Science.gov

Sample records for research-based pharmaceutical companies

  1. Transcription Pharmaceutical Company

    E-print Network

    Oliva, Aude

    Transcription Pharmacy CDC Pharmaceutical Company Pharmacy Benefits Manager Analytics ICU Statistics Registries Social Services Public Health Clinical Lab Copy&Transport Associations Debt Collection thedatamap.org #12;Transcription Pharmacy CDC Pharmaceutical Company Pharmacy Benefits Manager Analytics

  2. The Relationship Between Pharmaceutical Companies and Physicians

    E-print Network

    Aggarwal, Khushbu

    2010-01-01

    >. 7.Prescription Drugs: Pharmaceutical Research andpharmaceutical representatives, prefer and rapidly prescribe the advertised drug,Pharmaceutical companies provide a more efficient alternative to learning about the newest drugs

  3. 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

  4. 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 ...

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

    PubMed

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

    2014-01-01

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

  6. Business process analysis of yield data flow at a newly merged pharmaceutical company

    E-print Network

    Jiang, Nan, M. Eng. Massachusetts Institute of Technology

    2010-01-01

    Tracking, monitoring, and documentation of the manufacturing performance are significant for pharmaceutical companies under the regulations of Food and Drug Administration (FDA). However, the current yield data are not ...

  7. The study of inventory management of raw materials for a pharmaceutical company

    E-print Network

    Khor, Si Ming Thomas

    2007-01-01

    TCG is a multinational pharmaceutical company. As part of its drive to adopt lean manufacturing methodology in the plant and to stay competitive in the industry, TCG plans to effectively maximize its capital assets and ...

  8. 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

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

    PubMed

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

    2013-01-01

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

  10. INTRODUCTION ADVERTISEMENT FEATURE Every pharmaceutical company craves perpetuity but, in

    E-print Network

    Cai, Long

    a few -- the right to option research usually doesn't come hand-in-hand with the initial investment-based Radius Health. Sometimes the rub lays not so much in finding the partner as in getting that company

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

    PubMed

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

    2012-01-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  14. 38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...Network (VISN) means one of the networks of VA medical facilities located...requested by the VA employee. (3) Marketing to students. Pharmaceutical company...representatives are prohibited from marketing to medical, pharmacy,...

  15. 38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...Network (VISN) means one of the networks of VA medical facilities located...requested by the VA employee. (3) Marketing to students. Pharmaceutical company...representatives are prohibited from marketing to medical, pharmacy,...

  16. 38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...Network (VISN) means one of the networks of VA medical facilities located...requested by the VA employee. (3) Marketing to students. Pharmaceutical company...representatives are prohibited from marketing to medical, pharmacy,...

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

    Heinemann, Lutz

    2009-01-01

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

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

    PubMed Central

    Nagaich, Upendra; Sadhna, Divya

    2015-01-01

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

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

    PubMed Central

    2015-01-01

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

  1. 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

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

    ERIC Educational Resources Information Center

    Education Development Center, Inc., Newton, MA.

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

  3. 38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false On-site activities by pharmaceutical company representatives at VA medical facilities. 1.220 Section 1.220 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS GENERAL PROVISIONS Security and Law Enforcement at Department of Veterans Affairs Facilities...

  4. 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

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

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

    PubMed Central

    Alssageer, Mustafa A.; Kowalski, Stefan R.

    2012-01-01

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

  6. 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

  7. 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

  8. 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

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

    PubMed Central

    2013-01-01

    Background The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8?±?45.6, during the Bush Administration (2001–2008) it was 120.4?±?33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0?±?17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3?±?36.4), Bush (29.5?±?16.2) and Obama (41.7?±?11.1). Conclusions Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required. PMID:23339419

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

    PubMed

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

    2004-01-01

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

  11. 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

  12. The Terminology and Mathematical Analysis of Diagnostic Tests Carl Wagner 2012 When a pharmaceutical company develops a diagnostic test for a given disease, it wants the test

    E-print Network

    Wagner, Carl

    a pharmaceutical company develops a diagnostic test for a given disease, it wants the test to be as accurate positive) and false negatives (individuals who have the disease, but test negative). So, once the test the disease, give them the test, and identify the subset P who test positive. The proportion P(P|D) is known

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

    PubMed

    Lassale, Catherine; Sibenaler, Claire; Béhier, Jehan-Michel; Barthélémy, Philippe; Plétan, Yannick; Courcier, Soizic

    2013-01-01

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

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

    PubMed

    Corot, Claire; Warlin, David

    2013-01-01

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

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

    PubMed

    Malkowski, Jennifer

    2014-01-01

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

  16. 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 ...

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

    PubMed

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

    2015-05-01

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

  18. Herbicide and pharmaceutical relationships

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  19. Need of the regulation for profit percentage investment by pharmaceutical companies in new drug discovery research from the various local traditional medicinal and plant systems.

    PubMed

    Bhattarai, M D

    2012-01-01

    In the modern medical systems the active pharmacological ingredients, effective against any disease is identified, purified and studied for its various effects and side-effects whereas it is not so in the traditional systems. Therefore, it is not surprising that safety concerns have often been raised about the traditional medical products. The major issue now, is to make appropriate situation with basic supports to bring all the available experts and resources together for the identification, purification, and study of efficacy and safety of the active molecules of the popular traditional medicines. Government and public sectors in the countries with such rich traditional medicinal and plant systems have related experts, but they also have much hurdle regarding recruitment and retention of expert human resources, getting fund, purchase and maintenance of equipment, bureaucratic formalities and others. The pharmaceutical companies have basic laboratories with related infrastructure and human resources as well as interest about bringing the drug molecules. To bridge the gap, there is a need of the regulation which will make the pharmaceutical companies to invest certain percentage of their profit in the field of research to identify new drug molecules and to study their effects. It is just not an issue of discovering the active molecule but also of creating the concept and culture of research, purity and quality of drugs, safety of people, and future direction of the human society. PMID:23591178

  20. 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

  1. 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

  2. 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

    ...typically promoted by pharmaceutical sales representatives. Similarly...the largest possible number of sales representatives and VA medical...part of an established drug class, it is important that the proposed...d)) and the behavior of sales representatives on the...

  3. 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

    ...typically promoted by pharmaceutical sales representatives. Similarly...the largest possible number of sales representatives and VA medical...part of an established drug class, it is important that the proposed...d)) and the behavior of sales representatives on the...

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

    PubMed

    Morris, John S

    2011-02-01

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

  5. [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

  6. Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and

    E-print Network

    Davis, Jesse

    Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. In our the statistical team in Leiden supporting the research and development (R&D) as well as vaccine process

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

    PubMed

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

    2008-01-01

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

  8. A Supply Chain Generalized Network Oligopoly Model for Pharmaceuticals

    E-print Network

    Nagurney, Anna

    Pharmaceutical Product Supply Chains #12;The Pharmaceutical Industry Pharmaceutical, that is, medicinal drug in manufacturing, storage, and distribution methods, pharmaceutical drug companies are far from effectively satisfying market demands on a consistent basis. In fact, it has been argued that pharmaceutical drug supply

  9. GW-1000. GW Pharmaceuticals.

    PubMed

    Smith, Paul F

    2004-07-01

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

  10. 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

    ... Pharmaceutical Quality System: A Practical Approach to Effective Life- Cycle Implementation of Systems and... Approach to Effective Life- Cycle Implementation of Systems and Processes for Pharmaceutical Manufacturing... from companies that have implemented a Pharmaceutical Quality System across the product life...

  11. A Supply Chain Generalized Network Oligopoly Model Pharmaceuticals Under Brand Differentiation

    E-print Network

    Nagurney, Anna

    A Supply Chain Generalized Network Oligopoly Model for Pharmaceuticals Under Brand Differentiation construct a generalized network oligopoly model with arc mul- tipliers for supply chains of pharmaceutical competition. Keywords: Perishable products, pharmaceutical companies, healthcare, supply chains, brand

  12. Agreements at the Pharmaceutical/University Interface.

    ERIC Educational Resources Information Center

    Ku, Katherine

    1987-01-01

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

  13. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

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

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

  14. Recognizing misleading pharmaceutical marketing online.

    PubMed

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

    2014-01-01

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

  15. Pharmaceutical Supply Chain

    E-print Network

    Nagurney, Anna

    ingredients for drugs sold in the United States are outsourced (Economy In Crisis (2010)). PharmaceuticalPharmaceutical Supply Chain Networks with Outsourcing Nagurney, Li, and Nagurney Pharmaceutical Engineering University of Hartford, West Hartford, CT 06117 #12;Pharmaceutical Supply Chain Networks

  16. Mergers and innovation in the pharmaceutical industry.

    PubMed

    Comanor, William S; Scherer, F M

    2013-01-01

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

  17. 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 ...

  18. Johnson & Johnson Pharmaceutical Research & Development L.L.C., a member of Johnson and Johnson's family of companies, is recruiting for a Principal Research Scientist for Network

    E-print Network

    Dalkilic, Mehmet

    's family of companies, is recruiting for a Principal Research Scientist for Network Pharmacology, located to accelerate time to market of differentiated medicines for immunology through the use of informatics research groups in these areas. The individual will be responsible for working with internal teams

  19. Pharmaceutical Analysis as a Branch of Pharmaceutics

    ERIC Educational Resources Information Center

    Connors, Kenneth A.

    1977-01-01

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

  20. 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.

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

    PubMed

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

    2013-10-01

    Short term toxicity studies are conducted in animals to provide information on major adverse effects typically at the maximum tolerated dose (MTD). Such studies are important from a scientific and ethical perspective as they are used to make decisions on progression of potential candidate drugs, and to set dose levels for subsequent regulatory studies. The MTD is usually determined by parameters such as clinical signs, reductions in body weight and food consumption. However, these assessments are often subjective and there are no published criteria to guide the selection of an appropriate MTD. Even where an objective measurement exists, such as body weight loss (BWL), there is no agreement on what level constitutes an MTD. A global initiative including 15 companies, led by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), has shared data on BWL in toxicity studies to assess the impact on the animal and the study outcome. Information on 151 studies has been used to develop an alert/warning system for BWL in short term toxicity studies. The data analysis supports BWL limits for short term dosing (up to 7days) of 10% for rat and dog and 6% for non-human primates (NHPs). PMID:23602904

  2. Master Degree in Pharmaceutical

    E-print Network

    Pettenella, Davide

    -active communications between pharmaceutical scientists and all professionals converging in the R&D process of drugs and formulate innovative drugs Graduates in Pharmaceutical Biotechnologies will acquire a solid knowledge1 Master Degree in Pharmaceutical Biotechnologies Department of Pharmaceutical and Pharmacological

  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. 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 ...

  5. 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 ...

  6. Pharmaceutical supply chain risks: a systematic review

    PubMed Central

    2013-01-01

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

  7. Pharmaceutical strategy and innovation: an academics perspective.

    PubMed

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

    2007-06-01

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

  8. Information flow in the pharmaceutical supply chain

    PubMed Central

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

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

  9. Information flow in the pharmaceutical supply chain.

    PubMed

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

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

  10. Drug Discovery and the Pharmaceutical Industry

    E-print Network

    Brutlag, Doug

    Drug Discovery and the Pharmaceutical Industry Louis Lu Douglas Brutlag Genomics and Medicine 12-Clinical Animal Tests Toxicity Efficacy #12;Clinical Phase I Small group of healthy volunteers (10's) Safety Companies http://www.duke.edu/web/soc142/team2/ shifts.html #12;What's the Industry Like Today? Time

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

    PubMed

    Taylor, Douglas

    2014-11-01

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

  12. Pharmacovigilance in pharmaceutical companies: An overview.

    PubMed

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

    2013-12-01

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

  13. 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.…

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

    PubMed

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

    2012-12-15

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

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

    PubMed Central

    Orzan, G; Zara, IA; Purcarea, VL

    2012-01-01

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

  16. [E-commerce of pharmaceuticals].

    PubMed

    Shani, Segev

    2003-05-01

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

  17. Company Presentation Company Presentation

    E-print Network

    Anand, Mahesh

    , fracture mechanics, crack growth FMECA structural reliability, technical risk assessment, statistics #12Company Presentation #12;Company Presentation Essentials Designers and manufacturers of spacecraft 04.10.2010 I page 2 #12;Company Presentation OHB Technology AG Group Structure © MT Aerospace

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

    PubMed

    Beach, Robert

    2012-01-01

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

  19. Institutional mistrust in the organization of pharmaceutical clinical trials

    PubMed Central

    2010-01-01

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

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

    PubMed

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

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

  1. Pharmaceutical Education in Poland

    ERIC Educational Resources Information Center

    Furmanowa, Miroslawa; Borke, Mitchell L.

    1978-01-01

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

  2. Microbiological research for the Hungarian pharmaceutical industry.

    PubMed

    Ambrus, G

    2001-10-01

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

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

    PubMed

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

    2014-01-01

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

  4. Electrospinning for pharmaceutical applications

    E-print Network

    Brettmann, Blair Kathryn

    2012-01-01

    The pharmaceutical industry is currently shifting from batch to continuous manufacturing, and for downstream processes, this shift can reduce costs and improve quality provided the new unit operations are chosen properly. ...

  5. 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

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

    PubMed Central

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

    2014-01-01

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

  7. 65th Roy A. Bowers Pharmaceutical Conference SAVE THE DATE--SEPTEMBER 30, 2015

    E-print Network

    Neimark, Alexander V.

    65th Roy A. Bowers Pharmaceutical Conference SAVE THE DATE--SEPTEMBER 30, 2015 Next Generation in discovering drug effects and changing how drugs are used. Who Should Attend For further information, please: The Radisson, 21 Kingsbridge Road, Piscataway, NJ Pharmacists Physicians Nurses Pharmaceutical Companies State

  8. 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…

  9. 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. ...

  10. 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 ...

  11. 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.

  12. 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

  13. 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

  14. 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

  15. Impacts of international sanctions on Iranian pharmaceutical market

    PubMed Central

    2013-01-01

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

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

    PubMed

    LaMattina, John L

    2011-08-01

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

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

    PubMed

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

    2007-01-01

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

  18. Reflections on Pharmaceutical Education.

    ERIC Educational Resources Information Center

    Smith, Robert E.

    1992-01-01

    A discussion of the implications of adopting a new example for pharmaceutical education focuses on the need to develop a new pharmacy college culture and on the faculty's role in addressing stated educational goals. Anticipated changes in staffing and faculty development and difficulties in reorganizing curricula are examined. (MSE)

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

    PubMed Central

    Stinchcomb, Audra L.

    2010-01-01

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

  20. Systems Medicine in Pharmaceutical Research and Development.

    PubMed

    Kuepfer, Lars; Schuppert, Andreas

    2016-01-01

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

  1. Pharmaceutical Management Branch (PMB)

    Cancer.gov

    The Pharmaceutical Management Branch (PMB) deployed a new and improved mechanism for ordering investigational agents. Agents should now be ordered online. The Online Agent Order Processing (OAOP) application provides online agent ordering, order status review, FedEx tracking information, and assistance with selecting information that typically resulted in processing delays with faxed order requests (e.g. correct protocol number, correct investigator number and current shipping address, agent NSC number and agent strength and formulation).

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

    PubMed

    Wild, F

    2013-06-01

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

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

    PubMed

    Pokorny, A M J; Gittins, C B

    2015-10-01

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

  4. 3rd annual symposium of chemical and pharmaceutical structure analysis.

