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

Transcription Pharmaceutical Company  

E-print Network

Transcription Pharmacy CDC Pharmaceutical Company Pharmacy Benefits Manager Analytics ICU thedatamap.org #12;Transcription Pharmacy CDC Pharmaceutical Company Pharmacy Benefits Manager Analytics Management Researcher Consulting Physician Health IT Other Government Federal Trade Commission You

Oliva, Aude

2

Results of a survey on applied quality standards in non-interventional studies among the members of the German Association of Research-based Pharmaceutical Companies  

PubMed Central

After the regulatory approval has been obtained, epidemiological studies are acknowledged scientific medical research methods for a new drug which provide additional knowledge about routine application of the drug in clinical daily routine. These studies are performed according to the recommendations of both international and national expert associations, the recommendations of the higher federal authorities in Germany and according to the recommendations of the associations of the pharmaceutical industry. Two surveys among the member companies of the Association of Research-based Pharmaceutical Companies investigated the status of the implementation of the recommendations in the years 2008 and 2010 and compared the results with each other. It could be shown that these recommendations were implemented successfully and were fully adhered to during the conduct of non-interventional studies in Germany. The recommendations define a quality standard which justifies a high level of confidence in the validity of the data collected and the results from these investigations. PMID:21063466

Hahn, Michael; Ruppert, Thorsten; Bethke, Thomas D.; Hundt, Ferdinand

2010-01-01

3

Value of Services Provided by Pharmaceutical Companies  

Microsoft Academic Search

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

Ralph M. Gaedeke; Dennis H. Tootelian; Eric E. Sanders

1999-01-01

4

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

PubMed Central

Objective: The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP) ordinance (German: GCP-Verordnung, GCP-V), the quality of evaluations of those applications by Ethics Committees (ECs)/Investigational Review Boards (IRBs) in Germany as well as the pattern of EC objections in their reasoned opinions (vote). In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008. Methods: Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC) in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa) was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared. Results: Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18) took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I–IV clinical trials submitted to the regulatory authorities (BfArM and PEI) in 2011. In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007) was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007). The amount of objections increased by 21% from 1,299 (2007) to 1,574 (2011) resulting in an average of 4.5 (2007) vs. 6.3 (2011) objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent form followed in descending order by trial protocol content, miscellaneous, other application documents pursuant to § 7 (2) and (3) GCP-V, formal deficiencies pursuant to § 8 (1) GCP-V, and investigator and site qualifications. A trend towards a slightly increased rate of objections concerning patient information and consent form (+4%) and a minimal decrease in objections concerning investigator and site qualifications (–2%) was observed. As in 2007, about 1 in 6 applications was still incomplete with formal objections. Whilst the proportion of study applications with objections related to the patient information and consent form (+7.2%), the trial protocol content (+11.6%), and documents according to § 7 (2) and (3) GCP-V (+11.8%) increased in 2011 compared to 2007, the amount of study applications with objections related to the investigator and site qualifications decreased by 6.3%. Conclusions: The majority of findings with respect to quantity, quality and main focus of objections reported in the first survey in 2008 were also found in 2012, indicating a shared understanding of applicable measures and criteria by sponsors and ECs on how to ensure patient rights and well-being, data integrity, and high quality documentation in clinical trials. PMID:25698912

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

2015-01-01

5

Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.  

PubMed

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

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

2014-03-01

6

Inventory management in a pharmaceutical company : minimizing discard practices  

E-print Network

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

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

2010-01-01

7

INTRODUCTION ADVERTISEMENT FEATURE Every pharmaceutical company craves perpetuity but, in  

E-print Network

to Norwalk, Connecticut-based IMS Health, the US pharmaceutical industry experienced its lowest growth rateINTRODUCTION ADVERTISEMENT FEATURE S2 Every pharmaceutical company craves perpetuity but with the risky business of bringing new medicines to market have never been more acute. In the US, prescription

Cai, Long

8

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

Microsoft Academic Search

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

Peter Trim; Hao Pan

2005-01-01

9

Occupational asthma in workers of a pharmaceutical company processing spiramycin  

Microsoft Academic Search

After investigation of one worker with occupational asthma, all 51 employees of a pharmaceutical company processing the macrolide antibiotic spiramycin were investigated to determine the frequency of the condition and the risk factors. The antibiotic was produced for short periods four to five times a year. The first part of the investigation, conducted before a production period, consisted of the

J L Malo; A Cartier

1988-01-01

10

The Research-Based Pharmaceutical Industry and Society:: What Is at Stake in the Future?  

Microsoft Academic Search

The US House of Representatives passed the far-reaching Pharmaceutical Market Access Act in July of 2003. If this bill or any similar language becomes law, the provision of health care would be affected radically on a worldwide basis. The author discusses the implica- tions of such a law for governments, society, the pharmaceutical industry, and consumers, touching on societal expectations

Karl Wündisch

2005-01-01

11

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

12

Occupational asthma in workers of a pharmaceutical company processing spiramycin.  

PubMed Central

After investigation of one worker with occupational asthma, all 51 employees of a pharmaceutical company processing the macrolide antibiotic spiramycin were investigated to determine the frequency of the condition and the risk factors. The antibiotic was produced for short periods four to five times a year. The first part of the investigation, conducted before a production period, consisted of the following: questionnaire, skinprick tests, blood sample, spirometry, assessment of bronchial responsiveness to methacholine, and monitoring of peak expiratory flow rates (PEF). The second part of the survey was carried out in 48 of the 51 workers during the production period, and included the same assessments except for skin testing. No FEV1 values had changed by more than 9% or PEF by more than 19%. Inhalation challenge with spiramycin was performed in 12 of the 14 individuals who had a history of occupational asthma, a provocative concentration of methacholine (PC20) of 16 mg/ml or less, or a PC20 that fell by 2.5 fold or more during the production period (or a combination of these). Three subjects experienced immediate bronchoconstriction. All reported symptoms, and all had a fall in PC20 methacholine during the production period. It is concluded that the minimum frequency of occupational asthma in this company processing spiramycin is 4/51 (7.8%). The combination of a positive response to the questionnaire and a change in bronchial hyperresponsiveness during the production period appeared to be the best detector of individuals with occupational asthma, as confirmed by inhalation challenge with spiramycin. PMID:3194865

Malo, J L; Cartier, A

1988-01-01

13

Trade Secrets in Life Science and Pharmaceutical Companies.  

PubMed

Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through "improper means" is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today's interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees' careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft. PMID:25414378

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

2014-11-20

14

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

15

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

PubMed

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

16

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 Responsibilities: The person will provide statistical assessments and develop models for drug manufacturing process, SAS · Experience in lean, six sigma, DOE ------------------------------------------- Jie Sheng

Shepp, Larry

17

The Physician Payments Sunshine Act and the Problem of Pharmaceutical Companies' Influence Over Prescribing Physicians  

Microsoft Academic Search

Recently, concerns over physicians' conflict of interest have increased as the details of some doctors' consulting relationships with pharmaceutical companies surface. In an effort to cleanse medicine of egregiously conflicted doctors, Senator Grassley proposed of the Physician Payments Sunshine Act (\\

Andrew L Younkins

2009-01-01

18

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

E-print Network

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

Khor, Si Ming Thomas

2007-01-01

19

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

20

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

21

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

Microsoft Academic Search

Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an

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

2008-01-01

22

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

, Pharmaceutical information management, DRM, Information management, Outsourcing, Copyright, Pharma Documentation1 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

Paris-Sud XI, Université de

23

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

PubMed Central

Background Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. Objective The objective of this study was to systematically review the effects of interventions targeting practising physicians’ interactions with pharmaceutical companies. Eligibility criteria We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. Data sources The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. Appraisal and synthesis methods We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Results Of 11?189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a ‘collaborative approach’ between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. Limitations We identified too few studies to allow strong conclusions. Conclusions Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians’ prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical companies. PMID:24989618

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

2014-01-01

24

Pharmaceutical Companies as a Source of Health Information: A Pilot Study of the Effects of Source, Web Site Interactivity, and Involvement  

Microsoft Academic Search

While pharmaceutical companies provide abundant health and medical information on their Web sites, little is known about consumers' perceptions of pharmaceutical companies as a health information source and the impact of pharmaceutical Web sites on health-related attitudes and behaviors. Findings from this study suggest that a pharmaceutical company can be perceived to be just as credible as a government health

Hyojin Kim

2011-01-01

25

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

26

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

27

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

28

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

29

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

30

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

PubMed

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

Kim, Hyojin

2011-01-01

31

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

32

Pharmaceutical Company Influence on Non-Steroidal Anti-inflammatory Drug Prescribing Behaviors  

PubMed Central

Objectives Adherence to safer nonsteroidal anti-inflammatory drug (NSAID) prescribing strategies remains low, despite their acceptance as markers of high-quality care and their aggressive dissemination. This study describes the taxonomy of methods used by pharmaceutical companies to influence physicians’ NSAID prescribing behaviors and elicits physicians’ perceptions of and counter-balances to these influences. Study Design In-depth interviews analyzed using the constant comparative method of qualitative data analysis. Methods Qualitative interviews were conducted with physicians representing various clinical specialties. Interviews were transcribed and coded inductively using grounded theory. Recruitment was stopped at 25 participants after the attainment of thematic saturation, when no new concepts emerged from ongoing analysis of consecutive interviews. Results Physicians described a variety of influences that shaped their NSAID prescribing behaviors, including detailing and direct contact with pharmaceutical representatives, requests from patients inspired by direct-to-consumer advertisements, and marketing during medical school and residency training. Physicians described practice guidelines, peer-reviewed evidence and opinions of local physician experts as important counterweights to pharmaceutical company influence. Local physician experts interpreted and provided context for new clinical evidence, practice guidelines and NSAID related marketing. Conclusions The social and communicative strategies used by pharmaceutical companies can be adapted to improve physicians’ adoption of guidelines for safer NSAID prescribing. The communicative interactions between local experts and other physicians who prescribe NSAIDs may be the critical target for future interventions to promote safer NSAID prescribing. PMID:19341315

Naik, Aanand D.; Woofter, Aaron L.; Skinner, Jessica M.; Abraham, Neena S.

2010-01-01

33

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

PubMed Central

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

34

Pharmaceutical policies used by private health insurance companies in Saudi Arabia  

PubMed Central

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

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

2012-01-01

35

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

36

[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

37

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. PMID:25328898

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

2014-01-01

38

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

PubMed

Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an evidence-based review of acute toxicity studies and assessed the value of the data generated. Preclinical and clinical information was shared on 74 compounds. The analysis indicated acute toxicity data was not used to (i) terminate drugs from development (ii) support dose selection for repeat dose studies in animals or (iii) to set doses in the first clinical trials in humans. The conclusion of the working group is that acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe. PMID:18295384

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

2008-04-01

39

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

PubMed Central

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

Heinemann, Lutz

2009-01-01

40

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

41

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

PubMed Central

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

Nagaich, Upendra; Sadhna, Divya

2015-01-01

42

Per pill price differences across therapeutic categories: A study of the essential drug brands marketed by multinational and local pharmaceutical companies in Bangladesh  

Microsoft Academic Search

The objective of this study was to comprehend the pricing differentiation of essential drugs between the local pharmaceutical companies (LPC) and multinational pharmaceutical companies (MNC) of Bangladesh. Thirty five (35) essential drug prices were collected from a local drug directory, namely Bangladesh National Formulary 2006. The mean and standard deviation of the prices of drugs belonging to all therapeutics categories

Nishat Chowdhury; Eva Rahman Kabir

43

Pharmaceuticals  

Microsoft Academic Search

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

Andreas Schiermeyer; Stefan Schillberg

44

R&D investments for neglected diseases can be sensitive to the economic goal of pharmaceutical companies.  

PubMed

A fundamental problem with neglected diseases is how to induce pharmaceutical companies to invest resources for developing effective treatments. A recent debate focused on the role of economic incentives represented by monetary transfers to the firms. In this article I focus on the economic goals of pharmaceutical companies, as determinants for R&D effort. In particular, within a stylized framework, the work compares expected profit and expected productivity maximization, arguing that the former in general induces higher R&D investments than the latter. Therefore, as it is currently the case, when pharmaceutical firms focus on productivity, appropriate economic incentives might be needed for them to invest in R&D for neglected diseases. PMID:22414544

Dimitri, Nicola

2012-08-01

45

Key Success Factors for Implementation of Advanced Manufacturing Technologies (AMTs)Case Study Conducted on Selected Pharmaceutical Companies in Bangladesh  

Microsoft Academic Search

This paper analyzes the key factors that affect implementation of Advanced Manufacturing Technologies (AMTs) in some selected pharmaceutical companies in Bangladesh. In this regard, we go through literature review to identify success factors for implementation and based on the literature review a framework is established to examine the key success factors. We conduct a questionnaire survey to collect necessary primary

Bikash Barua; M. M. Obaidul Islam

2008-01-01

46

Essential and non-essential drugs marketed by the 20 largest European pharmaceutical companies in developing countries.  

PubMed

This study estimates the proportion of essential drugs out of all drugs offered for sale in six regions of the developing world by the 20 largest European pharmaceutical companies. The total number of drugs offered for sale by the 20 companies is estimated from citations in the most important drug compendia in each region for 1988 and 1989. Essential drugs are defined as drugs listed on the 1988 version of the World Health Organization's (WHO) essential drugs list or equivalent to WHO essential drugs. Only 482, or 16% of a total of 3021 cited drugs were essential drugs or equivalent to an essential drug. The proportion for each company ranged from a low of 5.4% to a maximum of 39.0%. A high proportion, 41.7%, of the 2539 non-essential drugs cited in the compendia contained two or more active ingredients, compared to only 9.5% of the essential drugs. The results indicate that European pharmaceutical companies have yet to focus their drug marketing efforts in developing countries on the essential drugs recommended by the WHO. The ethical responsibility of the pharmaceutical companies is discussed, particularly in respect to their sales on the private market. PMID:8211308

Hartog, R

1993-10-01

47

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

PubMed Central

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

2014-01-01

48

A survey of pharmaceutical company representative interactions with doctors in Libya  

PubMed Central

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

Alssageer, Mustafa A.; Kowalski, Stefan R.

2012-01-01

49

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

PubMed

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

Twine, Richard

2013-12-01

50

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

PubMed Central

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

2013-01-01

51

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

52

[Pharmaceutical companies as sponsors of clinical trials--advantages and limitations].  

PubMed

The therapeutic progress achieved in the second half of this century was made possible only due to the interest taken by the pharmaceutical industry in the research field. It can be considered as the primum movens of the therapeutic revolution which has strongly benefited the humanity in these last decades. The clinical trials of new drugs constitute an integral part of the pharmaceutical and medical research. However its complexity and the costs involved make its execution impossible without the help or sponsorship of the pharmaceutical firms. Even in the more advanced countries it would be unthinkable that clinical trials could be carried out without the assistance of the pharmaceutical industry. The sponsorship by the pharmaceutical firms turns the relationship doctor-firm into a symbiotic association as both the parties reap benefits thereof: the physician because he is able to satisfy his inquisitiveness and his interest for the clinical research and the pharmaceutical firm because through these trials it will collect the information it requires. Besides having to bear the expenses inherent to the research, the sponsoring firms equally contribute for other pursuits usually of academical character and of interest to the investigator. Therefore it is not rare that these firms assume the costs of presence of these investigators in scientific meetings or to contribute for the arrangements of such meetings or even subsidise the acquisition of the equipment for the hospital services, etc.--measures which in countries with poor investments in research sector, such as Portugal, may constitute the only possibility to be carried out.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:1632988

Reis, L L

1992-04-01

53

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

54

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

E-print Network

pharmaceutical hub, Rutgers Business School (RBS) has evolved as an academic leader in pharmaceutical management offering a cutting-edge MBA in Pharmaceutical Management for 10 years. Over the last decade, some and pharmaceutical industry. The Rutgers Pharmaceutical Management MBA has provided the industry a pipeline

Lin, Xiaodong

55

What do Libyan doctors perceive as the benefits, ethical issues and influences of their interactions with pharmaceutical company representatives?  

