Sample records for research-based pharmaceutical companies

  1. Why are pharmaceutical companies gradually abandoning vaccines?

    PubMed

    Offit, Paul A

    2005-01-01

    During the past fifty years, the number of pharmaceutical companies making vaccines has decreased dramatically, and those that still make vaccines have reduced resources to make new ones. Pharmaceutical companies are gradually abandoning vaccines because the research, development, testing, and manufacture of vaccines are expensive and because the market to sell vaccines is much smaller than the market for other drug products. Congressional action could assure both a steady supply of existing vaccines and the promise of vaccines for the future. PMID:15886152

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

    PubMed

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

    2014-03-01

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

  3. Evaluation of clinical trials by Ethics Committees in Germany: experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA).

    PubMed

    Russ, Hagen; Busta, Susanne; Riedel, Axel; Zöllner, Gereon; Jost, Bertfried

    2009-01-01

    The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12(th) Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively) in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation. With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA) was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee), the type and frequency of formal and content-related objections to applications according to section sign 7 of the German Good Clinical Practice (GCP) Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I-IV studies submitted between January and December 2007 to 40 ethics committees were evaluated. This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to some extent to the differing and/or unclear requirements of the individual ethics committees on the content and comprehension of the submission documents. However, applicants also need to pay more attention to the completeness and validity of the submission documents. The majority of content-related objections apply to the patient information and consent documents and study protocols submitted. Applicants on average acted upon only 3 out of 4 objections, for various reasons: the relevant information was already given in the submitted documents, but had not been taken into consideration by the ethics committees; objections were not applicable; objections lacked a legal basis. In such cases the applicants made reference to the specific information already submitted or gave reasons for not acting on the objection. This course of action was accepted by the ethics committees, with few exceptions. The survey sheds light on the existing inconsistencies in the evaluations of applications by the various ethics committees and suggests ways in which the existing constructive dialogue between applicants and ethics committees may provide a basis to further harmonize both the requirements regarding form and content of application documents, and the criteria for evaluation of applications by ethics committees within the legal framework. PMID:19675747

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

    PubMed

    Lee, Stacey B

    2010-01-01

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

  5. Post-approval fate of pharmaceutical companies.

    PubMed

    Kinch, Michael S

    2015-02-01

    For a fortunate subset of pharmaceutical companies, a regulatory approval is the culmination of massive investment in time, work and money. What happens next? Some companies proceed to build a pipeline and obtain additional approvals. Others do not. In this present report, post-approval fate is evaluated and it was found that most companies are ultimately acquired. A subset achieved a second approval six-to-eight years after the first approval, whereas a shrinking subset, designated as 'singlets', remains active in drug discovery with only a single approval. The likelihood that a company will remain a singlet or be acquired relates to therapeutic indication, with oncology associated with increased acquisition potential and infectious-disease-based companies being less commonly acquired. PMID:25448760

  6. 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

  7. Inventory management in a pharmaceutical company : minimizing discard practices

    E-print Network

    Wang, Xiaojun, M. Eng. Massachusetts Institute of Technology

    2010-01-01

    Pharmaceutical company SPM has over 400 cases of inventory discards over the past five years which constitute a significant operating cost. Due to the complexity and randomness of each case, the root causes that result in ...

  8. A new product launch strategy (NPLS) model for pharmaceutical companies

    Microsoft Academic Search

    Peter Trim; Hao Pan

    2005-01-01

    Purpose – The purpose of this paper is to make explicit how marketers employed in the pharmaceutical sector can ensure that the company is positioned in the industry as a result of a sustainable competitive advantage being achieved. Various factors are highlighted, including high research and development costs, stringent government regulations and cultural factors such as religion. Design\\/methodology\\/approach – The

  9. Evolving concepts of pharmaceutical company-sponsored surveillance studies.

    PubMed

    Koeth, Laura M; Miller, Linda A

    2005-08-15

    As a result of increasing bacterial resistance to antimicrobial agents, there is a need to conduct studies that monitor changes in susceptibility. In addition to studying the emergence and dissemination of antibacterial resistance, pharmaceutical companies perform surveillance studies for a number of reasons. As an example, the Alexander Project was conducted to study community-acquired respiratory infections internationally over 10 years. The project's findings have been valuable in the study of antimicrobial resistance. The Alexander Project has also been instrumental in the study of the evolution of resistance genes and in predictions of future rates of resistance, as well as in establishing the importance of high-quality data, the complexity of the evolution of resistance, and the need to disseminate the results in a variety of formats. Although there has been a reduction in pharmaceutical company studies, consolidated efforts between industry, government, and private groups have increased. Future surveillance efforts by pharmaceutical companies will likely be more targeted and disease directed. PMID:16032566

  10. 77 FR 12997 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Representatives at VA Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ...art in the industry that are...understood by pharmaceutical company representatives...limitations on the pharmaceutical company provision...extent that industry ethical standards...2) If industry-sponsored...participation in pharmaceutical...

  11. 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

  12. Compliant Manufacturing with SAP in the Pharmaceutical Industry Extending software applications from top floor to shop floor streamlines compliant manufacturing processes for pharmaceutical companies

    Microsoft Academic Search

    James Sabogal; Jürgen Thölke

    Summary Today, pharmaceutical companies are at a crossroads. Price discounts, shrinking margins, reductions in market exclusiv- ity, product commoditization ? as well as Part 11 validation compliance ? repre- sent new challenges for pharmaceutical companies of all sizes. Equally daunting are pressures on the supply chain. It is not enough to simply deliver the right ac- tive ingredient. It must

  13. Improvement of manufacturing operations at a pharmaceutical company : A lean manufacturing approach

    Microsoft Academic Search

    Boppana V. Chowdary; Damian George

    2012-01-01

    Purpose – The current good manufacturing practices (cGMP) are followed in the pharmaceutical sector to ensure that products are consistently produced and controlled to the appropriate quality standards as required by the marketing agencies. The purpose of this paper is to share improvement experiences due to implementation of lean principles combined with cGMP in a pharmaceutical company. Design\\/methodology\\/approach – To

  14. 75 FR 24510 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Sales Representatives at VA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ...promotion of drugs by large pharmaceutical companies and only a small...operational reasons. Drugs means pharmaceuticals or chemicals intended for...following guidelines: (1) Industry sponsorship must be disclosed...the name or logo of the pharmaceutical manufacturer or be...

  15. 75 FR 26160 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Sales Representatives at VA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ...promotion of drugs by large pharmaceutical companies and only a small...operational reasons. Drugs means pharmaceuticals or chemicals intended for...following guidelines: (1) Industry sponsorship must be disclosed...the name or logo of the pharmaceutical manufacturer or be...

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

    PubMed Central

    Somerset, Maggie; Weiss, Marjorie; Fahey, Tom

    2001-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

    Kim, Hyojin

    2011-01-01

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

  19. Narrowing the gap: access to HIV treatments in developing countries. A pharmaceutical company's perspective

    Microsoft Academic Search

    James Cochrane

    2000-01-01

    The advent of new antiretroviral medicines means that the effects of HIV can now be curbed, but only one in twenty infected people have so far benefited. For those living in developing countries, the new treatments are practically unattainable. Governments, UNAIDS and pharmaceutical companies recognise this only too well and have rethought established assumption in order to try and overcome

  20. Location choice and the internationalization sequence : Insights from Indian pharmaceutical companies

    Microsoft Academic Search

    Poh-Lin Yeoh

    2011-01-01

    Purpose – The purpose of this paper is to contribute to the literature on emerging multinationals by studying the internationalization strategies of two established companies in the Indian pharmaceutical industry: Ranbaxy and Wockhardt. Design\\/methodology\\/approach – The study utilizes a longitudinal case-study approach to capture Ranbaxy's and Wockhardt's dynamic internationalization patterns. An extensive literature review using recently published works, government documents,

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

    PubMed

    Compagni, Amelia; Cavalli, Laura; Jommi, Claudio

    2008-09-01

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

  2. Pharmaceutical policies used by private health insurance companies in Saudi Arabia

    PubMed Central

    Bawazir, Saleh A.; Alkudsi, Mohammed A.; Al Humaidan, Abdullah S.; Al Jaser, Maher A.; Sasich, Larry D.

    2012-01-01

    Background Currently, the Council of Cooperative Health Insurance (CCHI) is the body responsible for regulating health insurance in the KSA. While the cooperative health insurance schedule (i.e., model policy for health insurance) is available on the CCHI web site, policies related to pharmaceuticals are ambiguous. Aims The primary objective of this study was to assess the impact of health insurance policies provided by health insurance companies in KSA on access to medication and its use. Settings and Design This study was descriptive in design and used a survey, which was conducted through face-to-face interviews with the medical managers of health insurance companies. Methods and Material The survey took place between March and June, 2011. All 25 insurance companies accredited by CCHI were eligible to be included in the study. Out of these 25 companies, three were excluded from this survey as no response was received. Results All the 16 companies responded “Yes” that they had a prior authorization policy; however, their reasons varied. Eight (50%) of the companies were concerned about the duration of treatment. While 10 (62.5%) did not offer additional coverage over the CCHI model policy, the other 6 (37.5%) reported that they could reconcile certain conditions. The survey also demonstrated that 10 insurance companies allowed refilling of medication but with certain limitations. Six out of the 10 permitted refilling within a maximum time of three months, whereas the other four companies did not have any time-based limits for refilling. The other six companies did not allow refilling without prescription. Conclusions Although this paper was primarily descriptive, the findings revealed a substantial scope for improvement in terms of pharmaceutical policy standards and regulation in the health insurance companies in KSA. Additionally, the study highlighted such areas to augment the overall quality use of medication, over-prescribing and irrational use of medication. Further research, thus, is definitely needed. PMID:23960843

  3. [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

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

    PubMed

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

    2012-01-01

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

  5. 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

  6. 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

  7. Pharmaceuticals

    Microsoft Academic Search

    Andreas Schiermeyer; Stefan Schillberg

    \\u000a Plants and plant cell cultures have been evaluated over the past two decades as alternative production platforms for biopharmaceuticals.\\u000a A large number of candidate proteins has been successfully produced in a range of plant species and the most advanced products\\u000a are currently progressing through the clinical development stages. We first discuss principles for the production of plant-made\\u000a pharmaceuticals including plant

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

    PubMed

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

    2015-07-01

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

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

    PubMed Central

    2014-01-01

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

  10. Symbiotic relationship between a research institute and a pharmaceutical company: the Baker Institute/Glaxo Australia story.

    PubMed

    Angus, J A

    1992-01-01

    1. The Baker Medical Research Institute is a non-profit, charitable institution to advance knowledge and solve problems in the area of cardiovascular medicine. This allows scientists to collaborate within a critical mass and be flexible in their approach to research. 2. The Institute has interactions with the pharmaceutical industry at three levels: (i) contract research on a specific molecule; (ii) clinical trials; and (iii) collaborative basic research agreements. 3. The Glaxo Australia-Baker Medical Research Institute Agreement is for curiosity driven research in specified areas of vascular pharmacology of interest to Glaxo Group Research. 4. The relationship between universities, research institutes and the pharmaceutical industry is discussed in terms of the starting point for drug development. 5. The enormous cost (US$100 million), lead time (10 years) and uncertainty of a successful profitable drug are compelling reasons why an independent pharmaceutical company is unlikely to succeed in Australia today. PMID:1623639

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

    PubMed

    Twine, Richard

    2013-12-01

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

  12. 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

  13. The Pfizer Institute for Pharmaceutical Materials Science The Pfizer Institute for Pharmaceutical

    E-print Network

    Lasenby, Joan

    The Pfizer Institute for Pharmaceutical Materials Science The Pfizer Institute for Pharmaceutical Materials Science #12;The Pfizer Institute for Pharmaceutical Materials Science Modelling and Experimental What is it? The Pfizer Institute for Pharmaceutical Materials Science is a research based collaboration

  14. 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

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

    PubMed Central

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

    2014-01-01

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

  16. ERP System Implementation and Business Process Change: Case Study of a Pharmaceutical Company

    Microsoft Academic Search

    Vesna Bosilj-vuksic; Mario Spremic

    2005-01-01

    The main objective of this paper is to present the impacts of information technology (IT) and enterprise resource planning (ERP) systems in business process renovation and to discuss selected aspects of the business processes and information modelling. This study presents the results of research conducted on reengineering business processes in Croatian companies, together with the results of analysis of the

  17. Process systems engineering of continuous pharmaceutical manufacturing

    E-print Network

    Abel, Matthew J

    2010-01-01

    Continuous manufacturing offers a number of operational and financial benefits to pharmaceutical companies. This research examines the critical blending step for continuous pharmaceutical manufacturing and the characteristics ...

  18. High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey

    PubMed Central

    Kurihara, Chieko; Kusuoka, Hideo; Ono, Shunsuke; Kakee, Naoko; Saito, Kazuyuki; Takehara, Kenji; Tsujide, Kiyokazu; Nabeoka, Yuzo; Sakuhiro, Takuya; Aoki, Hiroshi; Morishita, Noriko; Suzuki, Chieko; Kachi, Shigeo; Kondo, Emiko; Komori, Yukiko; Isobe, Tetsu; Kageyama, Shigeru; Watanabe, Hiroshi

    2014-01-01

    Introduction International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Method Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. Results With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. Conclusion Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data. PMID:24416332

  19. Statement at the Senate Environment and Public Works Committee Subcommittee on Transportation Safety, Infrastructure Security, and Water Quality Pharmaceuticals in the Nation's Drinking Water: assessing potential risks and actions to address the issue

    Microsoft Academic Search

    Alan Goldhammer

    2008-01-01

    Thank you Mr. Chairman and members of the Committee. My name is Alan Goldhammer, Ph.D., and I am the Deputy Vice President for Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing the leading research-based pharmaceutical and biotechnology companies. PhRMA member companies invested an estimated $44.5 billion in 2007 for innovative biomedical research to

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

    PubMed

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

    2012-01-01

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

  1. 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

  2. Healthcare in developing countries and the role of business: a global governance framework to enhance the accountability of pharmaceutical companies

    Microsoft Academic Search

    Janna Greve

    2008-01-01

    Purpose – The purpose of this paper is to defend the appropriateness of a global governance framework for the transnational pharmaceutical corporations (TNPCs) as a way to tackle the problems resulting out of a non-implementation or violation of the “right to health” by a lack of accessibility of vital medicines in developing countries, and control the risks of the TNPCs

  3. [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

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

    PubMed

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

    2011-01-01

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

  5. Animal health pharmaceutical industry

    Microsoft Academic Search

    Richard A. Carnevale; Thomas R. Shryock

    2006-01-01

    The animal health pharmaceutical industry has proactively reported on the volumes of member company antimicrobial active ingredients sold in the U.S. At the individual company level, reporting of finished product distribution data to the FDA is a regulatory requirement, with applications to surveillance and pharmacovigilance. An accounting of product manufactured is done for purposes of good business practices, as well

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

    PubMed

    Malhotra, Prabodh; Lofgren, Hans

    2004-11-01

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

  7. [Why are some drugs so expensive? The price policy of pharmaceutical companies--"digging the grave of our health insurance-system"?].

    PubMed

    Glaeske, Gerd

    2008-01-01

    A decisive influence on the attractiveness of the German drug market is exerted by the institutions responsible for the prescribability of a drug in the framework of the Statutory Health Insurance (SHI). In this most lucrative segment of the German market, a host of reforms in recent years has led to declining transparency, where the short-lived regulatory interventions aimed - with limited success - at containing the increase in expenditure on drugs. From 1997 to 2003, however, new and patented drugs were largely protected against regulatory measures, such as fixed reimbursement rates (reference prices). However, only little use was made of this additional promotion of research activities. The majority of the new drugs in this period were me-too products, which only rarely had therapeutic advantages or advantages in the price competition with established medicines. In addition, the pharmaceutical companies widely use the privilege to set a price for drugs being prescribed in the SHI without undertaking any negotiations or presenting cost-effectiveness studies, which is unique in the European comparison. In future, the decision regarding the reimbursability of, or the reimbursable amount for, a preparation should thus be geared to lasting, transparent and unequivocal criteria guided by efficiency optimization and therapeutic progress. PMID:19004366

  8. Exploring Execution of Ecological Engineering and Cleaner Production in Pharmaceutical Industry

    Microsoft Academic Search

    Miao Ze-hua; Bian Na; Dong Li; Sun Wen-bo

    2011-01-01

    The pharmaceutical industry is the focus of State Environmental Protection Plan among the 12 industries, the execution of ecological engineering and furthering of cleaner production is a key way to sustainable development with enhancing production vitality of pharmaceutical companies. With the consideration of the pollution from pharmaceutical companies, this paper examines the implementation of cleaner production for the pharmaceutical companies

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

    PubMed

    Littman, Bruce H; Marincola, Francesco M

    2011-01-01

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

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

    PubMed

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

    2004-01-01

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

  11. Philosophy Research Base

    NSDL National Science Digital Library

    1999-01-01

    Danne Polk, an instructor in the Department of Philosophy at Villanova University, has meticulously compiled and annotated the numerous resources in the Philosophy Research Base. This extensive metasite emphasizes the work of western continental philosophers but also includes diverse sections on subjects such as British and American philosophy, non-western philosophy, environmental philosophy, feminist philosophy, and psychoanalytic philosophy, among many more. In addition, the metasite links to two virtual classrooms designed by Polk for courses taught in the Spring 1999 semester: Classic American Philosophy and Ecofeminism.

  12. Quality and pressure: BS5750 and the pharmaceutical environment

    Microsoft Academic Search

    Reva Berman Brown; Martyn J. Woodland

    1994-01-01

    The legislation regarding product quality throughout the veterinary pharmaceuticals industry is very stringent and firmly enforced by several government agencies. Product quality is necessarily high as poor quality products simply cannot be licensed. The pharmaceutical companies have lived with ‘quality’ for so long that quality of production is ingrained into their culture. All companies wish to be regarded as quality

  13. What future physicians want : a comparative analysis of the perception of medical students and pharmaceutical industry executives regarding the future of pharmaceutical sales

    E-print Network

    Khan, Rehan A. (Rehan Abbas)

    2007-01-01

    The leading publicly traded pharmaceutical companies ("Big Pharma) in the US are facing a commercial crisis - their sales structure collectively consisting of more than 100,000 pharmaceutical sales representatives, originally ...

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

    Cancer.gov

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

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

    PubMed Central

    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. PMID:22355280

  16. Implementation of the new FDA quality by design guidance in pharmaceutical production

    E-print Network

    Tozer, Stephanie Michelle

    2008-01-01

    Due to the highly regulated environment, it is difficult to implement changes to a pharmaceutical process. Even small change request approvals can require months of effort for pharmaceutical companies and regulatory agencies. ...

  17. 77 FR 26768 - Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ...International Society for Pharmaceutical Engineering (ISPE...representatives and industry experts in face-to-face...regulatory strategies, while industry professionals from some of today's leading pharmaceutical companies present...

  18. Lessons from 60 years of pharmaceutical innovation.

    PubMed

    Munos, Bernard

    2009-12-01

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

  19. Pharmaceutical counterfeiting.

    PubMed

    Deisingh, Anil K

    2005-03-01

    Pharmaceutical counterfeiting is becoming a serious problem both in developed and developing countries. This paper considers the extent of the problem and provides several examples of drugs which have been counterfeited. Additionally, the effects of counterfeit products on consumers, health care providers, drug manufacturers and governments are discussed. Several of the currently used methods of detection are described and these include near-infrared spectroscopy, Raman spectroscopy, isotopic characterization, tensiography, chromatographic and mass spectrometric approaches. Finally, anti-counterfeiting measures such as the use of holograms, tracers and taggants and electronic tracking are summarized. PMID:15724152

  20. Pharmaceutical Supply Chain

    E-print Network

    Nagurney, Anna

    Engineering University of Hartford, West Hartford, CT 06117 #12;Pharmaceutical Supply Chain NetworksPharmaceutical Supply Chain Networks with Outsourcing Nagurney, Li, and Nagurney Pharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna Nagurney1, Dong (Michelle

  1. Managing maintenance costs of pharmaceutical research and development

    E-print Network

    Butts, Jared (Jared C.)

    2009-01-01

    Drug Discovery is a race to be the first to patent a drug that meets a significant medical need in the world. Many pharmaceutical companies are now using automation extensively to improve consistency and aid personnel in ...

  2. Improving energy efficiency in a pharmaceutical manufacturing environment -- production facility

    E-print Network

    Zhang, Endong, M. Eng. Massachusetts Institute of Technology

    2009-01-01

    The manufacturing plant of a pharmaceutical company in Singapore had low energy efficiency in both its office buildings and production facilities. Heating, Ventilation and Air-Conditioning (HVAC) system was identified to ...

  3. GMP Compliance for Pharmaceutical Excipients in the Glycerin Industry

    E-print Network

    Elliot, Christina

    2008-12-19

    management systems – excipient quality systems, management responsibility, resource management, product realization, and measurement, analysis and improvement. Company XYZ sells refined glycerin to customers for use in pharmaceutical and food...

  4. Pharmacovigilance in pharmaceutical companies: An overview

    PubMed Central

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

    2013-01-01

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

  5. 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…

  6. 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.…

  7. Pharmaceuticals in the Environment

    Microsoft Academic Search

    Klaus Kümmerer

    2010-01-01

    Pharmaceuticals are chemicals that are used because of their biological activity. They are often excreted unchanged and can reach the environment. Throughout developed countries, the pharmaceutical concentrations in the aquatic environment are in the same range (?g L and below); however, it is not clear whether this holds for less-developed countries too. The health risks of active pharmaceutical ingredients (APIs)

  8. Pharmaceuticals in the Environment

    Microsoft Academic Search

    Klaus Kümmerer

    Pharmaceuticals are chemicals that are used because of their biological activity. They are often excreted unchanged and can reach the environment. Throughout developed countries, the pharmaceutical concentrations in the aquatic environment are in the same range (?g L?1 and below); however, it is not clear whether this holds for less-developed countries too. The health risks of active pharmaceutical ingredients (APIs)

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

    PubMed

    Dzhalilova, K I; Alieva, K Ia

    2012-01-01

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

  10. Innovative and industrial performance in pharmaceutical R&D, a management control perspective

    Microsoft Academic Search

    SWF Omta; LM Bouter; JML Van Engelen

    1994-01-01

    In this paper management control is related to innovative and industrial performance in 14 non-biotech pharmaceutical companies. The study consisted of questionnaires, sent to the heads of the different research departments of European research laboratories of leading pharmaceutical companies, combined with structured interviews with the R&D Directors of the companies. Given the limitations of a cross-sectional design and a relatively

  11. GMK (Progenics Pharmaceuticals).

    PubMed

    Knutson, Keith L

    2002-01-01

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

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

    Cancer.gov

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

  13. District cooling and thermal storage in pharmaceutical applications

    SciTech Connect

    Strause, R.; Morgan, T. [Stanley Consultants, Inc., Muscatine, IA (United States)

    1995-12-31

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

  14. Pharmaceutical Education in Nigeria.

    ERIC Educational Resources Information Center

    Oyegbile, F. Rachel

    1988-01-01

    Nigeria has six pharmacy schools, most offering graduate programs. The undergraduate program is being expanded from four to five years. Although behavioral and clinical sciences are offered, emphasis is on the pharmaceutical sciences. Overall, pharmaceutical education is oriented toward hospice practice. (Author/MSE)

  15. Book Review Pharmaceutical Biotechnology

    E-print Network

    Mallela, Krishna M. G.

    and whole cell-based therapeutics such as stem cells. The future of pharmaceuticals belongs to protein chromatographic purification via size-exclusion, ion-exchange, hydrophobic interaction or affinity) and proteinBook Review Pharmaceutical Biotechnology ­ Concepts and Applications GaryWalsh Wiley, Chichester

  16. How the research-based industry approaches vaccine development and establishes priorities.

    PubMed

    André, F E

    2002-01-01

    Over the past two decades, progress in immunology, molecular biology and genomics as well as some technological breakthroughs in computer science has opened the way to the development of prophylactic vaccines against most acute infectious diseases. Therapeutic vaccines against chronic infections, allergic conditions, auto-immune diseases and cancer have also come into the realm of possibility. It is estimated that wordwide there are about 400 vaccine projects in R&D laboratories of academic institutions, research institutes and vaccine manufacturers. Most of these projects will not yield a licensed vaccine for routine or even targeted immunisation. This is mostly not because of scientific barriers but due to financial and politicoeconomic obstades that make their development feasible only by the handful of major research-based vaccine manufacturers that nowadays all form part of large global pharmaceutical corporations. Such enterprises have to be profitable to survive and priority setting, when it comes to R&D projects, has to take into account potential return on all investments, particularly as it currently costs between 200 and 500 million US dollars to bring a new vaccine from the concept stage to market. Factors that influence the decision to embark upon an R&D project on a new vaccine include the medical need for the vaccine, gauged by the global burden of the targeted disease, potential and probable market size - judged on volume (number of doses required) and value (total sales) -, probability of success and expertise of the company in the field (both R&D and marketing) as well as the likelihood of competitors taking a large part of the market. Moral imperatives such as the urgent need for vaccines against HIV/AIDS, malaria and an improved vaccine against tuberculosis to save the several millions of lives claimed each year by these diseases also play a role. However, for such investments to be sustainable other sources of financing than the commercial market will be required. PMID:12477303

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

    PubMed

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

    2014-01-01

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

  18. Improving energy efficiency in a pharmaceutical manufacturing environment : analysis of EUI and cooling load

    E-print Network

    Liu, Haoyu

    2009-01-01

    Reducing energy consumption without compromising the quality of products and the comfort of occupants is important in maintaining the competence of a pharmaceutical company. An energy management tool is developed to monitor ...

  19. Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

    Microsoft Academic Search

    Aaron S. Kesselheim; Michelle M. Mello; David M. Studdert

    2011-01-01

    Aaron Kesselheim and colleagues analyzed unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing, and develop a taxonomy of the various off-label practices.

  20. The effects of licensing and equity financing cycles on pharmaceutical development

    E-print Network

    Alspaugh, Jonathan D. (Jonathan Douglas)

    2011-01-01

    The purpose of this paper is to examine the interactions between licensing status, equity issuance cycles, and drug development success at the small pharmaceutical companies that originate these development projects. ...

  1. 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…

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

    ERIC Educational Resources Information Center

    Soronson, Bryan M.; Shaw, Diana V.

    1994-01-01

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

  3. Visual priming of pharmaceutical advertising disclosures: effects of a motivation factor

    Microsoft Academic Search

    Alex Wang

    2012-01-01

    Purpose – This study seeks to examine how consumers perceive a pharmaceutical company's advertisement through visual priming of the disclosure featured in the advertisement. Design\\/methodology\\/approach – An online study with a convenience sample consisting of college students is used to examine the effects of a visually primed pharmaceutical advertising disclosure on attitude toward responsible advertising practice, trust toward the advertisement

  4. Pharmaceutical Management Branch (PMB)

    Cancer.gov

    Skip to Content Home | Investigator Resources | Protocol Development | Initiatives/Programs/Collaborations | Links to More Resources | Funding Opportunities | About CTEP Home | Sitemap | Contact CTEP Search this site Pharmaceutical Management Branch

  5. Amorphous pharmaceutical solids.

    PubMed

    Vrani?, Edina

    2004-07-01

    Amorphous forms are, by definition, non-crystalline materials which possess no long-range order. Their structure can be thought of as being similar to that of a frozen liquid with the thermal fluctuations present in a liquid frozen out, leaving only "static" structural disorder. The amorphous solids have always been an essential part of pharmaceutical research, but the current interest has been raised by two developments: a growing attention to pharmaceutical solids in general, especially polymorphs and solvates and a revived interest in the science of glasses and the glass transition. Amorphous substances may be formed both intentionally and unintentionally during normal pharmaceutical manufacturing operations. The properties of amorphous materials can be exploited to improve the performance of pharmaceutical dosage forms, but these properties can also give rise to unwanted effects that need to be understood and managed in order for the systems to perform as required. PMID:15629010

  6. Ecotoxicology of human pharmaceuticals.

    PubMed

    Fent, Karl; Weston, Anna A; Caminada, Daniel

    2006-02-10

    Low levels of human medicines (pharmaceuticals) have been detected in many countries in sewage treatment plant (STP) effluents, surface waters, seawaters, groundwater and some drinking waters. For some pharmaceuticals effects on aquatic organisms have been investigated in acute toxicity assays. The chronic toxicity and potential subtle effects are only marginally known, however. Here, we critically review the current knowledge about human pharmaceuticals in the environment and address several key questions. What kind of pharmaceuticals and what concentrations occur in the aquatic environment? What is the fate in surface water and in STP? What are the modes of action of these compounds in humans and are there similar targets in lower animals? What acute and chronic ecotoxicological effects may be elicited by pharmaceuticals and by mixtures? What are the effect concentrations and how do they relate to environmental levels? Our review shows that only very little is known about long-term effects of pharmaceuticals to aquatic organisms, in particular with respect to biological targets. For most human medicines analyzed, acute effects to aquatic organisms are unlikely, except for spills. For investigated pharmaceuticals chronic lowest observed effect concentrations (LOEC) in standard laboratory organisms are about two orders of magnitude higher than maximal concentrations in STP effluents. For diclofenac, the LOEC for fish toxicity was in the range of wastewater concentrations, whereas the LOEC of propranolol and fluoxetine for zooplankton and benthic organisms were near to maximal measured STP effluent concentrations. In surface water, concentrations are lower and so are the environmental risks. However, targeted ecotoxicological studies are lacking almost entirely and such investigations are needed focusing on subtle environmental effects. This will allow better and comprehensive risk assessments of pharmaceuticals in the future. PMID:16257063

  7. Quality Control of Pharmaceuticals

    PubMed Central

    Levi, Leo; Walker, George C.; Pugsley, L. I.

