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Sample records for research-based pharmaceutical companies

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

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-01-01

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

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

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-04-27

    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.

  3. 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

  4. Cardiovascular drug discovery: a perspective from a research-based pharmaceutical company.

    PubMed

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

    2014-06-02

    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.

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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.

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

    PubMed

    Nango, Eishu

    2015-01-01

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

  12. Integrating pharmacology and clinical pharmacology in pharmaceutical companies.

    PubMed

    Hunter, Jackie A

    2012-06-01

    Integration of clinical and preclinical pharmacology in pharmaceutical companies could be improved by several key recommendations: Companies should ensure that there is an adequate pool of trained clinical pharmacologists and preclinical pharmacologists. Training should include topics that allow clinical pharmacologists to be cognizant of the methods, issues and challenges faced by the preclinical pharmacologists and vice versa. Companies should incentivize such integration internally by aligning objectives and metrics/incentives. In academic medicine and the NHS there should be support for involvement of clinical pharmacologists in basic academic research and industrial R & D and new ways of facilitating and incentivizing preclinical pharmacologists and clinical pharmacologists to move between these various environments should be sought.

  13. 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.

  14. 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

  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. 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.

  18. 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

  19. Trade secrets in life science and pharmaceutical companies.

    PubMed

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

    2014-11-20

    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.

  20. 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

  1. The effect of capital structure on the profitability of pharmaceutical companies the case of iran.

    PubMed

    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.

  2. [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.

  3. [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

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

    PubMed Central

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

    2014-01-01

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

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. [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.

  12. [Role of pharmaceutical company pharmacist in provision of drug information for cancer chemotherapy].

    PubMed

    Koshida, Iori; Kubota, Kenichi; Yamashita, Masaki; Katayanagi, Hideya; Noda, Kohei; Terada, Hakaru; Yoshioka, Shinichi; Sekine, Nobuyuki; Kameda, Toshikazu; Terada, Kiyoshi

    2009-04-01

    Recently, oxaliplatin(L-OHP)and irinotecan hydrochloride hydrate(CPT-11)have gained recognition as key drugs in the treatment of advanced colorectal cancer. In this article, we describe the results of a survey of medical institutions by pharmacists working at a pharmaceutical company. First, questions from medical institutions on L-OHP and CPT-11 were totaled and analyzed. The results showed that most of these questions concerned safety, with many of these addressing side effects. Next, a questionnaire on FOLFOX and FOLFIRI regimens was administered to medical institutions. The results indicated that staff are interested in the safety and critical path of these regimens. These results suggest that a lot of medical institutions require more information from pharmaceutical companies. This indicates that pharmacists should do more to take the needs of medical institutions into account in providing improved customer support.

  13. 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

  14. [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

  15. 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

  16. 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.

  17. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.

    PubMed

    Robinson, Sally; Delongeas, Jean-Luc; Donald, Elizabeth; Dreher, David; Festag, Matthias; Kervyn, Sophie; Lampo, Ann; Nahas, Kamil; Nogues, Vicente; Ockert, Deborah; Quinn, Kirsty; Old, Sally; Pickersgill, Nigel; Somers, Kev; Stark, Claudia; Stei, Peter; Waterson, Lynne; Chapman, Kathryn

    2008-04-01

    Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an evidence-based review of acute toxicity studies and assessed the value of the data generated. Preclinical and clinical information was shared on 74 compounds. The analysis indicated acute toxicity data was not used to (i) terminate drugs from development (ii) support dose selection for repeat dose studies in animals or (iii) to set doses in the first clinical trials in humans. The conclusion of the working group is that acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe.

  18. 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

  19. 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

  20. Bone pain from granulocyte colony stimulating factor: does clinical trial sponsorship by a pharmaceutical company influence its reporting?

    PubMed

    Aldairy, Y; Nguyen, P L; Jatoi, A

    2011-01-01

    It is alleged that pharmaceutical companies sometimes unfairly present clinical trial results. To our knowledge, studies have not explored whether such alleged unfair reporting also occurs in the testing of palliative care agents in cancer patients, a particularly vulnerable group. Therefore, a systematic search was conducted to retrieve all published, prospective clinical trials that used granulocyte colony stimulating factor starting in 2003. Because granulocyte colony stimulating factor can cause severe bone pain - a concerning but historically under-reported symptom in cancer patients - this symptom was assessed to determine whether differences in reporting occurred based on pharmaceutical company-sponsorship. A total of 239 published clinical trials met the present study's eligibility criteria and were retrievable. Within this entire group of studies, 65 (27%) were pharmaceutical company-sponsored, and only 31 (13%) reported on bone pain. However, pharmaceutical company-sponsored trials reported on bone pain at a higher rate compared with other studies: 23% versus 9% (P= 0.005), and this conclusion did not change after adjusting for dose, use of the slow release formulation and year of publication. The reporting of adverse events from cancer symptom control and palliative care interventions should be improved - especially in trials not sponsored by pharmaceutical companies.

  1. 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

  2. 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

  3. Trust: Need for an Improved Communication between the Public World and the Pharmaceutical Companies

    PubMed Central

    Heinemann, Lutz

    2009-01-01

    In the industrialized world, the negative image that many people (including politicians) have of pharmaceutical companies not only makes the life for those working in this field more difficult, in a sense it is a road block. Without an improvement in communication between the public world and the pharmaceutical industry, one can foresee this industry steadily becoming a more difficult environment to work in. There is a clear need for knowing more about all the work done inside these companies before a new drug is approved (it is not all about marketing…). That society has no understanding of the ever-increasing costs of new drugs is also related to this lack of understanding of how tricky and cumbersome the process is to take a new idea for treating a certain disease to production of a marketed drug. With a relatively small investment of money, but with an investment of much good will, brain power, and trust, it should be possible to bring all relevant parties together and make a change. PMID:20046667

  4. 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

  5. Opportunities to minimise animal use in pharmaceutical regulatory general toxicology: a cross-company review.

    PubMed

    Sparrow, Susan S; Robinson, Sally; Bolam, Sue; Bruce, Christopher; Danks, Andy; Everett, David; Fulcher, Stephen; Hill, Rose E; Palmer, Helen; Scott, Elspeth W; Chapman, Kathryn L

    2011-11-01

    Toxicity studies in animals are carried out to identify the intrinsic hazard of a substance to support risk assessment for humans. In order to identify opportunities to minimise animal use in regulatory toxicology studies, a review of current study designs was carried out. Pharmaceutical companies and contract research organisations in the UK shared data and experience of standard toxicology studies (ranging from one to nine months duration) in rodents and non-rodents; and carcinogenicity studies in the rat and mouse. The data show that variation in study designs was primarily due to (i) the number of animals used in the main study groups, (ii) the use of animals in toxicokinetic (TK) satellite groups, and (iii) the use of animals in off-treatment recovery groups. The information has been used to propose a series of experimental designs where small adjustments could reduce animal use in practice, while maintaining the scientific objectives.

  6. 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

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

    PubMed Central

    Gupta, Sandeep Kumar; Nayak, Roopa Prasad

    2014-01-01

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

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

    PubMed

    Zaid, Abdel Naser; Ghosh, Abeer Abu

    2011-07-01

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

  9. 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…

  10. [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.

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

    PubMed Central

    Alssageer, Mustafa A.; Kowalski, Stefan R.

    2012-01-01

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

  12. Drug information pharmacists at health-care facilities, universities, and pharmaceutical companies.

    PubMed

    Gong, S D; Millares, M; VanRiper, K B

    1992-05-01

    A national survey was conducted to provide a profile of drug information pharmacists. Questionnaires were mailed to 436 drug information pharmacists whose names were obtained from directors of drug information centers (DICs) at health-care facilities, universities, and pharmaceutical companies. The net response rate was 64% (278 usable replies). Most respondents were 30 to 39 years of age and had practiced in drug information for four years or less. There were equal numbers of male and female respondents. More than half had a doctor of pharmacy (Pharm.D.) degree, and about half had completed a postgraduate residency or fellowship. Respondents with a Pharm.D. degree or postgraduate training reported a more favorable professional outcome, including position, income, and job satisfaction. Respondents reported a high level of professional involvement, including faculty appointment, publishing, and professional membership. Common reasons cited for choosing a career in drug information were an opportunity to continually learn, job satisfaction, and regular work hours. More than 70% of respondents were either very satisfied or extremely satisfied with their current job position. The most frequently reported income range was $40,000-44,999; distribution of income differed significantly among geographic regions. Drug information pharmacists report a high level of job satisfaction and involvement in professional activities; they often have completed advanced pharmacy education or postgraduate training.

  13. Arabian nights—1001 tales of how pharmaceutical companies cater to the material needs of doctors: case report

    PubMed Central

    Giannakakis, Ioannis A; Ioannidis, John P A

    2000-01-01

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

  14. 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

  15. 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.

  16. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

    PubMed

    Arpinelli, Fabio; Bamfi, Francesco

    2006-01-01

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs. PMID:17076891

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. The company we keep: why physicians should refuse to see pharmaceutical representatives.

    PubMed

    Brody, Howard

    2005-01-01

    Whether physicians ought to interact with pharmaceutical sales representatives (reps) is a question worthy of careful ethical analysis. The issue presents a challenge to both professional integrity and time management. Empirical data suggest that interactions with pharmaceutical reps increase the chances that the physician will act contrary to duties owed to the patient. Ideally, a physician might both interact with reps and also do the research necessary to counteract the commercial bias in their messages. But a physician who actually did that research would, in turn, be devoting a good deal of time that might better be spent in other activities. The counterargument, that one is obligated to see representatives to obtain free samples to best serve one's patients, can be shown in most practice settings not to be compelling. Physicians ought to refuse to visit with representatives as a matter of both professional integrity and sensible time management.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. Persuasion and types of enticements offered by pharmaceutical companies to Gold Coast general practitioners in an attempt to encourage a health website recommendation.

    PubMed

    Usher, Wayne; Skinner, James

    2010-01-01

    This study was undertaken to determine if pharmaceutical companies persuade and offer enticements to Gold Coast (Queensland, Australia) general practitioners (GPs), in an attempt to encourage them to recommend health websites to the health consumer. A survey instrument consisting of seven single response questions was mailed to 250 (61%) out of 410 GPs. Questions were designed to measure the percentages (%) and proportions associated with levels of persuasion and types of enticements pharmaceutical companies are offering GPs, in an attempt to encourage them to recommend health websites to the health consumer. The survey instrument allowed participants to indicate their (1) gender, (2) age and (3) years of experience (less experienced or= 10 years). One hundred and eight (43%) of the 250 GPs returned a completed survey. The return rate for male GPs was 72 (40%) and for female GPs, it was 36 (33%). Sixty-eight (63%) GPs indicated that they actively recommend health websites to their patients [male GPs--48 (71%), female GPs--20 (29%)]. This study highlights that female GPs (80%), those aged between 31 and 40 (77%) and GPs with < 10 years experience (72%) were more frequently targeted by pharmaceutical companies. This study reports that pharmaceutical companies are offering various types of enticements in an attempt to persuade Gold Coast GPs to recommend specific health websites to the health consumer. Further research should explore if similar levels of persuasion and types of enticements are being offered to GPs across Australia.

  9. Persuasion and types of enticements offered by pharmaceutical companies to Gold Coast general practitioners in an attempt to encourage a health website recommendation.

    PubMed

    Usher, Wayne; Skinner, James

    2010-01-01

    This study was undertaken to determine if pharmaceutical companies persuade and offer enticements to Gold Coast (Queensland, Australia) general practitioners (GPs), in an attempt to encourage them to recommend health websites to the health consumer. A survey instrument consisting of seven single response questions was mailed to 250 (61%) out of 410 GPs. Questions were designed to measure the percentages (%) and proportions associated with levels of persuasion and types of enticements pharmaceutical companies are offering GPs, in an attempt to encourage them to recommend health websites to the health consumer. The survey instrument allowed participants to indicate their (1) gender, (2) age and (3) years of experience (less experienced or= 10 years). One hundred and eight (43%) of the 250 GPs returned a completed survey. The return rate for male GPs was 72 (40%) and for female GPs, it was 36 (33%). Sixty-eight (63%) GPs indicated that they actively recommend health websites to their patients [male GPs--48 (71%), female GPs--20 (29%)]. This study highlights that female GPs (80%), those aged between 31 and 40 (77%) and GPs with < 10 years experience (72%) were more frequently targeted by pharmaceutical companies. This study reports that pharmaceutical companies are offering various types of enticements in an attempt to persuade Gold Coast GPs to recommend specific health websites to the health consumer. Further research should explore if similar levels of persuasion and types of enticements are being offered to GPs across Australia. PMID:19674124

  10. [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.

  11. 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

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

    PubMed

    Jastifer, James; Roberts, Sarah

    2009-01-01

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

  13. 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

  14. 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.

