These are representative sample records from Science.gov related to your search topic.
For comprehensive and current results, perform a real-time search at Science.gov.
1

A New Pharmaceutical Company Library  

Microsoft Academic Search

In April of 1984, after 6 years of planning, the Upjohn Company Corporate Technical Library officially opened its new library facility in Kalamazoo, Michigan. A fairly large corporate library of some 25,000 square feet net usable space, it expressed a bold commitment to space for printed publications at a time when the paperless office and the paperless library were being

Lorraine Schulte

1986-01-01

2

[Public health and chemical-pharmaceutical companies].  

PubMed

This article is concerned with the establishment of the Brazilian pharmaceutical industry. It addresses some issues of relevance to social-economic history, such as the emergence of the public health system, procedures for combating infectious disease, the relations between disinfection campaigns and the chemical industry, serotherapy and the production of serums and vaccines by public research institutions and private pharmaceutical companies. Focusing on the private pharmaceutical industry in Brazil, with special reference to the Instituto Pinheiros - Produtos Terapêuticos S.A., this article highlights the relations between scientists technology and product development. It also considers the debate which involved the scientific community and some governmental research institutions for public health policy development in the state of São Paulo. PMID:16683337

Ribeiro, M A

3

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

PubMed

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

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

1999-01-01

4

Doctors' opinions of information provided by Libyan pharmaceutical company representatives  

PubMed Central

Objective To examine the opinions of Libyan doctors regarding the quality of drug information provided by pharmaceutical company representatives (PCRs) during detailing visits. Method An anonymous survey was conducted among 1,000 doctors from selected institutes in Tripoli, Benghazi and Sebha. Doctors were asked questions regarding the quality of information provided during drug-detailing visits. Results A questionnaire return rate of 61% (608 returned questionnaires out of 1,000) was achieved. The majority (n=463, 76%) of surveyed participants graded the quality of information provided as average. Approximately, 40% of respondents indicated that contraindications, precautions, interactions and adverse effects of products promoted by PCRs were never or rarely mentioned during promotional visits, and 65% of respondents indicated that an alternative drug to the promoted product was never or rarely mentioned by the representatives. More than 50% of respondents (n=310, 51%) reported that PCRs were not always able to answer all questions about their products. Only seven respondents (1%) believed that PCRs never exaggerated the uniqueness, efficacy or safety of their product. The majority of respondents (n=342, 56%) indicated that verbal information was not always consistent with written information provided. Seven per cent of respondents (n=43) admitted that they did not know whether or not the verbal information provided by PCRs was consistent with written information. Conclusion Doctors believe that the provision of drug information by PCRs in Libya is incomplete and often exaggerated. Pharmaceutical companies should ensure that their representatives are trained to a standard to provide reliable information regarding the products they promote. PMID:23205141

Alssageer, Mustafa A.; Kowalski, Stefan R.

2012-01-01

5

Pharmaceutical company perspectives on current safety risk communications in Japan.  

PubMed

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

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

2014-01-01

6

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

PubMed Central

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

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

2013-01-01

7

Subject: A Statistical Consultant opening at a major Pharmaceutical Company manufacturing site  

E-print Network

Subject: A Statistical Consultant opening at a major Pharmaceutical Company manufacturing site Experiences: · MSc. in Statistics, natural science or Chemical Engineering background a plus, at least 7 years of experience as statistician in pharmaceutical processing or analytical testing · Deep statistical

Shepp, Larry

8

The production planning and inventory management of intermediate products for a pharmaceutical company  

E-print Network

TCG is a multinational pharmaceutical company. As part of its drive to stay lean and competitive, TCG hopes to effectively maximize its capital assets by reducing warehouse inventory. This thesis aims to reduce the inventory ...

Kok, Yixiong

2007-01-01

9

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

E-print Network

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 ...

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

2010-01-01

10

Dynamic Learning Capability and Actionable Knowledge Creation: Clinical R&D in a Pharmaceutical Company.  

ERIC Educational Resources Information Center

Interviews with participants in research and development in a pharmaceutical company explored the use of organizational learning mechanisms to create knowledge. Results indicate that dynamic learning capability is embedded in and influenced by company culture, existing skills and competence, capacity for continuous change, and leadership.…

Ingelgard, Anders; Roth, Jonas; Shani, A. B. (Rami); Styhre, Alexander

2002-01-01

11

The effects of vendor and quality control variability in the procurement of raw materials in a bio-pharmaceutical company  

E-print Network

Pharmaceutical companies have traditionally placed little emphasis on supply chain efficiencies and operations costs. With the changing landscape of expiring intellectual property rights and increased market segmentation, ...

Wheeler, Jake T

2011-01-01

12

Gifts, Drug Samples, and other Items Given to Medical Specialists by Pharmaceutical Companies  

Microsoft Academic Search

Aim  To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.Design and Setting  Fifty-one medical Sydney specialists were asked to collect all gifts, offers, invitations, and items received from pharmaceutical companies

Paul M. McNeill; Ian H. Kerridge; Catherine Arciuli; David A. Henry; Graham J. Macdonald; Richard O. Day; Suzanne R. Hill

2006-01-01

13

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

PubMed Central

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

Somerset, Maggie; Weiss, Marjorie; Fahey, Tom

2001-01-01

14

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

PubMed Central

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

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

2010-01-01

15

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

PubMed Central

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

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

2013-01-01

16

NATURE|Vol 435|26 May 2005 AVIAN FLU NEWS FEATURE he pharmaceutical company Roche  

E-print Network

NATURE|Vol 435|26 May 2005 AVIAN FLU NEWS FEATURE 407 T he pharmaceutical company Roche didn't have Tamiflu in 1999. Flu is a fact of life, and doctors have been advising aspirin, hot lemon andbed against the threat of a pandemic flu virus that could arise at any time. Given

Cai, Long

17

Insights into the issues facing pharmaceutical companies for information provision: a report on the P-D-R special meeting, La Grande Motte, 28-29  

E-print Network

1 Insights into the issues facing pharmaceutical companies for information provision: a report: The article reports on the use of primary information in pharmaceutical companies, on global services arising the pharmaceutical industry. The pharmaceutical industry is the only corporate sector with a long and profitable

Paris-Sud XI, Université de

18

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

PubMed

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

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

2012-01-01

19

This document is a template memorandum of understanding ("MOU") between the National Institutes of Health ("NIH") and collaborating pharmaceutical companies in the NIH-Industry  

E-print Network

of Health ("NIH") and collaborating pharmaceutical companies in the NIH-Industry Pilot Program: Discovering the NIH and the specific collaborating pharmaceutical companies, this template MOU expresses the general intentions and expectations of the NIH and the collaborating pharmaceutical companies regarding

Bandettini, Peter A.

20

What is missing on their web sites? An evaluation of national and international pharmaceutical companies in Turkey.  

PubMed

The Turkish Pharmaceutical Manufacturers Association-Ilaç Endüstrisi Isverenler Sendikasi (IEIS) set guidelines for pharmaceutical companies when designing their websites in 2003. The objective of this study is to evaluate whether pharmaceutical company websites comply with these guidelines. The list of all the national and international pharmaceutical companies active in Turkey is obtained from Farmalist Vademecum. We evaluated each site in terms of availability of drug advertisement, mail address, e-mail address, telephone number, fax number, update information, indication of target group, links, references, information, appropriate content for the intended target group, disclaimer stating the given information is only for health care professionals, disclaimer stating the given information cannot replace a health care professional, responsible body for the website design. The search was done throughout February 2005. We used x(2) test and Fisher's exact x(2) tests for statistical analysis. Of the 82 pharmaceutical companies active in Turkey, 51 had a website eligible for evaluation. Of the 51 companies, 34 (66.7%) were national and 17 (33.3%) were international. Eighteen companies had drug advertisement on the home page of their websites (64.7%). Of the total companies majority had mail address (89.2%); telephone number (89.2%); fax number (84.3%); links (66.7%); and appropriate content for the health care professionals (62.7%). The frequency of having update information and a separate pharmacist/physician information part was higher among international pharmaceutical company websites compared to the national ones. These differences were statistically significant (p < 0.05). As a result of the evaluation, the majority of the pharmaceutical companies failed to comply wholly with the guidelines set by IEIS when designing their website on the Internet. PMID:16430388

Yegenoglu, Selen; Aslan, Dilek; Acar, Aylin; Calgan, Zeynep

2005-12-01

21

[Anti-counterfeit activities of pharmaceutical companies in Japan: for patient safety].  

PubMed

Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceutical companies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceutical companies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceutical companies extend comprehensive measures against counterfeit and illicit trading. PMID:24492224

Shofuda, Ken-ichi; Aragane, Katsumi; Igari, Yasutaka; Matsumoto, Kinya; Ito, Kazuya

2014-01-01

22

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

PubMed Central

The advent of new antiretroviral medicines means that the effects of HIV can now be curbed, but only one in twenty infected people have so far benefited. For those living in developing countries, the new treatments are practically unattainable. Governments, UNAIDS and pharmaceutical companies recognise this only too well and have rethought established assumption in order to try and overcome the challenges posed by cost, inadequate health services and unreliable local supply of medicines. Key Words: AIDS • treatment gap • developing countries • Glaxo Wellcome • access to medicines • public health PMID:10701172

Cochrane, J.

2000-01-01

23

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

PubMed Central

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

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

2012-01-01

24

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

PubMed Central

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.

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

2014-01-01

25

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

PubMed

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

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

2012-01-01

26

Impact of regulatory requirements on medicine registration in African countries - perceptions and experiences of pharmaceutical companies in South Africa  

PubMed Central

Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. Methods: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and efficacy of medicines. The experience of pharmaceutical companies indicated that country specific regulatory requirements are a barrier to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific labeling were cited as key problems. Conclusion: Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI). PMID:23093897

Narsai, Kirti; Williams, Abeda; Mantel-Teeuwisse, Aukje Kaija

2012-01-01

27

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

PubMed Central

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

Gupta, Sandeep Kumar; Nayak, Roopa Prasad

2014-01-01

28

The production planning and inventory management of finished goods for a pharmaceutical company  

E-print Network

This thesis is the result of a three month internship at TCG Pharmaceuticals, Singapore. With the worldwide initiative of lean in TCG, it has implemented the TCG Production System which finds its roots in the famous Toyota ...

Gupta, Sumit, M. Eng. Massachusetts Institute of Technology

2007-01-01

29

Our Client, GlaxoSmithKline is one of the world's leading research-based pharmaceutical companies. With 90000 employees world-wide, the company is  

E-print Network

are: Thrilled by mobile apps! Love to develop mobile applications for iOS and Android! Like and is looking for motivated professionals to join the team at the position of: Mobile applications developer You to experience new mobile development platforms! The role: Develops mobile applications for various GSK

Kasparian, Azniv

30

Pharmaceutical companies' variation of drug prices within and among countries can improve long-term social well-being.  

PubMed

Drug prices vary considerably across and within countries. On average, pharmaceutical companies charge lower prices in low-income countries than in industrialized nations. Manufacturers' ability to price products differently for different markets--a practice known as price discrimination--increases their profits overall. But it is also likely to result in greater investment in research and development, and therefore in more new drugs on the market. Although reducing price discrimination in order to cut costs might benefit consumers in the short run, it would harm them in the long run by reducing the number of new drugs developed. PMID:21821571

Lichtenberg, Frank R

2011-08-01

31

[The attractive position of France in international clinical research: 2006 survey assessed by Leem (French pharmaceutical companies)].  

PubMed

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Initiated in 2006, the current survey was much more representative than the previous ones with 20 companies accounting for 61% of the French market. This survey included 352 international phase II and III clinical studies carried out in 2004 and 2005, 74 countries, 17 345 centres and 137 989 patients. France has participated to half of the overall number of international clinical trials. France ranked among the best European recruiters (0,19 patient/1000 inhabitants) at the second position behind Scandinavian countries, taking in account numbers of inhabitants. Protocols are now to be given the go-ahead by Ethics Committee (CCPPRB) within 60 days. With a high productivity in phase IIb and in oncology, France is still an attractive place to locate clinical research. PMID:17243270

Courcier, Soizic; Sibenaler, Claire; Couderc, Monique; Trinquet, Françoise; Plétan, Yannick; Lassale, Catherine

2006-01-01

32

[France, an attractive country for international clinical research: 2008 survey assessed by Leem (French association of pharmaceutical companies)].  

PubMed

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Nineteen companies (61.9 % of the French market) have participated in the current survey which included 385 international phase II and III clinical studies, 77 countries, 29,708 centres and 312,835 patients (included in 2006/2007). France (400 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2006, France has improved administrative processes and reduced deadlines for hospital contracts. Protocols are now to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. Its performance in early phases, oncology/hematology and vaccines/anti-infectious contribute to the attractiveness of France in international clinical research. PMID:19154705

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

2008-01-01

33

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

PubMed

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

Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

2012-01-01

34

Reducing systems biology to practice in pharmaceutical company research; selected case studies.  

PubMed

Reviews of the productivity of the pharmaceutical industry have concluded that the current business model is unsustainable. Various remedies for this have been proposed, however, arguably these do not directly address the fundamental issue; namely, that it is the knowledge required to enable good decisions in the process of delivering a drug that is largely absent; in turn, this leads to a disconnect between our intuition of what the right drug target is and the reality of pharmacological intervention in a system such as a human disease state. As this system is highly complex, modelling will be required to elucidate emergent properties together with the data necessary to construct such models. Currently, however, both the models and data available are limited. The ultimate solution to the problem of pharmaceutical productivity may be the virtual human, however, it is likely to be many years, if at all, before this goal is realised. The current challenge is, therefore, whether systems modelling can contribute to improving productivity in the pharmaceutical industry in the interim and help to guide the optimal route to the virtual human. In this context, this chapter discusses the emergence of systems pharmacology in drug discovery from the interface of pharmacokinetic-pharmacodynamic modelling and systems biology. Examples of applications to the identification of optimal drug targets in given pathways, selecting drug modalities and defining biomarkers are discussed, together with future directions. PMID:22161355

Benson, N; Cucurull-Sanchez, L; Demin, O; Smirnov, S; van der Graaf, P

2012-01-01

35

The Pfizer Institute for Pharmaceutical Materials Science The Pfizer Institute for Pharmaceutical  

E-print Network

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

Lasenby, Joan

36

An analysis of the relationship between staff qualification and export readiness of pharmaceutical companies: the case of iran.  

PubMed

Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceutical companies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them. PMID:24250528

Mohammadzadeh, Mehdi

2012-01-01

37

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

PubMed

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

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

2013-01-01

38

[France, an attractive country for international clinical research: 2010 survey assessed by Leem (French association of pharmaceutical companies)].  

PubMed

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Twenty-nine companies (72% of the French market) including 10 newly participants, have participated in the current survey which included 328 international phase II and III clinical studies, 79 countries, 24,337 centres and 249,704 patients (included in 2008/2009). France (291 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2008, protocols are still to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. The continuation of reduction in deadlines for hospital contracts is encouraging and highlights the positive effect of CeNGEPS. French state-of-art is well recognized in Oncology/Hematology and Orphan disease which could be an example to improve the competitiveness of France in other key therapeutic areas such as Alzheimer's disease and Immuno-Inflammation. PMID:21466772

Lassale, Catherine; Sibenaler, Claire; Behier, Jehan-Michel; Pletan, Yannick; Courcier, Soizic

2011-01-01

39

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

PubMed

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

Corot, Claire; Warlin, David

2013-01-01

40

Sponsored by Stevens Pharmaceutical Center and AIChE The Pharmaceutical Industry /  

E-print Network

Sponsored by Stevens Pharmaceutical Center and AIChE The Pharmaceutical Industry / Academia & Bioanalytical Development Pharmaceutical Development, Bristol-Myers Squibb Company ABSTRACT Dr. Scypinski's presentation will focus on the current directions in technology in Pharmaceutical Manufacturing. He will also

Fisher, Frank

41

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

PubMed Central

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

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

2014-01-01

42

Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.  

PubMed

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal obligations were addressed in a fashion which allowed the conduct of a trial adopting a proven methodology but novel infrastructure such that it was a totally independent study with regards conduct and reporting of final data, irrespective of the results being either positive or negative. This may represent a more acceptable way to ensure that future clinical trials are devoid of undue influence from the pharmaceutical industry which may still fund the study. PMID:15685926

Beran, Roy G

2004-01-01

43

Partnership between pharmaceutical industry and RBS ensures relevant curriculum producing top-talent graduates pharma companies need  

E-print Network

Partnership between pharmaceutical industry and RBS ensures relevant curriculum producing top-talent, creating a new demand for talented, motivated individuals with a special knowledge of the healthcare of talented managers, well-versed in health-care and pharmaceutical issues. One of the strengths

Lin, Xiaodong

44

Process systems engineering of continuous pharmaceutical manufacturing  

E-print Network

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 ...

Abel, Matthew J

2010-01-01

45

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

Code of Federal Regulations, 2013 CFR

...evaluation and mitigation strategy or other duty imposed by...evaluation and mitigation strategy required by the Food and Drug...the VA employee. (3) Marketing to students. Pharmaceutical...representatives are prohibited from marketing to medical, pharmacy,...

2013-07-01

46

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

Code of Federal Regulations, 2012 CFR

...evaluation and mitigation strategy or other duty imposed by...evaluation and mitigation strategy required by the Food and Drug...the VA employee. (3) Marketing to students. Pharmaceutical...representatives are prohibited from marketing to medical, pharmacy,...

2012-07-01

47

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

PubMed Central

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

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

2012-01-01

48

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

PubMed

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

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

2012-01-01

49

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

PubMed

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

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

2008-01-01

50

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

PubMed

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

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

2011-01-01

51

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

PubMed

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

Glaeske, Gerd

2008-01-01

52

20-Year CCOP Research Bases  

Cancer.gov

Community Clinical Oncology Program Celebrates 20 Years of Research 20-Year CCOP Research Bases Research Bases develop and implement the cancer prevention and control clinical trials of the CCOP program. The following Research Bases have been a continuous

53

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

PubMed Central

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

2011-01-01

54

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

PubMed

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

Littman, Bruce H; Marincola, Francesco M

2011-01-01

55

Department of Pharmaceutics and Pharmaceutical Chemistry  

E-print Network

, engineering, biochemistry, microbiology, mathematics, biology, biomedical science or pharmaceutical scienceDepartment of Pharmaceutics and Pharmaceutical Chemistry www.pharmacy.utah.edu/pharmaceutics in pharmaceutics comprises intensive coursework covering essential topics in basic sciences, and most importantly

Tipple, Brett

56

China: current trends in pharmaceutical drug discovery.  

PubMed

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

Luo, Ying

2008-04-01

57

Doctors and pharmaceutical industry.  

PubMed

The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine. PMID:20157968

Beran, Roy G

2009-09-01

58

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

and health outcomes data to generate new hypotheses is required. Experience in network analysis, modeling'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

Dalkilic, Mehmet

59

Frequently Asked Questions - Research Bases  

Cancer.gov

NCI Community Oncology Research Program (NCORP) Updated Frequently Asked Questions on Research Bases Request for Application (RFA) Select a category by clicking on its title below. How to search the content of the FAQs: Click on the FAQ Category you

60

Recognizing misleading pharmaceutical marketing online.  

PubMed

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

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

2014-01-01

61

Chemistry in the Pharmaceutical Industry  

NASA Astrophysics Data System (ADS)

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.

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

62

Pharmaceutical Supply Chain  

E-print Network

Engineering University of Hartford, West Hartford, CT 06117 #12;Pharmaceutical Supply Chain NetworksPharmaceutical Supply Chain Networks with Outsourcing Nagurney, Li, and Nagurney Pharmaceutical is gratefully acknowledged. #12;Pharmaceutical Supply Chain Networks with Outsourcing Nagurney, Li, and Nagurney

Nagurney, Anna

63

Mergers and innovation in the pharmaceutical industry.  