    1964-01-01

    Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed. PMID:14199105

  8. Engineering Pharmaceutical Nanoparticles

    E-print Network

    Berkland, Cory

    2006-10-26

    Engineering Pharmaceutical Nanoparticles Cory Berkland Assistant Professor Department of Pharmaceutical Chemistry Assistant Professor Department of Chemical and Petroleum Engineering The University of Kansas 2 Acknowledgements Postdocs: David Shi....retsch.de 8 For example, the bioavailability of poorly soluble drugs can be enhanced. Spironalactone is a synthetic 17-lactone steroid. Nanoparticle suspensions of this drug dramatically enhance the drug dissolution. 9 For example, tumor accumulation via...

  9. 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

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

    PubMed

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

    2014-01-01

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

  11. 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

  12. 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

  13. Quality management benchmarking: FDA compliance in pharmaceutical industry

    Microsoft Academic Search

    Roland Jochem; Katja Landgraf

    2010-01-01

    Purpose – By analyzing and comparing industry and business best practice, processes can be optimized and become more successful mainly because efficiency and competitiveness increase. This paper aims to focus on some examples. Design\\/methodology\\/approach – Case studies are used to show knowledge exchange in the pharmaceutical industry. Best practice solutions were identified in two companies using a benchmarking method and

  14. Designing Secure IT Environments for Pharmaceutical Clinical Trial Data Systems

    Microsoft Academic Search

    Paul Drapeau

    2002-01-01

    Pharmaceutical companies are subject to regulations imposed by the FDA (Food and Drug Administration). Key elements of these regulations are rules governing the information technology space in drug production and research organizations. The requisite security infrastructure by these systems is sufficiently different from the security requirements in other IT areas because of these FDA regulations. Security professionals need to be

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

    ERIC Educational Resources Information Center

    Reilly, William J., Jr.

    1989-01-01

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

  16. 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

  17. [Competition success of the pharmaceutical organization study of some factors].

    PubMed

    Beglarian, M G

    2011-06-01

    The financial and economic activities of pharmaceutical company (trade policy, production, availability of original and generic drugs, the correlation between pharmacy staff and customers' perceptions, etc.) using the questionnaire method was investigated. The factors that have a significant influence on competitiveness, profitability and efficiency were evaluated and the needs to provide quality health care for society were identified. PMID:21778547

  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. PMID:25272639

  19. Biological and Pharmaceutical Nanomaterials

    Microsoft Academic Search

    Challa S. S. R. Kumar

    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

  20. 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

  1. Promoting Research-Based Practices through Inclusion?

    ERIC Educational Resources Information Center

    Volonino, Victoria; Zigmond, Naomi

    2007-01-01

    In recent years, special educators' roles and responsibilities have undergone significant transformations deriving from both internal and external sources. This article initially reviews some of the reform movements that have sought to bring research-based practices into the classroom, particularly for students considered exceptional or at-risk.…

  2. Promoting Research-Based Practices Through Inclusion?

    Microsoft Academic Search

    Victoria Volonino; Naomi Zigmond

    2007-01-01

    In recent years, special educators' roles and responsibilities have undergone significant transformations deriving from both internal and external sources. This article initially reviews some of the reform movements that have sought to bring research-based practices into the classroom, particularly for students considered exceptional or at-risk. Although these reforms have changed both special and general education, they may not have necessarily

  3. How can states provide affordable pharmaceuticals to the underserved?

    PubMed

    Zara, Jane

    2006-11-01

    Advocates of drug price restrictions in the U.S. argue that pharmaceutical companies operate in an unregulated market, free to charge whatever price the market will bear. The pharmaceutical industry insists that these large profits are justified for investments toward discovering new life saving medicines. As innovation wanes, marketing costs soar, and drug profits rise, public interest advocates and state leaders are challenging this justification. This article examines current problems associated with the ability to procure affordable medicines, and examines mounting tensions between the federal government and the states, particularly regarding the states' ability to negotiate lower prices with drug manufacturers in light of the recent Medicare changes. It provides a brief survey of efforts underway to secure affordable pharmaceuticals for state's residents, addressing the history and feasibility of using compulsory licensing for producing affordable life-saving drugs with respect to public health, constitutional, eminent domain, and anti-trust issues. PMID:17242532

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

    NASA Technical Reports Server (NTRS)

    1978-01-01

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

  6. 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

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

    PubMed

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

    2014-05-01

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

  8. Chapter 25 The pharmaceutical industry

    Microsoft Academic Search

    F. M. Scherer

    2000-01-01

    This Handbook chapter surveys the extensive body of research on the economics of the pharmaceutical industry (with peripheral attention paid also to regulated medical devices). Pharmaceuticals is one of the world's most research-intensive industries, generating a continuing steam of new products that save lives and raise the quality of life. The discovery of new drugs has evolved over time from

  9. Environmental Effects of Human Pharmaceuticals

    Microsoft Academic Search

    John Phillip Sumpter

    2007-01-01

    In the last few years, it has been demonstrated that many human pharmaceuticals are present in the aquatic environment, albeit at very low concentrations. Nevertheless, in at least one case, that of ethinyl estradiol, it is very likely that in some locations ethinyl estradiol is adversely affecting fish through its “feminization” of males. Another pharmaceutical, diclofenac, has caused the deaths

  10. Pharmaceutical promotion and GP prescription behaviour.

    PubMed

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

    2006-01-01

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

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

    PubMed

    Dzhalilova, K I

    2009-11-01

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

  12. A comparison of pharmaceutical manufacturers as a source of drug information to a telephone inquiry: generic vs brand.

    PubMed

    Generali, J A; Hogan, L

    1983-01-01

    A telephone survey was conducted to evaluate and compare drug information received from the pharmaceutical manufacturer in response to a drug interaction question concerning concurrent administration of tetracycline and cimetidine. This study assumes that the pharmaceutical company may often be consulted by the hospital pharmacist seeking information about a particular medication. Forty-five pharmaceutical companies, all marketing tetracycline products, were selected for the study. A conversation protocol was utilized. It was designed to assure consistency and evaluate information received for accuracy, response time, clinical judgement offered, and referrals. Forty pharmaceutical manufacturers responded: 18 brand manufacturers and 22 generic companies. Eleven companies provided information on the interaction identified. Five manufacturers stated that there were no contraindications to concurrent administration of the drugs, one company identified a similar interaction, and five manufacturers successfully provided information identifying the interaction with supportive documentation. Two of the five companies offered clinical judgement as to the clinical significance of the interaction. Both reached different conclusions. The mean time of all phone calls was 4.29 minutes (range 0.39 to 15.41 minutes). The investigator was referred to outside sources by twelve companies. In this study, brand manufacturers performed better than generic companies. Results indicate that few manufacturers are organized to answer drug information requests involving current information sources in a response to a telephone request. PMID:10265096

  13. 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. PMID:25630504

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

    PubMed

    Ebeling, Mary

    2011-09-01

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

  15. [PICS: pharmaceutical inspection cooperation scheme].

    PubMed

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry. PMID:19152846

  16. OSI-774 OSI Pharmaceuticals.

    PubMed

    Norman, P

    2001-02-01

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

  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 pharmaceutical researchers. A strong decentralisation process characterises the pharmaceutical sector, with pharmacies in the provinces and districts while wholesalers remain located in Hanoi and Saigon. The presence of many middlemen has contributed to an increase in prices. Today, a concentration of pharmacies is still noted in inner cities while the suburbs and the villages still have difficulties supplying drugs for inhabitants. Solutions have been implemented such as the opening of new pharmacies and additional professional training for pharmacists. Prices were lowered while the quality of the supply chain was improved. Local production is encouraged as hospitals are prompted to prescribe Vietnamese products. The modernisation of the Vietnamese pharmaceutical industry is also visible through the importation of medical materials and an increase in the number of private hospitals financed with both the help of local and foreign investors, mainly through joint-ventures, most often in Saigon and Hanoi. The renovation of local hospitals was also possible with the help of France and Japan. Columbia Gia Dinh International, located in Saigon, is one of the very few US/Vietnamese medical institutions created with a local partner, the Gia Dinh hospital. The recovery of the economy will accelerate the creation of new projects designed to improve local medical infrastructures. Other private companies, some of which are based in Singapore, have been specifically designed to deliver care to expatriates working in Vietnam. Insurance coverage has been provided in Vietnam since in 1992. Other improvements concern the implementation of "Good Manufacturing Practices" (GMP) and "Good Laboratory Practices" and "Good Storage Practices". Most norms were implemented at the end of the 90s in joint companies linking foreign investors and local partners or in independent foreign drug manufacturers based in Vietnam. Special areas were created to receive high tech investments in the medical and pharmaceutical field. Prices should diminish as competition o

  18. Multiscale mechanistic modeling in pharmaceutical research and development.

    PubMed

    Kuepfer, Lars; Lippert, Jörg; Eissing, Thomas

    2012-01-01

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

  19. Proposed model for interaction between residents and residency training programs, and pharmaceutical industry.

    PubMed

    Razack, S; Arbour, L; Hutcheon, R

    1999-03-01

    Medical residents in training are as much targets of pharmaceutical-industry marketing as are physicians in practice. This interaction is often subtle and takes the form of sponsorship of meals at academic events, support for conference travel, books, and items such as pens and notepads. Most residency programs direct little time towards training in ethics and the critical analysis of pharmaceutical-industry marketing. We propose a model for the relationship between residents and residency programs, and the pharmaceutical industry that addresses the need for such interaction to be viewed in light of the patient-centered ethic of professional conduct and the ideal of unbiased medical practice. A committee of residents at different levels of training and two staff physicians received the mandate to examine this issue. The committee developed a set of guidelines and a proposed schema for the handling of funds from pharmaceutical companies (still not implemented). Each residency program would develop a common fund for money donated by pharmaceutical companies. This fund would be administered by a committee with defined priorities. The presence of residents on this committee under staff preceptorship would serve as a springboard for education on the subject. Guidelines for acknowledgement of sponsorship, solicitation of funds, gifts for care of patients, ongoing education, and the wider applicability of these proposals were also developed. Residents' interaction with the pharmaceutical industry during training could have lifelong influence on medical practice. We hope that our model will promote critical appraisal of the potential risks and benefits of this interaction. PMID:12378718

  20. 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.

  1. Aripiprazole (Otsuka Pharmaceutical Co).

    PubMed

    Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih

    2002-01-01

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

  2. WAMDAS: A Web Service-Based Wireless Alarm Monitoring and Data Acquisition System for Pharmaceutical Plants

    Microsoft Academic Search

    Edilberto García-Rodríguez; Manuel Rodriguez-martinez

    2006-01-01

    Typical IT infrastructures used in manufacturing companies such as pharmaceutical plants are based on enterprise servers, with vast capacities for large data sets, managed with relational database systems, with powerful capabilities for query processing. In addition, workstations running diagnostics and control applications that monitor critical status conditions in manufacturing equipments are located in far locations throughout the plant. These workstations

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

    ERIC Educational Resources Information Center

    Charbonneau, Deborah Hile

    2010-01-01

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

  4. 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…

  5. Response to “interactions between pharmaceutical representatives and doctors in training: A thematic review”

    Microsoft Academic Search

    Leana S. Wen; Christopher McCoy; Daniella A. Zipkin; Michael A. Steinman

    2006-01-01

    To the Editor:—The findings of Zipkin and Steinman’s review that residents have frequent interactions with pharmaceutical representatives and that the residents view the interactions to be favorable is hardly surprising. 1 The systematic ‘‘branding’’ of physicians begins in the earliest stages of medical training. Medical students receive lunches, pens, and books given by drug companies throughout their clinical training, and

  6. MediSeal GmbH improves pharmaceutical packaging efficiency for small batch sizes

    Microsoft Academic Search

    Christine Connolly

    2007-01-01

    Purpose – This paper aims to describe the advances made by a particular pharmaceutical packaging machinery manufacturer for dealing with short product runs. Design\\/methodology\\/approach – The company and its blister packaging machinery products are described, with special attention to the modular servo-driven range. The centralised control console and the capabilities of its software are reviewed. A collaborative investigation of a

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

    PubMed

    Rusu, Alexandru; Kuokkanen, Katja; Heier, Annabelle

    2011-10-01

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

  8. Manufacturing menopause: An analysis of the portrayal of menopause and information content on pharmaceutical web sites

    Microsoft Academic Search

    Deborah Hile Charbonneau

    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 content analysis of web sites for FDA-approved hormone therapies

  9. Manufacturing Menopause: An Analysis Of The Portrayal Of Menopause And Information Content On Pharmaceutical Web Sites

    Microsoft Academic Search

    Deborah H. Charbonneau

    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 content analysis of web sites for FDA-approved hormone therapies

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

    PubMed

    Schlette, Sophia; Hess, Rainer

    2013-10-01

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

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

    SciTech Connect

    Not Available

    1991-10-01

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

  12. 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 target rates; side effects were primarily limited to local skin reactions [349982]. Ligand has worldwide rights to market bexarotene capsules, and will market the drug in the US, Canada and selected European markets. In Spain, Portugal, Greece and Central and South America, Ferrer Internacional will market and distribute the drug. As of December 1999, Ligand was seeking additional distribution partners for select European and Asian markets [351604]. In January 2000, Alfa Wassermann signed an agreement with Ligand to exclusively market and distribute Targretin gel and capsules in Italy. Alfa paid US $0.75 million on signing with additional amounts up to an aggregate total of US $1.0 million on achievement of certain registration milestones, which are expected to be met in 2000 [351882]. PMID:11249708

  13. Psychiatric pharmaceuticals in the environment.

    PubMed

    Calisto, Vânia; Esteves, Valdemar I

    2009-11-01

    Psychiatric pharmaceuticals, such as anxiolytics, sedatives, hypnotics, and antidepressants, are among the most prescribed active substances throughout the world. The occurrence of these widely used compounds in environmental matrices (wastewaters, surface, ground and drinking waters, soils, sediments, bio-solids and tissue), as well as the first studies indicating their high persistence and toxicity to non-target organisms, justify the growing concern about these emerging environmental pollutants. Despite this increasing interest, there is a considerable lack of knowledge about the environmental fate of a large number of psychiatric pharmaceuticals and further research about this topic is needed. This paper aims to review the literature data related to the occurrence, persistence, environmental fate and toxicity for non-target organisms of this group of pharmaceuticals. The analytical methods developed for the determination of psychiatric medicines in environmental matrices are also highlighted. PMID:19815251

  14. Investment companies 

    E-print Network

    Sauer, Edward F

    1961-01-01

    haul. Short-term ups and downs of the market have no real impact on his investment decisions. "After all, " explains an official of a large brokerage house that handles no mutual funds, "that's what the fund buyer is paying for--some- one else.... Their Performance . Their Sales Methods Some Answers The "No-Load" Mutual Fund. . . . . . The Unmanaged Investment Company. The "Centennial" Type Fund . . . . . . The Regular Withdrawal Plan. . . . . . The Dividend Reinvestment Plan. . . . Accumulation Plan...

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

    PubMed

    Edwards, Brian; Chakraborty, Sweta

    2012-11-01

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

  16. The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing.

    PubMed

    Breslow, Lauren Hammer

    2003-01-01

    On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act, which is the government's most comprehensive legislation regarding pediatric research to date. The Act offers pharmaceutical companies a six-month exclusivity term in return for their agreement to conduct pediatric tests on drugs. It also provides public funding and organizes private funding to help conduct pediatric research on those drugs that pharmaceutical companies opt not to test in children. This Note reviews the history of pediatric research and traces the development of the Best Pharmaceuticals for Children Act's unique incentive and public funding structure. The Note contends that, while the Act is comprehensive and promotes important pediatric studies, its incentive structure forces consumers and taxpayers to bear the costs of testing pharmaceuticals in children instead of the manufacturers who research, develop, and market those drugs. Congress should consider mandating pediatric studies in any future enactment of the legislation. PMID:16594116

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

    PubMed

    Thomas, L G

    1992-01-01

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

  18. International Pharmaceutical Abstracts (IPA) What is International Pharmaceutical Abstracts?

    E-print Network

    Saskatchewan, University of

    topic into the search box. #12;2 2. Click on Search to continue. 3. Enter terms to describe another in your search results. "Or" broadens your search by letting you search for related terms or synonyms. #12-related health topics. Searching International Pharmaceutical Abstracts The example below illustrates a step

  19. Pharmaceutical Supply Chain Networks with Outsourcing

    E-print Network

    Nagurney, Anna

    Pharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna Amherst Pharmaceutical Supply Chain Networks with Outsourcing #12;Acknowledgments This research Supply Chain Networks with Outsourcing #12;This presentation is based on the paper: Nagurney, A., Li, D

  20. Pharmaceutical Retention Mechanisms by Nanofiltration Membranes 

    E-print Network

    Nghiem, Long D.; Schäfer, Andrea; Elimelech, Menachem

    2005-01-01

    by steric (size) exclusion, whereas both electrostatic repulsion and steric exclusion govern the retention of ionizable pharmaceuticals by a loose NF membrane. In the latter case, speciation of pharmaceuticals may lead to a dramatic change in retention as a...

  1. 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...

  2. Assessing decision inputs in drug development between small, early stage companies and big pharma : is there is a difference?

    E-print Network

    Rippy, Daniel S. (Daniel Spensley)

    2007-01-01

    The pipeline productivity challenge facing large, publicly traded pharmaceutical companies, collectively referred to as "Big Pharma," is well known. The unprecedented success Big Pharma achieved over the past few decades ...

  3. Physical and dielectric properties of pharmaceutical powders

    Microsoft Academic Search

    C. M McLoughlin; W. A. M McMinn; T. R. A Magee

    2003-01-01

    The limited availability of published physical and dielectric property data for pharmaceutical powders hinders the design of processing systems, particularly dryers. In this study, the physical properties (solubility and boiling point) and dielectric properties, in terms of temperature rise, dielectric constant, and dielectric loss factor, of selected pharmaceutical powders were measured. The pharmaceutical actives, paracetamol and aspirin, and selected common

  4. 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. PMID:24981648

  5. Bioremediation of industrial pharmaceutical drugs.

    PubMed

    Mansour, Hedi Ben; Mosrati, Ridha; Barillier, Daniel; Ghedira, Kamel; Chekir-Ghedira, Leila

    2012-07-01

    Recently, attention has been drawn toward the occurrence of pharmaceuticals in the environment. In recent years, many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in wastewater (PW), surface water, ground water, and in soil. The pharmaceutical sector is currently expanding in Tunisia, with more than 34 industries. The aim of this work was to evaluate the ability of Pseudomonas putida mt-2 to treat PW. P. putida was very efficient in reducing chemical oxygen demand (COD), total dissolved solids (TDS), and turbidity of solution (85.5, 89.1, and 81.5%, respectively). Genotoxicity of effluent, before and after biodegradation, was evaluated in vivo in mouse bone marrow by assessing the percentage of cells bearing different chromosome aberrations. Results indicated that PW showed a significant ability to induce DNA damage. In addition, PW induced a remarkable lipid peroxidation (LPO) effect, however, activities of both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) were unchanged when treated with PW, compared to nontreated PW. This toxicity was imputed to the presence of pharmaceutical compounds in wastewater. However, chromosome aberration, as well as LPO of PW, were significantly reduced after bioremediation. Thus, the use of this strain for testing on the industrial scale seems possible and advantageous. PMID:22313387

  6. Psychiatric pharmaceuticals in the environment

    Microsoft Academic Search

    Vânia Calisto; Valdemar I. Esteves

    2009-01-01

    Psychiatric pharmaceuticals, such as anxiolytics, sedatives, hypnotics, and antidepressants, are among the most prescribed active substances throughout the world. The occurrence of these widely used compounds in environmental matrices (wastewaters, surface, ground and drinking waters, soils, sediments, bio-solids and tissue), as well as the first studies indicating their high persistence and toxicity to non-target organisms, justify the growing concern about

  7. Pharmaceutical applications of Supercritical Fluids

    Microsoft Academic Search

    Michel PERRUT

    Scope : The pharmaceutical industry is facing many challenges : Invention of new drugs and improvement of the therapeutic drug efficacy against numerous pathologies, meanwhile supporting a continuous effort to move to environment-friendly processes and reducing the use of potentially harmful solvents. As Nature is almost an unlimited source of active substances, a great interest is paid to concentrate them

  8. Biological treatment of pharmaceutical wastewater

    Microsoft Academic Search

    S. P. Mayabhate; S. K. Gupta; S. G. Joshi

    1988-01-01

    A study of physicochemical and biological treatment of pharmaceutical wastewater by the activated sludge process was performed in an oxidation ditch. The physicochemical study using different coagulants revealed that all the coagulants used are not effective and their doses required were very high for COD reduction. In the biological oxidation study, it was found that the wastewater could be processed

  9. Pharmaceutically relevant metabolites from lichens

    Microsoft Academic Search

    K. Müller

    2001-01-01

    Lichen metabolites exert a wide variety of biological actions including antibiotic, antimycobacterial, antiviral, antiinflammatory, analgesic, antipyretic, antiproliferative and cytotoxic effects. Even though these manifold activities of lichen metabolites have now been recognized, their therapeutic potential has not yet been fully explored and thus remains pharmaceutically unexploited. In this mini-review, particular attention is paid to the most common classes of small-molecule

  10. Animal-Derived Pharmaceutical Proteins

    Microsoft Academic Search

    EL-Rashdy M. Redwan

    2009-01-01

    Livestock animals have made a significant contribution to human health and well-being throughout humankind's history. A significant contribution of farm animals to human health are the longstanding use of bovine and porcine for production of insulin (for treatment of diabetes), gelatin (for pharmaceutical and other purposes), as well as horse and sheep antibody against natural venoms, toxins, drugs and microbial

  11. CLINICAL PHARMACEUTICAL SCIENCES PROGRAM GOAL

    E-print Network

    Guo, Jing

    Pharmacogenetics of drug metabolism and transport (PHA6427) 2 Pharmacogenomics (PHA6449) 2 Pharmaceutical Analysis (PHA6416) 2 Statistics I (STA6166) or Applied Biostatistics I (GMS6862) 3 Statistics II (STA6167) or Applied Biostatistics II (GMS6863) 3 Advanced Pharmacokinetics (PHA6125) 3 Epidemiology (PHC6001) 3

  12. Counterfeiting and piracy of pharmaceuticals

    Microsoft Academic Search

    ANN GRACKIN

    2008-01-01

    Estimates on counterfeit trade exceed US$200 billion, and inspections across the world cost billions, yet only a very few shipments are actually inspected. This issue has particularly impacted the vital life sciences supply chain. This article discusses what solutions are at hand to reduce illicit trade and ensure a safe and secure supply of pharmaceuticals.

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

    PubMed Central

    Lexchin, J

    1993-01-01

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

  14. How to revive breakthrough innovation in the pharmaceutical industry.

    PubMed

    Munos, Bernard H; Chin, William W

    2011-06-29

    Over the past 20 years, pharmaceutical companies have implemented conservative management practices to improve the predictability of therapeutics discovery and success rates of drug candidates. This approach has often yielded compounds that are only marginally better than existing therapies, yet require larger, longer, and more complex trials. To fund them, companies have shifted resources away from drug discovery to late clinical development; this has hurt innovation and amplified the crisis brought by the expiration of patents on many best-selling drugs. Here, we argue that more breakthrough therapeutics will reach patients only if the industry ceases to pursue "safe" incremental innovation, re-engages in high-risk discovery research, and adopts collaborative innovation models that allow sharing of knowledge and costs among collaborators. PMID:21715677

  15. Research-Based Methods of Reading Instruction, Grades K-3

    ERIC Educational Resources Information Center

    Vaughn, Sharon; Linan-Thompson, Sylvia

    2004-01-01

    Get your reading program on the right track using research-based teaching strategies from this helpful guide. Learn what you need to know about five essential elements of reading, why you should teach them, and how. A treasure chest of research-based instructional activities helps you: (1) Build students phonemic awareness; (2) Teach phonics and…

  16. 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

  17. 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. PMID:25364862

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

    PubMed

    Seay, Melicia; Varma, Priya

    2005-12-31

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

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

    PubMed Central

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

    2014-01-01

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

  20. Accountability of the pharmaceutical industry.

    PubMed

    Dukes, M N Graham

    2002-11-23

    The pharmaceutical industry is accountable on the one hand to its shareholders and on the other to the community at large. These two obligations can, in principle, be met. However, the industry has developed practices that do not consider society, including excessive or inappropriate pricing of drugs, an indifference to the needs and limitations of the developing world, an imbalance between true innovation and promotional activity, interference with clinical investigations, and efforts to mould medical thinking and priorities as a means to enlarge the market. In such respects, the pharmaceutical industry must now be called to order. The industry has shown itself to be sufficiently resilient to adapt to change if society insists on it. However, to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society's public-health interests. PMID:12457804

  1. Volatile hydrocarbons in pharmaceutical solutions

    SciTech Connect

    Kroneld, R. (Department of Medicine, University of Turku (Finland))

    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.

  2. Economic analysis and pharmaceutical policy.

    PubMed

    Rovira, J

    1995-10-01

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

  3. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

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

  4. Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications

    Microsoft Academic Search

    Joel Lexchin

    Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies\\u000a can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely\\u000a to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible\\u000a ways

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

    PubMed

    Ohmori, Kenji

    2011-01-01

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

  6. Procter & Gamble Company Presentation

    E-print Network

    Schöne, Bernd R.

    Companies (#14) Fortune World's Most Admired Companies (#9) Chief Executive Magazine's Top Companies pgcareers.com #12;Universum Pan-European Ranking Top 100 Ideal Employers (#8) Fortune Top 50 Most Profitable

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

    PubMed

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

    2012-12-01

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

  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. PMID:20373253

  9. Research based instruction in the teaching of islamic education.

    PubMed

    Asyafah, Abas

    2014-01-01

    In an effort to produce skilled and competent graduates, Indonesia University of Education with its motto of "producing knowledgeable, educated and religious human-beings", considers the development of required scientific attitudes, good behaviour, and strong religious values of students as an integral and important component needed to develop students' noble character and their intellectual ability. Developing such qualities requires innovative teaching and learning techniques which are enjoyable and able to motivate students. In this paper, the author seeks to answer four(4) questions: 1. How can one plan a research-based instruction for an Islamic education seminar course? 2. What are the steps considered in research-based instruction for a seminar course? 3. How is the evaluation of research-based instruction in an Islamic education seminar course? And 4. What are the weaknesses and strength of the research based instruction model in regard to facilitating an Islamic education seminar? To establish an appropriate answer to these questions, the author has used a descriptive-qualitative approach. The data have been obtained through observation, interviews and a study of relevant documents. The findings reveal that the implementation of an instruction research-based model is appropriate and applicable in the teaching of Islamic education seminar course. The study concludes that instruction research based model has the capacity to engage students and it is able to improve their problem solving skills in daily life. PMID:25674481

  10. Networked Healthcare The network is the customer: Setting the stage for fundamental change in pharmaceutical sales and marketing

    Microsoft Academic Search

    Marc Pesse; Pablo Erat; Anna Erat

    What will the marketing and sales organisation of a typical pharmaceutical company look like in 5 years ' time? What activities will they be conducting? Who will be their customers? Crucially, how are they going to address the challenges the industry is facing, such as declining physician access, limited customer loyalty, downward pricing pressure and low levels of public trust?

  11. How much cash does your company need?

    PubMed

    Passov, Richard

    2003-11-01

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

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

    PubMed Central

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

    2004-01-01

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

  13. Specialty pharmaceuticals: developing a management plan.

    PubMed

    Willcutts, Dave

    2002-01-01

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

  14. 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

  15. Membrane filtration of pharmaceutical solutions.

    PubMed

    McKinnon, B T; Avis, K E

    1993-09-01

    The principles and uses of membrane filtration in the preparation of pharmaceutical solutions are discussed. The preparation of pharmaceutical solutions often requires their passage through a thin polymeric membrane containing many tiny pores. The purpose is to remove viable and nonviable particles in order to clarify or sterilize the solution. Particles may be retained by sieving, entrapment, or electrostatic attraction. The largest pore size that will yield a sterile filtrate is 0.2 microns. Membrane filters are either hydrophobic or hydrophilic. The rate of flow through a filter is affected by the resistance of the filter, the viscosity of the solution, and pressure. Filters are commonly composed of mixed esters of cellulose, polysulfone, polyvinylidene difluoride, nylon 66, polycarbonate, or polytetrafluoroethylene. In selecting a membrane filter, a pharmacist must consider pore size, compatibility, fluid volume, particulate load, and the filter holder. Various tests are available to evaluate the integrity of filters. Filters are useful in testing end products for sterility. The use of an in-line filter during the administration of large-volume injectable solutions can prevent the introduction of particles, air, and microorganisms into the patient. Therapies in which a 0.2-micron filter may be contraindicated include lipid emulsions, low-dose infusions, low-volume infusions, drugs for which the pharmacologic properties are altered by the membrane filter, and drugs that adhere to the membrane. Pharmacists need an in-depth understanding of the principles of filtration, the characteristics of filters, and their use in the filtration of pharmaceutical solutions. PMID:8135243

  16. Pharmaceutical applications for catanionic mixtures.

    PubMed

    Bramer, Tobias; Dew, Noel; Edsman, Katarina

    2007-10-01

    Mixtures of oppositely charged surfactants, so called catanionic mixtures, are a growing area of research. These mixtures have been shown to form several different types of surfactant aggregates, such as micelles of various forms and sizes, and lamellar structures, such as vesicles. In this review, a short introduction to the field of catanionic mixtures is presented and the pharmaceutical possibilities offered by such mixtures are reviewed. There are several interesting ideas on how to apply catanionic mixtures to improve the delivery of, for example, drug compounds and DNA, or for HIV treatment. PMID:17910806

  17. Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study

    Microsoft Academic Search

    Zorana Boltic; Nenad Ruzic; Mica Jovanovic; Slobodan Petrovic

    2010-01-01

    This article presents experience from the practice of a successful pharmaceutical company related to design and implementation\\u000a of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses\\u000a on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim

  18. Copyright 2008 TTX Company : : CONFIDENTIAL Copyright 2008 TTX Company : : CONFIDENTIAL

    E-print Network

    Barkan, Christopher P.L.

