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1

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.

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

2015-01-01

2

A Study on Performance Evaluation for Taiwan Pharmaceutical Company Diversification Strategy.  

E-print Network

??The business model of Taiwan local pharmaceutical company is different from original pharmaceutical company. Taiwan local pharmaceutical company gets major profits by selling generic products.… (more)

Chiang, Yi-Chen

2013-01-01

3

Informed consent: Enforcing pharmaceutical companies' obligations abroad.  

PubMed

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

Lee, Stacey B

2010-01-01

4

Ghost marketing: pharmaceutical companies and ghostwritten journal articles.  

PubMed

The use of ghostwriters by industry is subject to increasing public attention and scrutiny. This article addresses the practice and ethics of scientific ghostwriting. We focus on the type of ghostwriting that involves a pharmaceutical company hiring a medical education and communications company to write a paper favorable of their product, who then hires a well-known academic to publish it under his or her name without disclosing the paper's true origins. We argue that this practice is harmful both to the public and to the institutions of science and that it is not justified by an analogy to accepted scientific authorship practices. Finally, we consider ways to discourage the practice. PMID:17259673

Moffatt, Barton; Elliott, Carl

2007-01-01

5

Unethical Marketing Practices of Pharmaceutical Companies in Pakistan: A Case Study of Sukkur Division  

Microsoft Academic Search

Pakistani pharmaceutical industry is synchronized by various legal perspectives to make certain the health of people of Pakistan but unfortunately rising population, inflation and people's wish to have money to burn leads to unethical practices so as in Pharmaceutical companies of Pakistan. Keeping in view the rising trend of unethical drug promotional activities in Pharmaceutical industry, a prior study was

Saeed Abbas Shah; Hyder Ali Khawaja

2013-01-01

6

Communicating CSR via pharmaceutical company web sites : Evaluating message frameworks for external and internal stakeholders  

Microsoft Academic Search

Purpose – The purpose of this paper is to discover what corporate social responsibility (CSR) message themes are being communicated in selective pharmaceutical companies' mission and core values statements and their relevance to internal and external audiences. Design\\/methodology\\/approach – A content analysis of five pharmaceutical companies mission and value statement web pages are analyzed. A panel developed a list of

Morgan Sones; Susan Grantham; Edward T. Vieira

2009-01-01

7

Pharmaceutical innovation by the seven UK-owned pharmaceutical companies (1964-1985).  

PubMed Central

1 A total of three hundred and nineteen new chemical entities (NCEs) were investigated in man for the first time between 1964 and 1985 by seven UK-owned pharmaceutical companies. The majority (96.2%), were self-originated by the UK company or one of its overseas subsidiaries. 2 There was an increase in the number of NCEs investigated each year in man, doubling from an average of 12 per year up to 1980, to over 20 per year between 1981 and 1985. The majority of first drug evaluations in human volunteers were carried out in the UK (92.2%), in contrast to evaluation of new medicines in patients, where 42.9% were first tested outside the UK. 3 The majority of NCEs evaluated in man (78%), were in four therapeutic classes: anti-infectives (32%), anti-allergics (22%), drugs acting on the central nervous system (13%) and cardiovascular system agents (11%). 4 By the end of 1985, 49 (15.4%) of these NCEs had been marketed in the UK and 198 (62.0%) discontinued from further development. The main reasons for termination were inappropriate pharmacokinetics in man (39.4%), and lack of clinical efficacy (29.3%). 5 Average development times increased from less than 2 years between 1964 and 1965, to around 8 years in the 1980s with a consequent reduction in the effective patent life. PMID:3358900

Prentis, R A; Lis, Y; Walker, S R

1988-01-01

8

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

9

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

10

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

11

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

12

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

Microsoft Academic Search

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

Poh-Lin Yeoh

2011-01-01

13

Teaching appropriate interactions with pharmaceutical company representatives: The impact of an innovative workshop on student attitudes  

Microsoft Academic Search

BACKGROUND: Pharmaceutical company representatives (PCRs) influence the prescribing habits and professional behaviour of physicians. However, the skills for interacting with PCRs are not taught in the traditional medical school curriculum. We examined whether an innovative, mandatory workshop for third year medical students had immediate effects on knowledge and attitudes regarding interactions with PCRs. METHODS: Surveys issued before and after the

James L Wofford; Christopher A Ohl

2005-01-01

14

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

15

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

16

[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

17

Trust and transparency: patient perceptions of physicians' financial relationships with pharmaceutical companies.  