    PubMed

    Weng, Naidong; Zheng, Jenny; Lee, Mike

    2012-08-01

    The 3rd Annual Symposium on Chemical and Pharmaceutical Structure Analysis was once again held in Shanghai, where a rich history of 'East meets West' continued. This meeting is dedicated to bringing together scientists from pharmaceutical companies, academic institutes, CROs and instrument vendors to discuss current challenges and opportunities on the forefront of pharmaceutical research and development. The diversified symposia and roundtables are highly interactive events where scientists share their experiences and visions in a collegial setting. The symposium highlighted speakers and sessions that provided first-hand experiences as well as the latest guidance and industrial/regulatory thinking, which was reflected by the theme of this year's meeting 'From Bench to Decision Making - from Basics to Application.' In addition to the highly successful Young Scientist Excellence Award, new events were featured at this year's meeting, such as the Executive Roundtable and the inaugural Innovator Award. PMID:22943615

  5. Measuring US pharmaceutical industry R&D spending.

    PubMed

    Golec, Joseph; Vernon, John

    2008-01-01

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

  6. Replace pharmaceutical patents now.

    PubMed

    Grinols, Earl L; Henderson, James W

    2007-01-01

    Pharmaceutical patents are anachronistic holdovers from an era in which modern economic understanding and tax tools were unavailable. Superior mechanisms lie somewhere between a first best pricing solution for the entire economy at one extreme and the current arrangements at the other. We discuss the economics of suggested alternatives and suggest that the intertemporal bounty is the best way to meet the multiple objectives of immediate distribution at marginal cost pricing of newly innovated patented drugs and easily administered, efficient inducement to continued innovation. The intertemporal bounty prevents the expansion of monopoly power resulting from co-pay or -insurance provisions common to modern prescription drug plans. PMID:17488135

  7. 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

  8. Pharmaceutical Education and the Translation of Pharmaceutical Care into Practice.

    ERIC Educational Resources Information Center

    Newton, Gail D.

    1991-01-01

    A systematic approach to reform of pharmaceutical education is seen as necessary to link intended outcomes of reform to a progressive and generally accepted mission of professional practice. Cooperation between pharmaceutical education, professional organizations, and regulatory agencies is viewed as necessary and refinement of professional…

  9. 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

  10. Pharmaceutical Supply Chain Networks with Outsourcing

    E-print Network

    Nagurney, Anna

    ingredients for drugs sold in the United States are outsourced (Economy In Crisis (2010)). PharmaceuticalPharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna Amherst Pharmaceutical Supply Chain Networks with Outsourcing #12;Acknowledgments This research

  11. Designing a Pharmaceutical Care Curriculum.

    ERIC Educational Resources Information Center

    Perrier, Donald G.; And Others

    1995-01-01

    Guidelines for developing a pharmacy school curriculum based on the principle of pharmaceutical care and professional responsibility are offered, beginning with mission statements for profession, practice, and pharmaceutical education in general. The University of Toronto experience in designing such a curriculum is chronicled as an illustration…

  12. 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.

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

    PubMed

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

    2012-08-01

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

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

    PubMed

    Salazar, A; Howells, J

    2000-01-01

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

  15. Pharmaceutical study of Yashadabhasma

    PubMed Central

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

    2012-01-01

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

  16. Pharmaceutical considerations of nitroglycerin

    SciTech Connect

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

    1983-04-01

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

  17. [Pharmaceutical technology and pharmaceutical care in the dispensary].

    PubMed

    Remon, J P

    2007-01-01

    In this lecture the science 'Pharmaceutical Technology' was briefly elucidated, but the main part was about the concept of 'Pharmaceutical Care' in the community pharmacy. Pharmaceutical Care aims at ensuring a safe, efficacious, and cost-effective pharmacotherapy. Thus the pharmacist tries--in collaboration with other healthcare professionals --to improve the clinical and humanistic outcomes of the therapy. Moreover, an efficacious and rational drug therapy is cost-saving, for the patient as well as for the health insurer. A pharmacist delivering Pharmaceutical Care not only dispenses medication, but also takes responsibility about the outcome of the drug therapy. Pharmaceutical Care in community pharmacies encompasses the following activities: Advice about prescribed drugs, to ensure that patients take their medication as correct, as safe and as compliant as possible. Advice about self-care: counselling about OTC-medication. Prevention of medication errors, for example drug interactions. Pay attention to prevention of diseases: for example stimulation of vaccination. Collaboration with physicians, especially general practitioners, both aiming at an optimal drug therapy for the patient Pharmaceutical Care in the hospital setting ('Clinical Pharmacy'): clinical pharmacists participate in drawing up, evaluating and following up the pharmacotherapy of every individual patient, in close collaboration with physicians, nurses and other healthcare professionals on the ward. In Belgium Pharmaceutical Care is in the making. Scientific research on this topic is carried out by the Pharmaceutical Care Unit of Ghent University. An overview of their ongoing research projects was given. Finally, the problems encountered with the implementation of Pharmaceutical Care were highlighted. PMID:17580815

  18. [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

  19. 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

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

    PubMed

    Yoshioka, Ryuzo; Matsumoto, Kazuo

    2014-01-01

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

  1. Creating a global health care company.

    PubMed

    Bauman, R P

    1992-01-01

    Global pharmaceutical mergers have spread the huge costs of research and enabled companies to sell their products in countries where they previously lacked a presence. Here's how the Beecham-SmithKline Beckman marriage was developed to propel the organization into a position as a worldwide player in the drug industry. PMID:10117143

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

    PubMed

    Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

    2013-10-01

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

  3. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

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

  4. '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

  5. Developing and delivering clinical pharmacology in pharmaceutical companies

    PubMed Central

    Richards, Duncan

    2012-01-01

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

  6. [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

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

    PubMed Central

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

    2015-01-01

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

  8. 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.

  9. 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.

  10. The pharmaceutical industry in Cuba.

    PubMed

    Tancer, R S

    1995-01-01

    Cuba has developed a relatively sophisticated pharmaceutical sector, originally to provide medicinal products for her own population and, more recently, to earn hard currency through exports. Cuba has achieved both of these goals despite the US trade embargo, which isolates Cuba from commercial relations with US firms. Cuba is opening its economy to firms from other countries through the use of joint ventures and other forms of cooperation. US firms are unable to avail themselves of these opportunities, and the opportunities are thus being lost. In the case of pharmaceuticals, the Cubans recognize that they need assistance, particularly in the areas of marketing and packaging. Allowing the participation of US firms in the Cuban pharmaceutical industry could enhance the possibility of improving worldwide health care. PMID:8565042

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

    ERIC Educational Resources Information Center

    Charbonneau, Deborah Hile

    2010-01-01

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

  12. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made... Hydromorphone (9150) II Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. ] The company plans to manufacture Hydromorphone HCL for sale to other...

  13. 78 FR 3030 - Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

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

  14. 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…

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

    PubMed

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

    2013-05-01

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

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

    PubMed Central

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

    2013-01-01

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

  17. The World Bank and pharmaceuticals.

    PubMed

    Falkenberg, T; Tomson, G

    2000-03-01

    Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and the public sector, its in-house expertise in health economics, and lastly its ability to be listened to by governments through its power. PMID:10731235

  18. Pharmaceutical Uses of Aquatic Nabil A. NIMER

    E-print Network

    Pharmaceutical Uses of Aquatic Organisms Nabil A. NIMER Dept . Biotechnology & Genetic Engineering Faculty of Science Philadelphia University #12;Aquatic biotechnology is an emerging field encompassingAquatic biotechnology is an emerging field encompassing marine biomedicinemarine biomedicine ((new pharmaceuticals

  19. 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...

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

    PubMed

    Barrett, J S; Koprowski, S P

    2002-03-01

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

  1. 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

  2. Pharmaceutical care in smoking cessation

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Kim, Hak-Ju; Ruger, Jennifer Prah

    2008-01-01

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

  4. Pharmaceutical Supply Chain Networks with Outsourcing

    E-print Network

    Nagurney, Anna

    ingredients for drugs sold in the United States are outsourced (Economy In Crisis (2010)). PharmaceuticalPharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna of Massachusetts Amherst Pharmaceutical Supply Chain Networks with Outsourcing #12;Acknowledgments This research

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

    PubMed

    Bonnemain, Bruno

    2007-10-01

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

  6. 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

  7. Public Policy and Pharmaceutical Innovation

    PubMed Central

    Grabowski, Henry G.

    1982-01-01

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

  8. Biosafe Nanoscale Pharmaceutical Adjuvant Materials

    PubMed Central

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

    2014-01-01

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

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

    NASA Technical Reports Server (NTRS)

    1978-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  11. 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.

  12. Understanding pharmaceutical quality by design.

    PubMed

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

    2014-07-01

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

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

    PubMed

    Gray, Garry C

    2013-01-01

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

  14. The productivity crisis in pharmaceutical R&D.

    PubMed

    Pammolli, Fabio; Magazzini, Laura; Riccaboni, Massimo

    2011-06-01

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

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

    PubMed Central

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-01-01

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

  16. Global gene mining and the pharmaceutical industry

    SciTech Connect

    Knudsen, Lisbeth E.

    2005-09-01

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

  17. 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 ...

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

    EPA Science Inventory

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

  19. [Forensic chemistry as a pharmaceutical discipline].

    PubMed

    Salomatin, E M; Kalekin, R A

    2014-01-01

    The principal objectives and problems facing forensic chemistry expertise are considered. In addition, its development as a pharmaceutical discipline, its goals and practical tasks are discussed. PMID:25764870

  20. Pharmaceutical Compounds Studied Using NEXAFS

    SciTech Connect

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

    2007-02-02

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

  1. 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

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

    PubMed Central

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

    2015-01-01

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

  3. Vertical Integration and Market Entry in the Generic Pharmaceutical Industry

    E-print Network

    Kubo, Kensuke

    2011-01-01

    industry. Generic pharmaceuticals are drug products thatExclusivity of New Drugs A pharmaceutical product market isPharmaceutical Industry . 2.2.1 Marketing Exclusivity of New Drugs . . . . . . . . . . . . . . . .

  4. Synthetic biology advances for pharmaceutical production.

    PubMed

    Breitling, Rainer; Takano, Eriko

    2015-12-01

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

  5. The Graduate Certificate in Pharmaceutical Technology

    E-print Network

    Haimovich, Alexander

    with specialized knowledge and focused skills to sustain the creation, storage and maintenance of databases of biological information in order to support drug discovery develop- ment. The 12-credit graduate certificate in pharmaceutical technology prepares students for a variety of positions in drug manufac- turing, pharmaceutical

  6. 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…

  7. Synthetic biology advances for pharmaceutical production

    PubMed Central

    Breitling, Rainer; Takano, Eriko

    2015-01-01

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

  8. Pharmaceutical experiment aboard STS-67 mission

    NASA Technical Reports Server (NTRS)

    1995-01-01

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

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

    PubMed

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

    2014-01-01

    A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board of Health was, however, at that time of the opinion that there were no serious problems with organotherapeutics from those companies marketing such products. It requires studies in the unprinted journals of the Ministry of Health and the National Board of Health to find the background for and the causes of the request from the Ministry at this point concerning the control of the organotherapeutic products of the pharmaceutical industry. Neither were GEA's barbiturates innovative products. The "Gad Andresen Case" is interesting for two reasons. Firstly, it illustrates that the development of generics at this stage could not always take place exclusively in a pharmaceutical-chemical laboratory, but also required a certain minimum of clinical trials including human beings. Secondly, it shows that the industrial products had now slowly, but surely gained market shares and displaced the pharmacy-produced medicinal products to such an extent that it did not only worry the pharmacy owners and their trade orga- nization. Now this concern had also resulted in a counteract so that the pharmacies in the manufacture of their products had to copy the industrial products, however, in certain cases with a dubious result. Gealgica tablets and especially their content of fenacetine is not only a model example of how the opinion of the positive and negative properties of a medicinal product changes over time. It also shows how long time could pass before the health authorities took measures against a substance with problematic side effects in spite of the fact that less damaging substances had been available for a long time, in this case paracetamol. Medicinal products containing fenacetine were on the market for almost 100 years. On the contrary meprobamat is a model example of a drug substance where the opinion of its positive and negative properties changed essentially over a relatively short period. In spite of this it remained on the market for a little less than 40 years. Restenil and Trihistan are mentioned on Knud & Dagny Gad Andresen's homepage (in 20

  10. 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

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

    PubMed

    Lamkin, Matt; Elliott, Carl

    2014-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  14. 76 FR 51430 - Roots Pharmaceuticals, Inc.; Revocation of Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ...DEPARTMENT OF JUSTICE Drug Enforcement Administration Roots Pharmaceuticals, Inc.; Revocation of...of Diversion Control, Drug Enforcement Administration...to Show Cause to Roots Pharmaceuticals, Inc....

  15. Why Do Faculty Try Research Based Instructional Strategies?

    E-print Network

    Colorado at Boulder, University of

    Why Do Faculty Try Research Based Instructional Strategies? Melissa H. Dancy*, Chandra Turpen PI? and 2) What reasons do PI users give for first trying PI? In this paper we describe how faculty that faculty give for initially trying PI such as dissatisfaction with lecture methods, easy trialability of PI

  16. 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…

  17. 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.…

  18. 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…

  19. 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…

  20. A Research-Based Laboratory Course in Organic Chemistry

    ERIC Educational Resources Information Center

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

    2006-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  3. Research-Based Learning: Teaching Development through Fieldschools

    ERIC Educational Resources Information Center

    Guinness, Patrick

    2012-01-01

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

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

    ERIC Educational Resources Information Center

    Lencucha, Raphael

    2014-01-01

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

  5. 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…

  6. 2nd International China BioPharmaceutical Symposium.

    PubMed

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

    2009-03-01

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

  7. The emerging government requirement for economic evaluation of pharmaceuticals.

    PubMed

    Drummond, M

    1994-01-01

    With the advent of government guidelines for the provision of cost-effectiveness data, economic evidence has been elevated to a status similar to that of evidence of efficacy and safety, which is required before licensing of pharmaceutical products. Whilst the precise nature of government requirements is likely to vary from place to place, they pose a number of practical problems for pharmaceutical companies, in the funding of studies and in the need to modify the clinical trials programme to facilitate economic data collection. Economic evaluation requirements have been viewed by various parties as a basis for pricing and reimbursement, as a form of cost containment and as a way of securing more value for money in the healthcare system. It is unlikely that economic evidence could ever form the sole basis for setting price, since both industry and government often seek to introduce other factors into the price negotiations. Requirements for economic evidence may also be an inefficient form of cost containment, compared with other methods such as budgetary caps. These offer some potential as a way of securing more value for money, but they should be applied equally across all health technologies. In the future there needs to be much more clarity of purpose in government guidelines, and methodological standards for economic analysis need to be refined. PMID:10155586

  8. Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2013-03-01

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

  10. Evolution of Plant-Made Pharmaceuticals

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

    Kurtzman, Gary

    2005-01-01

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

  12. 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

  13. Using Collaborative Environments in Research-Based Science Education

    NASA Astrophysics Data System (ADS)

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

    2008-06-01

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

  14. Assessing the assessments: Pharmaceuticals in the environment

    SciTech Connect

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

    2007-11-15

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

  15. 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...

  16. 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...

  17. Continuous Plug Flow Crystallization of Pharmaceutical Compounds

    E-print Network

    Alvarez, Alejandro J.

    Crystallization processes in the pharmaceutical industry are usually designed to obtain crystals with controlled size, shape, purity, and polymorphic form. Knowledge of the process conditions required to fabricate crystals ...

  18. Funding pharmaceutical innovation through direct tax credits.

    PubMed

    Lybecker, Kristina M; Freeman, Robert A

    2007-07-01

    Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved. PMID:18634650

  19. Control Systems Engineering in Continuous Pharmaceutical Manufacturing

    E-print Network

    COMMENTARY Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20­21, 2014 to the development of control systems engineering technologies for continuous drug manufacturing. Industry and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who

  20. Active Pharmaceutical Ingredients and Aquatic Organisms

    EPA Science Inventory

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

  1. Continuous blending of dry pharmaceutical powders

    E-print Network

    Pernenkil, Lakshman

    2008-01-01

    Conventional batch blending of pharmaceutical powders coupled with long quality analysis times increases the production cycle time leading to strained cash flows. Also, scale-up issues faced in process development causes ...