    © Copyright 2008 TTX Company : : CONFIDENTIAL 1 © Copyright 2008 TTX Company : : CONFIDENTIAL 1 © Copyright 2008 TTX Company : : CONFIDENTIAL #12;© Copyright 2008 TTX Company : : CONFIDENTIAL 2 © Copyright 2008 TTX Company : : CONFIDENTIAL 2 Truck Performance Basics for TTX Jon Jeambey December 5, 2008

  19. [Assessment of the pharmaceutical expenditure in Hungary].

    PubMed

    Inotai, András; Merész, Gergo; Kaló, Zoltán

    2010-01-01

    Scarcity of health care resources draws attention to the expenditure on pharmaceuticals, as drugs are considered to be one of the major growth drivers of health care spending. This article assesses the Hungarian expenditure on pharmaceuticals by taking into account the economic status of the country and benchmarks from other OECD countries with special focus on indicators of Visegrad V4 countries (Czech Republic, Slovakia, Poland and Hungary). Our results highlight the heterogeneity of pharmaceutical expenditure data derived from different indicators among observed countries. Pharmaceutical spending is relatively higher in middle-income countries, mainly due the price convergence of innovative drug's, on contrary manpower cost of health care services are adjusted to local price levels, therefore the price differential of health care services between middle income and developed countries is greater. International trends of the global pharmaceutical market are also valid in Hungary. Increased private funding, mainly out of pocket payments above the average of V4 countries, has been the major growth driver of pharmaceutical expenditure recently in Hungary. Increased private pharmaceutical expenditure was mainly derived from the severe cost-containment measures in 2006. The annual growth rate of the National Health Insurance Fund's pharmaceutical budget for drug reimbursement was 1.37% in real terms between 1994 and 2009. This is much beneath the expansion of global pharmaceutical market. Consequently, cost-containment of public pharmaceutical spending was very successful in the last fifteen years, and the burden of market growth has been shifted to households. Public health programmes, investment into preventive care, with consideration on unfavourable Hungarian morbidity and mortality indicators, however, necessitate the increase of public pharmaceutical budget. In order to improve the allocative efficiency of health care spending, available resources should be spent only on effective, cost-effective, economically affordable medicines. PMID:21404477

  20. 75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ...FDA-2010-N-0001] Pharmaceutical Supply Chain; Public Workshop...entitled ``2010 PDA/FDA Pharmaceutical Supply Chain Workshop...to product quality in the pharmaceutical supply chain. Date and...supply chain among members of industry and regulatory...

  1. Trace Analysis of Pharmaceutical Pollutants and their Transformation

    E-print Network

    McCombe, Bruce D.

    Trace Analysis of Pharmaceutical Pollutants and their Transformation Products in Wastewater Trace Analysis of Pharmaceutical Pollutants and their Transformation Products in Wastewater For questions of the occurrence and levels of the most frequently detected pharmaceuticals in wastewater effluents n Challenges

  2. Microbial factories for recombinant pharmaceuticals

    PubMed Central

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

    2009-01-01

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

  3. Exploitation of biotechnology in a large company.

    PubMed

    Dart, E C

    1989-08-31

    Almost from the outset, most large companies saw the 'new biotechnology' not as a new business but as a set of very powerful techniques that, in time, would radically improve the understanding of biological systems. This new knowledge was generally seen by them as enhancing the process of invention and not as a substitute for tried and tested ways of meeting clearly identified targets. As the knowledge base grows, so the big-company response to biotechnology becomes more positive. Within ICI, biotechnology is now integrated into five bio-businesses (Pharmaceuticals, Agrochemicals, Seeds, Diagnostics and Biological Products). Within the Central Toxicology Laboratory it also contributes to the understanding of the mechanisms of toxic action of chemicals as part of assessing risk. ICI has entered two of these businesses (Seeds and Diagnostics) because it sees biotechnology making a major contribution to the profitability of each. PMID:2573093

  4. Pharmaceutical Supply Chain Networks with Outsourcing

    E-print Network

    Nagurney, Anna

    Pharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna of Massachusetts Amherst Pharmaceutical Supply Chain Networks with Outsourcing #12;Acknowledgments This research Supply Chain Networks with Outsourcing #12;This presentation is based on the paper: Nagurney, A., Li, D

  5. Electrochemical Determination of Dihydrocodeine in Pharmaceuticals

    Microsoft Academic Search

    J. M. P. J. Garrido; C. Delerue-Matos; F. Borges; T. R. A. Macedo; A. M. Oliveira-Brett

    2003-01-01

    Two analytical methods for the quality control of dihydrocodeine in commercial pharmaceutical formulations have been developed and compared with reference methods: a square wave voltammetric (SWV) method and a flow injection analysis system with electrochemical detection (FIA-EC). The electrochemical methods proposed were successfully applied to the determination of dihydrocodeine in pharmaceutical tablets and in oral solutions. These methods do not

  6. Assessing the assessments: Pharmaceuticals in the environment

    Microsoft Academic Search

    O. V. Enick; M. M. Moore

    2007-01-01

    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

  7. Department Head Pharmacy Practice and Pharmaceutical Sciences

    E-print Network

    Thomas, David D.

    care issues and the provision of pharmaceutical care in rural and tribal communities and is committed. The department head must establish a productive and supportive environment for all departmental faculty and staffDepartment Head Pharmacy Practice and Pharmaceutical Sciences College of Pharmacy University

  8. Human Pharmaceuticals in Wastewater Treatment Processes

    Microsoft Academic Search

    O. A. H. Jones; N. Voulvoulis; J. N. Lester

    2005-01-01

    The presence of human pharmaceutical compounds in surface waters is an emerging issue in environmental science. In this study the occurrence and behavior of human pharmaceuticals in a variety of wastewater treatment processes is reviewed. Although some groups are not affected by sewage treatment processes others are amenable to degradation, albeit incomplete. While water purification techniques such as granular activated

  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. European pharmacovigilance: increasingly outsourced to drug companies.

    PubMed

    2014-12-01

    New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator (benfluorex) disaster. The European Commission's original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations. Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers. The role of the new European Pharmacovigilance Risk Assessment Committee (PRAC) has been strengthened. Patients in every Member State have the right to report adverse drug effects directly to health authorities. EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved. However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest. Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies. Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are based on data preanalysed by the drug companies. In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments. In 2012, following France's Mediator disaster, several modest measures were added to the European regulations adopted in late 2010. They were mainly concerned with harmonising urgent decisions taken by Member States in response to drug safety issues arising from pharmacovigilance data. In each Member State, regional and national health authorities have an important role to play in bringing safety signals to the attention of Europe's decision-making bodies. And for robust pharmacovigilance, it is crucial to encourage healthcare professionals, patients and their relatives to report adverse effects. Finally, it is vital that, in developing a centralised quantitative approach to pharmacovigilance, the clinical and pharmacological analysis of spontaneous reports by independent teams, especially in pharmacovigilance centres, is not abandoned. PMID:25629153

  11. High Speed Video Applications In The Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Stapley, David

    1985-02-01

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

  12. 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

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

    PubMed

    Jones, Alan Wayne

    2011-06-01

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

  14. Drug Companies Drop South Africa Suit

    NSDL National Science Digital Library

    de Nie, Michael Willem.

    2001-01-01

    The news from South Africa yesterday was both good and bad for AIDS activists. Lawyers for a group of over 39 major pharmaceutical companies withdrew their legal challenge to a 1997 South African law that would allow the government to import or produce generic versions of the drugs. The lawsuit proved to be a tremendous public relations blunder for the drug companies, who were depicted as placing profits above human lives. Under the settlement reached yesterday, which was brokered by UN Secretary-General Kofi Annan, the South African government will consult the pharmaceutical industry when it crafts the regulations for the 1997 law and repeated its commitment not to breach international trade agreements. While hailed as an important victory and breakthrough in the fight against AIDS and other diseases in the world's poorer regions, it appears unlikely that the 4.7 million HIV-infected South Africans will have widespread access to inexpensive AIDS drugs any time soon. The government has made it clear that it has no plans to buy generic drugs and that any national program to provide medication is still far in the future.

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

    PubMed Central

    2010-01-01

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

  16. Adolescence, School Transitions, and Prevention: A Research-Based Primer.

    ERIC Educational Resources Information Center

    Berliner, BethAnn

    Preventionists have long recognized that the transition from elementary to secondary school represents a period of uncertainty and profound change in young adolescents' lives. This paper offers a research-based primer for teachers and other preventionists. It builds upon the prevention literature that focuses on protective factors as well as the…

  17. INTERNATIONAL PERCEPTIONS OF THE UK CHEMISTRY RESEARCH BASE

    E-print Network

    diseases. Chemistry will be indispensable in attacking the challenges of climate change, energyMedical Research Council INTERNATIONAL PERCEPTIONS OF THE UK CHEMISTRY RESEARCH BASE Chemistry for the Next Decade and Beyond #12;Chemistry for the Next Decade and Beyond International Review of UK

  18. Research-based communities of practice in UK higher education

    Microsoft Academic Search

    Lai Ling Ng; Jon Pemberton

    2012-01-01

    Research is an integral element of the work of higher education institutions, underpinning not only academics' responsibilities in developing intellectual skills and personal reputations, but contributing to the status of an organisation. Whilst formalised approaches are adopted for developing research, there is a growing trend towards informal groupings or communities of practice. This research, based on interviews with members of

  19. 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…

  20. 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…

  1. 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…

  2. 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.…

  3. 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…

  4. Alcohol and your health Research-based information from the

    E-print Network

    Bandettini, Peter A.

    Alcohol and your health Research-based information from the National Institutes of Health U Institutes of Health on alcohol use and its consequences. Alcohol use by adults in the United States* 7 in 10 for alcoholism, liver disease, and other problems *Although the minimum legal drinking age in the U.S. is 21

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

    PubMed Central

    Volodina, Anna; Sax, Sylvia; Anderson, Stuart

    2009-01-01

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

  6. Pharmaceutical Marketing in the Sanitary-Veterinary Sector

    Microsoft Academic Search

    Mihaela Cornelia Prejmerean; Simona Vasilache

    2007-01-01

    The paper discusses the particular problems marketing practice encounters in the pharmaceutical sector, investigating some of their underlying causes. The span of the pharmaceutical sector is then restricted to veterinary pharmaceutical marketing, as a domain in which not the clients themselves are targeted, but their physicians and owners, which are to decide on their behalf. If pharmaceutical marketing, in general,

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

    PubMed

    Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

    2014-02-01

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

  8. GUIDES TO POLLUTION PREVENTION: THE PHARMACEUTICAL INDUSTRY

    EPA Science Inventory

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

  9. The role and value of pharmaceutical marketing.

    PubMed

    Levy, R

    1994-04-01

    Pharmaceutical marketing is the last element of an information continuum, where research concepts are transformed into practical therapeutic tools and where information is progressively layered and made more useful to the health care system. Thus, transfer of information to physicians through marketing is a crucial element of pharmaceutical innovation. By providing an informed choice of carefully characterized agents, marketing assists physicians in matching drug therapy to individual patient needs. Pharmaceutical marketing is presently the most organized and comprehensive information system for updating physicians about the availability, safety, efficacy, hazards, and techniques of using medicines. The costs of pharmaceutical marketing are substantial, but they are typical of high-technology industries that must communicate important and complex information to sophisticated users. These costs are offset by savings resulting from proper use of medicines and from lower drug costs owing to price competition. PMID:8012620

  10. Assessing the assessments: Pharmaceuticals in the environment

    SciTech Connect

    Enick, O.V. [Department of Biological Sciences, Simon Fraser University, Burnaby, BC, V5A 1S6 (Canada)], E-mail: oana.enick@gov.bc.ca; Moore, M.M. [Department of Biological Sciences, Simon Fraser University, Burnaby, BC, V5A 1S6 (Canada)], E-mail: mmoore@sfu.ca

    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.

  11. 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...

  12. Exposure to Pharmaceuticals Present in the Environment

    Microsoft Academic Search

    Richard T. Williams; Jon C. Cook

    2007-01-01

    Pharmaceuticals have been detected in the environment with increasing frequency since the late 1990s. The concentrations detected are low. For example, the average concentration of a pharmaceutical detected in surface waters is 0.042 parts per billion (?g\\/L) when the value for samples reported to contain nondetectable levels of an analyte is assumed to be 0 and 0.151 when these samples

  13. Understanding hydrate formation in aqueous pharmaceutical environments

    Microsoft Academic Search

    Hakan Wikstrom

    2007-01-01

    The general objective of this project was to develop a mechanistic understanding of phase transformations occurring during high-shear wet granulation of pharmaceutical formulations. Processing-induced transformations are of great interest to the pharmaceutical industry, since such changes in solid-state form may lead to changes in bioavailability and chemical stability of the drug product. By understanding the mechanism underlying phase transformations during

  14. Miscellaneous Pharmaceutical Agents in Interventional Radiology

    PubMed Central

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

    2010-01-01

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

  15. Pharmaceuticals in the environment: an educational perspective

    Microsoft Academic Search

    Marco Eissen; Donata Backhaus

    Purpose  Pharmaceuticals are an integral part of a dignified life. However, a lack of degradability and threats to the welfare of living\\u000a beings cause concern due to their emission into the environment. There is also a lack of knowledge about cause and consequence.\\u000a Therefore, we intend to contribute to the development of educational programmes which should increasingly include the topic\\u000a ‘pharmaceuticals

  16. Pharmacogenetics and the pharmaceutical industry.

    PubMed

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

    2010-01-01

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

  17. Mobile Learning Application Research Based on iPhone

    Microsoft Academic Search

    Zong Hu; Dongming Huang

    \\u000a In recent years, as a new mode of learning, more and more domestic and foreign scholars pay attention to mobile learning.\\u000a This paper use iPhone act as mobile learning carrier, learners can get and interact information through iPhone. Application\\u000a research based on iPhone will maximize the potential advantages of iPhone, so that learners can participate in learning at\\u000a anytime, in

  18. Experiences with GCP in the pharmaceutical industry [corrected].

    PubMed

    Rämsch, K D

    1993-05-01

    The Declaration of Helsinki and the "new" Germany Drug Law of 1976 may be regarded as the first and all important step in the evolution of Good Clinical Practices (GCP) in Germany. "Regulations on the orderly conduct of clinical studies" (published in 1987), reflecting most elements of the GCPs, caused the German industry to make provisions for more successful drug approvals in the future. Pharmaceutical companies have improved their documentation systems with regard to study protocols and reports, increased their monitoring capacity, and began setting up SOPs. In preparation for the issuing of the E.C. GCP guidelines companies established Clinical Quality Assurance (CQA) units responsible for various CQA tasks such as training of monitors and investigators, auditing of protocols, reports, systems, and data. Typical problems connected with the implementation of GCP in Germany appear to be contradictory opinions of the various ethics committees, reluctancy on the part of investigators to assume additional bureaucratic workload, difficulties on the part of the sponsor resulting from the high financial and manpower requirements, as well as the relatively unfavorable political and public opinion of clinical research. The benefits achieved by the introduction of GCP are already visible, i.e., increased quality of study protocol, conduct and report of studies, reduced number of studies, transparency at all stages of clinical research and increased ethical awareness. PMID:8240533

  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. PMID:25673269

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

    PubMed

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

    2015-04-01

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

  1. Consumer Products Companies Company Website Headquarters

    E-print Network

    McGaughey, Alan

    .bsh-group.us Huntington Beach, CA Cadbury plc www.cadbury.com Uxbridge, UK California Oils Corporation www Diageo PLC www.diageo.com Stamford, CT Dole Food Company, Inc. www.dole.com Westlake Village, CA #12;Dr

  2. Business -Non-Pharmaceutical 3,189,360 Business -Pharmaceutical 241,422

    E-print Network

    Brownstone, Rob

    Contracts Business - Non-Pharmaceutical 3,189,360 Business - Pharmaceutical 241,422 Charities/Non-profits (pub & priv) 2,758,963 Federal Government (but not TriCou) 7,859,139 Nova Scotia Government 912,625 Other 234,202 Other Governments 977,593 Other University 1,512,272 United States Government 383

  3. Contracts Business -Non-Pharmaceutical 4,090,777 Business -Pharmaceutical 311,893

    E-print Network

    Brownstone, Rob

    Contracts Business - Non-Pharmaceutical 4,090,777 Business - Pharmaceutical 311,893 Charities/Non-profits (pub & priv) 2,635,662 Federal Government (but not TriCou) 8,147,015 Hospitals 17,971 Nova Scotia Government 764,218 Other 21,350 Other Governments 1,008,730 Other University 849,383 United States Government

  4. 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...

  5. Modeling reduction of pandemic influenza using pharmaceutical and non pharmaceutical interventions in a heterogeneous population

    E-print Network

    Teytelman, Anna

    2012-01-01

    In an event of a pandemic influenza outbreak such as the great "Spanish Flu" of 1918 and the more recent 2009-2010 H1N1 "Swine Flu" scare, pharmaceutical as well as non-pharmaceutical resources are limited in availability ...

  6. A complexity analysis model for management of Good Manufacturing Practice and ISO 9000-2001 compliancy simultaneous projects. Case study in the pharmaceutical industry

    Microsoft Academic Search

    De Falco; Maria Elena; Massimiliano Maria Schiraldi

    2002-01-01

    Quality improvement is definitively one of the major leading forces nowadays. In the manufacturing industry, the globalisation trend forces companies to modify their processes in order to comply to specific quality regulations. In pharmaceutical industry, the FDA Good Manufacturing Practices (GMPs) represent a landmark in defining the Quality Product, which is a complex multifaceted concept (\\

  7. 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

  8. 77 FR 65581 - Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-29

    ...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales)...

  9. 78 FR 3030 - Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales)...

  10. '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

  11. Selected aspects of europeization of pharmaceutical law.

    PubMed

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

    2010-01-01

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

  12. 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. PMID:24770424

  13. Research-based assessment instruments: Design, validation and interpretation

    NASA Astrophysics Data System (ADS)

    Adams, Wendy

    2014-03-01

    This presentation describes the process for creating and validating a research-based assessment instrument that measures the effectiveness of instruction. These assessments are designed to measure how well instruction causes students to think like experts. Although, the primary goal is not to obtain a comprehensive assessment of student learning; rather it is to provide formative assessment of teaching. Specific examples of instruments for physics conceptual understanding and student perceptions of the discipline of physics will be described, including the extent and limitations of how results can be interpreted.

  14. Business Improvement Company Description

    E-print Network

    Dahl, David B.

    expertise from all backgrounds, specifically accounting, finance, HR, supply chain and marketing; basically of the team. Company Description: Major banking firm Short Project Name: Improve and automate Collaboration

  15. Pharmaceutical compound content of municipal solid waste.

    PubMed

    Musson, Stephen E; Townsend, Timothy G

    2009-03-15

    The occurrence and fate of pharmaceuticals in landfills has been largely neglected. Once discarded in municipal solid waste (MSW), pharmaceuticals within a landfill may undergo degradation, adsorption, or enter the leachate and eventually exit the landfill. The active pharmaceutical ingredient (API) concentration of MSW was predicted using available statistics on medication usage and directly measured by a MSW composition study. Estimation calculations resulted in a potential concentration of APIs from 7.4 to 45 mg/kg of MSW, varying with the percentage of dispensed medications assumed to become unused. Direct measurement resulted in the collection of 22 APIs comprising a total of 22,910 mg. This resulted in a final concentration of 8.1 mg/kg within MSW. Additionally, 45 empty medication containers were collected which potentially contained 33 differing APIs upon disposal. PMID:18599201

  16. Pharmaceutical plasticizers for drug delivery systems.

    PubMed

    El-Gendy, Nashwa A

    2012-03-01

    In the field of pharmaceutical science and drug development, there are important and particular challenges related to the selection of suitable and compatible ingredients as well as the design of successful formulations. As plasticization is a phenomenon widely exploited in all formulation fields, plasticizers should be recognized as a critical aspect for drug delivery. The choice of an appropriate plasticizer requires a wide background of information. This is because they are incorporated into drug delivery systems containing an assortment of ingredients which may have different reactions to the presence of plasticizers. Concurrently, there are numerous pharmaceutical plasticizers and various environmental issues dictating favored solutions. To address these encumbrances, an extensive information concerning plasticizers; their types, properties, pharmaceutical roles, etc. is discussed. Additionally, the specific objective of this review is to substantiate the safety and performance of newly discovered plasticizers. PMID:22283652

  17. Modeling choice behavior for new pharmaceutical products.

    PubMed

    Bingham, M F; Johnson, F R; Miller, D

    2001-01-01

    This paper presents a dynamic generalization of a model often used to aid marketing decisions relating to conventional products. The model uses stated-preference data in a random-utility framework to predict adoption rates for new pharmaceutical products. In addition, this paper employs a Markov model of patient learning in drug selection. While the simple learning rule presented here is only a rough approximation to reality, this model nevertheless systematically incorporates important features including learning and the influence of shifting preferences on market share. Despite its simplifications, the integrated framework of random-utility and product attribute updating presented here is capable of accommodating a variety of pharmaceutical marketing and development problems. This research demonstrates both the strengths of stated-preference market research and some of its shortcomings for pharmaceutical applications. PMID:11704970

  18. Chapter 5. Essential equipment, pharmaceuticals and supplies

    Microsoft Academic Search

    Charles L. Sprung; Jozef Kesecioglu

    2010-01-01

    Purpose  To provide recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza\\u000a pandemic or mass disaster with a specific focus on essential equipment, pharmaceuticals and supplies.\\u000a \\u000a \\u000a \\u000a \\u000a Methods  Based on a literature review and expert opinion, a Delphi process was used to define the essential topics including essential\\u000a equipment, pharmaceuticals and supplies.\\u000a \\u000a \\u000a \\u000a \\u000a Results  Key recommendations include: (1) ensure

  19. Radiostability of pharmaceuticals under different irradiation conditions

    NASA Astrophysics Data System (ADS)

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

    2005-02-01

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

  20. Competitor Analysis Company Description

    E-print Network

    Dahl, David B.

    making fan gear such as chairs, tents, and bags with team logos on them. Short Project Name: Competitive chemical company providing the household and industrial detergent, personal care, lubricant, oilfield-based companies and their technologies that are geared for replacing petro-based raw materials. Dossiers would

  1. Zoltek Companies, Inc

    Microsoft Academic Search

    Kenneth Eades

    The CEO of Zoltek Companies, Inc., is faced with the opportunity to buy Magyar Viscosa, a company that has recently emerged from bankruptcy and that was not for sale as part of Hungary's privatization program. The student must first decide if acquiring Viscosa would be consistent with Zoltek's operating strategy and then must structure a bid for Viscosa that is

  2. 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)

  3. 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...

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

    PubMed Central

    Bubela, Tania; Boon, Heather; Caulfield, Timothy

    2008-01-01

    Background This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles. Results Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64%) and herbal remedy (53%) clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; ?2 = 7.8129; degrees of freedom = 2). Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies. Conclusion Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most published research based primarily on anecdotal accounts. Our results highlight how media coverage is not providing the public with the information necessary to make informed decisions about medical treatments. Most concerning is the lack of disclosure of trial funding and conflicts of interest that could influence the outcome or reporting of trial results. This lack of reporting may impact the medical research community, which has the most to lose by way of public trust and respect. PMID:19036123

  6. Price regulation in the pharmaceutical industry: Prescription or placebo?

    Microsoft Academic Search

    Thomas III Abbott

    1995-01-01

    President Clinton and several Legislators have proposed restrictions on price increases in the pharmaceutical industry similar to those on some public utilities. Studies, however, suggest that under conditions of rapidly changing demand (as found in pharmaceuticals), price-caps could be manipulated. Using simulations, we show that in reaction to regulation, pharmaceutical firms would optimally set launch prices 50 percent higher than

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

    Microsoft Academic Search

    Kevin V. Thomas; Martin J. Hilton

    2004-01-01

    This report describes a scoping study conducted in order to establish whether pharmaceutical compounds may be present in UK estuaries. Surface water samples collected from five UK estuaries were analysed for the presence of 14 pharmaceutical compounds selected from the priority lists of the UK Environment Agency and the Oslo and Paris Commission (OSPAR). The pharmaceutical compounds\\/metabolites clofibric acid, clotrimazole,

  8. Prioritizing veterinary pharmaceuticals for aquatic environment in Korea

    Microsoft Academic Search

    Younghee Kim; Jinyong Jung; Myunghyun Kim; Alistair B. A. Boxall; Kyungho Choi

    2008-01-01

    Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the

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

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

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

  10. Companies reduce prices for HIV drugs in developing countries.

    PubMed

    Gottlieb, S

    2000-01-01

    This article reports the decision of pharmaceutical companies to reduce the prices of anti-HIV drugs in developing countries. It is stated that some of the companies have pledged to sell the pharmaceuticals at prices just above the manufacturing costs, at a discount of up to 90%. This strategy is part of an unprecedented effort to combat AIDS in sub-Saharan Africa. Participating companies include Glaxo Wellcome, Boehringer Ingelheim, Bristol-Myers Squibb, Hoffman-La Roche and Merck & Co. Experts say that lowering the price of medicines is not the sole solution to the problem, but new efforts also must be introduced to improve prevention, medical infrastructure, international funding, and political involvement. On the other hand, President Bill Clinton issued an executive order regarding the actions of the US Trade Representative's office against nations who seek access to cheap drugs. The ruling provides that the office can no longer threaten trade sanctions against developing nations that use the intellectual property rules of the World Trade Organization to gain access to cheaper drugs. PMID:10916926

  11. Crystal engineering of novel pharmaceutical forms

    Microsoft Academic Search

    Jennifer Anne McMahon

    2006-01-01

    In the context of pharmaceutical development, it is abundantly clear that there is a need for greater understanding and control of crystalline phases. The field of crystal engineering is poised to address such issues and has matured into a paradigm for the supramolecular synthesis of new compounds with desired properties. Crystal structures are unpredictable by nature, however, the interactions that

  12. Pharmaceutical Education. Bulletin, 1921, No. 11

    ERIC Educational Resources Information Center

    Rudd, Wortley F.

    1921-01-01

    Any history of pharmaceutical education during the two years 1918 to 1920 would be wholly incomplete without a review of the influences, which have brought about the conditions during the period under consideration. In pharmacy, as in medicine and law, the preceptorial system largely prevailed for the first century of pharmacy in the United…

  13. 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;…

  14. 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)

  15. NMR techniques in biomedical and pharmaceutical analysis

    Microsoft Academic Search

    M. Malet-Martino; U. Holzgrabe

    2011-01-01

    This article focuses on the description of some of the NMR techniques used in the field of biomedical and pharmaceutical research. Indeed, the NMR method has special characteristics which make it uniquely suitable for these kinds of studies. It is non-selective so that all the low molecular weight compounds in the sample investigated are detected simultaneously in a single run.

  16. Online Database Coverage of Pharmaceutical Journals.

    ERIC Educational Resources Information Center

    Snow, Bonnie

    1984-01-01

    Describes compilation of data concerning pharmaceutical journal coverage in online databases which aid information providers in collection development and database selection. Methodology, results (a core collection, overlap, timeliness, geographic scope), and implications are discussed. Eight references and a list of 337 journals indexed online in…

  17. 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…

  18. Endocrine Disruptors and Pharmaceuticals in the Environment

    Microsoft Academic Search

    Shane A. Snyder

    Water treatment can reduce the concentrations of most contaminants. Ozone was evaluated at pilot and full scale, and found to readily reduce the estrogenicity of wastewater effluent. Free chlorine was found to be highly effective for the oxidation of phenolic steroids and acidic pharmaceuticals, while it was ineffective for ketone steroids (i.e., progesterone and testosterone). UV at typical disinfection doses

  19. [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

  20. Pharmaceutical Pricing in a Regulated Market

    Microsoft Academic Search

    Mats Ekelund; Björn Persson

    2003-01-01

    We compare how new pharmaceuticals are priced in the price-regulated Swedish market with how they are priced in the U.S. market, as studied by Lu and Comanor (1998). We collect a data set consisting of all new chemical entities (NCEs) launched in Sweden between 1987 and 1997, and test the same models as Lu and Comanor. In line with their

  1. Price regulation of pharmaceuticals in Canada

    Microsoft Academic Search

    Aslam H. Anis; Quan Wen

    1998-01-01

    Patent holding pharmaceutical firms are modeled as price-discriminating international monopolies. In an unregulated world market, firms set monopoly prices in each national market. Three types of regulatory rules: (i) ‘reasonable’ relationship rule, (ii) international price comparison rule, and, (iii) therapeutic class comparison rule, are examined. While price regulation may lead to lower introductory prices for new drugs, the price of

  2. Can the pharmaceutical industry reduce attrition rates?

    Microsoft Academic Search

    John Landis; Ismail Kola

    2004-01-01

    The pharmaceutical industry faces considerable challenges, both politically and fiscally. Politically, governments around the world are trying to contain costs and, as health care budgets constitute a very significant part of governmental spending, these costs are the subject of intense scrutiny. In the United States, drug costs are also the subject of intense political discourse. This article deals with the

  3. Adhesion of polymeric films to pharmaceutical solids

    Microsoft Academic Search

    Linda A. Felton; James W. McGinity

    1999-01-01

    The two major forces influencing polymer adhesion include the strength of the interfacial bonds between the polymeric film and the surface of the solid and the internal stresses within the film coating. While good adhesion between the polymer and the substrate is desirable for pharmaceutical products, the small size of the dosage form and the non-uniform surface roughness have created

  4. Pollution prevention in the pharmaceutical industry

    SciTech Connect

    Venkataramani, E.S. [Merck and Co., Inc., Rahway, NJ (United States)

    1995-09-01

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

  5. Welfare Effects of Pharmaceutical Informative Advertising

    Microsoft Academic Search

    Paris Cleanthous

    2011-01-01

    Pharmaceutical markets are characterized by a high degree of innovation, complexity and uncertainty, especially markets of idiosyncratic symptomatolgy and response to treatment such as the antidepressant market. It may, therefore, be unreasonable to assume that consumers are aware of all antidepressants for sale at the time of purchase, as is the case in traditional models of consumer choice. Such an

  6. Lecithin organogels as model carriers of pharmaceuticals

    Microsoft Academic Search

    M. Zoumpanioti; E. Karavas; C. Skopelitis; H. Stamatis; A. Xenakis

    Lecithin microemulsion based organogels (MGs) formulated with cellulose derivatives such as hydroxypropylmethyl cellulose (HPMC) and hydroxypropyl cellulose (HPC) were studied as matrices for the transdermal transport of drugs. Lecithin, as well as the cellulose derivatives used, are pharmaceutical-grade compounds. The general properties of these MGs containing drugs such as their stability in various organic solvents and ability to incorporate sizeable

  7. 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...