PubMed

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

Comanor, William S; Scherer, F M

2013-01-01

64

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

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 ...

Khan, Rehan A. (Rehan Abbas)

2007-01-01

65

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.

66

Reprivatizing pharmaceutical supplies in Africa.  

PubMed

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

Turshen, M

2001-01-01

67

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

PubMed Central

In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center. PMID:22355280

Ruppert, Thorsten; Hahn, Michael; Hundt, Ferdinand

2012-01-01

68

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

E-print Network

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

Tozer, Stephanie Michelle

2008-01-01

69

Crisis management in pharmaceuticals: evidence from Greece  

Microsoft Academic Search

Purpose – The purpose of this paper is to explore the practice, prevention, and problems pharmaceutical companies face with respect to crisis management (CM). The pharmaceutical sector is considered to be the most crisis prone of all industries. Design\\/methodology\\/approach – The study is exploratory in nature and data were collected by carrying out semi-structured in-depth interviews with key managers in

Constantinos-Vasilios Priporas; George Vangelinos

2008-01-01

70

TENURE TRACK FACULTY POSITION: DEPARTMENT OF PHARMACEUTICS AND PHARMACEUTICAL CHEMISTRY  

E-print Network

TENURE TRACK FACULTY POSITION: DEPARTMENT OF PHARMACEUTICS AND PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, invites applications, Faculty Search Committee, Dept. of Pharmaceutics University of Utah, 301 Skaggs Hall, Salt Lake City, UT

Tipple, Brett

71

Core Courses and Core Activities in the Pharmaceutical Engineering Program at NJIT: A Reevaluation of What Constitutes the Core Knowledge of an Emerging Engineering Field  

Microsoft Academic Search

Pharmaceutical engineering is the branch of engineering devoted to the application of engineering concepts, scientific principles, and codes of practice to develop processes and scale-up criteria for drug manufacturing and pharmaceutical operations, including the operation of industrial facilities for pharmaceutical production. Pharmaceutical engineering is a new engineering area in the academic world. Because of its proximity to many pharmaceutical companies,

Piero M. ARMENANTE; Joseph J. MANFREDI; Maureen A. HOWLEY; Steven A. OSTROVE

72

Pharmaceutical Research Design Problem  

NSDL National Science Digital Library

Through this lesson and its associated activity, students explore the role of biomedical engineers working for pharmaceutical companies. First, students gain background knowledge about what biomedical engineers do, how to become a biomedical engineer, and the steps of the engineering design process. The goal is to introduce biomedical engineering as medical problem solving as well as highlight the importance of maintaining normal body chemistry. Students participate in the research phase of the design process as it relates to improving the design of a new prescription medication. During the research phase, engineers learn about topics by reading scholarly articles written by others, and students experience this process. Students draw on their research findings to participate in discussion and draw conclusions about the impact of medications on the human body.

Bio-Inspired Technology and Systems (BITS) RET,

73

Automated Information Delivery in a Pharmaceutical Company  

Microsoft Academic Search

The computer system described in this article automates the process to deliver on-line information daily. On-line data (for this study we accessed the Scrip daily update file available through Data-star [Data-Star, Plaza Suite, 114 Jermyn Street, London, UK, SW1Y 6HJ.]) is automatically retrieved, downloaded onto a personal Computer, and uploaded to a VAX computer with a software communication package PROCOMM

Chih-Wu Chang; John G. Caster; Jed C. Morris; Roger P. Nelson; David L. Larson

1991-01-01

74

Institutional mistrust in the organization of pharmaceutical clinical trials  

Microsoft Academic Search

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze\\u000a trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies\\u000a must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a

Jill A. Fisher

2008-01-01

75

Modern pharmaceutical analysis: An overview  

Microsoft Academic Search

Pharmaceutical analysis simply means analysis of a pharmaceutical(s). Webster's dictionary defines a pharmaceutical as a medicinal drug. It is generally known that a pharmaceutical is a chemical entity of therapeutic interest. A more appropriate term for a pharmaceutical is active pharmaceutical ingredient (API) or active ingredient. In colloquial terms, it is simply referred to as “active”; the use of this

S. Ahuja

2001-01-01

76

Pharmaceutical industry sponsorship and research outcome and quality: systematic review  

Microsoft Academic Search

Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in A recent systematic review of the impact of financial conflicts on biomedical research found that studies financed by industry, although as rigorous as

Joel Lexchin; Lisa A Bero; Benjamin Djulbegovic; Otavio Clark

2003-01-01

77

Valuation and Design of Pharmaceutical R&D Licensing Deals  

E-print Network

Valuation and Design of Pharmaceutical R&D Licensing Deals Michael J. Rogers and Costas D. Maranas Dept. of Chemical Engineering, The Pennsylvania State University, University Park, PA 16802-1589 Min competitive business environment, pharmaceutical companies are augmenting their product pipelines by both

Maranas, Costas

78

Managing maintenance costs of pharmaceutical research and development  

E-print Network

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 ...

Butts, Jared (Jared C.)

2009-01-01

79

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

E-print Network

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 ...

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

2009-01-01

80

The Utilization of Project Management in the Pharmaceutical Industry.  

ERIC Educational Resources Information Center

A survey of 99 pharmaceutical companies concerning their organization and use of project management techniques for research and development found that the industry is using project management increasingly in a variety of ways for better business planning and operations. (MSE)

Krusko, Diane; Cangemi, Robert R.

1987-01-01

81

Pharmaceutical supply chain risks: a systematic review  

PubMed Central

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

2013-01-01

82

Pharmaceutics Graduate Student Handbook v12.0 2012 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY  

E-print Network

Pharmaceutics Graduate Student Handbook v12.0 2012 1 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics & Pharmaceutical Chemistry offers a Ph.D. degree program: The Department of Pharmaceutics and Pharmaceutical Chemistry seeks to create highly trained, versatile experts

Provancher, William

83

RFID in the Pharmaceutical Industry: Addressing Counterfeits with Technology.  

PubMed

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

Taylor, Douglas

2014-11-01

84

Engineering Pharmaceutical Nanoparticles  

E-print Network

Engineering Pharmaceutical Nanoparticles Cory Berkland Assistant Professor Department of Pharmaceutical Chemistry Assistant Professor Department of Chemical and Petroleum Engineering The University of Kansas 2 Acknowledgements Postdocs: David Shi... enough to enter cells. Particle size >200 nm enables intracellular delivery. www.genovis.com 6 Particle engineering is critical for pharmaceutical applications. ? Dissolution rate #0;z Control size ? Pulmonary delivery #0;z ~3 microns ? Nasal...

Berkland, Cory

2006-10-26

85

The impact of e-resources on document supply in a corporate pharmaceutical library: the experience of Novo Nordisk  

Microsoft Academic Search

Purpose – The paper seeks to describe the information provision issues facing an international pharmaceutical company, in particular in relation to document supply. Design\\/methodology\\/approach – The document supply service of a major international pharmaceutical company is described, together with recent service enhancements. Findings – Document supply has not declined as much as demand for copies for the company's collections. Automation

Helle Vibeke Kasarab

2006-01-01

86

Exposure of Medical Students to Pharmaceutical Marketing in Primary Care Settings: Frequent and Influential  

ERIC Educational Resources Information Center

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.…

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-01-01

87

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

PubMed

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

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

2012-12-15

88

The Development of a Generic Pharmaceutical Training Institute.  

ERIC Educational Resources Information Center

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

Lindeman, Lynn William; Boerner, Hank

89

A Research-Based Molecular Biology Laboratory  

NSDL National Science Digital Library

In an apprenticeship-style course that mimics experiences in research laboratories and better reflects trends in educational reform, students perform team projects through collaboration with corporate research institutions. This research-based, student-ce

Buising, Charisse; Henderson, Larhee

2001-02-01

90

Teacher Leaders In Research Based Science Education  

NSDL National Science Digital Library

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

2006-04-10

91

Biological and Pharmaceutical Nanomaterials  

NASA Astrophysics Data System (ADS)

This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.

Kumar, Challa S. S. R.

2006-01-01

92

Institutional mistrust in the organization of pharmaceutical clinical trials  

PubMed Central

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

2010-01-01

93

Pharmaceutical Education in Nigeria.  

ERIC Educational Resources Information Center

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

Oyegbile, F. Rachel

1988-01-01

94

Case histories in pharmaceutical risk management.  

PubMed

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

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

2009-12-01

95

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

PubMed

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

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

2014-07-01

96

The Effectiveness of Pharmaceutical Marketing.  

E-print Network

??Pharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote… (more)

Kappe, E.R.

2011-01-01

97

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.

98

Distribution of Off-Label Information by Pharmaceutical Manufacturers?  

Microsoft Academic Search

The 1999 Washington Legal Foundation (WLF) decision stated that the Food and Drug Administration (FDA) was in violation of the pharmaceutical\\/biotechnology industry's right to commercial free speech by unduly limiting its ability to distribute truthful, nonmisleading information about off-label uses of its products. The objective of this survey was to assess pharmaceutical companies' current practices for distributing peer-reviewed journal article

Meryl Weiss Robinson; Barry Grobman; David Graves

2001-01-01

99

Nanoparticles forNanoparticles for Pharmaceutical ApplicationsPharmaceutical Applications  

E-print Network

1 Nanoparticles forNanoparticles for Pharmaceutical ApplicationsPharmaceutical Applications Robert--soluble drugssoluble drugs 40% of pharmaceutical drugs in development40% of pharmaceutical drugs in development engineering 4 Solution: delivery system for PWS drugsSolution: delivery system for PWS drugs Melt extrusion

Lightsey, Glenn

100

Pharmaceutical Care Clinic Spring 2009  

E-print Network

Pharmaceutical Care Clinic Spring 2009 Ambulatory Pharmaceutical Care Clinic [Phar 6230] and, Advanced Pharmaceutical Care Clinic [Phar 6217] Spring Semester 2009 Course Director: Teaching Assistants, Director - Peters Institute of Pharmaceutical Care WDH 3-160 Priya Bardal, Pharm.D. Computer documentation

Thomas, David D.

101

Electrospinning for pharmaceutical applications  

E-print Network

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. ...

Brettmann, Blair Kathryn

2012-01-01

102

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

103

Optimisation in pharmaceutical sciences  

Microsoft Academic Search

Optimisation means finding the best possible value of a dependent variable by varying certain independent variables. Several optimisation techniques are discussed and their applications in pharmaceutical technology, analysis, clinical chemistry and medicinal chemistry are critically evaluated.

D. A. Doornbos

1981-01-01

104

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

PubMed Central

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

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

2014-01-01

105

Explaining Pharmaceutical R&D Growth Rates at the Industry Level: New Perspectives and Insights  

Microsoft Academic Search

This paper uses aggregate data for the major pharmaceutical companies in the U.S. to study the rate of growth in pharmaceutical R&D intensity over the period from 1952 to 2001. The theoretical model argues and the empirical findings suggest that pharmaceutical R&D spending increases with real drug prices, after holding constant other determinants of R&D. Simulations based on our multiple

Carmelo Giaccotto; Rexford Santerre; John Vernon

2003-01-01

106

Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.  

PubMed

In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. PMID:23339876

Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

2013-03-01

107

Psychiatric Training Program Engagement with the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One  

ERIC Educational Resources Information Center

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…

Mohl, Paul C.

2005-01-01

108

Survey of Medical Liaison Practices 3: Assessing Practice Trends across the Pharmaceutical Industry  

Microsoft Academic Search

In an effort to assess medical liaison trends across the pharmaceutical industry, two surveys of medical liaison managers were previously administered and published. The intent of these surveys was to identify overall approaches used by pharmaceutical companies in defining and managing the medical liaison role. We conducted this third survey to focus on areas identified by the initial survey participants

J. Lynn Bass; Christopher M. Marrone; Craig Klinger

2010-01-01

109

The pharmaceutical corporation and the ‘good work’ of managing women’s bodies  

Microsoft Academic Search

Pharmaceutical companies are intricately intertwined with every aspect of contemporary medical reality, and they increasingly drive the social process of medicalization in order to establish and dominate markets for their drugs and devices. In addition to funding the majority of clinical research, organizing it to generate an evidence base that favors their innovations, and influencing the regulation of pharmaceutical drugs

Tasleem Juana Padamsee

2011-01-01

110

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

E-print Network

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 ...

Liu, Haoyu

2009-01-01

111

The effects of licensing and equity financing cycles on pharmaceutical development  

E-print Network

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. ...

Alspaugh, Jonathan D. (Jonathan Douglas)

2011-01-01

112

Impacts of international sanctions on Iranian pharmaceutical market.  

PubMed

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

Cheraghali, Abdol Majid

2013-01-01

113

Do cost-sharing and entry deregulation curb pharmaceutical innovation?  

PubMed

This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceutical companies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity. PMID:23896384

Grossmann, Volker

2013-09-01

114

Ethical pharmaceutical promotion and communications worldwide: codes and regulations.  

PubMed

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

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

2014-01-01

115

Ethical pharmaceutical promotion and communications worldwide: codes and regulations  

PubMed Central

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

2014-01-01

116

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

PubMed

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

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

2006-11-01

117

The impact of mergers on pharmaceutical R&D.  

PubMed

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

LaMattina, John L

2011-08-01

118

Mergers and Acquisitions in the Pharmaceutical and Biotech Industries  

Microsoft Academic Search

This paper examines the determinants of M&A in the pharmaceutical-biotechnology industry and the effects of mergers using propensity scores to control for endogeneity. Among large firms, we find that mergers are a response to excess capacity due to anticipated patent expirations and gaps in a company's product pipeline. For small firms, mergers are primarily an exit strategy for firms in

Patricia M. Danzon; Andrew Epstein; Sean Nicholson

2003-01-01

119

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

E-print Network

??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… (more)

Rippy, Daniel S. (Daniel Spensley)

2007-01-01

120

Is the pharmaceutical market in Bulgaria innovative?  

PubMed

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

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

2003-09-01

121

The role of entrepreneurial activities in academic pharmaceutical science research.  

PubMed

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

Stinchcomb, Audra L

2010-06-01

122

The Role of Entrepreneurial Activities in Academic Pharmaceutical Science Research  

PubMed Central

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

Stinchcomb, Audra L.

2010-01-01

123

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

PubMed

A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceutical companies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans. PMID:11613536

Yamakawa, K

1995-01-01

124

[AIDS and social justice: pharmaceutical industry and economics].  

PubMed

This article takes a broad look at the complicated framework of relationships between the third world and pharmaceutical companies. In the first part of the work reference is made to the poverty of these countries, their lack of education in terms of health, the scarcity of basic hygiene, and their greatly limited access to medicines, especially those for treating AIDS. The article then proceeds to the issue of the pharmaceutical companies' degree of responsibility for the reduced availability of medicines in certain areas of the world. One of the factors that most limits access to medicines is their price, and many sectors of society propose taking action on the patents of drugs (rescinding or limiting them) in order to lower their price. However, the problem of patent exemption is more complicated than it seems at first glance, and comes with its own risks. If, for lack of funds or the uncertainty concerning a return on the capital invested, pharmaceutical companies discontinue research and development of new drugs, AIDS therapy would worsen. It is imperative and urgent to develop new drugs against the AIDS because of its resistance to the drugs currently available. The article concludes with the pharmaceutical industry's effort to look for possible forms of collaboration with developing countries. PMID:19166259

López Guzmán, José

2008-01-01

125

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).

126

PART III. EVALUATION OF RESEARCH-BASED TEACHING METHODS  

E-print Network

253 PART III. EVALUATION OF RESEARCH-BASED TEACHING METHODS Chapter 8. Courses, Teaching Methods as they are at the developing institution. Each of the three research-based teaching methods discussed in this chapter have. The three research-based teaching methods discussed in the next session were developed at University

Maryland at College Park, University of

127

Measuring US pharmaceutical industry R&D spending.  

PubMed

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

Golec, Joseph; Vernon, John

2008-01-01

128

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

E-print Network

Contracts Business - Non-Pharmaceutical 3,189,360 Business - Pharmaceutical 241,422 Charities,475 Total Contracts 18,069,051 Grants Business - Non-Pharmaceutical 1,137,954 Business - Pharmaceutical 681,377 Total Grants 100,491,805 Clinical Trials Business - Non-Pharmaceutical 262,177 Business - Pharmaceutical

Brownstone, Rob

129

Department Head Pharmacy Practice and Pharmaceutical Sciences  

E-print Network

Department Head Pharmacy Practice and Pharmaceutical Sciences College of Pharmacy University and Pharmaceutical Sciences invites nominations and applications for the position of Department Head. The department campus) and Hope Clinic (Duluth campus). The Department of Pharmacy Practice and Pharmaceutical Sciences

Thomas, David D.

130

College of Pharmacy PHS Pharmaceutical Science  

E-print Network

College of Pharmacy PHS Pharmaceutical Science KEY: # = new course * = course changed = course of radiopharmaceuticals. Radioanalytical applications in pharmaceutical sciences, including positron tomography and gamma dropped University of Kentucky 2013-2014 Undergraduate Bulletin 1 PHS 510 MODERN METHODS IN PHARMACEUTICAL

MacAdam, Keith

131

Quarterly Requirements Checklist for Pharmaceutical Sciences Students  

E-print Network

Quarterly Requirements Checklist for Pharmaceutical Sciences Students 2011-2012 The Division of Undergraduate Education requires all Pharmaceutical Sciences students to meet the following quarterly to ensure you meet all your administrative responsibilities with the Pharmaceutical Sciences Advising

Loudon, Catherine

132

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

PubMed Central

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

2008-01-01

133

INTRODUCTION ADVERTISEMENT FEATURE Every pharmaceutical company craves perpetuity but, in  

E-print Network

with the risky business of bringing new medicines to market have never been more acute. In the US, prescription drug sales grew a paltry 3.8% in 2007, reflecting the impact of generic competition, questions about product safety, problems with reimbursement, and a general slowdown in drug approvals. According

Cai, Long

134

Pharmaceutically Engineering Powders Using FHMG  

Microsoft Academic Search

Fluidized hot melt granulation (FHMG) is an innovative granulation process that has distinct advantages over techniques that are typically used in the pharmaceutical industry for powder agglomeration and mixing. The aim of this research was to investigate process and formulation parameters that affect FHMG, in a pharmaceutical context, using Lutrol® F68 (copolymer of polyoxyethylene-polyoxypropylene) as a meltable binder with inert

G. Walker; S. Bell; M. Vann; H. Zhai; D. Jones; G. Andrews

2007-01-01

135

GMP Compliance for Pharmaceutical Excipients in the Glycerin Industry  

E-print Network

rate. What went wrong in these cases? Documents were forged, buyers were not familiar with their suppliers, labels were taken at face value (contents were assumed to be accurately labeled), names of suppliers were removed from shipping papers... customers outside the pharmaceutical industry (Steinberg 2003, 150). The first group obviously needs to allow facility audits, but there are strong reasons for the second group to consider audits as well. If a company labels its products “USP...

Elliot, Christina

2008-12-19

136

Pharmaceutical Powder Diffraction: Structure Solution from PXRD  

E-print Network

Pharmaceutical Powder Diffraction: Structure Solution from PXRD How reliable are our structures? Pharmaceutical Powder Diffraction: Structure Solution from PXRD How reliable are our structures? Maryjane

137

Ethical Issues in Outsourcing: The Case of Contract Medical Research and the Global Pharmaceutical Industry  

Microsoft Academic Search

The outsourcing of medical research has become a strategic imperative in the global pharmaceutical industry. Spurred by the\\u000a challenges of competition, the need for speed in drug development, and increasing domestic costs, pharmaceutical companies\\u000a across the globe continue to outsource critical parts of their value chain activities, namely contract clinical research and\\u000a drug testing, to sponsors across the globe, typically

Henry Adobor

2012-01-01

138

Report raises questions about drug companies advertising budgets.  