  15. 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

  16. Strategies to reduce the risk of drug-induced QT interval prolongation: a pharmaceutical company perspective.

    PubMed

    Pollard, C E; Valentin, J-P; Hammond, T G

    2008-08-01

    Drug-induced prolongation of the QT interval is having a significant impact on the ability of the pharmaceutical industry to develop new drugs. The development implications for a compound causing a significant effect in the 'Thorough QT/QTc Study' -- as defined in the clinical regulatory guidance (ICH E14) -- are substantial. In view of this, and the fact that QT interval prolongation is linked to direct inhibition of the hERG channel, in the early stages of drug discovery the focus is on testing for and screening out hERG activity. This has led to understanding of how to produce low potency hERG blockers whilst retaining desirable properties. Despite this, a number of factors mean that when an integrated risk assessment is generated towards the end of the discovery phase (by conducting at least an in vivo QT assessment) a QT interval prolongation risk is still often apparent; inhibition of hERG channel trafficking and partitioning into cardiac tissue are just two confounding factors. However, emerging information suggests that hERG safety margins have high predictive value and that when hERG and in vivo non-clinical data are combined, their predictive value to man, whilst not perfect, is >80%. Although understanding the anomalies is important and is being addressed, of greater importance is developing a better understanding of TdP, with the aim of being able to predict TdP rather than using an imperfect surrogate marker (QT interval prolongation). Without an understanding of how to predict TdP risk, high-benefit drugs for serious indications may never be marketed.

  17. 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

  18. 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

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

    PubMed Central

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

    2012-01-01

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

  20. [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. 38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... ethical rules (5 CFR 2635.204(a)). However, such items may be donated to a medical center library or... accordance with 31 U.S.C. 1353, 41 CFR part 304, and VA policy regarding such gifts. (2) Samples of drugs and... company representatives are prohibited from marketing to medical, pharmacy, nursing and other...

  3. Ovation Pharmaceuticals, Inc.

    PubMed

    Deutsch, Barry

    2002-11-01

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

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

    PubMed

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

    2008-01-01

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

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

    PubMed

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

    2008-01-01

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

  6. What drives success for specialty pharmaceuticals?

    PubMed

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

    2008-07-01

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

  7. 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.

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

    PubMed

    Littman, Bruce H; Marincola, Francesco M

    2011-05-10

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

  9. 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

  10. The extended pharmaceutical enterprise.

    PubMed

    Cavalla, David

    2003-03-15

    The availability of widespread contractual services led to the birth of the virtual company in the 1990s. As the concept has matured, and the biotechnology sector diversified, interchange of intellectual property in the form of collaborative and license arrangements opens up still further the opportunities for outsourced forms of pharmaceutical R&D. PMID:12623241

  11. China: current trends in pharmaceutical drug discovery.

    PubMed

    Luo, Ying

    2008-04-01

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

  12. Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

    PubMed

    Russ, Hagen; Busta, Susanne; Jost, Bertfried; Bethke, Thomas D

    2015-01-01

    Ziel: Das Ziel dieses Projektes war es, die Qualität und Quantität der Erstantragstellung auf zustimmende Bewertung einer klinischen Prüfung gemäß § 7 der deutschen GCP-Verordnung (GCP-V), die Qualität des Bewertungsverfahrens bei den Ethik-Kommissionen (EKs) in Deutschland sowie das Muster der Einwände seitens der EKs in ihren mit Gründen versehenen Bewertungen (Bescheide) zu evaluieren. Um etwaige Veränderungen über die Zeit zu identifizieren, wurden außerdem die Ergebnisse dieser Umfrage, mit den Ergebnissen einer in 2008 durchgeführten Umfrage verglichen.Methoden: Auf der Grundlage von Bescheiden der für den Leiter der klinischen Prüfung jeweils zuständigen (federführenden) EK in 2011, wurde eine schriftliche Umfrage bei Mitgliedsunternehmen des Verbandes Forschender Arzneimittelhersteller e.V. (vfa) in 2012 durchgeführt. Die erhaltenen Antworten zu dem Fragebogen wurden deskriptiv ausgewertet. Da der in 2011 erhaltene Datensatz mit dem Datensatz in 2007 strukturell identisch war, wurden beide Umfragen miteinander verglichen.Ergebnisse: Von den 24 Unternehmen, die im vfa-Unterausschuss Klinische Forschung/Qualitätssicherung vertreten sind, nahmen 75% (18) an der Umfrage teil. Der Auswertung dieser Umfrage liegen insgesamt 251 Antragsverfahren dieser 18 Unternehmen bei 43 EKs zugrunde. Diese stellen rund 21% der 1.214 bei den Bundesoberbehörden (BfArM und PEI) 2011 gestellten Anträge auf Genehmigung kommerzieller und nicht-kommerzieller klinischer Prüfungen der Phasen I–IV dar.Im Vergleich zu 2007 wurden 2011 eine geringere Zahl von Anträgen (n=251 in 2011 vs. n=288 in 2007) bei einer geringfügig größeren Zahl an EKs (43 in 2011 vs. 40 in 2007) gestellt. Die Anzahl der Einwände stieg um 21% von 1.299 (2007) auf 1.574 (2011) und damit im Durchschnitt von 4,5 (2007) auf 6,3 (2011) Einwände pro Antrag. Insgesamt gesehen zeigt die Analyse der formalen und inhaltlichen Einwände ein Muster auf, das der vorangegangenen Umfrage sehr ähnlich ist. Die häufigsten Einwände betreffen die Patienteninformation und Einwilligungserklärung, in absteigender Reihenfolge gefolgt von Einwänden bezüglich Prüfplaninhalten, nicht-kategorisierende Einwände („Andere“), Einwände zu „Sonstigen Antragsunterlagen“ nach § 7 (2) und (3) GCP-V, Formmängel nach § 8 (1) GCP-V sowie Einwände, die sich auf Unterlagen zur Prüfer- und Prüfstellenqualifikation beziehen. Tendenziell zu beobachten war eine leicht erhöhte Rate von Einwänden bezüglich der Patienteninformation und Einwilligungserklärung (+4%) sowie eine geringfügige Abnahme von Einwänden, die sich auf Unterlagen zur Prüfer- und Prüfstellenqualifikation bezogen (–2%).Wie in 2007 ist etwa jeder sechste Antrag unvollständig und weist formale Einwände zu den Antragsunterlagen auf. Während der Anteil der Studienanträge mit Einwänden bezüglich der Patienteninformation und Einwilligungserklärung (+7,2%), den Prüfplaninhalten (+11,6%) und „Sonstigen Antragsunterlagen“ nach § 7 (2) und (3) GCP-V (+11,8%) in 2011 im Vergleich zu 2007 zunahm, nahm der Anteil der Studienanträge mit Einwänden, die Unterlagen zur Prüfer- und Prüfstellenqualifikation betrafen, um 6,3% ab.Schlussfolgerungen: Die Ergebnisse der ersten Umfrage in 2008 im Hinblick auf die Quantität, die Qualität und die Schwerpunkte der Einwände seitens der EKs, finden sich überwiegend auch in der Umfrage 2012. Dies zeigt ein übereinstimmendes Verständnis von Auftraggebern (Sponsoren) und EKs hinsichtlich der anzuwendenden Maßnahmen und Kriterien zur Sicherstellung der Rechte und des Wohlergehens der Patienten, der Datenintegrität und einer qualitativ hochwertigen Dokumentation in klinischen Prüfungen.

  13. Pharmaceutical Psychology.

    ERIC Educational Resources Information Center

    Dolinsky, Donna

    1979-01-01

    Defines areas that could comprise pharmaceutical psychology. The discussion includes a review of literature, outline of areas in pharmacy in which psychologists could become involved, description of a project involving the application of psychology to pharmacy, and analysis of the concept of pharmaceutical psychology. A 99-item bibliography is…

  14. 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.

  15. 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

  16. Direct evidence on the immune-mediated spontaneous regression of human cancer: an incentive for pharmaceutical companies to develop a novel anti-cancer vaccine.

    PubMed

    Saleh, F; Renno, W; Klepacek, I; Ibrahim, G; Dashti, H; Asfar, S; Behbehani, A; Al-Sayer, H; Dashti, A; Kerry, Crotty

    2005-01-01

    To develop an effective pharmaceutical treatment for a disease, we need to fully understand the biological behavior of that disease, especially when dealing with cancer. The current available treatment for cancer may help in lessening the burden of the disease or, on certain occasions, in increasing the survival of the patient. However, a total eradication of cancer remains the researchers' hope. Some of the discoveries in the field of medicine relied on observations of natural events. Among these events is the spontaneous regression of cancer. It has been argued that such regression could be immunologically-mediated, but no direct evidence has been shown to support such an argument. We, hereby, provide compelling evidence that spontaneous cancer regression in humans is immunologically-mediated, hoping that the results from this study would stimulate the pharmaceutical industry to focus more on cancer vaccine immunotherapy. Our results showed that patients with >3 primary melanomas (very rare group among cancer patients) develop significant histopathological spontaneous regression of further melanomas that they could acquire during their life (P=0.0080) as compared to patients with single primary melanoma where the phenomenon of spontaneous regression is absent or minimal. It seems that such regression resulted from the repeated exposure to the tumor which mimics a self-immunization process. Analysis of the regressing tumors revealed heavy infiltration by T lymphocytes as compared to non-regressing tumors (P<0.0001), the predominant of which were T cytotoxic rather than T helper. Mature dendritic cells were also found in significant number (P<0.0001) in the regressing tumors as compared to the non regressing ones, which demonstrate an active involvement of the different arms of the immune system in the multiple primary melanoma patients in the process of tumor regression. Also, MHC expression was significantly higher in the regressing versus the non

  17. 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.

  18. 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.

  19. A global pharmaceutical company initiative: an evidence-based approach to define the upper limit of body weight loss in short term toxicity studies.

    PubMed

    Chapman, Kathryn; Sewell, Fiona; Allais, Linda; Delongeas, Jean-Luc; Donald, Elizabeth; Festag, Matthias; Kervyn, Sophie; Ockert, Deborah; Nogues, Vicente; Palmer, Helen; Popovic, Marija; Roosen, Wendy; Schoenmakers, Ankie; Somers, Kevin; Stark, Claudia; Stei, Peter; Robinson, Sally

    2013-10-01

    Short term toxicity studies are conducted in animals to provide information on major adverse effects typically at the maximum tolerated dose (MTD). Such studies are important from a scientific and ethical perspective as they are used to make decisions on progression of potential candidate drugs, and to set dose levels for subsequent regulatory studies. The MTD is usually determined by parameters such as clinical signs, reductions in body weight and food consumption. However, these assessments are often subjective and there are no published criteria to guide the selection of an appropriate MTD. Even where an objective measurement exists, such as body weight loss (BWL), there is no agreement on what level constitutes an MTD. A global initiative including 15 companies, led by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), has shared data on BWL in toxicity studies to assess the impact on the animal and the study outcome. Information on 151 studies has been used to develop an alert/warning system for BWL in short term toxicity studies. The data analysis supports BWL limits for short term dosing (up to 7days) of 10% for rat and dog and 6% for non-human primates (NHPs).

  20. Mergers and innovation in the pharmaceutical industry.

    PubMed

    Comanor, William S; Scherer, F M

    2013-01-01

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

  1. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... products are manufactured by branded pharmaceutical companies and marketed and sold under a non-brand label... an additional year. Par is a New Jersey-based generic pharmaceutical company with 115 active products... Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

  2. Pharmaceutical virtue.

    PubMed

    Martin, Emily

    2006-06-01

    In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

  3. [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

  4. [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.

  5. 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.

  6. 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

  7. 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.

  8. 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)

  9. Research-Based Teacher Education.

    ERIC Educational Resources Information Center

    Peters, William H.

    There is an emerging research base on teacher effectiveness that should be used in redesigning teacher education programs. However, the complexity of teaching and learning does not permit simple solutions to complex problems. Several studies, projects, and programs with the goal of conducting research for teacher education programs are discussed.…

  10. Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

    PubMed

    Ruppert, Thorsten; Hahn, Michael; Hundt, Ferdinand

    2012-01-01

    In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.

  11. 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

  12. 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.

  13. 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…

  14. Drug information residency rotation with pharmaceutical industry.

    PubMed

    Cramer, R L

    1986-01-01

    A drug information rotation in pharmaceutical industry may be elected as a component of a hospital pharmacy residency program. Program objectives include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the pharmaceutical industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of various departments within the company. During the rotation, the resident serves as a member of the Drug Information Service. Resident activities include participating in interviews with corporate professionals, updating pharmacokinetic profiles, responding to drug information requests and participating in other information projects. This rotation enables the resident to better understand pharmaceutical industry's concerns and relate these concerns to clinical pharmacy practice. PMID:10277398

  15. 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.

  16. 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

  17. Pharmaceutical technology management--profitable business avenue.

    PubMed

    Puthli, Shivanand P

    2010-01-01

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

  18. 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

  19. 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.

  20. Pharmaceutical gift giving: analysis of an ethical dilemma.

    PubMed

    Stokamer, Charlene L

    2003-01-01

    When pharmaceutical companies market their products to, and through, healthcare professionals in hospitals and private practice, healthcare professionals face ethical dilemmas in their practice and their organizations. Pharmaceutical companies target nurse practitioners with prescribing privileges. The author describes the ethical dilemma faced by healthcare professionals when friendly salespeople offer tempting gifts. The article outlines cultural responses to gift giving and ethical issues surrounding healthcare professionals' responses to pharmaceutical marketing strategies. Nurse administrators need to acknowledge a growing threat to nursing integrity. Nurse administrators have the power to make and enforce ethical policies that prevent proprietary influences from clouding nursing judgment and contributing to the escalating costs of prescription medications.