  8. Pharmaceutical knowledge governance: a human rights perspective.

    PubMed

    Lemmens, Trudo

    2013-01-01

    Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. PMID:23581664

  9. Valuing Biodiversity for Use in Pharmaceutical Research

    Microsoft Academic Search

    R. David Simpson; Roger A. Sedjo; John W. Reid

    1996-01-01

    'Biodiversity prospecting' has been touted as a mechanism for both discovering new pharmaceutical products and saving endangered ecosystems. It is unclear what values may arise from such activities, however. Evidence from transactions is incomplete and existing theoretical models are flawed. The authors calculate an upper bound on the value of the 'marginal species.' Even under favorable assumptions this bound is

  10. Introduction The essence of pharmaceutical materi-

    E-print Network

    Elliott, James

    was in a 1991 article by Franks et al.,1 describing the application of materials science concepts to the produc. In fact, scientific articles describing the study of pharmaceutical materials and their unique range to apply principles from metallurgical powder compaction and to analyze powder be- havior using concepts

  11. Pharmaceutical Tablet Inspection Emil Sauer Lynge

    E-print Network

    Pharmaceutical Tablet Inspection Emil Sauer Lynge Kongens Lyngby 2012 IMM-B.Sc.-2012-06 #12;Summary (English) The goal of this thesis is to investigate, how an industrial machine vision solution can implementation. The results thus only reects the explanatory power of the tablets spectral response. A method

  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. Applications of Nanotechnology to Pharmaceutical Product Development

    E-print Network

    Fisher, Frank

    Applications of Nanotechnology to Pharmaceutical Product Development Wednesday January 27, 2010 physical forms can create limitations in terms of product performance and/or safety. Nanotechnology can of the clinical benefits of using nanotechnology in drug product development.. Bill Bosch has been involved

  14. Pharmaceuticals as Groundwater Tracers - Applications and Limitations

    NASA Astrophysics Data System (ADS)

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

    2003-12-01

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

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

    PubMed Central

    2013-01-01

    Background Strategic Functional-level planning should be aligned with business level and other functional strategies of a company. It is presumed that assimilating the strategies could have positive contribution to business performance, in this regard alignment between marketing strategy and financial strategy seems to be the most important strategies being studied. An empirical work in generic pharmaceutical manufacturing companies for evaluating effect of alignment between these two functions on organizational performance was developed in this paper. Methods All Iranian pharmaceutical generic manufactures listed in Tehran stock market have been tested for period of five years between 2006–2010 and their marketing strategies were determined by using Slater and Olson taxonomy and their financial strategies have been developed by calculating total risk and total return of sample companies for five years based on rate of risk and return in the frame of a 2 × 2 matrix. For the business performance three profitability indices including Q-Tubin (Rate of market value to net asset value), ROA (Return on Asset), ROE (Return on Equity) have been tested. For analysis, a series of one-way ANOVAs as a collection of statistical models within marketing strategies considering financial strategy as independent variable and the three performance measures as dependent variables was used. Results Results show strategic alignment between financial and marketing has significant impact on profitability of company resulting in arise of all three profitability indices. Q tubing’s rate were 2.33,2.09,2.29,2.58 and rate of ROA were 0.21,0.194,0.25,0.22 and rate of ROE were 0.44,0.46,0.45,0.42 for matched strategy types, respectively the rates shown here are more than average meaning that specific type of marketing strategy is fitted with specific type of financial strategy. Conclusion Managers should not consider decisions regarding marketing strategy independently of their financial strategy. PMID:23915467

  16. Pharmaceutical marketing practices: balancing public health and law enforcement interests; moving beyond regulation-through-litigation.

    PubMed

    Zalesky, Christopher D

    2006-01-01

    Fraudulent or abusive sales and marketing practices by pharmaceutical companies can result in costly overutilization of products that are increasingly paid for by government healthcare programs and may result in adverse health and safety consequences to the patient-beneficiaries of those programs. Federal enforcement efforts in this area are largely modeled on those used to combat white-collar crime, with cases taking years to reach conclusion. This approach overlooks the impact on patients who receive unnecessary care or are denied access to appropriate care during the course of the investigation. Many states are beginning to regulate certain pharmaceutical sales and marketing practices, but state-by-state regulation ignores the importance of a uniform federal regulatory and enforcement approach in an area already occupied by federal law. This Article explores current federal and state efforts to limit overutilization, fraud, and abuse in the sale and marketing of prescription drugs, and illustrates the merits of an expanded role for the U.S. Food and Drug Administration (FDA) to regulate pharmaceutical sales and marketing practices. This approach borrows lessons learned from the FDA's efficient and effective regulatory and enforcement methods and maintains a careful balance between the interests of patient-beneficiaries, the government and industry. PMID:17002233

  17. Inhalable dust measurements as a first approach to assessing occupational exposure in the pharmaceutical industry.

    PubMed

    Champmartin, C; Clerc, F

    2014-01-01

    Occupational exposure to active ingredients in the pharmaceutical industry has been the subject of very few published studies. Nevertheless, operations involving active powdered drugs or dusty operations potentially lead to operator exposure. The aim of this study was to collect occupational exposure data in the pharmaceutical industry for production processes involving powdered active ingredients. While the possibility of assessing drug exposure from dust level is examined, this article focuses on inhalable dust exposure, without taking chemical risk into account. A total of 377 atmospheric (ambient and personal) samples were collected in nine drug production sites (pharmaceutical companies and contract manufacturing organizations) and the dust levels were assessed. For each sample, relevant contextual information was collected. A wide range of results was observed, both site- and operation-dependent. Exposure to inhalable dust levels varied from 0.01 mg/m(3)to 135 mg/m(3). Though restricted to dust exposure, the study highlighted some potentially critical situations or operations, in particular manual tasks (loading, unloading, mechanical actions) performed in open systems. Simple preventive measures such as ventilation, containment, and minimization of manual handling should reduce dust emissions and workers' exposure to inhalable dust. PMID:24369930

  18. Validation of pharmaceutical potency determinations by quantitative nuclear magnetic resonance spectrometry.

    PubMed

    Webster, Gregory K; Marsden, Ian; Pommerening, Cynthia A; Tyrakowski, Christina M

    2010-05-01

    With the changing development paradigms in the pharmaceutical industry, laboratories are challenged to release materials for clinical studies with rapid turnaround times. To minimize cost demands, many businesses are looking to develop ways of using early Good Manufacturing Practice (GMP) materials of active pharmaceutical ingredients (API) for Good Laboratory Practice (GLP) toxicology studies. To make this happen, the analytical laboratory releases the material by one of three scenarios: (1) holding the GLP release until full GMP testing is ready, (2) issuing a separate lot number for a portion of the GMP material and releasing the material for GLP use, or (3) releasing the lot of material for GLP using alternate (equivalent) method(s) not specified for GMP release testing. Many companies are finding the third scenario to be advantageous in terms of cost and efficiency through the use of quantitative nuclear magnetic resonance (q-NMR). The use of q-NMR has proved to be a single-point replacement for routine early development testing that previously combined elements of identity testing, chromatographic assay, moisture analysis, residual solvent analysis, and elemental analysis. This study highlights that q-NMR can be validated to meet current regulatory analytical method guidelines for routine pharmaceutical analysis. PMID:20482973

  19. 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

  20. eCompany Now

    NSDL National Science Digital Library

    The online counterpart to the newly launched eCompany Magazine, eCompany Now strives "to be the straight-talking, sophisticated companion to business people who face the risks and opportunities the Web brings to the business world." Along with articles lifted from the print publication, eCompany Now has created several value-added features, including Web Files, which are online resources that correlate to articles in the paper version of the magazine. The site also provides interactive bulletin boards in its Discussion section, links, news headlines, and Hot Topics, which are groupings of articles, links, and bulletin boards related to single topics. While this site obviously has been created to enhance the print edition, eCompany Magazine, even those who don't subscribe to the hard copy will find the information on Web businesses helpful and interesting.

  1. company (company-name, city) 4.2 (h) Assume the companies may be located in

    E-print Network

    Sidorova, Natalia

    company (company-name, city) 4.2 (h) Assume the companies may be located in several cities. Find all companies located in every city in which SBC is located. { t | ccompany (t[comp-name]=c[comp-name] c1company (c1[comp-name] = "SBC" c2company (c2[comp-name]=c[comp-name] c2[city] = c1[city

  2. 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…

  3. Pharmaceutical speakers' bureaus, academic freedom, and the management of promotional speaking at academic medical centers.

    PubMed

    Boumil, Marcia M; Cutrell, Emily S; Lowney, Kathleen E; Berman, Harris A

    2012-01-01

    Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver "educational" talks to groups of physicians in the community to help market the company's brand-name drugs. Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most academic medical centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking. PMID:22789048

  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. Company and Industry Research guide

    E-print Network

    Azevedo, Ricardo

    these positions? What type of company ­ publicly traded, privately held, non-profit, etc.? Is the company partCompany and Industry Research guide career.uh.edu 713-743-5100 ucs@uh.edu #12;July 2013 University are going away, company buyouts, changing technology, along with other factors. In an age of downsizing

  6. Silo effect a prominence factor to decrease efficiency of pharmaceutical industry.

    PubMed

    Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

    2013-01-01

    To be sure, all the industries try to be involved in globalization with a constant trend to find out ways to increase productivity across different functions within an organization to maintain competitive advantage world. Pharmaceutical industries are not exceptional and further are based on fragmentation. So these kind of companies need to cope with several barriers such as silo mentality that may affect efficiency of their business activity. Due to eliminate a part of resources such as raw materials, new molecule developed, financial and human resources and so on, companies can gradually loss their competitive potentials in the market and increase their expenses. Furthermore, to avoid any business disturbances in financially connected companies due to silo effect, they should arrange their management to integrated organization form. Otherwise, actions taken by one business member of the chain can influence the profitability of all the other members in the chain. That is why recently supply chain has generated much interest in many business units. In this paper, it has been tried to investigate the different aspects of silo effect which can affect integrate supply chain. Finally, a fluent communication, high level of information exchange, fragmentation management, cross-functional control in a supply chain management format are needed to reduce or control silo effect within entire chain of the holding company by Supply chain management. PMID:24250690

  7. Proteomics in pharmaceutical research and development.

    PubMed

    Cutler, Paul; Voshol, Hans

    2015-08-01

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

  8. Overview of genotoxic impurities in pharmaceutical development.

    PubMed

    Bercu, Joel P; Dobo, Krista L; Gocke, Elmar; McGovern, Timothy J

    2009-01-01

    This symposium focuses on the management of genotoxic impurities in the synthesis of pharmaceuticals. Recent developments in both Europe and United States require sponsors of new drug applications to develop processes to control the risks of potential genotoxic impurities. Genotoxic impurities represent a special case relative to the International Conference on Harmonisation Q3A/Q3B guidances, because genotoxicity tests used to qualify the drug substance may not be sufficient to demonstrate safety of a potentially genotoxic impurity. The default risk management approach for a genotoxic impurity is the threshold of toxicological concern unless a more specific risk characterization is appropriate. The symposium includes descriptions of industry examples where impurities are introduced and managed in the synthesis of a pharmaceutical. It includes recent regulatory developments such as the "staged threshold of toxicological concern" when administration is of short duration (eg, during clinical trials). PMID:19966139

  9. Trust and the regulation of pharmaceuticals: South Asia in a globalised world

    PubMed Central

    2011-01-01

    Background Building appropriate levels of trust in pharmaceuticals is a painstaking and challenging task, involving participants from different spheres of life, including producers, distributors, retailers, prescribers, patients and the mass media. Increasingly, however, trust is not just a national matter, but involves cross-border flows of knowledge, threats and promises. Methods Data for this paper comes from the project 'Tracing Pharmaceuticals in South Asia', which used ethnographic fieldwork and qualitative interviews to compared the trajectories of three pharmaceuticals (Rifampicin, Oxytocin and Fluoxetine) from producer to patient in three sites (north India, West Bengal and Nepal) between 2005-08. Results We argue that issues of trust are crucial in reducing the likelihood of appropriate use of medicines. Unlike earlier discussions of trust, we suggest that trust contexts beyond the patient-practitioner relationship are important. We illustrate these arguments through three case studies: (i) a conflict over ethics in Nepal, involving a suggested revised ethical code for retailers, medical representatives, producers and prescribers; (ii) disputes over counterfeit, fake, substandard and spurious medicines, and quality standards in Indian generic companies, looking particularly at the role played by the US FDA; and (iii) the implications of lack of trust in the DOTS programmes in India and Nepal for the relationships among patients, government and the private sector. Conclusions We conclude that the building of trust is a necessary but always vulnerable and contingent process. While it might be desirable to outline steps that can be taken to build trust, the range of conflicting interests in the pharmaceutical field make feasible solutions hard to implement. PMID:21529358

  10. The superefficient company.

    PubMed

    Hammer, M

    2001-09-01

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

  11. Do Pharmaceutical Sales Respond to Scientific Evidence?

    Microsoft Academic Search

    Pierre Azoulay

    2002-01-01

    I investigate how different sources of information influence the diffusion of pharmaceutical innovations. In prescription-drug markets, both advertising and scientific information stemming from clinical trials can affect physicians' prescription choices. Using novel indices of clinical-research output, I find that both marketing and scientific evidence directly influence the diffusion process in the antiulcer-drug market, with marketing having a more pronounced influence.

  12. Infrared Imaging of Pharmaceutical Materials Undergoing Compaction

    Microsoft Academic Search

    Simon R. Bechard; G. R. B. Down

    1992-01-01

    The goal of this study was to use infrared thermography as a new technique to investigate the heat released during compaction and consolidation of pharmaceutical powders and granules. Real-time temperature measurements without physical contact with tablets were provided by a highly sensitive (±0.1°C at 30°C) infrared camera (Agema Infrared Systems, Model 470 with CM-SOFT software). High-resolution images were captured at

  13. POLAROGRAPHIC DETERMINATION OF LORNOXICAM IN PHARMACEUTICAL FORMULATIONS

    Microsoft Academic Search

    Nisa KOÇAK

    A simple, precise, fast and low-cost differential pulse polarographic (DPP) method for determination of lornoxicam in pharmaceutical formulations has been proposed. The results have been compared with those of high performance liquid chromatography (HPLC) method. Mean values and standard deviations calculated by ten determinations were 8.10 ± 0.12 mg for DPP and six determinations were 8.02 ± 0.08 mg for

  14. The increasingly complex fourth hurdle for pharmaceuticals.

    PubMed

    Cohen, Joshua; Stolk, Elly; Niezen, Maartje

    2007-01-01

    There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost effectiveness and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual unexplained variables, one of which may be budget impact. An economic rationale for carrying out budget impact analyses is opportunity cost, measured by the economic benefits foregone by using resources in one way rather than another. Under certain assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximising health gains, subject to a budget constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care. Although drugs that are cost effective may lead to unambiguous health gains among patient groups for whom the drugs are indicated, the opportunity costs could conceivably lead to a reduction in aggregate health gains, or failure to meet different kinds of equity considerations. The pertinent policy question is where to find the resources to fund new innovations, such as cost-effective pharmaceuticals, or drugs targeting severe diseases. It may be a matter of redeployment of resources across healthcare sectors, cancelling the funding of (older) pharmaceuticals that are less cost effective, or delisting drugs that are cost effective but target less burdensome conditions. PMID:17803332

  15. Places of pharmaceutical knowledge-making: global health, postcolonial science, and hope in South African drug discovery.

    PubMed

    Pollock, Anne

    2014-12-01

    This article draws on ethnographic research at iThemba Pharmaceuticals, a small South African startup pharmaceutical company with an elite international scientific board. The word 'iThemba' is Zulu for 'hope', and so far drug discovery at the company has been essentially aspirational rather than actual. Yet this particular place provides an entry point for exploring how the location of the scientific knowledge component of pharmaceuticals--rather than their production, licensing, or distribution--matters. The article explores why it matters for those interested in global health and postcolonial science, and why it matters for the scientists themselves. Consideration of this case illuminates limitations of global health frameworks that implicitly posit rich countries as the unique site of knowledge production, and thus as the source of unidirectional knowledge flows. It also provides a concrete example for consideration of the contexts and practices of postcolonial science, its constraints, and its promise. Although the world is not easily bifurcated, it still matters who makes knowledge and where. PMID:25608441

  16. Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era.

    PubMed

    Ferreira, Ana P; Tobyn, Mike

    2015-08-01

    In the pharmaceutical industry, chemometrics is rapidly establishing itself as a tool that can be used at every step of product development and beyond: from early development to commercialization. This set of multivariate analysis methods allows the extraction of information contained in large, complex data sets thus contributing to increase product and process understanding which is at the core of the Food and Drug Administration's Process Analytical Tools (PAT) Guidance for Industry and the International Conference on Harmonisation's Pharmaceutical Development guideline (Q8). This review is aimed at providing pharmaceutical industry professionals an introduction to multivariate analysis and how it is being adopted and implemented by companies in the transition from "quality-by-testing" to "quality-by-design". It starts with an introduction to multivariate analysis and the two methods most commonly used: principal component analysis and partial least squares regression, their advantages, common pitfalls and requirements for their effective use. That is followed with an overview of the diverse areas of application of multivariate analysis in the pharmaceutical industry: from the development of real-time analytical methods to definition of the design space and control strategy, from formulation optimization during development to the application of quality-by-design principles to improve manufacture of existing commercial products. PMID:24641280

  17. COORDINATING ON LOWER PRICES: PHARMACEUTICAL PRICING

    E-print Network

    Sadoulet, Elisabeth

    health care reform discussions in 1993, large-scale efforts to curb drug prices were debated and seemed;2 potential policy changes. For instance, the drug companies could have lowered vaccine prices in 1993

  18. [Impact Reimbursement Act on the pharmaceutical market in Poland].

    PubMed

    Giermaziak, Wojciech

    2014-04-01

    According to 12 may 2011 Reimbursement Act, the new regulations were introduced related to changes in so far in force rules on refunds of official prices and margins for drugs, foodstuffs of special purpose and medical products. After year of functioning of this regulation, in evaluation of the government, law gave measurable financial effects for public payer, sometimes through drastic actions, connected the of reduction of existing profits of manufacturers sector and importers drugs, as well wholesale and retail, both in treatment open and closed. Parallel to research and analysis of effects introduction in life act refund, conducted by government, to target current regulation possible negative phenomena can to be after-effects to regulation, systematically there are conducted analogous study to reputable companies specialized in evaluation and updating market Polish pharmaceutical, such as IMS Health Polska, Pharma Expert, Kamsoft, WHO and European a law firm. In their opinion to reimbursement act is the most serious regulation control system to introduced into Polish order legal, and first time for many years on such a large scale. Thoroughly changed policy of drugs State have important influence for all participants Polish pharmaceutical market, both those directly related to the drug trade, as the functioning doctors and health condition and financial Polish patient. Change in the way prices of drugs is determined as flexible to price formation mechanism, combining drugs similar profile pharmacological in so group limits and dependence of the level of refunds from application drug accordingly characteristics medicinal product, adaptation solutions to new law refund to the existing law about health services, gave measurable financial effect for the public payer. Rationalization expenses to NFZ, as main premise introduction refund act, created to broader than so far possibility to use new molecules of drugs, and the latest medical technology, even if in the revised or new drug programs. Important implications for even Polish image in Europe, especially from the point of view of cohesion policy and application to directive transparency EU have introduction refund act in context to introduction clear, transparent and verifiable procedures used with creating drug pricing mechanisms, foodstuffs of special purpose and medical product. PMID:24868902

  19. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2012-01-01

    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: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients. PMID:22894011

  20. Development, validation and transfer of a Near Infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product

    Microsoft Academic Search

    Antonio Peinado; Jonathan Hammond; Andrew Scott

    2011-01-01

    Pharmaceutical companies are progressively adopting and introducing the principles of Quality by Design with the main purpose of assurance and built-in quality throughout the whole manufacturing process. Within this framework, a Partial Least Square (PLS) model, based on Near Infrared (NIR) spectra and humidity determinations, was built in order to determine in-line the drying end point of a fluidised bed

  1. Occurrence and Fate of Human Pharmaceuticals in the Environment

    Microsoft Academic Search

    Sara C. Monteiro; Alistair B. A. Boxall

    \\u000a Pharmaceuticals from a wide spectrum of therapeutic classes are used in human medicine worldwide. Pharmaceutically active\\u000a compounds are defined as substances used for prevention, diagnosis or treatment of a disease and for restoring, correcting\\u000a or modifying organic functions (Daughton and Ternes 1999). Pharmaceuticals include more than 4000 molecules with different\\u000a physico-chemical and biological properties and distinct modes of biochemical action

  2. Assessment of Pharmaceuticals Fate in a Model Environment

    Microsoft Academic Search

    Xavier Domènech; Marc Ribera; José Peral

    2011-01-01

    A multiphase model based on the Mackay-type level II fugacity model has been used to predict the behaviour and final environmental\\u000a concentrations of some of the more consumed pharmaceuticals in Spain. The model takes into account the mean rate of consumption\\u000a of pharmaceuticals, the percentage of pharmaceutical metabolised, the formation of the corresponding glucuronide, which is\\u000a assumed to be hydrolysed

  3. Pharmaceuticals and Personal Care Products in the Environment

    Microsoft Academic Search

    Gheorghe Duca; Veaceslav Boldescu

    Various problems concerning the pharmaceutical and personal care products (PPCPs) in the environment of the Eastern European\\u000a countries are described. The main classes of PPCPs in the environment, as well as major occurrence pathways and PPCPs fate,\\u000a are depicted. The influence of specifics of the regional pharmaceutical market, medication consumption culture and pharmaceutical\\u000a waste disposal techniques on environmental pollution with

  4. Can poison control data be used for pharmaceutical poisoning surveillance?

    Microsoft Academic Search

    Christopher A Naun; Cody S Olsen; J Michael Dean; Lenora M Olson; Lawrence J Cook; Heather T Keenan

    2011-01-01

    ObjectiveTo determine the association between the frequencies of pharmaceutical exposures reported to a poison control center (PCC) and those seen in the emergency department (ED).DesignA statewide population-based retrospective comparison of frequencies of ED pharmaceutical poisonings with frequencies of pharmaceutical exposures reported to a regional PCC. ED poisonings, identified by International Classification of Diseases, Version 9 (ICD-9) codes, were grouped into

  5. Pharmaceutical Companies’ Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination

    PubMed Central

    Abiola, Sara; Colgrove, James

    2012-01-01

    Objectives. We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders’ perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry. Methods. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations. Results. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case. Conclusions. Although policymakers acknowledge the utility of manufacturers’ involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines. PMID:22420796

  6. 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…

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

    PubMed

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

    2014-01-01

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

  8. Sunshine Power Company MEA

    NSDL National Science Digital Library

    Kerri Caudill

    2012-08-03

    This Model Eliciting Activity (MEA) is written at a 4th grade level. In this open-ended problem, students must consider how to rank wind companies based on factors like windiness, noise levels, and power output. In teams, students determine their procedures and write letters back to the client.

  9. Gibson Insurance Company

    Microsoft Academic Search

    Mark Haskins; Kristy Lilly; Liz Smith

    This case provides students with an opportunity to practice a set of activity-based costing calculations. More importantly, it provides an instructor with the opportunity to challenge students to think about and to discuss the rationale used by the case protagonist to revise the means by which the company allocates corporate support costs to the product lines and to the business

  10. Aurora Textile Company

    Microsoft Academic Search

    Kenneth Eades; Lucas Doe

    This case asks the student to decide whether Aurora Textile Company can create value by upgrading its spinning machine to produce higher-quality yarn that sells for a higher margin. Cost information allows the student to produce cash-flow projections for both the existing spinning machine and the new machine. The cash flows have many different cost components, including depreciation, the number

  11. [Company Name] [Street Address

    E-print Network

    Weaver, Harold A. "Hal"

    [Company Name] [Street Address] [City, ST ZIP Code] Phone [phone] FIXED PRICE INVOICE INVOICE #[100 Building Baltimore, MD 21218-2685 PAYMENT TO: [Recipient Name] [Address] [City, ST and ZIP Code] [Phone FOR QUESTIONS CONCERNING THIS INVOICE ­ NAME, PHONE AND FAX NUMBER AND E-ADDRESS. Certification

  12. Mechanical Engineer Company Description

    E-print Network

    Kostic, Milivoje M.

    Mechanical Engineer Company Description Control Solutions Inc. is a small, dynamic, and rapidly. Position Description The Mechanical Engineer is responsible for all aspects associated with the mechanicalE Mechanism, when applicable. · Perform static, dynamic, vibration, thermal, and other engineering analysis

  13. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    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: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format. PMID:21699061

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

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

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

  15. Globalization in the pharmaceutical industry, Part I.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

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

  16. Globalization in the pharmaceutical industry, Part II.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

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

  17. Health care reform and the pharmaceutical industry.

    PubMed

    Mossinghoff, G J

    1994-08-01

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

  18. Price regulation of pharmaceuticals in Canada.

    PubMed

    Anis, A H; Wen, Q

    1998-01-01

    Patent holding pharmaceutical firms are modeled as price-discriminating international monopolies. In an unregulated world market, firms set monopoly prices in each national market. Three types of regulatory rules: (i) 'reasonable' relationship rule, (ii) international price comparison rule, and, (iii) therapeutic class comparison rule, are examined. While price regulation may lead to lower introductory prices for new drugs, the price of existing drugs may increase. Domestic price regulation may increase foreign prices. Canadian data supported the model's predictions. Policy makers should anticipate these responses that affects the entire vector of drug prices and not just those subject to specific regulations. PMID:10176313

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

    PubMed

    Arnold, Denis G; Oakley, James L

    2013-06-01

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

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

    NASA Astrophysics Data System (ADS)

    Kartono, R.; Basuki, Y. T.

    2014-03-01

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

  1. Examining the Process of Developing a Research-Based Mathematics Curriculum and Its Policy Implications

    ERIC Educational Resources Information Center

    Superfine, Alison Castro; Kelso, Catherine Randall; Beal, Susan

    2010-01-01

    The implementation of "research-based" mathematics curricula is increasingly becoming a central element of mathematics education reform policies. Given the recent focus on grounding mathematics curriculum policies in research, it is important to understand precisely what it means for a curriculum to be research-based. Using the Curriculum Research…

  2. Development of Research-Based Protocol Aligned to Predict High Levels of Teaching Quality

    ERIC Educational Resources Information Center

    Schumacher, Gary; Grigsby, Bettye; Vesey, Winona

    2011-01-01

    This study proposes a research-based teacher selection protocol. The protocol is intended to offer school district hiring authorities a tool to identify teacher candidates with the behaviors expected to predict effective teaching. It is hypothesized that a particular series of research-based interview questions focusing on teaching behaviors in…

  3. Using In-Service and Coaching to Increase Teachers' Accurate Use of Research-Based Strategies

    ERIC Educational Resources Information Center

    Kretlow, Allison G.; Cooke, Nancy L.; Wood, Charles L.

    2012-01-01

    Increasing the accurate use of research-based practices in classrooms is a critical issue. Professional development is one of the most practical ways to provide practicing teachers with training related to research-based practices. This study examined the effects of in-service plus follow-up coaching on first grade teachers' accurate delivery of…

  4. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ...International Society of Pharmaceutical Engineering (ISPE), is...a Culture of Quality'' Pharmaceutical Quality System (ICH Q10...and will draw on the best industry and regulator contributors...International Society for Pharmaceutical Engineering, 600...

  5. 75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ...for reducing or avoiding pharmaceutical waste; Practices for...managing types of unused pharmaceuticals; and Applicable disposal...help reduce the amount of pharmaceuticals that are discharged to water...organizations in the health care industry, as well as federal,...

  6. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-02

    ...Guidance for Industry on Regulatory...Classification of Pharmaceutical Co-Crystals...guidance for industry entitled...Classification of Pharmaceutical Co-Crystals...guidance for industry entitled...Classification of Pharmaceutical...

  7. 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

    ...Use (ICH) entitled ``Pharmaceutical Quality System (ICH Q10...Systems and Processes for Pharmaceutical Manufacturing.'' The...that have implemented a Pharmaceutical Quality System across the...conference will draw on the best industry and regulator...

  8. 76 FR 78259 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ...is the second-largest generic pharmaceutical manufacturer in the United States...27 years of experience in the pharmaceutical industry. He has extensive experience in areas such as pharmaceutical research and development,...

  9. 76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ...Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY...Pharmaceutical Science and Clinical Pharmacology. General Function of the...Pharmaceutical Science and Clinical Pharmacology (ACPS-CP) meeting,...