PubMed

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

1999-08-01

139

Safinamide (Newron Pharmaceuticals).  

PubMed

Safinamide (formerly PNU-151774E), a sodium and calcium channel modulator that also inhibits monoamine oxidase B (MAOB), is under development by Newron Pharmaceuticals for the potential treatment of epilepsy, Parkinson's disease (PD), pain and stroke [345222], [348351]. Phase I trials for epilepsy and PD have been completed, and dose-finding studies for both indications had commenced in March 2001 [401685]. The compound was previously developed by Pharmacia & Upjohn (P&U) for the potential treatment of epilepsy, an indication for which it initially reached phase I trials [294891], [345007]. Newron acquired the rights to safinamide from P&U at the end of 1998. Results from two phase I trials of the compound (single ascending dose and steady state at three doses), completed in March 2000, demonstrated that the drug is well tolerated with good bioavailability and linear pharmacokinetics [359652]. PMID:11572661

Chazot, P L

2001-06-01

140

Pharmaceutical study of Yashadabhasma  

PubMed Central

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

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

2012-01-01

141

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

ERIC Educational Resources Information Center

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

Vaughn, Sharon; Linan-Thompson, Sylvia

2004-01-01

142

Pharmaceutical promotion and GP prescription behaviour.  

PubMed

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

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

2006-01-01

143

The pharmaceutical industry as an informant.  

PubMed

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

Collier, Joe; Iheanacho, Ike

2002-11-01

144

Anadys Pharmaceuticals, Inc.  

PubMed

The people of Anadys are committed to advancing patient care by discovering, developing, and commercializing novel and powerful anti-infective medicines. Anadys is focused on the discovery and development of small molecule therapeutics for the treatment of infectious disease, including hepatitis C and bacterial infections. The company's lead program for the treatment of hepatitis C is currently in Phase IB testing. Anadys also has a broad portfolio of antiviral and antibacterial programs directed at novel targets, intervention points and mechanisms of action. With an integrated suite of technologies and capabilities, including Riboproteomics, ATLAS and structure-based drug design through a world-class medicinal chemistry team, Anadys is capable of quickly optimizing lead compounds for use in preclinical and clinical testing. The company's goal is to build a strong and continual pipeline of novel and powerful drug candidates directed to advance patient care. PMID:12831329

Basbaum, Andre

2003-07-01

145

The World Health Organization, the drugs company, and the $10,000 funding offer.  

PubMed

The World Health Organization faces allegations that it attempted to secure a $10,000 donation from a pharmaceutical company by asking a patients' group to act as a covert channel for the funds, an arrangement that would break the WHO's own rules on accepting money from the pharmaceutical industry. The WHO denies attempts to bend its donation rules. PMID:17844936

Day, Michael; Boseley, Sarah

2007-01-01

146

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...

147

Crystal Engineering of Pharmaceutical Cocrystals  

Microsoft Academic Search

Pharmaceutical cocrystals use principles of crystal engineering for the design of crystalline forms of drugs and can improve their solubility, bioavailability, stability and other important properties without changing the efficacy of the drug. Herein reported are pharmaceutical cocrystals of two API's, caffeine and Pentoxifylline.\\u000aResearch has indicated that caffeine has the ability to reverse AB; plaque deposition in the brain

Sreya Mukherjee

2011-01-01

148

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

PubMed

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

Ebeling, Mary

2011-09-01

149

Multiscale mechanistic modeling in pharmaceutical research and development.  

PubMed

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

Kuepfer, Lars; Lippert, Jörg; Eissing, Thomas

2012-01-01

150

Naming, labeling, and packaging of pharmaceuticals.  

PubMed

The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success. PMID:11715825

Kenagy, J W; Stein, G C

2001-11-01

151

The Pharmaceutical Engineering Program at NJIT: a Working Example of Industry-University Collaboration in a Novel and Fast-Growing Engineering Field  

Microsoft Academic Search

This article describes the newly established Master of Science Program in Pharmaceutical Engineering, which was developed at the New Jersey Institute of Technology (NJIT) in collaboration with industrial participants, and at the request of New Jersey-based pharmaceutical companies. The primary objective of the program, which started in January 2002, is to educate professionals and provide them with the skills required

Piero M. Armenante; Otto H. York; Joseph J. Manfredi

152

[An analysis of the pharmaceuticals market in Vietnam].  

PubMed

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

Simonet, D

2001-01-01

153

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

PubMed

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

Cohen, A F

1999-06-26

154

Guides to pollution prevention: The pharmaceutical industry. Final report  

SciTech Connect

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.

Not Available

1991-10-01

155

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

PubMed

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

Schlette, Sophia; Hess, Rainer

2013-10-01

156

Characteristics of physicians targeted by the pharmaceutical industry to participate in e-detailing.  

PubMed

Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing. PMID:19408179

Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David

2009-01-01

157

Marketing the use of the space environment for the processing of biological and pharmaceutical materials  

NASA Technical Reports Server (NTRS)

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.

1984-01-01

158

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

ERIC Educational Resources Information Center

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…

Charbonneau, Deborah Hile

2010-01-01

159

High performance work practices and firm performance: evidence from the pharmaceutical industry in China  

Microsoft Academic Search

The current study analyzed the relationship of high performance work practices and firm performance in a sample of pharmaceutical companies in China. We found that the human resource management index composed of high performance work practices such as extensive training, participation, detailed job definition, result-oriented performance appraisal, internal career opportunities, and profit sharing as reported by the human resource or

Yi-Chi Zhang; Shu-Ling Li

2009-01-01

160

Ethical Dilemma of Mandated Contraception in Pharmaceutical Research at Catholic Medical Institutions  

Microsoft Academic Search

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health

Murray Joseph Casey; Richard O’Brien; Marc Rendell; Todd Salzman

2012-01-01

161

Project Portfolio Management: A Powerful Strategic Weapon in Pharmaceutical Drug Development  

Microsoft Academic Search

International pharma market dynamics increasingly require that pharmaceutical companies add value to their organizations at all levels. In this respect, strategic research and development (R&D) portfolio management constitutes an extremely important tool to increase overall R&D project value. Unfortunately, the implications of this tool are very often seriously underestimated. Overall perspectives and methodologies of portfolio management have been changing. Qualitative

Rolf F. Tiggemann; David A. Dworaczyk; Hermann Sabel

1998-01-01

162

The microbiology of a pharmaceutical effluent and its public health implications  

Microsoft Academic Search

The effluent of a pharmaceutical company was examined microbiologically. Its bacterial count was 2.15 × 105 c.f.u.\\/ml and there was evidence of faecal contamination with MPN of > 1800. The organisms encountered included Staphylococcus aureus, Escherichia coli, Proteus vulgaris, Serratia marcescens and Pseudomonas aeruginosa. The resistances of the 25 bacterial strains isolated from the effluent to the commonly used antibiotics

A. Lateef

2004-01-01

163

The design of licensing contracts: Chemicals, Pharmaceuticals, and Electrical Engineering in Imperial Germany  

Microsoft Academic Search

We investigate a sample of 180 technology licensing contracts closed by German chemical, pharmaceutical, and electrical engineering companies between 1880 and 1913. Our empirical results suggest that strategic behaviour seems to be relevant for the design of licensing contracts, whereas inventor moral hazard and risk aversion of licensor or licensee seem to be irrelevant. Moreover, our results suggest that uncertainty

Carsten Burhop; Thorsten Lübbers

2011-01-01

164

The design of licensing contracts: Chemicals, pharmaceuticals, and electrical engineering in imperial Germany  

Microsoft Academic Search

The article investigates a sample of 180 technology licensing contracts closed by German chemical, pharmaceutical, and electrical engineering companies between 1880 and 1913. The empirical results suggest that strategic behaviour is relevant for the design of licensing contracts, whereas inventor moral hazard and risk aversion of licensor or licensee seem to be less important. Moreover, the results suggest that uncertainty

Carsten Burhop; Thorsten Lübbers

2012-01-01

165

The Historical Market for Technology Licenses: Chemicals, Pharmaceuticals, and Electrical Engineering in Imperial Germany  

Microsoft Academic Search

We investigate a sample of 180 technology licensing contracts closed by German chemical, pharmaceutical, and electrical engineering companies between 1880 and 1913. A regression ana- lysis shows that licensing contracts closed before a patent was granted and contracts closed be- tween firms and individual inventors had a higher probability of including a profit-sharing clause. This supports Jensen and Thursby's (2001)

Carsten Burhop; Thorsten Lübbers

166

The World Bank and pharmaceuticals.  

PubMed

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

Falkenberg, T; Tomson, G

2000-03-01

167

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

E-print Network

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

Saskatchewan, University of

168

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...

169

Pharmaceutical Supply Chain Networks with Outsourcing  

E-print Network

Pharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna, Amherst, Massachusetts 01003 2Department of Electrical and Computer Engineering University of Hartford Amherst Pharmaceutical Supply Chain Networks with Outsourcing #12;Acknowledgments This research

Nagurney, Anna

170

Pharmaceutical Supply Chain Networks with Outsourcing  

E-print Network

Pharmaceutical Supply Chain Networks with Outsourcing Under Price and Quality Competition Anna of Massachusetts, Amherst, Massachusetts 01003 2Department of Electrical and Computer Engineering University of Massachusetts Amherst Pharmaceutical Supply Chain Networks with Outsourcing #12;Acknowledgments This research

Nagurney, Anna

171

Doctors and drug companies: still cozy after all these years.  

PubMed

Geoff Spurling and colleagues report findings of a systematic review looking at the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing. They fail to find evidence of improvements in prescribing after exposure, and find some evidence of an association with higher prescribing frequency, higher costs, or lower prescribing quality. PMID:21072244

Henry, David

2010-01-01

172

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

E-print Network

Contracts Business - Non-Pharmaceutical 4,090,777 Business - Pharmaceutical 311,893 Charities 389,338 Total Contracts 18,236,337 Grants Business - Non-Pharmaceutical 874,007 Business - Pharmaceutical 1,582,333 CFI 14,103,020 Charities/Non-profits (pub & priv) 8,533,093 Research and International

Brownstone, Rob

173

Bioremediation of industrial pharmaceutical drugs.  

PubMed

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

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

2012-07-01

174

Pharmaceutical interventions from paediatric pharmacists  

Microsoft Academic Search

ObjectiveThe role of a clinical pharmacist is often seen simply as the supplier of prescribed medicines and their clinical and pharmaceutical knowledge is seldom recognised. Prescribing errors are common1 and feedback of errors improves both patient safety and future prescribing and raises standards in patient care. This study sets out to record clinical interventions made by pharmacists on the neonatal

A Law; A Lo; E Stephenson

2010-01-01

175

Pharmaceutically relevant metabolites from lichens  

Microsoft Academic Search

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

K. Müller

2001-01-01

176

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

PubMed

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

Yamada, H

1992-01-01

177

BUILDING A PHARMACEUTICAL CARE PRACTICE Spring 2014  

E-print Network

Page 1 BUILDING A PHARMACEUTICAL CARE PRACTICE Phar 6219 Spring 2014 2 credits Wednesday 1 practice and to develop a professional practice plan that allows the student to provide pharmaceutical care after graduation. 2) To understand the practice of pharmaceutical care well enough to teach others

Thomas, David D.

178

COORDINATING ON LOWER PRICES: PHARMACEUTICAL PRICING  

E-print Network

COORDINATING ON LOWER PRICES: PHARMACEUTICAL PRICING UNDER POLITICAL PRESSURE Sara Fisher Ellison of political activity on pharmaceutical prices, focusing on the health care reform period. We characterize. INTRODUCTION Pharmaceutical prices have been a prominent political issue over the past two decades, surfacing

Sadoulet, Elisabeth

179

Applications of Nanotechnology to Pharmaceutical Product Development  

E-print Network

Applications of Nanotechnology to Pharmaceutical Product Development Wednesday January 27, 2010 in finished pharmaceutical dosage forms is typically present either in molecular form (as a homogenous in the application of nanotechnology to pharmaceutical product development since 1992. He is currently Chief

Fisher, Frank

180

Cardiff School of Pharmacy and Pharmaceutical Sciences  

E-print Network

Cardiff School of Pharmacy and Pharmaceutical Sciences Undergraduate Degree Programme www.cardiff.ac.uk/phrmy our #12;Cardiff School of Pharmacy and Pharmaceutical Sciences Friendly One of the Top UK Schools Sciences 2 The Cardiff School of Pharmacy and Pharmaceutical Sciences one of 29 UK schools of Pharmacy

Davies, Christopher

181

GRADUATE STUDENT HANDBOOK Department of Pharmaceutical Sciences  

E-print Network

1 GRADUATE STUDENT HANDBOOK Department of Pharmaceutical Sciences THE UNIVERSITY OF TENNESSEE to pursue a career in the pharmaceutical sciences! We are very pleased that you are considering graduate is to provide you with information about the Department of Pharmaceutical Sciences. The brochure should tell you

Cui, Yan

182

Visualization Research Based on Cognitive Design Maneesh Agrawala  

E-print Network

Visualization Research Based on Cognitive Design Principles Maneesh Agrawala UC Berkeley 635 Soda Floraine Berthouzoz UC Berkeley 514 Soda Hall #1776 Berkeley, CA 94720 This is an online appendix of two or more visual representations for the same information. In the do- main of information

Agrawala, Maneesh

183

A Research-Based Laboratory Course in Organic Chemistry  

ERIC Educational Resources Information Center

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,…

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

2006-01-01

184

After the Crash: Research-Based Theater for Knowledge Transfer  

ERIC Educational Resources Information Center

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…

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

2008-01-01

185

Research-Based Learning: Teaching Development through Fieldschools  

ERIC Educational Resources Information Center

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…

Guinness, Patrick

2012-01-01

186

Principles of Assessment for Project and Research Based Learning  

ERIC Educational Resources Information Center

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

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

2010-01-01

187

Alcohol and your health Research-based information from the  

E-print Network

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

Bandettini, Peter A.

188

Equity and leadership: research-based strategies for school leaders  

Microsoft Academic Search

Principals are required by policy, regulation, legislation and democratic discourse to promote equity of outcomes. This integrated review investigates research on equity issues facing five student groups: special needs students; religious, cultural and racial minorities; groups disadvantaged by socioeconomic status; gender groups; and students differentiated by their sexual orientations. Sixteen research-based strategies for reducing the gap in achievement between advantaged

John A. Ross; Marie-Josée Berger

2009-01-01

189

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

PubMed

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

Breslow, Lauren Hammer

2003-01-01

190

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

E-print Network

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 ...

Rippy, Daniel S. (Daniel Spensley)

2007-01-01

191

Pharmaceutics Graduate Student Handbook v13.0 2012 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY  

E-print Network

including academic, research, administrative, business management, legal, regulatory and investment career tracks. This goal is accomplished through formal didactic courses, seminars and journal clubs, laboratory the modern field of pharmaceutics. These experts will serve to lead the world's industries and academic

192

Pharmaceutics Graduate Student Handbook v11.0 2011 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY  

E-print Network

to function independently, competently and technically in a variety of settings including academic, research through formal didactic courses, seminars and journal clubs, laboratory research rotations of pharmaceutics. These experts will serve to lead the world's industries and academic institutions to forward

Simons, Jack

193

Pharmaceutics Graduate Student Handbook v8.0 2010 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY  

E-print Network

to function independently, competently and technically in a variety of settings including academic, research through formal didactic courses, seminars and journal clubs, laboratory research rotations of pharmaceutics. These experts will serve to lead the world's industries and academic institutions to forward

Simons, Jack

194

Pharmaceutics Graduate Student Handbook v15.0 2013 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY  

E-print Network

to function independently, competently and technically in a variety of settings including academic, research through formal didactic courses, seminars and journal clubs, laboratory research rotations of pharmaceutics. These experts will serve to lead the world's industries and academic institutions to forward

Tipple, Brett

195

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

PubMed

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

Padamsee, Tasleem Juana

2011-04-01

196

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

PubMed

Zeneth is a new software application capable of predicting degradation products derived from small molecule active pharmaceutical ingredients. This study was aimed at understanding the current status of Zeneth's predictive capabilities and assessing gaps in predictivity. Using data from 27 small molecule drug substances from five pharmaceutical companies, the evolution of Zeneth predictions through knowledge base development since 2009 was evaluated. The experimentally observed degradation products from forced degradation, accelerated, and long-term stability studies were compared to Zeneth predictions. Steady progress in predictive performance was observed as the knowledge bases grew and were refined. Over the course of the development covered within this evaluation, the ability of Zeneth to predict experimentally observed degradants increased from 31% to 54%. In particular, gaps in predictivity were noted in the areas of epimerizations, N-dealkylation of N-alkylheteroaromatic compounds, photochemical decarboxylations, and electrocyclic reactions. The results of this study show that knowledge base development efforts have increased the ability of Zeneth to predict relevant degradation products and aid pharmaceutical research. This study has also provided valuable information to help guide further improvements to Zeneth and its knowledge base. PMID:25364862

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

2014-11-01

197

[A survey on the position of France in international clinical research as assessed by pharmaceutical laboratories].  

PubMed

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey was performed among pharmaceutical companies that are based in France or that have affiliates in France. The survey concerned international phase II and III clinical studies carried out in 2002 and 2003. Ten pharmaceutical companies representing 36% of the French market completed the survey. 134 trials were analysed in total. France recruited 8.3% of the overall number of patients recruited, and 15.0% of those recruited within Europe. France was within the overall mean with regard to the percentage of active centres (78.5% versus 79.5%) and the percentage of patients evaluable according to protocol (86.8% versus 87.3%). In contrast, France ranked within the last third of analysed countries with respect to the speed of recruitment (1.5 versus 1.9 patients/centre/month), and the number of queries per observation (16.8 versus 10.9). The analysis of the qualitative indicators of performance showed that, although the perception of pharmaceutical companies towards the quality of French medicine and administrative authorities is positive, France notably needs to improve the productivity of its clinical research in order to enhance its attractiveness for the pharmaceutical sponsors of clinical trials. PMID:15789827

Courcier-Duplantier, Soizic; Bouhours, Philippe; Pinton, Philippe; Sibenaler, Claire; Lassale, Catherine

2004-01-01

198

Accountability of the pharmaceutical industry.  

PubMed

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

Dukes, M N Graham

2002-11-23

199

Biosafe Nanoscale Pharmaceutical Adjuvant Materials  

PubMed Central

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.

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

2014-01-01

200

Quality analytics of Internet pharmaceuticals.  

PubMed

Trading pharmaceutical products through the Internet poses several challenges related to legal responsibilities, good distribution practices, information content and patient use, financial implications, but also regarding product quality. One of the major concerns is the well-known phenomenon of counterfeited and/or substandard drugs commercialized through rogue Internet sites. Therefore, controlling and assuring the quality of those products has become an important and challenging task for the authorities. This review gives an overview of the different quality attributes that can be evaluated to have a complete understanding of the quality of the finished pharmaceutical product traded through the Internet, as well as the current analytical techniques that serve this objective. Aspects considered are labelling and packaging, physicochemical quality attributes, identification and assay of active substances and/or excipients, impurity profiling, biopharmaceutical testing and data interpretation. PMID:20582403

Baert, B; De Spiegeleer, B

2010-09-01

201

Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.  

PubMed

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

Yadav, Vikramaditya G; Stephanopoulos, Gregory

2014-07-01

202

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

PubMed Central

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

Lexchin, J

1993-01-01

203

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

NASA Technical Reports Server (NTRS)

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.