PubMed

Financial ties between physicians and pharmaceutical companies are pervasive and controversial. However, little is known about how patients perceive such ties. This paper describes an experiment examining how a national sample of U.S. adults perceived a variety of financial relationships between physicians and drug companies. Each respondent read a single scenario about a hypothetical physician and his financial ties to the pharmaceutical industry; scenarios varied in terms of payment type of (e.g., payment for meals vs. consulting fees) and amount. Respondents then evaluated the physician on several dimensions (e.g., expertise, trustworthiness, knowledge of new treatments, moral character, focus on patients' interests). Findings revealed that perceptions of the physician were more strongly influenced by payment type than by payment amount. Specifically, respondents were quite critical of doctors who owned drug company stock or received industry payments for meals and lodging, but were more forgiving of physicians who received free drug samples (which were perceived as benefiting patients) or consulting fees (which were seen as signaling physician expertise). Interestingly, physicians who received no payments, while seen as honest, were also viewed by some respondents as inexperienced or uninformed about new treatments. Implications for public policy and future research are discussed. PMID:25565614

Perry, Joshua E; Cox, Dena; Cox, Anthony D

2014-12-01

18

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

19

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

20

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

21

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

22

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

23

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

E-print Network

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

Lasenby, Joan

24

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

PubMed Central

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

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

2014-01-01

25

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

PubMed

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

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

2013-01-01

26

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

E-print Network

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

Lin, Xiaodong

27

Transcription Pharmaceutical Company  

E-print Network

Human Resources Disease Management Mental & Addiction Dental/Vision Payer (Insurer) SSA Employee Union Human Resources Disease Management Mental & Addiction Dental/Vision Payer (Insurer) SSA Employee Union

Oliva, Aude

28

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

29

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

30

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

Microsoft Academic Search

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

Janna Greve

2008-01-01

31

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

32

[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

33

China Today: Pharmaceutical Distribution in China  

Microsoft Academic Search

The country strives to modernize its distribution logistics as thousands of small companies compete for profits China today represents a $15-billion market for pharmaceutical products. China's pharmaceutical industry has been expanding at about 20% over the past five years. It has been predicted that China will become the world's fifth largest single pharmaceutical market by 2010. With such a fast-growing

Eliza Yibing Zhou

34

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

35

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

36

Doctors and pharmaceutical industry.  

PubMed

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

Beran, Roy G

2009-09-01

37

Pharmaceutical Decision and Game Theory  

Microsoft Academic Search

\\u000a A pharmaceutical or biopharmaceutical company is a commercial business licensed to research, develop, market, and\\/or distribute\\u000a drugs, most commonly in the context of healthcare. It is subject to a variety of laws and regulations regarding the patenting,\\u000a testing, and marketing of drugs, particularly prescription drugs.

Mark Chang

38

Data Warehouse Design for Pharmaceutical Drug Discovery Research  

Microsoft Academic Search

Pharmaceutical companies spend billions of dollars annually on drug discovery research. In the process, they generate vast amounts of scientific data. Data warehousing could significantly shorten the research cycle that leads to a new drug. We propose a framework for the application of data warehousing to integrate a pharmaceutical company's drug discovery data. We provide an analysis of the principal

Melinda G. Axel; Il-yeol Song

1997-01-01

39

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.