  10. Extracting company names from text

    Microsoft Academic Search

    Lisa F. Rau

    1991-01-01

    A detailed description is given of an implemented algorithm that extracts company names automatically from financial news. Extracting company names from text is one problem; recognizing subsequent references to a company is another. The author addresses both problems in an implemented, well-tested module that operates as a detachable process from a set of natural language processing tools. She implements a

  11. Company Annual Reports Online (CAROL)

    NSDL National Science Digital Library

    Company Annual Reports Online (CAROL) is a free corporate service offering direct links to the annual reports of a variety of European companies. The reports are arranged in alphabetical order by company name or industry type for direct searches or browsing. In addition, recent articles and statistics on Investor Relations and the Internet are available from CAROL's The Marketplace index.

  12. 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…

  13. Company profile: tengion.

    PubMed

    Bertram, Timothy

    2009-05-01

    Founded in 2005, Tengion is a clinical-stage organ regeneration company with products in urologic, vascular and renal regeneration based on its proprietary Autologous Organ Regeneration Platform. Tengion uses biocompatible materials and a patient's own (autologous) cells to assemble neo-organs or neo-tissues that are designed to catalyze the body's innate ability to regenerate. Tengion is a fully-integrated organization, with scalable US and European manufacturing and distribution capabilities, experienced research, development, clinical and commercial teams, and significant intellectual property. The company's corporate headquarters and commercial manufacturing facility are in East Norriton, PA, USA, and its research offices, a development laboratory and a pilot manufacturing facility are located in Winston-Salem, NC, USA. Tengion's product candidates may ultimately address the most critical problems facing organ and tissue failure patients, enabling people to lead healthier lives without donor transplants or the side effects of related therapies. PMID:19438309

  14. Uptake of human pharmaceuticals by plants grown under hydroponic conditions

    Microsoft Academic Search

    Patrick A. Herklotz; Prakash Gurung; Brian Vanden Heuvel; Chad A. Kinney

    2010-01-01

    Cabbage (Brassica rapa var. pekinensis) and Wisconsin Fast Plants (Brassica rapa) were chosen for a proof of concept study to determine the potential uptake and accumulation of human pharmaceuticals by plants. These plants were grown hydroponically under high-pressure sodium lamps in one of two groups including a control and test group exposed to pharmaceuticals. The control plants were irrigated with

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

    ERIC Educational Resources Information Center

    Hepler, Charles D.

    1987-01-01

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

  16. Fixed Budgets as a Cost Containment Measure for Pharmaceuticals

    Microsoft Academic Search

    David Granlund; Niklas Rudholm; Magnus Wikström

    2004-01-01

    In the county of Västerbotten, Sweden, there are two health centres which (contrary to all other health centres in the region) have a strict responsibility over their pharmaceutical budget. The purpose of this paper is to examine if the prices and quantities of pharmaceuticals prescribed by physicians working at these health centres differ significantly from those prescribed by physicians at

  17. Fixed budgets as a cost containment measure for pharmaceuticals

    Microsoft Academic Search

    David Granlund; Niklas Rudholm; Magnus Wikström

    2006-01-01

    In Västerbotten County, Sweden, there are two health centers which (in contrast to all other health centers in the region) bear strict responsibility over their pharmaceutical budget. This study examined whether the prices and quantities of pharmaceuticals prescribed by physicians working at these health centers differ significantly from those prescribed by physicians at health centers with open-ended budgets. Estimation results

  18. Removal of pharmaceuticals and fragrances in biological wastewater treatment

    Microsoft Academic Search

    Adriano Joss; Elvira Keller; Alfredo C. Alder; Anke Göbel; Christa S. McArdell; Thomas Ternes; Hansruedi Siegrist

    2005-01-01

    The removal of seven pharmaceuticals and two fragrances in the biological units of various full-scale municipal wastewater treatment plants was studied. The observed removal of pharmaceuticals was mainly due to biological transformation and varied from insignificant (90% (ibuprofen). However, no quantitative relationship between structure and activity can be set up for the biological transformation. Overall, it can be concluded that

  19. Biotechnology, nanotechnology, and pharmacogenomics and pharmaceutical compounding, Part 1.

    PubMed

    Allen, Loyd V

    2015-01-01

    The world of pharmaceuticals is changing rapidly as biotechnology continues to grow and nanotechnology appears on the horizon. Biotechnology is gaining in importance in extemporaneous pharmaceutical compounding, and nanotechnology and pharmacogenomics could drastically change the practice of pharmacy. This article discusses biotechnology and the factors to consider when compounding biotechnology drugs. PMID:25902626

  20. Ways of Learning in the Pharmaceutical Sales Industry

    ERIC Educational Resources Information Center

    Hunter, Carrie Patricia

    2010-01-01

    Purpose: The purpose of this paper is to document the ways pharmaceutical representatives learn for work and report attributes of (in)formality and other characteristics of ways of learning perceived as effective and frequently used. Design/methodology/approach: A total of agents 20 from 11 pharmaceutical manufacturers across Canada participated…

  1. Pharmaceutical Sales--An Experiential Learning Elective Course.

    ERIC Educational Resources Information Center

    Scribner, William; And Others

    1979-01-01

    To provide an opportunity for pharmacy students to acquire a better understanding of the medical service representative's functions as a member of the pharmaceutical industries' marketing force, a practice experience elective course in pharmaceutical sales was developed at the University of Cincinnati. Course planning and implementation are…

  2. Significance of pharmaceutical excipients in prescribed medicines: a case report

    PubMed Central

    Maharaj, Sandeep; Pandey, Sureshwar; Maharaj, Keshwar; Sheik, Meera Sharief; Dhingra, Sameer

    2014-01-01

    Key Clinical Message Pharmaceutical excipients need careful observation as they play a significant role in treatment outcomes. It is imperative for a physician to collect complete patient profile before prescribing new medications for current treatment. We present a case report on the significance of pharmaceutical excipients in prescribed medicines. PMID:25548626

  3. The importance of the pharmaceutical industry to the UK economy

    Microsoft Academic Search

    Alan Earl-Slater

    1998-01-01

    The objective of this paper is to indicate the importance of the pharmaceutical industry to the UK economy. Data on various aspects of the industry are presented and examined. As background information a collection of policies and pressures on the pharmaceutical environment are identified and discussed. The evidence shows what the UK economy stands to lose if it loses its

  4. Effects of pharmaceuticals on Daphnia survival, growth, and reproduction.

    PubMed

    Flaherty, Colleen M; Dodson, Stanley I

    2005-10-01

    Pharmaceuticals have been globally detected in surface waters, and the ecological impacts of these biologically-active, ubiquitous chemicals are largely unknown. To evaluate the aquatic toxicity of individual pharmaceuticals and mixtures, we performed single species laboratory toxicity tests with Daphnia magna, a common freshwater zooplankton. We conducted acute (6-day) and chronic (30-day) exposure pharmaceutical bioassays and evaluated survivorship and morphology of adults and neonates, adult length, resting egg production, brood size (fecundity), and the proportion of male broods produced (sex ratio). In general, exposure to a single pharmaceutical in the 1-100 microg/l range yielded no apparent effects on the normal life processes of Daphnia. However, chronic fluoxetine exposure (36 microg/l) significantly increased Daphnia fecundity, and acute clofibric acid exposure (10 microg/l) significantly increased sex ratio. A mixture of fluoxetine (36 microg/l) and clofibric acid (100 microg/l) caused significant mortality; the same fluoxetine concentration mixed with 10 microg/l clofibric acid resulted in significant deformities, including malformed carapaces and swimming setae. Mixtures of three to five antibiotics (total antibiotic concentration 30-500 microg/l) elicited changes in Daphnia sex ratio. We conclude: (1) individual and mixtures of pharmaceuticals affect normal development and reproduction of Daphnia magna, (2) aquatic toxicity of pharmaceutical mixtures can be unpredictable and complex compared to individual pharmaceutical effects, and (3) timing and duration of pharmaceutical exposure influence aquatic toxicity. PMID:16168743

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

    PubMed

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

    2013-03-24

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

  6. Diffuse pollution of surface water by pharmaceutical products

    Microsoft Academic Search

    J. G. M. Derksen; G. B. J. Rijs; R. H. Jongbloed

    2004-01-01

    Pharmaceutical products for humans or animals, as well as their related metabolites (degradation products) end up in the aquatic environment after use. Recent investigations from abroad show that low concentrations of pharmaceuticals are detectable in municipal waste water, surface water, groundwater and even drinking water. Little is known about the effects, and with that the risk, of long term exposure

  7. Comparing pharmaceutical and pesticide loads into a small Mediterranean river

    Microsoft Academic Search

    Laetitia Comoretto; Serge Chiron

    2005-01-01

    During 2003\\/2004, water samples were collected upstream and downstream of two wastewater treatment plant (WWTP) outlets in order to determine the contribution of urban centres to concentration of selected pharmaceuticals (antiphlogistics, lipid regulators and carbamazepine) and pesticides into a Mediterranean river basin (Arc river, Aix en Provence, France). Pharmaceutical loads were compared to pesticide ones. They could be nearly regarded

  8. Pharmaceuticals and PCPs in groundwater: Results from French National screening

    E-print Network

    Paris-Sud XI, Université de

    personal care products and life style products, caffeine is the most frequently OC detected (40 potential uses and origins. Among the 411 Organic compounds (OC) targeted, 131 pharmaceutical products, 13 and pharmaceuticals to surface water ecosystems. Environ Toxicol Chem, 2008. 27(12): p. 2457-68. hal-00949271,version1

  9. Cary Institute of Ecosystem Studies 1 INVESTIGATING INTERACTIONS AMONG PHARMACEUTICAL

    E-print Network

    Lovett, Gary M.

    Cary Institute of Ecosystem Studies 1 INVESTIGATING INTERACTIONS AMONG PHARMACEUTICAL COMPOUNDS Studies, Box AB, Millbrook NY, 12545 Abstract. Pharmaceutical and personal care products (PPCPS) are any products used by people for health, or cosmetic reasons or for veterinary purposes. Trace amounts of PPCPs

  10. Occurrence of veterinary pharmaceuticals in the aquatic environment in Flanders

    Microsoft Academic Search

    K. Servaes; G. Vanermen; P. Seuntjens

    2009-01-01

    There is a growing interest in the occurrence of pharmaceuticals in the aquatic environment. Pharmaceuticals are classified as so-called `emerging pollutants'. `Emerging pollutants' are not necessarily new chemical compounds. Often these compounds are already present in the environment for a long time. But, their occurrence and especially their impact on the environment has only recently become clear. Consequently, data on

  11. The Chemical and Pharmaceutical Industry Susan Brench (1984)

    E-print Network

    Goldschmidt, Christina

    1984-01-01

    The Chemical and Pharmaceutical Industry Susan Brench (1984) If you have any questions, or would like to ask for some careers advice about working in the Chemical Manufacturing industry from Susan:alumnae@murrayedwards.cam.ac.uk The products and services of the chemical and pharmaceutical industry deliver clean water, vital medicines

  12. Good Manufacturing Practice for Investigational Pharmaceutical Products in Japan

    Microsoft Academic Search

    Kunio Kawamura

    1994-01-01

    Good manufacturing practice (GMP) is essential in the manufacturing of pharmaceuticals used in the investigational stage as well as in the manufacturing of commercial products. GMP at the investigational new drug (IND) stage is now being studied by government and industry. Several characteristics inherent to the manufacturing of pharmaceuticals used for clinical trials should be taken into consideration and focused

  13. Effluent from drug manufactures contains extremely high levels of pharmaceuticals

    Microsoft Academic Search

    D. G. Joakim Larsson; Cecilia de Pedro; Nicklas Paxeus

    2007-01-01

    It is generally accepted that the main route for human pharmaceuticals to the aquatic environment is via sewage treatment plants receiving wastewater from households and hospitals. We have analysed pharmaceuticals in the effluent from a wastewater treatment plant serving about 90 bulk drug manufacturers in Patancheru, near Hyderabad, India—a major production site of generic drugs for the world market. The

  14. Pharmaceutical Cocrystallization: Engineering a Remedy for Caffeine Hydration

    E-print Network

    de Gispert, Adrià

    Pharmaceutical Cocrystallization: Engineering a Remedy for Caffeine Hydration Andrew V. Trask, W. D pharmaceutical compound caffeine to prepare a cocrystal that, unlike caffeine, is physically stable at all relative humidities (RH). Six cocrystal materials containing caffeine with one of several dicarboxylic

  15. Pharmaceutical Concern and Prioritization Framework for Aquatic Life Effects

    EPA Science Inventory

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

  16. [The development of the Japanese pharmaceutical industry (part 7). Histories of medical advertisements from Taisho Era till Showa Era].

    PubMed

    Takehara, J; Yamada, H

    1999-01-01

    Medical advertisements in newspapers have been used quite often as a means of sales promotion since the Meiji Era. Medical advertisements were quantitatively the leading advertisements in Japanese newspapers from the Taisho Era to early in the Showa Era. When World War II broke out, the quanity of advertisements in newspapers decreased markedly. After the war ended, the quantity of radio commercials for medicine increased quite rapidly. In the 1960s, however, pharmaceutical companies were criticized for over-promoting and improperly using medicines. PMID:11624347

  17. Prioritizing veterinary pharmaceuticals for aquatic environment in Korea.

    PubMed

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

    2008-09-01

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

  18. Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters

    PubMed Central

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

    2014-01-01

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

  19. IRRIGATION FOR VACCINE PRODUCTION IN PHARMACEUTICAL TOBACCO

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  20. Graduate School of Pharmaceutical Sciences, Laboratory of Chemical Pharmacology Action-Potential Modulation During Axonal Conduction

    E-print Network

    Imai, Hiroshi

    2010-1-31 Graduate School of Pharmaceutical Sciences, Laboratory of Chemical Pharmacology Action) Laboratory of Chemical Pharmacology Graduate School of Pharmaceutical Sciences The University of Tokyo

  1. Lean supply chain in pharmaceutical industry : modeling and simulation of a SAP environment

    E-print Network

    Hou, Billy

    2011-01-01

    The global pharmaceutical business environment has been rapidly changing and has more competitive. Competition in pharmaceutical industry extended far beyond the traditional battle field, research and development. Bayer ...

  2. Company Name Company Website Company Type BergerABAM www.abam.com Civil & Environmental Engineering

    E-print Network

    Company Name Company Website Company Type BergerABAM www.abam.com Civil & Environmental Engineering.geosyntec.com Environmental Consulting Gray & Osborne, Inc. www.g-o.com Consulting Engineers Guy F. Atkinson Construction, LLC BP www.bp.com/uscollegecareers Oil & Gas CDM www.cdm.com Full services Engineering DCI Engineers www.dci-engineers

  3. 75 FR 71417 - 2010 Company Organization Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ...companies report only on basic company affiliation and operations of...years, all multi-establishment companies with 250 or more employees report survey information. Also, groups of smaller companies that are divided into...

  4. 78 FR 64911 - 2013 Company Organization Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ...companies report only on basic company affiliation and operations of...years, all multi- establishment companies with 250 or more employees report survey information. Also, groups of smaller companies that are divided into...

  5. 76 FR 62759 - 2011 Company Organization Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ...companies report only on basic company affiliation and operations of...years, all multi- establishment companies with 250 or more employees report survey information. Also, groups of smaller companies that are divided into...

  6. Human pharmaceutical products in the environment - the "problem" in perspective.

    PubMed

    Taylor, David; Senac, Thomas

    2014-11-01

    Concerns about the potential for significant environmental impact from residues of human pharmaceuticals emerged at the beginning of the 21st century. Since then there has been an exponential rise in the number of publications and conferences on this "problem". However, this intense focus on human pharmaceuticals is misplaced. Pharmaceuticals do not consist of a coherent group of substances with similar chemical, structural, biological or toxicological properties. Pharmaceuticals are only identifiable from their use: in other words substances can be divided into two classes, those that are used as pharmaceuticals and those for which a possible pharmaceutical use has not yet been discovered. For example, nitro-glycerine, Warfarin and dimethyl fumarate, initially sold respectively as an explosive, a rodenticide and a mould inhibitor have subsequently all been used as pharmaceuticals. As analytical science advances, an increasing range of environmental contaminants, including pharmaceuticals, is being identified at sub ?gL(-1) concentrations. Although, human and environmental exposure to these contaminants will be low, all of them need to be subjected to risk assessment on a case by case basis. Many of these substances, including human pharmaceuticals, may have little, if any, impact on human health or the environment, however for some substances there may be a significant risk and in these cases appropriate action should be taken. However considering all human pharmaceuticals as a special case, isolated from the wider range of emerging contaminants, is scientifically unjustifiable and diverts resources away from the consideration of other substances that may be of considerably more significance. PMID:24525259

  7. Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review

    Microsoft Academic Search

    David Gunnell; Julia Saperia; Deborah Ashby

    2005-01-01

    Objective To investigate whether selective serotonin reuptake inhibitor (SSRI) antidepressants are associated with an increased risk of suicide related outcomes in adults. Design Meta-analysis of randomised controlled trials of SSRIs compared with placebo in adults submitted by pharmaceutical companies to the safety review of the Medicines and Healthcare products Regulatory Agency (MHRA). Participants Over 40 000 individuals participating in 477

  8. The determinants of pricing in pharmaceuticals: are US prices really so high?

    PubMed

    Cabrales, Antonio; Jiménez-Martín, Sergi

    2013-11-01

    This paper studies price determination in pharmaceutical markets using data for 25 countries, 6?years, and a comprehensive list of products from the MIDAS IMS database. A key finding is that the USA has prices that are not significantly higher than those of countries with similar income levels, especially those that are 'lightly regulated'. More importantly, price differences to the US levels increase for 'branded', world top selling, or innovative products, and decrease, regardless of the level of regulation for mature or widely diffused molecules. Because prices for top selling molecules may be easier to perceive and recollect and more important for companies, they may bias the public discussion about international price differences. PMID:23303712

  9. [Adaptation possibility of chosen aspects of pharmaceutical marketing for realization of promotion in health care].

    PubMed

    Syrycki, Marek

    2002-01-01

    Reform of health service in Poland introduced reliable economic bill and elements of competition among its subjects as well. It created a new situation both for doctors and managers of health service. Need of search for rules and ways of competition exists at present among institutions of health care. Certain solutions can be modelled on the example of pharmaceutical companies already present on the market. As an example of such activities, which they can be applied directly in this new situation may serve so called personal sale and related to it case of institutions the best direct contact between the next but more controversial form of marketing activities worth spreading. The use of direct marketing and advertisements carries most problems with itself. This latter should be easier to accept when it selects an important social aim. PMID:15002289

  10. A decade of innovation in pharmaceutical R&D: the Chorus model.

    PubMed

    Owens, Paul K; Raddad, Eyas; Miller, Jeffrey W; Stille, John R; Olovich, Kenneth G; Smith, Neil V; Jones, Rosie S; Scherer, Joel C

    2015-01-01

    Chorus is a small, operationally independent clinical development organization within Eli Lilly and Company that specializes in drug development from candidate selection to clinical proof of concept. The mission of Chorus is to achieve proof of concept rapidly and at a low cost while positioning successful projects for 'pharma-quality' late-stage development. Chorus uses a small internal staff of experienced drug developers and a network of external vendors to design and implement chemistry, manufacturing and control processes, preclinical toxicology and biology, and Phase I/II clinical trials. In the decade since it was established, Chorus has demonstrated substantial productivity improvements in both time and cost compared to traditional pharmaceutical research and development. Here, we describe its development philosophy, organizational structure, operational model and results to date. PMID:25503514

  11. Pharmaceutical regulation in the European Community: barriers to single market integration.

    PubMed

    Orzack, L H; Kaitin, K I; Lasagna, L

    1992-01-01

    The European Community (EC) plans to create a single market for pharmaceutical medicines, but the drug industry is closely linked to cultural and societal values concerning health; to the national regulatory agencies responsible for the evaluation of safety, quality, and efficacy of new drugs; to multinational and domestic companies competing in national and international markets; and to varied interest groups of professionals and consumers organized along national and multinational lines. We review the history of the EC's policy proposals, examine reactions from all these interested parties, and assess the prospects for integration into a single market. The contentious debate that continues among the parties over national prerogatives, industrial interests, professional mandates, and consumer concerns clouds the prospects for a system of centralized drug registration that will be acceptable to all EC member states. PMID:1299692

  12. Attitudes of internal medicine faculty and residents toward professional interaction with pharmaceutical sales representatives.

    PubMed

    McKinney, W P; Schiedermayer, D L; Lurie, N; Simpson, D E; Goodman, J L; Rich, E C

    1990-10-01

    We surveyed faculty and residents from seven hospitals affiliated with three academic internal medicine training programs about their perceptions of the informational and service benefits vs the risks of ethical compromise involved in interactions with pharmaceutical sales representatives. Questionnaires were returned by 467 (81%) of 575 physicians surveyed. Residents and faculty generally had somewhat negative attitudes toward the educational and informational value of detailing activities at their institutions but indicated that representatives supported important conferences and speakers. Residents were more likely than faculty to perceive contacts with sales representatives as potentially influencing physician decision making. Sixty-seven percent of faculty and 77% of residents indicated that physicians could be compromised by accepting gifts. More than half of the physicians who suggested that such compromise was possible indicated that acceptance of gifts worth more than +100 from drug companies would be likely to compromise a physician's independence and objectivity. A majority of both faculty and house staff favored eliminating presentations by pharmaceutical representatives at their hospitals. Only 10% thought they had had sufficient training during medical school and residency regarding professional interaction with sales representatives. PMID:2398609

  13. Pharmaceutical services in the United States Navy.

    PubMed

    Bayles, B C; Hall, G E; Hostettler, C; Gibson, J; Woker, D R

    1997-04-01

    The status of pharmaceutical services in the United States Navy is described. In support of operational forces, pharmacists serve on hospital ships and in tent-based-fleet hospitals. The Navy has a long-term commitment to ensuring that its pharmacists receive postgraduate education and training; each year, pharmacists are selected for specific programs. Pharmacy technicians in the Navy have considerably more responsibility than their civilian counterparts; all complete a 23-week course, and many are board certified. Increasingly, Navy pharmacists provide pharmacokinetic services, counsel patients, serve as an information resource for provides, work in pharmacist-managed clinics, develop clinical pathways, and evaluate drug therapy. Automation and computerization are viewed as answers to challenges created by continued "rightsizing" of the staff and fiscal restraints. A project is under way that will consolidate historical and current patient information for improved clinical decision-making. The scope of Navy pharmacy practice is expanding dramatically. PMID:9099344

  14. Cancer nanoimmunotherapy using advanced pharmaceutical nanotechnology.

    PubMed

    Li, Wei; Wei, Huafeng; Li, Huafei; Gao, Jie; Feng, Si-Shen; Guo, Yajun

    2014-11-01

    Immunotherapy is a promising option for cancer treatment that might cure cancer with fewer side effects by primarily activating the host's immune system. However, the effect of traditional immunotherapy is modest, frequently due to tumor escape and resistance of multiple mechanisms. Pharmaceutical nanotechnology, which is also called cancer nanotechnology or nanomedicine, has provided a practical solution to solve the limitations of traditional immunotherapy. This article reviews the latest developments in immunotherapy and nanomedicine, and illustrates how nanocarriers (including micelles, liposomes, polymer-drug conjugates, solid lipid nanoparticles and biodegradable nanoparticles) could be used for the cellular transfer of immune effectors for active and passive nanoimmunotherapy. The fine engineering of nanocarriers based on the unique features of the tumor microenvironment and extra-/intra-cellular conditions of tumor cells can greatly tip the triangle immunobalance among host, tumor and nanoparticulates in favor of antitumor responses, which shows a promising prospect for nanoimmunotherapy. PMID:25490427

  15. The pharmaceutical death-ride of dihydroartemisinin

    PubMed Central

    2010-01-01

    In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV), can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements? PMID:20649950

  16. The ethics and economics of pharmaceutical pricing.

    PubMed

    Parker-Lue, Sara; Santoro, Michael; Koski, Greg

    2015-01-01

    The cost of drugs is a major and rapidly rising component of health-care expenditures. We survey recent literature on the ethics and economics of skyrocketing pharmaceutical prices and find that advances in economic research have increased the sharpness and focus of the ethically based calls to increase access by modifying patent protection and reducing prices. In some cases, research supports ethical arguments for broader access. Other research suggests that efforts to broaden access result in unintended consequences for innovation and the medical needs of patients. Both ethicists and economists need to be more cognizant of the real clinical settings in which physicians practice medicine with real patients. Greater cross-disciplinary interaction among economists, ethicists, and physicians can help reduce the disjunction between innovation and access and improve access and patient care. This dialogue will impact private industry and may spur new multistakeholder paradigms for drug discovery, development, and pricing. PMID:25149920

  17. Are pharmaceutical patents protected by human rights?

    PubMed

    Millum, J

    2008-11-01

    The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. PMID:18974405

  18. Voltammetric assay of Guaifenesin in pharmaceutical formulation.

    PubMed

    Tapsoba, I; Belgaied, J-E; Boujlel, K

    2005-06-01

    The electrochemical oxidation of Guaifenesin in a pharmaceutical formulation containing Guaifenesin has been carried out in Britton-Robinson buffer (BRB) (0.04 mol L-1) on platinum electrode. Guaifenesin exhibits a well-defined irreversible oxidation peak at 0.924 V/ref. The influence of pH on the oxidation of Guaifenesin was studied in BRB (pH range 2-5). A method for the analysis of Guaifenesin in BRB (0.04 mol L-1, pH 2), which allows quantification over the range 20-60 microg mL-1, was proposed and successfully applied to the determination of Guaifenesin in syrup with mean recovery and relative standard deviation of 103.3% and 1.32%, respectively. PMID:15907635

  19. Ecotoxicity and genotoxicity assessment of cytostatic pharmaceuticals.

    PubMed

    Zounková, Radka; Odráska, Pavel; Dolezalová, Lenka; Hilscherová, Klára; Marsálek, Blahoslav; Bláha, Ludek

    2007-10-01

    The fate and effects of cytostatic (anticancer or antineoplastic) pharmaceuticals in the environment are largely unknown, but they can contaminate wastewater treatment effluents and consequently aquatic ecosystems. In this paper, we have focused on five cytostatic compounds used in high amounts (cyclophosphamide, cisplatin, 5-fluorouracil, doxorubicin, and etoposide), and we have investigated their ecotoxicity in bacterial Pseudomonas putida growth-inhibition test, algal Pseudokirchneriella subcapitata growth-inhibition test, and Dapnia magna acute immobilization test. Genotoxicity also was assessed with Escherichia coli SOS-chromotest (with and without metabolic activation) and the GreenScreen Assay using yeast S. cerevisiae. All tested compounds showed significant effects in most of the assays with lowest-observed-effect concentrations and concentrations causing 50% effects (EC50s) values ranging within microg/L to mg/L. The most toxic compound was 5-fluorouracil in the assays with P. putida (EC50 = 0.027 mg/L) and P. subcapitata (EC50 = 0.11 mg/L), although cisplatin and doxorubicin were the most toxic to D. magna (EC50 = 0.64 and 2.0 mg/L, respectively). These two chemicals were also the most genotoxic in the SOS-chromotest (minimum genotoxic concentrations [MGC] = 0.07-0.2 mg/L), and 5-fluorouracil was the most genotoxic in the eukaryotic yeast assay (MGC = 0.02 mg/L). Our investigation seems to indicate generally lower risks of acute effects at concentrations expected in the environment. However, some effective concentrations were relatively low and chronic toxicity of cytostatics (and/or their transformation products), as well as specific sources of human pharmaceuticals such as hospital effluents, require research attention. PMID:17867890

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

    PubMed Central

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

    2010-01-01

    Purpose To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. Methodology A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006–2008. Definition of company size was based on ranking by total revenues (Scrip’s Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). Results In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P?companies (P?=?0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P?Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development. PMID:21049297

  1. Suspended biofilm carrier and activated sludge removal of acidic pharmaceuticals.

    PubMed

    Falås, P; Baillon-Dhumez, A; Andersen, H R; Ledin, A; la Cour Jansen, J

    2012-03-15

    Removal of seven active pharmaceutical substances (ibuprofen, ketoprofen, naproxen, diclofenac, clofibric acid, mefenamic acid, and gemfibrozil) was assessed by batch experiments, with suspended biofilm carriers and activated sludge from several full-scale wastewater treatment plants. A distinct difference between nitrifying activated sludge and suspended biofilm carrier removal of several pharmaceuticals was demonstrated. Biofilm carriers from full-scale nitrifying wastewater treatment plants, demonstrated considerably higher removal rates per unit biomass (i.e. suspended solids for the sludges and attached solids for the carriers) of diclofenac, ketoprofen, gemfibrozil, clofibric acid and mefenamic acid compared to the sludges. Among the target pharmaceuticals, only ibuprofen and naproxen showed similar removal rates per unit biomass for the sludges and biofilm carriers. In contrast to the pharmaceutical removal, the nitrification capacity per unit biomass was lower for the carriers than the sludges, which suggests that neither the nitrite nor the ammonia oxidizing bacteria are primarily responsible for the observed differences in pharmaceutical removal. The low ability of ammonia oxidizing bacteria to degrade or transform the target pharmaceuticals was further demonstrated by the limited pharmaceutical removal in an experiment with continuous nitritation and biofilm carriers from a partial nitritation/anammox sludge liquor treatment process. PMID:22209263

  2. Investigation of active pharmaceutical ingredient loss in pharmaceutical compounding of capsules.

    PubMed

    D'Hondt, Matthias; Wynendaele, Evelien; Vandercruyssen, Kirsten; Bauters, Tiene; Vandenbroucke, Johan; Mullens, Steven; Vervaet, Chris; Remon, Jean Paul; De Spiegeleer, Bart

    2014-08-01

    Pharmaceutical compounding of capsules is still an important corner stone in today's health care. It allows for a more patient specific treatment plan as opposed to the "one size fits all"-approach, used by the pharmaceutical industry when producing fixed dose finished drug products. However, loss of active pharmaceutical ingredient (API) powder during pharmaceutical capsule compounding can lead to under-dosed finished drug products and annul the beneficiary therapeutic effects for the patient. The amount and location of API loss was experimentally determined during capsule compounding of five different preparations: 10 and 20mg hydrocortisone capsules, 4mg triamcinolone capsules and 0.25mg dexamethasone capsules, using a 10% m/m self-made or commercial trituration. The total API amount present in the five capsule preparations varied between 90.8% and 96.6%, demonstrating that for certain preparations, significant API mass loss occurred during the pharmaceutical compounding of capsules. Swabbing results of the different compounding equipment and working areas indicated the mortar surface as the largest API loss location. An agate mortar accounted for the least amount of API loss, whereas an extensively used porcelain mortar accounted for the highest amount of API loss. Optical microscopy and roughness (Ra) determination by profilometry of the different mortar surfaces revealed a significant influence of the mortar surface wear and tear on the observed API loss. This observation can be explained by physical deformation, or scratch formation, of the relatively soft porcelain mortar surface, in which the API particles can become adsorbed. Furthermore, a small effect of the capsulation device material on the API loss was also observed. The presence of a chemical molecule effect on the API loss was demonstrated through data mining using a set of assay results containing 17 different molecules and 1922 assay values. The 17 median assay values were modeled in function of corresponding molecular descriptors, using stepwise multiple linear regression. The obtained MLR model, containing RDF060m, R6e(+) and R3m(+) variables, explained 92.5% of the observed variability between the 17 median assay values. PMID:24727282

  3. Drug companies cut HIV drug prices in the developing world.

    PubMed

    Yamey, G

    2000-05-20

    The UN has reported that five multinational pharmaceutical companies would cut down HIV drug prices in the developing world. One of these drug companies is GlaxoWellcome, which has promised to reduce the price of zidovudine and lamivudine to US$2 in the poorest nations, a fifth of its price in the US. Although Peter Piot, director of the UN Program on HIV/AIDS, welcomed the companies' promises, he warned that price cuts alone will not curb the epidemic. He stated that this initiative is only one critical factor in what must become a much broader and more urgent effort to help people living with HIV/AIDS. Moreover, health and development agencies expressed concern that AIDS drugs will still be unaffordable for the vast majority of those in need in developing countries. In addition, poor countries lack the infrastructure to deliver these drugs safely and effectively. During the time of the UN announcement, US President Bill Clinton also signed an executive order allowing sub-Saharan Africa to adopt legal measures to obtain cheap HIV drugs. Meanwhile, South Africa's reaction to the offer to cut antiretroviral drug prices has been lukewarm. PMID:10818010

  4. The institutionalization of pharmaceutical administration after the korean liberation: focusing on regulating the pharmaceutical affairs law(yaksabeop) in 1953.