PubMed Central

Introduction Evidence suggests that 80-90% of doctors in most countries across the world are frequently visited by pharmaceutical company representatives (PCRs). The objective of study to examine perceptions of Libyan doctors between August and October 2010, regarding the benefits, ethical issues and influences of their interactions with (PCRs). Methods An anonymous questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. Results The major benefits of PCR visits reported in the 608 evaluable responses were; receiving new information about products (94.4%). The majority of doctors (75%) were not against the provision of gifts but were more comfortable if it was “cheap” (51%) and had educational value (51%). Doctors who received more printed materials, simple gifts or drug samples were less likely to disapprove of accepting gifts (p5]. Effective marketing can positively influence an individual's attitude towards a product and because there is an association between attitude, intention and behaviour [6], persuasive communication can generate a positive attitude and increase the potential for influence [7]. PCRs can accomplish behaviour change because they directly communicate with prescribers. During a visit they attempt to raise awareness of their products, provide product information and encourage a favourable attitude towards their company and product [8]. They employ verbal persuasion techniques and also provide other incentives such as gifts, free drug samples and sponsored educational events [2]. The provision of promotional gifts can be seen as a friendship building technique to reinforce the communication nexus between PCRs and doctors but it can also potentially erode professional barriers [9]. Contact between a PCR and a medical practitioner is therefore viewed by drug companies as a vital part of their marketing strategy and frequent visits, together with written promotional materials, gifts and other incentives, can help alter behaviour even if the initial attitudes towards a product were weak or unclear [10]. PMID:23734277

Alssageer, Mustafa Ali; Kowalski, Stefan Robert

2013-01-01

56

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

PubMed

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

Malkowski, Jennifer

2014-01-01

57

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

58

Evaluating the reliability and accuracy of the promotional brochures for the generic pharmaceutical companies in Iraq using World Health Organization guidelines  

PubMed Central

Background: Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. Physician targeted promotion through medical representatives is one of the most common tactic for drug promotion by pharmaceutical drug companies. WHO states that medical representatives to work in an ethical way should make available to prescribers and dispensers complete and unbiased information for each product discussed; therefore this study aimed to evaluate the ethics in the medical brochures of generic pharmaceutical companies that are given through medical representatives to physicians in Iraq. Materials and Methods: An observational, cross-sectional study was conducted in Iraq – Baghdad from February to April 2014. Promotional drug brochures were collected mainly from pharmaceutical exhibition during attendance of medical conferences that were sponsored by generic pharmaceutical companies. Evaluation of each brochure was based primarily on WHO criteria for ethical medicinal drug promotion. The availability of emotional pictures in each brochure was also examined. Furthermore, references were checked to find their retrievability, source, and authenticity of presentations. Results: Most medical brochures were for antibiotics, and drugs for cardiovascular diseases. All brochures mention drug name, with its active ingredient and indication, but there is a significant absence for drug interaction, while drug side effects and contraindications if present were written in a small font. Emotional picture presented in 70% of brochures. Reference citation was present in 72% of brochures, however only 75% of references in these brochures were correct. Conclusions: The information that is provided in medical brochures is biased and mainly persuasive since it is mainly focusing on the positive aspect of drug therapy. PMID:25709340

Mikhael, Ehab Mudher

2015-01-01

59

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

60

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

61

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

62

The prevalence and incidence of medical conditions in healthy pharmaceutical company employees who volunteer to participate in medical research  

PubMed Central

Aims Although clinical research in healthy volunteers is commonly performed there have been few studies of the value of the medical screening of subjects. The aim of this study was to investigate the prevalence and incidence of medical conditions found during the medical screening of ‘healthy’ subjects employed in a pharmaceutical company who volunteered to participate in medical research. Methods This was a retrospective study of the medical notes of all the subjects who volunteered for membership of the Zeneca Clinical Pharmacology Unit’s healthy volunteer panel over a 4 year period from 1990 to 1994. The prevalence of medical conditions found at presentation was determined. The incidence of medical conditions during the 4 year observation period was also ascertained. Medical screening included a full medical history and examination, clinical chemistry, haematology and urinalysis screens, pulmonary function tests, ECGs, 24 h ambulatory cardiac monitoring and a request for information from the volunteer’s General Practitioner. Results Prevalence-1293 subjects volunteered to join the panel of which 156 subjects (12%) were not accepted at presentation including 141 (10.9%) for medical reasons. The most medical common reasons were; previously diagnosed medical conditions (3.3%), cardiovascular abnormalities (1.9%), abnormal liver function tests (1.9%), anaemia (1.2%), hyperlipidaemia (1.1%), excess alcohol intake (0.6%) and thyroid disease (0.5%). Incidence—36 of the 1137 volunteers (0.8% per year) accepted onto the panel subsequently developed medical conditions of which the most common were; anaemia (0.29% per year), cardiovascular abnormalities (0.13% per year) and vasovagal syncope (0.13% per year). Conclusions This study demonstrates the importance of medical screening before healthy volunteers participate in clinical research. PMID:10383556

Singh, S D; Williams, A J

1999-01-01

63

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

PubMed

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

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

2015-05-01

64

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

Microsoft Academic Search

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

Alan Goldhammer

2008-01-01

65

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

Code of Federal Regulations, 2014 CFR

...AFFAIRS GENERAL PROVISIONS Security and Law Enforcement at Department...during duty hours, including patient care and other educational...protected health information or patient participation in pharmaceutical...Drug Administration. (4) Patient educational materials...

2014-07-01

66

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

Code of Federal Regulations, 2013 CFR

...AFFAIRS GENERAL PROVISIONS Security and Law Enforcement at Department...during duty hours, including patient care and other educational...protected health information or patient participation in pharmaceutical...Drug Administration. (4) Patient educational materials...

2013-07-01

67

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

Code of Federal Regulations, 2012 CFR

...AFFAIRS GENERAL PROVISIONS Security and Law Enforcement at Department...during duty hours, including patient care and other educational...protected health information or patient participation in pharmaceutical...Drug Administration. (4) Patient educational materials...

2012-07-01

68

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

PubMed

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

Bhattarai, M D

2012-01-01

69

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

70

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

71

Findings from a questionnaire survey on new guidelines for preparing drug guide for patients and a perspective from a pharmaceutical company as the information provider.  

PubMed

  Draft versions of two products of based on a "Drug Guide for Patients" have been prepared the guidelines proposed in "Research on risk communication between patients and healthcare professionals regarding information on safety measures for drugs, etc." by Health and Labour Sciences Research Grants. We conducted a questionnaire survey on the draft to identify issues regarding the contents and their preparation from the viewpoint of pharmaceutical companies as authors. The questionnaire results indicated that, the segments of the contents of the "Drug Guide for Patients" based on the new guidelines are generally acceptable. In this paper, the author offers proposals to address issues regarding the preparation of easy-to-read contents for patients and strategies to promote the overall understanding recognition of Drug Guide for Patients. Drug Guide for Patients are expected to be utilized as materials providing information to be used for routine risk minimization activities of the Risk Management Plan in the future. PMID:25747228

Asada, Kazuhiro

2015-01-01

72

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

73

Sponsored by Stevens Pharmaceutical Center and AIChE The Pharmaceutical Industry /  

E-print Network

in Chemistry from Seton Hall University, South Orange, NJ USA. Involved in analytical and pharmaceuticalSponsored by Stevens Pharmaceutical Center and AIChE The Pharmaceutical Industry / Academia & Bioanalytical Development Pharmaceutical Development, Bristol-Myers Squibb Company ABSTRACT Dr. Scypinski

Fisher, Frank

74

[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

75

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

76

Sulfite-containing Canadian pharmaceutical products available in 1991.  

PubMed Central

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

Miyata, M; Schuster, B; Schellenberg, R

1992-01-01

77

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

78

Managing Pharmaceutical Expenditure while Increasing Access: The Pharmaceutical Management Agency (PHARMAC) Experience  

Microsoft Academic Search

The role of the Pharmaceutical Management Agency (PHARMAC) is to manage pharmaceutical subsidy expenditure in New Zealand. PHARMAC has adopted a proactive approach. It selects the drugs that are to be subsidised and declines to subsidise others. It has established reference pricing across many drug groups, has entered into a range of innovative commercial contracts with pharmaceutical companies, and has

Richard Braae; Wayne McNee; David Moore

1999-01-01

79

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

80

Impact of Brand Orientation, Internal Marketing and Job Satisfaction on the Internal Brand Equity: The Case of Iranian’s Food and Pharmaceutical Companies  

Microsoft Academic Search

Internal branding has been emerging recently as an important issue in marketing field. This study provides insights into how job satisfaction, internal marketing and brand orientation shape employees internal brand equity. Empirical data were collected by a questionnaire distributed to food and pharmaceutical firms. The empirical results indicated that while brand orientation and internal marketing were found to have impact

Shahriar Azizi; Fateme Ghytasivand; Sina Fakharmanesh

2012-01-01

81

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

82

Agreements at the Pharmaceutical/University Interface.  

ERIC Educational Resources Information Center

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

Ku, Katherine

1987-01-01

83

Pharmaceutical Policy regarding Generic Drugs in Belgium  

Microsoft Academic Search

Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to

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

2005-01-01

84

Clean Room Monitoring System for Pharmaceutical  

E-print Network

Clean Room Monitoring System for Pharmaceutical Companies Anastasia Mourka Kongens Lyngby 2013 IMM Systems to have an overview of the environmental conditions inside clean rooms, where the pharmaceuticals the environmental conditions in clean rooms, but the systems they are using are coupled and, thus, difficult

85

Philosophy Research Base  

NSDL National Science Digital Library

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

1999-01-01

86

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

's family of companies, is recruiting for a Principal Research Scientist for Network Pharmacology, located the opportunity to increase understanding and adoption of network pharmacology across the broader Johnson of the In Silico Immunology team. This position requires close interaction with scientists across informatics

Dalkilic, Mehmet

87

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

88

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

PubMed

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

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

2004-01-01

89

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.

90

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

91

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

92

Data Warehouse Design for Pharmaceutical Drug Discovery Research Melinda G. Axel and Il-Yeol Song  

E-print Network

: Enterprise description #12;2.1: Chemistry and chemical compounds Pharmaceutical companies have departmentsData Warehouse Design for Pharmaceutical Drug Discovery Research Melinda G. Axel and Il-Yeol Song: axel@superlink.net, songiy@post.drexel.edu Abstract Pharmaceutical companies spend billions of dollars

Song, Il-Yeol

93

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

94

[Questions about pharmaceutical expertise].  

PubMed

Over the last thirty years, many areas of expertise have developed in the pharmaceutical industry, from research and production to delivery to the patient. Strict European regulations and international best practice guidelines have shaped the expertise of pharmaceutical firms. Governments have set up health agencies to strengthen the supervision of private operators by recruiting in-house scientific experts and expert committees. The private and public sectors compete to recruit the best experts, and conflicts of interest must be addressed. The recent 'Mediator' (Benfluorex) case in France raises many questions about the potential failures of the health security system. Beyond the primary responsibility of the company, the main concern is off-label use. An effort to strengthen the legal framework and the tools used to collect, analyze and publicize pharmacovigilance data is currently underway at a national and European level. The competent authorities must restore public confidence through a more diligent and transparent handling of sensitive issues related to high-risk medicine. In a country where drug consumption is particularly high, doctors and pharmaceutical experts have been accused of becoming accustomed to risk and of loosing sight of the benefit to the patient. Health professionals in the private and public sectors must regain the appropriate health security reflexes to promote a more rational use of drugs. PMID:22730611

Sauer, Fernand

2012-01-01

95

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

96

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

PubMed

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

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

2013-10-01

97

Pharmaceutical virtue.  

PubMed

In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good. PMID:16835808

Martin, Emily

2006-06-01

98

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

99

Pharmaceutical sales representatives and the doctor\\/patient relationship  

Microsoft Academic Search

As marketing efforts by drug companies become more aggressive, physicians are being asked to provide clinical “preceptorships” to pharmaceutical sales representatives. During a “preceptorship” of this type, the company representative spends a day with the physician seeing patients “as an educational experience,” and the physician receives an “honorarium” from the drug company in return. We explore the implications of this

L. Lewis Wall; Douglas Brown

2002-01-01

100

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

101

General Information Research Bases FAQs  

Cancer.gov

The RFA, in Section IV, # 2, under Budget for Entire Period, states, "NCORP Research Base affiliation agreements MUST be included." But this is not reiterated or mentioned in the NCORP Program Guidelines.

102

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

103

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,

104

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

105

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

106

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

107

GMP Compliance for Pharmaceutical Excipients in the Glycerin Industry  

E-print Network

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

Elliot, Christina

2008-12-19

108

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

109

Customer relationship management architecture in the pharmaceutical industry  

Microsoft Academic Search

The pharmaceutical industry is undergoing a fundamental transformation. Institutional regulations that have been in place for decades are being removed and competitive pressures on various levels force pharmaceutical companies to adopt customer-oriented strategies. Information technology is an important enabler to improve the interaction with key customer segments, such as physicians, and patients. This research presents a framework that has been

Rainer Alt; Hubert Oesterle; Thomas Puschmann; Vladimir Barak; Thomas Huber

2003-01-01

110

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

111

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

E-print Network

Pharmaceutics Graduate Student Handbook v13.0 2012 1 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics & Pharmaceutical Chemistry offers including academic, research, administrative, business management, legal, regulatory and investment career

112

76 FR 75939 - ZipGlobal Holdings, Inc., Symbollon Pharmaceuticals, Inc., Microholdings US, Inc., ComCam...  

Federal Register 2010, 2011, 2012, 2013, 2014

...File No. 500-1] ZipGlobal Holdings, Inc., Symbollon Pharmaceuticals, Inc., Microholdings US, Inc., ComCam International...company stock and its financial statements. 2. Symbollon Pharmaceuticals, Inc. (f/k/a Symbollon Corp.) is a Delaware...

2011-12-05

113

Pharmacovigilance in pharmaceutical companies: An overview  

PubMed Central

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

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

2013-01-01

114

A CASE STUDY ON THE DESIGN OF PHARMACEUTICAL R&D LICENSING DEALS  

E-print Network

. In a sample case study, the OptFolio model of pharmaceutical R&D portfolio management is used to evaluateA CASE STUDY ON THE DESIGN OF PHARMACEUTICAL R&D LICENSING DEALS Michael J. Rogers, Min Ding's intensely competitive business environment, pharmaceutical companies are augmenting their product pipelines

Maranas, Costas

115

Concordance of the Toxicity of Pharmaceuticals in Humans and in Animals  

Microsoft Academic Search

This report summarizes the results of a multinational pharmaceutical company survey and the outcome of an International Life Sciences Institute (ILSI) Workshop (April 1999), which served to better understand concordance of the toxicity of pharmaceuticals observed in humans with that observed in experimental animals. The Workshop included representatives from academia, the multinational pharmaceutical industry, and international regulatory scientists. The main

Harry Olson; Graham Betton; Denise Robinson; Karluss Thomas; Alastair Monro; Gerald Kolaja; Patrick Lilly; James Sanders; Glenn Sipes; William Bracken; Michael Dorato; Koen Van Deun; Peter Smith; Bruce Berger; Allen Heller

2000-01-01

116

Pharmaceutical strategy and innovation: an academics perspective.  

PubMed

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

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

2007-06-01

117

Pharmaceutical technology management--profitable business avenue.  

PubMed

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

Puthli, Shivanand P

2010-01-01

118

Pharmaceutical industry overview: optimal drug therapy.  

PubMed

Today's revolutionary genomics research is the key to the search for tomorrow's new drugs. Over the next 10 to 20 years, there could be 15 times the number of therapeutic agents that there are today. With these scientific advances, optimal drug therapy becomes an even more significant component of health care. Canada's Research-Based Pharmaceutical Companies have proposed a therapeutic management system designed to make the optimum use of health care while controlling costs. The proposal is based on the disease management approach, applied first to diseases that are the most widespread in the population and that represent the highest costs for the health care system. The concept involves comparing the best available practices with the care provided and making the necessary adjustments to improve patients' health in line with the most cost effective approach. Preliminary results from similar programs underway in Canada, such as those in the field of asthma treatment, suggest that they can lead to improvements in the quality of care and represent a step forward in comparison with measures focusing only on cutting costs. The future will bring new challenges in achieving optimal drug therapy as genomics leads to tailor-made medications, necessitating changes in drug plan policies and reimbursement. With personalized treatment regimens and an increased understanding of how to prevent and treat diseases, optimal drug therapy can be taken to a new level. Quality of life can be further improved, more lives can be saved and the health care system can be saved more money while providing the best possible treatments. PMID:11586380

Blake, P

2001-01-01

119

Study of Incentives being provided by Medical companies to retailers TD 390 Report  

E-print Network

chain. In India, major pharmaceutical companies have outsourced their supply chain management]. Pharmaceutical companies promote their sales by offering incentives to doctors. These incentives range from. As a result, drugs are routinely sold over the counter without any prescription [5]. Hence, pharmaceutical

Sohoni, Milind

120

Pharmaceutical manufacturers are facing significant changes. According to a prominent analyst they are encountering increased  

E-print Network

Pharmaceutical manufacturers are facing significant changes. According to a prominent analyst ways to streamline their lengthy R&D cycles. One pharmaceutical company is already turning these market the company's management, clinical research, finance, sales, compliance and other operations. The new virtual

Fisher, Kathleen

121

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

122

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

123

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

124

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

PubMed Central

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, IA; Purcarea, VL

2012-01-01

125

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

126

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

127

3M Corporation -Volunteer Program Alexion Pharmaceuticals, Inc.  