40

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

PubMed

To develop an effective pharmaceutical treatment for a disease, we need to fully understand the biological behavior of that disease, especially when dealing with cancer. The current available treatment for cancer may help in lessening the burden of the disease or, on certain occasions, in increasing the survival of the patient. However, a total eradication of cancer remains the researchers' hope. Some of the discoveries in the field of medicine relied on observations of natural events. Among these events is the spontaneous regression of cancer. It has been argued that such regression could be immunologically-mediated, but no direct evidence has been shown to support such an argument. We, hereby, provide compelling evidence that spontaneous cancer regression in humans is immunologically-mediated, hoping that the results from this study would stimulate the pharmaceutical industry to focus more on cancer vaccine immunotherapy. Our results showed that patients with >3 primary melanomas (very rare group among cancer patients) develop significant histopathological spontaneous regression of further melanomas that they could acquire during their life (P=0.0080) as compared to patients with single primary melanoma where the phenomenon of spontaneous regression is absent or minimal. It seems that such regression resulted from the repeated exposure to the tumor which mimics a self-immunization process. Analysis of the regressing tumors revealed heavy infiltration by T lymphocytes as compared to non-regressing tumors (P<0.0001), the predominant of which were T cytotoxic rather than T helper. Mature dendritic cells were also found in significant number (P<0.0001) in the regressing tumors as compared to the non regressing ones, which demonstrate an active involvement of the different arms of the immune system in the multiple primary melanoma patients in the process of tumor regression. Also, MHC expression was significantly higher in the regressing versus the non-regressing tumors (P <0.0001), which reflects a proper tumor antigen expression. Associated with tumor regression was also loss of the melanoma common tumor antigen Melan A/ MART-1 in the multiple primary melanoma patients as compared to the single primary ones (P=0.0041). Furthermore, loss of Melan A/ MART-1 in the regressing tumors significantly correlated with the presence of Melan A/ MART-1-specific CTLs in the peripheral blood of these patients (P=0.03), which adds to the evidence that the phenomenon of regression seen in these patients was immunologically-mediated and tumor-specific. Such correlation was also seen in another rare group of melanoma patients, namely those with occult primary melanoma. The lesson that we could learn from nature in this study is that inducing cancer regression using the different arms of the immune system is possible. Also, developing a novel cancer vaccine is not out of reach. PMID:16248806

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

2005-01-01

41

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

42

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.

43

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

44

Biotechnology in pharmaceuticals: the Japanese challenge.  

PubMed

The products of biotechnology are being developed for new diagnostics and therapeutics, and it is predicted that they will have great impact on the pharmaceutical industry. In the United States, pharmaceutical companies are incorporating biotechnology into their research and development programs, often with the contractual assistance of small biotechnology firms. Their strongest competition is arising in Japan, where there are now concerted government and industry efforts to expand biotechnology capabilities and to optimize commercialization. Strategies used by the United States and Japan to incorporate biotechnology into their pharmaceutical industries are examined and compared. PMID:3898361

Dibner, M D

1985-09-20

45

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,

46

Alicaforsen. Isis Pharmaceuticals.  

PubMed

Alicaforsen (ISIS-2302) is an RNase H-dependent antisense inhibitor of the intercellular adhesion molecule ICAM-1 under development by Isis Pharmaceuticals, for the potential treatment of a variety of inflammatory disorders [175741]. As of April 1997 it was in phase III trials for Crohn's disease (CD); however, the trial failed and, in December 1999, the company suspended development for this indication [352801]. In October 2000, the company re-initiated development in CD [384820] and new phase III trials had begin by May 2001 [409704]. In August 2000, phase II studies of alicaforsen in an enema formulation for ulcerative colitis and a topical formulation for psoriasis were ongoing [378715]. Development of the compound for the potential treatment of rheumatoid arthritis (RA) was discontinued in 1999 [347579]. By the end of 1998, alicaforsen was in phase II trials for kidney transplant rejection. At this time, these trials were expected to finish in mid-1999 [343460]. However, they were ongoing in September 1999, although no further development has been reported for this indication since that time [338672]. In February 1995, Isis Pharmaceuticals and Boehringer Ingelheim (BI) signed a collaborative agreement on cell adhesion inhibitors, including alicaforsen [174111]. By early 1999, Isis and BI were to decide on the next developmental step for alicaforsen following further analyses of its performance against CD [292915], [315439]. Their joint development agreement was terminated in 1999; Isis regained rights to the product and by September 1999 was in talks to license alicaforsen to another partner for CD [338672]. In June 2000, Cytogenix entered into a sponsored research agreement with Baylor College of Medicine at the Texas Medical Center Houston for the use of its ssDNA expression system for the development of antisense strategies directed against intercellular adhesion molecules for the purpose of reducing lung inflammation and injury in disease states and conditions [369677]. US-05514788, and other patents, cover antisense cell adhesion molecule inhibitors [212289], [234792]. PMID:11890355

Gewirtz, A T; Sitaraman, S

2001-10-01

47

Pharmacovigilance in pharmaceutical companies: An overview.  

PubMed

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

2013-12-01

48

Multinational pharmaceutical companies gather in Berlin.  