  2. MULTIFUNCTIONAL AND STIMULI-SENSITIVE PHARMACEUTICAL NANOCARRIERS

    PubMed Central

    Torchilin, Vladimir

    2011-01-01

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

  3. Understanding Oxidative Instability of Protein Pharmaceuticals

    E-print Network

    Chu, Jhih-Wei

    Mechanism of oxidation of methionine residues in protein pharmaceuticals by hydrogen peroxide was investigated via ab initio calculations. Specifically, two reactions, hydrogen transfer of hydrogen peroxide to form water ...

  4. 75 FR 73071 - Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

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

  5. Adapting Project Management Practices to Research-Based Projects

    NASA Technical Reports Server (NTRS)

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

    2007-01-01

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

  6. 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

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

    PubMed Central

    Lee, Munjae; Choi, Mankyu

    2015-01-01

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

  8. 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

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

    PubMed

    Curcio, Pasqualina Curcio

    2008-10-01

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

  10. Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market

    PubMed Central

    2014-01-01

    Background Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies’ competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). Results The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. Conclusion This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets’ needs. PMID:24708770

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

    PubMed

    Melethil, Srikumaran

    2005-01-01

    The major purpose of this article is to emphasize the need for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Economic incentives for drug discovery and development clash with societal needs for low-cost pharmaceuticals in the United States and all over the world. The Hatch-Waxman Act of 1984 was enacted to promote public health by balancing the interests of brand name and generic companies. Patent protection, which provides a monopoly for a limited time, is aimed to provide such incentives. Creation of patents requires the interaction between scientists and lawyers, an endeavor made difficult by the differing intellectual spheres of their respective disciplines. Therefore, in the first place, a thorough understanding of patent fundamentals among pharmaceutical scientists will help them work more efficiently with patent attorneys. Second, it will enable them to appreciate the strengths and weaknesses of individual patents, which is critical in developing strategies amidst the ongoing patent tug-of-war between brand-name and generic companies. PMID:16353948

  12. 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

  13. 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...

  14. 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 ...

  15. Water and stability of pharmaceutical solids

    NASA Astrophysics Data System (ADS)

    Shalaev, Evgenyi

    2007-03-01

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

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

    PubMed

    Kruse, Edith

    2008-01-01

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

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

    PubMed

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-03-01

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

  20. 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

  1. Thermal properties of food and pharmaceutical powders

    NASA Astrophysics Data System (ADS)

    Abiad, Mohamad Ghassan

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

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

    SciTech Connect

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

    2012-11-15

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Erices, Rainer; Frewer, Andreas; Gumz, Antje

    2015-07-01

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

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

    PubMed

    Kanavos, Panos; Angelis, Aris

    2014-01-01

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

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

    MedlinePLUS

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

  8. 75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ...HEALTH AND HUMAN SERVICES Food and Drug Administration...Pharmaceutical Supply Chain; Public Workshop AGENCY: Food and Drug Administration...SUMMARY: The Food and Drug Administration...Pharmaceutical Supply Chain Workshop-- Enough...

  9. 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...

  10. Risks to aquatic organisms posed by human pharmaceutical use

    EPA Science Inventory

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

  11. Predicting variability of aquatic concentrations of human pharmaceuticals

    EPA Science Inventory

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

  12. New pharmaceuticals in inflammatory bowel disease

    PubMed Central

    ?odyga, Micha?; Eder, Piotr; Bartnik, Witold; Gonciarz, Maciej; K?opocka, Maria; Linke, Krzysztof; Ma?ecka-Panas, Ewa; Radwan, Piotr

    2015-01-01

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

  13. Data Analytics for Pharmaceutical Discoveries Shobeir Fakhraei

    E-print Network

    Daume III, Hal

    Chapter 1 Data Analytics for Pharmaceutical Discoveries Shobeir Fakhraei Department of Computer.1 Introduction ....................................................... 2 1.1.1 Pre-marketing stage ....................................... 2 1.1.2 Post-marketing stage ...................................... 3 1.1.3 Data sources and other

  14. Pollution prevention in the pharmaceutical industry

    SciTech Connect

    Venkataramani, E.S.

    1995-09-01

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

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

    PubMed

    Oldani, Michael

    2014-06-01

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

  16. Roles for Educational Psychologists in Pharmaceutical Education.

    ERIC Educational Resources Information Center

    Speedie, Stuart M.

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

  17. The Pharmaceutical Care Movement: Opportunities for Collaboration.

    ERIC Educational Resources Information Center

    Temple, Thomas R.

    1996-01-01

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

  18. Pharmaceutical 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…

  19. The State of Pharmaceutical Innovation Bernard Munos

    E-print Network

    Napp, Nils

    InnoThink The State of Pharmaceutical Innovation Bernard Munos Founder InnoThink Center For Research in Biomedical Innovation Chicago July 16, 2012 #12;· The state of innovation · Facts about innovation · Where does innovation come from? · Priorities for returning innovation to drug R&D 2 Outline

  20. Communicating pharmaceutical outcomes to hospital administration.

    PubMed

    Mountzuris, J

    1995-10-01

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

  1. Halal pharmaceutical industry: opportunities and challenges.

    PubMed

    Nor Norazmi, Mohd; Lim, Li Sze

    2015-08-01

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

  2. 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...

  3. An Innovative Pharmaceutical Care Practical Course

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  4. NUTRACEUTICAL AND PHARMACEUTICAL USES OF LEGUMES

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  5. 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

  6. Pharmaceuticals as Groundwater Tracers - Applications and Limitations

    NASA Astrophysics Data System (ADS)

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

    2003-12-01

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

  7. A Mathematical Programming Model for Scheduling Pharmaceutical Sales Representatives

    E-print Network

    Gautam, Natarajan

    that these drugs will be sold are given. The aim is to determine a schedule for which pharmaceutical salesA Mathematical Programming Model for Scheduling Pharmaceutical Sales Representatives Lauren Hertel. of IME, Penn State Univ., University Park, PA 16802, USA Abstract To increase revenues, pharmaceutical

  8. The Master of Science Program in Pharmaceutical Bioprocessing

    E-print Network

    Haimovich, Alexander

    technological requirements of this highly regulated work environment. WHY STUDY PHARMACEUTICAL BIOPROCESSING with the pharmaceutical and biopharmaceutical industry and works directly with industry advisors to ensure as professionals working in the pharmaceutical and biotechnology industry or related fields. IS PART-TIME STUDY

  9. Running head: PHARMACEUTICAL ADVERTISING Of Plight and Providence: Big Pharma and The Effects of Pharmaceutical Advertising on

    E-print Network

    Chen, Zhongping

    Running head: PHARMACEUTICAL ADVERTISING 1 Of Plight and Providence: Big Pharma and The Effects of Pharmaceutical Advertising on U.S. patients with RLS, Insomnia, GERD, and GAD Farley Hamada Advisor: Dr. Keith Murphy University of California, Irvine Spring 2011 #12;Running head: PHARMACEUTICAL ADVERTISING 2

  10. Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem

    NASA Astrophysics Data System (ADS)

    Kodesova, Radka; Klement, Ales; Kocarek, Martin; Fer, Miroslav; Golovko, Oksana; Grabic, Roman; Jaksik, Ondrej

    2014-05-01

    It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from ?áslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with decreasing adsorption. In all cases (including non contaminated soil sample) biological activity initially increased (1 and 2 day after the pharmaceutical application) and then dropped down on 5th day (Trimetoprim, Clindamycin, Atenolol, Sulfamethoxazol) or 23rd day (Clarithromycin, Metoprolol, Carbamazepin) of soil sample incubation. A closer correlation between the numbers of colony forming unites and degradation rates were not revealed. Acknowledgement: Authors acknowledge the financial support of the Czech Science Foundation (Project No. 13-12477S).

  11. Patent indicators: a window to pharmaceutical market success.

    PubMed

    Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

    2013-07-01

    Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market. PMID:23611022

  12. [The pharmaceutical industry and the adverse effects of the drugs].

    PubMed

    Lamarque, V; Plétan, Y

    2007-09-01

    New drug development is a long, expensive and hazardous process especially regarding the final outcome. During the first non-clinical steps, molecules identified as potential candidates are screened for their toxicological profile, which allows to eliminate some but also to identify possible "target" organs. Then clinical trials are conducted, where tolerance profile knowledge is increased through the development with the detection of the most frequent adverse effects (between 1% and 1 per thousand). At marketing authorization, because of the limited number and of the selectivity of patients enrolled in clinical trials, the drug safety profile is based on the more frequent adverse effects. In Europe, since November 2005, a new regulation - the Risk Management system - has been added to Pharmacovigilance. These are designed to better anticipate and even minimize important identified or potential risks or to better inform on populations not studied during the clinical trials. This concept is based on risk reduction throughout drug's life cycle with specific strategic actions in addition to the product information, in order to optimise the drug benefit/risk ratio. Pharmaceutical companies will therefore invest significantly in post-marketing, allowing proper and safety use of their products. As they played a major role in the clinical development few years ago, they could from now on, be recognised as the key player towards this new paradigm defined as the post-approval development. PMID:17982378

  13. 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

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

    PubMed

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

    2014-02-01

    In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms. PMID:24311373

  15. [Relationship between pharmaceutical industry and the French government during the last two centuries].

    PubMed

    Bonnemain, Henri; Bonnemain, Bruno

    2002-01-01

    Between the law of germinal an XI and the 1941 law, the relationship between the pharmaceutical industry and the French government were driven by the official practice of pharmacy. The State trues pharmacist who has to contrôle financially and deontologically his company. After 1941, the State will more and more regulate and control all the activities of the pharmaceutical products industry due to the major financial impact of these products on Health Care and Social Security budgets. French State will be progressively concerned with medical information and good practices (good manufacturing practices, good laboratory practices...) It will also regulate the pricing of new drugs, the development process and will encourage the marketing of innovative products. These rules, on the basis of the European directive of 1965, will be more or less harmonized for all European countries. Since 1989, this harmonization process is looking for an expansion outside of Europe, at least for the marketing authorization, in order to facilitate the registration of innovative products in all countries. One can then observe on a period of two centuries the evolution from freedom of the pharmaceutical industry more and more to a strict controlled freedom. PMID:12378715

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

    PubMed Central

    2013-01-01

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

  17. Chitosan Modification and Pharmaceutical/Biomedical Applications

    PubMed Central

    Zhang, Jiali; Xia, Wenshui; Liu, Ping; Cheng, Qinyuan; Tahirou, Talba; Gu, Wenxiu; Li, Bo

    2010-01-01

    Chitosan has received much attention as a functional biopolymer for diverse applications, especially in pharmaceutics and medicine. Our recent efforts focused on the chemical and biological modification of chitosan in order to increase its solubility in aqueous solutions and absorbability in the in vivo system, thus for a better use of chitosan. This review summarizes chitosan modification and its pharmaceutical/biomedical applications based on our achievements as well as the domestic and overseas developments: (1) enzymatic preparation of low molecular weight chitosans/chitooligosaccharides with their hypocholesterolemic and immuno-modulating effects; (2) the effects of chitin, chitosan and their derivatives on blood hemostasis; and (3) synthesis of a non-toxic ion ligand—D-Glucosaminic acid from Oxidation of D-Glucosamine for cancer and diabetes therapy. PMID:20714418

  18. Metabolomics in pharmaceutical research and development.

    PubMed

    Puchades-Carrasco, Leonor; Pineda-Lucena, Antonio

    2015-12-01

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

  19. Controlling Pharmaceutical Crystallization with Designed Polymeric Heteronuclei

    PubMed Central

    2015-01-01

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

  20. Controlling pharmaceutical crystallization with designed polymeric heteronuclei.

    PubMed

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

    2015-01-21

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

  1. Pharmaceutical salts of ciprofloxacin with dicarboxylic acids.

    PubMed

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

    2015-09-18

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

  2. 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

  3. Supercritical fluid chromatography in pharmaceutical analysis.

    PubMed

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

    2015-09-10

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

  4. 75 FR 5075 - Coalinga Cogeneration Company, Kern River Cogeneration Company, Mid-Set Cogeneration Company...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ...ER10-610-000; ER10-609-000; ER10-612-000; ER10-611-000] Coalinga Cogeneration Company, Kern River Cogeneration Company, Mid-Set Cogeneration Company, Salinas River Cogeneration Company, Sargent Canyon Cogeneration...

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

    NASA Astrophysics Data System (ADS)

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

    2015-01-01

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

  6. Cubanes: Super explosives and potential pharmaceutical intermediates

    NASA Technical Reports Server (NTRS)

    Bashir-Hashemi, A.

    1994-01-01

    The cubane molecule, in which eight carbon atoms are locked in a cubic framework, shows great potential for both military and pharmaceutical applications. Octanitrocubane, with a predicted density of 2.1 g/cc and strain energy of more than 165 kcal/mol, is considered to be the 'super-explosive', while cubane derivatives submitted to the National Institutes of Health for preliminary biological activity screening have displayed promising anti-cancer and anti-HIV activity.

  7. Pricing and reimbursement of pharmaceuticals in Belgium.

    PubMed

    Annemans, L; Crott, R; De Clercq, H; Huybrechts, M; Peys, F; Robays, H; Steens, I; Vanschoubroek, K; Winderickx, P

    1997-03-01

    The Belgian healthcare system has a tradition of access and equity at affordable prices. As in other countries, the system becomes pressured by increasing healthcare costs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement. Nearly all people in Belgium are covered by compulsory health insurance. The system is paid for by social security, the patients and the federal and regional authorities. The part of the consumption of pharmaceuticals that is charged to insurance was about 62.1 billion Belgian francs (BeF), i.e. about 50% of the pharmaceutical market in 1994. Price setting in Belgium has been rather low due to the positive reimbursement list, where the price of a new drug is compared to existing drugs in a comparable therapeutic class (so-called reimbursement criteria). The expenditure on pharmaceuticals is increasing faster than global funding for public health. In order to control drug budgets, different cost-containment measures have been or are being taken, i.e. a mix of price, reimbursement and volume controls. These cost-containment measures are not necessarily in accordance with a health economic approach. This paper suggests the scope for better implementation of pharmacoeconomic evaluation, which can lead to more flexible reimbursement systems in specific indications. Therefore, a formal recognition of the role of objective economic evaluations is needed for both hospital and ambulatory care. This process should be proceeded by improving the understanding and robustness of pharmacoeconomic evaluations. PMID:10165309

  8. The Pharmaceutical Benefits Scheme 2003–2004

    PubMed Central

    Harvey, Ken J

    2005-01-01

    The Pharmaceutical Benefits Scheme (PBS) grew by 8% in 2003–04; a slower rate than the 12.0% pa average growth over the last decade. Nevertheless, the sustainability of the Scheme remained an ongoing concern given an aging population and the continued introduction of useful (but increasingly expensive) new medicines. There was also concern that the Australia-United States Free Trade Agreement could place further pressure on the Scheme. In 2003, as in 2002, the government proposed a 27% increase in PBS patient co-payments and safety-net thresholds in order to transfer more of the cost of the PBS from the government to consumers. While this measure was initially blocked by the Senate, the forthcoming election resulted in the Labor Party eventually supporting this policy. Recommendations of the Pharmaceutical Benefits Advisory Committee to list, not list or defer a decision to list a medicine on the PBS were made publicly available for the first time and the full cost of PBS medicines appeared on medicine labels if the price was greater than the co-payment. Pharmaceutical reform in Victorian public hospitals designed to minimise PBS cost-shifting was evaluated and extended to other States and Territories. Programs promoting the quality use of medicines were further developed coordinated by the National Prescribing Service, Australian Divisions of General Practice and the Pharmacy Guild of Australia. The extensive uptake of computerised prescribing software by GPs produced benefits but also problems. The latter included pharmaceutical promotion occurring at the time of prescribing, failure to incorporate key sources of objective therapeutic information in the software and gross variation in the ability of various programs to detect important drug-drug interactions. These issues remain to be tackled. PMID:15679896

  9. Pharmaceutical Composition for Improving Physical Working Capacity.

    PubMed

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

    2015-11-01

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

  10. Pharmaceutical policy reform in the Russian Federation.

    PubMed

    Rudisill, Caroline; Vandoros, Sotiris; Antoun, Joseph George

    2014-06-01

    Of Russia's 142 million citizens, fewer than 20 million are enrolled in outpatient drug coverage plans. The current government aims to establish universal health insurance including outpatient medicines. Based on the current political and regulatory environment, this report explores pharmaceutical pricing options for Russia that balance greater access to medicines with achieving government plans of boosting local pharmaceutical production. To match innovative medicine prices with their health benefits, in the long run, we suggest that Russia consider adopting value-based pricing, and in the short term, that it introduce direct price negotiations and price drugs according to reference countries that use health technology assessment. Although generic market shares are high, generic medicine prices are higher than they should be. We propose tenders at the manufacturer level for the pricing of high-selling generics, and free pricing for products with sufficient market competition. These policy recommendations are a jumping-off point for further discussion about how pharmaceutical policy could aid this major economy to achieve its population health and health service goals. PMID:24603082

  11. Photo-pharmaceutical therapy: features and prospects

    NASA Astrophysics Data System (ADS)

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

    2001-07-01

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

  12. 75 FR 5075 - Coalinga Cogeneration Company, Kern River Cogeneration Company, Mid-Set Cogeneration Company...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

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

  13. 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

  14. Life cycle analysis within pharmaceutical process optimization and intensification: case study of active pharmaceutical ingredient production.

