of the EMA, and provide a brief summary of recent initiatives related to cancer drug regulation. The EMA recently published its Road Map to 2015. Over the next 5 years, the agency aims to continue to stimulate drug development in areas of unmet medical needs. Concerning drug safety, one of the priorities over the next few years will be to establish a more proactive approach in ensuring patient safety. This is the result of new EU legislation coming into force in 2012 that will strengthen the way the safety of medicines for human use is monitored in the EU. In terms of its general operation, the agency is committed to increased openness and transparency, and to build on its interactions with stakeholders, including members of academia, health care professionals, patients, and health technology assessment bodies. The agency recently created an oncology working party to expand the current guideline for the development and evaluation of cancer drugs. The guideline focuses on both exploratory and confirmatory studies for different types of agents. The current revision will address a number of topics, including the use of biomarkers as an integrated part of drug development and the use of progression-free survival as a primary endpoint in registration trials. PMID:21844037

  11. High Speed Video Applications In The Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Stapley, David

    1985-02-01

    The pursuit of quality is essential in the development and production of drugs. The pursuit of excellence is relentless, a never ending search. In the pharmaceutical industry, we all know and apply wide-ranging techniques to assure quality production. We all know that in reality none of these techniques are perfect for all situations. We have all experienced, the damaged foil, blister or tube, the missing leaflet, the 'hard to read' batch code. We are all aware of the need to supplement the traditional techniques of fault finding. This paper shows how high speed video systems can be applied to fully automated filling and packaging operations as a tool to aid the company's drive for high quality and productivity. The range of products involved totals some 350 in approximately 3,000 pack variants, encompassing creams, ointments, lotions, capsules, tablets, parenteral and sterile antibiotics. Pharmaceutical production demands diligence at all stages, with optimum use of the techniques offered by the latest technology. Figure 1 shows typical stages of pharmaceutical production in which quality must be assured, and highlights those stages where the use of high speed video systems have proved of value to date. The use of high speed video systems begins with the very first use of machine and materials: commissioning and validation, (the term used for determining that a process is capable of consistently producing the requisite quality) and continues to support inprocess monitoring, throughout the life of the plant. The activity of validation in the packaging environment is particularly in need of a tool to see the nature of high speed faults, no matter how infrequently they occur, so that informed changes can be made precisely and rapidly. The prime use of this tool is to ensure that machines are less sensitive to minor variations in component characteristics.

  12. 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

  13. Utility company views of geothermal development

    NASA Technical Reports Server (NTRS)

    Hinrichs, T. C.

    1974-01-01

    The views of geothermal development from a utility company standpoint are presented. The impediments associated with such developments as required reliability and identification of risks are discussed. The utility industry historically is not a risk-taking industry. Support of rapid geothermal development by the utility industry requires identification and elimination of risks or absorption of the risks by other agencies. Suggestions as to the identification and minimization of risks are made.

  14. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

    PubMed

    Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel

    2015-12-01

    The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively. PMID:26627049

  15. Companies as Business Laboratories.

    ERIC Educational Resources Information Center

    Rebernik, Miroslav

    2002-01-01

    Describes a business education program whose underlying philosophy is that business education for students who will be employed by smaller companies which feature de-specialization of job tasks, resource poverty, and self-employment must be different from business education for larger companies. (EV)

  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. 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

  18. 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

  19. 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

  20. 2nd International China BioPharmaceutical Symposium.

    PubMed

    Soule, Mason H; Robinson, David M; Price, Richard M; Saunders-Price, Barbara

    2009-03-01

    In the second of what promises to become a biennial event (the first was held at the same time and venue in 2006), the ICBPS-2 was a repeat collaboration between the two principal organizers: the Chinese Pharmaceutical Association (CPA) of Beijing, China, and the Battelle Memorial Institute, headquartered in Columbus, OH, USA. The CPA is the regulatory and professional body for pharmacists and pharmaceutical scientists in China and is closely aligned with China's State Food and Drug Administration (SFDA). Battelle is an international technology development company and is the world's largest nonprofit independent research and development organization. Applied Science and Analysis, Inc. (HI, USA), assisted Battelle and the CPA in organizing and managing the ICBPS-2. The meeting's main objective was to continue the introduction of Western biotech firms and regulatory entities into the Chinese biopharmaceutical industry initiated at the 2006 symposium. The principal themes of the second gathering were vaccines, antibodies and gene therapeutics. Approximately 40 mainly scientific or policy papers were delivered to an audience of approximately 150 participants, including 50 attendees from outside China. PMID:24410648