PubMed

The 39th Annual General Meeting of the Pharma Documentation Ring (PDR) was held in Berlin, Germany, on September 26, 1997. Common themes reported on included the impact and widespread use of intranet technology; expansion in end-user searching; experience with electronic journals; and programs for the development of electronic archiving and document management systems. Other sessions discussed aspects of chemistry systems; copyright; drug information systems on development products; information management, in-house management of databases; Intranet/Internet activities; and patents. The core topic presented at the meeting involved an overview on document delivery/electronic journals. There is considerable activity in this area by primary and secondary publishers with real momentum seen in the area of electronic document delivery services on the Internet. The 40th anniversary of the PDR will be celebrated at the upcoming AGM, to be held in Montpellier, France, September 30 October 2, 1998. PMID:15616643

Dubosc, Y; Mullen, A; Otto, C

1998-02-01

49

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

50

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

51

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

52

Assessment of the Mutagenicity of Some Pharmaceutical Effluents  

Microsoft Academic Search

Problem statement: The pharmaceutical industry is a major contributor to industrial wastes globally. Effluents from this industry are usually discharged into the environment and when not properly handled and disposed, they affect both hum an health and the environment. Approach: This study evaluated the mutagenic potentials of effluen ts from six pharmaceutical companies in the Lagos province of Nigeria using

A. Akintonwa; O. Awodele; A. T. Olofinnade; C. Anyakora; G. O. Afolayan; H. A. B. Coker

2009-01-01

53

Pharmaceutical supply chain risks: a systematic review  

PubMed Central

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

2013-01-01

54

Pharmaceutical regulation in France 1980-2003.  

PubMed

This paper provides an overview of French pharmaceutical policy between 1980 and 2003, which was dominated by price control and management of the positive list during the 1980s, with new policy instruments being introduced in the 1990s. The development and diffusion of prescription guidelines has been used to promote more appropriate use of medicines, and some measures aimed at developing the generic market have been implemented. In parallel, attempts have been made to set expenditure caps for physicians' prescriptions and for pharmaceutical companies' turnover. This second option seems to be more durable and effective, although its effectiveness in controlling increases in pharmaceutical expenditure remains limited. Pharmaceutical regulation is now more transparent than it used to be, and the monitoring of prescriptions is steadily improving. However, some areas remain problematic, for example over-prescription of certain classes of medicines such as antibiotics and probably psycholeptics. PMID:16335080

Paris, Valérie

2005-01-01

55

Pharmaceuticals from natural products: current trends  

Microsoft Academic Search

The use of products extracted from plants for medicinal purposes can be traced to the beginnings of civilization and up until the end of the nineteenth century natural products were the principal source of medicines. Since then their relative importance has oscillated according to the strategies of large pharmaceutical companies. Now that these strategies are changing, there are new opportunities

PETER R. SEIDL; Escola de Química

2002-01-01

56

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

57

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

58

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

59

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

60

Solvent selection for pharmaceuticals  

Microsoft Academic Search

The presence of solvents is essential in all steps of pharmaceutical processes (reaction, separation, and formulation). For toxicological reasons, drug manufacturers are increasingly required to minimize the number of solvents employed in pharmaceutical processes. In practice, the selection of solvents and antisolvents for pharmaceuticals mostly relies on experience, analogy and experimental testing.Our work aims to systematically investigate the solubility of

Petr Kolá?; Jun-Wei Shen; Akio Tsuboi; Takeshi Ishikawa

2002-01-01

61

A new e-beam application in the pharmaceutical industry  

NASA Astrophysics Data System (ADS)

The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a "miniature" low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned.

Sadat, Theo; Malcolm, Fiona

2005-10-01

62

[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

63

GMK (Progenics Pharmaceuticals).  

PubMed

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

Knutson, Keith L

2002-01-01

64

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

PubMed

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

Cohen-Kohler, Jillian Clare; Esmail, Laura C

2007-09-01

65

Case histories in pharmaceutical risk management.  

PubMed

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

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

2009-12-01

66

Department of Pharmaceutics and Pharmaceutical Chemistry  

E-print Network

, to modeling of drug action and therapeutic performance. Utah Pharmaceutics, is ranked #2 nationally include: · Gene medicine, including novel therapeutic gene and siRNA delivery and targeting methods (polymers, peptides, nanosystems) and new drug forms (e.g., transgenes, proteins, peptides) to build

Tipple, Brett

67

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

68

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

69

Inventory strategies for patented and generic products for a pharmaceutical supply chain  

E-print Network

This thesis presents a model to determine safety stock considering the distinct planning parameters for a pharmaceutical company. Traditional parameters such as forecast accuracy, service level requirements and average ...