E-print Network

Assurant, Inc. Athens Group Inc. Attachmate Auto Club Inter-Insurance Exchange AutoZone, Inc. Companies Group, Inc. American Safety Insurance, American Tower Corporation Ameriprise Financial, Inc (for Employees and Employee Ad visors (P1)) Amgen, Inc. Amica Mutual Insurance Company Amylin Pharmaceuticals

Rosen, Jay

128

[E-commerce of pharmaceuticals].  

PubMed

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

Shani, Segev

2003-05-01

129

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.

130

Microcap pharmaceutical firms: linking drug pipelines to market value.  

PubMed

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

Beach, Robert

2012-01-01

131

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

132

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

PubMed

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

André, F E

2002-01-01

133

[Conflict of interest regarding clinical physicians' relationship with pharmaceutical industry and medical education].  

PubMed

The relationship between clinical physicians and the pharmaceutical industry is becoming an important social issue. Many lawsuits against drug companies in the area of psychiatric medicine have been heavily covered by the mass media in the U.S., and the injustices of drug companies and clinical physicians have been revealed in court. Although there are few such large social issues in Japan, the relationship between clinical physicians and the pharmaceutical industry in Japan appears inappropriate. A study on the relationship between Japanese clinical physicians and the pharmaceutical industry revealed that many physicians received "gifts" from pharmaceutical companies. This is one form of evidence for the inappropriate relationship between Japanese physicians and pharmaceutical industries. Recently, many recommendations to realize an appropriate relationship between physicians and the pharmaceutical industry have been published in the U.S. However, discussion concerning the relationship between clinical physicians and pharmaceutical companies in Japan is not active. We have received a lot of financial support for continuing medical education from pharmaceutical industries. Without such support, we may not be able to maintain the same level of medical education. Understanding such present conditions, we need to discuss what is an appropriate relationship between clinical physicians and the pharmaceutical industry. PMID:21226250

Miyata, Yasushi

2010-01-01

134

Pharmaceutics Graduate Student Handbook v16.0 2014 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY  

E-print Network

Pharmaceutics Graduate Student Handbook v16.0 2014 1 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics & Pharmaceutical Chemistry offers a Ph.D. degree program, administrative, business management, legal, regulatory and investment career tracks. This goal is accomplished

Feschotte, Cedric

135

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

E-print Network

Pharmaceutics Graduate Student Handbook v15.0 2013 1 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics & Pharmaceutical Chemistry offers a Ph.D. degree program, administrative, business management, legal, regulatory and investment career tracks. This goal is accomplished

Tipple, Brett

136

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

E-print Network

Pharmaceutics Graduate Student Handbook v11.0 2011 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics & Pharmaceutical Chemistry offers a Ph.D. degree program, administrative, business management, legal, regulatory and investment career tracks. This goal is accomplished

Simons, Jack

137

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

E-print Network

Pharmaceutics Graduate Student Handbook v8.0 2010 1 THE GRADUATE PROGRAM IN PHARMACEUTICS & PHARMACEUTICAL CHEMISTRY The Department of Pharmaceutics & Pharmaceutical Chemistry offers a Ph.D. degree program, administrative, business management, legal, regulatory and investment career tracks. This goal is accomplished

Simons, Jack

138

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

PubMed

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

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

2014-01-01

139

Identification of Pharmaceutical Impurities  

Microsoft Academic Search

Identification of pharmaceutical impurities is a critical analytical activity in the drug development process whose goal is to fully elucidate the chemical structures of unknown pharmaceutical impurities present in either drug substances or drug products above a particular threshold. Knowledge of the chemical structure of an impurity is essential to assess its toxicological implications and to gain an understanding of

Fenghe Qiu; Daniel L. Norwood

2007-01-01

140

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

PubMed

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

141

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

142

Effective executive management in the pharmaceutical industry.  

PubMed

Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they need vision as well as commitment regarding the unique requirements of the industry. PMID:18972973

Tran, Hoang; Kleiner, Brian H

2005-01-01

143

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

144

A root cause analysis of stock-outs in the pharmaceutical industry  

E-print Network

PharCo (an assumed name) is a leading global healthcare company with well-recognized brands of both pharmaceutical and consumer healthcare products. As PharCo continues to expand its global presence, product stock-outs in ...

Sun, Xuewen, M. Eng. Massachusetts Institute of Technology

2014-01-01

145

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

146

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

147

Transformation in the Pharmaceutical Industry - Developing Customer Orientation at Pharma Corp  

Microsoft Academic Search

The pharmaceutical industry is in the midst of a fundamental transformation. Institutional regulations that have been in place for decades are being removed and competitive pressures force pharmaceutical companies to adopt customer-oriented strategies. Information technology which has traditionally been applied to many processes in this industry is an important enabler for the interaction with key customer segments such as physicians

Rainer Alt

148

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

149

Physicians' Adoption of Pharmaceutical E-Detailing: Application of Rogers' Innovation-Diffusion Model  

Microsoft Academic Search

Electronic detailing (e-detailing) means using digital technology by pharmaceutical companies as a means of relaying information about pharmaceutical products to physicians. This study addresses the factors that could affect the decision of physicians to adopt e-detailing technology. Based on the theoretical foundations of technology adoption models, Rogers' work on diffusion of innovations could be useful to study physicians' adoption of

Fadi M. Alkhateeb; Nile M. Khanfar; David Loudon

2009-01-01

150

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

151

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

PubMed

United States pharmaceutical companies are marketing or manufacturing drugs in less developed countries which add hazards to the diseases they are intended to control. For many pharmaceutical companies the financial benefits outweigh any possible risks. In many cases U.S. export laws and other nations' import laws are not enforced and people are denied their right to be provided with full unbiased disclosure of all medications they are considering consenting to. PMID:20841092

Friedman, J A; Alkhateeb, W

1981-01-01

152

Doctors and Drug Companies: Still Cozy after All These Years  

Microsoft Academic Search

David Henry discusses a research article by Geoffrey Spurling and colleagues that examined the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing.

David Henry

2010-01-01

153

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

154

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

155

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

156

Legal considerations for social media marketing by pharmaceutical industry.  

PubMed

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

Yang, Y Tony; Chen, Brian

2014-01-01

157

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

158

Racing to define pharmaceutical R&D external innovation models.  

PubMed

The pharmaceutical industry continues to face fundamental challenges because of issues with research and development (R&D) productivity and rising customer expectations. To lower R&D costs, move beyond me-too therapies, and create more transformative portfolios, pharmaceutical companies are actively capitalizing on external innovation through precompetitive collaboration with academia, cultivation of biotech start-ups, and proactive licensing and acquisitions. Here, we review the varying innovation strategies used by pharmaceutical companies, compare and contrast these models, and identify the trends in external innovation. We also discuss factors that influence these external innovation models and propose a preliminary set of metrics that could be used as leading indicators of success. PMID:25448753

Wang, Liangsu; Plump, Andrew; Ringel, Michael

2014-10-30

159

Mega-Mergers in the Pharmaceutical Industry: In Whose Interests?  

Microsoft Academic Search

Companies merge to achieve economies of scale. In an industry such as the pharmaceutical industry which relies on a high level of investment in research and development, such mergers appear rational. However, it is not at all obvious that a higher level of investment by a smaller number of firms will necessarily lead to an increased rate of genuine innovations.

Alain Li Wan Po

1998-01-01

160

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

161

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

162

Conflict of interest in economic evaluations of pharmaceuticals  

Microsoft Academic Search

Objective. The objective of this study was to investigate conflict of interest attributed to the affiliation (non-profit organization vs pharmaceutical companies) of the sponsors of economic evaluations of new drugs. ^ Methods. Regression models consisting of Sponsor alone were compared with models including other explanatory variables. Primary analysis used logistic regression to assess the binary dependent variable, Qualitative Conclusion of

Thomas J Hogan

2007-01-01

163

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

PubMed

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

Beglarian, M G

2011-06-01

164

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

165

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

Charisse Buising

2001-02-01

166

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

167

Risk management in the development of new products in the pharmaceutical industry  

Microsoft Academic Search

One of the greatest challenges facing the pharmaceutical industry is the process of selecting which new products to develop. In this study, the product development and investment decision problem was examined. A hypothetical case of new product investment in either Product A and\\/or Product B by a hypothetical company called Healthcare Company was investigated. As employed in previous empirical studies,

Ewa Kleczyk

2008-01-01

168

Biotech-Pharmaceutical Alliances as a Signal of Asset and Firm Quality  

Microsoft Academic Search

We examine the determinants of biotech-pharmaceutical alliance prices to determine whether the market for alliances is characterized by asymmetric information. We find that inexperienced biotech companies receive substantially discounted payments when forming their first alliance. A jointly developed drug is more likely to advance in clinical trials than a drug developed by a single company, so the first-deal discount is

Sean Nicholson; Patricia M. Danzon; Jeffrey McCullough

2005-01-01

169

PHARMACEUTICAL STATISTICS Pharmaceut. Statist. 2007; 6: 171180  

E-print Network

with clinical trial applications Alex Dmitrienko1, *,y and Ajit C. Tamhane2 1 Eli Lilly and Company examples are used to illustrate the procedures and their important properties. Copyright # 2007 John Wiley reflects the hierarchical nature of the problem and improves the power of they E-mail: dmitrienko alex@lilly

Bustamante, Fabián E.

170

Pharmaceutical Risk Control Systems  

Microsoft Academic Search

This paper outlines an initial investigation of the bio-pharmaceutical industry (BPI) and the steps it is taking to meet the new FDA risk mandate. It reviews the industry's' current strategy of improving its quality management systems that are central to achieving best practices within its operations. In addition the paper also reviews the strategy for upgrading to the next generation

Warren Adis

2008-01-01

171

Photoinduced chemiluminescence of pharmaceuticals.  

PubMed

A screening test for the forward development of chemiluminescence systems able to determine pharmaceutical compounds is reported. The test is based on the on-line photodegradation of the drugs by using a photoreactor consisting of 697 cmx0.5 mm PTFE tubing helically coiled around an 8 W low-pressure mercury lamp. Photodegraded pharmaceuticals are detected by direct chemiluminescence of the resulting photofragments and their subsequent reaction with potassium permanganate in sulphuric acid medium as oxidant. The screening comprised 97 compounds with different molecular structures and relevant members of the most important families of pharmaceuticals are tested (amino acids, carboxylic acids, nitrocompounds, phenyl-alkyl and aromatic amines, sulphonic acid amides, polycarbocyclics, monocyclic N-containing heterocyclics, bicyclic N-containing heterocyclics, tricyclic N-containing heterocyclics, N-S containing heterocyclics...). Due to the relevant influence of the medium for the photodegradation a wide range of pH's and buffer solutions were studied. The proposed strategy (photoinduced chemiluminescence, Ph-CL) allows the development of systems for the determination of many pharmaceuticals which do not present "native" chemiluminescence (e.g. chloramphenicol, dextromethorpham, riboflavin, ephedrine, piperazinamide, chlotrimazole, theophylline...). Moreover, Ph-CL allows to increase the sensitivity of chemiluminescence procedures based on direct chemiluminescence detection (e.g. sulphonamides, thiazides, nicontinamide, nortryptiline, levamisole, phenylbarbituric acid...). PMID:16413738

Gómez-Taylor, B; Palomeque, M; García Mateo, J V; Martínez Calatayud, J

2006-05-01

172

Bioconjugation in pharmaceutical chemistry  

Microsoft Academic Search

Polymer conjugation is of increasing interest in pharmaceutical chemistry for delivering drugs of simple structure or complex compounds such peptides, enzymes and oligonucleotides. For long time drugs, mainly with antitumoral activity, have been coupled to natural or synthetic polymers with the purpose of increasing their blood permanence time, taking advantage of the increased mass that reduces kidney ultrafiltration. However only

F. M. Veronese; M. Morpurgo

1999-01-01

173

[New transparency between physicians and the pharmaceutical industry].  

PubMed

The long-lasting trusting partnership between physicians and the pharmaceutical industry with respect to experience from applied research of medications and vocational training, was severely tested by campaign-like dissemination of collective accusations of corruption. Instead of standing by their responsibility to financing clinical research and vocational training of physicians, the health insurance companies in particular claim that physicians are being extensively bribed by the pharmaceutical industry. In order to continuously improve the mutual targets, i.e. the treatment options for patients, both groups have developed transparency regulations. PMID:25047594

Bühmann, W

2014-08-01

174

Promoting Research-Based Practices Through Inclusion?  

Microsoft Academic Search

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

Victoria Volonino; Naomi Zigmond

2007-01-01

175

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).

176

Influence of pharmaceutical marketing on prescription practices of physicians.  

PubMed

In India same drug molecules are sold under different brand names by different pharmaceuticals. To persuade the physicians to prescribe their brands pharmaceuticals engage in marketing techniques like giving samples, gifts, sponsoring travel etc. Many countries are striving to reduce the impact of incentives on prescription behaviour. This study explores the influence of pharmaceutical marketing on the prescription practices of doctors in India. There were 103 study subjects - 50 doctors and 53 sales personnel. Data collection was done by a self administered questionnaire. Data were collected on 36 variables which were supposed to influence prescription. The effectiveness of the promotional strategies on prescription behaviour was marked in a seven point Likert scale ranging from "not at all effective" (score=1) to "extremely effective" (score=7). Open ended questions were used to collect qualitative data. Good rapport with the doctor, launch meetings, reputation of the company, quality of the drug and brand names significantly influenced prescription behaviour, while direct mailers, advertisements in journals and giving letter pads and other brand reminders were less effective. Commonly used method of giving samples was not among the twenty most effective methods influencing prescription. Product quality and good company are still factors that influence prescription. Pharmaceutical marketing influences the choice of brands by a physician. The more expensive strategies involved in public relations are more effective. Sending mails and journal advertisements are less effective strategies. How expensive marketing strategies affect cost of the medicines has to be explored further. PMID:24000508

Narendran, Roshni; Narendranathan, M

2013-01-01

177

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

PubMed

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

Salazar, A; Howells, J

2000-01-01

178

Fate of a representative pharmaceutical in the environment  

E-print Network

to the build-up of resistance in microbial populations. Antibiotics enter the environment from a variety of sources including discharges from domestic wastewater treatment plants and pharmaceutical companies, runoff from animal feeding operations, infiltration... this information, the health effects to humans and animals may be estimated by toxicologists. An additional problem that may be created by the presence of antibiotics at low concentrations in the environment is the development of antibiotic resistant bacteria...

Morse, Audra; Jackson, Andrew

179

Innovation Profitability Analysis in the Assessment of Pharmaceutical R&D Projects  

Microsoft Academic Search

\\u000a In management circles, the pharmaceutical industry is referred to as a “high-risk industry”, as it takes a very long time\\u000a to develop a drug and success is difficult to assess.1 This perception is borne out by practical examples. Thus, for example, the in-house early warning system at pharmaceutical\\u000a company Bayer was ignored in 2001 in connection with the anticholesterolemic Lipobay,

Wilhelm Schmeisser

180

North Atlantic Innovative Relations of Swiss Pharmaceuticals and the Proximities with Regional Biotech Arenas  

Microsoft Academic Search

Under the pressure of increased global competition and processes of concentration, the pharmaceutical giants are reorganizing their innovative capaci- ties. Technology and research and development (R&D) play a key role in the compet- itive strategies of multinational pharmaceutical companies. This article analyzes the interrelation of the far-reaching but spatially selective international expansion of R&D and technology of a major Swiss

Christian Zeller

2004-01-01

181

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

182

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

NASA Technical Reports Server (NTRS)

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

1978-01-01

183

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

184

Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.  