1978-01-01

204

The CTSA Pharmaceutical Assets Portal - a public-private partnership model for drug repositioning  

PubMed Central

The Pharmaceutical Assets Portal aims to facilitate industry-academic collaborations for discovery of new indications for compounds no longer being developed by pharmaceutical companies, through eliminating barriers to access such compounds. The Portal’s enabling infrastructure includes a national investigator database; a Foci-of-Expertise browser; a material transfer agreement template; and a funding partner. Whereas the goal of creating a shared compound repository remains to be achieved, the Portal has established a mechanism to facilitate future drug repositioning opportunities. PMID:22768020

Marusina, Kate; Welsch, Dean J.; Rose, Lynn; Brock, Doug; Bahr, Nathan

2011-01-01

205

MediLexicon: Medical Abbreviations Dictionary, Medical News and Pharmaceutical Searches  

NSDL National Science Digital Library

Boasting the world's largest online database of pharmaceutical and medical abbreviations this site provides free access to their growing collections. The home page provides a series of quick search boxes which allow users easy access to unraveling the acronyms and abbreviations from the fields of medicine, pharmacy, and health care. The database has daily updates with new acronyms and abbreviations and their meanings. Also of use to users are a series of searchable databases which provide basic information about Pharmaceutical Companies, Medical Associations and Hospitals throughout the world.

2006-11-17

206

Adapting Project Management Practices to Research-Based Projects  

NASA Technical Reports Server (NTRS)

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.

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

2007-01-01

207

Consumer Products Companies Company Website Headquarters  

E-print Network

Company www.columbia.com Portland, OR ConAgra Foods, Inc www.conagrafoods.com Omaha, NE Conair Corporation www.dartcontainer.com Mason, MI Daymon Worldwide www.daymon.com Stamford, CT Dean Foods Company www.deanfoods.com Dallas, TX Del Monte Foods Company www.delmonte.com San Francisco, CA Dell www.dell.com Round Rock, TX

McGaughey, Alan

208

Interactions between Medical Residents and Drug Companies: A National Survey after the Mediator(R) Affair  

PubMed Central

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

Montastruc, Francois; Moulis, Guillaume; Palmaro, Aurore; Gardette, Virginie; Durrieu, Genevieve; Montastruc, Jean-Louis

2014-01-01

209

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

PubMed

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

Gray, Garry C

2013-01-01

210

Ethical Considerations in the Use of Direct-To-Consumer Advertising and Pharmaceutical Promotions: The Impact on Pharmaceutical Sales and Physicians  

Microsoft Academic Search

The influence of direct-to-consumer advertising and physician promotions are examined in this study. We further examine some of the ethical issues which may arise when physicians accept promotional products from pharmaceutical companies. The data revealed that direct-to-consumer advertising is likely to increase the request rates of both the drug category and the drug brand choices, as well as the likelihood

R. Stephen Parker; Charles E. Pettijohn

2003-01-01

211

Introduction: Institutional corruption and the pharmaceutical policy.  

PubMed

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. PMID:24088143

Rodwin, Marc A

2013-01-01

212

"Does Organizational Culture Influence the Ethical Behavior in the Pharmaceutical Industry?"  

PubMed Central

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

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-01-01

213

Pharmaceutical Cocrystals and Their Physicochemical Properties  

PubMed Central

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

2009-01-01

214

Experiences of new faculty implementing research-based instructional strategies  

NSDL National Science Digital Library

As part of an ongoing study to better understand and improve the diffusion of research-based pedagogies, we are following 15 faculty for 5 semesters after attending the Physics and Astronomy New Faculty Workshop. In this paper we report on the experiences of these faculty the first semester after the workshop. Faculty were interviewed both before and after the semester. Instructional artifacts and course outcome data were also collected. We discuss how the New Faculty Workshop experience impacted these faculty, the concerns and challenges the faculty encountered and how these faculty report spending their time. Implications for the diffusion of innovations are discussed.

Dancy, Melissa H.; Henderson, Charles R.

2012-04-25

215

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

PubMed

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

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

2012-12-01

216

Pharmaceutical Compounds Studied Using NEXAFS  

NASA Astrophysics Data System (ADS)

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.

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

2007-02-01

217

American Foundation for Pharmaceutical Education Survey of Scientific Manpower Needs in the Pharmaceutical Industry.  

ERIC Educational Resources Information Center

Those disciplines in the pharmaceutical sciences where critical manpower shortages now exist or will occur are identified by 34 pharmaceutical manufacturers in response to a request by the American Foundation for Pharmaceutical Education, which awarded fellowships in four critical areas. High priority needs are appended. (JMD)

Fisher, Albert B., Jr.

1979-01-01

218

Research-based recommendations for implementing international service-learning.  

PubMed

An increasing number of schools of nursing are incorporating international service-learning and/or immersion experiences into their curriculum to promote cultural competence. The purpose of this paper is to identify research-based recommendations for implementing an international service-learning program. A review of literature was conducted in the Cumulative Index of Nursing and Allied Health Literature database using the keywords international, immersion, cultural competence, nursing, and international service-learning. Additional references were located from the reference lists of related articles. Planning of international or immersion experiences requires consideration of the type of country, the length of time, and design of the program; the use of a service-learning framework; opportunities that require the student to live and work in the community, provide hands-on care, participate in unstructured activities, and make home visits; and a method of reflection. Increasing cultural competence does not require foreign travel, but it does necessitate that students are challenged to move outside their comfort zone and work directly with diverse populations. These research-based recommendations may be used either internationally or locally to promote the most effective service-learning opportunities for nursing students. PMID:24720947

Amerson, Roxanne

2014-01-01

219

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

PubMed Central

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

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

2004-01-01

220

Microbial factories for recombinant pharmaceuticals  

PubMed Central

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

Ferrer-Miralles, Neus; Domingo-Espin, Joan; Corchero, Jose Luis; Vazquez, Esther; Villaverde, Antonio

2009-01-01

221

Not good enough for us but fit for them — An examination of the chemical and pharmaceutical export trades  

Microsoft Academic Search

The paper provides ample evidence that major European pharmaceutical and chemical multinational companies are engaged in trading hazardous products to third world countries. In the manufacturer's country, these drugs and pesticides are usually banned or at least severely restricted in their use. EEC foreign trade policy has been founded in liberalism, neglecting the dangers which these products impose upon third

Andrew Chetley

1986-01-01

222

How financialisation shapes productive models in pharmaceutical industry: the domination and contradictions of the blockbuster conception of control (In French)  

Microsoft Academic Search

This article analyses the interaction between competition, productive models and financialisation of the main pharmaceutical companies. After having studied the institutional specificities and the constraints that shape productive models, we analyze how transformations of ownership structures and corporate governance are connected with institutional relationships of the industry, leading to the emergence of a conception of control inciting dominant firms to

Matthieu MONTALBAN

2009-01-01

223

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

Federal Register 2010, 2011, 2012, 2013

...Drug Enforcement Administration Roots Pharmaceuticals, Inc.; Revocation of Registration...issued an Order to Show Cause to Roots Pharmaceuticals, Inc. (Registrant), of American...Registration BR9610571, issued to Roots Pharmaceuticals, Inc., be, and it hereby...

2011-08-18

224

An export-marketing model for pharmaceutical firms (the case of iran).  

PubMed

Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires. PMID:24250597

Mohammadzadeh, Mehdi; Aryanpour, Narges

2013-01-01

225

Drug discovery market exclusivity after KSR: the challenge to pharmaceutical scientists and the US congress.  

PubMed

The Hatch-Waxman Act provides 180 days of market exclusivity to encourage generic companies to challenge the validity of pharmaceutical patents issued to innovator pharmaceutical companies. The consequent patent losses have been exacerbated owing to the application of holdings of the 2007 Supreme Court KSR decision to questions of pharmaceutical patentability by the judiciary and the US Patent Office. The resulting negative effect on support for new drug and formulation discovery by pharmaceutical scientists is discussed. To counteract the societal detriment of this negative effect, the adoption of a 12-year US Food and Drug Administration (FDA) market exclusivity paradigm for all approved new chemical entities including prodrugs is proposed. Such market exclusivities have already been enacted in the United States for follow-on biologicals and are in substantial harmony with those of the European Union, Japan, and Canada. An extension of the existing 3-year FDA market exclusivity for new formulations under 21 U.S.C. (United States Code) §505(b)(2) to 5 years should also be considered. PMID:21472728

Wolff, Manfred E

2011-08-01

226

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

PubMed

The qualitative and quantitative capabilities of ion mobility spectrometry (IMS) as a comprehensive and powerful tool in workplace air monitoring have been demonstrated on the example of a Spanish pharmaceutical company. The developed IMS based procedure is capable of detecting and determining in air samples the active pharmaceutical ingredients (APIs) manipulated and/or produced in this pharmaceutical industry. Sensitivity, in the ng-pg range, selectivity, possibly to provide results in near real time, and reduction of analysis costs are the most important properties that ratify IMS as a serious alternative in occupational exposure assessment. The possibility of false positives by drift time interferences and false negatives by competitive ionization and also desorption process interferences has been deeply evaluated. Moreover, chemometric strategies based on self-modeling curve resolution (SMCR) have been applied to obtain qualitative and quantitative individual component information from overlapped peaks. The IMS procedure has been successfully applied to evaluate the concentration of APIs (nimesulide, dexketoprofen, deflazacort) handled by the pharmaceutical company employees in the making of tablets and granulates, and control measures have been suggested in accordance. PMID:22500648

Armenta, S; Blanco, M

2012-05-15

227

Pharmaceutical Pricing and Reimbursement Policies in Sweden  

Microsoft Academic Search

This paper examines aspects of the policy environment and market characteristics of the Swedish pharmaceutical sector, assesses the degree to which Sweden has achieved certain policy goals, and puts forth some key findings and conclusions. Thanks to low mark-ups in the distribution chain and no VAT for prescribed medicines, Sweden's public prices for pharmaceuticals are relatively low, in contrast to

Pierre Moïse

2007-01-01

228

Pharmaceuticals, Hormones, and Other Organic Wastewater  

E-print Network

Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999 To provide the first nationwide reconnaissance of the occurrence of pharmaceuticals, hormones, and other as biogenic hormones are released directly to the environment after passing through wastewater treatment

229

Human Pharmaceuticals in Wastewater Treatment Processes  

Microsoft Academic Search

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

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

2005-01-01

230

Pharmaceutical experiment aboard STS-67 mission  

NASA Technical Reports Server (NTRS)

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

1995-01-01

231

Introduction The essence of pharmaceutical materi-  

E-print Network

Introduction The essence of pharmaceutical materi- als science is the application of fundamen- tal and in vivo experimental studies. Background Although research in pharmaceutical materials science concepts in the physical sciences to the challenges of understanding the behavior of soft, mostly organic

Elliott, James

232

Biotech pharmaceuticals and biotherapy: an overview.  

PubMed

Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals. PMID:10945918

Steinberg, F M; Raso, J

1998-01-01

233

The pharmaceutical sciences in 2020—Report of a conference organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP)  

Microsoft Academic Search

In accordance with its missions, the Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (scientists, academicians, regulators, industrialists, venture capitalists…) who shared their views on the forces that might determine how the pharmaceutical sciences

Vinod P. Shah; Luc J. R. Besançon; Pieter Stolk; Geoffrey Tucker; Daan J. A. Crommelin

2009-01-01

234

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

PubMed Central

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

Kurtzman, Gary

2005-01-01

235

A business model for diagnostic startups-a business model for a new generation of diagnostics companies.  

PubMed

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

Kurtzman, Gary

2005-10-01

236

Pharmaceutical care in Kuwait: hospital pharmacists' perspectives.  

PubMed

Background Pharmaceutical care practice has been championed as the primary mission of the pharmacy profession, but its implementation has been suboptimal in many developing countries including Kuwait. Pharmacists must have sufficient knowledge, skills, and positive attitudes to practise pharmaceutical care, and barriers in the pharmacy practice model must be overcome before pharmaceutical care can be broadly implemented in a given healthcare system. Objective To investigate hospital pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care, and the barriers to its implementation in Kuwait. Setting Six general hospitals, eight specialized hospitals and seven specialized health centers in Kuwait. Method A descriptive, cross-sectional survey was distributed to all pharmacists working in the governmental hospitals in Kuwait (385 pharmacists). Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (standard deviations) were calculated and compared using statistical package for social sciences, version 20. Statistical significance was accepted at a p value of <0.05. Main outcome measure Pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care competencies, and the barriers to its implementation in Kuwait. Results Completed surveys were received from 250 (64.9 %) of the 385 pharmacists. Pharmacists expressed overall positive attitudes towards pharmaceutical care. They felt well prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Pharmacists with more practice experience expressed significantly more positive attitudes towards pharmaceutical care (p = 0.001) and they felt better prepared to provide pharmaceutical care competencies (p < 0.001) than those with less experience as practitioners. The respondents agreed/strongly agreed that the most significant barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (87.6 %), organizational obstacles (81.6 %), inadequate staff (79.6 %), and lack of pharmacist time and adequate technology (76.0 %). Conclusion Hospital pharmacists in Kuwait advocate implementation of pharmaceutical care while also appreciating the organizational, technical and professional barriers to its widespread adoption. Collaborative efforts between health authorities and educational institutions, and the integration of innovative approaches in pharmacy management and education could overcome these barriers and achieve the transition towards pharmaceutical care practice. PMID:25204259

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

2014-12-01

237

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

PubMed Central

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

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

2013-01-01

238

Drug Companies Drop South Africa Suit  

NSDL National Science Digital Library

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

De Nie, Michael W.

2001-01-01

239

Marketing Norm Perception Among Medical Representatives in Indian Pharmaceutical Industry  

PubMed Central

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

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

2012-01-01

240

Bangladesh pharmaceutical policy and politics.  

PubMed

An analysis of the politics of Bangladesh pharmaceutical policy in the 1980s shows how significant health policy reforms in developing countries depend on political conditions both inside and outside the country. Bangladesh's drug policy of 1982 illustrates that governments can sometimes change public policy in ways unfavourable to multinational corporations, while the failed health policy reform of 1990 shows that reforms unfavourable to powerful domestic interest groups can be more difficult to achieve, even contributing to a government's downfall. The case provides evidence of basic changes in how the international agenda for health policy is set, especially the growing role of non-governmental organizations in international agencies and national policy debates. Understanding the political patterns of policy reform in Bangladesh has important implications for strategies to affect health policy in developing countries. PMID:15726775

Reich, M R

1994-06-01

241

Evolution of Plant-Made Pharmaceuticals  

PubMed Central

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

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

2011-01-01

242

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

MedlinePLUS

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

243

Early drug discovery and the rise of pharmaceutical chemistry.  

PubMed

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

Jones, Alan Wayne

2011-06-01

244

2nd International China BioPharmaceutical Symposium.  

PubMed

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

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

2009-03-01

245

Models for financing the regulation of pharmaceutical promotion  

PubMed Central

Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs. PMID:22784944

2012-01-01

246

Models for financing the regulation of pharmaceutical promotion.  

PubMed

Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs. PMID:22784944

Lexchin, Joel

2012-01-01

247

Proposing a redefinition of pharmaceutical care.  

PubMed

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

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

2012-03-01

248

Quality evaluation of pharmaceutical formulations containing hydrochlorothiazide.  

PubMed

Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations. PMID:25335110

de Oliveira, Marcelo Antonio; Yoshida, Maria Irene; Silva, Daphne Carina Gonçalves Monteiro da

2014-01-01

249

Research-Based Reading Instruction in an Adult Basic Education Program  

ERIC Educational Resources Information Center

There is a growing emphasis in adult basic education on research-based reading instruction. Using Kruidenier's (2002) framework of principles and trends, we describe research-based techniques found during a visit to an adult basic education program. We also describe how the program moved to research-based instruction, and the factors that seem…

Perin, Dolores; Greenberg, Daphne

2007-01-01

250

To provide exceptional research based educational services to children with autism spectrum disorder  

E-print Network

Autism Center provides research based assessment and intervention to children with autism spec- trum analysts) with training in research-based interventions for children with autism spectrum disordersMission To provide exceptional research based educational services to children with autism spectrum

251

Research-based active-learning instruction in physics  

NASA Astrophysics Data System (ADS)

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

Meltzer, David E.; Thornton, Ronald K.

2013-04-01

252

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

PubMed Central

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

2010-01-01

253

Selecting Non-Pharmaceutical Interventions for Influenza Rachael M. Jonesa  

E-print Network

Selecting Non-Pharmaceutical Interventions for Influenza Rachael M. Jonesa and Elodie Adidab to the selection of model parameters. Specifically, we show that the optimum combination of non-pharmaceutical strategies include pharmaceutical interventions (e.g., vaccination and anti-viral medications) and non-pharmaceutical

Adida, Elodie

254

The 32nd Annual J.P. Morgan Healthcare Conference (January 13-16, 2014 - San Francisco, California, USA): Auxilium Pharmaceuticals.  

PubMed

CEO and President Adrian Adams described Auxilium Pharmaceuticals as "the same as a Big Pharma company, only smaller." This 'specialty biopharmaceutical company' has transformed itself in the last 6 to 9 months to become the "leading men's healthcare franchise with a broad and diverse product portfolio." All of this has led to a very busy 2013, which began with the USD 600 million acquisition (Q2) and integration of Actient Pharmaceuticals, the licensing of avanafil (Stendra™) for erectile dysfunction and ended with the approval of collagenase Clostridium histolyticum (Xiaflex®) in Peyronie's disease. From a portfolio of 2 products at the beginning of 2013, Auxilium ended the year with 12. PMID:24696871

Watt, J

2014-03-01

255

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...

256

Essays on pharmaceuticals and health care expenditures  

E-print Network

The U.S. pharmaceutical industry has been remarkably successful in developing new treatments for many of the leading causes of morbidity and mortality. These new treatments and their high prices lead government and private parties to increase...

Karaca, Zeynal

2009-06-02

257

Pharmaceutical Services in Long Term Care Facilities.  

National Technical Information Service (NTIS)

Information pertinent to the development of policies and procedures for pharmaceutical services in long-term care facilities in the State of Washington is presented. Topics to be included in policy and procedures manuals are outlined, with references to a...

1976-01-01

258

Understanding Oxidative Instability of Protein Pharmaceuticals  

E-print Network

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 ...

Chu, Jhih-Wei

259

Continuous Plug Flow Crystallization of Pharmaceutical Compounds  

E-print Network

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 ...

Alvarez, Alejandro J.

260

MRIGlobal Pharmaceutical Development and Repository Management  

Cancer.gov

Meetings & Events Investigators' - Site Coordinators' Opportunity for Research Excellence (I-SCORE) Workshop March 20-21, 2014 Poster Presentations – Full List « Previous | Next »   MRIGlobal Pharmaceutical Development and Repository Management Jonathan

261

Continuous blending of dry pharmaceutical powders  

E-print Network

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 ...

Pernenkil, Lakshman

2008-01-01

262

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

NASA Astrophysics Data System (ADS)

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

Wu, Huiquan; Khan, Mansoor

2012-08-01

263

Corporate social responsibility in countries with mature and emerging pharmaceutical sectors  

PubMed Central

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

Volodina, Anna; Sax, Sylvia; Anderson, Stuart

2009-01-01

264

Continuing education for general practice and the role of the pharmaceutical industry.  