  1. 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

  2. Schizophrenia, drug companies and the internet.

    PubMed

    Read, John

    2008-01-01

    To investigate differences in the content of websites funded, and not funded, by drug companies, the top 50 websites about 'schizophrenia' in Google and Yahoo were analysed in relation to five variables: three scales relating to causes, treatments and violence, and two categorical variables about the condition being extremely severe and about linking coming off medication to violence. Fifty eight percent of the websites analysed received funding from drug companies. Drug company funded websites were significantly more likely to espouse bio-genetic rather than psycho-social causal explanations, to emphasise medication rather than psycho-social treatments, to portray 'schizophrenia' as a debilitating, devastating and long-term illness, and to link violence to coming off medication. They were neither more nor less likely to describe 'schizophrenics' as violent. These results suggest that the documented influence of the pharmaceutical industry over research, professional organisations, teaching institutions, clinical practice and regulatory bodies may now extend to public promotion, via the internet, of perspectives conducive to maximisation of sales. PMID:17826878

  3. The mortality of companies.

    PubMed

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

    2015-05-01

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

  4. 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

  5. 31 CFR 223.18 - Performance of agency obligations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 2 2011-07-01 2011-07-01 false Performance of agency obligations. 223.18 Section 223.18 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... WITH THE UNITED STATES § 223.18 Performance of agency obligations. (a) Every company shall...

  6. 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

  7. 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

  8. 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

  9. Proposing a redefinition of pharmaceutical care.

    PubMed

    Blackburn, David F; Yakiwchuk, Erin M; Jorgenson, Derek J; Mansell, Kerry D

    2012-03-01

    In many clinical practice settings, individual pharmaceutical care practitioners have thousands of patients who may receive their service. However, the pharmaceutical care approach provides virtually no guidance regarding how patients should be identified or prioritized by practicing pharmacists. We believe that pharmacists need to be "officially" accountable to specific patient groups at high risk for drug- or disease-induced morbidity within their practice. Consequently, the current definition of pharmaceutical care and its associated care processes need to be modified to ensure the activities of pharmacists are being focused on high-priority patients on a consistent basis. PMID:22395251

  10. Metrology in Pharmaceutical Industry - A Case Study

    NASA Astrophysics Data System (ADS)

    Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

    2016-07-01

    Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area.

  11. Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.

    PubMed

    Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

    2014-01-01

    Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. PMID:25342901

  12. Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

    PubMed Central

    Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

    2014-01-01

    Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. PMID:25342901

  13. Examination of Electric Utility CEO Compensation 2000-2011 and its significance to Company Earnings, Company Revenue, Company Stock and the Dow Jones Utility Average

    NASA Astrophysics Data System (ADS)

    Labovitch, Andrew

    This dissertation examined electric utility CEO compensation during the years 2000 through 2011 for United States owned and operated companies. To determine the extent to which agency theory may apply to electric utility CEO compensation, this examination segmented the industry by four types of company financial metrics: revenue, earnings, stock price and the Dow Jones Utility Average; by five categories of CEO compensation: base salary, bonus, stock grants, all other compensation and total compensation; and by four categories of company size as measured by revenue: large, medium, small and the industry as a whole. Electric utility CEO compensation data was analyzed with the financial metrics to determine correlations. No type of compensation was highly correlated to any of the financial metrics for any size industry segment indicating that there was little agency. CEO compensation in large electric utility companies was higher than compensation in medium and smaller companies even though the CEOs at larger companies earned less per dollar of revenue and per dollar of earnings than their counterparts in smaller companies.

  14. 75 FR 18208 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ...: Census of Finance Companies. Agency form number: FR 3033p. OMB control number: 7100-0277. Frequency: One... Freedom of Information Act (5 U.S.C. 552). Abstract: The FR 3033 information collection includes the Census of Finance Companies (FR 3033p) and the Quinquennial Finance Company Survey (FR 3033s). The...