  1. 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.…

  2. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Johnson Matthey Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... company's customers. No comments or objections have been received. DEA has considered the factors in 21 U... the company's registration is consistent with the public interest. The investigation has included... November 28, 2011, 76 FR 72974, Johnson Matthey Pharmaceutical Materials Inc., Pharmaceutical Service,...

  3. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... Pharmaceutical Inc. to ensure that the company's registration is consistent with the public interest. The... FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made... commercial distribution. ] The company plans to manufacture Hydromorphone HCL for sale to other...

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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…

  9. [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

  10. [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.

  11. 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

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

    PubMed

    Dzhalilova, K I; Alieva, K Ia

    2012-01-01

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

  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. 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

  15. 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.

  16. 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.

  17. [Healthy pharmaceutical policy].

    PubMed

    González Pier, Eduardo

    2008-01-01

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

  18. [Pharmaceuticals as pollution].

    PubMed

    Grung, Merete; Langford, Katherine; Thomas, Kevin V

    2012-05-29

    The pharmaceuticals we humans use to treat illness and disease typically enter the aquatic environment via the sewer network and wastewater treatment works. Understanding the risks posed to the aquatic environment by these chemicals requires an understanding of the concentrations that exist in the environment and whether they are sufficiently high to have adverse effects on aquatic organisms. The main source of pharmaceuticals to wastewater treatment works is pharmaceuticals used by the general population. Only a small contribution is believed to come from hospitals. The predicted environmental concentrations of pharmaceuticals suggest that certain pharmaceuticals may pose a risk to the environment, but measurement of the actual concentrations present in effluents and recipient waters suggest that sophisticated wastewater treatment is effective for significantly reducing effluent concentrations, and that environmental concentrations of pharmaceuticals, in the Oslo Fjord, for example, are generally low. Humans also excrete the metabolites of the pharmaceuticals that they have used and these too may be released into the environment, sometimes in greater concentrations than the parent drug. The occurrence of most pharmaceuticals and their metabolites in the environment poses little acute environmental risk. However, the effects of long-term chronic exposure to these compounds are still poorly understood and the long-terms risks to the environment are still not clear. What is clear is that certain pharmaceuticals pose a greater environmental risk than others, and that where possible this knowledge should be used to inform users of more environmentally friendly alternatives.

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

    PubMed

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

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

  20. Institutional mistrust in the organization of pharmaceutical clinical trials.

    PubMed

    Fisher, Jill A

    2008-12-01

    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.

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

    PubMed

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

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

  2. Institutional mistrust in the organization of pharmaceutical clinical trials

    PubMed Central

    2010-01-01

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

  3. Acquainting veterinary students with careers in the pharmaceutical industry.

    PubMed

    McGregor, Douglas D; Fraser, David R; Haven, Michelle L; Hickey, Gerard J

    2007-01-01

    Careers in the pharmaceutical industry were revealed in modules facilitated by senior scientists from companies that sponsor the Cornell Leadership Program for Veterinary Students. One module was structured as a series of interviews for different positions in industry, the other as a competition between hypothetical companies created by students. The interview-based module stimulated wide-ranging discussion of the activities and responsibilities of veterinarians employed in a discovery-intensive pharmaceutical firm and of the characteristics such companies seek in prospective employees, from both professional and personal perspectives. The second module explored the drug discovery and development process from the perspective of animal-health companies that are competitors in the market for animal health care products. The exercise provided insights into the manner in which companies discover new chemical entities, screen candidate drugs, allocate resources, and pursue the development of products through testing, licensing, and distribution.

  4. Smart Companies.

    ERIC Educational Resources Information Center

    Galagan, Patricia A.

    1997-01-01

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

  5. [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

  6. Case histories in pharmaceutical risk management.

    PubMed

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

    2009-12-01

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

  7. 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.

  8. 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.

  9. [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.

  10. [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

  11. 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

  12. 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

  13. 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

  14. Pharmaceutical Industry in Syria

    PubMed Central

    2010-01-01

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

  15. 78 FR 69134 - Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... Pharmaceuticals By Notice dated July 23, 2013, and published in the Federal Register on July 31, 2013, 78 FR 46372... (9740) II Fentanyl (9801) II The company plans to manufacture small quantities of the listed...

  16. 78 FR 33441 - Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

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

  17. 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…

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

    PubMed

    Friedman, J A; Alkhateeb, W

    1981-01-01

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

  19. 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

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

    PubMed

    Yang, Y Tony; Chen, Brian

    2014-01-01

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

  1. 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

    2014-03-29

    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.

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

    PubMed

    Yang, Y Tony; Chen, Brian

    2014-01-01

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

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

    PubMed

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

    2006-11-01

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

  5. 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.

  6. 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

  7. 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.

  8. 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

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

    PubMed

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

    2006-02-01

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

  10. [Fourcroy and pharmaceutical journals].

    PubMed

    Bonnemain, Bruno

    2011-04-01

    Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

  11. 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

  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. Technology evaluation: ISIS-2503, Isis Pharmaceuticals.

    PubMed

    Morse, M A

    2001-12-01

    ISIS-2503, a 20-mer antisense oligonucleotide that inhibits Ha-Ras expression, is being developed by Isis Pharmaceuticals Inc as a potential treatmentfor cancer, particularly tumors that commonly have abnormalities of Ras function. It is in phase II trials. According to an April 2001 report by Bear Stearns & Co, Elan Corp plc had an unspecified collaboration with Isis for the development of ISIS-2503 [419357], but Isis later clarified that there was no agreement between the two companies and that ISIS-2503 had merely been used for the 'OraSense' joint venture that explores the use of antisense oligonucleotidesfor oral administration [419673].

  14. [Pharmaceutical marketers: professional and informative aspects].

    PubMed

    Hevia, A; López-Valpuesta, F J; Vázquez, J A; Castellanos, A

    1993-10-01

    This study tries to know the opinion of pharmaceutical detailers about their profession, as well as their pharmacological knowledge. 75 questionnaires were distributed to an equal number of detailers. The questionnaires were composed of two parts. In the first one, several questions about their profession were posed. In the second one, the questions were about Pharmacology. The main results were that most of them have got only lower degrees; however, they all have carried out training courses in their companies. With regard to pharmacological questions, percentage of success was 61%.

  15. 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

  16. 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

  17. Strategic imperatives for globalization of industries in developing countries: an Indian pharmaceutical industry example.

    PubMed

    Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish

    2004-01-01

    The annual global pharmaceutical sales have grown over 466 billion dollars, almost 50% of which comes from North America. Among developing countries, India, with 16% of the world population, accounts for only a small percentage of the global pharmaceutical industry. Until recently, India has had virtually no pharmaceutical industry worth the name producing drugs from basic raw materials and it used to rely mostly on the imports from countries like the USA and England for all its requirements of drugs. On the other hand, India has seen a plethora of multinational pharmaceutical companies come and do business in India. This paper develops a matrix which provides a broad guidance to the mid- to large-size Indian pharmaceutical domestic companies, which should embark on the path to global expansion to establish their might as well.

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

    PubMed

    Yongue, Julia S

    2014-01-01

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

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

    PubMed

    Yongue, Julia S

    2014-01-01

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

  20. 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

  1. 77 FR 12621 - Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... controlled substances is consistent with the public interest, and with United States obligations under... FR 81978, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made... the company's compliance with state and local laws, and a review of the company's background...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... for distribution to its customers. Regarding the drug code (8333), the company plans to use this... ensure that the company's registration is consistent with the public interest. The investigation has..., 77 FR 2324, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024,...

  3. [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

  4. 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.

  5. 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

  6. [Pharmaceutical reference pricing in Germany: definition of therapeutic groups, price setting through regression procedure and effects].

    PubMed

    Stargardt, T; Schreyögg, J; Busse, R

    2005-07-01

    The German reference pricing system defines a reimbursement threshold for groups of pharmaceuticals. Pharmaceuticals are grouped according to certain criteria by the Federal Joint Committee. To make different active ingredients comparable, so called reference values are defined. Subsequently, the federal association of sickness funds sets reference prices using a regression procedure. However, the impact of the reference price system is limited. On the one hand there is a strong incentive for pharmaceutical companies to decrease prices to the reference price. On the other hand there is no incentive for further price reductions. Additionally, only one part of the pharmaceutical market is affected by reference pricing. Therefore the instrument has only managed to lower pharmaceutical expenditure in the short run. For sustainable long-term cost containment the use of other regulatory instruments is necessary. Nevertheless, compared to other instruments of price-regulation, reference pricing seems to be a good alternative to control pharmaceutical prices, since rationing is kept as little as possible.

  7. 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

  8. 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

  9. 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.

  10. [New transparency between physicians and the pharmaceutical industry].

    PubMed

    Bühmann, W

    2014-08-01

    The long-lasting trusting partnership between physicians and the pharmaceutical industry with respect to experience from applied research of medications and vocational training, was severely tested by campaign-like dissemination of collective accusations of corruption. Instead of standing by their responsibility to financing clinical research and vocational training of physicians, the health insurance companies in particular claim that physicians are being extensively bribed by the pharmaceutical industry. In order to continuously improve the mutual targets, i.e. the treatment options for patients, both groups have developed transparency regulations.

  11. Pharmaceutical spray freeze drying.

    PubMed

    Wanning, Stefan; Süverkrüp, Richard; Lamprecht, Alf

    2015-07-01

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

  12. Trade, TRIPS, and pharmaceuticals.

    PubMed

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

    2009-02-21

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

  13. 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

  14. [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

  15. [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.

  16. 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

  17. [Laqueur and Organon. The university laboratory and the pharmaceutical industry in the Netherlands].

    PubMed

    Oudshoorn, N

    1999-01-01

    Since the 1970s cooperation between universities and pharmaceutical firms is business as usual. This has not always been the case. The first alliances between academic scientists and the pharmaceutical industry can be traced back to the 1920s. Compared to the U.S. and most other European countries, the creation of networks between the Dutch academy and industry shows a rather peculiar pattern that is illustrative in clarifying how the relationships between scientists and the pharmaceutical companies were built. Dutch scientists could not ally themselves with the pharmaceutical industry, simply because no Dutch pharmaceutical company specialized in organpreparations existed prior to the 1920s. This situation forced scientists to opt for the strongest form of alliance they could create, namely to take part in the founding of a pharmaceutical company. Ernst Laqueur, a professor in pharmacology at the University of Amsterdam, was one of the three founders of Organon, the Dutch pharmaceutical firm that was founded in 1923. Based on an analysis of the early history of sex endocrinology, this paper examines the creation of networks between Laqueur and Organon. The paper concludes that the university laboratory played a crucial role in the development of Organon. Organon was dependent on Laqueurs laboratory for the provision of the required biological essay techniques in order to manufacture standardized hormone products, Moreover, Laqueur mediated all the contacts between Organon and the clinic, required for the clinical testing of hormones and the provision of raw materials for the making of hormones into chemicals and drugs.

  18. Evaluation of pharmaceutical concerns in Germany: frequency and potential reasons

    PubMed Central

    Gradl, Gabriele; Krieg, Eva-Maria

    2016-01-01

    Background: Generic substitution can have unintended consequences. In Germany, brand name to generic or generic to generic switching is mainly driven by rebate contracts. Frequent switching may raise concerns about bio- and therapeutic equivalence. Expected patient confusion may result in compromised medication adherence or new onset of other drug-related problems. Since 2008, pharmacists are allowed to deviate from rebate contracts by denying substitution due to pharmaceutical concerns on an individual basis. Objectives: To explore the frequency of documented pharmaceutical concerns in Germany between July 2011 and December 2013 and to identify the medicines most frequently related to pharmaceutical concerns in 2013. Methods: We analyzed documented pharmaceutical concerns in all prescribed drugs at the expense of any statutory health insurance company requiring pharmacies’ generic substitution according to rebate contracts. Results: Since July 2011, the frequency of documented pharmaceutical concerns in relation to prescribed drug products with rebate contracts requiring substitution increased consistently and doubled between July 2011 and July 2013. Overall in 2013, the trend of the two previous years continued and reached approximately 1.5%. The most affected drugs/drug classes were thyroid hormones (in particular combinations with iodide; 15.9%) followed by ondansetron (12.5%), and levothyroxine (11.3%). For all drugs/drug classes under investigation, product-, patient- or disease-related aspects could be identified which are potential reasons to deny substitution and to document pharmaceutical concerns. Conclusions: Although there is no electronic recording of the specific reasons for pharmaceutical concerns in claims data, our analyses support the assumption that pharmacists make use of this instrument based on individual clinical decisions and as required by contract. Pharmaceutical concerns are, therefore, an important instrument for pharmacies to refuse

  19. [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

  20. 3rd annual symposium of chemical and pharmaceutical structure analysis.