PubMed

A survey of the involvement in and attitudes towards continuing medical education of 101 general practitioners achieved a 95% response rate. Ninety per cent of the 96 doctors worked in practices which held meetings the content of which was organized by representatives of pharmaceutical companies but only 46% worked in practices which organized their own educational meetings. Seventy six per cent attended meetings away from their practice which were organized by drug companies and 75% had attended at some time continuing medical education activities organized by a local postgraduate centre. The promotional aspects of the drug company organized meetings were disliked by a majority of respondents (58%); more of the trainers (62%) and more of those who had entered general practice within the last seven years (71%) disliked this aspect. Nonetheless the educational content of both meetings held in the practice and those held elsewhere was the aspect most liked by over half of the respondents (59% and 53% respectively). Only 16% of all respondents thought that visits by representatives from pharmaceutical companies were educationally valuable and 37% thought that educational events organized by these companies were of value. Surprisingly 60% of those who worked in practices which held meetings organized by drug company representatives thought them to be of little or no educational value. There is clearly a need for practice based continuing medical education but the current level of dependence on drug companies for organizing these meetings must be questioned. Alternative strategies for the provision of independent non-sponsored educational activities should be sought. PMID:2282231

Hayes, T M; Allery, L A; Harding, K G; Owen, P A

1990-12-01

265

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

Federal Register 2010, 2011, 2012, 2013

...Transmission Company, LLC, Transcontinental Gas Pipe Line Company, LLC, Enterprise Field...Transmission Company, LLC, Transcontinental Gas Pipe Line Company, LLC, and Enterprise Field...with the Commission and open to public inspection. The filing is available for review...

2010-03-22

266

Allergan, a global health care company focused on discovering, developing and commercializing  

E-print Network

, Allergan Medical, in Goleta, California. For one of the world's leaders in the field, the move to the area innovative pharmaceuticals, biologics and medical devices, has established its Medical Device R & D center concerns of technology based companies, such as Allergan Medical, in their choice for a headquarters

Akhmedov, Azer

267

Orphan Drug Development: Opportunities and Challenges from a Midsized to Large Company Perspective  

Microsoft Academic Search

Orphan diseases may be one of the last frontiers in drug development. With an estimated 50 million or more people affected across Europe and North America by over 6,000 rare diseases, the unmet medical need is daunting. This research explores the question of whether the opportunities outweigh the challenges and provide incentives for midsized to large pharmaceutical and biotechnology companies

Rosann Reinhart; Krysten Madrzjewski

2010-01-01

268

Stem cells in pharmaceutical biotechnology.  

PubMed

Multiple populations of stem cells have been indicated to potentially participate in regeneration of injured organs. Especially, embryonic stem cells (ESC) and recently inducible pluripotent stem cells (iPS) receive a marked attention from scientists and clinicians for regenerative medicine because of their high proliferative and differentiation capacities. Despite that ESC and iPS cells are expected to give rise into multiple regenerative applications when their side effects are overcame during appropriate preparation procedures, in fact their most recent application of human ESC may, however, reside in their use as a tool in drug development and disease modeling. This review focuses on the applications of stem cells in pharmaceutical biotechnology. We discuss possible relevance of pluripotent cell stem populations in developing physiological models for any human tissue cell type useful for pharmacological, metabolic and toxicity evaluation necessary in the earliest steps of drug development. The present models applied for preclinical drug testing consist of primary cells or immortalized cell lines that show limitations in terms of accessibility or relevance to their in vivo counterparts. The availability of renewable human cells with functional similarities to their in vivo counterparts is the first landmark for a new generation of cell-based assays. We discuss the approaches for using stem cells as valuable physiological targets of drug activity which may increase the strength of target validation and efficacy potentially resulting in introducing new safer remedies into clinical trials and the marketplace. Moreover, we discuss the possible applications of stem cells for elucidating mechanisms of disease pathogenesis. The knowledge about the mechanisms governing the development and progression of multitude disorders which would come from the cellular models established based on stem cells, may give rise to new therapeutical strategies for such diseases. All together, the applications of various cell types derived from patient specific pluripotent stem cells may lead to targeted drug and cellular therapies for certain individuals. PMID:21902635

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

2011-11-01

269

Competitor Analysis Company Description  

E-print Network

advances in chemical production from green/environmentally friendly resources. Conduct research and analyze Competitive analysis Company Description: A privately owned environmentally conscious global specialty

Dahl, David B.

270

Internet Company Handbook  

NSDL National Science Digital Library

Published by Morgan Stanley Dean Witter, The Internet Company Handbook is a report which serves as "a rudimentary one-stop shop for the basics for today's top Internet companies." The report focusses on the leading 90 Internet companies, as defined by market capitalization and Media Metrix ratings which include average length of visit and average number of page views a month. The main body of this study consists of a collection of profiles of these companies including short descriptions and snapshots of their Websites. The publication has been broken into six chapters, and within each chapter, tables and key information are easily accessible from the table of contents.

271

Limits to neoliberal reforms in the health sector: the case of pharmaceutical management in New Zealand.  

PubMed

In New Zealand in 1993, a pharmaceutical management agency (PHARMAC) was established during the height of neoliberal reforms in the health sector. The agency's relationship with pharmaceutical companies, patient lobby groups, and health professionals has been hostile at times, but despite this hostility, PHARMAC has remained substantially independent from political interference. This article draws on critical theory and Durkheimian perspectives to explain how such a strong regulatory organization was established during a time when attempts were made to reshape the health sector to conform to a neoliberal agenda. An analysis of historical and contemporary issues demonstrates the contradictory position of the state in relation to the regulation and subsidization of pharmaceuticals, with conflicting demands to retain popular support, restrain state expenditure, and respond to expectations to provide pharmaceuticals to its citizens. This article demonstrates how the establishment of PHARMAC reconciles these contradictory demands, arguing that it removes decision making from political control and has been able to sustain its place by appealing to objective assessment criteria. This case signals limits of the neoliberal agenda. PMID:24684088

Dew, Kevin; Davis, Amy

2014-01-01

272

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

PubMed

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

Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

2014-02-01

273

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...

274

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

E-print Network

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 ...

Teytelman, Anna

2012-01-01

275

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

PubMed Central

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

2014-01-01

276

Water and stability of pharmaceutical solids  

NASA Astrophysics Data System (ADS)

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?

Shalaev, Evgenyi

2007-03-01

277

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

PubMed

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

Levin, M

2001-06-01

278

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

Federal Register 2010, 2011, 2012, 2013

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

2013-01-15

279

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

Federal Register 2010, 2011, 2012, 2013

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

2012-10-29

280

Selected aspects of europeization of pharmaceutical law.  

PubMed

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

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

2010-01-01

281

'Linkage' pharmaceutical evergreening in Canada and Australia  

PubMed Central

'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

Faunce, Thomas A; Lexchin, Joel

2007-01-01

282

Pharmaceutical identifier confirmation via DART-TOF.  

PubMed

Pharmaceutical analysis comprises a large amount of the casework in forensic controlled substances laboratories. In order to reduce the time of analysis for pharmaceuticals, a Direct Analysis in Real Time ion source coupled with an accurate mass time-of-flight (DART-TOF) mass spectrometer was used to confirm identity. DART-TOF spectral data for pharmaceutical samples were analyzed and evaluated by comparison to standard spectra. Identical mass pharmaceuticals were differentiated using collision induced dissociation fragmentation, present/absent ions, and abundance comparison box plots; principal component analysis (PCA) and linear discriminant analysis (LDA) were used for differentiation of identical mass mixed drug spectra. Mass assignment reproducibility and robustness tests were performed on the DART-TOF spectra. Impacts on the forensic science community include a decrease in analysis time over the traditional gas chromatograph/mass spectrometry (GC/MS) confirmations, better laboratory efficiency, and simpler sample preparation. Using physical identifiers and the DART-TOF to confirm pharmaceutical identity will eliminate the use of GC/MS and effectively reduce analysis time while still complying with accepted analysis protocols. This will prove helpful in laboratories with large backlogs and will simplify the confirmation process. PMID:24770424

Easter, Jacob L; Steiner, Robert R

2014-07-01

283

'Linkage' pharmaceutical evergreening in Canada and Australia.  

PubMed

'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

Faunce, Thomas A; Lexchin, Joel

2007-01-01

284

Tobacco companies and products  

NSDL National Science Digital Library

Tobacco companies have been restricted in what they can do to advertise their products. Some have been accused of soliciting children to begin smoking. Most tobacco companies are required to place some type of warning label on their packages warning smokers of the diseases that tobacco use can cause.

Adrian Pingstone (None;)

2008-03-19

285

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

PubMed

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

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

2012-01-01

286

Growth of the Asian health-care market: global implications for the pharmaceutical industry.  

PubMed

The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceutical companies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets. PMID:17853900

Epstein, Richard J

2007-10-01

287

Pharmaceutical group purchasing cuts costs, expands knowledge.  

PubMed

The CHA-CSHP pharmaceutical group purchasing program has provided several benefits to participating hospitals and related institutions in Connecticut. The program is run by pharmacists and staffed by individuals knowledgeable in good purchasing techniques. Pharmacist compliance has been good because of maximum input into program decisions by all participating pharmacy departments. Pharmaceutical industry participation has been excellent, because each bid invitation includes information on the previous year's purchases by participating hospitals and on the committed volume for the contract period. In addition, the program is self-supporting. Thus, larger hospitals, which would often be able to obtain good pricing independently, are not obliged to support the bulk of this program, as is often the case when participating institutions pay dues based on their bed size. As a result of the pharmaceutical group purchasing plan of the Connecticut Hospital Association, hospitals have received significant benefits in cost savings and shared drug information. PMID:939514

Lipman, A G; Bauer, E P

1976-04-16

288

Thermal properties of food and pharmaceutical powders  

NASA Astrophysics Data System (ADS)

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.

Abiad, Mohamad Ghassan

289

"New Jersey is the pharmaceutical capital of the country and Rutgers is at the center of it all," says Marc Paolantonio. After receiving his under-  

E-print Network

and advertising division at the U.S. Food and Drug Administration, was a recent guest lecturer in Legal company. MBA in Pharmaceutical Management A Healthy Dose of Real-World Experience Special Courses Students case studies and news. Recent topics have included stem cell research, direct to consumer advertising

Lin, Xiaodong

290

[Quality improvement potential in the pharmaceutical industry].  

PubMed

The performance of the German pharmaceutical industry, future challenges and obstacles to quality improvement are assessed from a systems-of-innovation perspective, using appropriate innovation indicators. The current close-to-market performance indicators paint an unfavourable picture. Early R&D indicators (e.g., publications, patents), however, reveal a positive trend. A lot of obstacles to quality improvements are identified with respect to knowledge base, knowledge/technology transfer, industrial R&D processes, capital markets, market attractiveness and both regulatory and political framework conditions. On this basis, recommendations will finally be derived to improve quality in the pharmaceutical industry. PMID:17711261

Nusser, Michael

2007-01-01

291

Radiostability of pharmaceuticals under different irradiation conditions  

NASA Astrophysics Data System (ADS)

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

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

2005-02-01

292

Content Analysis of Oncology-Related Pharmaceutical Advertising in a Peer-Reviewed Medical Journal  

PubMed Central

Background The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. Methods/Principal Findings Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology) between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005–2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. Conclusion/Significance Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period. PMID:22952970

Yonemori, Kan; Hirakawa, Akihiro; Ando, Masashi; Hirata, Taizo; Yunokawa, Mayu; Shimizu, Chikako; Tamura, Kenji; Fujiwara, Yasuhiro

2012-01-01

293

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 ...

294

TRD -Your Partner for Technical R&D Pharmaceutical Preformulation  

E-print Network

TRD - Your Partner for Technical R&D Pharmaceutical Preformulation Wei-Qin (Tony) Tong, Ph.D. Novartis Pharmaceuticals Corporation Integrated Drug Product Development Process (3 day-course), University

Tipple, Brett

295

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...

296

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...

297

A Mathematical Programming Model for Scheduling Pharmaceutical Sales Representatives  

E-print Network

A Mathematical Programming Model for Scheduling Pharmaceutical Sales Representatives Lauren Hertel, Industrial Engineering, Schering-Plough Corp., Kenilworth, NJ 07033, USA Natarajan Gautam, Marcus Dept. of IME, Penn State Univ., University Park, PA 16802, USA Abstract To increase revenues, pharmaceutical

Gautam, Natarajan

298

Microfluidic Approach to Cocrystal Screening of Pharmaceutical Parent Compounds  

E-print Network

Microfluidic Approach to Cocrystal Screening of Pharmaceutical Parent Compounds Sachit Goyal & Biomolecular Engineering, University of Illinois at Urbana-Champaign, 600 South Mathews Avenue, Urbana, Illinois 61801, United States Materials Science, Global Pharmaceutical R & D, Abbott Laboratories, 1401

Kenis, Paul J. A.

299

Development Document for Effluent Limitations Guidelines and Standards for the Pharmaceuticals Manufacturing. Point Source Category.  

National Technical Information Service (NTIS)

Pharmaceutical plants manufacture biological products, medicinal chemicals, botanical products, and other pharmaceutical products. EPA identified 466 operating facilities involved in the manufacture of pharmaceutical products. Most of the pharmaceutical i...

1982-01-01

300

An overview of pharmaceutical cocrystals as intellectual property.  

PubMed

This review article focuses on the interaction among certain scientific, legal, and regulatory aspects of pharmaceutical crystal forms. The article offers an analysis of pharmaceutical cocrystals as patentable inventions by drawing upon recent scientific developments in the field. Several potential commercial advantages of pharmaceutical cocrystals are highlighted, and a number of recent court decisions involving salient issues are summarized. The article provides an outlook on how the developing field of cocrystallization may impact the pharmaceutical intellectual property landscape. PMID:17477544

Trask, Andrew V

2007-01-01

301

Instruction of Research-Based Comprehension Strategies in Basal Reading Programs  

Microsoft Academic Search

Research supports using research-based comprehension strategies; however, comprehension strategy instruction is not highly visible in basal reading programs or classroom instruction, resulting in many students who struggle with comprehension. A content analysis examined which research-based comprehension strategies were presented in five elementary school basal readers and how the basals suggest that the strategies be taught. The analysis found that two

Paola Pilonieta

2010-01-01

302

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

ERIC Educational Resources Information Center

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

Schumacher, Gary; Grigsby, Bettye; Vesey, Winona

2011-01-01

303

When the Rubber Meets the Road: Putting Research-based Methods to Test in Urban Classrooms  

E-print Network

When the Rubber Meets the Road: Putting Research-based Methods to Test in Urban Classrooms Junlei" instructional scenario in which a knowledgeable researcher, under the guidance of an experienced classroom teacher, carried out a set of research- based science instruction in a low-SES urban school. The training

Klahr, David

304

The size, extent and nature of the learning disability nursing research base: A systematic scoping review  

Microsoft Academic Search

Background A research base should be of sufficient quality and quantity to inform nursing practice. It must allow nurses to access information about clients' needs and to identify effective strategies for meeting those needs. This paper presents the findings of a scoping review of [`]learning disability nursing research'. The review aimed to determine whether there is a research base sufficient

Peter Griffiths; Janette Bennett; Elizabeth Smith

2009-01-01

305

Mechanical Engineer Company Description  

E-print Network

Mechanical Engineer Company Description Control Solutions Inc. is a small, dynamic, and rapidly. Position Description The Mechanical Engineer is responsible for all aspects associated with the mechanical enclosures, brackets, cabling assemblies among others. Systems include mechanisms, sensors, hydraulics, among

Kostic, Milivoje M.

306

Small company, big plans  

NASA Astrophysics Data System (ADS)

German company Novaled has built a business around a doping technology that increases the efficiency of organic LEDs. Its materials have broken many efficiency records and are being used in a wide range of applications, reports Nadya Anscombe.

2009-08-01

307

eCompany Now  

NSDL National Science Digital Library

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

308

Roles for Educational Psychologists in Pharmaceutical Education.  

ERIC Educational Resources Information Center

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…

Speedie, Stuart M.

309

Production of isoprenoid pharmaceuticals by engineered microbes  

E-print Network

Production of isoprenoid pharmaceuticals by engineered microbes Michelle C Y Chang & Jay D Keasling that is becoming more accessible as the tools for engineering microbes are further developed. By reconstructing sources such as soft coral or unculturable microbes, there may not even exist enough raw material

Cai, Long

310

The role of UHPLC in pharmaceutical development.  

PubMed

Pharmaceutical separations can be divided into three categories: high throughput, high productivity, and high resolution. These categories contain specific pharmaceutical applications, each of which has distinct separation goals. Traditionally, these goals have been achieved utilizing conventional HPLC with typical column dimensions and particle sizes. The recent introduction of ultra-HPLC (UHPLC) has provided a new potential for method development and analysis. Pharmaceutical chemists must determine the impact of this emerging technology. UHPLC is achieved by using sub-2 microm particle size column packing at increased linear velocities. In order to utilize this technology, mobile phase viscosity must be minimized or the chromatography system must be redesigned to withstand an increased backpressure. Today, there are many commercially available UHPLC systems capable of exceeding conventional pressure limits of 400 bar. The advantage of UHPLC over conventional HPLC is the capability to increase the speed without sacrificing efficiency. In comparison to traditional HPLC, our research showed that UHPLC can decrease run times up to 7 x. In addition, for high resolution applications, UHPLC achieved significant efficiency advantages over traditional HPLC. This paper will evaluate the potential roles for utilizing UHPLC in the pharmaceutical industry. PMID:17595953

Chesnut, Stephen M; Salisbury, John J

2007-05-01

311

DEPARTMENT OF PHARMACEUTICS Fall 2013 Seminars  

E-print Network

INTRADERMAL DELIVERY OF NANOPARTICLE VACCINE FORMULATION VIA MICRONEEDLE SYSTEM INDUCES BALANCED Th1/Th2 of Pharmaceutics, U Minnesota (bio) September 12 CHALLENGES IN THE BRAIN DELIVERY OF A PROMISING MEK1/2 INHIBITOR DISPERSIONS Pinal Mistry, Graduate Student September 26 IMPROVING THE TABLETABILITY OF DRUG-LAYERED BEADS

Thomas, David D.

312

Deep pharma: psychiatry, anthropology, and pharmaceutical detox.  

PubMed

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

Oldani, Michael

2014-06-01

313

Old Yet New--Pharmaceuticals from Plants  

Microsoft Academic Search

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

Peter J. Houghton

2001-01-01

314

PHARMACEUTICAL EQUIVALENCE OF GENERIC ESSENTIAL DRUGS  

Microsoft Academic Search

The use of multisource essential drugs widely contributes to the accessibility to health care for populations in difficulties in developing countries or in case of emergency aids. The issue of bioavailability questions the simplistic theories about drugs interchangeability. Bioequivalence studies must be carried out to ensure the therapeutic equivalence of two pharmaceutic equivalent drugs. However, by looking at drugs circulation

C. ABELLI; O. ANDRIOLLO; L. MACHURON; J. Y. VIDEAU; B. VENNAT; M. P. POUGET

2001-01-01

315

Anaerobic pretréatment of concentrated pharmaceutical wastes  

Microsoft Academic Search

The purpose of this study was to investigate the anaerobic ammonification of wastewater from an estrogen extracting pharmaceutical plant. The wastewater was very high in total dissolved solids (TDS), nitrogen (TKN) and organic carbon (TOC). Both flow?through and batch anaerobic reactors were used. TDS concentrations over 17 g L in the flow?through reactors and in excess of 10 g L

S. Shafai; Jan A. Oleszkiewicz

1987-01-01

316

Recent advances with liposomes as pharmaceutical carriers  

Microsoft Academic Search

Liposomes — microscopic phospholipid bubbles with a bilayered membrane structure — have received a lot of attention during the past 30 years as pharmaceutical carriers of great potential. More recently, many new developments have been seen in the area of liposomal drugs — from clinically approved products to new experimental applications, with gene delivery and cancer therapy still being the

Vladimir P. Torchilin

2005-01-01

317

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...

318

Captive subjects: Pharmaceutical testing and prisoners  

Microsoft Academic Search

The debate about using prison inmates for medical testing has again surfaced. A federal panel of medical advisors from the Institute of Medicine (IOM) of the National Academy of Sciences has recommended that the government loosen restrictions limiting testing of pharmaceutical agents on prisoners [1]. Current regulations, passed in 1978, allow prison inmates to participate in federally financed biomedical research

Timothy J. Wiegand

2007-01-01

319

An Interdisciplinary Course in Pharmaceutical Advertising.  