  15. 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

  16. 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

  17. The devil is in the details: the pharmaceutical industry's use of gifts to physicians as marketing strategy.

    PubMed

    McFadden, David W; Calvario, Elizabeth; Graves, Cynthia

    2007-06-01

    Marketing costs exceed 30% of revenues for the pharmaceutical industry, with over 90% of the effort aimed at physicians. Although there are currently unprecedented numbers of regulatory activities focusing on relationships between the pharmaceutical industry and the medical profession, such legislation is often unrecognized or flouted. The potential influence, although minimized by both parties, must not be ignored. Physicians and drug companies will need to re-evaluate their responsibilities to their patients and their shareholders, and both groups should assume proactive and guidance roles in the transformation. PMID:17481979

  18. 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

  19. 78 FR 11638 - Michigan Consolidated Gas Company, DTE Gas Company, DTE Gas Company; Notice of Petition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

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

  20. 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

  1. Pharmacogenetics and the pharmaceutical industry.

    PubMed

    Raaijmakers, Jan A M; Koster, Ellen S; Maitland-van der Zee, Anke-Hilse

    2010-01-01

    The detailed knowledge of the human genome has not fulfilled its promise as yet. It seems fair to say that we are far from treating existing diseases by therapeutic interventions developed on the basis of genetic knowledge. However, pharmacogenetics has shown to be useful in improving our understanding of pharmacotherapy. Industry is starting to embed this knowledge in the design of innovative drugs and there are three important areas of interest: safety, efficacy and target identification. Application of pharmacogenetics e.g. in patient selection are leading to the direction of more personalised medicine. The future will bring more of such applications. However, current knowledge also leads to a more integrated approach of pharmacogenetics as part of systems biology, providing an even more complete image of reality surrounding disease and therapy, including for example environmental factors and behaviour. In addition, collaborative efforts with academic partners are very much welcomed by the pharmaceutical industry and are expected to have a synergistic effect on progression in this field. PMID:20205665

  2. New insights in pharmaceutical analysis.

    PubMed

    Guillarme, Davy; Schappler, Julie; Boccard, Julien; Veuthey, Jean-Luc; Rudaz, Serge

    2012-01-01

    The research unit of pharmaceutical analytical chemistry (PAC) has been active in the field of separation sciences for many years. Liquid chromatography (LC) and its latest improvements such as ultra-high performance chromatography (UHPLC) and supercritical fluid chromatography (SFC) are deeply and thoroughly studied, from a fundamental viewpoint to its various application capabilities. Electro-driven separations such as capillary electrophoresis (CE) are also a major field of interest, especially for macromolecules, and low cost. All these techniques are investigated with various detection modes including mass spectrometry (MS) for various applications where high sensitivity and selectivity is needed. Extracting the relevant information from the overwhelming amount of data generated by modern analytical platforms has become an important issue for knowledge discovery in various research fields. The appropriate treatment of such data is therefore of crucial importance to provide valuable information. Numerous works in our research group have demonstrated the usefulness of statistical and mathematical methodologies to improve quality of the results. Therefore, well-established chemometric approaches (e.g. design of experiments, multivariate data analysis, etc.) are implemented to optimize the analytical process from method development to data analysis. PMID:22867546

  3. MULTIFUNCTIONAL AND STIMULI-SENSITIVE PHARMACEUTICAL NANOCARRIERS

    PubMed Central

    Torchilin, Vladimir

    2011-01-01

    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; stimili-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 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

  4. 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.

  5. 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...

  6. 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

  7. 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 ...

  8. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

    EPA Science Inventory

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

  9. The Telephone Company Agrees

    ERIC Educational Resources Information Center

    Stokes, Rembert R.

    1975-01-01

    A representative of the American Telephone and Telegraph Company responds to a statement by the director of the National Institute for Rehabilitation Engineering on telephone communication systems for the hearing impaired. (GW)

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

    NASA Astrophysics Data System (ADS)

    Wu, Huiquan; Khan, Mansoor

    2012-08-01

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

  11. Methods for handling uncertainty within pharmaceutical funding decisions

    NASA Astrophysics Data System (ADS)