PubMed

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised. PMID:19184498

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-12-01

185

Pharmacy Practice I 4 Pharmacy Practice II 4 Pharmacy Practice III 4 Pharmaceutics IBiopharmaceutics 3 Pharmaceutics IIIPharmacokinetics 3 Pharmaceutics II Dosage Forms & 4  

E-print Network

IBiopharmaceutics 3 Pharmaceutics IIIPharmacokinetics 3 Pharmaceutics II ­ Dosage Forms & 4 Pharmaceutical Chemistry I 3 Pharmaceutical Chemistry II 3 Drug Delivery Systems Organic Chemistry Physical Chemistry Pharmaceutical Chemistry III 3 Biostatistics 3 Histology 2 Pharmacological Biochemistry Law and Ethics 2 Concepts

Gleeson, Joseph G.

186

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

PubMed

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

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

2014-05-01

187

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

PubMed

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

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

2012-08-01

188

Bolaamphiphiles: A Pharmaceutical Review  

PubMed Central

The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179

Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.

2014-01-01

189

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

PubMed

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

Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

2013-10-01

190

The Pharmaceutical Commons  

PubMed Central

In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures.

Lezaun, Javier

2015-01-01

191

Physicians and the Pharmaceutical Industry  

Microsoft Academic Search

Context Controversy exists over the fact that physicians have regular contact with the pharmaceutical industry and its sales representatives, who spend a large sum of money each year promoting to them by way of gifts, free meals, travel subsidies, spon- sored teachings, and symposia. Objective To identify the extent of and attitudes toward the relationship between physicians and the pharmaceutical

Ashley Wazana

2006-01-01

192

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

193

Process automation in the pharmaceutical industry—a case study of process automation at the caps holdings drug factory  

Microsoft Academic Search

This brief exercise reviews a process automation project at the CAPS Holding pharmaceutical plant in Harare.CAPS is a holding company producing and distributing industrial and medical drugs in Zimbabwe. It is 54% government owned. At the top of the company is the Managing Director of CAPS Holdings. The CAPS drugs production wing is headed by a General Manager who supervises

R. S. Maya

1989-01-01

194

Developing and delivering clinical pharmacology in pharmaceutical companies  

PubMed Central

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

Richards, Duncan

2012-01-01

195

Preclinical Pharmacokinetic/Pharmacodynamic Modeling and Simulation in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape.  

PubMed

The application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its broad application. An important goal of preclinical PK/PD analysis in all pharmaceutical companies is for the selection/optimization of doses and/or dose regimens, including prediction of human efficacious doses. Oncology was the therapeutic area with the most PK/PD analysis support and where it showed the most impact. Consistent use of more complex systems pharmacology models and hybrid physiologically based pharmacokinetic models with PK/PD components was less common compared to traditional PK/PD models. Preclinical PK/PD analysis is increasingly being included in regulatory submissions with ~73% of companies including these data to some degree. Most companies (~86%) have seen impact of preclinical PK/PD analyses in drug development. Finally, ~59% of pharmaceutical companies have plans to expand their PK/PD modeling groups over the next 2 years indicating continued growth. The growth of preclinical PK/PD modeling groups in pharmaceutical industry is necessary to establish required resources and skills to further expand use of preclinical PK/PD modeling in a meaningful and impactful manner. PMID:25630504

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

2015-03-01

196

Technology evaluation: PRO-542, Progenics Pharmaceuticals inc.  

PubMed

Progenics's rCD4-IgG2 (PRO-542) is a recombinant fusion protein, which has been developed using the company's Universal Antiviral Binding (UnAB) technology, and is in phase I/II clinical trials for the treatment of human immunodeficiency virus type I (HIV-1) infection [273391]. At the beginning of 1997, Progenics received a Phase II Small Business Innovation Research Program (SBIR) grant from the National Institute of Allergy and Infectious diseases (NIAID) to fund the development of PRO-542 [236048]. A further grant of $2.7 million was awarded in August 1998 for the clinical evaluation of PRO-542 and other anti-HIV therapies [294200]. Progenics is collaborating with the Aaron Diamond AIDS Research Center (ADARC) in New York and the Center for Disease Control and Prevention in Atlanta [178410]. In February 2000, Progenics and Genzyme Transgenics Corp signed an agreement to continue the development of a transgenic source of PRO-542. Genzyme will develop transgenic goats that produce PRO-542 in their milk in exchange for undisclosed fees and milestone payments. Genzyme will supply PRO-542 to Progenics for clinical trials with a possibility for eventual commercial supply [357291]. Following on from this, in October 2000, Progenics received an SBIR grant to fund a two-year project with Genzyme Transgenics into the development of cost-effective methods for the manufacture of PRO-542, by optimization of the production of the drug in the milk of transgenic dairy animals [385982]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of PRO-542 and GMK (Progenics Pharmaceuticals) in 2002 [390063]. PMID:11249748

Mukhtar, M; Parveen, Z; Pomerantz, R J

2000-12-01

197

'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

198

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

199

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

200

Pharmaceutical considerations of nitroglycerin  

SciTech Connect

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

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

1983-04-01

201

Needs for new plant-derived pharmaceuticals in the post-genome era: an industrial view in drug research and development  

Microsoft Academic Search

Plant metabolites have been the successful source of drugs and provided considerable value not only to the pharmaceutical\\u000a industry but also to human health problems. Although pharmaceutical companies significantly decreased their activities in\\u000a natural product discovery during the past few decades, various multidisciplinary approaches have been made to create new opportunities\\u000a for finding innovative plant derived pharmaceuticals in post-genome era.

Ying Wang

2008-01-01

202

Drug companies, UNAIDS make drugs available.  

PubMed

The United Nations AIDS (UNAIDS) initiative is working with several drug companies and four countries on a pilot program to build a health infrastructure that provides affordable drugs to insure that combination therapies are used appropriately. The countries involved in the program are Uganda, Chile, Vietnam and Cote d'Ivoire, and the drug companies are Glaxo Wellcome, Hoffmann-La Roche, and Virco NV. Each country agreed to form national HIV/AIDS drug advisory boards, and non-profit companies will act as clearinghouses. Financing will come from the pharmaceutical companies, local health ministries, and a $1 million grant from UNAIDS. The program will be evaluated in terms of improvements to overall health care delivery, number of people treated, the impact on emergency care, and the rate of illness and death. PMID:11364863

1998-01-01

203

[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

204

Exploring the nonlinear effects of patent citations, patent share and relative patent position on market value in the US pharmaceutical industry  

Microsoft Academic Search

This study applied artificial neural networks to explore the influences of the quantitative and qualitative patent indicators upon corporate market value in the US pharmaceutical industry. The results showed that US pharmaceutical companies should not concentrate most of their R&D resources on one particular technological field, but create wider technological capabilities to avoid missing new technological opportunities and to decrease

Yu-Shan Chen; Ke-Chiun Chang

2010-01-01

205

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

206

Metabolic bioactivation and drug-related adverse effects: current status and future directions from a pharmaceutical research perspective.  

PubMed

Retrospective studies indicate that many drugs that cause clinical adverse reactions, such as hepatotoxicity, undergo metabolic bioactivation, resulting in the formation of electrophilic intermediates capable of covalently modifying biological macromolecules. A logical extension of these findings is a working hypothesis that compounds with reduced levels of bioactivation should be inherently safer drug molecules and thus have a greater likelihood of success in drug development. Whereas some research-based pharmaceutical companies have adopted a strategy of addressing metabolic bioactivation early in drug discovery, much skepticism remains on whether such an approach would enable the industry to reach the desired objectives. The debate is centered on the question of whether there is a quantitative correlation between bioactivation and the severity of drug-treatment-related toxicity, and whether covalent protein modification represents only one of several possible mechanisms underlying observed tissue injury. This communication is intended to briefly review the current understanding of drug-induced hepatotoxicity and to discuss the controversy and future directions with respect to the effort of minimizing the probability of clinical adverse reactions. PMID:19939207

Tang, Wei; Lu, Anthony Y H

2010-05-01

207

[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

208

[Development of pharmaceutical expenses in German private health insurance].  

PubMed

Health Insurance costs in Germany have grown by 3 % p. a. over the last ten years and amount to approx. 280 bn EUR in 2009. While costs for stationary treatment as the largest cost category have been intensely analyzed over the past years, pharmaceutical expenses have been analyzed in less detail, mostly focusing on the Statutory Health Insurance side, even though pharmaceutical expenses have grown almost twice as much as costs for ambulant treatments. This research article therefore focuses on the question how pharmaceutical expenses in a large German private health insurance company are allocated with respect to age and indication groups, and how those have developed during the past four years. Therefore, the data of a private health insurance company with more than 600.000 customers was split into price and volume effects per age group to understand if price or volume drives the cost development. Additionally, the two largest indication groups are analyzed in detail. As a result, both price and volume effects drive an overall cost increase of 7,3 %. These effects are even stronger in older age groups. This strong cost increase is not sustainable for the German health insurance system over a longer period of time and will even further increase due to the ageing of the German population. PMID:22619020

Böcking, W; Tidelski, O; Skuras, B; Kitzmann, F; Zuehlke, L

2012-06-01

209

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...

210

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

211

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

212

Implications of outsourcing on operations planning: findings from the pharmaceutical industry  

Microsoft Academic Search

Purpose – The purpose of this paper is to understand the implications of outsourcing at the operational planning level, i.e. how the operational planning function is complicated owing to the strategic outsourcing decisions that have been made in the past. Design\\/methodology\\/approach – First, a literature review on outsourcing is conducted. Second, two case studies at three pharmaceutical companies are conducted

Youssef Boulaksil; Jan C. Fransoo

2010-01-01

213

Current Status of Conducting Alternative Testing to Mammalian Toxicity Studies in the Japan Pharmaceutical Manufacturers Association  

Microsoft Academic Search

To measure the use of alternatives to in vivo mammalian toxicity studies dur- ing drug research and development, the Japan Pharmaceutical Manufacturers Association (JPMA) distributed a questionnaire to its 99 member companies, of which 85 responded and 50 (59%) of them had some experiences in using alter- natives to in vivo mammalian toxicity studies. The results show alternative methods have

Toshiaki Matsuzawa; Akira Koda; Masaharu Hashimato; Toshiji Igarashi

1998-01-01

214

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

215

Routine laboratory analysis for preclinical research in the pharmaceutical industry in Italy: An overview  

Microsoft Academic Search

Last year, the GEET (Italian Association for Haematology and Haematochemistry in Toxicology), which covers most pharmaceutical companies and contract laboratories in Italy, carried out an explorative survey on the analytical procedures commonly used for measuring haematological and clinicochemical parameters in laboratory animals.

R. Airaghi; S. Berlingozzi; S. Cannata; G. Negro; E. Melloni; F. Motta

1994-01-01

216

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

217

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

218

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

219

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

Microsoft Academic Search

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

Edilberto García-Rodríguez; Manuel Rodriguez-martinez

2006-01-01

220

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

PubMed

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

Rusu, Alexandru; Kuokkanen, Katja; Heier, Annabelle

2011-10-01

221

Is Industry-University Interaction Promoting Innovation in the Brazilian Pharmaceutical Industry?  

ERIC Educational Resources Information Center

This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment…

Paranhos, Julia; Hasenclever, Lia

2011-01-01

222

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

223

Aripiprazole (Otsuka Pharmaceutical Co).  

PubMed

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

Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih

2002-01-01

224

42 CFR 482.25 - Condition of participation: Pharmaceutical services.  

Code of Federal Regulations, 2010 CFR

...false Condition of participation: Pharmaceutical services. 482.25 Section 482...25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the...

2010-10-01

225

Medicine and pharmacy--facts and myths about the development of an innovative pharmaceutical industry in Poland.  

PubMed

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. Innovation is necessary. The human population is ageing, and the task of an innovative pharmaceutical industry is to keep it in a good condition. The use of innovative drugs can translate directly into lowering the costs of illness. A continuous reduction in spending on healthcare has been observed. The costs of inventing an innovative drug are enormous though (US dollar 800 million), and studies on a new drug last between 10 and 13 years. An essential element in recovering the incurred costs and ensuring funds needed for new research is protection by patent. Innovative pharmaceutical companies in Poland are committed to increasing the competitiveness and sustaining the development of not only the market, but also the entire pharmaceutical sector. It is a group of companies of crucial importance to the Polish healthcare system, as it influences improvement in the quality of medical services. Through their investments and spending on research and development, innovative companies accelerate economic growth. In Poland, the innovative pharmaceutical industry is represented by the Association of Pharmaceutical Companies Representatives in Poland (SPFFwP). PMID:15726998

Kubiak, W?odzimierz

2005-01-01

226

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

227

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

PubMed

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

Edwards, Brian; Chakraborty, Sweta

2012-11-01

228

Anaerobic pretreatment of pharmaceutical wastewaters  

SciTech Connect

The US Department of Energy's (DOE) Office of Industrial Technologies (OIT) sponsors research and development (R D) to improve the energy efficiency of American industry and to provide for fuel flexibility. The pharmaceutical industry generates considerable amounts of wastewater that require extensive treatment before they are released. A common method of disposal is aerobic biological treatment, but this method is energy intensive and expensive. An alternative process--anaerobic digestion--costs less, saves energy, generates less sludge requiring disposal, and produces a usable fuel--methane. OIT and HydroQual, Inc., with Merck Co. recently completed a joint project that demonstrated the anaerobic biological treatment of wastewaters generated by the pharmaceutical industry. The objectives of the project were to demonstrate how the anaerobic biological process and the resulting energy savings can apply to the pharmaceutical industry and how effective and beneficial the process is to sludge management operations at pharmaceutical plants. This technical case study provides an overview of the DOE-HydroQual-Merck R D project and highlights the field tests done on pilot-scale anaerobic wastewater treatment units at a pharmaceutical plant. This document makes field test and data analysis results available to other researchers and private industry. It discusses project status; summarizes field-test efforts; and reviews potential technology impacts in terms of commercial applications, benefits, and full-scale system economics. 5 figs., 1 tab.

Not Available

1990-10-01

229

[The pharmaceutical industry during the Second World War: issues and evolution].  

PubMed

During the Second World War, French pharmaceutical industry was facing several crises at the same time: economic, social and political crisis, in its relationship with the German occupying forces and the Vichy regime. However, the industrial pharmacy continued its investments and innovation: several specialties were born. Other specialties are largely increasing their sales as they replace missing food (sugar, oil). Relationship with the occupying forces are first to try to escape constraints that are imposed to the companies. But contracts signed with German companies are obviously related to the defeated position of France. Allied are also a source of breach between French companies and their subsidiaries abroad (UK or USA). In this context, the new French law of September 11, 1941 on French Pharmacy appears for Vichy's regime and German occupying forces as a way among others to control the French pharmaceutical industry. PMID:12712987

Bonnemain, Bruno

2002-01-01

230

Marketing to the consumer: perspectives from the pharmaceutical industry.  

PubMed

Individualized health management is one of the most exciting challenges facing health care marketing today. Greater access to health information has empowered consumers to take more control of their health needs, creating a whole new landscape for marketers, manufacturers, and service providers. Customization is the key to creating marketing campaigns that successfully target today's health-conscious consumers. Drawing on individualized market intelligence and available genetic information, pharmaceutical companies are learning to tailor products to meet the needs of this growing market. PMID:11291513

David, C

2001-01-01

231

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 of the implementation. This is one reason why when an institution adopts a curriculum or teaching method developed as they are at the developing institution. Each of the three research-based teaching methods discussed in this chapter have

Maryland at College Park, University of

232

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

233

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...

234

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

235

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

236

DEPARTMENT OF PHARMACEUTICS Fall 2014 Seminars  

E-print Network

PHARMACEUTICAL DOSAGE FORMS Raj Suryanarayanan, Ph.D., Professor of Pharmaceutics and Peters Endowed Chair, U EFFECT OF AMYLOID-BETA PROTEINS ON INSULIN SIGNALING / TRAFFICKING DYNAMICS AT THE BLOOD- BRAIN BARRIER

Weiblen, George D

237

Physical and dielectric properties of pharmaceutical powders  

Microsoft Academic Search

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

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

2003-01-01

238

Agenda for an anthropology of pharmaceutical practice  

Microsoft Academic Search

Over the last two decades, patterns of pharmaceutical-related behavior and the cultural interpretation of medicines have been examined by anthropologists in several cultural settings. In this paper the authors identify additional issues warranting study so as to broaden the scope of pharmaceutical anthropology, utilizing as a unifying focus the examination of pharmaceutical use in the context of social transformation. Ten

Mark Nichter; Nancy Vuckovic

1994-01-01

239

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

240

Introduction The essence of pharmaceutical materi-  

E-print Network

of applications and proper- ties have appeared in the chemistry, physics, and pharmaceutical literature for wellIntroduction The essence of pharmaceutical materi- als science is the application of fundamen- tal, crystalline, and amorphous materials of relevance to the pharmaceutical industry. Like its parent discipline

Elliott, James

241

GRADUATE STUDENT HANDBOOK Department of Pharmaceutical Sciences  

E-print Network

divisions, Medicinal Chemistry, Pharmaceutics, and Health Outcomes and Policy Research. For further1 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

Cui, Yan

242

Pharmaceutical Care Clinic Spring 2009  

E-print Network

Poplavaska Office hours: By appointment popl0017@umn.edu Course Faculty: Robert Cipolle, Pharm.D., FASHP, Director - Peters Institute of Pharmaceutical Care WDH 3-160 Priya Bardal, Pharm.D. Computer documentation. Pharm.D. III students enrolled in this course conduct patient assessments. Pharm.D. I students

Thomas, David D.