ERIC Educational Resources Information Center

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

Grieshaber, Larry D.; And Others

1980-01-01

320

COURSE OUTLINE -PHAR 6222 Advanced Pharmaceutical Compounding  

E-print Network

Director: Gary Carlson, B.A., B.S. Pharm., RPh Office: Fairview Compounding Pharmacy 711 Kasota Ave, MplsCOURSE OUTLINE - PHAR 6222 Advanced Pharmaceutical Compounding 2 Credits, Spring 2013 Course, the student will be able to: 1. Explain methods used to compound most commonly prescribed dosage forms

Thomas, David D.

321

An Innovative Pharmaceutical Care Practical Course  

ERIC Educational Resources Information Center

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…

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

2007-01-01

322

Direct to consumer advertising in pharmaceutical markets  

Microsoft Academic Search

We study effects of direct-to-consumer advertising (DTCA) in the prescription drug market. There are two pharmaceutical firms providing horizontally differentiated (branded) drugs. Patients differ in their susceptibility to the drugs. If DTCA is allowed, this can be employed to induce (additional) patient visits. Physicians perfectly observe the patients’ type (of illness), but rely on information to prescribe the correct drug.

Kurt R. Brekke; Michael Kuhn

2006-01-01

323

Reversed Phase Stationary Phases in Pharmaceutical Sciences  

Microsoft Academic Search

The considerations behind the selection of reversed phase stationary phases in the pharmaceutical sciences and industry is reviewed throughout the various stages of drug development, from the lead discovery to the manufacturing stage. The selection of the appropriate stationary phase and column in every stage, according to the analytical needs, is described.

Shulamit Levin

2005-01-01

324

Pharmaceutical Applications of Ion-Exchange Resins  

ERIC Educational Resources Information Center

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…

Elder, David

2005-01-01

325

Market Size and Pharmaceutical Innovation Pierre Dubois, Olivier de Mouzony  

E-print Network

Market Size and Pharmaceutical Innovation Pierre Dubois, Olivier de Mouzony , Fiona Scott market size and innovation in the pharmaceutical industry using improved, and newer, methods and data. We implication of the hypothesis that innovation in pharmaceuticals is becoming more di� cult and expensive over

Sekhon, Jasjeet S.

326

FINITE ELEMENT ANALYSIS OF CAPPING MECHANISMS DURING PHARMACEUTICAL POWDER COMPACTION  

E-print Network

Institute for Pharmaceutical Materials Science, Department of Materials Science and Metallurgy, UniversityFINITE ELEMENT ANALYSIS OF CAPPING MECHANISMS DURING PHARMACEUTICAL POWDER COMPACTION Chuan-Yu. Wu1 In this paper, the compaction of lactose powder, a typical pharmaceutical excipient, is modelled using finite

de Gispert, Adrià

327

Companies reduce prices for HIV drugs in developing countries.  

PubMed

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

Gottlieb, S

2000-01-01

328

Pharmaceuticals as Groundwater Tracers - Applications and Limitations  

NASA Astrophysics Data System (ADS)

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.

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

2003-12-01

329

The superefficient company.  

PubMed

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

Hammer, M

2001-09-01

330

Patent indicators: a window to pharmaceutical market success.  

PubMed

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

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

2013-07-01

331

Horizontal divestiture of energy companies  

Microsoft Academic Search

Discussions in the past have centered around both vertical (company ownership of production, refining, transportation, marketing) and horizontal (company ownership of oil, coal, uranium, shale, and other energy sources) integration. Many think that integration of either type is undesirable and propose instead, divestiture - breaking up the energy companies in component parts. Vertical divestiture would break up an oil company

T. Ruefli; H. Askari; M. Kennedy

1977-01-01

332

The light company  

SciTech Connect

The story of the Houston Lighting and Power Company reflects the history of Houston and Texas' upper Gulf Coast. Their stories intertwine through more than a century of booms and busts, hurricanes and floods, disputes and agreements, oil bonanzas and oil embargoes, and an assortment of wars and riots. The author presents the facts in human terms, with scores of first-person accounts. She traces the growth of the company from its beginnings as a novel business venture by a few entrepreneurs into the powerful corporation that today serves eleven counties and more than 3.5 million Texans. The story of Houston Lighting and Power Company captures the determination and pioneering spirit of people who for more than one hundred years have met the growing demands of the most dynamic region in Texas.

Budd, M.

1987-01-01

333

No more pens: what the 2009 Pharmaceutical Research and Manufacturer's Association code changes really mean.  

PubMed

In 2002, new guidelines for interactions with the pharmaceutical industry and physicians were published as an official code of conduct. Adherence to the guidelines was voluntary, and there were no provisions for discipline to companies who did not subscribe to the code or who subscribed but did not comply. Many of the code standards are routinely violated, sometimes egregiously, with many violations on easy display at national professional meetings. In response to further problems and complaints, tougher code standards-now famous for the specific ban on logo pens and coffee cups-were adopted in 2009. Subscription to the new code is voluntary, and there are no provisions for discipline or punishment for those companies who chose not to subscribe or who may violate its standards. PMID:19539160

Meffert, Jeffrey J

2009-01-01

334

Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection  

PubMed Central

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

Chollet, John L.; Jozwiakowski, Michael J.

2012-01-01

335

A framework for pharmaceutical value-based innovations.  

PubMed

The rapidity of change and increasing complexity of today's healthcare environment dictates that pharmaceutical companies refine their drug development process to ensure that products provide maximal value to consumers. Innovation should receive the support and encouragement it deserves but the balance between cost of therapy and enhanced benefits to the end users, the patients, must not be compromised. The health or quality-of-life outcomes that therapies are likely to achieve need to be clearly stated for patients so they know what to expect before beginning treatment. A drug development program that incorporates principles of 'patient-centered medicine' early on can help define the true value of a health technology. This demands not only demonstrating value as measured by actual patient experience and patient-reported outcomes, but understanding the unmet needs of multiple stakeholders: what is their perception of what represents value? What factors impact healthcare coverage decisions? In this paper, we describe an illustrative framework designed to weave 'patient-centric' medical and real-world evidence into the phases of research and development. This evidence and value development framework works iteratively, providing useful insights parallel to product development from early phase to life-cycle management while forming a progressive evidence chain throughout the phases of research and development. This in turn leads to the creation of value-based innovation with robust foundational evidence for clinical decisions, postlaunch coverage and reimbursement evaluations. PMID:24237316

Salimi, Tehseen; Lehner, Jean-Pierre; Epstein, Robert S; Tunis, Sean R

2012-01-01

336

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

PubMed

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

Lamarque, V; Plétan, Y

2007-09-01

337

Which Pharmaceutical Sales Representatives' Features do Slovenian Family Physicians Value?  

PubMed Central

Introduction: One of the key strategies for marketing new drugs to physicians is personal selling by pharmaceutical sales representatives (PSRs). Goal: The aim of this study was to determine which features of PSR’s are most valued by Slovenian family physicians (FPs). Methods: We performed a cross-sectional observational postal survey in FPs. We sent the invitation for cooperation in the study to all Slovenian FPs working in family practices at the primary level of care (N = 895). Data was collected using a validated PSRs’ assessment scale. It consists of 12 questions on PSRs’ assessment that could be answered on a seven-point Likert scale. Results: The response rate was 27.6%. There were 174 (70.4%) of female physicians among the respondents. Average age of the respondents was 48.3 ± 9.0 years. Highly assessed PSRs’ characteristics were “Provides objective product information”, “Does not mislead”, and “Shows good knowledge on the subject promoted”. Worst rated PSRs’ characteristics were “Possesses knowledge on health care system”, “Same person for the product of company for a longer period of time”, and “Acts friendly”. Conclusions: Slovenian FPs value PSRs’ selling and communication skills and trustworthiness highly. FPs and PSRs develop a personal relationship which reflects in different perceptions of various PSRs’ characteristics by FPs. PMID:24554801

Klemenc-Ketis, Zalika; Kersnik, Janko

2013-01-01

338

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

PubMed

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

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

2014-02-01

339

General public knowledge, perceptions and practice towards pharmaceutical drug advertisements in the Western region of KSA.  

PubMed

This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor-patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceutical companies and drug suppliers. PMID:24648823

Al-Haddad, Mahmoud S; Hamam, Fayez; Al-Shakhshir, Sami M

2014-04-01

340

Health technology assessment. The pharmaceutical industry perspective.  

PubMed

Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations. PMID:12053418

Schubert, Francois

2002-01-01

341

Chitosan Modification and Pharmaceutical/Biomedical Applications  

PubMed Central

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

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

2010-01-01

342

Bioceramics and pharmaceuticals: A remarkable synergy  

NASA Astrophysics Data System (ADS)

The research on controlled drug delivery systems using bioceramics as host matrices presents two distinct sides; one route aims at embedding pharmaceuticals in biomaterials designed for the reconstruction or regeneration of living tissues, in order to counteract inflammatory responses, infections, bone carcinomas and so forth, while the other route deals with the more traditional drug introduction systems, i.e. oral administration. The incorporation of pharmaceuticals to bioceramic matrices could be very interesting in clinical practice. It is rather common in these days for an orthopedic surgeon working in bone reconstruction to use bioceramics. An added value to the production of these ceramics would be the optional addition of pharmaceuticals such as antibiotics, anti-inflammatories, anti-carcinogens, etc. In this sense, if we take into account the infections statistics at hip joint prostheses, the incidence varies between 2 and 4%, reaching up to a 45% in bolts used as external fixation. One of the main problems in these situations is the access to the infected area of the bone, in order to deliver the adequate antibiotic. If the pharmaceutical could be included within the implant itself, the added value would be straightforward. And if the bioceramic is bioactive, and therefore precursor of new bone tissue, the capability to introduce peptides, proteins or growth factors at its pores could accelerate the bone regeneration processes. We are facing a fine example of multidisciplinary research, where the so-called transversal supply of knowledge from and between the domains of materials science, biology and medicine will empower the know-how and applications that shall, undoubtedly, give rise to new advances in science and technology.

Vallet-Regí, María; Balas, Francisco; Colilla, Montserrat; Manzano, Miguel

2007-09-01

343

In silico toxicology for the pharmaceutical sciences  

Microsoft Academic Search

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

Luis G. Valerio Jr.; Luis G

2009-01-01

344

Cubanes: Super explosives and potential pharmaceutical intermediates  

NASA Technical Reports Server (NTRS)

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.

Bashir-Hashemi, A.

1994-01-01

345

March 9-10, 2006: Community Clinical Oncology Program CCOP/MBCCOP & Research Base Meeting  

Cancer.gov

Principal Investigators, Administrators, and other key individuals that are involved in the research program(s) supported through the CCOP, Minority-Based CCOP and Research Base cooperative agreements.

346

Pharmaceutical policy reform in the Russian Federation.  

PubMed

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

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

2014-06-01

347

Astronomy Research Based Science Education at the National Optical Astronomy Observatory  

NSDL National Science Digital Library

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

2010-05-18

348

Comparisons between in vitro whole cell imaging and in vivo zebrafish-based approaches for identifying potential human hepatotoxicants earlier in pharmaceutical development.  

PubMed

Drug-induced liver injury (DILI) is a major cause of attrition during both the early and later stages of the drug development and marketing process. Reducing or eliminating drug-induced severe liver injury, especially those that lead to liver transplants or death, would be tremendously beneficial for patients. Therefore, developing new pharmaceuticals that have the highest margins and attributes of hepatic safety would be a great accomplishment. Given the current low productivity of pharmaceutical companies and the high costs of bringing new medicines to market, any early screening assay(s) to identify and eliminate pharmaceuticals with the potential to cause severe liver injury in humans would be of economic value as well. The present review discusses the background, proof-of-concept, and validation studies associated with high-content screening (HCS) by two major pharmaceutical companies (Pfizer Inc and Jansen Pharmaceutical Companies of Johnson & Johnson) for detecting compounds with the potential to cause human DILI. These HCS assays use fluorescent-based markers of cell injury in either human hepatocytes or HepG2 cells. In collaboration with Evotec, an independent contract lab, these two companies also independently evaluated larval zebrafish as an early-stage in vivo screen for hepatotoxicity in independently conducted, blinded assessments. Details about this model species, the need for bioanalysis, and, specifically, the outcome of the phenotypic-based zebrafish screens are presented. Comparing outcomes in zebrafish against both HCS assays suggests an enhanced detection for hepatotoxicants of most DILI concern when used in combination with each other, based on the U.S. Food and Drug Administration DILI classification list. PMID:22242931

Hill, Adrian; Mesens, Natalie; Steemans, Margino; Xu, Jinghai James; Aleo, Michael D

2012-02-01

349

Company Town Shutdown.  

ERIC Educational Resources Information Center

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…

Turnage, Martha A.

350

Accounting Projects Company Description  

E-print Network

Accounting Projects Company Description: CPA firm performing accounting services, bookkeeping for multiple years, starting with the 2008 calendar year, using QuickBooks accounting software. Bank and credit card statements will be used for multiple checking, savings, and credit card accounts to capture data

Dahl, David B.

351

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

PubMed

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

Morgan, Steven; Daw, Jamie; Thomson, Paige

2013-04-01

352

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

PubMed

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

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

2002-01-01

353

Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: A pharmaceutical company commitment  

Microsoft Academic Search

Objective: Glaxo Wellcome becomes aware of prenatal exposures to its medications as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all Glaxo Wellcome medicines has been developed. For specific products there are prospective pregnancy registries. Study Design: The registries are observational, case-registration, and follow-up studies designed to detect evidence of teratogenicity associated

Robbin Reiff-Eldridge; Cindy R. Heffner; Sara A. Ephross; Patricia S. Tennis; Alice D. White; Elizabeth B. Andrews

2000-01-01

354

Partnerships between the Pharmaceutical Industry and Patient Groups: A Company Example  

Microsoft Academic Search

This paper discusses the development of the partnership between Rhône-Poulenc Rorer (RPR) and two patient groups that are dedicated to the care of patients with amyotrophic lateral sclerosis (ALS) or (Lou Gehrig disease): the ALS Association (ALSA) and the Muscular Dystrophy Association (MDA). This partnership covered the preapproval, approval, and postapproval periods in the drug development of Rilutek® (riluzole), which

Larry K. Powe

2000-01-01

355

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

PubMed Central

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

2011-01-01

356

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

PubMed

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

Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

2013-01-01

357

Silo Effect a Prominence Factor to Decrease Efficiency of Pharmaceutical Industry  

PubMed Central

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

Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

2013-01-01

358

"Dualities of interest": the inter-organizational relationships between disease-specific nonprofits and the pharmaceutical industry.  

PubMed

Health care and biomedical research environments in the United States are largely characterized by strategic relational practices conducted beyond the public gaze. The very nature of health care has been widely reconceptualized from a response to physical/biological imperatives regulated by health promotion and the epidemiological distribution of diseases to profit/market imperatives regulated by "product/brand" promotion and market dynamics. At critical decision points throughout the system, we find the multinational pharmaceutical industry wielding the influence that its wealth and power have bought. This study contributes to the growing body of work that seeks to illuminate the relationships between the pharmaceutical industry and the various entities that constitute the U.S. health and research systems. Through the use of case studies, it examines the relationships between the multinational pharmaceutical industry and the large disease-specific public and professional nonprofit organizations. It explores several questions, including: Is the concept of what constitutes a conflict of interest being purposefully manipulated? Is the public benevolence afforded to nonprofits extended to their corporate partners in ways that preclude critical oversight of relational dynamics? And are public donations, solicited by and given in good faith to these organizations, inevitably serving the economic interests and profits of donor pharmaceutical companies? PMID:22611657

Paluzzi, Joan E

2012-01-01

359

[Mechanism and implication of regulation of the pricing of essential medicines in the private pharmaceutical sector in Mali].  

PubMed

The healthcare and pharmaceutical professions in Mali were privatized in 1985. Privatization led to swift expansion of the private sector and upset the balance that had existed between the public and private sectors. A national pharmaceutical policy did not emerge until a decade later. Its purpose was to promote a system ensuring fair access to essential generic medicines for all. It was hoped that synergy between the two sectors would promote that objective. However, the policy calling for distribution of essential generic medicine through the private sector was not accompanied by an adequate system for pricing. This problem led the government to adopt a price regulation policy to realign market dynamics with public health goals. This experience shows that a sustained effort from public policy makers is necessary to prevail against the professional and business interests that can conflict with the public interest. Analysis of this experience also demonstrates the need to improve, restructure, and control the pharmaceutical industry. The government must continue to play its crucial role in the context of limited resources and inequality between consumers and pharmaceutical companies. PMID:20486360

Maïga, D; Maïga, S; Maïga, M D

2010-04-01

360

Rapid methods for the microbiological surveillance of pharmaceuticals.  

PubMed

The use of rapid microbiological methods in pharmaceutical laboratories has improved the quality control analysis of water, products, raw materials, and enhanced the antimicrobial effectiveness testing of pharmaceutical finished products. Rapid release of samples has resulted in the optimization of manufacturing, product testing, and release allowing high throughput and simultaneous analysis of pharmaceutical formulations. ATP Bioluminescence, Impedance, Direct Viable Counts, and Flow Cytometry determine the total microbial content in a given pharmaceutical sample while PCR and Immunoassays detect the presence or absence of specific microbial species. Rapid methods provide reliable and cost effective analysis for the microbiological evaluation of pharmaceutical environments. The dramatic reduction in detection times and analysis, e.g., from 30 hours to 90 minutes, by using rapid methods will ultimately lead the pharmaceutical industry closer to real time monitoring of processes and samples. PMID:11605251

Jimenez, L

2001-01-01

361

Company profile: tengion.  

PubMed

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

Bertram, Timothy

2009-05-01

362

Crabtree and Company  

NSF Publications Database

2 McBride, Lock & Associates February 16, 2001 REPORT SUMMARY AND HIGHLIGHTS National Science Foundation Office of Inspector General 4201 Wilson Boulevard Arlington, Virginia 22230 PURPOSE AND SCOPE OF AUDIT We have performed an audit of the costs claimed by Crabtree + Company to the National Science Foundation on the following NSF award: Award Number Award Period Audit Period LPA 97-14153. Those standards and the National Science Foundation Audit Guide require that we plan and perform the ...

363

FACULTY OF ARTS & SCIENCE 2012/13 PHARMACEUTICAL CHEMISTRY  

E-print Network

Forensic chemist Fundraiser Hazardous materials manager Laboratory technician Medical librarian & SCIENCE 2012/13 Pharmacology/Toxicology/Pharmaceutical Chemistry (PTP) Internship The Pharmacology/Toxicology

Toronto, University of

364

Bioremediation companies engineer new consortia  

SciTech Connect

Bioremediation companies face technical and legal hurdles, which may result in the amalgamation of smaller remedial action companies. New breakthroughs in genetic engineering promise to counteract the specificity problems of microbial consortia.

Johnson, E.

1996-07-01

365

No Company Is An Island  

E-print Network

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...

Maddox, A.

366

Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations.  

PubMed

Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL(-1) for ciprofloxacin, 28.5-700 ng mL(-1) for enoxacin, 29.5-800 ng mL(-1) for norfloxacin and 33.5-1000 ng mL(-1) for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL(-1) for ciprofloxacin, 8.5 ng mL(-1) for enoxacin, 9.2 ng mL(-1) for norfloxacin and 9.98 ng mL(-1) for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method. PMID:18977686

Ulu, Sevgi Tatar

2009-02-01

367

Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations  

NASA Astrophysics Data System (ADS)

Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL -1 for ciprofloxacin, 28.5-700 ng mL -1 for enoxacin, 29.5-800 ng mL -1 for norfloxacin and 33.5-1000 ng mL -1 for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL -1 for ciprofloxacin, 8.5 ng mL -1 for enoxacin, 9.2 ng mL -1 for norfloxacin and 9.98 ng mL -1 for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method.