    Stevenson, Matt; Tappenden, Paul; Squires, Hazel

    2014-01-01

    This article provides a position statement regarding decision making under uncertainty within the economic evaluation of pharmaceuticals, with a particular focus upon the National Institute for Health and Clinical Excellence context within England and Wales. This area is of importance as funding agencies have a finite budget from which to purchase a selection of competing health care interventions. The objective function generally used is that of maximising societal health with an explicit acknowledgement that there will be opportunity costs associated with purchasing a particular intervention. Three components of uncertainty are discussed within a pharmaceutical funding perspective: methodological uncertainty, parameter uncertainty and structural uncertainty, alongside a discussion of challenges that are particularly pertinent to health economic evaluation. The discipline has focused primarily on handling methodological and parameter uncertainty and a clear reference case has been developed for consistency across evaluations. However, uncertainties still remain. Less attention has been given to methods for handling structural uncertainty. The lack of adequate methods to explicitly incorporate this aspect of model development may result in the true uncertainty surrounding health care investment decisions being underestimated. Research in this area is ongoing as we review.

  12. [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

  13. Rejection of pharmaceuticals by forward osmosis membranes.

    PubMed

    Jin, Xue; Shan, Junhong; Wang, Can; Wei, Jing; Tang, Chuyang Y

    2012-08-15

    Rejection of four pharmaceutical compounds, carbamazepine, diclofenac, ibuprofen and naproxen, by forward osmosis (FO) membranes was investigated in this study. For the first time, the rejection efficiency of the pharmaceutical compounds was compared between commercial cellulose triacetate (CTA) based membranes and thin film composite (TFC) polyamide based membranes. The rejection behavior was related to membrane interfacial properties, physicochemical characteristics of the pharmaceutical molecules and feed solution pH. TFC polyamide membranes exhibited excellent overall performance, with high water flux, excellent pH stability and great rejection of all pharmaceuticals investigated (>94%). For commercial CTA based FO membranes, hydrophobic interaction between the compounds and membranes exhibited strong influence on their rejection under acidic conditions. The pharmaceuticals rejection was well correlated to their hydrophobicity (log D). Under alkaline conditions, both electrostatic repulsion and size exclusion contributed to the removal of deprotonated molecules. The pharmaceuticals rejection by CTA-HW membrane at pH 8 followed the order: diclofenac (99%)>carbamazepine (95%)>ibuprofen (93%) ≈ naproxen (93%). These results can be important for FO membrane synthesis, modification and their application in water purification. PMID:22640821

  14. Bromination of selected pharmaceuticals in water matrices.

    PubMed

    Benitez, F Javier; Acero, Juan L; Real, Francisco J; Roldan, Gloria; Casas, Francisco

    2011-11-01

    The bromination of five selected pharmaceuticals (metoprolol, naproxen, amoxicillin, phenacetin, and hydrochlorothiazide) was studied with these compounds individually dissolved in ultra-pure water. The apparent rate constants for the bromination reaction were determined as a function of the pH, obtaining the sequence amoxicillin>naproxen>hydrochlorothiazide≈phenacetin≈metoprolol. A kinetic mechanism specifying the dissociation reactions and the species formed for each compound according to its pK(a) value and the pH allowed the intrinsic rate constants to be determined for each elementary reaction. There was fairly good agreement between the experimental and calculated values of the apparent rate constants, confirming the goodness of the proposed reaction mechanism. In a second stage, the bromination of the selected pharmaceuticals simultaneously dissolved in three water matrices (a groundwater, a surface water from a public reservoir, and a secondary effluent from a WWTP) was investigated. The pharmaceutical elimination trend agreed with the previously determined rate constants. The influence of the main operating conditions (pH, initial bromine dose, and characteristics of the water matrix) on the degradation of the pharmaceuticals was established. An elimination concentration profile for each pharmaceutical in the water matrices was proposed based on the use of the previously evaluated apparent rate constants, and the theoretical results agreed satisfactorily with experiment. Finally, chlorination experiments performed in the presence of bromide showed that low bromide concentrations slightly accelerate the oxidation of the selected pharmaceuticals during chlorine disinfection. PMID:21906777

  15. 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

  16. 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

  17. The future for pharmaceuticals in a health care crisis.

    PubMed

    Redwood, H

    1989-02-01

    When an industry reaches a turning point, everyone in it is drawn into the turmoil. Not that it happens frequently, but most industries pass more than one major turning point in the course of an executive career of average length. The experience is unsettling--especially if preceded by a general reluctance to anticipate it or its consequences. Corporate strategy is usually concerned above all with the competitive positioning of a company within an industry or, if diversified, in a number of industries. To this two-dimensional picture, which takes the company and its competitors as the main variables, we need to add the changing background of the industry itself: a third dimension that challenges the powers of adaptation of all the competitors. It compels them to acknowledge as real the forces that are unleashed by time as industries mature and society changes. This paper explores the turning points that have occurred during the past 30 years in one particular industry--pharmaceuticals--and seeks to distil from it a number of lessons that may be relevant to industrial strategy in a wider framework. PMID:10303347