    PubMed

    Weng, Naidong; Zheng, Jenny; Lee, Mike

    2012-08-01

    The 3rd Annual Symposium on Chemical and Pharmaceutical Structure Analysis was once again held in Shanghai, where a rich history of 'East meets West' continued. This meeting is dedicated to bringing together scientists from pharmaceutical companies, academic institutes, CROs and instrument vendors to discuss current challenges and opportunities on the forefront of pharmaceutical research and development. The diversified symposia and roundtables are highly interactive events where scientists share their experiences and visions in a collegial setting. The symposium highlighted speakers and sessions that provided first-hand experiences as well as the latest guidance and industrial/regulatory thinking, which was reflected by the theme of this year's meeting 'From Bench to Decision Making - from Basics to Application.' In addition to the highly successful Young Scientist Excellence Award, new events were featured at this year's meeting, such as the Executive Roundtable and the inaugural Innovator Award.

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

    PubMed

    Pokorny, A M J; Gittins, C B

    2015-10-01

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

  2. Micellar nanocarriers: pharmaceutical perspectives.

    PubMed

    Torchilin, V P

    2007-01-01

    Micelles, self-assembling nanosized colloidal particles with a hydrophobic core and hydrophilic shell are currently successfully used as pharmaceutical carriers for water-insoluble drugs and demonstrate a series of attractive properties as drug carriers. Among the micelle-forming compounds, amphiphilic copolymers, i.e., polymers consisting of hydrophobic block and hydrophilic block, are gaining an increasing attention. Polymeric micelles possess high stability both in vitro and in vivo and good biocompatibility, and can solubilize a broad variety of poorly soluble pharmaceuticals many of these drug-loaded micelles are currently at different stages of preclinical and clinical trials. Among polymeric micelles, a special group is formed by lipid-core micelles, i.e., micelles formed by conjugates of soluble copolymers with lipids (such as polyethylene glycol-phosphatidyl ethanolamine conjugate, PEG-PE). Polymeric micelles, including lipid-core micelles, carrying various reporter (contrast) groups may become the imaging agents of choice in different imaging modalities. All these micelles can also be used as targeted drug delivery systems. The targeting can be achieved via the enhanced permeability and retention (EPR) effect (into the areas with the compromised vasculature), by making micelles of stimuli-responsive amphiphilic block-copolymers, or by attaching specific targeting ligand molecules to the micelle surface. Immunomicelles prepared by coupling monoclonal antibody molecules to p-nitrophenylcarbonyl groups on the water-exposed termini of the micelle corona-forming blocks demonstrate high binding specificity and targetability. This review will discuss some recent trends in using micelles as pharmaceutical carriers. PMID:17109211

  3. [Adhesive cutaneous pharmaceutical forms].

    PubMed

    Gafiţanu, E; Matei, I; Mungiu, O C; Pavelescu, M; Mîndreci, I; Apostol, I; Ionescu, G

    1989-01-01

    The adhesive cutaneous pharmaceutical forms aimed to local action release the drug substance in view of a dermatological, traumatological, antirheumatic, cosmetic action. Two such preparations were obtained and their stability, consistency and pH were determined. The "in vitro" tests of their bioavailability revealed the dynamics of calcium ions release according to the associations of each preparation. The bioavailability determined by evaluating the pharmacological response demonstrated the antiinflammatory action obtained by the association of calcium ions with the components extracted from poplar muds. The therapeutical efficiency of the studied preparations has proved in the treatment of some sport injuries.

  4. 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

  5. Pharmacoeconomics in the new millennium. A pharmaceutical industry perspective.

    PubMed

    Thwaites, R; Townsend, R J

    1998-02-01

    The primary purpose of pharmacoeconomic research is to assist in making healthcare decisions. Rapid growth in the supply of pharmacoeconomic data over the past few years suggests that pharmacoeconomics can be of help in delivering good, cost-effective healthcare. Greater challenges in decision-making coupled with improvements in the techniques of pharmacoeconomic research point to a greater role for pharmacoeconomics into the new millennium. This in turn will have consequences for companies in the pharmaceutical industry. More successful access to markets and better commercialisation of products will be the rewards for those companies committing to pharmacoeconomics and to the broader goal of delivering value for money in healthcare.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. [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

  13. [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

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

    PubMed

    Wall, L Lewis; Brown, Douglas

    2002-09-01

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

  15. 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.

  16. The case for entrepreneurship in R&D in the pharmaceutical industry.

    PubMed

    Douglas, Frank L; Narayanan, V K; Mitchell, Lesa; Litan, Robert E

    2010-09-01

    A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity.

  17. 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.

  18. 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.

  19. Globalization of the pharmaceutical industry and the growing dependency of developing countries: the case of Turkey.

    PubMed

    Semin, Semih; Güldal, Dilek

    2008-01-01

    In developing countries, the effect of globalization on the pharmaceutical sector has resulted in a decrease in exportation and domestic production, accompanied by an increase in importation of pharmaceuticals and a rise in prices and expenditures. As an example of a developing country, Turkey has been facing the long-standing and increasing pressure of global regulations placed on its pharmaceutical sector. This has led to an increasing dependency on multinational companies and a gradual deterioration of an already weakened domestic pharmaceutical sector. This case study of Turkey offers points to consider in the world of increasing globalization, as it offers lessons on ways of examining the effects of globalization on the pharmaceutical industry of developing countries.

  20. 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

  1. Pharmaceutical promotion and GP prescription behaviour.

    PubMed

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

    2006-01-01

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

  2. UPLC: a preeminent technique in pharmaceutical analysis.

    PubMed

    Kumar, Ashok; Saini, Gautam; Nair, Anroop; Sharma, Rishbha

    2012-01-01

    The pharmaceutical companies today are driven to create novel and more efficient tools to discover, develop, deliver and monitor the drugs. In this contest the development of rapid chromatographic method is crucial for the analytical laboratories. In precedent decade, substantial technological advances have been done in enhancing particle chemistry performance, improving detector design and in optimizing the system, data processors and various controls of chromatographic techniques. When all was blended together, it resulted in the outstanding performance via ultra-high performance liquid chromatography (UPLC), which holds back the principle of HPLC technique. UPLC shows a dramatic enhancement in speed, resolution as well as the sensitivity of analysis by using particle size less than 2 pm and the system is operational at higher pressure, while the mobile phase could be able to run at greater linear velocities as compared to HPLC. This technique is considered as a new focal point in field of liquid chromatographic studies. This review focuses on the basic principle, instrumentation of UPLC and its advantages over HPLC, furthermore, this article emphasizes various pharmaceutical applications of this technique.

  3. 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

  4. 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

  5. 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

  6. 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.

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

    PubMed

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

    2015-03-01

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

  8. 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.

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

    PubMed

    Cohen, A F

    1999-06-26

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

  10. Pharmaceutical prospects of phytoestrogens.

    PubMed

    Usui, Takeshi

    2006-02-01

    Interest in the physiologic and pharmacologic role of bioactive compounds present in plants has increased dramatically over the last decade. Of particular interest in relation to human health are the classes of compounds known as the phytoestrogens, which embody several groups of non-steroidal estrogens, including isoflavones and lignans that are widely distributed within nature. The impact of dietary phytoestrogens on normal biologic processes was first recognized in sheep. Observations of sheep grazing on fields rich in clover and cheetahs fed high soy diets in zoos suggested that flavonoids and related phytochemicals can affect mammalian health. Endogenous estrogens have an important role not only in the hypothalamic-pituitary-gonadal axis, but also in various non-gonadal systems, such as cardiovascular systems, bone, and central nervous systems, and lipid metabolism. There have been several clinical studies of hormone replacement therapy (HRT) in post-menopausal women to examine whether HRT has beneficial effects on the cardiovascular system, bone fractures, lipid metabolism, and Alzheimer's disease. In addition, estrogen contributes to the development of some estrogen-dependent cancers, such as breast cancer and prostate cancer and the number of patients with these cancers is increasing in developed countries. Although recent mega-studies showed negative results for classical HRT in the prevention of some of these diseases, the molecules that interact with estrogen receptors are candidate drugs for various diseases, including hormone-dependent cancers. This review focuses on the molecular properties and pharmaceutical potential of phytoestrogens.

  11. 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...

  12. 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

  13. [Pharmaceutical chemistry of general anaesthetics].

    PubMed

    Szász, György; Takácsné, Novák Krisztina

    2004-01-01

    The paper represents the first part of a planned series of reviews about pharmaceutical chemistry of drugs acting on the central nervous system. The authorial aim and editorial concepts are the same were followed in a former series of papers about pharmaceutical chemistry of agents effecting the heart, blood circulation and vegetative nervous system. Consequently, general anaesthetics are discussed in the present paper through the chapters "history, preparation; structure-properties-activity; application; analysis".

  14. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

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

    2015-12-01

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

  15. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

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

    2015-12-01

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

  16. [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

  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. 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

  19. 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

  20. 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.

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

    PubMed

    Bonnemain, Bruno

    2015-12-01

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

  2. 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

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

    PubMed

    Lemasson, Elise; Bertin, Sophie; West, Caroline

    2016-01-01

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

  4. 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

  5. [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'.

  6. [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

  7. Bexarotene ligand pharmaceuticals.

    PubMed

    Hurst, R E

    2000-12-01

    Bexarotene (LGD-1069), from Ligand, was the first retinoid X receptor (RXR)-selective, antitumor retinoid to enter clinical trials. The company launched the drug for the treatment of cutaneous T-cell lymphoma (CTCL), as Targretin capsules, in the US in January 2000 [359023]. The company filed an NDA for Targretin capsules in June 1999, and for topical gel in December 1999 [329011], [349982] specifically for once-daily oral administration for the treatment of patients with early-stage CTCL who have not tolerated other therapies, patients with refractory or persistent early stage CTCL and patients with refractory advanced stage CTCL. The FDA approved Targretin capsules at the end of December 1999 for once-daily oral treatment of all stages of CTCL in patients refractory to at least one prior systemic therapy, at an initial dose of 300 mg/m2/day. After an NDA was submitted in December 1999 for Targretin gel, the drug received Priority Review status for use as a treatment of cutaneous lesions in patients with stage IA, IB or IIA CTCL [354836]. The FDA issued an approvable letter in June 2000, and granted marketing clearance for CTCL in the same month [370687], [372768], [372769], [373279]. Ligand had received Orphan Drug designation for this indication [329011]. At the request of the FDA, Ligand agreed to carry out certain post-approval phase IV and pharmacokinetic studies [351604]. The company filed an MAA with the EMEA for Targretin Capsules to treat lymphoma in November 1999 [348944]. The NDA for Targretin gel is based on a multicenter phase III trial that was conducted in the US, Canada, Europe and Australia involving 50 patients and a multicenter phase I/II clinical program involving 67 patients. Targretin gel was evaluated for the treatment of patients with early stage CTCL (IA-IIA) who were refractory to, intolerant to, or reached a response plateau for at least 6 months on at least two prior therapies. Efficacy results exceeded the protocol-defined response

  8. 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.

  9. 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

  10. 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…

  11. 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…

  12. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

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

  13. 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...

  14. Pharmaceutical and industrial protein engineering: where we are?

    PubMed

    Amara, Amro Abd-Al-Fattah

    2013-01-01

    The huge amount of information, the big number of scientists and their efforts, labs, man/hrs, fund, companies all and others factors build the success of the amazing new branch of genetic engineering the 'protein engineering' (PE). It concerns with the modification of protein structure/function(s) or building protein from scratch. The engineered proteins usually have new criteria(s). Engineering proteins can be mediated on the level of genes or proteins. PE fined its way in different important sectors including industrial, pharmaceutical and medicinal ones. Aspects about PE and its applications will be discussed with this review. The concept, tools, and the industrial applications of the protein, engineered proteins and PE will be under focus. In order to get up to date knowledge about the applications of PE in basic protein and molecular biology, several examples are discussed. PE can play a significant role in different industrial and pharmaceutical sectors if used wisely and selectively.

  15. 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

  16. 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.

  17. [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

  18. 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

  19. 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

  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.

  1. 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

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

    ERIC Educational Resources Information Center

    Clements, Douglas H.

    2007-01-01

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

  3. 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

  4. 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

  5. The World Bank and pharmaceuticals.

    PubMed

    Falkenberg, T; Tomson, G

    2000-03-01

    Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and

  6. The World Bank and pharmaceuticals.

    PubMed

    Falkenberg, T; Tomson, G

    2000-03-01

    Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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...

  13. Patrick Couvreur: inspiring pharmaceutical innovation.

    PubMed

    Stanwix, Hannah

    2014-05-01

    Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.

  14. 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

  15. 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

  16. Pharmaceutical care in smoking cessation

    PubMed Central

    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

  17. Career pathways in research: pharmaceutical.

    PubMed

    Kenkre, J E; Foxcroft, D R

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

  18. 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

  19. [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

  20. 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.

  1. 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.

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

    PubMed

    Yadav, Vikramaditya G; Stephanopoulos, Gregory

    2014-07-01

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

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

    PubMed

    Yadav, Vikramaditya G; Stephanopoulos, Gregory

    2014-07-01

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

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

    PubMed

    Seay, Melicia; Varma, Priya

    2005-12-31

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

  5. [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

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

    PubMed

    Bonnemain, Bruno

    2007-10-01

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

  7. 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.