Ulu, Sevgi Tatar

2009-02-01

368

Production of pharmaceutical proteins by transgenic animals.  

PubMed

Proteins started being used as pharmaceuticals in the 1920s with insulin extracted from pig pancreas. In the early 1980s, human insulin was prepared in recombinant bacteria and it is now used by all patients suffering from diabetes. Several other proteins and particularly human growth hormone are also prepared from bacteria. This success was limited by the fact that bacteria cannot synthesize complex proteins such as monoclonal antibodies or coagulation blood factors which must be matured by post-translational modifications to be active or stable in vivo. These modifications include mainly folding, cleavage, subunit association, gamma-carboxylation and glycosylation. They can be fully achieved only in mammalian cells which can be cultured in fermentors at an industrial scale or used in living animals. Several transgenic animal species can produce recombinant proteins but presently two systems started being implemented. The first is milk from farm transgenic mammals which has been studied for 20 years and which allowed a protein, human antithrombin III, to receive the agreement from EMEA (European Agency for the Evaluation of Medicinal Products) to be put on the market in 2006. The second system is chicken egg white which recently became more attractive after essential improvement of the methods used to generate transgenic birds. Two monoclonal antibodies and human interferon-beta 1a could be recovered from chicken egg white. A broad variety of recombinant proteins were produced experimentally by these systems and a few others. This includes monoclonal antibodies, vaccines, blood factors, hormones, growth factors, cytokines, enzymes, milk proteins, collagen, fibrinogen and others. Although these tools have not yet been optimized and are still being improved, a new era in the production of recombinant pharmaceutical proteins was initiated in 1987 and became a reality in 2006. In the present review, the efficiency of the different animal systems to produce pharmaceutical proteins are described and compared to others including plants and micro-organisms. PMID:18243312

Houdebine, Louis-Marie

2009-03-01

369

Parameterization of annealing kinetics in pharmaceutical glasses.  

PubMed

Numerical simulations indicate that neglecting the canonical nonlinearity of glassy-state annealing kinetics in pharmaceutical (and other) glasses leads to good KWW fits to the dependence of enthalpy on annealing time, but with spurious KWW parameters that are affected by nonlinearity. A simplified treatment of nonlinearity that uses the Struik shift factor is found to be a useful approximation for these analyses, and can account for previously reported differences between linear and nonlinear KWW parameters (Kawakami K, Pikal MJ. 2005. J Pharm Sci 94:948-965). PMID:23661359

Hodge, Ian M

2013-07-01

370

Globalization in the pharmaceutical industry, Part I.  

PubMed

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

Casadio Tarabusi, C; Vickery, G

1998-01-01

371

Globalization in the pharmaceutical industry, Part II.  

PubMed

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

Casadio Tarabusi, C; Vickery, G

1998-01-01

372

In silico toxicology for the pharmaceutical sciences  

SciTech Connect

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.

Valerio, Luis G., E-mail: Luis.Valerio@fda.hhs.go [Science and Research Staff, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak 51 Room 4128, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002 (United States)

2009-12-15

373

But it's doctor recommended and I read the fine print: antecedents to drug companies' perceived credibility.  

PubMed

Using 2009 National Consumer Survey data from Experian Simmons, the authors found that dependence on doctor recommendations to assess the integrity of advertised drugs and the extent of reading small print in direct-to-consumer prescription drug advertising positively related to consumers' perceived credibility of health information from pharmaceutical companies, which in turn positively influenced willingness to ask their doctor for a specific medicine they saw or heard advertised. The potential effect of small print reading on willingness to request prescription was partially mediated by perceived credibility of information from drug companies. The findings are discussed in light of their practical implications. PMID:23458482

Park, Jin Seong; Hoy, Mariea Grubbs

2013-01-01

374

Competitive intelligence in Tunisian companies  

Microsoft Academic Search

Purpose – The purpose of this study is to investigate the degree of knowledge of competitive intelligence in Tunisian companies. Design\\/methodology\\/approach – This exploratory study was conducted using semi-in-depth interviews and focus group with six executives in six companies in Tunisia. Three sectors were chosen for this study: communication technologies, manufacturing and commercial retailing. These companies are prevalent in Tunisia

Wadie Nasri

2011-01-01

375

Pharmaceutical Applications of Ion-Exchange Resins  

NASA Astrophysics Data System (ADS)

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

Elder, David P.

2005-04-01

376

Metaphors and myths in pharmaceutical advertising.  

PubMed

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

Delbaere, Marjorie

2013-04-01

377

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

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; Apertus Pharmaceuticals By Notice dated July 23, 2013, and...31, 2013, 78 FR 46372, Apertus Pharmaceuticals, 331 Consort Drive, St Louis, Missouri...determined that the registration of Apertus Pharmaceuticals to manufacture the listed basic...

2013-11-18

378

78 FR 52802 - Manufacturer of Controlled Substances; Notice of Registration; Morton Grove Pharmaceuticals  

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; Morton Grove Pharmaceuticals By Notice dated March 12, 2013...2013, 78 FR 17231, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove...that the registration of Morton Grove Pharmaceuticals to manufacture the listed basic...

2013-08-26

379

78 FR 12104 - Manufacturer of Controlled Substances; Notice of Registration; Cedarburg Pharmaceuticals, Inc.  

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; Cedarburg Pharmaceuticals, Inc. By Notice dated November 5...13, 2012, 77 FR 67676, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton...that the registration of Cedarburg Pharmaceuticals, Inc., to manufacture the...

2013-02-21

380

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

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; Cedarburg Pharmaceuticals, Inc. By Notice dated January 6...17, 2012, 77 FR 2324, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton...that the registration of Cedarburg Pharmaceuticals, Inc. to manufacture the...

2012-05-21

381

78 FR 5503 - Manufacturer of Controlled Substances, Notice of Registration; Morton Grove Pharmaceuticals  

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; Morton Grove Pharmaceuticals By Notice dated September 25, 2012...2012, 77 FR 60144, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove...that the registration of Morton Grove Pharmaceuticals to manufacture the listed basic...

2013-01-25

382

77 FR 75672 - Manufacturer of Controlled Substances, Notice of Registration, Halo Pharmaceutical, Inc.  

Federal Register 2010, 2011, 2012, 2013

...Substances, Notice of Registration, Halo Pharmaceutical, Inc. By Notice dated July 30...August 7, 2012, 77 FR 47114, Halo Pharmaceutical, Inc., 30 North Jefferson Road...determined that the registration of Halo Pharmaceutical, Inc., to manufacture the...

2012-12-21

383

78 FR 12104 - Manufacturer of Controlled Substances; Notice of Registration; INB Hauser Pharmaceutical Services...  

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; INB Hauser Pharmaceutical Services, Inc. By Notice dated November...2012, 77 FR 67398, InB Hauser Pharmaceutical Services, Inc., 6880 N. Broadway...that the registration of InB Hauser Pharmaceutical Services, Inc., to...

2013-02-21

384

77 FR 60145 - Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals, LLC  

Federal Register 2010, 2011, 2012, 2013

...Notice of Registration; Apertus Pharmaceuticals, LLC By Notice dated June 4, 2012...12, 2012, 77 FR 35058, Apertus Pharmaceuticals, LLC., 331 Consort Drive, St Louis...determined that the registration of Apertus Pharmaceuticals, LLC., to manufacture the...

2012-10-02

385

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

Federal Register 2010, 2011, 2012, 2013

...Substances, Notice of Registration; Halo Pharmaceutical Inc. By Notice dated December 2...December 14, 2011, 76 FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road...determined that the registration of Halo Pharmaceutical Inc. to manufacture the listed...

2012-03-20

386

77 FR 34072 - Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc.  

Federal Register 2010, 2011, 2012, 2013

...Substances; Notice of Registration; Meda Pharmaceuticals, Inc. By Notice dated April 2...April 12, 2012, 77 FR 21998, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur...determined that the registration of Meda Pharmaceuticals Inc. to import the basic class...

2012-06-08

387

Journal of Pharmaceutical and Biomedical Analysis 56 (2011) 944949 Contents lists available at ScienceDirect  

E-print Network

Journal of Pharmaceutical and Biomedical Analysis 56 (2011) 944­949 Contents lists available at ScienceDirect Journal of Pharmaceutical and Biomedical Analysis journal homepage: www online 17 August 2011 Keywords: Data fusion Multivariate analysis Pharmaceutical powder mixtures Fourier

Will, Sebastian

388

75 FR 63508 - Warner Chilcott Pharmaceuticals, Inc. Including On-Site Leased Workers From Adecco Engineering...  

Federal Register 2010, 2011, 2012, 2013

...Warner Chilcott Pharmaceuticals, Inc. Including...Workers From Adecco Engineering and Technical...the supply of pharmaceutical research and...leased from Adecco Engineering and Technical...Warner Chilcott Pharmaceuticals, Inc., including...workers from Adecco Engineering and...

2010-10-15

389

Numerical and experimental investigation of capping mechanisms during pharmaceutical tablet compaction  

E-print Network

Institute for Pharmaceutical Materials Science, Department of Materials Science and Metallurgy, UniversityNumerical and experimental investigation of capping mechanisms during pharmaceutical tablet December 2006 Abstract Capping is a common problem in the pharmaceutical tabletting process in which

Elliott, James

390

University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences  

E-print Network

University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences School of Pharmacy and Pharmaceutical Sciences Needs Improvement Satisfactory Exceeded Expectations;University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Guidelines

Gleeson, Joseph G.

391

SSPPS STRATEGIC PLAN Pharmacy Education, Pharmaceutical Sciences Research, Clinical Pharmacy Practice  

E-print Network

SSPPS STRATEGIC PLAN Pharmacy Education, Pharmaceutical Sciences Research, Clinical Pharmacy of Pharmacy and Pharmaceutical Sciences (SSPPS). The plan emanates from the work of three committees and has. Educational Excellence in Pharmacy and Pharmaceutical Sciences 1. Provide a premier professional education

Gleeson, Joseph G.

392

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

PubMed Central

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

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

2008-01-01

393

Occurrence of veterinary pharmaceuticals in the aquatic environment in Flanders  

Microsoft Academic Search

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

K. Servaes; G. Vanermen; P. Seuntjens

2009-01-01

394

Application of Fourier Transform Infrared Spectrophotometry in Pharmaceutical Drugs Analysis  

Microsoft Academic Search

This review provides some background to infrared spectroscopy including Fourier transform infrared spectroscopy. It is not meant to be complete or exhaustive but to provide the reader with sufficient background for selected applications in pharmaceutical analysis. Fourier transform infrared spectroscopy (FTIR) is a fast and nondestructive analytical method. Associated with chemometrics, it can become a powerful tool for the pharmaceutical

Andrei A. Bunaciu; Hassan Y. Aboul-Enein; Serban Fleschin

2010-01-01

395

Does pharmaceutical advertising affect journal publication about dietary supplements?  

Microsoft Academic Search

BACKGROUND: Advertising affects consumer and prescriber behaviors. The relationship between pharmaceutical advertising and journals' publication of articles regarding dietary supplements (DS) is unknown. METHODS: We reviewed one year of the issues of 11 major medical journals for advertising and content about DS. Advertising was categorized as pharmaceutical versus other. Articles about DS were included if they discussed vitamins, minerals, herbs

Kathi J Kemper; Kaylene L Hood

2008-01-01

396

Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less  

E-print Network

37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 Pharmaceutical: pharmaceuticals, generic entry, patent policy. This paper has benefited substantially from conversations

Rothman, Daniel

397

Ways of Learning in the Pharmaceutical Sales Industry  

ERIC Educational Resources Information Center

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…

Hunter, Carrie Patricia

2010-01-01

398

DEVELOPMENTS IN FAST LIQUID CHROMATOGRAPHIC ANALYSIS OF PHARMACEUTICALS  

Microsoft Academic Search

The need for pharmaceutical analytical laboratories to increase sample throughput and speed of analysis to meet accelerated drug development timelines has led to considerable interest in the development of fast liquid chromatographic technology. Fast liquid chromatographic pharmaceutical analysis is accomplished by developments in ultra-fast high performance liquid chromatographic instrumentation, emerging technologies in column stationary phases and high temperature liquid chromatographic

Theresa K. Natishan

2011-01-01

399

A Supply Chain Generalized Network Oligopoly Model for Pharmaceuticals  

E-print Network

A Supply Chain Generalized Network Oligopoly Model for Pharmaceuticals Under Brand Differentiation, Chicago, IL April 20-23, 2012 University of Massachusetts Amherst Pharmaceutical Product Supply Chains #12 Product Supply Chains #12;This talk is based on the paper: Masoumi, A. H., Yu, M., Nagurney, A., 2012

Nagurney, Anna

400

Global risk of pharmaceutical contamination from highly populated developing countries.  

PubMed

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

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

2013-03-24

401

Astronaut William Gregory works with pharmaceutical experiments on middeck  

NASA Technical Reports Server (NTRS)

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.

1995-01-01

402

A Cure for Crime? Psycho-Pharmaceuticals and Crime Trends  

Microsoft Academic Search

In this paper we consider possible links between the advent and diffusion of a number of new psychiatric pharmaceutical therapies and crime rates. We describe recent trends in crime and review the evidence showing mental illness as a clear risk factor both for criminal behavior and victimization. We then briefly summarize the development of a number of new pharmaceutical therapies

Dave E. Marcotte; Sara Markowitz

2009-01-01

403

Managing pharmaceutical regulation in Germany: Overview and economic assessment  

Microsoft Academic Search

Rising costs in pharmaceutical expenditure have become a major concern for policy makers in Germany over the last years. Therefore the pharmaceutical market in Germany has been increasingly targeted by different kinds of regulations, focussing both on the supply and the demand side, using price, volume and spending controls. Specific regulations include price reductions, reference pricing, pharmacy rebate for sickness

Jonas Schreyögg; Klaus-Dirk Henke; Reinhard Busse

2004-01-01

404

Sex, gender, and pharmaceutical politics: From drug development to marketing  

Microsoft Academic Search

Background: Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing.Objectives: This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for

Jill A. Fisher; Lorna M. Ronald

2010-01-01

405

Improving through inspecting: pharmaceutical inspectors in nursing homes  

Microsoft Academic Search

English health authorities are required to inspect pharmaceutical practice in registered nursing homes within their area. The inspection process provides opportunities to improve as well as monitor practice. An exploratory study is reported in which the verbal and non-verbal behaviour of pharmaceutical inspectors was recorded. Brief questionnaires explored the views of the staff inspected on the inspection process. Marked differences

Roger Paxton; M. N. Asghar

2002-01-01

406

GENERAL RESEARCH Real Options Based Analysis of Optimal Pharmaceutical Research  

E-print Network

GENERAL RESEARCH Real Options Based Analysis of Optimal Pharmaceutical Research and Development Portfolios Michael J. Rogers, Anshuman Gupta, and Costas D. Maranas* Department of Chemical Engineering optimization model (OptFolio) of pharmaceutical research and development (R&D) portfolio management using

Maranas, Costas

407

RISK MANAGEMENT IN REAL OPTIONS BASED PHARMACEUTICAL PORTFOLIO PLANNING  

E-print Network

RISK MANAGEMENT IN REAL OPTIONS BASED PHARMACEUTICAL PORTFOLIO PLANNING Michael J. Rogers, Anshuman Gupta, and Costas D. Maranas* Department of Chemical Engineering, The Pennsylvania State University incorporate a Monte Carlo simulation procedure to a stochastic optimization model (OptFolio) of pharmaceutical

Maranas, Costas

408

Pharmaceutical Drugs Chatter on Online Social Networks Matthew T. Wileya  

E-print Network

Pharmaceutical Drugs Chatter on Online Social Networks Matthew T. Wileya , Canghong Jinb* , Vagelis Science and Engineering, University of California, Riverside, CA, USA bCollege of Computer Science and the context of pharmaceutical drugs. We aimed to examine the impact of a given OSN's characteristics onthe

Hristidis, Vagelis

409

Future training needs in the pharmaceutical sciences: Academia – Industry  

Microsoft Academic Search

The markets for the traditional output of schools of pharmacy, namely education, research and graduates, are changing. The main private client in these markets, the pharmaceutical industry, is moving fast to become more efficient, under pressure from overly costly drug development. The challenges to the industry that emanate from the fantastic rate of advances in the biomedical sciences and pharmaceutical

Douwe D. Breimer

2001-01-01

410

Modelling the mechanical behaviour of pharmaceutical powders during compaction  

E-print Network

Modelling the mechanical behaviour of pharmaceutical powders during compaction C.-Y. Wua,T, O.M. Ruddyb , A.C. Benthamb , B.C. Hancockc , S.M. Besta , J.A. Elliotta a Pfizer Institute for Pharmaceutical Materials Science, Department of Materials Science and Metallurgy, University of Cambridge, Pembroke Street

Elliott, James

411

Numerical Simulation on Pharmaceutical Powder Compaction Lianghao Han1,a  

E-print Network

Numerical Simulation on Pharmaceutical Powder Compaction Lianghao Han1,a , James Elliott1,b Department of Materials Science and Metallurgy, University of Cambridge, CB2 3QZ,UK 2 Pfizer Global R elasticity law developed to describe the compaction behavior of pharmaceutical powders. The model

Elliott, James

412

Pharmaceutical Sociology: Issues in Research, Education and Service.  

ERIC Educational Resources Information Center

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…

Svarstad, Bonnie L.

1979-01-01

413

Membrane bioprocesses for pharmaceutical micropollutant removal from waters.  

PubMed

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

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

2014-01-01

414

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

ERIC Educational Resources Information Center

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…

Rosenshine, Barak

2012-01-01

415

Research-based Instructional Software in Modern Physics RICHARD N. STEINBERG  

E-print Network

modern physics is important include photonics, mesoscopic engineering, and medical diagnostics basedResearch-based Instructional Software in Modern Physics RICHARD N. STEINBERG Department of Physics, City College of New York, New York, NY, 10031 rstein@physics.umd.edu GRAHAM E. OBEREM Physics

Steinberg, Richard N.

416

Getting Research-based Information on Water and Pollutants to Those Who Need It  

E-print Network

Getting Research-based Information on Water and Pollutants to Those Who Need It By Steve Ress Becoming a one-stop shop for information on watershed management and agricultural nonpoint source pollution is a goal of the Heartland Regional Water Quality Coordination Initiative. The new initiative, developed

Nebraska-Lincoln, University of

417

Research-Based Educational Practices for Students with Autism Spectrum Disorders  

ERIC Educational Resources Information Center

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…

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

2011-01-01

418

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

ERIC Educational Resources Information Center

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'…

Zhu, Guangtian; Singh, Chandralekha

2012-01-01

419

What's in a leaflet? Identifying research-based persuasive messages in European alcohol-education leaflets  

Microsoft Academic Search

Cognitive antecedents of alcohol consumption have been identified and psychologists have provided research-based recommendations regarding the content of persuasive communication designed to reduce health-endangering drinking. Yet, there has been little research into the correspondence between such recommendations and the content of publicly available health education leaflets. This study assessed the extent to which messages in leaflets designed to reduce alcohol

Charles Abraham; Lorraine Southby; Sabine Quandte; Barbara Krahé; Winfried van der Sluijs

2007-01-01

420

PRISM--Pittsburgh's Research Based Instructional Supervisory Model for Staff Development.  