Krishnamurthy, Prashanth, M. Eng. Massachusetts Institute of Technology

2012-01-01

70

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

71

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

72

A Research-Based Molecular Biology Laboratory  

NSDL National Science Digital Library

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

Buising, Charisse; Henderson, Larhee

2001-02-01

73

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

74

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

75

Impacts of international sanctions on Iranian pharmaceutical market  

PubMed Central

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

2013-01-01

76

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

PubMed

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

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

2006-11-01

77

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

78

Direct marketing of pharmaceuticals to consumers.  

PubMed

Revised FDA regulations governing pharmaceutical companies' broadcast advertisements directed to consumers produced substantial increases in direct-to-consumer advertising (DTCA) expenditures. Proponents of DTCA claim it supports patient autonomy in the patient-physician relationship and has motivated some consumers to seek a physician's care for conditions they previously had not discussed with a doctor. However, DTCA's blend of promotion and information has produced more prescription drug awareness than knowledge--it has been largely ineffective in educating patients with medical conditions about the medications for those conditions. The evidence for DTCA's increase in pharmaceutical sales is as impressive as is the lack of evidence concerning its impact on the health of the public. Broadcast advertisements are too brief to include extensive technical information; consequently, the impact of FDA regulations to assure a fair balance of risk and benefit in DTCA is still being assessed. PMID:11910055

Lyles, Alan

2002-01-01

79

Technology evaluation: ISIS-2503, Isis Pharmaceuticals.  

PubMed

ISIS-2503, a 20-mer antisense oligonucleotide that inhibits Ha-Ras expression, is being developed by Isis Pharmaceuticals Inc as a potential treatmentfor cancer, particularly tumors that commonly have abnormalities of Ras function. It is in phase II trials. According to an April 2001 report by Bear Stearns & Co, Elan Corp plc had an unspecified collaboration with Isis for the development of ISIS-2503 [419357], but Isis later clarified that there was no agreement between the two companies and that ISIS-2503 had merely been used for the 'OraSense' joint venture that explores the use of antisense oligonucleotidesfor oral administration [419673]. PMID:11804274

Morse, M A

2001-12-01

80

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

PubMed

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

Yongue, Julia S

2014-01-01

81

Raman mapping of pharmaceuticals.  

PubMed

Raman spectroscopy may be implemented through a microscope to provide fine scale axial and lateral chemical maps. The molecular structure of many drugs makes Raman spectroscopy particularly well suited to the investigation of pharmaceutical systems. Chemometric methods currently used to assess bulk Raman spectroscopic data are typically applied to Raman mapping data from pharmaceuticals; few reports exist where the spatial information inherent to a mapped dataset is used for the calculation of chemical maps. Both univariate and multivariate methods have been applied to Raman mapping data to determine the distribution of active pharmaceutical ingredients (APIs) in tablets, solid dispersions for increased solubility and controlled release devices. The ability to axially (depth) profile using Raman mapping has been used in studies of API penetration through membranes, cellular uptake of drug delivery liposomes, and initial API distribution and subsequent elution from coatings of medical devices. New instrumental developments will increase the efficiency of Raman mapping and lead to greater utilisation of Raman mapping for analyses of pharmaceutical systems. PMID:21194560

Gordon, Keith C; McGoverin, Cushla M

2011-09-30

82

Cyclodextrins as pharmaceutical solubilizers  

Microsoft Academic Search

Cyclodextrins are useful functional excipients that have enjoyed widespread attention and use. The basis for this popularity from a pharmaceutical standpoint, is the ability of these materials to interact with poorly water-soluble drugs and drug candidates resulting in an increase in their apparent water solubility. The mechanism for this solubilization is rooted in the ability of cyclodextrin to form non-covalent

Marcus E. Brewster; Thorsteinn Loftsson

2007-01-01

83

Pharmaceutical applications of chitosan  

Microsoft Academic Search

Considerable research efforts have been directed towards the development of safe and efficient chitosan-based drug delivery systems. In this review, the authors outline the major new approaches to the pharmaceutical applications of chitosan and discuss its mechanisms of action in various in vitro and in vivo models.

Valérie Dodane; Vinod D Vilivalam

1998-01-01

84

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

85

Models for open innovation in the pharmaceutical industry.  