    PubMed

    Sihn, Kyu-Hwan

    2013-12-01

    The pharmaceutical administration under U.S Military Government in Korea and government of the Republic of Korea aimed at cleaning up the vestiges of Japanese imperialism which the pharmaceutical administration attached police administration and preparing with legal and systemic basis after the Korean liberation. The pharmaceutical bureau under U.S Military Government in Korea was reorganized as the independent division. The pharmaceutical bureau focused on preserving order, narcotics control and the distribution of relief drug. U.S Military Government proceeded supply side pharmaceutical policy for the distribution of relief drug without constructing human and material infrastructure. After the Korean War, Korean society asked the construction of system for nation building. Korean national assembly regulated National Medical Law(Gukmin uiryobeop) for promotion of public health in 1951. The Pharmaceutical Affairs Law(Yaksabeop) was regulated in 1953, and it prescribed the job requirement of pharmacist, apothecary, and drug maker and seller, and presented the frame of managing medical supplies. The Pharmaceutical Law originally planned the ideal pharmaceutical administration, but it rather secured the status of traditional apothecary, and drug maker and seller. On the contrary, though the Pharmaceutical Law guaranteed the traditional druggists, it did not materialize reproduction system such as educational and license system. It means that the traditional druggists would be degenerated in the near future. After the armistice agreement in 1953, Korean was in medical difficulties. Korean government was suffered from the deficiency of medical resources. Because of destruction of pharmaceutical facilities, Korean had to depend on United States and international aid. The Pharmaceutical Affairs Law did not cleaned up the vestiges of Japanese imperialism, and compromised with reality lacked human and material infrastructure. As a result, the law became the origin of pharmaceutical disputes such as pharmacist voluntary prescription, the separation of pharmacy and clinic, the compounding of traditional medicines, and the traditional pharmacist system. However, it was meaningful that the law was the turning point of the institutionalization of pharmaceutical administration after the Korean Liberation. PMID:24503923

  5. Making progress and gaining momentum in global 3Rs efforts: how the european pharmaceutical industry is contributing.

    PubMed

    Fleetwood, Gill; Chlebus, Magda; Coenen, Joachim; Dudoignon, Nicolas; Lecerf, Catherine; Maisonneuve, Catherine; Robinson, Sally

    2015-03-01

    Animal research together with other investigational methods (computer modeling, in vitro tests, etc) remains an indispensable part of the pharmaceutical research and development process. The European pharmaceutical industry recognizes the responsibilities inherent in animal research and is committed to applying and enhancing 3Rs principles. New nonsentient, ex vivo, and in vitro methods are developed every day and contribute to reducing and, in some instances, replacing in vivo studies. Their utility is however limited by the extent of our current knowledge and understanding of complex biological systems. Until validated alternative ways to model these complex interactions become available, animals remain indispensable in research and safety testing. In the interim, scientists continue to look for ways to reduce the number of animals needed to obtain valid results, refine experimental techniques to enhance animal welfare, and replace animals with other research methods whenever feasible. As research goals foster increasing cross-sector and international collaboration, momentum is growing to enhance and coordinate scientific innovation globally-beyond a single company, stakeholder group, sector, region, or country. The implementation of 3Rs strategies can be viewed as an integral part of this continuously evolving science, demonstrating the link between science and welfare, benefiting both the development of new medicines and animal welfare. This goal is one of the key objectives of the Research and Animal Welfare working group of the European Federation of Pharmaceutical Industries and Associations. PMID:25836966

  6. [Historical sketch of modern pharmaceutical science and technology (Part 3). From the second half of the 19th century to World War II].

    PubMed

    Yamakawa, K

    1995-01-01

    The history of modern pharmaceutical science and technology, from the second half of the 19th century to the end of World War II, is divided into nine sections for the purpose of discussion. 1. The European medical and pharmaceutical science and technology at the end of the 19th century is reviewed. Pharmacology, bacteriology and biochemistry were built in this period. 2. The Meiji Government accepted Western medicine and medical law and regulations in 1883. Consequently, the Japanese physician changed from Eastern (Kanpooi) to Western (Seiyooi). 3. Modern scientific and engineering education had been accepted in America, England, Germany, and France etc. Foreign scientists and engineers (Oyatoi-gai-kokujin) were educated by practice and theory. The Faculty of Engineering was established in the universities in Japan. This fact is one of the differences in the history of universities in Europe and America. 4. Pharmaceutical education in the Meiji period (1873-1911). Twenty-nine schools of pharmacy were built in this period. However, 20 schools of pharmacy had been closed. Pharmacy and pharmaceutical industry was not established in the Meiji era. 5. The profession of pharmacist in 1873-1944. The policy of medicine was changed by the Meiji Government in 1889, when Western physicians were allowed to prepare medicines for patients, and this practice continues today. Political and technological power of Japanese pharmacists was weak, so their role was not estimated. 6. Consequences of world War I, and the establishment of the pharmaceutical industry. The Sino-Japanese War (1894-95) and Russo-Japanese War (1904-05) were won fortunately. The first pharmaceutical company was established in 1885. At this times, many pharmaceutical manufacturing companies, which were converted from whole sale merchants, were built. Then started the manufacturing of commercial drugs. 7. Hygienic chemistry and some problems of public hygiene. The causes of diseses unique to Japan, such as beriberi (Katuke), were searched for in medical and agricultural laboratories. Dr. Suzuki discovered olizanine from rice bran, which was effective for deficiency of vitamin B1 disease. However, pharmaceutical scientists did not participate in this research. Hygienic and forensic chemistry were included in pharmaceutical departments. 8. Pharmaceutical scientific studies in Europe and Japan in the first half of the 20th century. The discovery of a drug for the treatment of syphilis by Ehrlich-Hata (1889), then chemotherapeutics were started. Adrenalin, the first isolated hormone, by Takamine (1900), after this time many hormones were discovered. The first Japanese pharmacists who studied abroad studied in Germany and came back to Japan. Then, they built the pharmaceutical sciences. Studies on natural products by chemistry and organic chemistry were started. 9. Pharmaceutical scientific and technology during 15 Years of War (1931-45). Since 1930, theoretical organic chemistry was developed in England and America. The discovery of chemotherapeutics and antibiotics (sulfonamides and penicillin) and studies on some vitamins and hormones proceeded during the 15 years of war (1931-45) at Tokyo and Kyoto Universities, and some institutes in China and Manchuria. Studies on anti-maralia, sulfonamides and penicillins were carried out. PMID:11613518

  7. Price regulation in the pharmaceutical industry: prescription or placebo?

    PubMed

    Abbott, T A

    1995-12-01

    President Clinton and several Legislators have proposed restrictions on price increases in the pharmaceutical industry similar to those on some public utilities. Studies, however, suggest that under conditions of rapidly changing demand (as found in pharmaceuticals), price-caps could be manipulated. Using simulations, we show that in reaction to regulation, pharmaceutical firms would optimally set launch prices 50 percent higher than in an unregulated market. Although initially hurt, after seven years consumers benefit as the unregulated price rises above the price-cap. Thus, before enacting legislation, Congress should assess America's willingness to pay more now for lower prices in the future. PMID:10156501

  8. Astronomy Research Based Science Education at the National Optical Astronomy Observatory

    NSDL National Science Digital Library

    This is the web site home for the Teacher Leaders in Research Based Science Education (TLRBSE) program supported by the National Optical Astronomy Observatory. It is designed to retain and renew middle and high school teachers of science by integrating the best practices of Research Based Science and Astronomy Education with the process of mentoring. The program involves teachers in research while also building leadership skills and pedagogical tools.

  9. High-throughput crystallization: polymorphs, salts, co-crystals and solvates of pharmaceutical solids

    Microsoft Academic Search

    Sherry L. Morissette; Örn Almarsson; Matthew L. Peterson; Julius F. Remenar; Michael J. Read; Anthony V. Lemmo; Steve Ellis; Michael J. Cima; Colin R. Gardner

    2004-01-01

    The concepts of high-throughput (HT) screening and combinatorial synthesis have been integrated into the pharmaceutical discovery process, but are not yet commonplace in the pharmaceutical development arena. Emerging strategies to speed pharmaceutical development and capture solid form diversity of pharmaceutical substances have resulted in the emergence of HT crystallization technologies. The primary type of diversity often refers to polymorphs, which

  10. Bio/Pharmaceutical Production Open Applicant Pool BioMARC/IDRC/OVPR/CSU

    E-print Network

    Stephens, Graeme L.

    Bio/Pharmaceutical Production Open Applicant Pool BioMARC/IDRC/OVPR/CSU This open application pool. The jobs covered in this pool include: LS0041 Bio/Pharmaceutical Production Specialist I Additional: The category of Bio/Pharmaceutical Production (also known as Bio/Pharmaceutical Manufacturing) provides

  11. Bio/Pharmaceutical Production Open Applicant Pool BioMARC/IDRC/OVPR/CSU

    E-print Network

    Stephens, Graeme L.

    Bio/Pharmaceutical Production Open Applicant Pool BioMARC/IDRC/OVPR/CSU This open application pool. The jobs covered in this pool include: LS0042 Bio/Pharmaceutical Production Specialist II Additional: The category of Bio/Pharmaceutical Production (also known as Bio/Pharmaceutical Manufacturing) provides

  12. Bio/Pharmaceutical Production Open Applicant Pool BioMARC/IDRC/OVPR/CSU

    E-print Network

    Stephens, Graeme L.

    Bio/Pharmaceutical Production Open Applicant Pool BioMARC/IDRC/OVPR/CSU This open application pool. The jobs covered in this pool include: LS0043 Bio/Pharmaceutical Production Specialist III Additional: The category of Bio/Pharmaceutical Production (also known as Bio/Pharmaceutical Manufacturing) provides

  13. Expert Stakeholders' Views on the Management of Human Pharmaceuticals in the Environment

    Microsoft Academic Search

    Nora A. Doerr-MacEwen; Murray E. Haight

    2006-01-01

    Human pharmaceuticals are ubiquitous water contaminants that may have subtle detrimental effects on aquatic organisms, and possibly also on human health. The risks of pharmaceuticals, or pharmaceutically active compounds, remain poorly understood. Awareness of the presence of pharmaceuticals in the environment, coupled with evidence of effects such as fish feminization, however, suggest that precautionary management action to reduce the release

  14. Occurrence and fate of pharmaceuticals in wastewater treatment plants and rivers in Korea

    Microsoft Academic Search

    Won-Jin Sim; Ji-Woo Lee; Jeong-Eun Oh

    2010-01-01

    We measured 25 pharmaceuticals in ten municipal wastewater treatment plants (WWTPs), one hospital WWTP and five rivers in Korea. In the municipal WWTP influents, acetaminophen, acetylsalicylic acid and caffeine showed relatively high concentrations. The occurrence of pharmaceuticals in the wastewater seems to be influenced by production and consumption of pharmaceuticals. The hospital WWTP influent showed higher total concentrations of pharmaceuticals

  15. Voltammetric determination of vitamins in a pharmaceutical formulation.

    PubMed

    Siddiqui, I; Pitre, K S

    2001-12-01

    Direct current polarography and differential pulse polarographic methods have been developed for the qualitative as well as quantitative analysis of vitamin B1, B2 and B6. Thiamin (vitamin B1) produced a well-defined wave in 0.1 M KCl at pH 5.2 with E(1/2)=-1.2 V and E(p)=-1.22 V versus saturated calomal electrode (SCE). Riboflavin (vitamin B2) gave two distinct waves in Britton Robinson buffer at pH 1.8 with E(1/2) values=-0.13 and -0.34 V versus SCE and at pH 6.5 with E(1/2)=-1.10 V and E(p)=-1.2 V versus SCE. Pyridoxin (vitamin B6) produced a well-defined wave in Britton Robinson buffer at pH 6.5 with E(1/2)=-1.7 V and E(p)=-1.68 V versus SCE. All the three vitamins under study are reversibly reduced at the electrode surface. The number of electrons involved in the electrode process for vitamin B1 and B6 is one in each case where as for the two waves of B2 it is one and two, respectively. This has been confirmed by the measurement of E(3/4)-E(1/4) values and also from the log plot slopes for the reduction waves. The wave height of polarogram was found to be proportional to the vitamin concentration. The developed methods have been standardised for the determination of these compounds in pharmaceutical formulation. The concentration of vitamin B1, B2 and B6 are found to be 9.96, 9.92 and 3.01 mg, respectively in 240 mg of capsule powder of a standard company (name has not been disclosed due to secrecy purpose). The results have been found to be in excellent agreement to that claimed by the manufacturer. The observed data has been subjected to statistical analysis, which revealed high reliability and precision. PMID:11600314

  16. Chemical ecology: a view from the pharmaceutical industry.

    PubMed Central

    Caporale, L H

    1995-01-01

    Biological diversity reflects an underlying molecular diversity. The molecules found in nature may be regarded as solutions to challenges that have been confronted and overcome during molecular evolution. As our understanding of these solutions deepens, the efficiency with which we can discover and/or design new treatments for human disease grows. Nature assists our drug discovery efforts in a variety of ways. Some compounds synthesized by microorganisms and plants are used directly as drugs. Human genetic variations that predispose to (or protect against) certain diseases may point to important drug targets. Organisms that manipulate molecules within us to their benefit also may help us to recognize key biochemical control points. Drug design efforts are expedited by knowledge of the biochemistry of a target. To supplement this knowledge, we screen compounds from sources selected to maximize molecular diversity. Organisms known to manipulate biochemical pathways of other organisms can be sources of particular interest. By using high throughput assays, pharmaceutical companies can rapidly scan the contents of tens of thousands of extracts of microorganisms, plants, and insects. A screen may be designed to search for compounds that affect the activity of an individual targeted human receptor, enzyme, or ion channel, or the screen might be designed to capture compounds that affect any step in a targeted metabolic or biochemical signaling pathway. While a natural product discovered by such a screen will itself only rarely become a drug (its potency, selectivity, bioavailability, and/or stability may be inadequate), it may suggest a type of structure that would interact with the target, serving as a point of departure for a medicinal chemistry effort--i.e., it may be a "lead." It is still beyond our capability to design, routinely, such lead structures, based simply upon knowledge of the structure of our target. However, if a drug discovery target contains regions of structure homologous to that in other proteins, structures known to interact with those proteins may prove useful as leads for a medicinal chemistry effort. The specificity of a lead for a target may be optimized by directing structural variation to specificity-determining sites and away from those sites required for interaction with conserved features of the targeted protein structure. Strategies that facilitate recognition and exploration of sites at which variation is most likely to generate a novel function increase the efficiency with which useful molecules can be created. Images Fig. 1 Fig. 3 PMID:7816850

  17. Pharmaceutical compounds in wastewater: wetland treatment as a potential solution.

    PubMed

    White, John R; Belmont, Marco A; Metcalfe, Chris D

    2006-01-01

    Pharmaceutical compounds are being released into the aquatic environment through wastewater discharge around the globe. While there is limited removal of these compounds within wastewater treatment plants, wetland treatment might prove to be an effective means to reduce the discharge of the compounds into the environment. Wetlands can promote removal of these pharmaceutical compounds through a number of mechanisms including photolysis, plant uptake, microbial degradation, and sorption to the soil. We review relevant laboratory research on these various mechanisms and provide data on the few studies that have examined wetland removal. There is a need to document the degree to which various pharmaceutical compounds are removed in full-scale treatment wetlands, as there is a paucity of data on overall pharmaceutical removal rates. PMID:17195871

  18. Hydroxyalkyl phosphine compounds for use as diagnostic and therapeutic pharmaceuticals

    DOEpatents

    Katti, K.V.; Singh, P.R.; Reddy, V.S.; Katti, K.K.; Volkert, W.A.; Ketring, A.R.

    1999-03-02

    This research discloses a compound and method of making a compound for use as a diagnostic or therapeutic pharmaceutical comprises a functionalized hydroxyalkyl phosphine ligand and a metal combined with the ligand. 16 figs.

  19. FACULTY OF ARTS & SCIENCE 2012/13 PHARMACEUTICAL CHEMISTRY

    E-print Network

    Toronto, University of

    Forensic chemist Fundraiser Hazardous materials manager Laboratory technician Medical librarian://pharmacy.utoronto.ca/pharmchem Pharmaceutical Chemistry combines knowledge of the biological, medical, and physical sciences in the study Pharmacologist chemist Product tester Research assistant Teacher Chemotherapist Clinical chemist Laboratory

  20. [New pharmaceuticals in treatment of chronic dust bronchitis].

    PubMed

    Kosarev, V V; Vakurova, N V; Babanov, S A

    2007-01-01

    The study was dedicated to the assessment of the therapeutic possibilities provided by erespal (fenspirid) as a new class of pharmaceuticals inhibiting the inflammatory process, in patients with chronic dust bronchitis. PMID:18219958

  1. Improving energy efficiency in a pharmaceutical manufacturing environment -- office building

    E-print Network

    Li, Wu, M. Eng Massachusetts Institute of Technology

    2009-01-01

    Reducing energy consumption without compromising the quality of products in a pharmaceutical manufacturing environment and maintaining the comfort of employees is of critical important in maintaining the financial viability ...

  2. Analysis of global channel costs for the pharmaceutical industry

    E-print Network

    Rimling, Eric C. (Eric Christopher)

    2009-01-01

    The pharmaceutical industry creates products which often have more than one supply chain channel, defined as a route through the supply chain network from sourcing to the end market. Each channel's specific cost characteristics ...

  3. Essays in the industrial organization of the pharmaceutical industry

    E-print Network

    Shapiro, Bradley T. (Bradley Thomas)

    2014-01-01

    This dissertation comprises of three chapters, each exploring different issues in the industrial organization of the pharmaceutical industry. In the first chapter, I study the effects of television advertising of antidepressants ...

  4. Three essays on the development and diffusion of pharmaceutical innovations

    E-print Network

    Azoulay, Pierre

    2001-01-01

    The thesis comprises three essays on various aspects of the development and diffusion of pharmaceutical innovations, woven together by the idea that the production of clinical knowl- edge influences organizational design, ...

  5. ORIGINAL ARTICLE Rapid analysis of pharmaceuticals and excreted xenobiotic

    E-print Network

    Vertes, Akos

    ORIGINAL ARTICLE Rapid analysis of pharmaceuticals and excreted xenobiotic and endogenous for the analysis of xenobiotic and endogenous metabolites (Dett- mer et al. 2007; Glassbrook et al. 2000; Nicholson

  6. Study of polymeric film bonding for pharmaceutical applications

    E-print Network

    Cardell, Alyse (Alyse Christine)

    2011-01-01

    Currently employed batch manufacturing processes for tablet-making in the pharmaceutical industry are estimated to cause the loss of as much as 25% of revenues due to batch rejection, rework and investigations. An alternate ...

  7. The pharmaceutical industry: a further study in corporate power.

    PubMed

    McCraine, N; Murray, M J

    1978-01-01

    This article represents an updated version of previous research conducted on the United States pharmaceutical industry. The unstated purpose of this article is to present new findings which supplement the earlier research. This article describes three aspects of the United States pharmaceutical industry: its strategy and structure within the world market, its global expansion beyond the territorial boundaries of the United States, and its interlocking directorates with banking institutions. The thesis presented here is twofold: first, the United States pharmaceutical industry has become increasingly integrated into larger and more heterogeneous production units operating on the world market; and second, the United States pharmaceutical industry has become increasingly linked to large United States banking firms through interlocking directorates. PMID:730410

  8. PHARMACEUTICALS IN THE ENVIRONMENT: SOURCES AND THEIR MANAGEMENT

    EPA Science Inventory

    An issue that began to receive more attention by environmental scientists in the late 1990s was the conveyancy of pharmaceuticals in the environment by way of their use in human and veterinary medical practices and personal care...

  9. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...the patients. The institution must have a pharmacy directed by a registered pharmacist or...pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be...

  10. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...the patients. The institution must have a pharmacy directed by a registered pharmacist or...pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be...

  11. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...the patients. The institution must have a pharmacy directed by a registered pharmacist or...pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be...

  12. Business models for information commons in the pharmaceutical industry

    E-print Network

    Bharadwaj, Ragu

    2009-01-01

    The pharmaceutical industry needs new modes of innovation. The industry's innovation system - based on massive investments in R&D protected by intellectual property rights - has worked well for many years, providing ...

  13. Physicians' attitudes towards interaction with the pharmaceutical industry.

    PubMed

    Alosaimi, F D; Al Kaabba, A; Qadi, M; Albahlal, A; Alabdulkarim, Y; Alabduljabbar, M; Alqahtani, F

    2014-12-01

    The relationship between physicians and the pharmaceutical industry has ethical implications for patient care. This study examined knowledge and attitudes towards the pharmaceutical industry, and associations with actual behaviour, among physicians working in Saudi Arabia. In a cross-sectional study in 2012, a 100-point score was created from 17 5-point Likert-scale questions to assess knowledge and attitudes. The overall score of 659 participants was 63.1 (SD 8.5), with a majority holding a generally positive attitude. Higher (i.e. better) scores were significantly associated with a lack of interactions with the pharmaceutical industry and with refusal of gifts but not with education about ethics. In multivariate analysis, refusing gifts, additional income and Saudi nationality remained independently associated with higher scores. Overall, there was suboptimal knowledge and a generally positive attitude towards the pharmaceutical industry among the sample of physicians in Saudi Arabia. PMID:25664520

  14. The business case for continuous manufacturing of pharmaceuticals

    E-print Network

    Wilburn, Kristopher Ray

    2010-01-01

    Manufacturing in the pharmaceutical industry is presently characterized as a batch production system, which has existed in its current form for decades. This structure is the result of historical regulatory policy as well ...

  15. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2014-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part. PMID:24964711

  16. Achieving business and operational excellence in the pharmaceutical industry

    E-print Network

    Coffey, Shonna (Shonna Marie)

    2008-01-01

    Historically the pharmaceutical industry has been highly profitable. However, the increasing regulatory requirements, bargaining power of buyers, and drug failures together with the threat of biosimilars and decreasing R&D ...

  17. Uptake of human pharmaceuticals by plants grown under hydroponic conditions.

    PubMed

    Herklotz, Patrick A; Gurung, Prakash; Vanden Heuvel, Brian; Kinney, Chad A

    2010-03-01

    Cabbage (Brassica rapa var. pekinensis) and Wisconsin Fast Plants (Brassica rapa) were chosen for a proof of concept study to determine the potential uptake and accumulation of human pharmaceuticals by plants. These plants were grown hydroponically under high-pressure sodium lamps in one of two groups including a control and test group exposed to pharmaceuticals. The control plants were irrigated with a recirculating Hoagland's nutrient solution while the test plants were irrigated with a Hoagland's nutrient solution fortified with the pharmaceuticals carbamazepine, salbutamol, sulfamethoxazole, and trimethoprim at 232.5 microg L(-1). When plants reached maturity, nine entire plants of each species were separated into components such as roots, leaves, stems, and seedpods where applicable. An analytical method for quantifying pharmaceuticals and personal care products was developed using pressurized liquid extraction and liquid chromatography electrospray ionization mass spectrometry (LC/ESI/MS) in positive and negative ion modes using single ion monitoring. The method detection limits ranged from 3.13 ng g(-1) to 29.78 ng g(-1) with recoveries ranging from 66.83% to 113.62% from plant matrices. All four of the pharmaceuticals were detected in the roots and leaves of the cabbage. The maximum wet weight concentrations of the pharmaceuticals were detected in the root structure of the cabbage plants at 98.87 ng g(-1) carbamazepine, 114.72 ng g(-1) salbutamol, 138.26 ng g(-1) sulfamethoxazole, and 91.33 ng g(-1) trimethoprim. Carbamazepine and salbutamol were detected in the seedpods of the Wisconsin Fast Plants while all four of the pharmaceuticals were detected in the leaf/stem/root of the Wisconsin Fast Plants. Phloroglucinol staining of root cross-sections was used to verify the existence of an intact endodermis, suggesting that pharmaceuticals found in the leaf and seedpods of the plants were transported symplastically. PMID:20096438

  18. [Pharmacokinetic evaluation of afobazole pharmaceutical composition with modified release].

    PubMed

    Bochkov, P O; Litvin, A A; Kolyvanov, G B; Viglinskaya, A O; Zherdev, V P; Blynskaya, E V; Alekseev, K V

    2015-01-01

    The main pharmacokinetic parameters (AUC0-?, Tmax, Cmax, Cl/F, t1/2 el, MRT, Cmax/AUC0-I, Vd/F) of afobazole base in a new pharmaceutical composition and afobazole dihydrochloride substance after single peroral administration have been determined in rats. The availability of afobazole base pharmaceutical composition relative to that of the substance amounted to 153.2%. PMID:26036008

  19. Chitin and Chitosan as Direct Compression Excipients in Pharmaceutical Applications

    PubMed Central

    Badwan, Adnan A.; Rashid, Iyad; Al Omari, Mahmoud M.H.; Darras, Fouad H.