ERIC Educational Resources Information Center

PRISM, the Pittsburgh Research-Based Instructional Supervisory Model, was initiated when the superintendent convened an Instructional Leadership Committee (ILC) to develop a plan for improving instruction and instructional leadership within the district. The Pittsburgh Public Schools' Learning Research Development Center then conducted a…

Marshall, Ann

421

Perceptions of Alabama School Personnel of Research-based Instructional Strategies to Improve Student Achievement  

Microsoft Academic Search

This study was designed to explore the perceptions of school personnel concerning the use of research-based instructional strategies as outlined in School Improvement Plans of selected Alabama school districts to improve student achievement. The principal and School Improvement Chairperson at 281 Alabama public secondary schools, identified for School Improvement as mandated by NCLB, composed the population. All subjects received a

Christopher Glenn Pritchett

2007-01-01

422

PRISM: Pittsburgh Research-Based Instructional Supervisory Model. A Staff Development Program.  

ERIC Educational Resources Information Center

Addressing the Pittsburgh public school system's need for staff evaluation, Pittsburgh's Research-Based Instructional Supervisory Model (PRISM) is an adaptation of Madeline Hunter's materials on effective teaching and Theodore Forte's synthesis of Hunter's materials in his "Workshop on Instructional Skills." While total PRISM implementation…

Wallace, Richard C., Jr.

423

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

ERIC Educational Resources Information Center

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…

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

2009-01-01

424

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

ERIC Educational Resources Information Center

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

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

2012-01-01

425

Community Psychology's Search for a Viable Paradigm: Establishing an Ecologically Valid Intervention Research Base.  

ERIC Educational Resources Information Center

This paper suggests that community psychology may be going through an identity crisis because of its lack of empirical demonstrations of community intervention effectiveness, and an ecologically valid intervention research base. Although the majority of research in community psychology has used an individualistic paradigm that conceptualizes…

Fiene, Richard

426

Multiple Perspectives, Loyalties and Identities: Exploring Intrapersonal Spaces through Research-Based Theatre  

ERIC Educational Resources Information Center

This paper recounts the investigative journey of a small group of faculty and graduate students at the University of British Columbia who extensively employed research-based theatre methods to collaboratively and performatively explore three distinct but related contexts that represent critical "moments" in the professional lives of educators and…

White, Vince; Belliveau, George

2011-01-01

427

Using Research Based Assessment Tools in Professional Development in Current Electricity  

ERIC Educational Resources Information Center

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…

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

2007-01-01

428

Research-Based Reading Interventions: The Impact of Indiana's Early Literacy Grant Program. Policy Research Report.  

ERIC Educational Resources Information Center

With the passage of the Reading Excellence Act, states and their schools have increasingly emphasized the implementation of research-based literacy interventions, and both parties are eager to know the effectiveness of their efforts. However, the evaluation of the impact of any reform is complicated by the presence of other types of interventions…

St. John, Edward P.; Manset, Genevieve; Chung, Choong-Geun; Simmons, Ada B.; Musoba, Glenda Droogsma

429

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

ERIC Educational Resources Information Center

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…

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

430

Regulatory Oversight of Foreign Clinical Trials: An Examination of the Industry's Influence on FDA Pharmaceutical Regulation and the Implications for Enforcement Activity Both Domestic and Abroad  

E-print Network

This vaccine was developed to prevent both pneumococcal diseases, which includes meningitis, sepsis, pneumonia, and otitis media, as well as bacterial respiratory infections. 2 8 Most of the parents of trial subjects were under-age, illiterate, or did... In the 1990s, French company Aventis Pharmaceuticals (later Sanofi- Aventis) began conducting clinical trials of a new antibiotic, Ketek (telithromycin), developed to treat bacterial respiratory infections such as sinusitis, bronchitis, and pneumonia. 3 2...

Kashani, Beeta

2012-04-01

431

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

E-print Network

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 ...

Hou, Billy

2011-01-01

432

University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences  

E-print Network

University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Updated between UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) faculty, administration

Gleeson, Joseph G.

433

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

PubMed

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

Taylor, David; Senac, Thomas

2014-11-01

434

Conducting pharmaceutical R&D in India - Critical components of entry strategies.  

PubMed

In the face of challenges associated with expiring patents, the rising cost of R&D and pressure on pricing, most major pharmaceutical companies are seeking ways to enhance productivity, reduce costs and augment the late-stage new-product pipeline. Exploiting the R&D capabilities in India is one option that can be helpful in achieving these goals. However, considering the challenges involved, important considerations must be incorporated to ensure that an appropriate R&D strategy is meticulously implemented. In creating suitable strategies, it is important to understand the historical perspective that provides insight into the relative strengths of companies in India across the R&D value chain. In addition, the ability of a company to take risks and commit to a long-term investment will largely determine the model that is selected. To implement a given model, an understanding of cultural differences and infrastructural challenges that must be overcome is extremely important. The ultimate factor that determines success or failure, however, lies within the organization. Preparing an organization by establishing appropriate structures and processes is imperative. PMID:18988126

Gulati, Rajiv

2008-11-01

435

Pharmaceutical Particle Engineering via Spray Drying  

PubMed Central

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

2007-01-01

436

[Pharmaceutical botanical studies on some Glycyrrhiza species].  

PubMed

Some Glycyrrhiza species grown in several domestic research gardens of medicinal plants were collected by the Osaka University of Pharmaceutical Sciences and were cultivated to compare their morphological properties. HPLC profile analysis was performed and index compounds of MeOH extracts of aerial parts and EtOAc extracts of subterranean parts were determined. Glycyrrhizin contents and growth rates of the underground parts of some types of Glycyrrhiza uralensis and Glycyrrhiza glabra were compared and four excellent types were selected as candidates for cultivation. One of them was due to Kanzo-Yashiki (Enzan, Yamanashi prefecture), where G. uralensis was cultivated in the Edo period. Alkaloidal constituents of G. uralensis and G. glabra were also investigated and anabasine (an insecticide) and a new tricyclic alkaloid were obtained. PMID:12931658

Kusano, Genjiro; Shibano, Makio; Watanabe, Hitoshi; Ozaki, Kazuo

2003-08-01

437

The menopause and the pharmaceutical industry.  

PubMed

Since 1975, pharmaceutical firms specializing in the endocrine field have made a vigorous attempt to develop a large market in estrogens for the long-term treatment of postmenopausal women. The success of the contraceptive 'pill' had demonstrated the commercial attractiveness of developing products for an essentially healthy population. The scientific challenge was to demonstrate the value of such treatment, e.g. in countering osteoporosis; another problem was the generally poor compliance observed when patients receive drugs other than for the relief of acute conditions. Techniques used included the selective emphasis to physicians of those research findings pointing to the value of hormonal replacement, the development of direct approaches to the public to stimulate interest in a treatment which might prolong life or delay some parts of the ageing process ('feminine forever'), and the creation of intermediary institutes to undertake selective research and influence opinion. PMID:9219115

Dukes, M N

1997-06-01

438

Pharmaceutical intervention of advanced glycation endproducts.  

PubMed

Recent studies have revealed that reducing sugars, such as glucose, react with proteins through non-enzymatic glycosylation to form irreversible, covalently cross-linked proteins known as advanced glycation endproducts (AGEs). Furthermore, it has been demonstrated that this naturally occurring process, accelerated in diabetics due to hyperglycaemia, impairs biological functions leading to cardiovascular disorders, as well as diabetic and age-related complications. Pharmaceutical intervention to prevent or reverse these complications have focused on inhibiting the formation of AGEs by compounds such as dimethyl-3-phenacylthiazolium chloride or breaking the glucose derived cross-links by selective cleavage. Intervention targeted at AGE cross-links in vivo offers a way to interfere with age-related changes of tissues. PMID:11280026

Cerami, A; Ulrich, P

2001-01-01

439

Energy Management at Deere & Company  

E-print Network

's operations. However, such an audit does allow one to prioritize the energy conservation effort to maximize its effectiveness. A full-time energy coordinator on location is essential to obtain maximum success in a conserva tion program. In a company...'s operations. However, such an audit does allow one to prioritize the energy conservation effort to maximize its effectiveness. A full-time energy coordinator on location is essential to obtain maximum success in a conserva tion program. In a company...

Boyd, M. P.

1979-01-01

440

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

Microsoft Academic Search

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

David Gunnell; Julia Saperia; Deborah Ashby

2005-01-01

441

Are Drug Companies Living Up to Their Human Rights Responsibilities? Moving Toward Assessment  

PubMed Central

Background to the debate The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The “Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines” include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines. PMID:20927356

Gruskin, Sofia; Raad, Zyde

2010-01-01

442

Are Drug Companies Living Up to Their Human Rights Responsibilities? The Merck Perspective  

PubMed Central

Background to the debate The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The “Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines” include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines. PMID:20927355

Ritter, Geralyn S.

2010-01-01

443

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

PubMed

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

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

2014-08-01

444

Drug companies cut HIV drug prices in the developing world.  

PubMed

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

Yamey, G

2000-05-20

445

Attention-deficit hyperactivity disorder, drug companies and the internet.  

PubMed

This study investigated the influence of drug-company funding on websites about attention-deficit hyperactivity disorder (ADHD). Websites in the top 60 for either Google or Yahoo!Xtra with information about causation and treatment were analysed. Likert scales, based on those used in previous similar studies, were developed to rate aetiological explanations and recommended treatment approaches, on a dimension from psycho-social to biological. Overall, the quality of information on websites was poor with a strong bias towards bio-genetic aetiological explanations of ADHD. Twenty-one of the 57 websites (37%) were funded by drug companies. The drug-company funded (DCF) websites were significantly more likely than non-DCF websites to recommend medication rather than psycho-social treatments. The selective lack of consideration of psycho-social treatments by DCF websites is discussed in relation to the relevant research literature, including the evidence in favour of a multimodal approach. The findings, which are consistent with previous similar studies in relation to websites about adult mental health problems, confirm that the pharmaceutical industry is seeking to influence public opinion via the internet. PMID:21429977

Mitchell, Jessica; Read, John

2012-01-01

446

Marketed marine natural products in the pharmaceutical and cosmeceutical industries: tips for success.  

PubMed

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

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

2014-02-01

447

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

PubMed

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

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

2008-06-01

448

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

PubMed Central

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

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

2014-01-01

449

Environmental sustainability assessments of pharmaceuticals: an emerging need for simplification in life cycle assessments.  

PubMed

The pharmaceutical and fine chemical industries are eager to strive toward innovative products and technologies. This study first derives hotspots in resource consumption of 2839 Basic Operations in 40 Active Pharmaceutical Ingredient synthesis steps through Exergetic Life Cycle Assessment (ELCA). Second, since companies are increasingly obliged to quantify the environmental sustainability of their products, two alternative ways of simplifying (E)LCA are discussed. The usage of averaged product group values (R(2) = 3.40 × 10(-30)) is compared with multiple linear regression models (R(2) = 8.66 × 10(-01)) in order to estimate resource consumption of synthesis steps. An optimal set of predictor variables is postulated to balance model complexity and embedded information with usability and capability of merging models with existing Enterprise Resource Planning (ERP) data systems. The amount of organic solvents used, molar efficiency, and duration of a synthesis step were shown to be the most significant predictor variables. Including additional predictor variables did not contribute to the predictive power and eventually weakens the model interpretation. Ideally, an organization should be able to derive its environmental impact from readily available ERP data, linking supply chains back to the cradle of resource extraction, excluding the need for an approximation with product group averages. PMID:25244162

De Soete, Wouter; Debaveye, Sam; De Meester, Steven; Van der Vorst, Geert; Aelterman, Wim; Heirman, Bert; Cappuyns, Philippe; Dewulf, Jo

2014-10-21

450

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

PubMed

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

Iñesta, Antonio; Oteo, Luis Angel

2011-06-01

451

Financial success in biotechnology: company age versus company science  

Microsoft Academic Search

The purpose of this research effort is to use the tenets of institutional theory to explore the relative stock market success of biotechnology companies. Previous research (Deng, Z., Lev, B., Narin, F., 1999. Science and technology as predictors of stock performance. Financial Analysts Journal 55(3), 20–32.) has highlighted the relationship between the quality of companies' technology, as measured using quantitative

G. Steven McMillan; Patrick Thomas

2005-01-01

452

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

PubMed

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

Syrycki, Marek

2002-01-01

453

Impurity profiling of pharmaceuticals by thin-layer chromatography.  

PubMed

Although there is a tendency in current pharmacopoeias for favouring HPLC, thin-layer chromatography (TLC) is still a very popular and frequently used analytical method in the pharmaceutical industry. This paper highlights the possibilities of this method in the different areas of pharmaceutical analysis like in-process and intermediate control, illustrated by impurity testing of active ingredients and final products, as well as its application in pharmaceutical research and development, based on some examples reported mainly in the last five years. PMID:21255781

Ferenczi-Fodor, K; Végh, Z; Renger, B

2011-05-13

454

Research-based Innovative Units for Enhancing Student Cognitive Outcomes and Interest in Science  

Microsoft Academic Search

This paper is organised around two issues, firstly locating interests in science within science education research and secondly\\u000a providing examples of four types of research-based approaches to curriculum. The first issue, from the extant literature,\\u000a is concerned with present trends in science enrolments and interest in science, primarily in developed nations. Three questions\\u000a organise this Section: do current science curricula

David F. Treagust

455

Nurture or nature? The growth paradox of research-based spin-offs  

Microsoft Academic Search

This study explores the effect of institutional origin (‘nurture’) and economic context (‘nature’) on the financial resource endowment and subsequent early employment growth of research-based spin-offs (RBSOs). The nurture dimensions capture the relationship between the parent research institution and the RBSO during the start-up phase: the type of incubation model, the formal vs informal transfer of technology and the extent

Stefania Zerbinati; Vangelis Souitaris; Nathalie Moray

2012-01-01

456

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

PubMed Central

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

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

2011-01-01

457

[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

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

van der Hoogte, Arjo Roersch; Pieters, Toine

2010-01-01

458

Comparing the Effectiveness of Research-based Curricula for Teaching Introductory Mechanics  

NSDL National Science Digital Library

This study examines the effects of implementing various research-based forms of curricula for teaching introductory physics course at the College of DuPage in Glen Ellyn, IL and the University of Maine in Orono, ME. Introductory courses at each of these institutions were modified at each of these institutions over the course of several years. For each course, baseline data were collected during a year in which at least one form of research-based curricula was used. In subsequent years, other research-based curricula were implemented in addition to the baseline treatment at the University of Maine and in place of the baseline treatment at the College of DuPage. Data collected using the Force and Motion Conceptual Evaluation and the Force Concept Inventory were analyzed using the Model Analysis method developed by Bao and Redish to determine the manner(s) in which the curricular modifications affected studentsâ conceptual development throughout a course. The results of this analysis show that the majority of curricular changes had little overall effect on studentsâ conceptual understanding of physics. Several exceptions to this generality are discussed.

Smith, Trevor I.

2011-08-30

459

Will Restructuring Hungarian Companies Innovate?  

Microsoft Academic Search

Based on insights from Joseph Berliner's work on innovation in the Soviet centrally planned economy and its reform variants, we analyze process innovation (technological development) and product development in restructuring Humngarian companies from 1992 to 1995. Using data from a survey questionaire responded to by 325 Hungarian companies, we conclude that decision-makers recognize the increasing uncertainty in their business environment

John P Bonin; Istvan Abel

1998-01-01

460

Will Restructuring Hungarian Companies Innovate?  

Microsoft Academic Search

Based on insights from Joseph Berliner's work on innovation in the Soviet centrally planned economy and its reform variants, we analyze process innovation (technological development) and product development in restructuring Humngarian companies from 1992 to 1995. Using data from a survey questionaire responded to by 325 Hungarian companies, we conclude that decision-makers recognize the increasing uncertainty in their business environment

John P Bonin; Istvan Abel

461

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

E-print Network

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

Stephens, Graeme L.

462

Pharmaceutical Chemistry B.S. 1. General description and characteristics of the program.  

E-print Network

Pharmaceutical Chemistry B.S. 1. General description and characteristics of the program. Pharmaceutical Chemistry is the study of the molecular and mechanistic aspects of pharmaceuticals. The discipline, and targeting. The development of new pharmaceuticals is critically dependent on a molecular-level understanding

463

CERNA WORKING PAPER SERIES Pharmaceutical Regulation and Intellectual Property: the Third Side of the Triangle  

E-print Network

1 CERNA WORKING PAPER SERIES Pharmaceutical Regulation and Intellectual Property: the Third Side&D-intensive industries, such as pharmaceuticals. The Pharmaceutical Sector Inquiry published by the European Commission3 antitrust law limit pharmaceutical firms' intellectual property rights? When does influencing a regulatory

Paris-Sud XI, Université de

464

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

E-print Network

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

Stephens, Graeme L.

465

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

E-print Network

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

Stephens, Graeme L.

466

Overview of Major The Pharmaceutical Sciences Department offers a Bachelor's of Science degree  

E-print Network

Overview of Major The Pharmaceutical Sciences Department offers a Bachelor's of Science degree that brings together the many scientific disciplines that make up Pharmaceutical Sciences to provide a unified in Pharmaceutical Sciences will be in a strong position to move directly to research positions in pharmaceutical

Rose, Michael R.

467

Silicate release from glass for pharmaceutical preparations.  

PubMed

Glass is made of polymeric silica and other minor components, which are necessary for turning the silica into a material more easily moldable and resistant to temperature changes. Glass containers for pharmaceutical usage are classified according to their resistance to a chemical attack, a test carried out in the presence of water and heat. The test is designed to show the released alkalinity, a variable dependent on the amount of sodium oxide, one of the minor components added to the glass mass. In this work, the release of silica from glass by action of constituents from pharmaceutical formulations was investigated. The study included products used in large volumes and usually stored in glass containers. Solutions of amino acids, electrolytes, glucose, oligoelements and others such as heparin and sodium bicarbonate were individually stored in glass containers and heated at 121 degrees C for 30min, as in the water attack test. The test was also carried out only with water, where the pH varied from 2 to 12. The released silicate was measured either by photometry or atomic absorption spectrometry, depending on the nature of the sample. The results showed that silicate is released during the heating cycle even if the contact is with pure water only. The pH exerts a considerable influence on the release, being that the higher the pH, the higher the silica dissolved. An elevated pH, however, is not the only factor responsible for silica dissolution. While in the solutions of NaCl, KCl, Mg Cl2 and ZnSO4 and in most of the amino acids, the concentration of silicate was as high as in pure water (0.1-1.0mg Si/L). In the solutions of sodium acetate, bicarbonate and gluconate, its concentration was much higher, over 30mg Si/L. These results were confirmed by the analysis of commercial products, where in solutions of amino acids the level of silicate ranged from 0.14 to 0.19mg Si/L. On the other hand, calcium gluconate, sodium bicarbonate and potassium phosphate presented silicate levels from 1 to 4mg/L. Although silica is not considered a toxic substance for humans, it is necessary to be aware of its presence in solutions for parenteral nutrition due to the direct introduction into the bloodstream and the large volume usually administrated, even to pre-term infants. PMID:18272302

Bohrer, Denise; Bortoluzzi, Fabiana; Nascimento, Paulo Cícero; Carvalho, Leandro Machado; Ramirez, Adrian Gustavo

2008-05-01

468

Pharmaceutical drug marketing strategies and tactics: a comparative analysis of attitudes held by pharmaceutical representatives and physicians.  

PubMed

A variety of promotional strategies have been used to stimulate sales of pharmaceutical drugs. Traditionally, push techniques have been the predominant means used to encourage physicians to prescribe drugs and thus increase sales. Recently, the traditional push strategy has been supplemented by a pull strategy. Direct-to-consumer advertising is increasingly used to encourage consumers to request advertised drugs from their physicians. This research compares the attitudes of two of the most affected participants in the prescriptive sales processes; physicians and pharmaceutical sales representatives. The findings indicate differences between physicians and pharmaceutical sales representatives regarding the efficacy and ethical considerations of various promotional strategies. PMID:16597582

Parker, R Stephen; Pettijohn, Charles E

2005-01-01

469

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

PubMed

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