243

Pharmaceutical waste management under uncertainty  

Microsoft Academic Search

Due to seasonal differences in production demands, effluent streams from batch manufacturing sites may exhibit considerable variations in number, amount as well as composition. Pharmaceutical and fine chemical production distinguishes itself also in recycling practices since stringent purity requirement often prohibit direct reuse of raw materials in the next batch. Further complications stem from ever changing production campaigns, where each

Andreas A. Linninger; Aninda Chakraborty

2001-01-01

244

Green Chemistry, a Pharmaceutical Perspective  

Microsoft Academic Search

As the Green Chemistry1,2 movement has gained momentum, definitions of Green Chemistry have been dominated predomi- nantly by academic viewpoints. Green Chemistry concepts, however, apply to an incredible diversity of scientific endeavor, which has invariably led to differences between and amongst both academia and industry regarding what constitutes Green Chemistry. Speaking primarily of the pharmaceutical industry and considering the advances

John L. Tucker

2006-01-01

245

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

246

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Cogeneration Company, Sargent Canyon Cogeneration Company, Sycamore Cogeneration Company; Supplemental Notice That Initial Market-Based...Cogeneration Company, Sargent Canyon Cogeneration Company, and Sycamore Cogeneration Company's application for market-based...

2010-02-01

247

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.

248

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

249

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

250

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

PubMed

The German reference pricing system defines a reimbursement threshold for groups of pharmaceuticals. Pharmaceuticals are grouped according to certain criteria by the Federal Joint Committee. To make different active ingredients comparable, so called reference values are defined. Subsequently, the federal association of sickness funds sets reference prices using a regression procedure. However, the impact of the reference price system is limited. On the one hand there is a strong incentive for pharmaceutical companies to decrease prices to the reference price. On the other hand there is no incentive for further price reductions. Additionally, only one part of the pharmaceutical market is affected by reference pricing. Therefore the instrument has only managed to lower pharmaceutical expenditure in the short run. For sustainable long-term cost containment the use of other regulatory instruments is necessary. Nevertheless, compared to other instruments of price-regulation, reference pricing seems to be a good alternative to control pharmaceutical prices, since rationing is kept as little as possible. PMID:16103970

Stargardt, T; Schreyögg, J; Busse, R

2005-07-01

251

University of Washington Company Website Company Type  

E-print Network

University of Washington Company Website Company Type Army Corps of Engineers www.usace.army.mil Public Works Cary Kopczynski & Company www.ckcps.com Structural Engineering Consulting CDM cdm://hnip.net Non-profit Harder Mechanical Contractors www.hardermech.com Mechanical Contractor Harriott Smith

252

Innovation strategies for generic drug companies: moving into supergenerics.  

PubMed

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

Ross, Malcolm S F

2010-04-01

253

The productivity crisis in pharmaceutical R&D.  

PubMed

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

Pammolli, Fabio; Magazzini, Laura; Riccaboni, Massimo

2011-06-01

254

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

255

How much cash does your company need?  

PubMed

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

Passov, Richard

2003-11-01

256

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

Microsoft Academic Search

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

Joel Lexchin

257

Copyright 2008 TTX Company : : CONFIDENTIAL Copyright 2008 TTX Company : : CONFIDENTIAL  

E-print Network

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

Barkan, Christopher P.L.

258

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. PMID:25429253

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

2014-01-01

259

Cell banking for pharmaceutical research.  

PubMed

The provision of high-quality eukaryotic cells through robust cell banking processes is essential for the progression of drug discovery projects throughout the pharmaceutical research process. Numerous models exist to meet this aim, and this review describes many of the underlying principles, challenges and opportunities as well as detailing how these have been addressed within AstraZeneca. Crucial aspects discussed include cell line acquisition, cell bank generation, cryopreservation, storage, tracking and distribution. Because quality assurance underpins much of the process, quality control (QC) testing including mycoplasma screening and cell line authentication are also discussed in detail. Furthermore, because many of the underlying principles of cell banking are applicable in non-pharmaceutical settings, it is hoped that this review will prove a useful resource across the wider scientific community. PMID:24858015

Wrigley, Jonathan D; McCall, Eileen J; Bannaghan, Claire L; Liggins, Laura; Kendrick, Clare; Griffen, Alison; Hicks, Ryan; Fröderberg-Roth, Linda

2014-10-01

260

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

261

Stability of Pharmaceuticals in Space  

NASA Technical Reports Server (NTRS)

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

Nguyen, Y-Uyen

2009-01-01

262

Last year sitagliptin was awarded the Prix Galien for the Best Pharmaceutical Agent in the United States. This award recognizes outstanding achievement in the pharmaceutical industry in the development of new medicines  

Microsoft Academic Search

At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a research-driven pharmaceutical company discovering, developing and marketing a broad range of innovative medicines and vaccines to improve human health. Merck Frosst is one of the top 25 R&D investors in Canada, with an investment of close to $110 million in 2007. More information about Merck Frosst is available

263

[The legal regulation of life cycle of orphan pharmaceuticals].  

PubMed

The legislation of the USA, countries of EU and Japan is analyzed concerning orphan diseases and pharmaceuticals developed for their treatment (orphan pharmaceuticals). The main characteristics and stages of registration of orphan pharmaceuticals in the USA, countries of EU and Japan are considered. Thee peculiarities of orphan pharmaceuticals and pharmaceutical market of orphan pharmaceuticals in the Russian Federation are discussed. The legislative regulation of turnover of orphan pharmaceuticals in the Russian Federation and corresponding obstacles and perspectives are considered. PMID:25219041

Gildeyeva, G N; Kartavtsova, T V

2014-01-01

264

Global gene mining and the pharmaceutical industry  

SciTech Connect

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

Knudsen, Lisbeth E. [Institute of Public Health, University of Copenhagen, Blegdamsvej 3, DK2100 Copenhagen O (Denmark)

2005-09-01

265

Exploitation of biotechnology in a large company.  

PubMed

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

Dart, E C

1989-08-31

266

European pharmacovigilance: increasingly outsourced to drug companies.  

PubMed

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

2014-12-01

267

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

PubMed

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

Lamkin, Matt; Elliott, Carl

2014-01-01

268

An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)  

PubMed Central

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

269

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

270

OxyContin and a Regulation Deficiency of the Pharmaceutical Industry: Rethinking State-Corporate Crime  

Microsoft Academic Search

On May 10, 2007, three executives of the pharmaceutical company Purdue Pharma pled guilty in federal court to misleading doctors\\u000a and patients about the risk of addiction and potential for abuse of OxyContin. Additionally, Purdue Pharma paid over $600\\u000a million in fines and other payments to the United States government and the Commonwealth of Virginia. The drug OxyContin was\\u000a first

O. Hayden Griffin; Bryan Lee Miller

271

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection  

Microsoft Academic Search

The pharmaceutical industry has an outstanding record of innovative performance over the past 50 years. The R&D process has become more knowledge-based and a market for innovation has emerged between research start-ups, development-stage firms, and the larger, multinational companies. At the same time, R&D costs have increased several fold over time and generic products now dominate many traditional therapeutic areas.

Henry Grabowski

2011-01-01

272

MERGERS & ACQUISITIONS IN THE PHARMACEUTICAL INDUSTRY IN SOUTH AMERICA: ACTIVITY AND STRATEGIC INTENTIONS  

Microsoft Academic Search

The popularity of mergers and acquisitions (M&A) used by companies to realize their corporate strategy or attain growth has significantly increased in the past decades. Little attention has been paid to M&A in South America in particular, however, therefore we study the activity and strategic intention of M&A deals that have taken place in the pharmaceutical industry in South America

Christopher B. Kummer

273

Pharmaceutical patent expropriation and technology strategy: strategic options to compulsory licensing  

Microsoft Academic Search

Developing country governments in Sub-Saharan Africa, South America and Southeast Asia, have legislated the controversial business practices of compulsory licensing and parallel importing of HIV\\/AIDS drug therapies – allowing for the domestic manufacture or foreign importing of HIV\\/AIDS generic drug therapies without the consent of the patent holding pharmaceutical industry companies. This article provides a descriptive overview of the economic

Thomas A. Hemphill

2010-01-01

274

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

Microsoft Academic Search

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

Zorana Boltic; Nenad Ruzic; Mica Jovanovic; Slobodan Petrovic

2010-01-01

275

The predictivity of the toxicity of pharmaceuticals in humans from animal data — an interim assessment  

Microsoft Academic Search

This project was undertaken by the International Life Sciences Institute's Health and Environmental Sciences Institute (ILSI-HESI) to develop an improved understanding of the extent to which various types of human toxicities (HTs) manifested during clinical trials could be predicted from standard toxicology studies. A multi-company database of 131 pharmaceutical agents to-date was based on compounds with one or more demonstrated

Harry Olson; Graham Betton; Jeffrey Stritar; Denise Robinson

1998-01-01

276

Marketing Pharmaceuticals: A Constitutional Right to Sell Prescriber-Identified Data?  

Microsoft Academic Search

Pharmaceutical companies have strong economic interests in influencing physician-prescribing behaviors. They advertise direct-to-the-consumer and to the physician. Beyond general marketing, manufacturers promote their drugs to physicians through “detailing”—sales representatives (“detailers”) visiting medical offices to persuade physicians to prescribe their products.\\u000aBy law, pharmacies receive specific information with every prescription, including the physician’s name, the drug, and the dose. Pharmacies sell

Lawrence O. Gostin

2012-01-01

277

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

278

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

279

Pharmaceutical Compounds Studied Using NEXAFS  

SciTech Connect

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; Schroeder, Sven L. M. [Molecular Materials Center, University of Manchester (United Kingdom); Purton, John; Patel, Sunil [Daresubry SRS (United Kingdom)

2007-02-02

280

After compulsory licensing: coming issues in Canadian pharmaceutical policy and politics.  

PubMed

Bills C-22 and C-91 eliminated compulsory licensing for pharmaceutical products in Canada. However, in the wake of these bills there are pressing issues of pharmaceutical policy that need to be decided. The value of additional spending in pharmaceutical R and D has yet to be evaluated. There needs to be a public debate about how far government policy should go in encouraging pharmaceutical R and D as opposed to investing resources in other areas. There has been a continuing escalation in the cost of the average prescription, due to the introduction of newer, but not necessarily more effective, medications. So far government has not been willing to commit resources to promote cost-effective prescribing. Pharmaceutical companies are now lobbying for more rapid approval of products and an extension to the normal patent period to make up for the time that drugs spend in the regulatory process. The process that the government uses to resolve these issues will be just as important as the ultimate decisions. PMID:10165902

Lexchin, J

1997-04-01

281

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

282

Consumer Products Companies Company Website Headquarters  

E-print Network

General Electric Company www.ge.com Fairfield, CT General Mills www.generalmills.com Minneapolis, MN Goya Marini Skin Research www.janmarini.com San Jose, CA Jarden Corporation www.jardencorp.com Rye, NY Jockey.deanfoods.com Dallas, TX Del Monte Foods Company www.delmonte.com San Francisco, CA Dell www.dell.com Round Rock, TX

McGaughey, Alan

283

ACE American Insurance Company (A Stock Company)  

E-print Network

; 6. Health insurance information, worker's compensation, or automobile insurance informationACE American Insurance Company (A Stock Company) Philadelphia, PA (Herein called We, Us, Our if the Covered Person had an accident. "Covered Person" means the person insured under the applicable ACE policy

Fraden, Seth

284

ACE American Insurance Company (A Stock Company)  

E-print Network

the doctor can be reached; 6. Health insurance information, worker's compensation, or automobile insuranceACE American Insurance Company (A Stock Company) Philadelphia, PA (Herein called We, Us, Our to recover from any of your responsible insurers any expenses we incurred. ATTENTION Medical Personnel

Martinez, Tony R.

285

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 Willem.

2001-01-01

286

Impact of the New US Health-Care-Reform Legislation on the Pharmaceutical Industry: Who Are the Real Winners?  

Microsoft Academic Search

Over the past two years, the US pharmaceutical and biotechnology industries were preparing themselves for passage of some type of health-reform legislation with a clear appreciation—and concern—about the enormous impact any law would be likely to have on the structure and viability of the research-based industry. Now, with final passage in March 2010 of the Patient Protection and Affordable Care

C-P Milne; K I Kaitin

2010-01-01

287

A Supply Chain Generalized Network Oligopoly Model for Pharmaceuticals  

E-print Network

A Supply Chain Generalized Network Oligopoly Model for Pharmaceuticals Under Brand Differentiation. A supply chain generalized network oligopoly model for pharmaceuticals under brand differentiation market, accounting for 44% of global industry sales. In 2011, the global pharmaceutical industry

Nagurney, Anna

288

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

289

Biobusiness in the pharmaceutical industry.  

PubMed

Although conventional biotechnology used for the synthesis of antibiotics, vitamins, amino acids, nucleotides, enzyme inhibitors and immunomodulating compounds has still a major impact in the production of pharmaceutical compounds, the importance of the new biotechnology is increasing. Whereas in conventional biotechnology naturally occurring strains are screened for production of pharmacologically active compounds, in new biotechnology known organisms are programmed by genetic engineering to produce a distinct protein or glycoprotein of human origin for substitution therapy. Such complex compounds from new biotechnology can be divided into products which might replace compounds which are already on the market by safer recombinant products such as human insulin, human growth hormone, urokinase, factor VIII and products which are new on the market such as interferons, lymphokines, tissue plasminogen activator, oligonucleotide probes, monoclonal antibodies and subunit vaccines. However, only a few of these recombinant products have reached the market such as human insulin, interferon alpha, interferon beta, human growth hormone and recombivax HB. In most cases, depending on the difficulties in demonstrating clinical efficacy, the investigated drugs have reached the marketing phase much faster than conventional chemical drugs. Return on investment of biotechnical produced pharmaceutics mainly depends on the issues of whether the product has to compete with chemically synthesized drugs, whether it is totally new but competes with other bioproducts, whether it is exceptional but the proof of clinical efficacy is difficult, or whether it is totally new and clinical studies are promising.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:3435605

Werner, R G

1987-09-01

290

Industry's efforts: devices and pharmaceuticals.  

PubMed

The pharmaceutical industry has been irreversibly affected by the changes occurring in healthcare. Despite the obvious contributions of pharmaceuticals to human health, our customers are demanding that we help the patient and contribute to value, whether it be in terms of cost, clinical outcomes, or quality of life. We are learning to balance the variables to ensure that cost plus quality equals value in the marketplace in three ways: by focusing on the needs of the customers and demonstrating value through outcomes research, by maintaining an emphasis on innovation, and by taking an active role in the public arena to direct the course of our future. Outcomes research proves the value of what we do. Economic data will have to be correlated with clinical data. In addition to standard clinical and economic parameters, we must also provide quality of life data. Collaboration between the academic and the practicing community produces a win-win situation for both parties. Industry and practitioners are bonded together ineluctably in the service of the patient. Working together we can shape our future and the future of our patients. PMID:8526683

Sanders, C A

1995-11-01

291

INTERNATIONAL PERCEPTIONS OF THE UK CHEMISTRY RESEARCH BASE  

E-print Network

Medical Research Council INTERNATIONAL PERCEPTIONS OF THE UK CHEMISTRY RESEARCH BASE Chemistry also thank our colleagues from the Medical Research Council (MRC), the Biotechnology and Biological Chemistry Research 19 - 24 April 2009 "If the victory at Waterloo, which set the stage for Britain's pre

292

Research-based communities of practice in UK higher education  

Microsoft Academic Search

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

Lai Ling Ng; Jon Pemberton

2012-01-01

293

A Research-Based Narrative Assignment for Global Health Education  

ERIC Educational Resources Information Center

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

Lencucha, Raphael

2014-01-01

294

Research-Based Teaching Unit on the Tides. Research Report  

ERIC Educational Resources Information Center

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

Viiri, Jouni; Saari, Heikki

2004-01-01

295

What Successful Science Teachers Do: 75 Research-Based Strategies  

ERIC Educational Resources Information Center

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

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

2010-01-01

296

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

Microsoft Academic Search

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

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

2010-01-01

297

Technology Integration: A Research-Based Professional Development Program  

ERIC Educational Resources Information Center

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

Faulder, Tori Rose

2011-01-01

298

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

299

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

300

The Impact of Biotechnology on Pharmaceutics.  