    PubMed

    Ott, Denise; Kralisch, Dana; Den?i?, Ivana; Hessel, Volker; Laribi, Yosra; Perrichon, Philippe D; Berguerand, Charline; Kiwi-Minsker, Lioubov; Loeb, Patrick

    2014-12-01

    As the demand for new drugs is rising, the pharmaceutical industry faces the quest of shortening development time, and thus, reducing the time to market. Environmental aspects typically still play a minor role within the early phase of process development. Nevertheless, it is highly promising to rethink, redesign, and optimize process strategies as early as possible in active pharmaceutical ingredient (API) process development, rather than later at the stage of already established processes. The study presented herein deals with a holistic life-cycle-based process optimization and intensification of a pharmaceutical production process targeting a low-volume, high-value API. Striving for process intensification by transfer from batch to continuous processing, as well as an alternative catalytic system, different process options are evaluated with regard to their environmental impact to identify bottlenecks and improvement potentials for further process development activities. PMID:25251078

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

    NASA Astrophysics Data System (ADS)

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

    2014-12-01

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

  16. Silo Effect a Prominence Factor to Decrease Efficiency of Pharmaceutical Industry

    PubMed Central

    Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

    2013-01-01

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

  17. Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea

    PubMed Central

    Lee, Munjae

    2015-01-01

    Objectives The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). Results The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p < 0.05). No statistical significance was found in the shareholding ratio of institutional investors and the ratio of outside directors. Conclusion The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits. PMID:26473092

  18. [Impact of demographic chance on pharmaceutical expenses in private health insurance--a scenario-based analysis].

    PubMed

    Böcking, W; Tidelski, O; Skuras, B; Bäumler, A; Kitzmann, F

    2012-08-01

    Health Insurance costs in Germany have grown constantly over the last years. This increase of costs is not only observable in the total consideration but also in all single items. An outstanding growth rate exists in the field of pharmaceutical expenses. Detailed analyses of distribution and development of these costs, separated by age and indication groups, are currently only sporadically available and mostly focusing on the Statutory Health Insurance system in Germany. This research article is based on an initial data analysis and focuses on the question how pharmaceutical expenses in a German private health insurance company will develop until the year 2050, if the observed trend of the past years continues in the same way. This analysis focuses on different age groups. The objective is the demonstration of several scenarios, which illustrate the level of influence of different parameters (demographic changes, developments of prices for pharmaceuticals). Based on the cognition of certain effects measures for handling the growing challenge of financing the health system can be deduced. As a result, both demographic changes and price effects have an significant impact on the future development of per capita pharmaceutical expenses. Whereas older age groups will still cause the highest costs, the middle-aged people will show the highest growth rates. This strong cost increase is not sustainable for the German health insurance system. In addition to previous measures of a regulatory health policy (especially improved cost-benefit-assessments) the article shows new approaches for an intensified prevention and health promotion. PMID:22872541

  19. Occurrence of Pharmaceuticals in Calgary's Wastewater and Related Surface Water.

    PubMed

    Chen, M; Cooper, V I; Deng, J; Amatya, P L; Ambrus, D; Dong, S; Stalker, N; Nadeau-Bonilla, C; Patel, J

    2015-05-01

    The influents/effluents from Calgary's water resource recovery facilities and the surface water were analyzed for pharmaceuticals in the present study. The median concentrations in the effluents for the 15 targeted pharmaceuticals were within the range of 0.006 to 3.32 ppb. Although the wastewater treatment facilities were not designed to remove pharmaceuticals, this study indicates that the wastewater treatment processes are effective in removing some of the pharmaceuticals from the aqueous phase. The removal rate estimated can be 99.5% for caffeine, whereas little or no removal was observed for carbamazepine. Biodegradation, chemical degradation, and sorption could be some of the mechanisms responsible for the removal of pharmaceuticals. The drug residues in downstream surface water could be associated with incomplete removal of pharmaceuticals during the treatment process and may lead to concerns in terms of potential impacts on the aquatic ecosystem. However, this study does not indicate any immediate risks to the downstream aquatic environment. PMID:26460461

  20. 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

  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[comp-name]=c[comp-name] c1company (c1[comp-name] = "SBC" c2company (c2[comp-name]=c[comp-name] c2[city] = c1[city-name]=c[comp-name] c2[city] = c1[city] )))} #12;select c.company-name from company c where not exists ((select city

  2. In silico toxicology for the pharmaceutical sciences

    SciTech Connect

    Valerio, Luis G.

    2009-12-15

    The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy of in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical prediction of human drug metabolism, mechanisms of action for pharmaceuticals, and newer models for predicting human adverse effects. How accurate are these approaches is both a statistical issue and challenge in toxicology. In this review, fundamental concepts and the current capabilities and limitations of this technology will be critically addressed.

  3. Biocatalysis in development of green pharmaceutical processes.

    PubMed

    Tao, Junhua; Xu, Jian-He

    2009-02-01

    Biocatalysis is one of the greenest technologies for the synthesis of chiral molecules due to exquisite regioselectivity and stereoselectivity in water under mild conditions. For example, protection and deprotection of functional groups are usually not required for biotransformations, high or low temperature reactions can often be circumvented and usage of organic solvents are drastically minimized. To truly empower the green chemistry feature of biocatalysis, it is essential to integrate enzymatic transformations strategically into chemical transformations at the retrosynthetic level. This review focuses on the development of novel biocatalytic pharmaceutical processes to replace chemical routes with poorer process efficiency and higher manufacturing costs. PMID:19264533

  4. Internship List Company: Gordmans

    E-print Network

    Minnesota, University of

    Website: http://careerlink.com/job/view/3153/006607 Company: Verizon Wireless Position: Retail/Management Location: Fargo, ND Degree: Management Website: http://www.verizon.com/jobs/north-dakota/campus/jobid334296-intern-retail-verizon-jobs/ Company: Essentia Health Position: Administration Location: Fargo, ND Degree

  5. Marketing Plan Company Description

    E-print Network

    Dahl, David B.

    Marketing Plan Company Description: Consumer company that provides a product to helps boost productivity without the jitters/crash of normal energy drinks and shots. Short Project Name: Internet Marketing Swat Team Project Description and Deliverables: The team will Identify the best online vehicles

  6. The mortality of companies.

    PubMed

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

    2015-05-01

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

  7. The mortality of companies

    PubMed Central

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

    2015-01-01

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

  8. COMPANIES RECRUITING AT VANDERBILT 1 Companies Recruiting

    E-print Network

    Bordenstein, Seth

    Pipe Aon Ascension Health Avondale Partners, LLC Babson Capital Management LLC Bain & Company Baker Hughes Bank of America Merrill Lynch BlackArch Partners BlackRock Blue Stone International Brentwood Capital Advisors Brooksource Buffalo Royalties, LLC Bush Consulting Cambridge Associates, LLC Cancer

  9. 75 FR 13524 - Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas Transmission Company, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... Energy Regulatory Commission Northern Natural Gas Company, Southern Natural Gas Company, Florida Gas... of Application March 16, 2010. Take notice that on March 5, 2010, Northern Natural Gas Company... other owners, Southern Natural Gas Company, Florida Gas Transmission Company, LLC, Transcontinental...

  10. Old Yet New--Pharmaceuticals from Plants

    NASA Astrophysics Data System (ADS)

    Houghton, Peter J.

    2001-02-01

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

  11. The Future of Pharmaceutical Manufacturing Sciences.

    PubMed

    Rantanen, Jukka; Khinast, Johannes

    2015-11-01

    The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state-of-art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular-based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot-melt processing and printing-based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3612-3638, 2015. PMID:26280993

  12. [Amorphous form in pharmaceutical technological research].

    PubMed

    Mártha, Csaba; Jójártné, Laczkovich Orsolya; Szabóné, Révész Piroska

    2011-01-01

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

  13. Metaphors and myths in pharmaceutical advertising.

    PubMed

    Delbaere, Marjorie

    2013-04-01

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

  14. Applications of terahertz spectroscopy to pharmaceutical sciences.

    PubMed

    Taday, Philip F

    2004-02-15

    The application of terahertz pulsed spectroscopy within the US Food and Drug Administration's (FDA's) recent process analytical technology (PAT) initiative is considered. As a case study the potency levels in paracetamol (4-acetamidophenol) and aspirin (acetylsalicylic acid) test tablets have been recovered from the terahertz absorption spectra using a multivariate partial-least-squares (PLS) calibration model. Root-mean-square errors of cross-validation (RMSECVs) of 2.85% and 3.90% were obtained for paracetamol and aspirin, respectively. Information about other excipients can also be obtained; for example, using the strong lactose absorption lines in the tablets, RMSECVs of 3.65% and 4.30% could be recovered from the paracetamol and aspirin samples, respectively. As active ingredients may also change their solid-state form during formulation processing or storage and as this can adversely affect the final dosage performance, monitoring of pharmaceutical ingredients is essential for a 'right-first-time' philosophy within the industry. Terahertz pulse spectroscopy is a high-throughput technique with many areas of potential exploitation in the pharmaceutical industry; these issues are discussed in this paper. PMID:15306525

  15. Triboelectrification of pharmaceutical powders by particle impact.

    PubMed

    Watanabe, Hideo; Ghadiri, Mojtaba; Matsuyama, Tatsushi; Ding, Yu Long; Pitt, Kendal G; Maruyama, Hiroyuki; Matsusaka, Shuji; Masuda, Hiroaki

    2007-04-01

    Pharmaceutical powders are very prone to electrostatic charging by colliding and sliding contacts with walls and other particles. In pharmaceutical formulation processes, particle charging is often a nuisance and can cause problems in the manufacture of products, such as affecting powder flow, and reducing fill and dose uniformity. For a fundamental understanding of the powder triboelectrification, it is essential to study charge transfer due to a single contact of a particle with a target plane under well-defined physical, mechanical and electrical conditions. In this study, charge transfer due to a single impact of a particle against a stainless steel target was measured for alpha-lactose monohydrate, aspirin, sugar granules and ethylcellulose. The amount of transferred charge is expressed as a function of impact velocity and impact angle as well as the initial charge. The maximum contact area during impact between a particle and a target plane is estimated by an elastic-plastic deformation model. It is found that the transferred charge is a linear function of the contact area. For a given material, there is an initial particle charge for which no charge transfer occurs due to impact. This is found to be independent of impact velocity and angle, and is hence viewed as a characteristic property, which is related to the contact potential difference and tribo-electric series of the sample powders. PMID:17141989

  16. Towards a healthy use of pharmaceuticals.

    PubMed

    Laporte, J R

    1985-01-01

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

  17. Opportunities for Electronic Health Record Data to Support Business Functions in the Pharmaceutical Industry—A Case Study from Pfizer, Inc.

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2008-01-01

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

  19. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ...Pharmaceutical Quality System: A Practical...Approach to Effective Life- Cycle Implementation of Systems and Processes...for Registration of Pharmaceuticals...Pharmaceutical Quality System (ICH Q10...Approach to Effective Life- Cycle Implementation of Systems and...

  20. 75 FR 54232 - Proposed Collection; Comment Request for Report of Covered Pharmaceutical Manufacturers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ...Title: Report of Covered Pharmaceutical Manufacturers and Importers...Number: Report of Covered Pharmaceutical Manufacturers and Importers...Abstract: Report of Covered Pharmaceutical Manufacturers and Importers...selling branded prescription drugs to specified government...

  1. 78 FR 46373 - Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ...DEPARTMENT OF JUSTICE Drug Enforcement Administration...Johnson Matthey Pharmaceutical Materials, Inc...Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Services, 25 Patton...by renewal to the Drug Enforcement...

  2. Synthesis of a Cationic Inorganic Layered Material for Trapping Anionic Pharmaceutical Pollutants

    E-print Network

    Sergo, Kevin Michael

    2013-01-01

    variety of pharmaceutical classes of drugs (NSAIDs, Beta-Pharmaceutical pollutants Non-steroidal anti-inflammatory drugs (pharmaceuticals, very little is known about chronic low level exposure to these drugs

  3. 75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

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

  4. 76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ...Committee for Pharmaceutical Science and Clinical Pharmacology...Committee for Pharmaceutical Science and Clinical Pharmacology...Committee for Pharmaceutical Science and Clinical Pharmacology...committee will further discuss the definition and list of NTI drugs,...

  5. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ...Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug...Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants...classification of pharmaceutical co-crystal solid-state forms. This guidance...

  6. 78 FR 46371 - Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

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

  7. 77 FR 12621 - Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... FR 81978, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals...), and determined that the registration of Mylan Pharmaceuticals, Inc. to import the basic classes...

  8. 75 FR 33824 - Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ...Pharmaceutical Products and Chemical Intermediates, Fourth...Pharmaceutical Products and Chemical Intermediates, Fourth...Project Leader, Office of Industries (202-205-3424 or...pharmaceutical products and chemical intermediates used primarily...request_letter.pdf. The Commission...

  9. 75 FR 54232 - Proposed Collection; Comment Request for Report of Covered Pharmaceutical Manufacturers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... Internal Revenue Service Proposed Collection; Comment Request for Report of Covered Pharmaceutical... comments concerning Form-8947, Report of Covered Pharmaceutical Manufacturers and Importers. DATES: Written... Pharmaceutical Manufacturers and Importers. OMB Number: 1545-XXXX. Form Number: Report of Covered...

  10. 75 FR 33824 - Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ... Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition of Certain Products to the Pharmaceutical Appendix to the HTS AGENCY: United States International Trade Commission... investigation No. 332-520, Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice...

  11. 78 FR 33441 - Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ..., 78 FR 12101, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical... registration of Caraco Pharmaceutical Laboratories, Ltd., to import the basic class of controlled substance...

  12. 75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

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

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

    ERIC Educational Resources Information Center

    Svarstad, Bonnie L.

    1979-01-01

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

  14. 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...