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

    PubMed

    Timmermans, Karin

    2004-01-01

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

  19. Managing laboratory automation in a changing pharmaceutical industry.

    PubMed

    Rutherford, M L

    1995-01-01

    The health care reform movement in the USA and increased requirements by regulatory agencies continue to have a major impact on the pharmaceutical industry and the laboratory. Laboratory management is expected to improve effciency by providing more analytical results at a lower cost, increasing customer service, reducing cycle time, while ensuring accurate results and more effective use of their staff. To achieve these expectations, many laboratories are using robotics and automated work stations. Establishing automated systems presents many challenges for laboratory management, including project and hardware selection, budget justification, implementation, validation, training, and support. To address these management challenges, the rationale for project selection and implementation, the obstacles encountered, project outcome, and learning points for several automated systems recently implemented in the Quality Control Laboratories at Eli Lilly are presented. PMID:18925014

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

    PubMed

    Levin, M

    2001-06-01

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

  1. Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency

    PubMed Central

    Rose, Klaus; Spigarelli, Michael G.

    2015-01-01

    The European Pediatric Pharmaceutical Legislation wants children to benefit more from pharmaceutical progress. In rare diseases, concerns have been raised that this legislation might damage research and stymie drug development. We discuss the role of the European Medicines Agency (EMA) and its Pediatric Committee (PDCO) in the development of ivacaftor, first-in-class for cystic fibrosis (CF) patients with the G551D mutation (and eight other mutations later) and of lumacaftor and ataluren, two more potential break-through CF medications. Ivacaftor was USA-approved early 2012 and six months later in the EU. Registration was based on the same data. We analyzed these drugs’ EU pediatric investigation plans (PIPs) and compared the PIP-studies with the pediatric CF studies listed in www.clinicaltrials.gov. The ivacaftor PIP studies appear to reflect what the developer planned anyway, apart from a study in 1–23-month-olds, which has not yet started. The total negotiation time for the current PIP version was approximately 5.5 years. For companies that develop drugs in pediatric diseases, e.g., CF, PIPs represent considerable additional procedural workload with minimal or no additional benefit for the patients. New drugs for pediatric diseases should not be hampered by additional, unnecessary and costly bureaucracy, but be registered as rapidly as possible without compromising safety. PMID:27417354

  2. Southern Company`s standby generator program

    SciTech Connect

    Swartz, S.

    1995-12-01

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

  3. [Early achievements of the Danish pharmaceutical industry--8. Lundbeck].

    PubMed

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

    2016-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 8 deals with products from Lundbeck. Lundbeck which today is known as a considerable international pharmaceutical company could in 2015 celebrate its 100 years' jubilee. Among the early Danish medicinal companies H. Lundbeck & Co. is in many ways an exception as the company was not originally established as a pharmaceutical company. Not until several years after the foundation the company began to import foreign ready-made medicinal products and later-on to manufacture these medicinal products in own factory and even later to do research and development of own innovative products. When Lundbeck was established in 1915 several Danish medicinal companies, not only the well-known such as Alfred Benzon and Løvens kemiske Fabrik (LEO Pharma), but also Skelskør Frugtplantage, Ferrin and Ferraton, had emerged due to the respective enterprising pharmacy owners who had expanded their traditional pharmacy business and even with commercial success. Other medicinal companies, such as C.R. Evers & Co., Leerbeck & Holms kemiske Fabriker, Chr. F. Petri, Erslevs kemiske Laboratorium, Edward Jacobsen, Th. Fallesen-Schmidt, and yet other companies which were named after the founder had all been established by pharmacists with the primary intention to manufacture and sell medicinal products. Also for the limited companies Medicinalco, Ferrosan, Pharmacia, and GEA the primary task was to manufacture and sell medicinal products, and also in these companies pharmacists were involved in the foundation. Not until 1924, fully 9 years after the foundation, Lundbeck started to be interested in medicinal products and initiated import and sale of foreign medicinal products manufactured by a.o. German and French companies which had not established their own sales companies in Denmark. Almost all contemporary Danish manufacturers of

  4. Technology policy and planning in the Third World pharmaceutical sector: the Cuban and Caribbean community approaches.