ERIC Educational Resources Information Center

The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

Block, Lawrence H.

1990-01-01

301

Review article Hydrogels in pharmaceutical formulations  

E-print Network

Review article Hydrogels in pharmaceutical formulations N.A. Peppasa,*, P. Buresa , W. Leobandunga , H. Ichikawab a Biomaterials and Drug Delivery Laboratories, School of Chemical Engineering, Purdue University, West Lafayette, IN, USA b Faculty of Pharmaceutical Sciences, Kobe Gakuin University, Kobe, Japan

Peppas, Nicholas A.

302

Potential bias in ophthalmic pharmaceutical clinical trials  

PubMed Central

To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data and observed clinical results. PMID:19668731

Varner, Paul

2008-01-01

303

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

304

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

305

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

306

Nursing role in the pharmaceutical life cycle.  

PubMed

Biologically active, nontherapeutic levels of pharmaceuticals have been detected in waterways and effluent. Although the vast majority of releases stem from human or animal excretion and production effluent, some come from disposal practices. Studies have demonstrated numerous links between environmental exposures from pharmaceutical compounds and their impact upon aquatic life. Nurses need to be aware of this issue since their roles in health care are expanding and considered among the most trusted. Throughout the life cycle of pharmaceuticals (design, approval/regulation, production, use, and discharge/disposal), nursing can play pivotal roles in reducing and eliminating pharmaceutical waste as well as improving public safety through decreasing poisoning and drug abuse. This article discusses the environmental impact of the pharmaceutical life cycle and what roles nurses have as clinicians, educators, advocates, and researchers. PMID:20838174

Becker, Julie; Méndez-Quigley, Teresa; Phillips, Maureen

2010-01-01

307

Review of the performance of the 3T3 NRU in vitro phototoxicity assay in the pharmaceutical industry.  

PubMed

Based on current regulatory guidelines a substantial proportion of drug development portfolios within the pharmaceutical industry trigger the requirements for photosafety testing i.e. absorb light in the range 290-700 nm, and are either applied locally/topically, or 'reach' (EMEA)/'significantly partition to' (FDA) the skin or eyes. There has been growing concern within the pharmaceutical industry over recent years regarding the performance of the in vitro photosafety tests with respect to in vivo predictivity (in animals and in humans). Therefore, the Safety Ad hoc Group (SAHG) of the European Federation of Pharmaceutical Industries and Associations (EFPIA) commissioned a survey of member companies to better understand the triggers for photosafety testing and how in vitro hazard characterisation translated to in vivo risk (both in animal models and in humans). Data were collated for 361 compounds from 10 EFPIA member companies and the results of the phototoxicity survey are reported. Based on these results, it appears that the in vitro photosafety assays are substantially over predicting animal photosafety hazard in vivo and also human photosafety risk in the clinic. This raises concern regarding the use of in vitro photosafety assays for the assessment of chemical photosafety of pharmaceuticals for regulatory purposes. At the very least, a review of the current guidance documents for the photosafety evaluation of pharmaceuticals should be undertaken urgently. PMID:20060695

Lynch, Anthony M; Wilcox, Phillip

2011-03-01

308

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

PubMed Central

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

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

2014-01-01

309

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

310

Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective  

PubMed Central

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

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

2013-01-01

311

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

312

Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association.  

PubMed Central

The history of health care delivery in Canada has been marked by close collaboration between physicians and the pharmaceutical and health supply industries, this collaboration extending to research as well as to education. Since medicine is a self-governing profession physicians have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their duties toward their patients and society. The following guidelines have been developed by the CMA to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents and interns as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA considers that the same principles apply to the relationship between its members and manufacturers of medical devices, infant formulas and similar products, and health care products and service suppliers in general. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada. PMID:8287348

1994-01-01

313

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

314

[Pharmaceutical distribution and retail pharmacy].  

PubMed

In this chapter, the main characteristics of pharmaceutical distribution and retail pharmacy are described. The author analyses the structure of this sector, the agents operating in it -wholesalers, hospital pharmacy services and chemists- and the very few modifications introduced in it in the recent years, focusing on the incentives of its current structure and their consistency with health aims. On the basis of this analysis, the author outlines some possible ways to redefine the sector, which should focus on the promotion of desirable health objectives rather than on the survival of the inefficacies that hinder its evolution. The author pays special attention to the need to modify the inadequate existing retribution system and to substitute it for a different one, which focuses on the professionalism of the service provided, rather than on the profit margin or the sales. PMID:16539978

Meneu, Ricard

2006-03-01

315

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

316

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

317

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

318

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

319

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

320

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

321

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

PubMed

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

Curcio, Pasqualina Curcio

2008-10-01

322

Rx Roulette: combatting counterfeit pharmaceuticals in developing nations  

Microsoft Academic Search

The debate over access to medicines has principally centered on pharmaceutical patents and prohibitively high drug prices. Although a less recognized problem, counterfeit pharmaceuticals are certainly a more insidious barrier to access. Pharmaceutical counterfeiting is an invisible threat, not only by nature, but also because the industry has historically downplayed it. However, that has changed. Pharmaceutical firms now not only

Kristina M. Lybecker

2007-01-01

323

FACULTY OF ARTS & SCIENCE 2012/13 PHARMACEUTICAL CHEMISTRY  

E-print Network

FACULTY OF ARTS & SCIENCE 2012/13 PHARMACEUTICAL CHEMISTRY http://pharmacy.utoronto.ca/pharmchem Pharmaceutical Chemistry combines knowledge of the biological, medical, and physical sciences in the study PROGRAM Pharmaceutical Chemistry (specialist) FIRST-YEAR COURSES The Pharmaceutical Chemistry program does

Toronto, University of

324

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

325

Experiences with GCP in the pharmaceutical industry [corrected].  

PubMed

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

Rämsch, K D

1993-05-01

326

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

PubMed

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

Timmermans, Karin

2004-01-01

327

[Interactions between the pharmaceutical industry and nurses].  

PubMed

The relations between healthcare professionals and pharmaceutical laboratories can influence treatment choices. Increasingly, nurses are a target for a visit from a medical representative. The French National Authority for Health supports professionals in their reception of medical information. PMID:24839688

Grenouilleau, Anne-Sophie; Nabarette, Hervé

2014-04-01

328

Assessing the assessments: Pharmaceuticals in the environment  

SciTech Connect

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

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

2007-11-15

329

Active Pharmaceutical Ingredients and Aquatic Organisms  

EPA Science Inventory

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

330

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

331

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...

332

Department of Pharmaceutical Sciences Seminars Fall 2014  

E-print Network

Department of Pharmaceutical Sciences Seminars Fall 2014 Thursdays 4:00 pm, Phar 305 October 2 New, PhD College of Engineering and Computer Science, Syracuse University "Controlling Bacterial Biofilms

Grünwald, Niklaus J.

333

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.

334

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

335

[The history of modern Korean pharmaceutical education].  

PubMed

During the Korean colonial days from 1910 to 1945, many Japanese pharmacists, druggists, apothecaries and pharmaceutical scientists worked in Korea. Although these fields belong to Japanese pharmaceutical history, there are very few papers about modern Korean pharmaceutical education written in Japanese. There is, however, a huge amount of general books written in Japanese which were published during Korean colonial days. These books are reprinted versions of originals, reprinted in Japan or Korea. It is possible to read these books at the Seoul National University Central Library, Medical Library, the History of Hospital Institute Library, the Central National Library in Seoul, the library in the Pusan Modern History Museum or the Pusan Municipal Library. While reading these books over four weeks in September 2008 in Seoul, information about modern Korean pharmaceutical education was obtained for this paper. PMID:20527293

Ishida, Sumio

2009-01-01

336

Pharmaceutical marketing research and the prescribing physician.  

PubMed

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue. PMID:17502635

Greene, Jeremy A

2007-05-15

337

ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY  

EPA Science Inventory

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

338

Environmental management practices in the Lebanese pharmaceutical industries: implementation strategies and challenges.  

PubMed

This research attempts to provide an understanding of the Lebanese pharmaceutical industries' environmental management strategies, priorities, and perceptions as well as drivers, barriers, and incentives regarding the implementation of the voluntary ISO 14001 Environmental Management System. Accordingly, a semistructured in-depth interview was conducted with the pharmaceutical industries. The findings revealed a significant lack of knowledge about the standard among the industries. The main perceived drivers for adopting the ISO 14001 are improving the companies' image and overcoming international trade. The main perceived barriers for acquiring the standard are the lack of government support and the fact that ISO 14001 is not being legally required or enforced by the government. Moreover, results revealed that adopting the ISO 14001 standard is not perceived as a priority for the Lebanese pharmaceutical industries. Although the cost of certification was not considered as a barrier for the implementation of ISO 14001, the majority of the pharmaceutical industries are neither interested nor willing to adopt the Standard if they are not exposed to any regulatory pressure or external demand. They are more concerned with quality and safety issues with the most adopted international standard among the industries being the ISO 9001 quality management system. This study highlights the aspect that financial barriers are not always the hurdles for implementing environmental management strategies in developing countries and underscores the need for regulatory frameworks and enforcement. PMID:25673269

Massoud, May A; Makarem, N; Ramadan, W; Nakkash, R

2015-03-01

339

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

PubMed

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

Abraham, John

2008-09-01

340

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

PubMed

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

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

2015-04-01

341

Pharmaceuticals in the environment: an educational perspective  

Microsoft Academic Search

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

Marco Eissen; Donata Backhaus

342

Animal-derived pharmaceutical proteins.  

PubMed

Livestock animals have made a significant contribution to human health and well-being throughout humankind's history. A significant contribution of farm animals to human health are the longstanding use of bovine and porcine for production of insulin (for treatment of diabetes), gelatin (for pharmaceutical and other purposes), as well as horse and sheep antibody against natural venoms, toxins, drugs and microbial peptides. Gelatin being the biggest animal protein consumed in human health, follows with antibodies fragments. The chronic problem of animal-derived therapeutics, especially those of high molecular weight, is the immunogenicity induction in addition to their biosafety. However, the invertebrates and lower vertebrates donate the human being a several crucial emergency saving life small-peptides or their analogs such as Refludan, Prialt, Exendin. Not only, but the farm animals are enormously using as models for novel surgical strategies, testing of biodegradable implants and sources of tissue replacements, such as skin and heart valves. Recently, they are being harnessing as bioreactor for production of biopharmaceutical related products through gene farming with efficiency far greater than any conventional microbial or cell-culture production systems. Only 16 transgenic cows would be covering the worldwide needs from human growth hormone. The transgenic, especially animal, technology would be solving a several biopharmaceutical products disadvantages, such as cost, biosafety, immunogenicity and the availability dimensions. PMID:19591041

Redwan, el-Rashdy M

2009-01-01

343

Rejection of pharmaceuticals by forward osmosis membranes.  

PubMed

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

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

2012-08-15

344

Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications  

Microsoft Academic Search

Objectives To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies. Design 42 placebo controlled studies of five selective serotonin reuptake inhibitors submitted to the Swedish drug regulatory authority as a basis for marketing approval for treating major depression were compared with the studies actually published (between

Hans Melander; Jane Ahlqvist-Rastad; Gertie Meijer; Björn Beermann

2003-01-01

345

Current Pharmaceutical Design, 2005, 11, 000-000 1 1381-6128/05 $50.00+.00 2005 Bentham Science Publishers Ltd.  

E-print Network

and effective arsenal of drugs, pharmaceutical companies abandoned their antimicrobial drug development programs of Antimicrobials Osnat Gillor*, Lisa M. Nigro and Margaret A. Riley Department of Ecology and Evolutionary Biology, Yale University, New Haven, CT 06511, USA Abstract: The discovery of penicillin by Fleming in 1928

Gillor, Osnat

346

A Thing Patented is a Thing Divulged: Francis E. Stewart, George S. Davis, and the Legitimization of Intellectual Property Rights in Pharmaceutical Manufacturing, 1879“1911  

Microsoft Academic Search

This article examines the efforts of pharmacist and physician Francis E. Stewart to legitimize the commercial introduction of new drugs by reinterpreting the ethical status of patent rights in pharmaceutical manufacturing. I argue that patents had long been understood by the orthodox medical community as an unethical form of medical monopoly and that, as a result, drug companies that marketed

Joseph M. Gabriel

2009-01-01

347

"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

-- Mixing Medicine with Business, hosted by Bristol-Myers Squibb The Pharmaceutical Industry in getting to know the companies and the people now," he points out. New Jersey is truly the medicine chest and advertising division at the U.S. Food and Drug Administration, was a recent guest lecturer in Legal

Lin, Xiaodong

348

General Electric Trading Company  

Microsoft Academic Search

The General Electric Trading Company (GETC) was launched in 1982 as a potential American sogoshosha through its double mission of: (1) exporting both its own and other companies' products, and (2) countertrading. However, an unfavorable international environment and a new corporate strategy under Chairman Jack Welch led to the abandonment of GETC's exporting task and to the downscaling of its

Joanne Hvala; Anne C Perry; Jean J Boddewyn

1990-01-01

349

The Networking Company  

Microsoft Academic Search

Past research has consistently shown that companies have business and nonbusiness, formal and informal relationships with other actors. With focus on product and process development activities, empirical studies have shown the importance of collaboration with, for example, customers, suppliers, research institutions, and competitors. Research also has highlighted that a company's various relationships are interconnected with each other. But why and

Thomas Ritter

1999-01-01

350

Marketing Plan Company Description  

E-print Network

Marketing Swat Team Project Description and Deliverables: The team will Identify the best online vehicles online marketing plan - executable recommendations - 5 key blogger / Youtuber co-marketing relationshipsMarketing Plan Company Description: Consumer company that provides a product to helps boost

Dahl, David B.

351

Strategy Development Company Description  

E-print Network

that identifies key target markets, and outlines the strategic and tactical approach for launching the products · Forecast (3 years) · Revenue (3 years) B3. MEASURES C. STRATEGY C1. TARGET MARKET C2. POSITIONING STRATEGY. Company Description: A privately-held manufacturer of clever problem-solving products. The company markets

Dahl, David B.

352

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

353

Internship List Company: Gordmans  

E-print Network

Hospitality Intern Location: Fargo, ND Degree: Management Website: https://rn21.ultipro.com/tmi1000/JobInternship List Company: Gordmans Position: Store Intern Location: Fargo, ND Degree: Management Website: http://careerlink.com/job/view/3153/006607 Company: Verizon Wireless Position: Retail/Management

Minnesota, University of

354

Integrating internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio.  

PubMed

The portfolios of pharmaceutical companies have diversified substantially over recent years in recognition that monotherapies and/or small molecules are less suitable for modulating many complex disease etiologies. Furthermore, there has been increased pressure on drug-development budgets over this same period. This has placed new challenges in the path of bioanalytical scientists, both within the industry and with contract research organizations (CROs). Large pharmaceutical, biotechnology and small-medium healthcare enterprises have had to make important decisions on what internal capabilities they wish to retain and where CROs offers a significant strategic benefit to their business model. Our journey has involved asking where we believe an internal bioanalytical facility offers the greatest benefit to progressing drug candidates through the drug-development cycle and where externalization can help free up internal resources, adding flexibility to our organization in order to deal with the inevitable peaks and troughs in workload. PMID:24958115

Summerfield, Scott G; Evans, Christopher; Spooner, Neil; Dunn, John A; Szapacs, Matthew E; Yang, Eric

2014-05-01

355

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

PubMed Central

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

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

2011-01-01

356

Research-Based Implementation of Peer Instruction: A Literature Review  

PubMed Central

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

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

2015-01-01

357

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

PubMed

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

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

2015-03-01

358

The mortality of companies.  

PubMed

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

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

2015-05-01

359

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...