PubMed

The nature of the pharmaceutical industry is such that the main driver for its growth is innovation. In view of the vast challenges that the industry has been facing for several years and, in particular, how to manage stagnating research and development (R&D) productivity, pharmaceutical companies have opened their R&D organizations to external innovation. Here, we identify and characterize four new types of open innovator, which we call 'knowledge creator', 'knowledge integrator', 'knowledge translator' and 'knowledge leverager', and which describe current open R&D models. PMID:23892183

Schuhmacher, Alexander; Germann, Paul-Georg; Trill, Henning; Gassmann, Oliver

2013-12-01

86

Reference pricing of pharmaceuticals  

Microsoft Academic Search

We consider a therapeutic market with potentially three pharmaceutical firms. Two of the firms offer horizontally differentiated brand-name drugs. One of the brand-name drugs is a new treatment under patent protection that will be introduced if the profits are sufficient to cover the entry costs. The other brand-name drug has already lost its patent and faces competition from a third

Kurt R. Brekke; Ingrid Königbauer; Odd Rune Straume

2007-01-01

87

Trade, TRIPS, and pharmaceuticals.  

PubMed

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus. PMID:19167054

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

2009-02-21

88

3rd annual symposium of chemical and pharmaceutical structure analysis.  

PubMed

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

Weng, Naidong; Zheng, Jenny; Lee, Mike

2012-08-01

89

Companion diagnostics: emerging strategies and issues in pharmaceutical development.  

PubMed

This article summarizes the broad messages from pharmaceutical and diagnostic companies on the collaborations required to support companion diagnostics. Since the groundbreaking herceptin HER2 diagnostic model in 1998, it has taken until 2011 for the US FDA to issue a draft guidance document, which was then immediately followed with approvals for two new drugs and their companion diagnostics. This conference summarized the current state of thinking in new projects and innovative technologies in pharmaceutical and diagnostic codevelopment. Attitudes are slowly changing and collaborations are rapidly ensuing, although the alignment between pharmaceutical and diagnostic understanding of value, timelines, outcomes and impact is difficult and remains a contentious area. The value of this conference has been to address these issues. PMID:22845476

Thomas, Janette; Stratton, Elyse; Keppens, Mieke

2012-07-01

90

Molecular farming of pharmaceutical proteins  

Microsoft Academic Search

Molecular farming is the production of pharmaceutically important and commercially valuable proteins in plants. Its purpose\\u000a is to provide a safe and inexpensive means for the mass production of recombinant pharmaceutical proteins. Complex mammalian\\u000a proteins can be produced in transformed plants or transformed plant suspension cells. Plants are suitable for the production\\u000a of pharmaceutical proteins on a field scale because

Rainer Fischer; Neil Emans

2000-01-01

91

The validation of pharmaceutical buildings.  

E-print Network

??The construction, commissioning and hand-over of pharmaceutical manufacturing buildings have become increasingly controlled by the requirements of regulatory agencies. Legislation requires that the process of… (more)

Render, Neil

2006-01-01

92

Capillary electrophoresis for pharmaceutical analysis.  

PubMed

This chapter describes the application of capillary electrophoresis (CE) to pharmaceutical analysis. The areas of pharmaceutical analysis covered are enantiomer separation, analysis of small molecules such as amino acids or drug counter-ions, pharmaceutical assay, related substances determinations, and physiochemical measurements such as log P and pKa of compounds. The different electrophoretic modes available and their advantages for pharmaceutical analysis are described. Recent applications of CE for each subject area are tabulated with electrolyte details. Information on electrolyte choice and method optimization to obtain optimal separations is included. PMID:18392572

Marsh, Alex; Broderick, Margo; Altria, Kevin; Power, Joe; Donegan, Sheila; Clark, Brian

2008-01-01

93

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.

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

2014-01-01

94

GMP Compliance for Pharmaceutical Excipients in the Glycerin Industry  

E-print Network

will be shared with Company XYZ. - iv - Acronyms API – Active Pharmaceutical Ingredient cGMP’s – Current Good Manufacturing Practices COA – Certificate of Analysis DEG – Diethylene Glycol FDA – Food and Drug Administration FMEA – Failure Mode... Assurance R&D – Research and Development SOP – Standard Operating Procedure USP – United States Pharmacopoeia - v - Introduction Following the terrorist acts of September 11, 2001, the United States enacted the Public Health Security...

Elliot, Christina

2008-12-19

95

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

96

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

PubMed

A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity. PMID:20725093

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

2010-09-01

97

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

98

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

PubMed

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

Yoshioka, Ryuzo; Matsumoto, Kazuo

2014-01-01

99

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

100

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

101

Occupational contact dermatitis in the pharmaceutical industry.  