  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. C W MAPLETHORPE POSTDOCTORAL FELLOWSHIPS FOR PHARMACEUTICAL EDUCATION AND RESEARCH

    E-print Network

    Applebaum, David

    C W MAPLETHORPE POSTDOCTORAL FELLOWSHIPS FOR PHARMACEUTICAL EDUCATION AND RESEARCH R E G U L A T I O N S 1. The C W Maplethorpe Postdoctoral Fellowships for Pharmaceutical Education and Research have. The Fellowships are financed from income from the Maplethorpe Trust Fund and are administered by a Management

  17. 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…

  18. Astronaut William Gregory works with pharmaceutical experiments on middeck

    NASA Technical Reports Server (NTRS)

    1995-01-01

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

  19. New Zealand consumers' perceptions of private insurance for pharmaceuticals.

    PubMed

    Ragupathy, Rajan; Babar, Zaheer-Ud-Din; Mirza, Wasif; Daiya, Mitali; Chandra, Himesh; Yousif, Ali; Girn, Maninder

    2014-01-01

    Private insurance plays a minor role in paying for pharmaceuticals in New Zealand, despite controversy about access through the public health system. The present study examines New Zealand consumers' perceptions of private insurance for pharmaceuticals. A self-administered questionnaire was completed by 433 consumers at thirty pharmacies. The questionnaire included 18 questions on demographics, insurance status, perceptions of private insurance for pharmaceuticals and confidence in the public health system. Forty six percent of respondents had private health insurance. Respondents were more likely to have private health insurance as household income increased, and confidence in the public health system decreased. (Over two thirds of respondents were either confident or very confident in the public health system). Nineteen percent had private health insurance for pharmaceuticals, and the likelihood was not affected by household income or confidence in the public health system. Sixty one percent believed private insurance for pharmaceuticals would increase availability and affordability of pharmaceuticals. However, just over half were willing to pay for private insurance for pharmaceuticals. Of these, over two thirds were only willing to pay $20 per year or less. New Zealand pharmacy consumers' willingness to pay for private insurance for pharmaceuticals is very low. PMID:25332887

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

    PubMed

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

    2015-11-01

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

  1. Entry and Investment Decisions in the Pharmaceutical Industry

    E-print Network

    Mateo, Jill M.

    Entry and Investment Decisions in the Pharmaceutical Industry Anita Rao March 26 2015 Abstract The pharmaceutical industry is different from most industries where entry has been studied as it involves a time the substantial costs accumulated over the development process. Finally, unlike most industries, even after

  2. 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.

  3. 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

  4. 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

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

    PubMed

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

    2002-01-01

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

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

    PubMed

    Morgan, Steven; Daw, Jamie; Thomson, Paige

    2013-04-01

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

  8. 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…

  9. 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...

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

    PubMed Central

    Lee, Munjae; Choi, Mankyu

    2015-01-01

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

  11. Garden Variety Coffee Company

    E-print Network

    Wismath, Stephen

    Garden Variety Coffee Company Hiroba Nippon Got Fries? Icy's Subway Pitas, Wraps, Fruit Smoothies, Soup Coffees, Cappuccinos, Homemade Muffins Japanese Cuisine Breakfast Burgers, Soup, Hamburgers, Chicken Fingers, French Fries, Starbucks Coffee Tacos, Frozen Yogurt Sub Sandwiches, Salads, Soup

  12. Accounting Projects Company Description

    E-print Network

    Dahl, David B.

    and accounting oriented students to develop and implement a Quickbooks based accounting, finance and tax systems . Short Project Name: Finance, Tax, Accounting, and HR Project Description and Deliverables: SpecificallyAccounting Projects Company Description: CPA firm performing accounting services, bookkeeping

  13. Competitor Analysis Company Description

    E-print Network

    Dahl, David B.

    innovation, product quality and safety. Short Project Name: Green Chemical Movement and Chemical Production advances in chemical production from green/environmentally friendly resources. Conduct research and analyze information concerning emerging green chemical manufacturing technologies, raw materials and companies

  14. 42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...Condition for coverage—Pharmaceutical services. The ASC must provide drugs and biologicals in...designated responsible for pharmaceutical services. (a) Standard: Administration of drugs. Drugs must be...

  15. 42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...Condition for coverage—Pharmaceutical services. The ASC must provide drugs and biologicals in...designated responsible for pharmaceutical services. (a) Standard: Administration of drugs. Drugs must be...

  16. 42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...Condition for coverage—Pharmaceutical services. The ASC must provide drugs and biologicals in...designated responsible for pharmaceutical services. (a) Standard: Administration of drugs. Drugs must be...

  17. 42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...Condition for coverage—Pharmaceutical services. The ASC must provide drugs and biologicals in...designated responsible for pharmaceutical services. (a) Standard: Administration of drugs. Drugs must be...

  18. 42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...Condition for coverage—Pharmaceutical services. The ASC must provide drugs and biologicals in...designated responsible for pharmaceutical services. (a) Standard: Administration of drugs. Drugs must be...

  19. 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 ...

  20. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Johnson Matthey Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... November 28, 2011, 76 FR 72974, Johnson Matthey Pharmaceutical Materials Inc., Pharmaceutical Service, 25... substances: Drug Schedule Amphetamine (1100) II Methylphenidate (1724) II Nabilone (7379) II...

  1. 78 FR 46373 - Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ..., 2013, 78 FR 19017, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Services, 25 Patton...: Drug Schedule Amphetamine (1100) II Methylphenidate (1724) II Nabilone (7379) II Hydrocodone (9193)...

  2. Marine Polysaccharides in Pharmaceutical Applications: An Overview

    PubMed Central

    Laurienzo, Paola

    2010-01-01

    The enormous variety of polysaccharides that can be extracted from marine plants and animal organisms or produced by marine bacteria means that the field of marine polysaccharides is constantly evolving. Recent advances in biological techniques allow high levels of polysaccharides of interest to be produced in vitro. Biotechnology is a powerful tool to obtain polysaccharides from a variety of micro-organisms, by controlling the growth conditions in a bioreactor while tailoring the production of biologically active compounds. Following an overview of the current knowledge on marine polysaccharides, with special attention to potential pharmaceutical applications and to more recent progress on the discovering of new polysaccharides with biological appealing characteristics, this review will focus on possible strategies for chemical or physical modification aimed to tailor the final properties of interest. PMID:20948899

  3. Pharmaceutical Advertising and Medicare Part D

    PubMed Central

    Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

    2013-01-01

    We explore how and to what extent prescription drug insurance expansions affects incentives for pharmaceutical advertising. When insurance expansions make markets more profitable, firms respond by boosting advertising. Theory suggests this effect will be magnified in the least competitive drug classes, where firms internalize a larger share of the benefits from advertising. Empirically, we find that the implementation of Part D coincides with a 14% to 19% increase in total advertising expenditures. This effect is indeed concentrated in the least competitive drug classes. The additional advertising raised utilization among non-elderly patients outside the Part D program by about 3.6%. This is roughly half of the direct utilization effect of Part D on elderly beneficiaries. The results suggest the presence of considerable spillover effects from publicly subsidized prescription drug insurance on the utilization and welfare of consumers outside the program. PMID:24308884

  4. Are Pharmaceutical Patents Protected By Human Rights?

    PubMed Central

    Millum, Joseph

    2016-01-01

    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

  5. Pharmaceutical Particle Engineering via Spray Drying

    PubMed Central

    2007-01-01

    This review covers recent developments in the area of particle engineering via spray drying. The last decade has seen a shift from empirical formulation efforts to an engineering approach based on a better understanding of particle formation in the spray drying process. Microparticles with nanoscale substructures can now be designed and their functionality has contributed significantly to stability and efficacy of the particulate dosage form. The review provides concepts and a theoretical framework for particle design calculations. It reviews experimental research into parameters that influence particle formation. A classification based on dimensionless numbers is presented that can be used to estimate how excipient properties in combination with process parameters influence the morphology of the engineered particles. A wide range of pharmaceutical application examples—low density particles, composite particles, microencapsulation, and glass stabilization—is discussed, with specific emphasis on the underlying particle formation mechanisms and design concepts. PMID:18040761

  6. Pharmaceutical quality of anthelmintics sold in Kenya.

    PubMed

    Monteiro, A M; Wanyangu, S W; Kariuki, D P; Bain, R; Jackson, F; McKellar, Q A

    1998-04-11

    Nine anthelmintic products in pharmacies and from agricultural merchants in Kenya were tested for pharmaceutical quality. The concentration of active drug was compared with the claim on the label, and the variability of several products was tested between batches and between bottles within the same batch. All the products purchased claimed to contain levamisole but its mean (sd) concentration varied from 0 to 118.0 (13.3) per cent of the claimed. The concentration of levamisole in different batches of the same product ranged from 0 to 85.4 per cent of that claimed. One product consisting in part of mebendazole was found to contain 73.2 (9.4) per cent of the claimed concentration of this active component and two products consisting in part of oxyclozanide were found to contain 106.0 (14.4) and 120.6 (6.1) per cent of the expected concentration of oxyclozanide. PMID:9586132

  7. 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

  8. Prospects for Anti-Biofilm Pharmaceuticals

    PubMed Central

    Stewart, Philip S.

    2015-01-01

    This commentary highlights several avenues currently being pursued in research labs to the development of new anti-biofilm pharmaceuticals. There is a real need for alternative therapeutic modalities for treating the persistent infections that sometimes form on implanted medical devices or compromised niches within the body. Strategies being researched include discovering new antimicrobial agents that kill microorganisms in biofilms more effectively than do existing antibiotics, designing drugs that block microbial adhesion or interfere with intercellular communication, developing chemistries to disperse biofilms, and combining agents with different mechanisms of action. Though the need is great, the pathway to commercialization of new drugs is steep. One possible streamlined approach to navigating the regulatory approval process is to repurpose old drugs, a strategy that a few groups have shown can yield agents with anti-biofilm properties. PMID:26343685

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

    PubMed

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

    2015-11-01

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

  10. Marketed Marine Natural Products in the Pharmaceutical and Cosmeceutical Industries: Tips for Success

    PubMed Central

    Martins, Ana; Vieira, Helena; Gaspar, Helena; Santos, Susana

    2014-01-01

    The marine environment harbors a number of macro and micro organisms that have developed unique metabolic abilities to ensure their survival in diverse and hostile habitats, resulting in the biosynthesis of an array of secondary metabolites with specific activities. Several of these metabolites are high-value commercial products for the pharmaceutical and cosmeceutical industries. The aim of this review is to outline the paths of marine natural products discovery and development, with a special focus on the compounds that successfully reached the market and particularly looking at the approaches tackled by the pharmaceutical and cosmetic companies that succeeded in marketing those products. The main challenges faced during marine bioactives discovery and development programs were analyzed and grouped in three categories: biodiversity (accessibility to marine resources and efficient screening), supply and technical (sustainable production of the bioactives and knowledge of the mechanism of action) and market (processes, costs, partnerships and marketing). Tips to surpass these challenges are given in order to improve the market entry success rates of highly promising marine bioactives in the current pipelines, highlighting what can be learned from the successful and unsuccessful stories that can be applied to novel and/or ongoing marine natural products discovery and development programs. PMID:24549205

  11. [Specificities of patent protection in the pharmaceutical industry: modalities and traits of intellectual property].

    PubMed

    Jannuzzi, Anna Haydée Lanzillotti; Vasconcellos, Alexandre Guimarães; de Souza, Cristina Gomes

    2008-06-01

    Different forms of protection for inventions in the pharmaceutical industry point to strategies for the perpetuation of patent protection. Based on a literature review showing the specificities of patenting in the industry, the article provides a brief history of drug patents in Brazil, a discussion of patentable and non-patentable inventions, and the modalities and traits of patent protection that aim to extend the temporary monopoly granted under the patent. Such strategies include patents targeting polimorphs and optical isomers of drugs and drug combinations and specific clinical preparations, increasingly present in the drug patent claims filed by pharmaceutical companies. The study's objective is to discuss the specificities of drug patent claims in order to help develop expertise in the area and discuss the impact of expanding the scope of patent protection. In conclusion, while the tendency to expand towards more a permissive protective scope could produce opportunities for Brazilian national inventors, it could also be harmful to a policy for access to medicines. PMID:18545747

  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. Evaluation of Factors Affecting Prescribing Behaviors, in Iran Pharmaceutical Market by Econometric Methods

    PubMed Central

    Tahmasebi, Nima; Kebriaeezadeh, Abbas

    2015-01-01

    Prescribing behavior of physicians affected by many factors. The present study is aimed at discovering the simultaneous effects of the evaluated factors (including: price, promotion and demographic characteristics of physicians) and quantification of these effects. In order to estimate these effects, Fluvoxamine (an antidepressant drug) was selected and the model was figured out by panel data method in econometrics. We found that insurance and advertisement respectively are the most effective on increasing the frequency of prescribing, whilst negative correlation was observed between price and the frequency of prescribing a drug. Also brand type is more sensitive to negative effect of price than to generic. Furthermore, demand for a prescription drug is related with physician demographics (age and sex). According to the results of this study, pharmaceutical companies should pay more attention to the demographic characteristics of physicians (age and sex) and their advertisement and pricing strategies. PMID:25901174

  14. Cloud computing in pharmaceutical R&D: business risks and mitigations.

    PubMed

    Geiger, Karl

    2010-05-01

    Cloud computing provides information processing power and business services, delivering these services over the Internet from centrally hosted locations. Major technology corporations aim to supply these services to every sector of the economy. Deploying business processes 'in the cloud' requires special attention to the regulatory and business risks assumed when running on both hardware and software that are outside the direct control of a company. The identification of risks at the correct service level allows a good mitigation strategy to be selected. The pharmaceutical industry can take advantage of existing risk management strategies that have already been tested in the finance and electronic commerce sectors. In this review, the business risks associated with the use of cloud computing are discussed, and mitigations achieved through knowledge from securing services for electronic commerce and from good IT practice are highlighted. PMID:20443161

  15. 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

  16. 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

  17. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    PubMed

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch doctors during the interwar years--from rapprochement towards concerted action. PMID:22586821

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

    PubMed Central

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

    2011-01-01

    Background Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing. Methods and Findings We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996–October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non–mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non–mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%). Conclusions Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches. Please see later in the article for the Editors' Summary PMID:21483716

  19. [Risk-sharing schemes: a new paradigm in adopting innovative pharmaceuticals].

    PubMed

    Hammerman, Ariel; Greenberg, Dan

    2012-06-01

    In recent years, spending on prescription drugs contributes substantially to the continuous growth in health expenditure in most Western countries. This increase in spending is influenced by both a rise in the use of existing drugs and by the adoption of new and expensive drugs. Risk-sharing agreements between pharmaceutical companies and health insurers have emerged as insurers began to deny reimbursement of expensive innovative treatments with unfavorable cost-effectiveness ratios. This occurred in cases where the expected budgetary impact was too high or when the long-term effectiveness was questionable. Risk sharing agreements serve the interests of both the insurers and the drug manufacturers. Pharmaceutical companies' interests are to dispel the uncertainties encountered by the health insurers white deciding on drug reimbursement. The insurers are interested in these agreements in order to reduce the budgetary risk while allowing their patients access to innovative drugs. Currently, only a few risk sharing agreements have been implemented, and the scientific literature on such schemes is still sparse. Since the health insurers' interest is to develop mechanisms that will contain health costs, without affecting the insured, it appears that this trend will continue to emerge. It is also likely that the adoption of similar mechanisms in the Israeli National List of Health Services updating process, would improve the accuracy of early estimates of the budgetary impact, and the actual use of the new technologies would be close to early estimates. This article reviews the principles of risk-sharing schemes and issues involved in the actual implementation of such agreements. PMID:22991869

  20. Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research.

    PubMed

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

    2015-11-01

    Pharmaceutical human biomedical research is a multi-dimensional endeavor that requires collaboration among many parties, including those who sponsor, conduct, participate in, or stand to benefit from the research. Human subjects' protections have been promulgated to ensure that the benefits of such research are accomplished with respect for and minimal risk to individual research participants, and with an overall sense of fairness. Although these protections are foundational to clinical research, most ethics guidance primarily highlights the responsibilities of investigators and ethics review boards. Currently, there is no published resource that comprehensively addresses bioethical responsibilities of industry sponsors; including their responsibilities to parties who are not research participants, but are, nevertheless key stakeholders in the endeavor. To fill this void, in 2010 Eli Lilly and Company instituted a Bioethics Framework for Human Biomedical Research. This paper describes how the framework was developed and implemented and provides a critique based on four years of experience. A companion article provides the actual document used by Eli Lilly and Company to guide ethical decisions regarding all phases of human clinical trials. While many of the concepts presented in this framework are not novel, compiling them in a manner that articulates the ethical responsibilities of a sponsor is novel. By utilizing this type of bioethics framework, we have been able to develop bioethics positions on various topics, provide research ethics consultations, and integrate bioethics into the daily operations of our human biomedical research. We hope that by sharing these companion papers we will stimulate discussion within and outside the biopharmaceutical industry for the benefit of the multiple parties involved in pharmaceutical human biomedical research. PMID:26325424

  1. Making Progress and Gaining Momentum in Global 3Rs Efforts: How the European Pharmaceutical Industry Is Contributing

    PubMed Central

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

    2015-01-01

    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

  2. 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

  3. An energy alliance company

    SciTech Connect

    Bernhardt, T.