    PubMed

    Thrupp, L A

    1984-01-01

    There has been growing international concern over many aspects of the use and flow of medicines in developing countries. This article briefly reviews factors which have contributed to problems in this area including marketing and promotional practices of the pharmaceutical companies, rising drug import costs, and the unsuitability or poor quality of available drugs. This analysis is primarily concerned with policies that have emerged from efforts to alleviate such problems, to increase control over multinational drug companies, and to bring about changes in the technology transaction processes and in the pharmaceutical sector. It focuses on two cases: the regional cooperation scheme of the Caribbean countries (CARICOM) and the national-level policy of Cuba. It is shown that the CARICOM strategy has significant limitations, primarily due to its voluntary nature and lack of enforcement mechanisms for member countries. On the other hand, the Cuban approach has brought about positive effects and progressive changes, made through political commitment to achieve social benefits, and in conjunction with integrated broad reforms of the entire health system within a socialist framework. Thus, the problems and promises of such strategies are viewed in a context which emphasizes the prevailing forces of the global political economy. The lessons from this study, applicable to other developing countries, not only reveal important measures for the pharmaceutical sector, but also stress the ultimate need for strong commitment to enforce policies at the national level and for major structural changes, in order to adequately meet the health and medical needs of the people. PMID:6735538

  5. The superefficient company.

    PubMed

    Hammer, M

    2001-09-01

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

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

    PubMed

    Abraham, John

    2008-09-01

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

  7. 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

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

    PubMed Central

    Cottingham, Marci D.; Kalbaugh, Corey A.

    2014-01-01

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

  9. 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

  10. 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?

  11. 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...

  12. Corporate funding of human services agencies.

    PubMed

    Zippay, A

    1992-05-01

    This article reviews national trends in the organization of corporate giving to human services agencies, examines how corporations make funding decisions, and reports the results of a case study of philanthropic giving among 29 companies in Cambridge, Massachusetts. The study found that most corporations use an informal rather than a formal process for making funding decisions, with many firms relying on tradition, social contacts, and intuition to guide allocations. Suggestions that social services administrators can use to enhance development planning at their agencies are provided. PMID:1514129

  13. Captive insurance companies.

    PubMed

    Strauss, Peter

    2014-01-01

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

  14. 41 CFR 302-12.4 - For what relocation services expenses will my agency pay?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false For what relocation services expenses will my agency pay? 302-12.4 Section 302-12.4 Public Contracts and Property Management... services expenses will my agency pay? Your agency will pay the relocation services company's...

  15. Charting your company's future.

    PubMed

    Kim, W Chan; Mauborgne, Renée

    2002-06-01

    Few companies have a clear strategic vision. The problem, say the authors, stems from the strategic-planning process itself, which usually involves preparing a large document, culled from a mishmash of data provided by people with conflicting agendas. That kind of process almost guarantees an unfocused strategy. Instead, companies should design the strategic-planning process by drawing a picture: a strategy canvas. A strategy canvas shows the strategic profile of your industry by depicting the various factors that affect competition. And it shows the strategic profiles of your current and potential competitors as well as your own company's strategic profile--how it invests in the factors of competition and how it might in the future. The basic component of a strategy canvas--the value curve--is a tool the authors created in their consulting work and have written about in previous HBR articles. This article introduces a four-step process for actually drawing and discussing a strategy canvas. Readers will learn how one European financial services company used this process to create a distinct and easily communicable strategy. The process begins with a visual awakening. Managers compare their business's value curve with competitors' to discover where their strategy needs to change. In the next step--visual exploration--managers do field research on customers and alternative products. At the visual strategy fair, the third step, managers draw new strategic profiles based on field observations and get feedback from customers and peers about these new proposals. Once the best strategy is created from that feedback, it's time for the last step--visual communication. Executives distribute "before" and "after" strategic profiles to the whole company, and only projects that will help move the company closer to the "after" profile are supported. PMID:12048996

  16. Selected aspects of europeization of pharmaceutical law.

    PubMed

    Zimmermann, Agnieszka; Wengler, Lubomira; Pawłowski, 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

  17. 'Linkage' pharmaceutical evergreening in Canada and Australia.