  8. In silico prediction of pharmaceutical degradation pathways: a benchmarking study.

    PubMed

    Kleinman, Mark H; Baertschi, Steven W; Alsante, Karen M; Reid, Darren L; Mowery, Mark D; Shimanovich, Roman; Foti, Chris; Smith, William K; Reynolds, Dan W; Nefliu, Marcela; Ott, Martin A

    2014-11-01

    Zeneth is a new software application capable of predicting degradation products derived from small molecule active pharmaceutical ingredients. This study was aimed at understanding the current status of Zeneth's predictive capabilities and assessing gaps in predictivity. Using data from 27 small molecule drug substances from five pharmaceutical companies, the evolution of Zeneth predictions through knowledge base development since 2009 was evaluated. The experimentally observed degradation products from forced degradation, accelerated, and long-term stability studies were compared to Zeneth predictions. Steady progress in predictive performance was observed as the knowledge bases grew and were refined. Over the course of the development covered within this evaluation, the ability of Zeneth to predict experimentally observed degradants increased from 31% to 54%. In particular, gaps in predictivity were noted in the areas of epimerizations, N-dealkylation of N-alkylheteroaromatic compounds, photochemical decarboxylations, and electrocyclic reactions. The results of this study show that knowledge base development efforts have increased the ability of Zeneth to predict relevant degradation products and aid pharmaceutical research. This study has also provided valuable information to help guide further improvements to Zeneth and its knowledge base.

  9. 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.

  10. 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

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

    NASA Technical Reports Server (NTRS)

    1978-01-01

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

  12. 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.

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

    PubMed

    Gray, Garry C

    2013-01-01

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

  14. 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

  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. Quality analytics of Internet pharmaceuticals.

    PubMed

    Baert, B; De Spiegeleer, B

    2010-09-01

    Trading pharmaceutical products through the Internet poses several challenges related to legal responsibilities, good distribution practices, information content and patient use, financial implications, but also regarding product quality. One of the major concerns is the well-known phenomenon of counterfeited and/or substandard drugs commercialized through rogue Internet sites. Therefore, controlling and assuring the quality of those products has become an important and challenging task for the authorities. This review gives an overview of the different quality attributes that can be evaluated to have a complete understanding of the quality of the finished pharmaceutical product traded through the Internet, as well as the current analytical techniques that serve this objective. Aspects considered are labelling and packaging, physicochemical quality attributes, identification and assay of active substances and/or excipients, impurity profiling, biopharmaceutical testing and data interpretation.

  17. 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

  18. A Business Model for Diagnostic Startups-A Business Model for a New Generation Of Diagnostics Companies

    PubMed Central

    Kurtzman, Gary

    2005-01-01

    Venture capital has tended to shy away from diagnostics companies, whose products are not predicated on the blockbuster model of pharmaceuticals. But several new diagnostics companies are developing products that hold immense potential to improve healthcare delivery. Here’s why venture investors should take another look at the diagnostics area. PMID:23424311

  19. Economic analysis and pharmaceutical policy.

    PubMed

    Rovira, J

    1995-10-01

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

  20. 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

  1. “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

  2. Understanding pharmaceutical quality by design.

    PubMed

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

    2014-07-01

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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. Global gene mining and the pharmaceutical industry.

    PubMed

    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

  10. 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.

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

    PubMed

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

    2003-01-01

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

  12. 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.

  13. 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

  14. A qualitative glimpse at pharmaceutical care practice.

    PubMed

    Varela Dupotey, Niurka María; Ramalho de Oliveira, Djenane

    2009-12-01

    This manuscript presents an argument for a broader use of qualitative methodologies to investigate the practice and the surroundings of pharmaceutical care. Albeit the use of qualitative research methods is growing in the health care field, it is still insufficient in the area of pharmaceutical care. Pharmaceutical care, as a patient-centered practice, calls for a more comprehensive and humanistic approach to research. It is our contention that the attempt to understand pharmaceutical care practice from the perspective of patients, pharmacists and other health care professionals, by means of using qualitative methods, would notably contribute to a better assessment of the value of pharmaceutical care programs in the health care system. Moreover, because a deeper understanding of the nuances of this practice can be achieved with the use of qualitative methods, this approach might also assist us in making the necessary changes to create more effective pharmaceutical care practices.

  15. 75 FR 5075 - Coalinga Cogeneration Company, Kern River Cogeneration Company, Mid-Set Cogeneration Company...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

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

  16. 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

  17. Pharmaceutical Compounds Studied Using NEXAFS

    SciTech Connect

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

    2007-02-02

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

  18. 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...

  19. 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

  20. Pharmaceutical Cocrystals and Their Physicochemical Properties

    PubMed Central

    2009-01-01

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

  1. Toward a definition of pharmaceutical innovation.

    PubMed

    Morgan, Steven; Lopert, Ruth; Greyson, Devon

    2008-01-01

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

  2. 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.

  3. 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

  4. Research-Based Learning: Teaching Development through Fieldschools

    ERIC Educational Resources Information Center

    Guinness, Patrick

    2012-01-01

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

  5. Integrating Interdisciplinary Research-Based Experiences in Biotechnology Laboratories

    ERIC Educational Resources Information Center

    Iyer, Rupa S.; Wales, Melinda E.

    2012-01-01

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

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

    ERIC Educational Resources Information Center

    Goodwin, Deborah; Webb, Mary Ann

    2014-01-01

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

  7. Principles of Assessment for Project and Research Based Learning

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

    Faulder, Tori Rose

    2011-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  11. A Research-Based Development Economics Course for Undergraduates

    ERIC Educational Resources Information Center

    Singh, Prakarsh; Guo, Hongye; Morales, Alvaro

    2015-01-01

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

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

    ERIC Educational Resources Information Center

    Lencucha, Raphael

    2014-01-01

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

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  14. The AI Interdisciplinary Context: Single or Multiple Research Bases?

    ERIC Educational Resources Information Center

    Khawam, Yves J.

    1992-01-01

    This study used citation analysis to determine whether the disciplines contributing to the journal literature of artificial intelligence (AI)--philosophy, psychology, linguistics, computer science, and engineering--share a common AI research base. The idea that AI consists of a completely interdisciplinary endeavor was refuted. (MES)

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

    ERIC Educational Resources Information Center

    Viiri, Jouni; Saari, Heikki

    2004-01-01

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

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

    PubMed

    Titz, Alexandra; Döll, Petra

    2009-02-01

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

  17. 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.

  18. 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

  19. 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

  20. Ion mobility spectrometry: a comprehensive and versatile tool for occupational pharmaceutical exposure assessment.

    PubMed

    Armenta, S; Blanco, M

    2012-05-15

    The qualitative and quantitative capabilities of ion mobility spectrometry (IMS) as a comprehensive and powerful tool in workplace air monitoring have been demonstrated on the example of a Spanish pharmaceutical company. The developed IMS based procedure is capable of detecting and determining in air samples the active pharmaceutical ingredients (APIs) manipulated and/or produced in this pharmaceutical industry. Sensitivity, in the ng-pg range, selectivity, possibly to provide results in near real time, and reduction of analysis costs are the most important properties that ratify IMS as a serious alternative in occupational exposure assessment. The possibility of false positives by drift time interferences and false negatives by competitive ionization and also desorption process interferences has been deeply evaluated. Moreover, chemometric strategies based on self-modeling curve resolution (SMCR) have been applied to obtain qualitative and quantitative individual component information from overlapped peaks. The IMS procedure has been successfully applied to evaluate the concentration of APIs (nimesulide, dexketoprofen, deflazacort) handled by the pharmaceutical company employees in the making of tablets and granulates, and control measures have been suggested in accordance.

  1. [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

  2. [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

  3. Clevidipine (the Medicines Company).

    PubMed

    Zhang, Hongwei

    2002-10-01

    The Medicines Company (under license from AstraZeneca) is developing clevidipine, a short-acting dihydropyridine calcium antagonist, for the potential treatment of peri-operative hypertension. By 1997, the compound was undergoing phase II clinical evaluation by the original developer, AstraZeneca. By March 2002, The Medicines Company was conducting phase III clinical trials.

  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. 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.

  6. 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

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

    PubMed Central

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

    2013-01-01

    Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. Purpose: The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. Methodology: This paper represents a thorough literature review of the multifaceted sources including: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). Discussion: In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or – at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Conclusion: Numerous blockbuster drugs will be coming off

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

    PubMed Central

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

    2016-01-01

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

  9. 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…

  10. Nanostructured materials in electroanalysis of pharmaceuticals.

    PubMed

    Rahi, A; Karimian, K; Heli, H

    2016-03-15

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

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. [The development of the Japanese pharmaceutical industry (Part 8) - the change of opium alkaloid opioid analgesics in Japanese pharmaceutical companies.].

    PubMed

    Takehara, Jun

    2005-01-01

    After the Japan-England Friendship and Commercial Treaty of 1858 (Ansei 5), narcotic drugs have been strictly regulated by laws. The production of opium alkaloid analgesics, mainly morphine, became active in Japan after World War I (1918, Taisho 7). Having released the "Cancer Pain Relief" guideline by the WHO in 1986 (Showa 61) and the morphine sulfate controlled-release tablet "MS Contin" in 1989 (Heisei 1) in Japan, the demand for morphine in Japan expanded remarkably. Today, several more kinds of strong opioid analgesics are available for cancer pain treatment in Japan. An increase in the use of strong opioid analgesics is expected in the future.

  16. Adapting Project Management Practices to Research-Based Projects

    NASA Technical Reports Server (NTRS)

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

    2007-01-01

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

  17. 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. Models for financing the regulation of pharmaceutical promotion.

    PubMed

    Lexchin, Joel

    2012-07-11

    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.

  20. 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.

  1. 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...

  2. 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

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

    PubMed Central

    2010-01-01

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

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

    PubMed Central

    Lee, Munjae; Choi, Mankyu

    2015-01-01

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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. [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.

  10. 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.

  11. 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.

  12. 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 ...

  13. 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.

  14. 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...

  15. 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

  16. [The attitude of physicians regarding the promotion strategies of the pharmaceutical industry].

    PubMed

    Castresana, Leonardo; Mejia, Raul; Aznar, Mireya

    2005-01-01

    Pharmaceutical companies invest large sums of money promoting their products. They use a multifaceted approach to drug promotion, incorporating techniques such as hospital and office detailing by pharmaceutical representatives. Although these practices are commonly used, little has been published about the attitude of physicians concerning their interaction with the pharmaceutical industry. We performed a cross sectional anonymous survey to identify the extent of and attitudes towards the relationship between the physicians and the pharmaceutical industry and its representatives with its impact on the knowledge, attitude and behavior of the physicians. Internists, cardiologists and dermatologists who work in ambulatory settings from private and public hospitals in Buenos Aires city participated in this study, 44% were female, 35% residents, 65% staff physicians, averaging 41 years of age. Of these, 86% receive medical samples frecuently, 39% desk gifts, 19% invitations to congresses and 12% free lunches. Half of the doctors believe that receiving benefits from the pharmaceutical industry has an influence on medical prescription, but only 27% accept this as influential in their own prescriptions. Residents consider, more frequently than others, that these activities affect their decisions, (42% vs. 18% p = 0.007, global 30%). Most of the participants consider appropriate receiving these benefits, although 35% think that they affect the final price of medications. In conclusion, there is a high level of interaction between the pharmaceutical industry and our medical population. Although the latter recognize the influence of these interactions on prescriptions and the elevation of the cost of the final product, they find it appropriate to receive benefits.

  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.

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

    PubMed

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

    2015-03-01

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

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

    PubMed

    Lencucha, Raphael

    2014-03-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. Physics Faculty Perceptions of Research-based Assessment

    NASA Astrophysics Data System (ADS)

    Sayre, Eleanor

    2016-03-01

    When research-based resources are well aligned with the perceived needs of faculty, faculty members will more readily take them up. We used phenomenographic interviews of ordinary physics faculty and department chairs to identify four families of issues that faculty have around research-based assessments (RBAs). First, many faculty are interested in using RBAs, but need help with the practicalities of administering RBAs: how to find them, which ones there are, and how to administer them. Second, at the same time, many faculty think that RBAs are limited and don't measure many of the things they care about, or aren't applicable in their classes. They want assessments to measure skills, perceptions, and specific concepts. Third, many faculty want to turn to communities of other faculty and experts to help them interpret their assessment results and suggest other ways to do assessment. They want to better understand their assessment results by comparing to others and interacting with faculty from other schools to learn about how they do assessment. Fourth, many faculty consider their courses in the broader contexts of accountability and their departments. They want help with assessment in these broader contexts. We also discuss how faculty members' roles in their departments and institutions influence their perceived wants and needs around assessment. Supported by NSF DUE-1256354, DUE-1256354, DUE-1347821, DUE-1347728.

  2. The Use of Astronomy in Research Based Science Education

    NASA Astrophysics Data System (ADS)

    Jacoby, S. H.; Lockwood, J. F.; McCarthy, D. W.