    1991-10-01

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

  4. 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 ...

  5. PharmEcovigilance and the Environmental Footprint of Pharmaceuticals

    EPA Science Inventory

    The prescribing and usage of medications have ramifications extending far beyond conventional medical care. The healthcare industry has an environmental footprint because the active ingredients from pharmaceuticals enter the environment as pollutants by a variety of routes, prima...

  6. Framework for the determination of yield limits In pharmaceutical operations

    E-print Network

    Liow, Yuh Han John

    2010-01-01

    The manufacturing production of active pharmaceutical ingredients often involve a series of processing stages in which yield limits are prescribed to ensure that the target yield has been achieved for a batch and that the ...

  7. 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, ...

  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. PHARMACEUTICALS IN THE ENVIRONMENT: OVERVIEW OF SIGNIFICANCE, CONCERNS, AND SOLUTIONS

    EPA Science Inventory

    Pharmaceuticals and personal care products (PPCPs) comprise large, diverse arrays of chemicals that can occur in the environment as unregulated pollutants. They originate largely from the combined activities and actions of multitudes of individuals as well as from veterinary and ...

  10. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS (PPCPS) AS ENVIRONMENTAL POLLUTANTS

    EPA Science Inventory

    The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typical...

  11. Recent trends and future of pharmaceutical packaging technology

    PubMed Central

    Zadbuke, Nityanand; Shahi, Sadhana; Gulecha, Bhushan; Padalkar, Abhay; Thube, Mahesh

    2013-01-01

    The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future. PMID:23833515

  12. Exploration of parameters for the continuous blending of pharmaceutical powders

    E-print Network

    Lin, Ben Chien Pang

    2011-01-01

    The transition from traditional batch blending to continuous blending is an opportunity for the pharmaceutical industry to reduce costs and improve quality control. This operational shift necessitates a deeper understanding ...

  13. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS: DIVERSE GALAXY OF ENVIRONMENTAL POLLUTANTS

    EPA Science Inventory

    The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typical...

  14. 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 ...

  15. INTEGRATIVE SAMPLING OF ANTIBIOTICS AND OTHER PHARMACEUTICALLY-RELATED COMPOUNDS

    EPA Science Inventory

    Pharmaceuticals from human and veterinary use continually enter the environment through municipal wastewater treatment plants (WWTPs), surface runoff from animal waste, and direct disposal of unused medications. The presence of these chemicals, albeit often at subtherapeutic trac...

  16. Decomposition of persistent pharmaceuticals in wastewater by ionizing radiation

    NASA Astrophysics Data System (ADS)

    Kimura, Atsushi; Osawa, Misako; Taguchi, Mitsumasa

    2012-09-01

    Pharmaceuticals in wastewater were treated by the combined method of activated sludge and ionizing radiation in laboratory scale. Oseltamivir, aspirin, and ibuprofen at 5 ?mol dm-3 in wastewater were decomposed by the activated sludge at reaction time for 4 h. Carbamazepine, ketoprofen, mefenamic acid, clofibric acid, and diclofenac were not biodegraded completely, but were eliminated by ?-ray irradiation at 2 kGy. The rate constants of the reactions of these pharmaceuticals with hydroxyl radicals were estimated by the competition reaction method to be 4.0-10×109 mol-1 dm3 s-1. Decompositions of the pharmaceuticals in wastewater by ionizing radiation were simulated by use of the rate constants and the amount of total organic carbon as parameters. Simulation curves of concentrations of these pharmaceuticals as a function of dose described the experimental data, and the required dose for the elimination of them in wastewater by ionizing radiation can be estimated by this simulation.

  17. 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 ...

  18. 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 ...

  19. 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 ...

  20. Computer-aided rational solvent selection for pharmaceutical crystallization

    E-print Network

    Chen, Jie, Ph. D. Massachusetts Institute of Technology

    2010-01-01

    Solvents play an important role in crystallization, a commonly used separation and purification technique in the pharmaceutical, chemical and food industries. They affect crystal properties such as particle size distribution, ...

  1. 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.

  2. Crystallization process development and spherical agglomerates for pharmaceutical processing applications

    E-print Network

    Quon, Justin (Justin Louie)

    2013-01-01

    The control of crystallization steps is essential in the production of many materials in the pharmaceutical, materials, and chemical industries. Additionally, due to increasing costs of research and development, reductions ...

  3. 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 ...

  4. 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.

  5. Synthetic biology for pharmaceutical drug discovery

    PubMed Central

    Trosset, Jean-Yves; Carbonell, Pablo

    2015-01-01

    Synthetic biology (SB) is an emerging discipline, which is slowly reorienting the field of drug discovery. For thousands of years, living organisms such as plants were the major source of human medicines. The difficulty in resynthesizing natural products, however, often turned pharmaceutical industries away from this rich source for human medicine. More recently, progress on transformation through genetic manipulation of biosynthetic units in microorganisms has opened the possibility of in-depth exploration of the large chemical space of natural products derivatives. Success of SB in drug synthesis culminated with the bioproduction of artemisinin by microorganisms, a tour de force in protein and metabolic engineering. Today, synthetic cells are not only used as biofactories but also used as cell-based screening platforms for both target-based and phenotypic-based approaches. Engineered genetic circuits in synthetic cells are also used to decipher disease mechanisms or drug mechanism of actions and to study cell–cell communication within bacteria consortia. This review presents latest developments of SB in the field of drug discovery, including some challenging issues such as drug resistance and drug toxicity. PMID:26673570

  6. Phytotoxicity of composted herbal pharmaceutical industry wastes.

    PubMed

    Suthar, Surindra; Singh, Deepika

    2011-08-01

    This work demonstrates the phytotoxicity screening of composted herbal pharmaceutical industry waste (HPIW) using seed bioassay method. The composted industrial waste should be tested at lab scale prior to recommendation for land application. HPIW was mixed with soil to produce four treatments: T(1) (1:1), T(2) (1:2), T(3) (1:3), and T(4) (1:0) for toxicity screening using Pisum sativum seeds. After 72 h relative seed germination (RSG), relative root growth (RRG) and germination index (GI) were recorded. Seedlings were observed for further plant growth and tissue biochemistry (chlorophyll, soluble sugar, starch, carotenoid, and protein) estimation. RSG, RRG, and GI values were better in T(1) and T(2) than others. GI was in the ranges of 36.62 % (T(4)) to 170.38 % (T(2)). The seedling growth and biochemical parameters were better in seedling obtained from potting media containing low proportion of HPIW (i.e., T(1) and T(2)). Results clearly suggested that composted HPIW may be utilized effectively for crop production after dilution under sustainable farming system program. PMID:22648349

  7. What happens when pharmaceuticals meet colloids.

    PubMed

    Xing, Yingna; Chen, Xijuan; Zhuang, Jie; Chen, Xin

    2015-12-01

    Pharmaceuticals (PCs) have been widely detected in natural environment due to agricultural application of reclaimed water, sludge and animal wastes. Their potential risks to various ecosystems and even to human health have caused great concern; however, little was known about their environmental behaviors. Colloids (such as clays, metal oxides, and particulate organics) are kind of substances that are active and widespread in the environment. When PCs meet colloids, their interaction may influence the fate, transport, and toxicity of PCs. This review summarizes the progress of studies on the role of colloids in mediating the environmental behaviors of PCs. Synthesized results showed that colloids can adsorb PCs mainly through ion exchange, complexation and non-electrostatic interactions. During this process the structure of colloids and the stability of PCs may be changed. The adsorbed PCs may have higher risks to induce antibiotic resistance; besides, their transport may also be altered considering they have great chance to move with colloids. Solution conditions (such as pH, ionic strength, and cations) could influence these interactions between PCs and colloids, as they can change the forms of PCs and alter the primary forces between PCs and colloids in the solution. It could be concluded that PCs in natural soils could bind with colloids and then co-transport during the processes of irrigation, leaching, and erosion. Therefore, colloid-PC interactions need to be understood for risk assessment of PCs and the best management practices of various ecosystems (such as agricultural and wetland systems). PMID:26427370

  8. Thermal Analysis of Some Antidiabetic Pharmaceutical Compounds

    PubMed Central

    Attia, Ali Kamal; Ibrahim, Magda Mohamed; El-ries, Mohamed Abdel-Nabi

    2013-01-01

    Purpose: Thermal behavior of some antidiabetic drugs such as pioglitazone hydrochloride (PTZ), rosiglitazone maleate (RGZ), glibenclamide (GBD) and glimepiride (GMP) has been studied. Methods: Thermogravimetric analysis (TGA), derivative thermogravimetry (DTG) and differential thermal analysis (DTA) techniques were used to study the thermal behavior of the drugs under investigation. Results: Thermal analysis technique was used to obtain quality control parameters such as melting point 193.13 °C, 122.42 °C, 173.75 °C and 208 °C for PTZ, RGZ, GBD and GMP, respectively. The values of melting point of gave satisfactory results in comparison to that obtained by using the official method. Non-isothermal methods were employed to determine the activation energy values of the first stage of thermal decomposition. Comparison of the activation energy values suggests the following sequence of thermal stability: GMP > GBD > RGZ > PTZ. Conclusion: The results obtained are useful for the identification of these compounds and permitted interpretations concerning their thermal decomposition. Thermal stability of pharmaceutical compounds can be studied and compared by using thermal analysis techniques. PMID:24312870

  9. 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

  10. 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

  11. 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

  12. Pharmaceutical applications of vibrational chemical imaging and chemometrics: a review.

    PubMed

    Gendrin, C; Roggo, Y; Collet, C

    2008-11-01

    The emergence of chemical imaging (CI) has gifted spectroscopy an additional dimension. Chemical imaging systems complement chemical identification by acquiring spatially located spectra that enable visualization of chemical compound distributions. Such techniques are highly relevant to pharmaceutics in that the distribution of excipients and active pharmaceutical ingredient informs not only a product's behavior during manufacture but also its physical attributes (dissolution properties, stability, etc.). The rapid image acquisition made possible by the emergence of focal plane array detectors, combined with publication of the Food and Drug Administration guidelines for process analytical technology in 2001, has heightened interest in the pharmaceutical applications of CI, notably as a tool for enhancing drug quality and understanding process. Papers on the pharmaceutical applications of CI have been appearing in steadily increasing numbers since 2000. The aim of the present paper is to give an overview of infrared, near-infrared and Raman imaging in pharmaceutics. Sections 2 and 3 deal with the theory, device set-ups, mode of acquisition and processing techniques used to extract information of interest. Section 4 addresses the pharmaceutical applications. PMID:18819769

  13. Inkjet printing for pharmaceutics - A review of research and manufacturing.

    PubMed

    Daly, Ronan; Harrington, Tomás S; Martin, Graham D; Hutchings, Ian M

    2015-10-30

    Global regulatory, manufacturing and consumer trends are driving a need for change in current pharmaceutical sector business models, with a specific focus on the inherently expensive research costs, high-risk capital-intensive scale-up and the traditional centralised batch manufacturing paradigm. New technologies, such as inkjet printing, are being explored to radically transform pharmaceutical production processing and the end-to-end supply chain. This review provides a brief summary of inkjet printing technologies and their current applications in manufacturing before examining the business context driving the exploration of inkjet printing in the pharmaceutical sector. We then examine the trends reported in the literature for pharmaceutical printing, followed by the scientific considerations and challenges facing the adoption of this technology. We demonstrate that research activities are highly diverse, targeting a broad range of pharmaceutical types and printing systems. To mitigate this complexity we show that by categorising findings in terms of targeted business models and Active Pharmaceutical Ingredient (API) chemistry we have a more coherent approach to comparing research findings and can drive efficient translation of a chosen drug to inkjet manufacturing. PMID:25772419

  14. 12 CFR 583.15 - Parent company.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  15. Company Town Shutdown.

    ERIC Educational Resources Information Center

    Turnage, Martha A.

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

  16. The Company They Keep.

    ERIC Educational Resources Information Center

    Meier, Deborah

    1999-01-01

    High school students no longer keep company with the grown-ups they are about to become. Schools and districts have grown exponentially larger, impersonal, and bureaucratic, resembling post offices. Superintendents and boards who know their schools only through media representations or statistics fashion unrealistic policies. Coercion and…

  17. The Electric Company.

    ERIC Educational Resources Information Center

    Children's Television Workshop, New York, NY.

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

  18. [Company Name] [Street Address

    E-print Network

    [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

  19. 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

  20. Company profile: Sistemic Ltd.

    PubMed

    Reid, Jim

    2013-09-01

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

  1. No Company Is An Island 

    E-print Network

    Maddox, A.

    1989-01-01

    No company is an island. Utilities and their industrial customers are discovering that collaboration can breed opportunity while isolation can lead to ruin. Inter company relationships have changed over recent years and HL&P and its customers...

  2. 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

  3. Company Profile: Intramagnetics General Corporation

    SciTech Connect

    1992-09-01

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

  4. 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…

  5. Smart customers, dumb companies.

    PubMed

    Locke, C

    2000-01-01

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

  6. 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

  7. 76 FR 1666 - Susquehanna Union Railroad Company-Control Exemption-North Shore Railroad Company, Nittany & Bald...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... Company, Nittany & Bald Eagle Railroad Company, Shamokin Valley Railroad Company, Juniata Valley Railroad... Class III railroads: North Shore Railroad Company, Nittany & Bald Eagle Railroad Company,...

  8. 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.

  9. 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

  10. Pharmaceutical cocrystals: along the path to improved medicines.

    PubMed

    Duggirala, Naga K; Perry, Miranda L; Almarsson, Örn; Zaworotko, Michael J

    2015-12-24

    Cocrystals, a long known but understudied class of crystalline solids, have attracted interest from crystal engineers and pharmaceutical scientists in the past decade and are now an integral part of the preformulation stage of drug development. This is largely because cocrystals that contain a drug molecule, pharmaceutical cocrystals, can modify physicochemical properties without the need for covalent modification of the drug molecule. This review presents a brief history of cocrystals before addressing recent advances in design, discovery and development of pharmaceutical cocrystals that have occurred since an earlier review published in 2004. We address four aspects of cocrystals: nomenclature; design using hydrogen-bonded supramolecular synthons; methods of discovery and synthesis; development of pharmaceutical cocrystals as drug products. Cocrystals can be classified into molecular cocrystals (MCCs) that contain only neutral components (coformers) and ionic cocrystals (ICCs), which are comprised of at least one ionic coformer that is a salt. That cocrystals, especially ICCs, offer much greater diversity in terms of composition and properties than single component crystal forms and are amenable to design makes them of continuing interest. Seven recent case studies that illustrate how pharmaceutical cocrystals can improve physicochemical properties and clinical performance of drug substances, including a recently approved drug product based upon an ICC, are presented. PMID:26565650

  11. 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

  12. Innovative Research-Based Approaches to Learning and Teaching. OECD Education Working Papers, No. 79

    ERIC Educational Resources Information Center

    van den Broek, Gesa Sonja Elsa

    2012-01-01

    Building on an earlier 2008 summary prepared for OECD by Marlene Scardamalia and Carl Bereiter, this paper by Gesa S. E. van den Broek provides a more extensive discussion of approaches described as "research based innovation." "Fostering Communities of Learning" is a constructivist approach in which teachers help students discover important…

  13. Combination of the Research-Based Learning Method with the Modern Physics Experiment Course Teaching

    ERIC Educational Resources Information Center

    Liu, Xiaolai; Li, Qinghuai

    2011-01-01

    It has been the hotspot to reconstruct the education course based on the research-based learning in the course reform in many countries in recent years. The new course standard of China insists that the teaching is the interactive process that teachers and students communicate and develop together. In the teaching, the relationship between…

  14. 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…

  15. The Impact of a Research-Based Teacher Training Program on Indonesian Teachers, Classrooms, and Students.

    ERIC Educational Resources Information Center

    Djalil, Aria; Anderson, Lorin W.