    PubMed

    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

  18. Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices

    PubMed Central

    Raveis, Victoria H.; Friedman, Anne; Rothman, David J.

    2011-01-01

    Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed. We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant. As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy. PMID:21233424

  19. 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

  20. 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

  1. A risk-based approach to managing active pharmaceutical ingredients in manufacturing effluent.

    PubMed

    Caldwell, Daniel J; Mertens, Birgit; Kappler, Kelly; Senac, Thomas; Journel, Romain; Wilson, Peter; Meyerhoff, Roger D; Parke, Neil J; Mastrocco, Frank; Mattson, Bengt; Murray-Smith, Richard; Dolan, David G; Straub, Jürg Oliver; Wiedemann, Michael; Hartmann, Andreas; Finan, Douglas S

    2016-04-01

    The present study describes guidance intended to assist pharmaceutical manufacturers in assessing, mitigating, and managing the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations, including those from external suppliers. The tools are not a substitute for compliance with local regulatory requirements but rather are intended to help manufacturers achieve the general standard of "no discharge of APIs in toxic amounts." The approaches detailed in the present study identify practices for assessing potential environmental risks from APIs in manufacturing effluent and outline measures that can be used to reduce the risk, including selective application of available treatment technologies. These measures either are commonly employed within the industry or have been implemented to a more limited extent based on local circumstances. Much of the material is based on company experience and case studies discussed at an industry workshop held on this topic. PMID:26183919

  2. 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...

  3. 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... Abandonment Project proposed by Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas... affecting the quality of the human environment. The EA has been placed in the public files of the FERC...

  4. Pharmaceutical compounding or pharmaceutical manufacturing? A regulatory perspective.

    PubMed

    Timko, Robert J; Crooker, Philip E M

    2014-01-01

    At one time, nearly all prescriptions were compounded preparations. There is an ongoing demand for compounded prescription medications because manufacturers cannot fulfill the needs of all individual patients. Compounding pharmacies are a long standing yet less frequently discussed element in the complex matrix of prescription drug manufacturing, distribution, and patient use. The drug shortage situation for many necessary and life-saving drug products is a complicating factor that has led to the numerous quality issues that currently plague large-scale compounding pharmacies. The states are the primary regulator of pharmacies, including community drug stores, large chains, and specialty pharmacies. Pharmacies making and distributing drugs in a way that is outside the bounds of traditional pharmacy compounding are of great concern to the U.S. Food and Drug Administration. The U.S. Congress has recently passed the Drug Quality and Security Act. This legislation establishes a clear boundary between traditional compounders and compounding manufacturers. It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states' primary role in traditional pharmacy regulation. It clarifies the U.S. Food and Drug Administration's authority over the compounding of human drugs while requiring the Agency to engage and coordinate with states to ensure the safety of compounded drugs. PMID:24881112

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

  7. 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

  8. Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry.

    PubMed

    Song, Chie Hoon; Han, Jeung-Whan

    2016-01-01

    Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies. It further discusses how the mix of competition policies and strategic instruments can be used to maintain declining revenue streams from the blockbuster business model of the pharmaceutical industry. The review provides a comprehensive overview of the research on various strategies, offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity, and identifies knowledge gaps that needed to be addressed in order to improve efficiency in policy design. PMID:27347468

  9. 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

  10. Assessing water company customer preferences and willingness to pay for service improvements: A stated choice analysis

    NASA Astrophysics Data System (ADS)

    Willis, Kenneth G.; Scarpa, Riccardo; Acutt, Melinda

    2005-02-01

    Water and sewerage companies are regional monopolies in the UK. A government agency regulates these companies, setting standards on quality of service to customers, and every 5 years sets prices that companies can charge customers over the ensuing quinquennium. We use a stated choice experiment model to estimate benefits to water company customers of changes across 14 water service factors. The estimated values were quite similar for each service factor across models (conditional logit (CL), CL quadratic, nested logit (NL), or NL quadratic). Estimates of the cost of infrastructure maintenance and improvement with risk of asset failure, along with CL benefit estimates, permit economic optimization across the water company's whole investment program.

  11. 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

  12. The clinical development of molecularly targeted agents in combination with radiation therapy: a pharmaceutical perspective.