    2015-01-01

    Despite the numerous uses of chitin and chitosan as new functional materials of high potential in various fields, they are still behind several directly compressible excipients already dominating pharmaceutical applications. There are, however, new attempts to exploit chitin and chitosan in co-processing techniques that provide a product with potential to act as a direct compression (DC) excipient. This review outlines the compression properties of chitin and chitosan in the context of DC pharmaceutical applications. PMID:25810109

  20. Spectrophotometric determination of etodolac in pure form and pharmaceutical formulations

    Microsoft Academic Search

    Ayman A Gouda; Wafaa S Hassan

    2008-01-01

    BACKGROUND: Etodolac (ETD) is a non-steroidal anti-inflamatory antirheumatic drug. A survey of the literature reveals that there is no method available for the determination of ETD in pure form and pharmaceutical formulations by oxidation-reduction reactions. RESULTS: We describe three simple, sensitive and reproducible spectrophotometric assays (A-C) for the determination of etodolac in pure form and in pharmaceutical formulations. Methods A

  1. Part V—sorption of pharmaceuticals and personal care products

    Microsoft Academic Search

    Bo Pan; Ping Ning; Baoshan Xing

    2009-01-01

    Background, aim, and scope  Pharmaceuticals and personal care products (PPCPs) including antibiotics, endocrine-disrupting chemicals, and veterinary pharmaceuticals\\u000a are emerging pollutants, and their environmental risk was not emphasized until a decade ago. These compounds have been reported\\u000a to cause adverse impacts on wildlife and human. However, compared to the studies on hydrophobic organic contaminants (HOCs)\\u000a whose sorption characteristics is reviewed in Part

  2. Pharmaceutical crops in California, benefits and risks. A review

    Microsoft Academic Search

    Michelle Marvier

    2008-01-01

    Crops are being genetically engineered to produce a wide variety of drugs, vaccines and other pharmaceutical proteins. Although\\u000a these crops may open the door to less expensive and more readily available drugs, there is concern regarding the potential\\u000a for contamination of human food and livestock feed, as well as environmental harm. The outlook for the production of pharmaceutical\\u000a crops in

  3. Pharmaceutical Crops in California, Benefits and Risks: A Review

    Microsoft Academic Search

    Michelle Marvier

    Crops are being genetically engineered to produce a wide variety of drugs, vaccines and other pharmaceutical proteins. Although\\u000a these crops may open the door to less expensive and more readily available drugs, there is concern regarding the potential\\u000a for contamination of human food and livestock feed, as well as environmental harm. The outlook for the production of pharmaceutical\\u000a crops in

  4. Pharmaceuticals' sorptions relative to properties of thirteen different soils.

    PubMed

    Kodešová, Radka; Grabic, Roman; Ko?árek, Martin; Klement, Aleš; Golovko, Oksana; Fér, Miroslav; Nikodem, Antonín; Jakšík, Ond?ej

    2015-04-01

    Transport of human and veterinary pharmaceuticals in soils and consequent ground-water contamination are influenced by many factors, including compound sorption on soil particles. Here we evaluate the sorption isotherms for 7 pharmaceuticals on 13 soils, described by Freundlich equations, and assess the impact of soil properties on various pharmaceuticals' sorption on soils. Sorption of ionizable pharmaceuticals was, in many cases, highly affected by soil pH. The sorption coefficient of sulfamethoxazole was negatively correlated to soil pH, and thus positively related to hydrolytic acidity and exchangeable acidity. Sorption coefficients for clindamycin and clarithromycin were positively related to soil pH and thus negatively related to hydrolytic acidity and exchangeable acidity, and positively related to base cation saturation. The sorption coefficients for the remaining pharmaceuticals (trimethoprim, metoprolol, atenolol, and carbamazepine) were also positively correlated with the base cation saturation and cation exchange capacity. Positive correlations between sorption coefficients and clay content were found for clindamycin, clarithromycin, atenolol, and metoprolol. Positive correlations between sorption coefficients and organic carbon content were obtained for trimethoprim and carbamazepine. Pedotransfer rules for predicting sorption coefficients of various pharmaceuticals included hydrolytic acidity (sulfamethoxazole), organic carbon content (trimethoprimand carbamazepine), base cation saturation (atenolol and metoprolol), exchangeable acidity and clay content (clindamycin), and soil active pH and clay content (clarithromycin). Pedotransfer rules, predicting the Freundlich sorption coefficients, could be applied for prediction of pharmaceutical mobility in soils with similar soil properties. Predicted sorption coefficients together with pharmaceutical half-lives and other imputes (e.g., soil-hydraulic, geological, hydro-geological, climatic) may be used for assessing potential ground-water contamination. PMID:25569579

  5. Ionic liquids as active pharmaceutical ingredients.

    PubMed

    Ferraz, Ricardo; Branco, Luís C; Prudêncio, Cristina; Noronha, João Paulo; Petrovski, Zeljko

    2011-06-01

    Ionic liquids (ILs) are ionic compounds that possess a melting temperature below 100 °C. Their physical and chemical properties are attractive for various applications. Several organic materials that are now classified as ionic liquids were described as far back as the mid-19th century. The search for new and different ILs has led to the progressive development and application of three generations of ILs: 1) The focus of the first generation was mainly on their unique intrinsic physical and chemical properties, such as density, viscosity, conductivity, solubility, and high thermal and chemical stability. 2) The second generation of ILs offered the potential to tune some of these physical and chemical properties, allowing the formation of "task-specific ionic liquids" which can have application as lubricants, energetic materials (in the case of selective separation and extraction processes), and as more environmentally friendly (greener) reaction solvents, among others. 3) The third and most recent generation of ILs involve active pharmaceutical ingredients (API), which are being used to produce ILs with biological activity. Herein we summarize recent developments in the area of third-generation ionic liquids that are being used as APIs, with a particular focus on efforts to overcome current hurdles encountered by APIs. We also offer some innovative solutions in new medical treatment and delivery options. PMID:21557480

  6. Shock wave driven microparticles for pharmaceutical applications

    NASA Astrophysics Data System (ADS)

    Menezes, V.; Takayama, K.; Gojani, A.; Hosseini, S. H. R.

    2008-10-01

    Ablation created by a Q-switched Nd:Yttrium Aluminum Garnet (Nd:YAG) laser beam focusing on a thin aluminum foil surface spontaneously generates a shock wave that propagates through the foil and deforms it at a high speed. This high-speed foil deformation can project dry micro- particles deposited on the anterior surface of the foil at high speeds such that the particles have sufficient momentum to penetrate soft targets. We used this method of particle acceleration to develop a drug delivery device to deliver DNA/drug coated microparticles into soft human-body targets for pharmaceutical applications. The device physics has been studied by observing the process of particle acceleration using a high-speed video camera in a shadowgraph system. Though the initial rate of foil deformation is over 5 km/s, the observed particle velocities are in the range of 900-400 m/s over a distance of 1.5-10 mm from the launch pad. The device has been tested by delivering microparticles into liver tissues of experimental rats and artificial soft human-body targets, modeled using gelatin. The penetration depths observed in the experimental targets are quite encouraging to develop a future clinical therapeutic device for treatments such as gene therapy, treatment of cancer and tumor cells, epidermal and mucosal immunizations etc.

  7. Pharmaceutical Point of View on Parenteral Nutrition

    PubMed Central

    Stawny, M.; Olijarczyk, R.; Jaroszkiewicz, E.; Jeli?ska, A.

    2013-01-01

    Parenteral nutrition—a form of administering nutrients, electrolytes, trace elements, vitamins, and water—is a widely used mode of therapy applied in many diseases, in patients of different ages both at home and in hospital. The success of nutritional therapy depends chiefly on proper determination of the patient's energetic and electrolytic needs as well as preparation and administration of a safe nutritional mixture. As a parenterally administered drug, it is expected to be microbiologically and physicochemically stable, with all of the components compatible with each other. It is very difficult to obtain a stable nutritional mixture due to the fact that it is a complex, two-phase drug. Also, the risk of incompatibility between mixture components and packaging should be taken into consideration and possibly eliminated. Since parenteral nutrition is a part of therapy, simultaneous use of drugs may cause pharmacokinetic and pharmacodynamic interactions as well as those with the pharmaceutical phase. The aim of this paper is to discuss such aspects of parenteral nutrition as mixture stability, methodology, and methods for determining the stability of nutritional mixtures and drugs added to them. PMID:24453847

  8. [Justice challenges of pharmaceutical industry global research].

    PubMed

    Páez Moreno, Ricardo

    2010-01-01

    International research projects sponsored by the pharmaceutical industry are a recent modality of biomedical research, which is driven by interests that are not only scientific, but also commercial. This combination of interests is one of the natural consequences of globalization, which has brought unquestionable benefits for the world, but has also created a wider gap between the wealthy and the poor. Given that globalization has been led by the the world's leading economies, the level of injustice in the world has increased, often to the favor of the already wealthy. Globalization has a well-established dynamics, whose main characteristic is domain over the following: technological innovation, the organization of the production of goods and services, human needs, and consumption. International biomedical research fits well in this dynamics, and the result is often a poor distribution of benefits, added to a loss of scientific integrity for the sake of commercial interests. This phenomenon raises many ethical questions and it demands a reflection from different bioethical points of view, particularly an economic ethics and a global justice. PMID:21090847

  9. Novel pharmaceutical approaches to reflux disease.

    PubMed

    Dutta, Usha; Armstrong, David

    2013-03-01

    Acid suppression, with proton pump inhibitors (PPI), is the mainstay of therapy for reflux disease; despite this, symptoms and injury persist in many patients. Novel approaches have focused on (1) augmenting acid suppression with reformulated current PPIs, new PPIs or new acid pump blockers and (2) preventing reflux with reflux inhibitors. Other strategies to reduce reflux, improve gastric emptying or esophageal clearance, protect the mucosa, or reduce esophageal sensitivity are under investigation alone or in combination with PPIs; however, novel approaches face significant challenges. The safety and efficacy of current PPIs hamper demonstration of clinical superiority for new acid suppressants, and the multifactorial etiology of reflux disease means that monotherapy using a non-acid suppressant is unlikely to match PPI therapy while combination therapy will be superior only if susceptible patients can be identified reliably. Advances will come, not from a 'one size fits all' approach but rather from novel pharmaceuticals allied to novel investigations to permit targeted, personalized reflux therapy. PMID:23452633

  10. Pegylation: engineering improved pharmaceuticals for enhanced therapy.

    PubMed

    Molineux, G

    2002-04-01

    Conjugating biomolecules with polyethylene glycol (PEG), a process known as pegylation, is now an established method for increasing the circulating half-life of protein and liposomal pharmaceuticals. Polyethylene glycols are nontoxic water-soluble polymers that, owing to their large hydrodynamic volume, create a shield around the pegylated drug, thus protecting it from renal clearance, enzymatic degradation, and recognition by cells of the immune system. Agent-specific pegylation methods have been used in recent years to produce pegylated drugs that have biologic activity that is the same as, or greater than, that of the parent drug. These agents have distinct in vivo pharmacokinetic and pharmacodynamic properties, as exemplified by the self-regulated clearance of pegfilgrastim, the prolonged absorption half-life of pegylated interferon alpha-2a, and the altered tolerability profile of pegylated liposomal doxorubicin. Pegylated agents have dosing schedules that are more convenient and more acceptable to patients, and this can have a beneficial effect on the quality of life of patients with cancer. PMID:12173407

  11. Transferring pharmaceuticals into the gas phase

    NASA Astrophysics Data System (ADS)

    Christen, Wolfgang; Krause, Tim; Rademann, Klaus

    2008-11-01

    The dissolution of molecules of biological interest in supercritical carbon dioxide is investigated using pulsed molecular beam mass spectrometry. Due to the mild processing temperatures of most supercritical fluids, their adiabatic expansion into vacuum permits to transfer even thermally very sensitive substances into the gas phase, which is particularly attractive for pharmaceutical and biomedical applications. In addition, supercritical CO2constitutes a chemically inert solvent that is compatible with hydrocarbon-free ultrahigh vacuum conditions. Here, we report on the dissolution and pulsed supersonic jet expansion of caffeine (C8H10N4O2), the provitamin menadione (C11H8O2), and the amino acid derivative l-phenylalanine tert-butyl ester hydrochloride (C6H5CH2CH(NH2)COOC(CH3)3[dot operator]HCl), into vacuum. An on-axis residual gas analyzer is used to monitor the relative amounts of solute and solvent in the molecular beam as a function of solvent densityE The excellent selectivity and sensitivity provided by mass spectrometry permits to probe even trace amounts of solutes. The strong density variation of CO2 close to the critical point results in a pronounced pressure dependence of the relative ion currents of solute and solvent molecules, reflecting a substantial change in solubility.

  12. Biobullet: Innovative Pharmaceutical Compounding for Treating Cattle.

    PubMed

    Benischek, Rita L

    2006-01-01

    Large animals in herds are susceptible to illnesses related to proximity as well as to the stress of captivity. Thanks to innovative veterinarians and pharmacists, pharmaceutical technology has entered a new phase in delivery systems for medications and vaccines to large animals. An advanced method of administering prescription drugs in a manner that has dramaticaly reduced the stress of those who administer the drugs, as well as the veterinary patients receiving the drugs, is the Biobullet, a ballistic bullet with a core of antibiotic. This patented dosage form, which was developed by SolidTech Animal Health, Inc., located in Newcastle, Oklahoma, is an advanced method of medication adminstration that reduces labor costs preventing illness in cattle. As the name indicates, the medication is delivered by way of a ballistic system. The doses are uniform, premeasured, and require no dilution at the time of administration, therefore saving time on the range and eliminating dosage errors and use of syringes. This new dosage form has been used experimentally and therapeutically in bison, deer, antelope, and stressed zoo animals such as elephants. The benefits of this innovative treatment for large veterinary patients is far-reaching. Considering the strict requirements on medicinal treatments of food animals, veterinarians and compounding pharmacists should make the effort to learn more about this delivery option. PMID:23974415

  13. Pharmaceutical Industry and Trade Liberalization Using Computable General Equilibrium Model

    PubMed Central

    Barouni, M; Ghaderi, H; Banouei, AA

    2012-01-01

    Background Computable general equilibrium models are known as a powerful instrument in economic analyses and widely have been used in order to evaluate trade liberalization effects. The purpose of this study was to provide the impacts of trade openness on pharmaceutical industry using CGE model. Methods: Using a computable general equilibrium model in this study, the effects of decrease in tariffs as a symbol of trade liberalization on key variables of Iranian pharmaceutical products were studied. Simulation was performed via two scenarios in this study. The first scenario was the effect of decrease in tariffs of pharmaceutical products as 10, 30, 50, and 100 on key drug variables, and the second was the effect of decrease in other sectors except pharmaceutical products on vital and economic variables of pharmaceutical products. The required data were obtained and the model parameters were calibrated according to the social accounting matrix of Iran in 2006. Results: The results associated with simulation demonstrated that the first scenario has increased import, export, drug supply to markets and household consumption, while import, export, supply of product to market, and household consumption of pharmaceutical products would averagely decrease in the second scenario. Ultimately, society welfare would improve in all scenarios. Conclusion: We presents and synthesizes the CGE model which could be used to analyze trade liberalization policy issue in developing countries (like Iran), and thus provides information that policymakers can use to improve the pharmacy economics. PMID:23641393

  14. Pharmaceutical metabolites in the environment: analytical challenges and ecological risks.

    PubMed

    Celiz, Mary D; Tso, Jerry; Aga, Diana S

    2009-12-01

    The occurrence of human and veterinary pharmaceuticals in the environment has been a subject of concern for the past decade because many of these emerging contaminants have been shown to persist in soil and water. Although recent studies indicate that pharmaceutical contaminants can pose long-term ecological risks, many of the investigations regarding risk assessment have only considered the ecotoxicity of the parent drug, with very little attention given to the potential contributions that metabolites may have. The scarcity of available environmental data on the human metabolites excreted into the environment or the microbial metabolites formed during environmental biodegradation of pharmaceutical residues can be attributed to the difficulty in analyzing trace amounts of previously unknown compounds in complex sample matrices. However, with the advent of highly sensitive and powerful analytical instrumentations that have become available commercially, it is likely that an increased number of pharmaceutical metabolites will be identified and included in environmental risk assessment. The present study will present a critical review of available literature on pharmaceutical metabolites, primarily focusing on their analysis and toxicological significance. It is also intended to provide an overview on the recent advances in analytical tools and strategies to facilitate metabolite identification in environmental samples. This review aims to provide insight on what future directions might be taken to help scientists in this challenging task of enhancing the available data on the fate, behavior, and ecotoxicity of pharmaceutical metabolites in the environment. PMID:19663539

  15. [Pharmaceutical product quality control and good manufacturing practices].

    PubMed

    Hiyama, Yukio

    2010-01-01

    This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential. PMID:21381389

  16. WHO Expert Committee on specifications for pharmaceutical preparations.

    PubMed

    1996-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities, the report discusses activities related to the further development of The international pharmacopoeia, as well as simple test methodology, the stability of dosage forms, good manufacturing practices, legal and administrative aspects of the functioning of national drug regulatory authorities, and quality assurance in the supply system. The report is complemented by numerous annexes, including guidelines for the graphic representation of chemical formulae, lists of available International Chemical Reference Substances and International Infrared Reference Spectra, general recommendations for the preparation and use of infrared spectra in pharmaceutical analysis, and guidelines on stability testing of pharmaceutical products. In the context of good manufacturing practices, guidance is provided on the validation of manufacturing processes and for the manufacture both of investigational products for clinical trials and of herbal medicinal products. The final annexes contain guidelines adopted or endorsed by the Committee on registration requirements to establish the interchangeability of multisource pharmaceutical products, implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, the assessment of herbal medicines, and import procedures for pharmaceutical products. PMID:8952445

  17. HR/Organizational Company Description

    E-print Network

    Dahl, David B.

    and nutrition. Develops and manufactures high-quality nutritional supplements, healthy weight-management products, such as adapters, gateways, modems, and home network management software. The company also offers and Deliverables: Development of Global Staffing documentation within our company's knowledge management tool

  18. Financing Costs of Portuguese Companies

    Microsoft Academic Search

    Isabel Marques Gameiro; Nuno Gonçalo Ribeiro

    2007-01-01

    This paper aims at obtaining a set of measures of developments in the real financing costs of Portu- guese companies. To this end, calculation procedures are established and their methodological op- tions discussed. Such measures are proxies for the actual costs incurred by companies in various financing market segments, which, taking into account the corporate financial structure, may be aggre-

  19. Economic Regulation of Water Companies

    Microsoft Academic Search

    Michael Klein

    1999-01-01

    September 1996The key to effective regulation of water companies is to generate information that allows the regulator to make good rules and allows the interest groups to watch out for improprieties by the regulator.Both public and private water companies need regulation (of water price and quality) when real competition is not feasible. Piped water systems tend to be monopolies or

  20. A strategy for company improvement.

    PubMed

    Howley, L

    2000-03-01

    Strategies based on the kaizen methodology are designed to continuously improve company performance without the need for large capital investments. This article looks at how one company used simple kaizen principles to its advantage, achieving 67% increase in productivity and 10% reduction in the standard cost of product. PMID:10915491

  1. Business Plan Development Company Description

    E-print Network

    Dahl, David B.

    Business Plan Development Company Description: The company is not yet formed, although I have been market, marketing plan, web development, manufacturing plan to allow for maximum profit margin while such that costs and pricing can allow for maximum profit margin, according to the market. Distribution

  2. Real Estate Development Company Description

    E-print Network

    Dahl, David B.

    advantage and position itself vs. the competition in the real estate market. Company Description: LandReal Estate Development Company Description: The largest specialty family footwear retailer America, the Caribbean and South America. Short Project Name: Competitive Analysis - Real Estate Positions

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

    PubMed

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

    2013-01-01

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

  4. Pharmaceutical innovation: impact on expenditure and outcomes and subsequent challenges for pharmaceutical policy, with a special reference to Greece

    PubMed Central

    Karampli, E; Souliotis, K; Polyzos, N; Kyriopoulos, J; Chatzaki, E

    2014-01-01

    Over the recent decades, advances in healthcare technology have led to significant improvements in the quality of healthcare and in population health. At the same time, technological change in healthcare, rising national income and expansion of insurance coverage have been acknowledged as the main determinants of the historical growth in health spending in industrialized countries. The pharmaceutical sector is of particular interest as it constitutes a market characterized by rapid technological change and high expenditure growth rates. The purpose of this article is to provide an overview of research findings on the impact of pharmaceutical innovation on pharmaceutical expenditure growth, total health expenditure and population health outcomes and to bring forward the challenges that arise for pharmaceutical policy in Greece. PMID:25336869

  5. Pharmaceutical innovation: impact on expenditure and outcomes and subsequent challenges for pharmaceutical policy, with a special reference to Greece.

    PubMed

    Karampli, E; Souliotis, K; Polyzos, N; Kyriopoulos, J; Chatzaki, E

    2014-04-01

    Over the recent decades, advances in healthcare technology have led to significant improvements in the quality of healthcare and in population health. At the same time, technological change in healthcare, rising national income and expansion of insurance coverage have been acknowledged as the main determinants of the historical growth in health spending in industrialized countries. The pharmaceutical sector is of particular interest as it constitutes a market characterized by rapid technological change and high expenditure growth rates. The purpose of this article is to provide an overview of research findings on the impact of pharmaceutical innovation on pharmaceutical expenditure growth, total health expenditure and population health outcomes and to bring forward the challenges that arise for pharmaceutical policy in Greece. PMID:25336869

  6. Nonprofit and profit companies in monopolistic competition

    Microsoft Academic Search

    Morten Skak

    2011-01-01

    A homogenous goods market with nonprofit and profit companies engaged in monopolistic competition is proposed. In a short run equilibrium, entrance of more companies of both types increases consumer surplus and reduces company profit. However, nonprofit companies under a long run zero profit constraint will act inefficiently and have higher marginal costs than profit companies. From this follows that more

  7. The multinational drug companies in Zaire: their adverse effect on cost and availability of essential drugs

    SciTech Connect

    Glucksberg, H.; Singer, J.

    1982-01-01

    An analysis of the types and costs of drugs imported by seven multinational pharmaceutical companies in Zaire, an underdeveloped country in Africa, reveals that three-fourths of the drugs consisted of expensive and nonessential items. The prices of essential drugs (24 percent of their total imports) were much higher than those of available generic sources (average difference of 300 percent). The importation of nonessential drugs and high prices paid for essential drugs exacerbate the scarcity of needed items because of Zaire's limited supply of hard currency. In addition, two drug firms imported and promoted the sale of aminopyrone-dipyrone analgesic-antipyretics, drugs now rarely used in Western industrialized countries because of potentially fatal complications. Thus, in Zaire, the multinational pharmaceutical industry has an adverse effect on the availability and cost of drugs, as well as on the pattern of drug usage.

  8. Evaluation of cleaner production audit in pharmaceutical production industry: case study of the pharmaceutical plant in Dalian, P. R. China

    Microsoft Academic Search

    Li Zhi-dongZhang; Zhang Shu-shen; Zhang Yun; Zhang Yong; Wei Li

    2011-01-01

    The pharmaceutical industry in China makes an important contribution to the national economy. However, the associated pollution\\u000a problems cause gradual deterioration of the environment and impact adversely on the local community. Cleaner production (CP)\\u000a technology, an effective way to reduce waste emission and save resources, has been widely employed in the pharmaceutical industry\\u000a in the developed countries. Such technologies have

  9. 75 FR 11228 - Surety Companies Acceptable On Federal Bonds: Manufacturers Alliance Insurance Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ...Surety Companies Acceptable On Federal Bonds: Manufacturers Alliance Insurance Company AGENCY: Financial Management Service, Fiscal...31 U.S.C. 9305 to the following company: Manufacturers Alliance Insurance Company (NAIC 36897). Business....

  10. 75 FR 2126 - Calais Pipeline Company, LLC; Calais LNG Project Company, LLC; Notice of Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ...PF08-24-000] Calais Pipeline Company, LLC; Calais LNG Project Company, LLC; Notice of Application January...Take notice that on December 18, 2009, Calais LNG Project Company, LLC (Calais LNG) and Calais Pipeline Company, LLC (Calais...

  11. Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Page, Trevor; Dubina, Henry; Fillipi, Gabriele; Guidat, Roland; Patnaik, Saroj; Poechlauer, Peter; Shering, Phil; Guinn, Martin; Mcdonnell, Peter; Johnston, Craig

    2015-03-01

    This white paper focuses on equipment, and analytical manufacturers' perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. PMID:25448273

  12. 12 CFR 225.102 - Bank holding company indirectly owning nonbanking company through subsidiaries.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...COMPANIES AND CHANGE IN BANK CONTROL (REGULATION Y) Regulations Financial Holding Companies...Holding Company Act of 1956. It is stated that Y Company is an investment company which...ownership by X Corporation of voting shares of Y Company would be exempt by reason of...

  13. The role of marketing in pharmaceutical research and development.

    PubMed

    Calfee, John E

    2002-01-01

    Pharmaceutical marketing, which is primarily targeted at physicians, has been criticised because it may distort physician prescribing and thus potentially raise costs and/or worsen health. An alternative view, presented in this paper, is that successful marketing of pharmaceuticals can improve consumer welfare by increasing incentives for research and development (R&D) investment and by providing guidance to R&D to make it more consistent with consumer preferences. There are a number of arguments that support this view, despite impediments to pharmaceutical marketing such as the prohibited dissemination of off-label information in the US, difficulties in estimating potential pharmaceutical demand, and the long time lag between demand assessment and the introduction of new drugs. For example, physicians are often slow to modify their prescribing practices, even when new evidence-based practice guidelines are issued by prestigious organisations. Pharmaceutical promotion is likely to be particularly valuable because information plays a key role, is highly technical, and can change rapidly. Even consumer advertising can potentially improve health, for example, by improving patient compliance with drug therapy. In addition to disseminating information about the benefits of new therapies, an essential (and perhaps unique) role for pharmaceutical promotion is to encourage physicians and payers to pay closer attention to consumer needs (i.e. willingness to pay) for new medical technology. Moreover, successful marketing of pharmaceuticals increases the returns from R&D, thus increasing incentives to explore consumer demand and to contribute to basic research on the role of drug therapy. Consumer benefits from this process may be very large. PMID:12457428

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

    PubMed

    2003-01-01

    GW Pharmaceuticals is undertaking a major research programme in the UK to develop and market distinct cannabis-based prescription medicines [THC:CBD, High THC, High CBD] in a range of medical conditions. The cannabis for this programme is grown in a secret location in the UK. It is expected that the product will be marketed in the US in late 2003. GW's cannabis-based products include selected phytocannabinoids from cannabis plants, including D9 tetrahydrocannabinol (THC) and cannabidiol (CBD). The company is investigating their use in three delivery systems, including sublingual spray, sublingual tablet and inhaled (but not smoked) dosage forms. The technology is protected by patent applications. Four different formulations are currently being investigated, including High THC, THC:CBD (narrow ratio), THC:CBD (broad ratio) and High CBD. GW is also developing a specialist security technology that will be incorporated in all its drug delivery systems. This technology allows for the recording and remote monitoring of patient usage to prevent any potential abuse of its cannabis-based medicines. GW plans to enter into agreements with other companies following phase III development, to secure the best commercialisation terms for its cannabis-based medicines. In June 2003, GW announced that exclusive commercialisation rights for the drug in the UK had been licensed to Bayer AG. The drug will be marketed under the Sativex brand name. This agreement also provides Bayer with an option to expand their license to include the European Union and certain world markets. GW was granted a clinical trial exemption certificate by the Medicines Control Agency to conduct clinical studies with cannabis-based medicines in the UK. The exemption includes investigations in the relief of pain of neurological origin and defects of neurological function in the following indications: multiple sclerosis (MS), spinal cord injury, peripheral nerve injury, central nervous system damage, neuroinvasive cancer, dystonias, cerebral vascular accident and spina bifida, as well as for the relief of pain and inflammation in rheumatoid arthritis and also pain relief in brachial plexus injury. The UK Government stated that it would be willing to amend the Misuse of Drugs Act 1971 to permit the introduction of a cannabis-based medicine. GW stated in its 2002 Annual Report that it was currently conducting five phase III trials of its cannabis derivatives, including a double-blind, placebo-controlled trial with a sublingual spray containing High THC in more than 100 patients with cancer pain in the UK. Also included is a phase III trial of THC:CBD (narrow ratio) being conducted in patients with severe pain due to brachial plexus injury, as are two more phase III trials of THC:CBD (narrow ratio) targeting spasticity and bladder dysfunction in multiple sclerosis patients. Another phase III trial of THC:CBD (narrow ratio) in patients with spinal cord injury is also being conducted. Results from the trials are expected during 2003. Three additional trials are also in the early stages of planning. These trials include a phase I trial of THC:CBD (broad ratio) in patients with inflammatory bowel disease, a phase I trial of High CBD in patients with psychotic disorders such as schizophrenia, and a preclinical trial of High CBD in various CNS disorders (including epilepsy, stroke and head injury). GW Pharmaceuticals submitted an application for approval of cannabis-based medicines to UK regulatory authorities in March 2003. Originally GW hoped to market cannabis-based prescription medicines by 2004, but is now planning for a launch in the UK towards the end of 2003. Several trials for GW's cannabis derivatives have also been completed, including four randomised, double-blind, placebo-controlled phase III clinical trials conducted in the UK. The trials were initiated by GW in April 2002, to investigate the use of a sublingual spray containing THC:CBD (narrow ratio) in the following medical conditions: pain in spinal cord injury, pain and sleep in MS and spinal cord injury, neuro

  15. Interactions Between Pharmaceutical Representatives and Doctors in Training

    PubMed Central

    Zipkin, Daniella A; Steinman, Michael A

    2005-01-01

    Objective Medical school and residency are formative years in establishing patterns of prescribing. We aimed to review the literature regarding the extent of pharmaceutical industry contact with trainees, attitudes about these interactions, and effects on trainee prescribing behavior, with an emphasis on points of potential intervention and policy formation. Design We searched MEDLINE from 1966 until May 2004 for English language articles. All original articles were included if the abstract reported content relevant to medical training and the pharmaceutical industry. Editorials, guidelines, and policy recommendations were excluded. Measurements and Main Results Contact with pharmaceutical representatives was common among residents. The majority of trainees felt that the interactions were appropriate. A minority felt that their own prescribing could be influenced by contact or gifts, but were more likely to believe that others' prescribing could be influenced. Resident prescribing was associated with pharmaceutical representative visits and the availability of samples. A variety of policy and educational interventions appear to influence resident attitudes toward interactions with industry, although data on the long-term effects of these interventions are limited. Overall, residents reported insufficient training in this area. Conclusions The pharmaceutical industry has a significant presence during residency training, has gained the overall acceptance of trainees, and appears to influence prescribing behavior. Training programs can benefit from policies and curricula that teach residents about industry influence and ways in which to critically evaluate information that they are given. Recommendations for local and national approaches are discussed. PMID:16050893

  16. Dynamics and attenuation of acidic pharmaceuticals along a river stretch.

    PubMed

    Radke, Michael; Ulrich, Hanna; Wurm, Carolin; Kunkel, Uwe

    2010-04-15

    While substantial knowledge on the occurrence of pharmaceuticals in the environment is available, their behavior and fate in surface waters is still poorly understood. Therefore, the aims of this study were to analyze the short-term dynamics of selected pharmaceuticals along a 13.6 km long river stretch downstream of a wastewater treatment plant (WWTP), and to quantify their attenuation by a mass balance approach. Four acidic pharmaceuticals (bezafibrate, clofibric acid, diclofenac, naproxen) with different attenuation properties were measured over a period of three weeks at high temporal resolution, and in situ photolysis experiments were carried out. The average concentrations of pharmaceuticals were between 9 +/- 4 and 339 +/- 133 ng L(-1), corresponding to loads between 1.9 +/- 1.2 and 63 +/- 37 g d(-1) (n = 134). The temporal dynamics of pharmaceuticals was closely related to discharge of the WWTP and precipitation, and highest concentrations were observed at the beginning of a discharge event. During a dry period, naproxen was eliminated along the river stretch with a dissipation time (DT(50)) of 3.6 +/- 2.1 days while the other compounds did not exhibit significant attenuation. As photolysis and other abiotic processes were of limited quantitative relevance, the attenuation of naproxen can most likely be attributed to biotransformation. PMID:20235612

  17. Effects of Glycosylation on the Stability of Protein Pharmaceuticals

    PubMed Central

    SOLÁ, RICARDO J.; GRIEBENOW, KAI

    2008-01-01

    In recent decades, protein-based therapeutics have substantially expanded the field of molecular pharmacology due to their outstanding potential for the treatment of disease. Unfortunately, protein pharmaceuticals display a series of intrinsic physical and chemical instability problems during their production, purification, storage, and delivery that can adversely impact their final therapeutic efficacies. This has prompted an intense search for generalized strategies to engineer the long-term stability of proteins during their pharmaceutical employment. Due to the well known effect that glycans have in increasing the overall stability of glycoproteins, rational manipulation of the glycosylation parameters through glycoengineering could become a promising approach to improve both the in vitro and in vivo stability of protein pharmaceuticals. The intent of this review is therefore to further the field of protein glycoengineering by increasing the general understanding of the mechanisms by which glycosylation improves the molecular stability of protein pharmaceuticals. This is achieved by presenting a survey of the different instabilities displayed by protein pharmaceuticals, by addressing which of these instabilities can be improved by glycosylation, and by discussing the possible mechanisms by which glycans induce these stabilization effects. PMID:18661536

  18. Pharmaceuticals as indictors of sewage-influenced groundwater

    NASA Astrophysics Data System (ADS)

    Müller, Beate; Scheytt, Traugott; Asbrand, Martin; de Casas, Andrea Mross

    2012-09-01

    A set of human pharmaceuticals enables identification of groundwater that is influenced by sewage and provides information on the time of recharge. As the consumption rates of the investigated pharmaceuticals have changed over time, so too has the composition of the sewage. At the study area, south of Berlin (Germany), irrigation was performed as a method of wastewater clean-up at sewage irrigation farms until the early 1990s. Today, treated wastewater is discharged into the surface-water-stream Nuthegraben. Groundwater and surface-water samples were analyzed for the pharmaceutical substances clofibric acid, bezafibrate, diclofenac, carbamazepine and primidone, the main ions and organic carbon. The pharmaceutical substances were detected at concentrations up to microgram-per-liter level in groundwater and surface-water samples from the Nuthegraben Lowland area and from the former irrigation farms. Concentrations detected in groundwater are generally much lower than in surface water and there is significant variation in the distribution of pharmaceutical concentrations in groundwater. Groundwater influenced by the irrigation of sewage water shows higher primidone and clofibric-acid concentrations. Groundwater influenced by recent discharge of treated sewage water into the surface water shows high carbamazepine concentrations while concentrations of primidone and clofibric acid are low.