    1998-01-01

    Educational outreach programs of the National Optical Astronomy Observatories will be summarized, in particular ``The Use of Astronomy in Research Based Science Education (RBSE)", a NSF-funded Teacher Enhancement Program which began in the summer of 1997. This program offers a research experience to middle and high school teachers during summer workshops and helps extend the experience to their classrooms during the academic year. Participants observe with telescopes on Kitt Peak, learn image analysis techniques through Image Processing for Teaching workshops, develop strategies for teaching a research-based science course and receive astronomy content instruction necessary to understand the pre-selected datasets investigated during the summer program. Academic year followup includes mentoring opportunities with astronomers drawn from the national user base of NOAO facilities and technical support from NOAO Educational Outreach. This presentation will describe results of our Pilot Test Study run in the summer of 1997 and plans for future years. Different models for bringing research into the classroom will be described as will opportunities for astronomers interested in being local mentors to participating teachers.

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

    PubMed

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

    2015-03-01

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

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

    PubMed Central

    2010-01-01

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

  5. Pharmaceutical research: paradox, challenge or dilemma?

    PubMed

    Sheikh, Abdul Latif

    2006-01-01

    A great deal of pharmaceutical research is nowadays carried out in developing countries such as Pakistan. Is it, however, beneficial for the country and the participants, often the poorly educated and illiterate? Pharmaceutical research in Pakistan can bring benefits to both patients and country. Promotion of good clinical practice and the development of national guidelines are advocated. Government and industry both have a role to play to maintain the right balance.

  6. 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.

  7. 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

  8. The new pharmaceutical policy in Italy.

    PubMed

    Fattore, G; Jommi, C

    1998-10-01

    Pressed by an impressive series of corruption scandals and by a change of attitude towards cost-containment, the Italian pharmaceutical sector's regulatory environment was radically changed in 1994. Regulatory power was concentrated on a national technical body (CUF) and a new set of measures was taken, including a nationwide drug expenditure budget, a redefinition of both the positive list and the cost-sharing rules, and new price-setting models. As a result, in the period 1993-1996, nominal expenditures decreased by about L 1600 billion (ECU 83.6 billion at 1997 exchange rate), that is from 13.3% to 11.0% of current National Health Service (NHS) expenditure. While in the 1980s Italy was one of the most generous countries in funding pharmaceuticals, it is now one of the most parsimonious. Although the overall pharmaceutical market shrank in 1994 and 1995, a substantial part of NHS drug-bill savings resulted from cost-shifting from the public sector to patients, mainly because physicians have not aligned their prescribing behaviour to the new positive list. The new Italian approach to containing pharmaceutical costs has been certainly effective, at least in the short run. However, new relevant issues are emerging regarding the fall of NHS pharmaceutical coverage, the centralised nature of the Italian pharmaceutical policy and the gap between scientific based policies and actual prescribing behaviours.

  9. [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

  10. [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

  11. 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.

  12. 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

  13. Patent issues in drug development: perspectives of a pharmaceutical scientist-attorney.

    PubMed

    Melethil, Srikumaran

    2005-10-27

    The major purpose of this article is to emphasize the need for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Economic incentives for drug discovery and development clash with societal needs for low-cost pharmaceuticals in the United States and all over the world. The Hatch-Waxman Act of 1984 was enacted to promote public health by balancing the interests of brand name and generic companies. Patent protection, which provides a monopoly for a limited time, is aimed to provide such incentives. Creation of patents requires the interaction between scientists and lawyers, an endeavor made difficult by the differing intellectual spheres of their respective disciplines. Therefore, in the first place, a thorough understanding of patent fundamentals among pharmaceutical scientists will help them work more efficiently with patent attorneys. Second, it will enable them to appreciate the strengths and weaknesses of individual patents, which is critical in developing strategies amidst the ongoing patent tug-of-war between brand-name and generic companies.

  14. Expectations and satisfaction of academic investigators in nonclinical collaboration with the pharmaceutical industry.

    PubMed

    Amiri, Marjan; Michel, Martin C

    2015-06-01

    In light of a growing role of research collaborations between academia and the pharmaceutical industry, we have explored expectations and experience of academic investigators with preclinical collaborations. Researchers from Western Europe, North America, and Japan with preclinical publications in the obstructed airways or diabetes fields were invited to anonymously participate in a web-based survey. A total of 134 investigators (28 % of invitees) participated in the two sequentially performed surveys with similar responses in both therapeutic areas. A secondary but prespecified subgroup analysis was based on region of residence, gender, and career level of the investigator. Across all groups, responders considered freedom to publish, obtaining funding and obtaining compounds to be the most important objectives of nonclinical collaborations with the pharmaceutical industry, whereas cultivating professional relationships, getting external scientific input, direct relationship to disease treatment, and involvement with drug development were less important. Among eight attributes of the primary contact person in the company, trustworthiness ranked highest, followed by a collaborative spirit and transparent information sharing; supportiveness, scientific qualification, accessibility, and timeliness of responses ranked lower, and friendliness, lowest. Related to their most recent collaboration, investigators also expressed the highest level of satisfaction with the trustworthiness attribute. On the other hand, the process of reaching a contract was often considered too long and difficult, for which both university and company legal departments were reported as culprits. We conclude that academic researchers are generally satisfied with their preclinical collaboration with the pharmaceutical industry but look for improved contracting procedures. PMID:25720948

  15. 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...

  16. [The reference pricing of pharmaceuticals in European countries].

    PubMed

    Gildeyeva, G N; Starykh, D A

    2013-01-01

    The article presents the analysis of various approaches to estimation of pharmaceuticals prices in conditions of actual systems of pharmaceuticals support. The pricing is considered in pegging to actual systems of pharmaceuticals support based on the principles of insurance and co-financing. The detailed analysis is presented concerning the methodology of estimation of reference prices of pharmaceuticals in different countries of Europe. The experience of European countries in evaluation of interchangeability of pharmaceuticals is discussed.

  17. Stem cells in pharmaceutical biotechnology.

    PubMed

    Zuba-Surma, Ewa K; Józkowicz, Alicja; Dulak, Józef

    2011-11-01

    Multiple populations of stem cells have been indicated to potentially participate in regeneration of injured organs. Especially, embryonic stem cells (ESC) and recently inducible pluripotent stem cells (iPS) receive a marked attention from scientists and clinicians for regenerative medicine because of their high proliferative and differentiation capacities. Despite that ESC and iPS cells are expected to give rise into multiple regenerative applications when their side effects are overcame during appropriate preparation procedures, in fact their most recent application of human ESC may, however, reside in their use as a tool in drug development and disease modeling. This review focuses on the applications of stem cells in pharmaceutical biotechnology. We discuss possible relevance of pluripotent cell stem populations in developing physiological models for any human tissue cell type useful for pharmacological, metabolic and toxicity evaluation necessary in the earliest steps of drug development. The present models applied for preclinical drug testing consist of primary cells or immortalized cell lines that show limitations in terms of accessibility or relevance to their in vivo counterparts. The availability of renewable human cells with functional similarities to their in vivo counterparts is the first landmark for a new generation of cell-based assays. We discuss the approaches for using stem cells as valuable physiological targets of drug activity which may increase the strength of target validation and efficacy potentially resulting in introducing new safer remedies into clinical trials and the marketplace. Moreover, we discuss the possible applications of stem cells for elucidating mechanisms of disease pathogenesis. The knowledge about the mechanisms governing the development and progression of multitude disorders which would come from the cellular models established based on stem cells, may give rise to new therapeutical strategies for such diseases. All

  18. 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

  19. 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.

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

    PubMed

    Edwards, Brian

    2004-01-01

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

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

    PubMed

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

    2015-04-01

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

  2. 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

  3. 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…

  4. What Companies Look For.

    ERIC Educational Resources Information Center

    Rosenberg, Ronald

    1985-01-01

    Examines reasons why technology companies are locating new facilities in various areas across the country. Also explains a microelectronics firm's paramount concern of selecting a site with proximity to university research and technical education, a criterion recognized as essential by industry when selecting a potential site. (DH)

  5. Smart customers, dumb companies.

    PubMed

    Locke, C

    2000-01-01

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

  6. [Social change and Pharmaceutical Affairs Law (PAL)].

    PubMed

    Masuyama, Koichi; Isobe, Soichiro

    2010-01-01

    Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943. This is also regarded as the origin of the current PAL (LawNo.145 in 1960). Through this analysis, we tried to clarify the relationship between the social change and the role of PAL in society. During the War, the bill was discussed, aiming at the improvement of both human resources who treated drugs, and the quality of drug materials. Diet members discussed three main points, namely, "the duty of pharmacists", "the mission of the Japan Pharmaceutical Association" and "the quality control of pharmaceutical products". Notably, the bill pharmacists are required not only to dispense drugs, a role they had previously, but also to manage drug and food hygiene through the quality control of pharmaceutical products and the inspection of food and drink, in order to improve the public health in Japan. Originally, the law was passed to deal with the extraordinary circumstances during the War, but through our analysis, we found that they proactively improved the role of the law to comply with various drug issues raised during the War, the rapid change of the pharmaceutical hygiene concept and the social transformation. PMID:21032892

  7. 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?

  8. 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...

  9. Company profile: Sistemic Ltd.

    PubMed

    Reid, Jim

    2013-09-01

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

  10. Optimising the design of preliminary toxicity studies for pharmaceutical safety testing in the dog.

    PubMed

    Smith, David; Combes, Robert; Depelchin, Olympe; Jacobsen, Soren Dyring; Hack, Ruediger; Luft, Joerg; Lammens, Lieve; von Landenberg, Friedrich; Phillips, Barry; Pfister, Rudolf; Rabemampianina, Yvon; Sparrow, Susan; Stark, Claudia; Stephan-Gueldner, Markus

    2005-03-01

    A working party, comprising two animal welfare organisations and some 12 pharmaceutical companies in Europe, was established to minimise the use of the dog in safety testing. As first step, the participants defined the major objectives of preliminary dose-range finding/MTD toxicity studies in non-rodents, defined the principles and requirements for this study type and agreed on a proposal for an optimised study design, based on collective experience of conducting such studies in industry, involving an evaluation of 100 individual study data sets. The suggested study design is explained and described, and reflects current best practice in the pharmaceutical industry in Europe. The implementation of such an optimised design is believed to result in a reduction in the overall numbers of animals used for this purpose, without jeopardising the scientific rationale and usefulness of the studies for informing the conduct of later regulatory studies.

  11. 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.

  12. 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.

  13. 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

  14. The simple economics of risk-sharing agreements between the NHS and the pharmaceutical industry.

    PubMed

    Barros, Pedro Pita

    2011-04-01

    The introduction of new (and expensive) pharmaceutical products is one of the major challenges for health systems. The search for new institutional arrangements is natural. The use of the so-called risk-sharing agreements is one example. Recent discussions have somewhat neglected the economic fundamentals underlying risk-sharing agreements. We argue here that risk-sharing agreements, although attractive due to the principle of paying by results, also entail risks. Too many patients may be put under treatment. Prices are likely to be adjusted upward, in anticipation of future risk-sharing agreements between the pharmaceutical company and the third-party payer. An available instrument is a verification cost per patient treated, which allows obtaining the first-best allocation of patients to the new treatment, under the agreement. Overall, the welfare effects of risk-sharing agreements are ambiguous, and caution is urged regarding their use.

  15. 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

  16. 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.

  17. 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

  18. Health advocacy organizations and the pharmaceutical industry: an analysis of disclosure practices.

    PubMed

    Rothman, Sheila M; Raveis, Victoria H; Friedman, Anne; Rothman, David J

    2011-04-01

    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.

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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

  7. Microbial growth in small-volume pharmaceuticals.

    PubMed

    Whyte, W; Niven, L; Bell, N D

    1989-01-01

    The ability of aseptically filled pharmaceuticals to support microbial growth was tested on 43 small-volume products (mainly parenterals). These were inoculated with a variety of microorganisms which were known to be associated with contamination of pharmaceutical products. In general, Gram-negative bacteria were found to be much more likely to grow than Gram-positive. It was possible for an inoculum of a few cells to multiply to levels up to 10(7)/mL. The presence of preservatives also influenced the likelihood of growth, 12 out of 19 (63%) of the pharmaceuticals without preservatives supporting growth of one or more microorganisms; only 3 out of 24 (12%) of those with preservatives supported growth. The importance of these observations is discussed with reference to formulation of aseptically filled products, environmental sampling and the quality of cleanroom conditions necessary for production. It is suggested that those pharmaceuticals which are designed to be sterile but not to be terminally sterilized, should be tested before production begins, for their ability to support microbial growth. In this way, the risks involved in aseptically filling can be ascertained. A test is proposed in which "indicator" microorganisms would predict the likelihood of pharmaceutical formulations supporting growth.

  8. Pharmaceutical identifier confirmation via DART-TOF.

    PubMed

    Easter, Jacob L; Steiner, Robert R

    2014-07-01

    Pharmaceutical analysis comprises a large amount of the casework in forensic controlled substances laboratories. In order to reduce the time of analysis for pharmaceuticals, a Direct Analysis in Real Time ion source coupled with an accurate mass time-of-flight (DART-TOF) mass spectrometer was used to confirm identity. DART-TOF spectral data for pharmaceutical samples were analyzed and evaluated by comparison to standard spectra. Identical mass pharmaceuticals were differentiated using collision induced dissociation fragmentation, present/absent ions, and abundance comparison box plots; principal component analysis (PCA) and linear discriminant analysis (LDA) were used for differentiation of identical mass mixed drug spectra. Mass assignment reproducibility and robustness tests were performed on the DART-TOF spectra. Impacts on the forensic science community include a decrease in analysis time over the traditional gas chromatograph/mass spectrometry (GC/MS) confirmations, better laboratory efficiency, and simpler sample preparation. Using physical identifiers and the DART-TOF to confirm pharmaceutical identity will eliminate the use of GC/MS and effectively reduce analysis time while still complying with accepted analysis protocols. This will prove helpful in laboratories with large backlogs and will simplify the confirmation process.