    PubMed

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

    2012-11-15

    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

  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 applications of sulfobuthylether-beta-cyclodextrin].

    PubMed

    Sebestyén, Zita; Szepesi, Katalin; Szabó, Barnabás

    2013-01-01

    Sulfobuthylether-beta-cyclodextrin (SBECD) is a substituted derivative of a cyclic oligosaccharide containing seven glucopyranose units, which bear pH-independent negative charges because of sulfonate groups. This derivative has better solubility and toxicological characteristics than the unsubstituted beta-cyclodextrin, and the presence of sulfobuthyl groups opens new dimensions in the interactions acting the part of the complex formation. These create opportunities for the pharmaceutical applications of this compound. Currently six pharmaceutical preparations circulate--moiety of these circulates in Hungary also--which have a composition containing SBECD as pharmaceutical excipient. Out of the main effects of the complex-forming agent the solubility enhancement is utilized in these compositions to achieve the solution of a therapeutic dose in the case of intravascular administration. Available experimental evidences and published patents are indicative of broadening the circle of the applications in point of both technological advantages and dosage forms. PMID:23926650

  15. 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.

  16. 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

  17. 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…

  18. Drug company's consumer health portal encourages return visits.

    PubMed

    2004-07-01

    How do you get consumers to return to your site? For some health-site surfers, the offer of a portal where they can customize pages and store their own data may have so much appeal that they'll make it their home on the Web. But to really win their loyalty, a consumer portal has to offer a lot of features that will help them manage their health activities. A good example is My Health Zone, launched by pharmaceutical company Schering-Plough. PMID:15346971

  19. Terahertz study on porosity and mass fraction of active pharmaceutical ingredient of pharmaceutical tablets.

    PubMed

    Bawuah, Prince; Tan, Nicholas; Tweneboah, Samuel Nana A; Ervasti, Tuomas; Axel Zeitler, J; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2016-08-01

    In this study, terahertz time-domain spectroscopic (THz-TDS) technique has been used to ascertain the change in the optical properties, as a function of changing porosity and mass fraction of active pharmaceutical ingredient (API), of training sets of pharmaceutical tablets. Four training sets of pharmaceutical tablets were compressed with microcrystalline cellulose (MCC) excipient and indomethacin API by varying either the porosity, height, and API mass fraction or all three tablet parameters. It was observed, as far as we know, for the first time, that the THz time-domain and frequency-domain effective refractive index, as well as, the frequency-domain effective absorption coefficient both show linear correlations with the porosity and API mass fraction for training sets of real pharmaceutical tablets. We suggest that, the observed linear correlations can be useful in basic research and quality inspection of pharmaceutical tablets. Additionally, we propose a novel optical strain parameter, based on THz measurement, which yields information on the conventional strain parameter of a tablet as well as on the change of fill fraction of solid material during compression of porous pharmaceutical tablets. We suggest that the THz measurement and proposed method of data analysis, in addition to providing an efficient tool for basic research of porous media, can serve as one of the novel quality by design (QbD) implementation techniques to predict critical quality attributes (CQA) such as porosity, API mass fraction and strain of flat-faced pharmaceutical tablets before production. PMID:27288937

  20. A new reimbursement system for innovative pharmaceuticals combining value-based and free market pricing.

    PubMed

    Persson, Ulf; Svensson, Johanna; Pettersson, Billie

    2012-07-01

    Sweden has experienced a national value-based pricing (VBP) system for innovative outpatient drugs operated by the Pharmaceutical Benefits Board - LFN (now called the Dental and Pharmaceutical Benefits agency - TLV) since 2002. VBP has the character of a monopoly system, leading to reimbursement decisions where usage of new medicines is limited to subgroups and not the population for which the drug is approved. VBP relies on a broad societal perspective, encouraging innovations by signaling to firms that value-adding treatments are demanded. However, the VBP system is operated without a drug budget responsibility. The budget responsibility lies at the regional level, not operating VBP, thus an intrinsic conflict is built into the system. The aim of this article is to suggest a modification to the current reimbursement system in Sweden where payment for pharmaceuticals is split between the regional and national levels. The system is expected to make new innovative pharmaceuticals accessible to a larger number of patients and provide more consumer surplus without reducing the producer surplus. In short, the county councils pay the marginal cost of production while the state pays for the innovation. PMID:22676213