    1989-01-01

    Results of a study of 30 Indonesian fifth-grade teachers support the value of intensive, research-based teacher training programs in changing teacher behavior and increasing teacher effectiveness. The effect of such programs appears limited to those behaviors and outcomes which reflect the primary focus or emphasis of the program. (IAH)

  16. Meeting of Two Minds: Research-Based Literacy Activities in Practice

    ERIC Educational Resources Information Center

    Borgia, Laurel G.; Jackson, Janet

    2009-01-01

    This study examines a collaborative project between a literacy professor and a classroom teacher. The professor used a Newbery Award winning novel to develop a unit for a fifth-grade classroom using curricular materials and methods that showcased research-based literacy practices. The fifth-grade teacher, in turn, used her knowledge of students'…

  17. 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…

  18. But Does It Last? Sustaining a Research-Based Curriculum in Upper-Division Electricity & Magnetism

    E-print Network

    Colorado at Boulder, University of

    But Does It Last? Sustaining a Research-Based Curriculum in Upper-Division Electricity & Magnetism course approach in junior-level electricity and magnetism (E&M). Almost all developed materials (i, electricity and magnetism, assessment PACS: 01.30.Ib, 01.40.Di, 01.40.Fk, 01.40.G-, 01.40.gb INTRODUCTION

  19. 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…

  20. UBC 09 Upper-Level Course Transformation Univ. of Colorado A research-based approach to

    E-print Network

    Colorado at Boulder, University of

    UBC 09 Upper-Level Course Transformation Univ. of Colorado A research-based approach Transformation Univ. of Colorado CU Physics Education Research Physics faculty: Michael Dubson Noah Finkelstein STEM #12;UBC 09 Upper-Level Course Transformation Univ. of Colorado Why Transform E&M I? ? Can our

  1. 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…

  2. 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…

  3. Thriving in Transitions: A Research-Based Approach to College Student Success

    ERIC Educational Resources Information Center

    Schreiner, Laurie A., Ed.; Louis, Michelle C., Ed.; Nelson, Denise D., Ed.

    2012-01-01

    "Thriving in Transitions: A Research-Based Approach to College Student Success" represents a paradigm shift in the student success literature. Grounded in positive psychology, the thriving concept reframes the student success conversation by focusing on the characteristics amenable to change and that promote high levels of academic,…

  4. Reading with Young Children. Reading: Research-Based Decision Making Series, Number 9302.

    ERIC Educational Resources Information Center

    Jackson, Nancy Ewald; Roller, Cathy M.

    This report provides research-based answers to questions about literacy development from infancy to age 6, with emphasis on the development of these skills in precocious readers. The question-answer format considers the importance of reading with young children, other activities to help young children learn to read, normal development of reading…

  5. Research-Based Instructions to Increase Communication Skills for Students with Severe Disabilities

    ERIC Educational Resources Information Center

    Pinto, Peg; Simpson, Cynthia; Bakken, Jeffrey P.

    2009-01-01

    Communication skills are of great importance for children with developmental disabilities to be functional and independent in their own lives. This paper provides results of a comprehensive literature review on current researched-based intervention strategies that appear effective to increase communication skills for students who have severe…

  6. 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…

  7. 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'…

  8. 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,…

  9. Developing Research-Based Curricula in College-Based Higher Education

    ERIC Educational Resources Information Center

    Healey, Mick; Jenkins, Alan; Lea, John

    2014-01-01

    This report fills a major gap in understanding the development of research-based curricula, focusing on college-based higher education (CBHE). Estimates suggest that, in England, somewhere between 8-10% of HE undergraduate students are taught in CBHE. In 2009, 17% of HE students in Scotland were enrolled in CBHE. In Wales this was 15% and in…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  11. A Research-Based Curriculum for Teaching the Photoelectric Effect S. B. McKagan,1

    E-print Network

    Colorado at Boulder, University of

    A Research-Based Curriculum for Teaching the Photoelectric Effect S. B. McKagan,1 W. Handley,2 K. K the photoelectric effect important, but many erroneously believe it is easy for students to understand. We have to correctly state both the observations made in the photoelectric effect experiment and the inferences

  12. 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…

  13. Use of Research-Based Instructional Strategies: How to Avoid Faculty Quitting

    ERIC Educational Resources Information Center

    Wieman, Carl; Deslauriers, Louis; Gilley, Brett

    2013-01-01

    We have examined the teaching practices of faculty members who adopted research-based instructional strategies (RBIS) as part of the Carl Wieman Science Education Initiative (CWSEI) at the University of British Columbia (UBC). Of the 70 that adopted such strategies with the support of the CWSEI program, only one subsequently stopped using these…

  14. Principles of Instruction: Research-Based Strategies That All Teachers Should Know

    ERIC Educational Resources Information Center

    Rosenshine, Barak

    2012-01-01

    This article presents 10 research-based principles of instruction, along with suggestions for classroom practice. These principles come from three sources: (a) research in cognitive science, (b) research on master teachers, and (c) research on cognitive supports. Each is briefly explained in this article. Even though these are three very different…

  15. Boycott threat forces French company to abandon RU486.

    PubMed

    Dorozynski, A

    1997-04-19

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

  16. SELECTED ASPECTS OF TERAHERTZ SPECTROSCOPY IN PHARMACEUTICAL SCIENCES.

    PubMed

    Nowak, Kacper; Pli?ski, Edward F; Karolewicz, Bo?ena; Jarz?b, Przemys?aw P; Pli?ska, Stanis?awa; Fuglewicz, Bogus?aw; Walczakowski, Micha? J; Augustyn, ?ukasz; Sterczewsk, ?ukasz A; Grzelczak, Micha? P; Hruszowiec, Mariusz; Beziuk, Grzegorz; Mikulic, Martin; Pa?ka, Norbert; Szustakowskip, Mieczys?aw

    2015-01-01

    THz-TDS techniques are applied to investigate selected pharmaceutical samples. Investigations were performed on selected pharmaceutical samples with active pharmaceutical ingredients (API)--famotidine, ranitidine, fenofibrate, lovastatin, simvastatin, aspirin, ketoconazole, acyclovir (hydrated and non-hydrated), on excipients--lactose, glucose (hydrated and non-hydrated), Pluronic 127, and on mixtures of selected compounds. Pseudo-polymorphism effects are considered as well. Examples of the terahertz imaging technique are also given. APIs and excipients can be easily recognized in the terahertz band by their specific "fingerprints" as individual components and in mixtures. The hydration process as a variety of polymorphism can also be easily monitored using the THz technique. Moreover, terahertz light can be useful for the penetration of tablets, giving clear pictures of possible defects in tablet coatings. PMID:26665391

  17. A Course Introducing the Principles of Pharmaceutical Care

    PubMed Central

    Chirico, Mark J.

    2010-01-01

    Objectives To develop, implement, and assess a course that introduces students to the process and application of pharmaceutical care. Design The course was offered to students in the third semester of the PharmD curriculum. The course's ability outcomes were to integrate and apply scientific and therapeutic knowledge in the delivery of evidence-based pharmaceutical care, and to develop the skills of a professional, lifelong learner. Assessment The students successfully applied the information learned in this course to the practice of pharmaceutical care. The 3 components of the course that appeared to be the most challenging were identifying drug-therapy problems, creating compound goals, and creating a care plan. Conclusion This course was effective in meeting ability-based outcomes. The assessment data helped the instructors determine what changes should be made to increase the course's success when it is offered again. PMID:21088737

  18. Inulin, a flexible oligosaccharide. II: Review of its pharmaceutical applications.

    PubMed

    Mensink, Maarten A; Frijlink, Henderik W; van der Voort Maarschalk, Kees; Hinrichs, Wouter L J

    2015-12-10

    Inulin is a flexible oligosaccharide which has been used primarily in food for decades. Recently new applications in the pharmaceutical arena were described. In a previous review (Mensink et al. (2015). Carbohydrate Polymers, 130, 405) we described the physicochemical characteristics of inulin, characteristics which make inulin a highly versatile substance. Here, we review its pharmaceutical applications. Applications of inulin that are addressed are stabilization of proteins, modified drug delivery (dissolution rate enhancement and drug targeting), and lastly physiological and disease-modifying effects of inulin. Further uses of inulin include colon specific drug administration and stabilizing and adjuvating vaccine formulations. Overall, the uses of inulin in the pharmaceutical area are very diverse and research is still continuing, particularly with chemically modified inulins. It is therefore likely that even more applications will be found for this flexible oligosaccharide. PMID:26428143

  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. 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

  1. Uncertainty of quantitative microbiological methods of pharmaceutical analysis.

    PubMed

    Gunar, O V; Sakhno, N G

    2015-12-30

    The total uncertainty of quantitative microbiological methods, used in pharmaceutical analysis, consists of several components. The analysis of the most important sources of the quantitative microbiological methods variability demonstrated no effect of culture media and plate-count techniques in the estimation of microbial count while the highly significant effect of other factors (type of microorganism, pharmaceutical product and individual reading and interpreting errors) was established. The most appropriate method of statistical analysis of such data was ANOVA which enabled not only the effect of individual factors to be estimated but also their interactions. Considering all the elements of uncertainty and combining them mathematically the combined relative uncertainty of the test results was estimated both for method of quantitative examination of non-sterile pharmaceuticals and microbial count technique without any product. These data did not exceed 35%, appropriated for a traditional plate count methods. PMID:26456251

  2. Analysis of Compounded Pharmaceutical Products to Teach the Importance of Quality in an Applied Pharmaceutics Laboratory Course

    PubMed Central

    Pignato, Alyssa

    2014-01-01

    Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding. Design. Second-year pharmacy students (N=77) participated in a pharmaceutical compounding laboratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry. Assessment. Reflection, survey instruments, and quiz questions were used to measure how well students understood the importance of quality in their compounded products. Product analysis showed that preparations compounded by students had an error range of 0.6% to 140%, with an average error of 23.7%. Students’ reflections cited common sources of error, including inaccurate weighing, contamination, and product loss during both the compounding procedure and preparation of the sample for analysis. Ninety percent of students agreed that the exercise improved their understanding of the importance of quality in compounded pharmaceutical products. Most students (85.7%) reported that this exercise inspired them to be more diligent in their preparation of compounded products in their future careers. Conclusion. Integrating an analytical assessment during a pharmaceutical compounding laboratory can enhance students’ understanding of quality of compounded pharmaceutical products. It can also provide students a chance to reflect on sources of error to improve their compounding technique in the future. PMID:24761022

  3. Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety.

    PubMed

    Olsen, Axel K; Whalen, Matthew D

    2009-01-01

    A survey of the US public titled 'Consumer Perceptions on Drug Safety' was conducted in October 2006. The survey was undertaken at that time because of the heightened public awareness of drug safety concerns over rofecoxib (Vioxx(R)) and pediatric antidepressant use. The survey was designed with questions related to public perception of the pharmaceutical industry, the US FDA, Congress and whether the US public perceived there to be a safety crisis. The survey consisted of 1726 US men and women aged 18 years and over. The survey results showed that the FDA, Congress and US pharmaceutical companies are perceived as having a notable amount of responsibility to ensure safety (by 75%, 41% and 70% of respondents, respectively). Additionally, 96% of the survey respondents indicated that they had some level of concern about adverse reactions to prescription drugs that are taken as directed. Seventy-six percent of the respondents were 'fairly' to 'extremely' concerned about adverse reactions, while approximately 42% of the survey respondents' opinions ranged from 'somewhat distrusting' to 'strongly distrusting' of the pharmaceutical companies that develop drugs. These findings are comparable to those in surveys conducted by the Kaiser Family Foundation in 2005 and PriceWaterhouseCoopers in 2007. These surveys suggest that about half the respondents believe there is both the need and desire for reform in drug safety by the pharmaceutical industry and the FDA. In reports from 2006 and 2007, the Institute of Medicine challenges the healthcare system and the FDA to adopt the principles of the culture of safety. While there have been steps taken to address the recommendations of the reports, as exemplified by the FDA Amendment Act of 2007 and the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium, true reform across the life sciences sector will only come through broad adoption of these principles. Thus, it is particularly important for individuals and healthcare providers to track and report safety-related events involving approved and unapproved indications and medication errors. Pharmacovigilance professionals provide the foundation upon which the principles of the culture of safety can be built. PMID:19722724

  4. Quality in the pharmaceutical industry – A literature review

    PubMed Central

    Haleem, Reham M.; Salem, Maissa Y.; Fatahallah, Faten A.; Abdelfattah, Laila E.

    2013-01-01

    Objectives The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. Design A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. Main outcome measures The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Results Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. Conclusions It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices. PMID:26594110

  5. 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.

  6. 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

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

    NASA Astrophysics Data System (ADS)

    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.

  8. UV resonance Raman sensing of pharmaceutical drugs in hollow fibers

    NASA Astrophysics Data System (ADS)

    Yan, D.; Popp, J.; Frosch, T.

    2014-05-01

    We report about the experimental combination of UV resonance Raman sensing (UV-RRS) and fiber enhanced Raman sensing (FERS) on pharmaceuticals. The results show that the chemical sensitivity is highly improved and at the same time the sample volume is reduced compared to conventional measurements. A hundreds-fold improvement of the limit of detection (LOD) has been achieved with the combination of resonance Raman enhancement and fiber enhancement. The enhanced Raman signal has a reliable linear relationship with the concentration of the analyte, and therefore shows great potential for quantitative analysis of pharmaceuticals.

  9. The malleable effect of name fluency on pharmaceutical drug perception.

    PubMed

    Cho, Hyejeung

    2015-10-01

    Based on the fluency theory, a recent study by Dohle and Siegrist revealed that complex pharmaceutical drug names are perceived as more hazardous than simple drug names and thus negatively influence patients' willingness to buy. This study explored the malleability of the name fluency effect on pharmaceutical drug perception by examining the fluency effect in the domain of risk versus advancedness judgment. The findings indicated that depending on how the fluency feeling is interpreted in the context of initial judgment task (e.g. advancedness vs risk), disfluent drug names can positively influence a patient's perception of the drug, reversing the typical fluency effect. PMID:24677431

  10. Spectrofluorimetric determination of famciclovir in pure and pharmaceutical preparations

    NASA Astrophysics Data System (ADS)

    Karasakal, A.; ULU, S. Tatar; Unal, D. Ozer

    2015-08-01

    A sensitive spectrofluorimetric method was developed for the determination of famciclovir in pure and pharmaceutical preparations. The method is based on the derivatization reaction of famciclovir with fluorescamine. The different experimental parameters that affect the fluorescence intensity were carefully studied, at once. The method was validated for linearity, limit of detection, limit of quantification, precision, accuracy, recovery, robustness. The assay was linear over the concentration range of 100 and 1000 ng/mL. The limits of detection and limit of quantification were calculated to be 51.13 and 153.39 ng/mL. The proposed method was applied to study of famciclovir in pure and in pharmaceutical preparations.