  19. The valuation of construction companies

    E-print Network

    Sassine, Edmond, 1980-

    2004-01-01

    The main objective of this thesis is to study the valuation of construction companies in mergers and acquisitions. The thesis is divided into three main parts; Mergers and Acquisitions, Valuation, and a Case Study. Mergers ...

  20. Building a better biotech company.

    PubMed

    Turner, L

    1999-02-01

    Invitrogen is a good case study for how to become successful in the rapidly changing field of biotechnology by observing basic business principles. It also shows that even the most successful companies make mistakes. The exciting opportunities that present themselves to high-technology companies in fast-growth fields can divert attention away from the most basic business tenets of quality, profitability, and market responsiveness. CEOs in the biotechnology sector would be well served to review their Business 101 lessons. PMID:10052312

  1. The pharmaceutical industry and the German National Socialist Regime: I.G. Farben and pharmacological research.

    PubMed

    López-Muñoz, F; García-García, P; Alamo, C

    2009-02-01

    Before the National Socialist party came to power, the German pharmaceutical industry constituted an international reference as far as the development of new medicines was concerned, having been responsible for synthetic analgesics (phenacetin, phenazones, acetylsalicylic acid), arsphenamine, barbiturates and sulfonamides. The year 1925 saw the founding of I.G. Farben (Interessen-Gemeinschaft Farbenindustrie AG), a conglomerate of companies that would monopolize the country's chemical production and come to own all its major pharmaceutical industries. During the World War II, I.G. Farben participated in numerous operations associated with the criminal activities of the Nazi executive, including the use of slave labour in plants built close to concentration camps, such as that at Auschwitz. With regard to medical and pharmacological research projects, I.G. Farben became involved in experimental programmes using patients from the Nazi regime's euthanasia programmes and healthy subjects recruited without their consent from concentration camps, on whom various pharmacological substances were tested, including sulfamide and arsenical derivatives and other preparations whose composition is not precisely known (B-1012, B-1034, 3382 or Rutenol, 3582 or Acridine), generally in relation to the treatment of infectious diseases, such as typhus, erysipelas, scarlet fever or paratyphoid diarrhoea. Furthermore, I.G. Farben played a decisive role in the German army's chemical warfare programme, contributing to the development of the first two neurotoxic substances, later known as 'nerve agents', tabun and sarin. Some of these activities came to light as a result of the one the famous Nuremberg Trials in 1947, which saw 24 executives and scientists from I.G. Farben brought to justice for, among other offences, the use of slave labour in the concentration camps and forced experimentation with drugs on prisoners. PMID:19125905

  2. Literacy and Young Children: Research-Based Practices. Solving Problems in the Teaching of Literacy.

    ERIC Educational Resources Information Center

    Barone, Diane M., Ed.; Morrow, Lesley Mandel, Ed.

    This book presents current, research-based best practices for supporting young children's development as readers and writers. From leading figures in early literacy, the book's essays demonstrate that scientifically grounded instruction need not be dull, drill-oriented, or "one-size-fits-all"--rather, it describes language-rich approaches to…

  3. Use of Research-Based Information among Leaders of Public Health Agencies

    ERIC Educational Resources Information Center

    Toomey, Traci L.; Tramel, Sarah; Erickson, Darin J.; Lenk, Kathleen M.

    2009-01-01

    Background: Researchers have identified numerous policies and programs effective in reducing public health problems, yet many of these programs and policies have not been implemented throughout communities and states. Purpose: To assess the use of research-based information among leaders in the local public health system. Methods: We conducted a…

  4. An Efficacy Trial of Research-Based Curriculum Materials with Curriculum-Based Professional Development

    ERIC Educational Resources Information Center

    Taylor, Joseph A.; Getty, Stephen R.; Kowalski, Susan M.; Wilson, Christopher D.; Carlson, Janet; Van Scotter, Pamela

    2015-01-01

    This study examined the efficacy of a curriculum-based intervention for high school science students. Specifically, the intervention was two years of research-based, multidisciplinary curriculum materials for science supported by comprehensive professional development for teachers that focused on those materials. A modest positive effect was…

  5. How Can You Evaluate Whether a Program Is Research Based? Parent Page. Winter 2007

    ERIC Educational Resources Information Center

    National Research Center on Learning Disabilities, 2007

    2007-01-01

    The benefit of selecting educational programs based on proven research is that they can deliver what is promised if they are implemented as intended. These research-based educational programs are like the medicine that your physician prescribes. Improvement in the medical condition requires that the medicine be taken as prescribed. These…

  6. Research-Based Methods of Reading Instruction for English Language Learners, Grades K-4

    ERIC Educational Resources Information Center

    Vaughn, Sharon; Linan-Thompson, Sylvia

    2007-01-01

    At last, a truly helpful, practical guide for K-4 teachers who want to ensure that their approach to teaching young English language learners is based on research and grounded in proven classroom practices. The authors of ASCD's best-selling book "Research-Based Methods of Reading Instruction, Grades K-3" explain how you can help the English…

  7. Research Based Tactile and Haptic Interaction Guidelines Jim Carter David Fourney

    E-print Network

    Carter, Jim

    , Ergonomics, Haptic I/O, Input devices and strategies, D.2.0 Software Engineering General, Standards GeneralResearch Based Tactile and Haptic Interaction Guidelines Jim Carter David Fourney carter, CANADA ABSTRACT In this paper, we survey guidance on tactile and haptic interactions provided by various

  8. Challenging the Research Base of the Common Core State Standards: A Historical Reanalysis of Text Complexity

    ERIC Educational Resources Information Center

    Gamson, David A.; Lu, Xiaofei; Eckert, Sarah Anne

    2013-01-01

    The widely adopted Common Core State Standards (CCSS) call for raising the level of text complexity in textbooks and reading materials used by students across all grade levels in the United States; the authors of the English Language Arts component of the CCSS build their case for higher complexity in part upon a research base they say shows a…

  9. Internet Searching by K-12 Students: A Research-Based Process Model

    ERIC Educational Resources Information Center

    Guinee, Kathleen

    2004-01-01

    Understanding K-12 students' Web-based research practices and the challenges posed by this task, can help educators assist students with learning to manage this complex process. In this presentation, I propose a research-based process model of K-12 students' Internet search practices. The model describes the ways in which students search for,…

  10. Identifying Themes for Research-Based Development of Pedagogy and Guidance in Higher Education

    ERIC Educational Resources Information Center

    Jääskelä, Päivikki; Nissilä, Pia

    2015-01-01

    The high value accorded to the research-based development of education in higher education communities means that researchers in the field have an important role in determining the foci of such efforts. However, it is important to ask whether higher education research is providing answers that satisfy practical educational needs. In this study,…

  11. Catapulting Shifts in Images, Understandings, and Actions for Family Members through Research-Based Drama

    ERIC Educational Resources Information Center

    Dupuis, Sherry L.; Gillies, Jennifer; Mitchell, Gail J.; Jonas-Simpson, Christine; Whyte, Colleen; Carson, Jennifer

    2011-01-01

    This article examined how images, understandings, and actions change for family members of persons with dementia after the introduction of a research-based drama called I'm Still Here. Guided by interpretivist phenomenology, a set of seven pre- and post-performance focus groups were conducted with family members (n = 48) in four cities. Findings…

  12. Research-Based Educational Practices for Students with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Ryan, Joseph B.; Hughes, Elizabeth M.; Katsiyannis, Antonis; McDaniel, Melanie; Sprinkle, Cynthia

    2011-01-01

    Autism spectrum disorder (ASD) has become the fastest growing disability in the United States, with current prevalence rates estimated at as many as 1 in 110 children (CDC, 2010). This increase in the number of students identified with ASD has significant implications for public schools. The most popular research-based educational practices for…

  13. Using Resource- and Research-Based Learning as a Method of In-Service Teacher Training.

    ERIC Educational Resources Information Center

    Wills, Alison

    2003-01-01

    Discusses teaching information literacy, collaboration between teachers and teacher librarians, incorporating information and communication technologies into the curriculum, and helping teachers become familiar with technology. Describes an applicable research-based activity that involved students in grades six through nine at the International…

  14. Experimental Evaluation of the Effects of a Research-Based Preschool Mathematics Curriculum

    ERIC Educational Resources Information Center

    Clements, Douglas H.; Sarama, Julie

    2008-01-01

    A randomized-trials design was used to evaluate the effectiveness of a preschool mathematics program based on a comprehensive model of research-based curricula development. Thirty-six preschool classrooms were assigned to experimental (Building Blocks), comparison (a different preschool mathematics curriculum), or control conditions. Children were…

  15. Issues Related to Student Persistence toward Graduation in Public Schools: A Research Based Tool for Educators

    ERIC Educational Resources Information Center

    Fritz, Ronald D.; Fisher, Deanne L.; Scott, Nancy L.

    2012-01-01

    This abstract focuses on a project report addressing persistence toward graduation. The product will provide a comprehensive resource for school district leaders to use in the identification of at-risk students and research based dropout prevention programs. With the passage of "No Child Left Behind" in 2002 legislation has put a greater…

  16. Using Research Based Assessment Tools in Professional Development in Current Electricity

    ERIC Educational Resources Information Center

    Shen, Ji; Gibbons, Patrick C.; Wiegers, John F.; McMahon, Ann P.

    2007-01-01

    We present a practical way of adapting and using four research-based assessments for different purposes in an electricity and magnetism course for K-8 science teachers. The course is designed to accomplish conceptual change toward accepted scientific conceptions as well as introducing teachers to materials and activities appropriate for their…

  17. Improving Students' Understanding of Quantum Measurement. II. Development of Research-Based Learning Tools

    ERIC Educational Resources Information Center

    Zhu, Guangtian; Singh, Chandralekha

    2012-01-01

    We describe the development and implementation of research-based learning tools such as the Quantum Interactive Learning Tutorials and peer-instruction tools to reduce students' common difficulties with issues related to measurement in quantum mechanics. A preliminary evaluation shows that these learning tools are effective in improving students'…

  18. Pharmaceutical innovation: possibilities and limits of personalised medicine.

    PubMed

    2008-06-01

    In the framework of the German EU Council Presidency, the Federal Ministry of Health and the Federal Institute for Drugs and Medical Devices, an expert conference on Pharmaceutical Innovation - Possibilities and Limits of Personalised Medicine was held in Bonn, on June 11-12, 2007. It was financially supported by the European Commission. The conference aimed to intensify a sustainable networking among the participants and develop robust concepts for the future design of pharmaceutical research and production within the EU. To this end, various stakeholders from the fields of pharmaceutical research, production and licensing were brought together. This publication summarises the main results of the conference. It may reflect the personal views of the individual contributors and is not necessarily the perspective of the Federal Ministry of Health or of the Federal Institute for Drugs and Medical Devices. PMID:18481031

  19. Production of Pharmaceutical Proteins in Solanaceae Food Crops

    PubMed Central

    Rigano, Maria Manuela; De Guzman, Giorgio; Walmsley, Amanda M.; Frusciante, Luigi; Barone, Amalia

    2013-01-01

    The benefits of increased safety and cost-effectiveness make vegetable crops appropriate systems for the production and delivery of pharmaceutical proteins. In particular, Solanaceae edible crops could be inexpensive biofactories for oral vaccines and other pharmaceutical proteins that can be ingested as minimally processed extracts or as partially purified products. The field of crop plant biotechnology is advancing rapidly due to novel developments in genetic and genomic tools being made available today for the scientific community. In this review, we briefly summarize data now available regarding genomic resources for the Solanaceae family. In addition, we describe novel strategies developed for the expression of foreign proteins in vegetable crops and the utilization of these techniques to manufacture pharmaceutical proteins. PMID:23434646

  20. Update in the pharmaceutical therapy of the irritable bowel syndrome.

    PubMed

    Thielecke, F; Maxion-Bergemann, S; Abel, F; Gonschior, A K

    2004-04-01

    The therapeutic management of the irritable bowel syndrome (IBS) is ineffective and not satisfying either patients or practitioners. Research in functions of the enteric nervous system and its interaction with the central nervous system is the basis for the development of emerging pharmaceuticals in therapy of the IBS. These pharmaceuticals include agents such as opioid agonists, psychotropic agents and particularly serotonin receptor modulators. These novel pharmaceuticals aim to provide a more comprehensive approach in the therapy of the IBS and will serve both patients and practitioners. So far, the US Food and Drug Administration has approved two agents specifically for the treatment of the IBS, both belonging to the group of serotonin receptor modulators. However, questions remain whether a single therapy is sufficient in the management of IBS because this disease is influenced by biological and psychological as well as cultural and social factors. PMID:15161123

  1. Click Chemistry, a Powerful Tool for Pharmaceutical Sciences

    PubMed Central

    Hein, Christopher D.; Liu, Xin-Ming; Wang, Dong

    2008-01-01

    Click chemistry refers to a group of reactions that are fast, simple to use, easy to purify, versatile, regiospecific, and give high product yields. While there are a number of reactions that fulfill the criteria, the Huisgen 1,3-dipolar cycloaddition of azides and terminal alkynes has emerged as the frontrunner. It has found applications in a wide variety of research areas, including materials sciences, polymer chemistry, and pharmaceutical sciences. In this manuscript, important aspects of the Huisgen cycloaddition will be reviewed, along with some of its many pharmaceutical applications. Bioconjugation, nanoparticle surface modification, and pharmaceutical-related polymer chemistry will all be covered. Limitations of the reaction will also be discussed. PMID:18509602

  2. Managing unused pharmaceuticals in a hospice setting: a pilot study.

    PubMed

    Kreisberg, Joel; Zheng, Connie

    2011-12-01

    With the escalating use of pharmaceuticals in health care, there has been increasing anxiety over the potential health risks associated with pharmaceutical waste accumulating in the environment. This research provided nurses in a hospice care facility in Concord, California, with education and training to offer patients a medication disposal service through the use of mail-back envelopes. Over the 6-month study period, 160 of the 400 distributed mailers were returned for disposal. The total weight of pharmaceuticals diverted for incineration was 107 pounds, with an average weight of 0.66 pounds per mailer. This study suggests that the mailer system and proper education of medical staff have the potential to improve medical waste management, but alternative approaches may be necessary to increase the rate of envelop return. PMID:21521709

  3. Listening for Prescriptions: A National Consultation on Pharmaceutical Policy Issues

    PubMed Central

    Morgan, Steve; Cunningham, Colleen M.

    2010-01-01

    Objectives and Methods: Pharmaceutical policy is an increasingly costly, essential and challenging component of health system management. We sought to identify priority pharmaceutical policy issues in Canada and to translate them into research priorities using key informant interviews, stakeholder surveys and a deliberative workshop. Results: We found consensus on overarching policy goals: to provide all Canadians with equitable and sustainable access to necessary medicines. We also found widespread frustration that many key pharmaceutical policy issues in Canada — including improving prescription drug financing and pricing — have been persistent challenges owing to a lack of policy coordination. The coverage of extraordinarily costly medicines for serious conditions was identified as a rapidly emerging policy issue. Conclusion: Targeted research and knowledge translation activities can help address key policy issues and, importantly, challenges of policy coordination in Canada and thereby reduce inequity and inefficiency in policy approaches and outcomes. PMID:22043223

  4. Eastern Kodak Company

    SciTech Connect

    Y.S. Tyan

    2009-06-30

    Lighting consumes more than 20% of electricity generated in the United States. Solid state lighting relies upon either inorganic or organic light-emitting diodes (OLEDs). OLED devices because of their thinness, fast response, excellent color, and efficiency could become the technology of choice for future lighting applications, provided progress is made to increase power efficiency and device lifetime and to develop cost-effective manufacturing processes. As a first step in this process, Eastman Kodak Company has demonstrated an OLED device architecture having an efficacy over 50 lm/W that exceeds the specifications of DOE Energy Star Program Requirements for Solid State Lighting. The project included work designed to optimize an OLED device, based on a stacked-OLED structure, with performance parameters of: low voltage; improved light extraction efficiency; improved internal quantum efficiency; and acceptable lifetime. The stated goal for the end of the project was delivery of an OLED device architecture, suitable for development into successful commercial products, having over 50 lum/W power efficiency and 10,000 hours lifetime at 1000 cd/m{sup 2}. During the project, Kodak developed and tested a tandem hybrid IES device made with a fluorescent blue emitter, a phosphorescent yellow emitter, and a phosphorescent red emitter in a stacked structure. The challenge was to find low voltage materials that do not absorb excessive amounts of emitted light when the extraction enhancement structure is applied. Because an extraction enhancement structure forces the emitted light to travel several times through the OLED layers before it is emitted, it exacerbates the absorption loss. A variety of ETL and HTL materials was investigated for application in the low voltage SSL device structure. Several of the materials were found to successfully yield low operating device voltages without incurring excessive absorption loss when the extraction enhancement structure was applied. An internal extraction layer comprises two essential components: a light extraction element (LEE) that does the actual extraction of emitted light and a light coupling layer (LCL) that allows the emitted light to interact with the extraction element. Modeling results show that the optical index of the LCL needs to be high, preferably higher than that of the organic layers with an n value of {approx}1.8. In addition, since the OLED structure needs to be built on top of it the LCL needs to be physically and chemically benign. As the project concluded, our focus was on the tandem hybrid device, which proved to be the more efficient architecture. Cost-efficient device fabrication will provide the next challenges with this device architecture in order to allow this architecture to be commercialized.

  5. Expert stakeholders' views on the management of human pharmaceuticals in the environment.

    PubMed

    Doerr-MacEwen, Nora A; Haight, Murray E

    2006-11-01

    Human pharmaceuticals are ubiquitous water contaminants that may have subtle detrimental effects on aquatic organisms, and possibly also on human health. The risks of pharmaceuticals, or pharmaceutically active compounds, remain poorly understood. Awareness of the presence of pharmaceuticals in the environment, coupled with evidence of effects such as fish feminization, however, suggest that precautionary management action to reduce the release of pharmaceuticals to the environment should be considered. The purpose of our study was to evaluate the scope of the issue and possible management strategies from the perspectives of expert stakeholders, drawn from government, academia, and the pharmaceutical and consulting industries, involved in scientific research or policy and management activity, from Canada, the United States, and Europe. Twenty-seven interviewees were asked about their views on management strategies such as pharmaceutical-return programs and incentives for the development of "green" pharmaceuticals. Interviewees generally believed that pharmaceuticals in the environment represented a concern for both human and ecosystem health, although they were more concerned about impacts on aquatic ecosystems. They believed that advanced wastewater treatment technology, education of medical professionals to reduce overprescription, pharmaceutical-return programs coupled with public education, and requirements for all municipalities to have a minimum of secondary wastewater treatment were the most effective management strategies to reduce the environmental impacts of pharmaceuticals. These strategies should be considered by governments interested in managing the risks of human pharmaceuticals in the environment. Combinations of management strategies will likely be most effective in mitigating the risks presented by pharmaceuticals. PMID:16955232

  6. Occurrence of veterinary pharmaceuticals in the aquatic environment in Flanders

    NASA Astrophysics Data System (ADS)

    Servaes, K.; Vanermen, G.; Seuntjens, P.

    2009-04-01

    There is a growing interest in the occurrence of pharmaceuticals in the aquatic environment. Pharmaceuticals are classified as so-called ‘emerging pollutants'. ‘Emerging pollutants' are not necessarily new chemical compounds. Often these compounds are already present in the environment for a long time. But, their occurrence and especially their impact on the environment has only recently become clear. Consequently, data on their occurrence are rather scarce. In this study, we focus on the occurrence of veterinary pharmaceuticals in surface water in Flanders. We have only considered active substances administered to cattle, pigs and poultry. Based on the literature and information concerning the use in Belgium, a selection of 25 veterinary pharmaceuticals has been made. This selection consists of the most important antibiotics and antiparasitic substances applied in veterinary medicine in Belgium. We develop an analytical methodology based on UPLC-MS/MS for the detection of these veterinary pharmaceuticals in surface water. Therefore, the mass characteristics as well as the optimum LC conditions will be determined. To obtain limits of detection as low as possible, the samples are concentrated prior to analysis using solid phase extraction (SPE). Different SPE cartridges will be tested during the method development. At first, this SPE sample pre-treatment is performed off-line. In a next step, online SPE is optimized for this purpose. The analytical procedure will be subject to an in-house validation study, thereby determining recovery, repeatability (% RSD), limits of detection and limits of quantification. Finally, the developed methodology will be applied for monitoring the occurrence of veterinary pharmaceuticals in surface water and groundwater in Flanders. These water samples will be taken in areas characterized by intensive cattle breeding. Moreover, the samples will be collected during springtime. In this season, farmers apply manure, stored during winter, onto the fields.

  7. Strategic challenges in neurotherapeutic pharmaceutical development.

    PubMed

    Gallen, Christopher C

    2004-01-01

    Developing new therapeutics presents formidable economic, scientific, and medical challenges that are exacerbated by special factors in neurotherapeutics development, e.g., the complexity of the CNS with its attendant need to sometimes affect multiple pathways, the lack of clarity of disease etiology, inadequacy of available animal models, and difficulties in defining disease populations and quantifying treatment response. This paper reviews the economic challenges faced by therapeutics developers in general and neurotherapeutics developers in particular. It discusses key scientific challenges, particularly those pertinent to neurotherapeutics development, as a background to proposing a different industrial strategy to drive future therapeutics development. This Biodesign strategy potentially surpasses previous paradigms by incorporating elements such as the use of disease modeling to select better targets and potential therapies, information science-based approaches to enhance small molecule chemistry, exploitation of the potential for biological technologies to rapidly generate mechanistic probes, and development of improved approaches for using animal models and studying human molecules mechanistically and biologically. Synergistic use of these elements can change the overall business model of companies engaged in neurotherapeutics development. The Biodesign paradigm has the potential to both markedly enhance the development of new therapies and to address some of the economic challenges facing healthcare systems and therapeutics developers alike. PMID:15717016

  8. Regulatory Aspects of Pharmaceuticals’ Exports in Gulf Cooperation Council Countries

    PubMed Central

    Pateriya, S; Janodia, MD; Deshpande, PB; Ligade, VS; Talole, KB; Kulshrestha, T; Kamariya, Y; Musmade, PB; Udupa, N

    2011-01-01

    The Gulf cooperation council (GCC) region is considered as “Emerging market” for pharmaceutical export and bilateral trade. The understanding of the regulatory requirements of this region can be beneficial for pharmaceutical export. Some incidents of the year 2008-09, like recession or economic slowdown in highly well-off and regulated market of the EU and US, raised the demand for alternate destinations for business. The regulations of Gulf countries are encouraging the import of quality generic products, which can be good news to the Indian drug manufacturers. PMID:21731362

  9. The potential of flow-through optosensors in pharmaceutical analysis.

    PubMed

    Molina Díaz, A; Ruiz Medina, A; Fernández de Córdova, M L

    2002-05-15

    The fundamental principles of flow-through optosensors, together with the most significant procedures and alternatives developed in the applications of flow-through optosensors to pharmaceutical analysis are reviewed. The most frequently used solid sensing zones, flow-through cells, manifolds, regeneration step and types of detection are considered. Single parameter, biparameter, and multiparameter sensors developed are reviewed and their most relevant features presented. Finally, a critical comparison with other analytical methodologies/techniques is performed and the potential of flow-through optosensors in pharmaceutical analysis and their future trends discussed. PMID:12008119

  10. Amorphization of Molecular Liquids of Pharmaceutical Drugs by Acoustic Levitation

    NASA Astrophysics Data System (ADS)

    Benmore, C. J.; Weber, J. K. R.

    2011-08-01

    It is demonstrated that acoustic levitation is able to produce amorphous forms from a variety of organic molecular compounds with different glass forming abilities. This can lead to enhanced solubility for pharmaceutical applications. High-energy x-ray experiments show that several viscous gels form from saturated pharmaceutical drug solutions after 10-20 min of levitation at room temperature, most of which can be frozen in solid form. Laser heating of ultrasonically levitated drugs can also result in the vitrification of molecular liquids, which is not attainable using conventional amorphization methods.

  11. Four state companies are markedly different

    SciTech Connect

    Aalund, L.R.

    1995-08-21

    The Journal continues its profiles of state owned oil companies with a return to the Persian Gulf, South America, and a first time look at the state oil company of Romania, one of Eastern Europe`s most active and oldest producers. The government of Kazakhstan`s activities are also covered in this report. These profiles detail the organization of the companies, with emphasis on upstream and downstream operations. Support functions, though essential to a company, are not covered in detail. Company projects and capabilities are only described in this report when necessary to put the company in perspective. Following are the profiles of state companies for Bahrain, Kuwait, Romania, and Venezuela.

  12. The pharmaceutical supply chain : a diagnosis of the state-of-the-art

    E-print Network

    Singh, Mahender Pal, 1965-

    2005-01-01

    This study explores the current supply chain trends in the pharmaceutical industry. The main objective of the study is to characterize the pharmaceutical industry and identify excellent supply chain practices. Indeed, the ...

  13. Design of a small-scale continuous linear motion pharmaceutical filtration module

    E-print Network

    Wong, Katherine Wing-Shan

    2010-01-01

    A new small-scale continuous linear motion pharmaceutical filtration prototype was designed, fabricated, and tested. The goal of this unit is to filter an Active Pharmaceutical Ingredient (API) from a mixture of API ...

  14. Deepening the Reform of Higher Pharmaceutical Education for the 21st Century.

    ERIC Educational Resources Information Center

    Wu, Xiaoming

    2000-01-01

    Development of the pharmaceutical industry in China depends on research and development of new drugs. The development of high-quality education for potential pharmaceutical practitioners is central to the development of this industry in China. (JM)

  15. Theoretical and experimental investigation of particle interactions in pharmaceutical powder blending

    E-print Network

    Pu, Yu, Ph. D. Massachusetts Institute of Technology

    2007-01-01

    In pharmaceutical manufacturing practices, blending of active pharmaceutical ingredient (API) with excipients is a crucial step in that homogeneity of active ingredient after blending is a key issue for the quality assurance ...

  16. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ...Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments...GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced in...

  17. Pharmaceuticals in Surface Waters and Potential Transfer to Irrigated Food Crops

    EPA Science Inventory

    A number of pharmaceuticals have been detected in surface waters across the United States. The objective of this study was to evaluate the presence of selected pharmaceuticals (macrolidic antibiotics and pseudoephedrine) and illicit drugs (methamphetamine, Ecstasy) in surface wat...

  18. Comparative pharmaceutical metabolism by rainbow trout (Oncorhynchus mykiss) liver S9 fractions

    EPA Science Inventory

    The occurrence of pharmaceuticals in the environment presents a challenge of growing concern. In contrast to many industrial compounds, pharmaceuticals undergo extensive testing prior to their introduction to the environment. In principle, therefore, it may be possible to employ ...

  19. Layer bonding of solvent-cast thin films for pharmaceutical solid dosage forms

    E-print Network

    Kim, Won, S.M. Massachusetts Institute of Technology

    2010-01-01

    In the pharmaceutical industry, the conventional tablet manufacturing process, a batch-based process based on solid powder handling, presents challenges such as inhomogeneous blending between Active Pharmaceutical Ingredients ...

  20. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY...Pharmaceutical Science and Clinical Pharmacology. General Function of the...a new patient-centric clinical pharmacology approach to drug...