  9. 'Linkage' pharmaceutical evergreening in Canada and Australia

    PubMed Central

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

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

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

    MedlinePlus

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

  11. Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

    PubMed Central

    Lexchin, J; Holbrook, A

    1994-01-01

    OBJECTIVE: To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). DESIGN: Analytic study. DATA SOURCE: All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. MAIN OUTCOME MEASURES: Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. MAIN RESULTS: Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. CONCLUSIONS: Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion. PMID:8004560

  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. 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

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

    PubMed

    Ekins, Sean; Wood, Jill

    2016-04-01

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

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

    PubMed

    Ekins, Sean; Wood, Jill

    2016-04-01

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

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

    PubMed Central

    McPartland, John M.

    2009-01-01

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

  17. 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

  18. 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.

  19. Marketing concepts for pharmaceutical service development.

    PubMed

    Grauer, D W

    1981-02-01

    Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.

  20. 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.

  1. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2009-01-01

    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 standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

  2. Smart customers, dumb companies.

    PubMed

    Locke, C

    2000-01-01

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

  3. Research-based active-learning instruction in physics

    NASA Astrophysics Data System (ADS)

    Meltzer, David E.; Thornton, Ronald K.

    2013-04-01

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

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

    NASA Astrophysics Data System (ADS)

    Lynch, Sharon

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

  5. 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

  6. Capillary zone electrophoresis in pharmaceutical analysis.

    PubMed

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

    1990-06-01

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

  7. Pharmaceutical patent law: the Canadian perspective.

    PubMed

    Aumand, Livia; Norman, John

    2016-07-01

    This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry. PMID:27346187

  8. Pharmaceutical patent law: the Canadian perspective.

    PubMed

    Aumand, Livia; Norman, John

    2016-07-01

    This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry.

  9. Multilingualism in Companies: An Introduction

    ERIC Educational Resources Information Center

    Sherman, Tamah; Strubell, Miquel

    2013-01-01

    This thematic collection of four papers explores a number of perspectives on companies in which multiple languages are used. The "organisational" perspective concerns the question of how the presence of or demand for multiple languages in the company is managed--how companies are guided by national and other policies in regard to the use…

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

    PubMed

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

    2015-11-01

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

  11. Do Spin-Offs Make the Academics' Heads Spin? The Impacts of Spin-Off Companies on Their Parent Research Organisation

    ERIC Educational Resources Information Center

    Zomer, Arend H.; Jongbloed, Ben W. A.; Enders, Jurgen

    2010-01-01

    As public research organisations are increasingly driven by their national and regional governments to engage in knowledge transfer, they have started to support the creation of companies. These research based spin-off companies (RBSOs) often keep contacts with the research institutes they originate from. In this paper we present the results of a…

  12. New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation.

    PubMed

    Chimonas, Susan; Rothman, David J

    2005-01-01

    In October 2002 the federal government issued a draft "Compliance Program Guidance for Pharmaceutical Manufacturers." The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and research grants, consultantcies, and gifts. Medical organizations and drug manufacturers proposed major revisions to the draft, arguing that current practices were in everyone's best interest. To evaluate the impact of their responses, we compare the draft, the changes requested by industry and organized medicine, and the final Guidance document (issued in April 2003). We also explore the implications--some intended, others unanticipated--of the final document.

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

    NASA Astrophysics Data System (ADS)

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

    2015-01-01

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

  14. 99M-technetium labeled macroaggregated human serum albumin pharmaceutical

    DOEpatents

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

    1977-05-17

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

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

    ERIC Educational Resources Information Center

    Groves, Michael J.; Klegerman, Melvin E.

    1988-01-01

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

  16. Risks to aquatic organisms posed by human pharmaceutical use

    EPA Science Inventory

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

  17. Predicting variability of aquatic concentrations of human pharmaceuticals

    EPA Science Inventory

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

  18. NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS

    EPA Science Inventory

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

  19. Pharmaceutical Applications of Ion-Exchange Resins

    ERIC Educational Resources Information Center

    Elder, David

    2005-01-01

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

  20. New pharmaceuticals in inflammatory bowel disease

    PubMed Central

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

    2015-01-01

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

  1. Electrostatics of Pharmaceutical Aerosols for Pulmonary Delivery.

    PubMed

    Lip Kwok, Philip Chi

    2015-01-01

    This paper provides a review on key research findings in the rapidly developing area of pharmaceutical aerosol electrostatics. Solids and liquids can become charged without electric fields, the former by contact or friction and the latter by flowing or spraying. Therefore, charged particles and droplets carrying net charges are produced from pharmaceutical inhalers (e.g. dry powder inhalers, metered dose inhalers, and nebulisers) due to the mechanical processes involved in aerosolisation. The charging depends on many physicochemical factors, such as formulation composition, solid state properties, inhaler material and design, and relative humidity. In silico, in vitro, and limited in vivo studies have shown that electrostatic charges may potentially influence particle deposition in the airways. However, the evidence is not yet conclusive. Furthermore, there are currently no regulatory requirements on the characterisation and control of the electrostatic properties of inhaled formulations. Besides the need for further investigations on the relationship between physicochemical factors and charging characteristics of the aerosols, controlled and detailed in vivo studies are also required to confirm whether charges can affect particle deposition in the airways. Since pharmaceutical aerosol electrostatics is a relatively new research area, much remains to be explored. Thus there is certainly potential for development. New findings in the future may contribute to the advancement of pharmaceutical aerosol formulations and respiratory drug delivery.

  2. Pharmaceutical drugs chatter on Online Social Networks.

    PubMed

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

    2014-06-01

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

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

    PubMed

    Oldani, Michael

    2014-06-01

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

  4. [Archeology of the radio pharmaceutical advertisement].

    PubMed

    Lefebvre, Thierry

    2002-01-01

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

  5. Electrostatics of Pharmaceutical Aerosols for Pulmonary Delivery.

    PubMed

    Lip Kwok, Philip Chi

    2015-01-01

    This paper provides a review on key research findings in the rapidly developing area of pharmaceutical aerosol electrostatics. Solids and liquids can become charged without electric fields, the former by contact or friction and the latter by flowing or spraying. Therefore, charged particles and droplets carrying net charges are produced from pharmaceutical inhalers (e.g. dry powder inhalers, metered dose inhalers, and nebulisers) due to the mechanical processes involved in aerosolisation. The charging depends on many physicochemical factors, such as formulation composition, solid state properties, inhaler material and design, and relative humidity. In silico, in vitro, and limited in vivo studies have shown that electrostatic charges may potentially influence particle deposition in the airways. However, the evidence is not yet conclusive. Furthermore, there are currently no regulatory requirements on the characterisation and control of the electrostatic properties of inhaled formulations. Besides the need for further investigations on the relationship between physicochemical factors and charging characteristics of the aerosols, controlled and detailed in vivo studies are also required to confirm whether charges can affect particle deposition in the airways. Since pharmaceutical aerosol electrostatics is a relatively new research area, much remains to be explored. Thus there is certainly potential for development. New findings in the future may contribute to the advancement of pharmaceutical aerosol formulations and respiratory drug delivery. PMID:26290198

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

    PubMed

    Oldani, Michael

    2014-06-01

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

  7. The Pharmaceutical Care Movement: Opportunities for Collaboration.

    ERIC Educational Resources Information Center

    Temple, Thomas R.

    1996-01-01

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

  8. Developing Closer Ties with the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Reid, Gregor; Hoddinott, Susan

    1991-01-01

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

  9. Pharmaceuticals and Hormones in the Environment

    EPA Science Inventory

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

  10. Pharmaceutical drugs chatter on Online Social Networks.

    PubMed

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

    2014-06-01

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

  11. Pharmaceutical technology, biopharmaceutics and drug delivery.

    PubMed

    Youn, Yu Seok; Lee, Beom-Jin

    2011-03-01

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

  12. An Interdisciplinary Course in Pharmaceutical Advertising.

    ERIC Educational Resources Information Center

    Grieshaber, Larry D.; And Others

    1980-01-01

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

  13. An Innovative Pharmaceutical Care Practical Course

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  14. Opportunities for pharmaceutical care with critical pathways.

    PubMed

    Koch, K E

    1995-01-01

    Critical pathways are multidisciplinary tools designed to improve patient care and efficiency. Almost every path requires some type of pharmacotherapeutic intervention, from selection of surgical prophylaxis to management of anticoagulation. Pharmacists should become involved with the critical pathway process because it offers an excellent opportunity to incorporate pharmaceutical care and to meet Joint Commission on Accreditation of Healthcare Organization compliance criteria.

  15. Pharmaceuticals as Groundwater Tracers - Applications and Limitations

    NASA Astrophysics Data System (ADS)

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

    2003-12-01

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

  16. Negotiating Pharmaceutical Prices: A Change in Chinese Health Policy.

    PubMed

    Costello, Michael M

    2016-01-01

    Like many other nations, China believed the key to restricting national health expenditures for pharmaceuticals was the use of governmentally imposed price caps. Given the recent growth in pharmaceutical expenditures, China is moving away from price caps to a new process that includes locally negotiated prices in the hope that such price competition will lower national pharmaceutical pricing. The success of this policy endeavour will depend significantly on managing other aspects of pharmaceutical purchasing. PMID:27358014

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

    PubMed

    Jedrey, Christopher M; Chaurette, Katherine A; Winn, Lara Beth

    2002-01-01

    On April 25, 2002, the Internal Revenue Service finalized the proposed Corporate Sponsorship regulations. The changes made in the final regulations pertain to the proposed $79 ceiling on disregarded benefits, the 2 percent threshold for disregarded benefits, the scope of disregarded benefits, Web site hyperlinks, the inclusion of certain electronic publications in the definition of periodicals, the valuation date for substantial return benefits, and the scope of use or acknowledgement. The proposed regulations were discussed in the Winter 2002 issue of Managed Care Quarterly in an article titled the same as this one. This article is based on the final IRS regulations and therefore supersedes the original article published in the Winter 2002 issue. PMID:12476660

  18. International best practices for negotiating 'reimbursement contracts' with price rebates from pharmaceutical companies.

    PubMed

    Morgan, Steven; Daw, Jamie; Thomson, Paige

    2013-04-01

    Reimbursement contracts, in which health insurers receive rebates from drug manufacturers instead of paying the transparent list price, are becoming increasingly common worldwide. Through interviews with policy makers in nine high-income countries, we describe the use of these contracts around the globe and identify related policy challenges and best practices. Of the nine countries surveyed, the majority routinely use confidential reimbursement contracts. This alternative to drug coverage at list prices offers benefits but is not without challenges. Payers face increased administrative costs, difficulties enforcing contracts, and reduced information about prices paid by others. Among the best practices identified, policy makers recommend establishing clear and consistent processes for negotiating contracts with relatively simple rebate structures and transparency to the public about the existence, purpose, and type of reimbursement contracts in place. Policy makers should also work to address undesirable price disparities within their countries and internationally, which may occur as a result of this new pricing paradigm.

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

    PubMed

    Jedrey, Christopher M; Chaurette, Katherine A; Winn, Lara Beth

    2002-01-01

    On April 25, 2002, the Internal Revenue Service finalized the proposed Corporate Sponsorship regulations. The changes made in the final regulations pertain to the proposed $79 ceiling on disregarded benefits, the 2 percent threshold for disregarded benefits, the scope of disregarded benefits, Web site hyperlinks, the inclusion of certain electronic publications in the definition of periodicals, the valuation date for substantial return benefits, and the scope of use or acknowledgement. The proposed regulations were discussed in the Winter 2002 issue of Managed Care Quarterly in an article titled the same as this one. This article is based on the final IRS regulations and therefore supersedes the original article published in the Winter 2002 issue.

  20. International best practices for negotiating 'reimbursement contracts' with price rebates from pharmaceutical companies.

    PubMed

    Morgan, Steven; Daw, Jamie; Thomson, Paige

    2013-04-01

    Reimbursement contracts, in which health insurers receive rebates from drug manufacturers instead of paying the transparent list price, are becoming increasingly common worldwide. Through interviews with policy makers in nine high-income countries, we describe the use of these contracts around the globe and identify related policy challenges and best practices. Of the nine countries surveyed, the majority routinely use confidential reimbursement contracts. This alternative to drug coverage at list prices offers benefits but is not without challenges. Payers face increased administrative costs, difficulties enforcing contracts, and reduced information about prices paid by others. Among the best practices identified, policy makers recommend establishing clear and consistent processes for negotiating contracts with relatively simple rebate structures and transparency to the public about the existence, purpose, and type of reimbursement contracts in place. Policy makers should also work to address undesirable price disparities within their countries and internationally, which may occur as a result of this new pricing paradigm. PMID:23569058

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

    ERIC Educational Resources Information Center

    Leschinsky, Maribeth; Messemer, Jonathan E.