PubMed

Occupation-induced skin reactions are not infrequently observed in the pharmaceutical industry. Workers may come in contact with irritant substances and also with chemically reactive intermediates or drugs that may be potential sensitizers. The skin lesions can be located at the site of contact, usually the hands, although airborne reactions on exposed and even nonexposed areas (eg, by particles trapped under clothing) are not uncommon. Generalized reactions may occur due to inhalation or transcutaneous absorption. An accidental exposure to a highly allergenic compound may cause a chemical burn, followed by primary sensitization and allergic contact dermatitis. The pharmaceutical contact allergens belong to many different pharmacologic classes. If several cases of contact dermatitis occur in multiple individuals in the same company, then the working conditions are implicated and should be changed to prevent their recurrence. Measures to be taken include dust control, installation of closed filter equipment, and keeping the workers informed about the potential risks associated with the manipulation of the chemicals. PMID:22014988

Goossens, An; Hulst, Kim Vander

2011-01-01

102

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

103

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

104

Crystal Engineering of Pharmaceutical Cocrystals  

Microsoft Academic Search

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

Sreya Mukherjee

2011-01-01

105

Ensuring Quality Science From “R” to “D”: An Optimal Adoption Strategy for In-Licensing of Pharmaceutical Innovation  

Microsoft Academic Search

In today's competitive business environment, phar- maceutical companies intensively explore contract R&D opportu- nities with small biotechnology companies and in-license externally discovered compounds to replenish their product pipelines. In or- der to maintain and increase external collaboration productivity, pharmaceutical companies must find the most promising outside compounds generated in the research stage as the inputs for later in-house development stages.

Guozhen Zhao; Wen Chen

2011-01-01

106

[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

107

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

PubMed

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

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

2009-01-01

108

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

109

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.  

PubMed

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions. PMID:16755695

Kelleher, Finnuala

2004-01-01

110

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

111

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

Microsoft Academic Search

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

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

1998-01-01

112

The dynamics of technological innovation: the case of the pharmaceutical industry  

Microsoft Academic Search

This is an empirical and historical study of the dynamics of technological innovation (TI) in the pharmaceutical industry from its establishment at the beginning of the 19th century to 1990. It is based on the identification and evaluation of the originality and commercial significance of 1736 product innovations (new medicines) commercialized between 1800 and 1990, and on company economic data

Basil Achilladelis; Nicholas Antonakis

2001-01-01

113

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

114

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

Microsoft Academic Search

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

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

2012-01-01

115

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

Microsoft Academic Search

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

Yi-Chi Zhang; Shu-Ling Li

2009-01-01

116

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

117

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

PubMed Central

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

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

2013-01-01

118

Ionic liquids in pharmaceutical applications.  

PubMed

In the past several years, ionic liquids (ILs) have been at the cutting edge of the most promising science and technology. ILs not only have found applications in classical areas of knowledge but also are important candidates to solve classical problems within several societal challenges, such as clean and efficient energy, through the development of a broad swath of energy technologies, such as advanced batteries, dye-sensitized solar cells, double-layer capacitors, actuators, fuel cells, thermo-cells, and water splitting, essentially related to highly efficient carbon capture and storage technologies and resource efficiency to date. This review focuses on the application of IL methodologies to solve critical pharmaceutical problems, in particular, the low solubility and thus bioavailability of pharmaceutical compounds and the presence of polymorphs, which severely hamper the efficacy of important commercially available drugs. The development of strategies to use ILs as carriers of pharmaceutical active compounds is an extremely promising and wide avenue. Further, the synthesis of liquid salts through the discerning combination of cations and anions with several distinct pharmaceutical roles provides answers to some of today's pharmaceutical industrial challenges. PMID:24910920

Marrucho, I M; Branco, L C; Rebelo, L P N

2014-01-01

119

Guiding Students through the Jungle of Research-Based Literature  

ERIC Educational Resources Information Center

Undergraduate students of today often lack the ability to effectively process research-based literature. In order to offer education students the most up-to-date methods, research-based literature must be considered. Hence a dilemma is born as to whether professors should discontinue requiring the processing of this type of information or teach…

Williams, Sherie

2005-01-01

120

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

ERIC Educational Resources Information Center

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

Clements, Douglas H.