360

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

361

Pharmaceutical reversal of insulin resistance.  

PubMed

Insulin action is approximately doubled following a meal. The mechanism of postprandial insulin sensitization is dependent on hepatic parasympathetic nerves regulated by the prandial status. The nerves provide a permissive signal to the liver that allows insulin to cause the release of a putative hepatic insulin sensitizing substance (HISS) that selectively stimulates glucose uptake into skeletal muscle but not liver or adipose tissue. The parasympathetic signal has several steps identified in the regulatory pathway; acetylcholine acts on muscarinic receptors leading to activation of nitric oxide synthase and generation of HISS. The meal-induced insulin (MIS) sensitization requires hepatic GSH, which decreases with fasting and several disease states. Interfering with the MIS process results in severe insulin resistance with the response to insulin being reduced by approximately 50% to levels seen in the fasted state. A wide range of conditions have been shown to be associated with insulin resistance attributed to lack of the MIS process including insulin resistance; in chronic liver disease produced by chemical damage or bile duct ligation, hepatic denervation, sucrose fed rats, aging, spontaneously hypertensive rats, fetal alcohol exposed adult offspring, spontaneously insulin resistant rats, animals with pharmacological blockade of hepatic muscarinic receptors, NO synthase, cyclooxygenase, hepatic cGMP, and hepatic GSH levels. Pharmaceutical reversal of insulin resistance has been shown in several models using a variety of approaches including mimicking or potentiating the parasympathetic signal using cholinergic agonists, NO donors, cholinesterase antagonists, phosphodiesterase antagonists, and replenishment of hepatic GSH levels. These compounds are being evaluated for therapeutic application by our international academic/industry collaborative team. The MIS process has now been demonstrated in mice, rats, guinea pigs, cats, dogs, and humans, and has been demonstrated by independent laboratories. PMID:15633605

Lautt, W Wayne; Macedo, M Paula; Sadri, Parissa; Legare, Dallas J; Reid, Maria A G; Guarino, Maria P

2004-01-01

362

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

PubMed

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

Kanavos, Panos; Angelis, Aris

2014-01-01

363

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

364

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

SciTech Connect

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

Ataman, Ozlem U., E-mail: ouataman@hotmail.com [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Sambrook, Sally J. [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Wilks, Chris [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Lloyd, Andrew [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Taylor, Amanda E. [Yellow Delaney Communications Ltd, Wilmslow, Cheshire (United Kingdom)] [Yellow Delaney Communications Ltd, Wilmslow, Cheshire (United Kingdom); Wedge, Stephen R. [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)

2012-11-15

365

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

Federal Register 2010, 2011, 2012, 2013, 2014

...International Society for Pharmaceutical Engineering Co-Sponsorship Educational...International Society of Pharmaceutical Engineering (ISPE), is announcing...International Society for Pharmaceutical Engineering, 600 North...

2013-05-06

366

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Notice of Registration; Johnson Matthey Pharmaceutical Materials Inc. By Notice dated November...2011, 76 FR 72974, Johnson Matthey Pharmaceutical Materials Inc., Pharmaceutical Service, 25 Patton Road, Devens,...

2012-03-20

367

78 FR 19017 - Manufacturer of Controlled Substances; Notice of Application; Johnson Matthey Pharmaceutical...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Notice of Application; Johnson Matthey Pharmaceutical Materials, Inc. Pursuant to Sec. 1301...on November 15, 2012, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Service, 25 Patton Road, Devens,...

2013-03-28

368

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Notice of Registration; Johnson Matthey Pharmaceutical Materials, Inc. By Notice dated March...2013, 78 FR 19017, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Services, 25 Patton Road, Devens,...

2013-07-31

369

'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

370

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Company, Florida Gas Transmission...Transcontinental Gas Pipe Line Company...Matagorda Offshore Pipeline System Abandonment Project and Request...Matagorda Offshore Pipeline System Abandonment Project (Project...Northern Natural Gas Company,...

2010-07-21

371

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Company, Florida Gas Transmission...Transcontinental Gas Pipe Line Company...Matagorda Offshore Pipeline System Abandonment Project November...Matagorda Offshore Pipeline System Abandonment Project proposed...Northern Natural Gas Company,...

2010-11-29

372

Modeling choice behavior for new pharmaceutical products.  

PubMed

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

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

2001-01-01

373

Marketing concepts for pharmaceutical service development.  

PubMed

Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers. PMID:7211890

Grauer, D W

1981-02-01

374

Pharmaceutical challenges in veterinary product development.  

PubMed

There are many similarities between the human health and animal health industries. Both industries are research driven, have global presence, are highly regulated, and have to profit in a competitive business environment. However, there are also notable differences. This review highlights and discusses those differences as they relate to the pharmaceutical challenges in veterinary product development. This paper provides a brief review of the animal health pharmaceutical product landscape, segmentation, and market evolution; highlights challenges and special considerations in veterinary drug delivery; and identifies unmet needs in animal health along with recent advances. PMID:12363436

Ahmed, Imran; Kasraian, Kasra

2002-10-01

375

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 ...

376

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...

377

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

378

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.

379

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

PubMed Central

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

Bubela, Tania; Boon, Heather; Caulfield, Timothy

2008-01-01

380

Company and Industry Research guide  

E-print Network

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

Azevedo, Ricardo

381

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

382

IMPROVING STRATEGIC RISK MANAGEMENT WITHIN PHARMACEUTICAL SUPPLY CHAIN  

Microsoft Academic Search

No modern supply chain is immune to both predictable and unpredictable risks. Because modern pharmaceutical supply chains are more than ever exposed to risks, it behooves the global pharmaceutical industry to implement strategic risk management. To prosper and flourish, it is imperative for the Ghanaian pharmaceutical industry to assess risks and develop comprehensive risk management strategies. One of the crucial

Chris I. Enyinda; Charles Briggs; Andrea Hawkins

2009-01-01

383

The role of quality in pharmaceutical care management  

Microsoft Academic Search

Pharmaceutical care has caused considerable attention in the pharmacy literature, because this concept alters the care and services that pharmacists provide to the public. In the pharmaceutical care concept, pharmacists must ultimately accept their responsibility not only to dispense drugs but also to identify, correct and prevent drug-related problems. Pharmaceutical care represents a significant transition in the profession of pharmacy,

Waleed M. S. Al-Shaqha; Mohamed Zairi

2001-01-01

384

The Pharmaceutical Sales Rep\\/Physician Relationship in Turkey  

Microsoft Academic Search

In many developed countries, the physician\\/pharmaceutical sales representative relationship has increasingly become the focus of ethical questions. Given this context, the purpose of the present study was to determine the ethical dilemmas faced by pharmaceutical sales representatives in Turkey in their relations with physicians, and to identify possible solutions. Through an investigator-designed questionnaire, the ethical problems perceived by 215 pharmaceutical

Dilaver Tengilimoglu; Adnan Kisa; Aykut Ekiyor

2005-01-01

385

Appendix C. Degree Requirements GRADUATE PROGRAM IN PHARMACEUTICAL CHEMISTRY  

E-print Network

25 Appendix C. Degree Requirements GRADUATE PROGRAM IN PHARMACEUTICAL CHEMISTRY M.S. DEGREE of the units must be graduate work in the major field. The 9-unit Pharmaceutical Chemistry sequence of CHE 130A units CHE 263 Introduction to Research Methodology 9 units CHE 296 Research in Pharmaceutical Chemistry

Ullrich, Paul

386

DEPARTMENT OF PHARMACEUTICS Spring 2014 Seminars  

E-print Network

) February 13 Insulin Trafficking at the Blood-Brain Barrier in Alzheimer's Disease VIDUR SARMA, Graduate.D., Associate Professor of Pharmaceutics, U Minnesota (bio) April 10 Alzheimer's Disease Amyloid Beta Protein-engineered Mesenchymal Stem Cells as Targeted Therapeutic Carriers SWAYAM PRABHA, MBA, Ph.D., Assistant Research

Weiblen, George D

387

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...

388

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.

389

The Pharmaceutical Care Movement: Opportunities for Collaboration.  

ERIC Educational Resources Information Center

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

Temple, Thomas R.

1996-01-01

390

Pollution prevention in the pharmaceutical industry  

SciTech Connect

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

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

1995-09-01

391

Oxidative treatment of pharmaceuticals in water  

Microsoft Academic Search

Environmentally relevant pharmaceuticals were chosen according to human consumption and occurrence in the aquatic environment like sewage plant effluents, rivers and groundwater to investigate their behavior during oxidative water treatment. Derived from data compilation in literature the lipid lowering agent clofibric acid and the analgesic agents ibuprofen and diclofenac were selected. Analyses of the acidic compounds were carried out after

C. Zwiener; F. H. Frimmel

2000-01-01

392

Valuing Biodiversity for Use in Pharmaceutical Research  

Microsoft Academic Search

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

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

1996-01-01

393

Phytoremediation of Pharmaceuticals—Preliminary Study  

Microsoft Academic Search

Phytoremediation of selected pharmaceuticals (diclofenac, ibuprofen, and acetaminophen) using Armoracia rusticana and Linum usitatissimum cell cultures and by hydroponically cultivated Lupinus albus, Hordeum vulgaris, and Phragmites australis plants in laboratory conditions is described. During in vitro experiments, the best results for acetaminophen were achieved using Armoracia rusticana hairy root cultures, where 100% of the starting amount was removed from the

Jan Kotyza; Petr Soudek; Zden?k Kafka; Tomáš Van?k

2010-01-01

394

NUTRACEUTICAL AND PHARMACEUTICAL USES OF LEGUMES  

Technology Transfer Automated Retrieval System (TEKTRAN)

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

395

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

396

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

397

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

398

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

399

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

400

Ability grouping and science education reform: Policy and research base  

NASA Astrophysics Data System (ADS)

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

Lynch, Sharon

401

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

PubMed Central

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

2013-01-01

402

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

403

Pharmaceutically Used Polymers: Principles, Structures, and Applications of Pharmaceutical Delivery Systems  

Microsoft Academic Search

\\u000a This chapter presents a general overview of pharmaceutically used polymers with respect to their physicochemical characteristics\\u000a and factors affecting drug delivery abilities. Pharmaceutical polymers, chemical structure, and properties are discussed for\\u000a their applications in controlled drug release systems. An additional focus is on new polymers (dendrimers, hyperbranched polymers),\\u000a considering their chemical versatility, uniqueness, and future implications. Problems associated with controlled

Jayant Khandare; Rainer Haag

404

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

405

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

PubMed

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

Champmartin, C; Clerc, F

2014-01-01

406

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

PubMed

During the past 10 years, immunologists, epidemiologists and parasitologists have made many new exciting discoveries in the field of helminth-mediated immune regulation. In addition, many animal experiments have shown that certain helminths or products derived from helminths can protect mice from developing allergic or autoimmune disease. Some clinical trials utilising Trichuris suis or Necator americanus for the treatment of allergic disorders and inflammatory bowel disease have been conducted. The outcomes of these trials suggest that they may be used to treat these disorders. However, to date no helminth therapy is routinely being applied to patients and no helminth-derived product therapy has been developed. In order to bring new drugs to the market and shoulder the enormous costs involved in developing such therapies, pharmaceutical companies need to be involved. However, currently the resources from the pharmaceutical industry devoted to this concept are relatively small and there are good reasons why the industry may have been reluctant to invest in developing these types of therapies. In this review article, the hurdles that must be overcome before the pharmaceutical industry might invest in these novel therapies are outlined. PMID:23291462

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

2013-03-01

407

Understanding pharmaceutical research manipulation in the context of accounting manipulation.  

PubMed

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

Brown, Abigail

2013-01-01

408

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

409

Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem  

NASA Astrophysics Data System (ADS)

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

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

2014-05-01

410

How should we teach faculty about research-based teaching?  

NASA Astrophysics Data System (ADS)

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

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

2015-01-01

411

An insight into the emerging role of regional medical advisor in the pharmaceutical industry.  

PubMed

The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines. PMID:24010061

Gupta, Sandeep Kumar; Nayak, Roopa P

2013-07-01

412

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

PubMed

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

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

2012-01-01

413

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

414

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

415

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

416

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 mechanicalE Mechanism, when applicable. · Perform static, dynamic, vibration, thermal, and other engineering analysis

Kostic, Milivoje M.

417

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

418

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

419

External referencing and pharmaceutical price negotiation.  

PubMed

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

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

2011-06-01

420

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

421

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

422

Biomagnetic Methods: Technologies Applied to Pharmaceutical Research  

Microsoft Academic Search

Biomagnetic methods have been designed for a wide range of applications. Recently, such methods have been proposed as alternatives\\u000a to scintigraphy for evaluating of a number of pharmaceutical processes in vitro as well as under the influence of gastrointestinal physiological parameters. In this review, physical characterization as\\u000a well as the most recent applications of Superconducting Quantum Interference Device (SQUID), Anisotropic

Luciana A. Corá; Madileine F. Américo; Ricardo B. Oliveira; Cristina H. R. Serra; Oswaldo Baffa; Raul C. Evangelista; Giselle F. Oliveira; José Ricardo Aruda Miranda

2011-01-01

423

Pricing and reimbursement of pharmaceuticals in Belgium.  

PubMed

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

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

1997-03-01

424

Spectrophotometric determination of codeine in pharmaceutical preparations  

Microsoft Academic Search

Two spectrophotometric methods are described for the determination of tiopronin in pharmaceuticals. They are based on the oxidation-reduction reaction between tiopronin and iron (III), then forming a complex between iron (II) and ferrozine or di-2-pyridyl ketone-2-thiophenoylhydrazone. The produced colored iron (II)-ferrozine complex (system I) absorbs at 562 nm, while the iron (II)-di-2-pyridyl ketone-2- thiophenoylhydrazone complex (system II) absorbs at 656

M. Jeliki?-Stankov; D. Veselinovi?; Z. Koricanac; T. Jovanovic

1981-01-01

425

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

426

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

PubMed

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

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

2012-08-01

427

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

PubMed

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

Ferreira, Ana P; Tobyn, Mike

2014-03-18

428

The impact of TRIPS on innovation and exports: a case study of the pharmaceutical industry in India.  

PubMed

Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India. PMID:18624153

Malhotra, Prabodh

2008-01-01

429

[Thoughts on a program for pharmaceutical practice].  

PubMed

The educational curriculum for pharmaceutical students in Japan will be dramatically changed in April, 2006. There has been active discussion about how to manage the additional two years in the new program to educate students most effectively. In particular, the program of clinical practice in pharmacies, which will be undertaken for 10 weeks, has been received enthusiastically, because it was not considered sufficient in the previous educational program and it will be one of the most important issues in the new curriculum. I am neither a pharmacist nor a professional in pharmaceutical education, but I believe firmly that an effective program of clinical practice in community pharmacies will be indispensable in making the new curriculum successful. I also believe that community pharmacists educated in the new course will change medical systems in this country from the viewpoint of a general thoracic surgeon and chief executive officer of Pharmedico, Co., Ltd. which manages eight pharmacies in Osaka, Japan. In this article, I give my opinions on the advisable vector of clinical practice for pharmaceutical students and the direction of clinical training in the new educational program. PMID:17268146

Hazama, Kenji

2007-02-01

430

Analysis of the World Bank's pharmaceutical lending.  

PubMed

This article analyzes the World Bank's lending activity on pharmaceuticals and medical products (PMP) during the fiscal years (FY) 1999-2001 by regions, borrower and supplier country, and procurement method. Data for the study derived from the World Bank Project and the Business Warehouse databases. The information included all Bank projects approved during the study period. Information for the PMP procurement contracts was extracted for the health sector components of all sector projects awarded. Contract dollar amount was aggregated by borrower and supplier countries. A total of 365 contracts of PMP for a value of US$ 364.5 million (2001 prices) were awarded. International competitive bidding was the most common procurement method used representing 46.0% of the total PMP contracts amount. Domestic providers supplied 52.5% of the PMP contracts managed by the borrower countries. Twenty-two countries accounted for 97.0% of the total PMP purchased during the period of analysis. Only a small fraction of the Bank activity was directed to the pharmaceutical sector. There is a need for more involvement of the World Bank to increase accessibility, affordability and rational use of pharmaceuticals and medical products. An evaluation of the different procurement methods and their implications on drug quality and prices should be performed. PMID:16824640

Rodríguez-Monguió, Rosa; Rovira, Joan; Seoane-Vázquez, Enrique

2007-04-01

431

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

432

Photo-pharmaceutical therapy: features and prospects  

NASA Astrophysics Data System (ADS)

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

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

2001-07-01

433

Solventless pharmaceutical coating processes: a review.  