    2010-01-01

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

  2. A pharmaceutical company user's perspective on the potential of high content screening in drug discovery.

    PubMed

    Hoffman, Ann F; Garippa, Ralph J

    2007-01-01

    It is early to fully reflect on the state of the art in high content screening (HCS), because it is still a relatively new approach in drug discovery. Although the development of the first microscopes are a century old and the first confocal microscope is only 20 yr old, the fluorescent probes used within HCS along with the combination of robotic automation and integrated software technologies are quite new. HCS will require a few more years to fully demonstrate its potential power in drug discovery. Within the last year, however, one has seen this ever-expanding field lure participants in from all areas of science, introducing newer versions of instruments and reagents such that the combined efforts result in platforms and tools that meet many organizational goals in multiple ways. The potential of HCS today lies in its versatility. HCS can be used for primary screening, basic research, target identification, biomarkers, cytotoxicity, and helping to predict clinical outcomes. HCS is being applied to stem cells, patient cells, primary hepatocytes, and immortalized cultured cells. We have noted for individual specialized assays, there are multiple solutions just as there are for those standardized universally accepted assays. Whether we have needed to query cellular processes under live conditions or wanted to follow kinetically the course of a compound's effects on particular cellular reactions, we have been hampered by only a few limitations. This chapter offers a glimpse inside the use of HCS in our drug discovery environment.

  3. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Condition of participation: Pharmaceutical services... Hospital Functions § 482.25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by...

  4. Development of an orphan drug by a start-up company. MetroGel for rosacea.

    PubMed

    Borgman, R J

    1992-01-01

    The Orphan Drug Act of 1983, along with the discovery of a new use for a known drug and an investor willing to assume the necessary risk, brought about the formation of a start-up pharmaceutical company. The primary incentive of the Orphan Drug Act of seven years of marketing exclusivity provided the protection from competition necessary for recovery of the significant research and development and marketing costs. The orphan product, MetroGel, for the treatment of rosacea, required approximately five years of development before it was approved for marketing by the Food and Drug Administration. MetroGel has become the number one drug in the United States for the treatment of rosacea. It currently is marketed in other countries through a licensing agreement with a major pharmaceutical company.

  5. [The company Willmar Schwabe in the Nazi era].

    PubMed

    Friedrich, Christoph; Meyer, Ulrich; Seyfang, Caroline

    2016-01-01

    This essay follows the history of the Schwabe Company between 1933 and 1945 when it, like all other companies at the time, had to subject to the state-enforced conformity ('Gleichschaltung'). While Willmar Schwabe II (1878-1935), the company's second director, kept clear of Nazi politics, both of his sons, who succeeded him at an early age, became members of the Nazi party: Willmar III (1907-1983) probably from initial conviction and Wolfgang (1912-2000), who joined in 1937, more likely for opportunistic reasons. The two lay journals published by Schwabe--the Leipziger Populäre Zeitschrift für Homöopathie and the Biochemische Monatsblätter--embraced the Nazi ideology more thoroughly than the general homeopathic journal Allgemeine Homöopathische Zeitung, including above all contributions on racial hygiene. Our research has revealed that Schwabe only employed foreign workers from 1942 on, that their number was much lower, at 0.9 per cent in 1942 and 3.6 per cent in 1944, than that of other pharmaceutical companies and that their pay hardly differed from that of German workers. The sales and profit figures investigated have shown that the company did not profit exceptionally from the new Nazi health policies ('Neue Deutsche Heilkunde'): while its sales and profits rose in the Nazi era due to the increased use of medication among the civil population during wartime, the drugs produced by Schwabe remained marginal also during the war, as is apparent also from its modest deliveries to the army. All in all one can conclude that the company offered neither resistance nor particular support to the Nazi ideology.

  6. [The company Willmar Schwabe in the Nazi era].

    PubMed

    Friedrich, Christoph; Meyer, Ulrich; Seyfang, Caroline

    2016-01-01

    This essay follows the history of the Schwabe Company between 1933 and 1945 when it, like all other companies at the time, had to subject to the state-enforced conformity ('Gleichschaltung'). While Willmar Schwabe II (1878-1935), the company's second director, kept clear of Nazi politics, both of his sons, who succeeded him at an early age, became members of the Nazi party: Willmar III (1907-1983) probably from initial conviction and Wolfgang (1912-2000), who joined in 1937, more likely for opportunistic reasons. The two lay journals published by Schwabe--the Leipziger Populäre Zeitschrift für Homöopathie and the Biochemische Monatsblätter--embraced the Nazi ideology more thoroughly than the general homeopathic journal Allgemeine Homöopathische Zeitung, including above all contributions on racial hygiene. Our research has revealed that Schwabe only employed foreign workers from 1942 on, that their number was much lower, at 0.9 per cent in 1942 and 3.6 per cent in 1944, than that of other pharmaceutical companies and that their pay hardly differed from that of German workers. The sales and profit figures investigated have shown that the company did not profit exceptionally from the new Nazi health policies ('Neue Deutsche Heilkunde'): while its sales and profits rose in the Nazi era due to the increased use of medication among the civil population during wartime, the drugs produced by Schwabe remained marginal also during the war, as is apparent also from its modest deliveries to the army. All in all one can conclude that the company offered neither resistance nor particular support to the Nazi ideology. PMID:27263220

  7. 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

  8. Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals

    PubMed Central

    Bubela, Tania; Boon, Heather; Caulfield, Timothy

    2008-01-01

    Background This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles. Results Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64%) and herbal remedy (53%) clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; χ2 = 7.8129; degrees of freedom = 2). Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies. Conclusion Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most published research based

  9. Organizational performance, Marketing strategy, and Financial strategic alignment: an empirical study on Iranian pharmaceutical firms

    PubMed Central

    2013-01-01

    Background Strategic Functional-level planning should be aligned with business level and other functional strategies of a company. It is presumed that assimilating the strategies could have positive contribution to business performance, in this regard alignment between marketing strategy and financial strategy seems to be the most important strategies being studied. An empirical work in generic pharmaceutical manufacturing companies for evaluating effect of alignment between these two functions on organizational performance was developed in this paper. Methods All Iranian pharmaceutical generic manufactures listed in Tehran stock market have been tested for period of five years between 2006–2010 and their marketing strategies were determined by using Slater and Olson taxonomy and their financial strategies have been developed by calculating total risk and total return of sample companies for five years based on rate of risk and return in the frame of a 2 × 2 matrix. For the business performance three profitability indices including Q-Tubin (Rate of market value to net asset value), ROA (Return on Asset), ROE (Return on Equity) have been tested. For analysis, a series of one-way ANOVAs as a collection of statistical models within marketing strategies considering financial strategy as independent variable and the three performance measures as dependent variables was used. Results Results show strategic alignment between financial and marketing has significant impact on profitability of company resulting in arise of all three profitability indices. Q tubing’s rate were 2.33,2.09,2.29,2.58 and rate of ROA were 0.21,0.194,0.25,0.22 and rate of ROE were 0.44,0.46,0.45,0.42 for matched strategy types, respectively the rates shown here are more than average meaning that specific type of marketing strategy is fitted with specific type of financial strategy. Conclusion Managers should not consider decisions regarding marketing strategy independently of their financial

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

    NASA Astrophysics Data System (ADS)

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

    2014-12-01

    rare in ecology. We feel that development and implementation of these types of active-learning, research based programs can help universities to produce undergraduate researchers capable of contributing meaningfully to research, and to greater societal issues by enhancing their problem solving and critical thinking skills.

  11. The Trans-Pacific Partnership and pharmaceutical innovation.

    PubMed

    Freeman, Robert A

    2016-01-01

    Trade agreements are an overlooked area of research and policy analysis that affect market access, pricing and reimbursement decisions by pharmaceutical manufacturers, and research and development decisions in the long term. The Trans-Pacific Partnership (TPP) is the most recent multi-national agreement under considerations that may have profound implications in developed and developing countries in the Pacific Rim. As in the case of other trade arrangements, the TPP negotiations are not transparent, but a major leak of the most recent draft has been published in WikiLeaks. The leaked document has raised a number of concerns about intellectual property rights (IPR) and regulatory data protection (RDP) that have implications for public health and economic policy throughout the region. In particular, IPR and RDP go beyond the minimum standards set under the World Trade Organization (WTO) and may affect drug access negatively by delaying generic drug and biosimilar product availability and by raising prices by removing national regulations dealing with drug pricing and reimbursement. Of particular concern is the establishment of a litigation process where multi-national companies can sue individual countries before a panel of private attorneys who are appointed by the World Bank or United Nations. This paper addresses these concerns along with a commentary on the likelihood of occurring and the need for future research. PMID:26803645

  12. Understanding pharmaceutical research manipulation in the context of accounting manipulation.

    PubMed

    Brown, Abigail

    2013-01-01

    The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied - though by no means solved - in financial accounting than in medicine. This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information. PMID:24088151

  13. The Trans-Pacific Partnership and pharmaceutical innovation.

    PubMed

    Freeman, Robert A

    2016-01-01

    Trade agreements are an overlooked area of research and policy analysis that affect market access, pricing and reimbursement decisions by pharmaceutical manufacturers, and research and development decisions in the long term. The Trans-Pacific Partnership (TPP) is the most recent multi-national agreement under considerations that may have profound implications in developed and developing countries in the Pacific Rim. As in the case of other trade arrangements, the TPP negotiations are not transparent, but a major leak of the most recent draft has been published in WikiLeaks. The leaked document has raised a number of concerns about intellectual property rights (IPR) and regulatory data protection (RDP) that have implications for public health and economic policy throughout the region. In particular, IPR and RDP go beyond the minimum standards set under the World Trade Organization (WTO) and may affect drug access negatively by delaying generic drug and biosimilar product availability and by raising prices by removing national regulations dealing with drug pricing and reimbursement. Of particular concern is the establishment of a litigation process where multi-national companies can sue individual countries before a panel of private attorneys who are appointed by the World Bank or United Nations. This paper addresses these concerns along with a commentary on the likelihood of occurring and the need for future research.

  14. Biological treatment of pharmaceutical wastewater from the antibiotics industry.

    PubMed

    Lefebvre, O; Shi, X; Wu, C H; Ng, H Y

    2014-01-01

    Pharmaceutical wastewater generated by an antibiotics (penicillin) company was treated by aerobic membrane bioreactors (MBRs) and sequencing batch reactors (SBRs). At a low organic loading rate of 0.22 kg-COD m(-3)d(-1), both types of reactors were capable of treating the wastewater such that the treated effluent met the discharge regulation except for the total dissolved solids. However, when the loading rate was increased to 2.92 kg-COD m(-3)d(-1), foaming issues resulted in unstable performance. Overall, the MBRs achieved better solid removal but the SBRs performed better in regards to the degradation of aromatic compounds, as determined by UV absorbance (UVA). Finally, ozonation was applied on two different streams and showed promise on the strong stream - that corresponds to the formulation effluent and contains most of the biorefractory compounds. Ozonation successfully reduced the UVA, lowered the pH and increased the biochemical oxygen demand : chemical oxygen demand (BOD5 : COD) ratio of the strong stream. However, it was less efficient on the effluent having undergone pre-treatment by a biofilter due to a lack of selectivity towards refractory compounds.

  15. Marketing Norm Perception Among Medical Representatives in Indian Pharmaceutical Industry

    PubMed Central

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

    2012-01-01

    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

  16. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  17. Understanding pharmaceutical research manipulation in the context of accounting manipulation.

    PubMed

    Brown, Abigail

    2013-01-01

    The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied - though by no means solved - in financial accounting than in medicine. This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information.

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

    PubMed

    Berkowitz, P

    1996-08-01

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

  19. Dropwise additive manufacturing of pharmaceutical products for solvent-based dosage forms.

    PubMed

    Hirshfield, Laura; Giridhar, Arun; Taylor, Lynne S; Harris, Michael T; Reklaitis, Gintaras V

    2014-02-01

    In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms.

  20. Prerequisites for the pharmaceutical industry to develop and commercialise helminths and helminth-derived product therapy.

    PubMed

    Tilp, Cornelia; Kapur, Vishal; Loging, Will; Erb, Klaus J

    2013-03-01

    During the past 10 years, immunologists, epidemiologists and parasitologists have made many new exciting discoveries in the field of helminth-mediated immune regulation. In addition, many animal experiments have shown that certain helminths or products derived from helminths can protect mice from developing allergic or autoimmune disease. Some clinical trials utilising Trichuris suis or Necator americanus for the treatment of allergic disorders and inflammatory bowel disease have been conducted. The outcomes of these trials suggest that they may be used to treat these disorders. However, to date no helminth therapy is routinely being applied to patients and no helminth-derived product therapy has been developed. In order to bring new drugs to the market and shoulder the enormous costs involved in developing such therapies, pharmaceutical companies need to be involved. However, currently the resources from the pharmaceutical industry devoted to this concept are relatively small and there are good reasons why the industry may have been reluctant to invest in developing these types of therapies. In this review article, the hurdles that must be overcome before the pharmaceutical industry might invest in these novel therapies are outlined.