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

    PubMed Central

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

    2009-01-01

    Background Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries [1]. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals [2]. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution. Methods Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. Results The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. Conclusion Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and consistently administered, limit the promulgation of corrupt practices. Other major contributing factors are the inconsistency in documentation of procedures, lack of public availability of such documentation, and inadequacies in monitoring and evaluation. What is most critical from this study is the identification of areas that still remain permeable to corruption and, perhaps, where more appropriate checks and balances are needed from the Nigerian government and the international community. PMID:19874613

  12. Inherent Anticipation in the Pharmaceutical and Biotechnology Industries.

    PubMed

    Goldman, Michael; Evans, Georgia; Zappia, Andrew

    2015-08-01

    Pharmaceutical and biotech research often involves discovering new properties of, or new methods to use, existing compositions. The doctrine of inherent anticipation, however, prevents the issuance and/or validity of a patent for discoveries deemed to have been implicitly disclosed in the prior art. This can be a barrier to patent rights in these technologies. Inherent anticipation therefore creates uncertainty for patent protection in the pharmaceutical and biotech sciences. Despite this uncertainty, Federal Circuit jurisprudence provides guidance on the boundaries of the inherent anticipation doctrine. In view of the case law, certain strategies may be employed to protect inventions that may potentially be viewed as inherent in the prior art. PMID:25877394

  13. 75 FR 3249 - Wyeth Pharmaceuticals, a Subsidiary of Wyeth, Currently Known as Pfizer, Rouses Point, NY; Wyeth...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... and Training Administration Wyeth Pharmaceuticals, a Subsidiary of Wyeth, Currently Known as Pfizer, Rouses Point, NY; Wyeth Pharmaceuticals, a Subsidiary of Wyeth, Currently Known as Pfizer, Chazy, NY; Wyeth Pharmaceuticals, a Subsidiary of Wyeth, Currently Known as Pfizer, Plattsburgh, NY;...

  14. Oil companies as tax collectors

    SciTech Connect

    Adelman, M.A.

    1985-01-01

    In 1972, the author published a paper subtitled ''Oil Companies as Tax Collectors.'' Fifteen years earlier, the oil companies could not accurately have been described as tax collectors. Nor could they today. But in between lies an interesting chapter of history, which the author elucidates. The multinational companies have now been almost completely expelled from their old producing areas, even when, as in Saudi Arabia, they remain to work for a fee. For a few years, indeed, some companies and governments, under the spell of oil prices riding up to glory forever, even incurred losses for the sake of access to the scarce resource. But in the private sector, while much of the illusion persists, access is a dead letter. Tax problems now exist only in noncartel oil-producing countries. Governments and companies are price takers, and negotiate over the division of rents. Taxes are income taxes, and the days of oil companies as excise tax collectors are gone.

  15. 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 ...

  16. Concentrations and mass loadings of cardiovascular pharmaceuticals in healthcare facility wastewaters

    EPA Science Inventory

    Healthcare facilities are an under-characterized source of pharmaceuticals to municipal wastewaters. In this study, the composition and magnitude of 16 cardiovascular active pharmaceutical ingredients (API) and two cardiovascular API metabolites in wastewater effluents from a ho...

  17. Role of electrostatic interactions in the retention of pharmaceutically active contaminants by a loose nanofiltration membrane 

    E-print Network

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

    2006-01-01

    The role of electrostatic interactions in the separation of pharmaceuticals by a loose nanofiltration (NF) membrane was examined. While retention of the non-ionizable pharmaceutical carbamazepine was relatively independent ...

  18. The Role of PharmEcovigilance in Reducing the Environmental Footprint of Pharmaceuticals

    EPA Science Inventory

    The prescribing and usage of medications have ramifications extending far beyond conventional medical care. The pharmaceutical and healthcare industries have an environmental footprint because the active pharmaceutical ingredients (APIs) can enter the environment as contaminants ...

  19. 76 FR 38188 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ...HUMAN SERVICES Food and Drug Administration [Docket...Advisory Committee for Pharmaceutical Science and Clinical...Meeting AGENCY: Food and Drug Administration, HHS...committee of the Food and Drug Administration (FDA...Advisory Committee for Pharmaceutical Science and...

  20. 77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-20

    ...HUMAN SERVICES Food and Drug Administration [Docket...Advisory Committee for Pharmaceutical Science and Clinical...Meeting AGENCY: Food and Drug Administration, HHS...committee of the Food and Drug Administration (FDA...Advisory Committee for Pharmaceutical Science and...

  1. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...HUMAN SERVICES Food and Drug Administration [Docket...Advisory Committee for Pharmaceutical Science and Clinical...Meeting AGENCY: Food and Drug Administration, HHS...committee of the Food and Drug Administration (FDA...Advisory Committee for Pharmaceutical Science and...

  2. Table of Contents 1 Sizing Research and Development Portfolios in the Pharmaceutical Industry

    E-print Network

    Table of Contents 1 Sizing Research and Development Portfolios in the Pharmaceutical Industry Jason.............................................................................................................. 10 Chapter 2: The Pharmaceutical Industry: An Overview..................11 2.1 History.....................................................................................................................15 2.2.3 Drug Culture: "A Pill for Every Ill

  3. 75 FR 11551 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ...HUMAN SERVICES Food and Drug Administration [Docket...Advisory Committee for Pharmaceutical Science and Clinical...Meeting AGENCY: Food and Drug Administration, HHS...presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced...

  4. 75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ...HUMAN SERVICES Food and Drug Administration [Docket...Advisory Committee for Pharmaceutical Science and Clinical...Meeting AGENCY: Food and Drug Administration, HHS...committee of the Food and Drug Administration (FDA...Advisory Committee for Pharmaceutical Science and...

  5. 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)

  6. 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...

  7. 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 emplo...

  8. Medicating the environment: Assessing risks of pharmaceuticals to wildlife and ecosystems

    EPA Science Inventory

    Global pharmaceutical consumption is rising with a growing and aging human population and more intensive food production. Recent studies have revealed pharmaceutical residues in a wide range of ecosystems and organisms. Environmental concentrations are often low, but pharmaceuti...

  9. 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 ...

  10. 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...

  11. Source characterization of nervous system active pharmaceutical ingredients in healthcare wastewaters

    EPA Science Inventory

    Nervous system active pharmaceutical ingredients (APIs), including anti-depressants and opioids, are important clinically administered pharmaceuticals within healthcare facilities. Concentrations and mass loadings of ten nervous system APIs and three nervous system API metaboli...

  12. THE THREE RS IN THE PHARMACEUTICAL INDUSTRY: PERSPECTIVES OF SCIENTISTS AND REGULATORS

    E-print Network

    Farrell, Anthony P.

    with industry priorities; examples included phenotypic characterization of GM animals and validation ..................................................................................................... 1 Animal use in the pharmaceutical industryTHE THREE RS IN THE PHARMACEUTICAL INDUSTRY: PERSPECTIVES OF SCIENTISTS AND REGULATORS by NICOLE

  13. PHARMACEUTICALS IN WASTE STREAMS AND SURFACE WATERS OF THE COLORADO RIVER BASIN

    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 and Ecstasy) in surface ...

  14. ENVIRONMENTAL FOOTPRINT OF PHARMACEUTICALS - THE SIGNIFICANCE OF FACTORS BEYOND DIRECT EXCRETION TO SEWERS

    EPA Science Inventory

    The combined excretion of active pharmaceutical ingredients (APIs) via urine and feces is considered the primary route by which APIs from human pharmaceuticals enter the environment. Disposal of unwanted, leftover medications by flushing into sewers has been considered a secondar...

  15. Estimating aquatic hazards posed by prescription pharmaceutical residues from municipal wastewater

    EPA Science Inventory

    Risks posed by pharmaceuticals in the environment are hard to estimate due to limited monitoring capacity and difficulty interpreting monitoring results. In order to partially address these issues, we suggest a method for prioritizing pharmaceuticals for monitoring, and a framewo...

  16. Solid-State Physical Form Detection and Quantitation of Pharmaceuticals in Formulations

    E-print Network

    Gorman, Eric

    2011-03-25

    The majority of pharmaceutical dosage forms are marketed as solids, and the active pharmaceutical ingredient (API) can exist in various physical forms. These physical forms can be either crystalline or amorphous, and will ...

  17. 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

    ...Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug...Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants...the appropriate classification of co-crystal solid-state forms. This draft...

  18. The Resolution of Important Pharmaceutical Building Blocks by Palladium-Catalyzed Aerobic Oxidation of Secondary Alcohols

    E-print Network

    Stoltz, Brian M.

    The Resolution of Important Pharmaceutical Building Blocks by Palladium-Catalyzed Aerobic Oxidation. Abstract: The palladium-catalyzed aerobic oxidative kinetic resolution of key pharmaceutical building selective aerobic oxidative kinetic resolu- tion yet described. Keywords: asymmetric catalysis; kinetic

  19. 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 ...

  20. Simulation modeling to predict drug pipeline throughput in early pharmaceutical R&D

    E-print Network

    Heyman, Jeffrey B. (Jeffrey Brian)

    2010-01-01

    With high costs and growing concern about research and development (R&D) productivity, the pharmaceutical industry is under pressure to efficiently allocate R&D funds. Nonetheless, pharmaceutical R&D involves considerable ...

  1. 78 FR 46372 - Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... Pharmaceuticals Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 14, 2013, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011,...

  2. 77 FR 67676 - Manufacturer of Controlled Substances; Notice of Application; Cedarburg Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-13

    ... Pharmaceuticals, Inc. Pursuant to Sec. 1301.33(a), of Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 21, 2012, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton,...

  3. 78 FR 69133 - Manufacturer of Controlled Substances; Notice of Application; Morton Grove Pharmaceuticals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... Pharmaceuticals Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on October 7, 2013, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove, Illinois...

  4. 77 FR 60144 - Manufacturer of Controlled Substances; Notice of Application; Morton Grove Pharmaceuticals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... Pharmaceuticals Pursuant to 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 12, 2012, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove, Illinois 60053-2633,...

  5. 78 FR 17231 - Manufacturer of Controlled Substances; Notice of Application: Morton Grove Pharmaceuticals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Pharmaceuticals Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 14, 2012, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove, Illinois...

  6. 78 FR 17634 - Foreign-Trade Zone 35-Philadelphia, Pennsylvania; Application for Subzone; Teva Pharmaceuticals...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... Pharmaceuticals USA, Inc.; North Wales, Chalfont, Kutztown and Sellersville, Pennsylvania An application has been... of FTZ 35, requesting special-purpose subzone status for the facilities of Teva Pharmaceuticals...

  7. 77 FR 35058 - Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... Pharmaceuticals, LLC Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 27, 2012, Apertus Pharmaceuticals, LLC, 331 Consort Drive, St Louis, Missouri...

  8. 78 FR 64017 - Manufacturer of Controlled Substances; Notice of Application; Cedarburg Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... Pharmaceuticals, Inc. Pursuant to Sec. 1301.33(a), of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 8, 2013, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin...

  9. 78 FR 19016 - Manufacturer of Controlled Substances; Notice of Application; Patheon Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... Pharmaceuticals, Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on February 22, 2013, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati,...

  10. 77 FR 67398 - Manufacturer of Controlled Substances; Notice of Application; INB Hauser Pharmaceutical Services...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... Pharmaceutical Services, Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 20, 2012, InB Hauser Pharmaceutical Services, Inc., 6880 N....

  11. 78 FR 58315 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ...Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration...Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee: To provide advice...

  12. 77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ...Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and...Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee...committee will discuss the clinical pharmacology aspects of pediatric clinical...

  13. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ...Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration...Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee: To provide advice...

  14. 76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ...Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and...Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee...mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics...

  15. Leveraging a large scale mammalian pharmacological dataset to prioritize potential environmental hazard of pharmaceuticals

    EPA Science Inventory

    The potential for pharmaceuticals in the environment to cause adverse ecological effects is of increasing concern. Given the thousands of active pharmaceutical ingredients (APIs) which can enter the aquatic environment through various means, a current challenge in aquatic toxicol...

  16. [Collaboration between academia and companies].

    PubMed

    Ueda, Minoru

    2008-05-01

    Recently the collaboration between academia and company has been recommended by the government and more than 1,000 venture companies have established since 2001. Indeed this situation caused the researchers active, on the other side many undesirable troubles has been increasing among researches in the university. In this paper the cause of these troubles related to the collaboration between academia and company has been analyzed and proposed the possible solutions for the problems. PMID:18464523

  17. [Chapter 1. A contemporary history of the Japanese pharmaceutical industry (1980-2010). A contemporary history of the Japanese Pharmaceutical Industry (1980-2010) Task Force].

    PubMed

    2014-01-01

    This publication, commemorating the sixty years since the founding of Japan Society for the History of Pharmacy (JSHP), provides an overview of the Japanese pharmaceutical industry over a thirty-year span from 1980 to 2010. In the first section, entitled Medical Evolution: The Growth Period for Pharmaceutical Products, and the second section, "Patient-Based Medicine: The Period of Information Prioritization, the following themes are examined. Changes in Drug Pricing Policies, Promotion of Bungy? (separation of prescription from dispensing), Measures to Improve the Safety of Pharmaceutical Products; Appropriate Use of Pharmaceutical Products, Drug Discovery: Changes in Pharmaceutical Product Development and Actual Conditions in the Domestic Launch of New Medicines; Marketing (Medical Representative) Reforms, Pharmaceutical Industry Mergers and Acquisitions, Internationalization of the Pharmaceutical Industry. The following papers are provided as further references to support the conclusions made in the sections above. Changes in Japanese Drug Discovery Technologies and Drug Development. Japan's Pharmaceutical Market and Shifts in Manufacturing and Sales. Changes in Clinical Trials in Japan and Appropriate Use of Pharmaceuticals. Internationalization of the Japanese Pharmaceutical Industry. PMID:25272635

  18. Improving Client-Centered Brain Injury Rehabilitation Through Research-Based Theater

    PubMed Central

    Kontos, Pia C.; Miller, Karen-Lee; Gilbert, Julie E.; Mitchell, Gail J.; Colantonio, Angela; Keightley, Michelle L.; Cott, Cheryl

    2013-01-01

    Traumatic brain injury often results in physical, behavioral, and cognitive impairments perceived by health care practitioners to limit or exclude clients’ full participation in treatment decision making. We used qualitative methods to evaluate the short- and long-term impact of “After the Crash: A Play About Brain Injury”, a research-based drama designed to teach client-centered care principles to brain injury rehabilitation staff. We conducted interviews and observations with staff of two inpatient neurorehabilitation units in Ontario, Canada. Findings demonstrate the effectiveness of the play in influencing practice through the avoidance of medical jargon to improve clients’ understanding and participation in treatment; newfound appreciation for clients’ needs for emotional expression and sexual intimacy; increased involvement of family caregivers; and avoidance of staff discussions as if clients were unaware. These findings suggest that research-based drama can effect reflexivity, empathy, and practice change to facilitate a client-centered culture of practice in brain injury rehabilitation. PMID:22941919

  19. Quantitative transmission Raman spectroscopy of pharmaceutical tablets and capsules.

    PubMed

    Johansson, Jonas; Sparén, Anders; Svensson, Olof; Folestad, Staffan; Claybourn, Mike

    2007-11-01

    Quantitative analysis of pharmaceutical formulations using the new approach of transmission Raman spectroscopy has been investigated. For comparison, measurements were also made in conventional backscatter mode. The experimental setup consisted of a Raman probe-based spectrometer with 785 nm excitation for measurements in backscatter mode. In transmission mode the same system was used to detect the Raman scattered light, while an external diode laser of the same type was used as excitation source. Quantitative partial least squares models were developed for both measurement modes. The results for tablets show that the prediction error for an independent test set was lower for the transmission measurements with a relative root mean square error of about 2.2% as compared with 2.9% for the backscatter mode. Furthermore, the models were simpler in the transmission case, for which only a single partial least squares (PLS) component was required to explain the variation. The main reason for the improvement using the transmission mode is a more representative sampling of the tablets compared with the backscatter mode. Capsules containing mixtures of pharmaceutical powders were also assessed by transmission only. The quantitative results for the capsules' contents were good, with a prediction error of 3.6% w/w for an independent test set. The advantage of transmission Raman over backscatter Raman spectroscopy has been demonstrated for quantitative analysis of pharmaceutical formulations, and the prospects for reliable, lean calibrations for pharmaceutical analysis is discussed. PMID:18028700

  20. Qualitative Phenomenological Examination of IT Project Management in Pharmaceutical Industry

    ERIC Educational Resources Information Center

    Ly, Phil

    2013-01-01

    The purpose of this study was to examine what caused IT projects to fail at a high rate in the pharmaceutical industry. IT projects failures delayed development of new drugs that can help save lives. It was imperative to evaluate what caused project failures because the collateral damage was delay in drug development. This qualitative…