PubMed

Coatings are an essential part in the formulation of pharmaceutical dosage form to achieve superior aesthetic quality (e.g., color, texture, mouth feel, and taste masking), physical and chemical protection for the drugs in the dosage forms, and modification of drug release characteristics. Most film coatings are applied as aqueous- or organic-based polymer solutions. Both organic and aqueous film coating bring their own disadvantages. Solventless coating technologies can overcome many of the disadvantages associated with the use of solvents (e.g., solvent exposure, solvent disposal, and residual solvent in product) in pharmaceutical coating. Solventless processing reduces the overall cost by eliminating the tedious and expensive processes of solvent disposal/treatment. In addition, it can significantly reduce the processing time because there is no drying/evaporation step. These environment-friendly processes are performed without any heat in most cases (except hot-melt coating) and thus can provide an alternative technology to coat temperature-sensitive drugs. This review discusses and compares six solventless coating methods - compression coating, hot-melt coating, supercritical fluid spray coating, electrostatic coating, dry powder coating, and photocurable coating - that can be used to coat the pharmaceutical dosage forms. PMID:17510883

Bose, Sagarika; Bogner, Robin H

2007-01-01

434

Pharmaceutical Research and Manufacturers of America  

MedlinePLUS

... Catalyst Blog New Report Highlights a Decade of Innovation in Rare Diseases New Analysis: Who Benefits from ... Stories Of Bringing New Treatments To Market Medical innovation from America’s biopharmaceutical research companies continues to help ...

435

Adsorption of pharmaceuticals onto trimethylsilylated mesoporous SBA-15.  

PubMed

The adsorption of a complex mixture of 12 selected pharmaceuticals to trimethylsilylated mesoporous SBA-15 (TMS-SBA-15) has been investigated by batch adsorption experiments. The adsorption of pharmaceuticals to TMS-SBA-15 was highly dependent on the solution pH and pharmaceutical properties (i.e., hydrophobicity (logKow) and acidity (pKa)). Good log-log linear relationships between the adsorption (Kd) and pH-dependent octanol-water coefficients (Kow(pH)) were then established among the neutral, anionic, and cationic compounds, suggesting hydrophobic interaction as a primary driving force in the adsorption. In addition, the neutral species of each compound accounted for a major contribution to the overall compound adsorption onto TMS-SBA-15. The adsorption kinetics of pharmaceuticals was evaluated by the nonlinear first-order and pseudo-second-order models. The first-order model gave a better fit for five pharmaceuticals with lower adsorption capacity, whereas the pseudo-second-order model fitted better for seven pharmaceuticals having higher adsorption capacity. In the same group of properties, pharmaceuticals having higher adsorption capacity exhibited faster adsorption rates. The rate-limiting steps for adsorption of pharmaceuticals onto TMS-SBA-15 are boundary layer diffusion and intraparticle diffusion including diffusion in mesopores and micropores. In addition, the adsorption of pharmaceuticals to TMS-SBA-15 was not influenced by the change of initial pharmaceutical concentration (10-100?gL(-1)) and the presence of natural organic matter. PMID:23643958

Bui, Tung Xuan; Pham, Viet Hung; Le, Son Thanh; Choi, Heechul

2013-06-15

436

International experience in controlling pharmaceutical expenditure: influencing patients and providers and regulating industry – a systematic review  

PubMed Central

Objective To review international policies to control expenditure on pharmaceuticals by influencing the behaviour of patients and providers and regulating the pharmaceutical industry. Method Systematic review of experimental and quasi-experimental studies. Published studies were identified with an electronic search strategy using MEDLINE and EMBASE from 1980 to May 2012. Studies were eligible if they assessed the effect of policies aimed at influencing the behaviour of patients and providers, and regulating the pharmaceutical industry. Outcome measures included pharmaceutical expenditure, prices or utilization; other resource use relating to pharmaceuticals; and health outcomes and patients’ or providers’ behaviour relating to pharmaceutical use. Quality assessment criteria for each study design were developed based on the standard criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group. The review includes studies based on randomized controlled trials and rigorous quasi-experimental designs (interrupted time-series and controlled before-and-after studies). Studies were excluded if they were conducted within a single hospital or practice; related to pharmaceutical care services or disease management; had less than 6 months of follow-up period (or less than 12 months overall for interrupted time series); if data in controlled before-and-after studies were not collected contemporaneously or if no rationale was stated for the choice of control group; or if relevant and interpretable data were not presented. Results A total of 255 studies met the inclusion criteria for this review. The majority of the studies relating to patients evaluated cost sharing interventions such as user charges (52 studies). User charges do reduce utilization of pharmaceuticals, and reduce public expenditure by shifting costs to patients. But they reduce the use of essential as well as non-essential drugs, and without adequate exemptions they affect vulnerable groups disproportionately. The majority of studies relating to doctors evaluated the effects of educational approaches (78 studies), reimbursement restrictions (48 studies) and incentive systems (22 studies). Evidence on these policies is of mixed quality. It appears possible to influence prescribing modestly, through various means, but it is essential that messages to prescribers are based on good evidence of effectiveness and cost-effectiveness. Twenty-nine studies related to industry regulation, and they were of mixed quality. Evidence from studies of reference pricing suggests that this may result in cost savings. These are, however, achieved not by companies reducing or restraining prices, or by reductions in the overall volume of prescriptions, but by some shifts in use and shifting costs to patients, with consequent adverse effects on the equity of access to medicines. Other price and profit controls remain almost completely lacking in evaluative evidence. Conclusions It may be that the undesirable consequences of policies influencing patients, particularly user charges, can outweigh the benefits. To influence demand for pharmaceuticals, it is more appropriate to influence prescribing doctors and although interventions to improve prescribing practice have been developed, they often achieve relatively modest benefits and sometimes at high cost. Good evaluative evidence related to industry regulation is scarce despite its policy importance. PMID:25092883

Lee, Iyn-Hyang; Hewitt, Catherine; Maynard, Alan

2015-01-01

437

Multilingualism in Companies: An Introduction  

ERIC Educational Resources Information Center

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

Sherman, Tamah; Strubell, Miquel

2013-01-01

438

The Dutch East India Company  

Microsoft Academic Search

The Dutch East India Company, founded in 1602, was one of the first companies in the world and became the largest company in the world in that period. This case offers an historical perspective on the development of economical and financial institutions, which were both critical to, and laid the foundations for, the development of capitalism. The case compares the

Wei Li

439

Company Annual Reports Online (CAROL)  

NSDL National Science Digital Library

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

440

[History of pharmaceutical packaging in modern Japan. II--Package size of pharmaceuticals].  

PubMed

When planning pharmaceutical packaging, the package size for the product is important for determining the basic package concept. Initially, the sales unit for herbal medicines was the weight; however in 1868, around the early part of the Meiji era, Japanese and Western units were being used and the sales unit was confusing. Since the Edo era, the packing size for OTC medicines was adopted using weight, numbers, dosage or treatment period. These were devised in various ways in consideration of convenience for the consumer, but the concept was not simple. In 1887, from the time that the first edition of the Japanese Pharmacopoeia came out, use of the metric system began to spread in Japan. Its use spread gradually for use in the package size of pharmaceutical products. At the time, the number of pharmaceutical units (i.e., tablets), became the sales unit, which is easy to understand by the purchaser. PMID:25799840

Hattori, Akira

2014-01-01

441

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

442

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

ERIC Educational Resources Information Center

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

Leschinsky, Maribeth; Messemer, Jonathan E.

2010-01-01

443

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

ERIC Educational Resources Information Center

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

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

2012-01-01

444

Preservice Teachers' Thinking within a Research-Based Framework: What Informs Decisions?  

ERIC Educational Resources Information Center

A research-based framework for teaching science is a heuristic tool used to help preservice teachers conceptualize many complexities of teaching while making explicit the strategy to use a research-based body of professional knowledge to inform instructional decision-making (Clough, 2003, Paper presented at the annual meeting of the Association…

Olson, Joanne K.

2007-01-01

445

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

446

Pharmaceutical expenditure, total health-care expenditure and GDP.  

PubMed

This paper analyses the evolution of pharmaceutical expenditure with respect to GDP for a group of the most important OECD economies. We find that this relationship is not stable across the sample considered (1960-2003), and heterogeneity is found in the temporal evolution of the variables and across countries. Furthermore, we can see differences in the income elasticity estimation when we disaggregate pharmaceutical expenditure into its private and government components or when the total health-care expenditure (Total HCE) is disaggregated into its pharmaceutical and non-pharmaceutical components. We conclude that the changes in the elasticity of pharmaceutical expenditure and in the Total HCE elasticity are due to the private component and the pharmaceutical expenditure behaviour, respectively. PMID:18050150

Clemente, Jesús; Marcuello, Carmen; Montañés, Antonio

2008-10-01

447

WHO Expert Committee on Specifications for Pharmaceutical Preparations.  

PubMed

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the latest volume of The International Pharmacopoeia and quality specifications for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on good trade and distribution practices for pharmaceutical starting materials, guidelines on the WHO scheme for the certification of pharmaceutical materials moving in international commerce, draft procedures for assessing quality control laboratories and procurement agencies for use by United Nations agencies, and guidelines for preparing a laboratory information file and a procurement agency information file. PMID:15024913

2003-01-01

448

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

PubMed

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

Arnold, Denis G; Oakley, James L

2013-06-01

449

Adequacy of pharmacological information provided in pharmaceutical drug advertisements in African medical journals  

PubMed Central

Pharmaceutical advertisement of drugs is a means of advocating drug use and their selling but not a substitute for drug formulary to guide physicians in safe prescribing. Objectives: To evaluate drug advertisements in Nigerian and other African medical journals for their adequacy of pharmacological information. Methods: Twenty four issues from each of West African Journal of Medicine (WAJM), East African Medical Journal (EAMJ), South African Medical Journal (SAMJ), Nigerian Medical Practitioner (NMP), Nigerian Quarterly Journal of Hospital Medicine (NQJHM) and Nigerian Postgraduate Medical Journal (NPMJ) were reviewed. While EAMJ, SAMJ and NMP are published monthly, the WAJM, NQJHM and NPMJ are published quarterly. The monthly journals were reviewed between January 2005 and December 2006, and the quarterly journals between January 2001 and December 2006. The drug information with regards to brand/non-proprietary name, pharmacological data, clinical information, pharmaceutical information and legal aspects was evaluated as per World Health Organisation (WHO) criteria. Counts in all categories were collated for each advertiser. Results: Forty one pharmaceutical companies made 192 advertisements. 112 (58.3%) of these advertisements were made in the African medical journals. Pfizer (20.3%) and Swipha (12.5%) topped the list of the advertising companies. Four (2.1%) adverts mentioned generic names only, 157 (81.8%) mentioned clinical indications. Adults and children dosage (39.6%), use in special situations such as pregnancy and renal or liver problems (36.5%), adverse effects (30.2%), average duration of treatment (26.0%), and potential for interaction with other drugs (18.7%) were less discussed. Pharmaceutical information such as available dosage forms and product and package information {summary of the generic and proprietary names, the formulation strength, active ingredient, route of administration, batch number, manufactured and expiry dates, and the manufacturer on both the container and pack of the drug} were mentioned in 65.6% and 50% adverts, respectively. The product and package descriptions were provided in 57 (72.2%) Nigerian medical journals, which was significantly higher than in other African medical journals 39 (37.9%) (P<0.001). Conclusions: None of the drug advertisements in the journals adequately provided the basic information required by the WHO for appropriate prescribing. More guidance and regulation is needed to ensure adequate information is provided. PMID:25152785

Oshikoya, Kazeem A.; Senbanjo, Idowu O.; Soipe, Ayo

2008-01-01

450

Essential drugs and registration of pharmaceuticals: the Sri Lankan experience.  

PubMed Central

Many factors influence the regulation of pharmaceuticals in a country. The essential drugs concept, formulated by the World Health Organization to assist developing countries in selecting appropriate drugs, also provides a basis for regulation. Sri Lanka has long regulated pharmaceuticals as part of its health policy. Over 70% of 3436 pharmaceutical product registrations were found to be drugs (or alternatives) named in the country's essential drugs list. This is despite the fact that product registrations are mainly for the private health care sector, and the list is for the state sector. The essential drugs concept therefore appears to have influenced the pharmaceuticals registered in Sri Lanka. PMID:8490987

Weerasuriya, K.

1993-01-01

451

WHO Expert Committee on Specifications for Pharmaceutical Preparations.  

PubMed

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format. PMID:21699061

2011-01-01

452

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

453

[Introduction to pharmaceutical sciences from the faculty of pharmaceutical science of Leuven: an experience of cohabitation].  

PubMed

Teaching Pharmacy Practice as an approach to pharmaceutical care started in 1991 at the Katholieke Universiteit Leuven (KUL). Although completely new, none of the courses related to pharmacy practice was compulsory for all students, due to the option system adopted at the Faculty of Pharmaceutical Sciences of the KUL. After 10 years the number of students choosing for the option community and hospital pharmacy (most related to pharmacy practice) is stabilized at about 60% of the total number of students. From the very beginning. It was quite difficult to harmonize the research field of pharmacy practice with the more fundamentally oriented research activities in the different pharmaceutical laboratories. This resulted in a "Living Apart Together" (LAT) relationship with some negative consequences on activity funding. Nevertheless interesting research projects emerged from the Division of Drug and Patient Information. One PhD thesis was achieved. In the near future external partners may play an important role in structural support of research activities. These research is necessary to ensure the presence of pharmaceutical care as a validated discipline in the training of future pharmacists. PMID:12476677

Laekeman, Gert; Leemans, Lies; De Vriese, Valerie

2002-01-01

454

Regulating the Pharmaceutical IndustryRegulating the Pharmaceutical Industry The Wharton School  

E-print Network

') -- the Thalidomide Disaster 1984: Hatch-Waxman Bill (`price') -- created the generic drug industry #12;Role the Pharmaceutical Industry History, Pricing, Drug Pipeline, Blockbuster Drugs, Legislative Trends, Federal Courts History, Pricing, Drug Pipeline, Blockbuster Drugs, Legislative Trends, Federal Courts #12;FDA: important

455

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

456

New areas of plant-made pharmaceuticals.  

PubMed

On October 15 2010 the meeting 'Recombinant Pharmaceutical Manufacturing from Plants - The Future of Molecular Farming' hosted by EuroScicon was held at BioPark Hertfordshire, Welwyn Garden city, UK. The scientific program of this very eventful meeting was wide ranging and covered diverse aspects of biopharming. The highlights presented included: safety issues in biopharming; coexpression of multiple proteins; steps towards vaccine generation; and engineering of secondary metabolites and medicinal plants. This article summarizes the stimulating scientific presentations and fruitful panel discussions that subsequently arose during and after this event. PMID:21332263

Hassan, Syed Waqas; Waheed, Mohammad Tahir; Lössl, Andreas G

2011-02-01

457

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

458

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

459

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

NASA Astrophysics Data System (ADS)

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

Kartono, R.; Basuki, Y. T.

2014-03-01

460

Pharmaceutical care education in Kuwait: pharmacy students’ perspectives  

PubMed Central

Background Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists’ physical separation from patient care areas (82.6%). Conclusion Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also recognizing the barriers to its widespread adoption. The education and training provided at Kuwait University Faculty of Pharmacy is designed to develop students to be the change agents who can advance pharmacist-provided direct patient care. PMID:25243027

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

2014-01-01

461

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

462

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-07-01

463

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

Federal Register 2010, 2011, 2012, 2013, 2014

...composed of an active pharmaceutical ingredient (API...product development. Pharmaceutical co-crystals have...the opportunity for engineering solid-state forms...product manufacture. Pharmaceutical co-crystals...

2013-04-26

464

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

465

ocietal pressures to reduce healthcare costs, coupled with the pharmaceutical industry's need to maintain its eco-  

E-print Network

ocietal pressures to reduce healthcare costs, coupled with the pharmaceutical industry's need to formulation development based on individual formulators' experiences are gone, and pharmaceutical scientists, several surveys have revealed a generally favorable consumer attitude toward 44 Pharmaceutical Technology

Peng, Yun

466

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

Federal Register 2010, 2011, 2012, 2013, 2014

...composed of an active pharmaceutical ingredient (API...product development. Pharmaceutical co-crystals have...the opportunity for engineering solid-state forms...product manufacture. Pharmaceutical co-crystals...

2011-12-02

467

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

468

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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