2007-01-01

121

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

122

Department Head Pharmacy Practice and Pharmaceutical Sciences  

E-print Network

Department Head Pharmacy Practice and Pharmaceutical Sciences College of Pharmacy University of Minnesota Duluth, Minnesota Campus The College of Pharmacy, Department of Pharmacy Practice head will have responsibility for all aspects of the Department of Pharmacy Practice and Pharmaceutical

Thomas, David D.

123

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...

124

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

125

Bioremediation of industrial pharmaceutical drugs.  

PubMed

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

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

2012-07-01

126

Pharmaceutical care in smoking cessation  

PubMed Central

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

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

2015-01-01

127

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

PubMed Central

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

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

2014-01-01

128

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

PubMed

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

Bonnemain, Bruno

2007-10-01

129

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.

130

MSI-78 Magainin Pharmaceuticals.  

PubMed

Magainin is developing MSI-78, a 22-amino acid peptide, based on compounds discovered in frog skin, as a topical anti-infective. It has broad-spectrum activity, covering Gram-positive and -negative bacteria, anaerobic bacteria and Candida albicans. The compound also has potential for the treatment of impetigo and healing wounds with various infections. In July 1998, Magainin filed an NDA with the US FDA for the treatment of infections in diabetic foot ulcers [292671]. It expects to launch the drug during the second quarter of 1999 [275844]. A completed pivotal, 584 patient, phase III trial demonstrated statistical equivalence between MSI-78 and orally-administered ofloxacin, for the treatment of infection in diabetic foot ulcers. MSI-78 was comparable to ofloxacin with respect to the primary endpoint of clinical response of infection at day ten of treatment, and at subsequent time points through to day 28, and at follow-up [220339]. These data were confirmed by the company's second phase III trial for the same indication, for which successful results were announced in March 1997 [239274]. Additional data from this second trial, presented at the 37th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), demonstrated that both drugs were comparable in terms of eradication rate of individual organisms and wound healing [264410]. Between 10% and 15% of wounds in patients treated with a combination of both drugs reached closure within four weeks. After six weeks, the closure rate increased to between 18% and 30%. This suggested that additional studies should be performed to evaluate the wound-healing effects further [275279]. The side-effects of both treatments were well-tolerated, although treatment with ofloxacin was associated with a significant excess of insomnia compared to MSI-78 [275844]. Further phase III trials are planned for treatment of surgical wounds, decubitus ulcers, venous stasis ulcers and infections associated with burns [173293]. The primary clinical endpoint is the cure of the infection and the secondary endpoint is the eradication of the organism. The first study has enrolled approximately 400 patients [195065]. The drug was also being developed for impetigo, but proved no better than placebo in phase III trials for the treatmentprimarily because 75% of controls showed clinical improvement as a result of better hygiene [293751]. Magainin is attempting to develop a recombinant process for commercial synthesis of MSI-78 to allow it to compete on price with conventional antibiotics [174944], [176153]. Magainin has a contract with Abbott for the manufacture of the drug [174944]. In February 1997, Magainin entered into a development, supply and distribution agreement in North America with SmithKline Beecham (SB) for Cytolex [234035]. Magainin has retained all rights to the drug outside of North America [275844], although it has also signed an agreement with Ambalal Sarabhai Enterprises (ASE) to commercialize MSI-78 (as Cytolex) in India [274544], [275556]. Analysts estimate the potential revenues of this compound, including off-label usage is between $200 and $250 million in the US and up to half as much again outside the US [191231]. PMID:18465601

Islam, K; Hawser, S P

1998-09-01

131

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

132

"Does organizational culture influence the ethical behavior in the pharmaceutical industry?".  

PubMed

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

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-12-01

133

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

PubMed Central

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

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-01-01

134

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

135

Water clusters in amorphous pharmaceuticals.  

PubMed

Amorphous materials, although lacking the long-range translational and rotational order of crystalline and liquid crystalline materials, possess certain local (short-range) structure. This paper reviews the distribution of one particular component present in all amorphous pharmaceuticals, that is, water. Based on the current understanding of the structure of water, water molecules can exist in either unclustered form or as aggregates (clusters) of different sizes and geometries. Water clusters are reported in a range of amorphous systems including carbohydrates and their aqueous solutions, synthetic polymers, and proteins. Evidence of water clustering is obtained by various methods that include neutron and X-ray scattering, molecular dynamics simulation, water sorption isotherm, concentration dependence of the calorimetric Tg , dielectric relaxation, and nuclear magnetic resonance. A review of the published data suggests that clustering depends on water concentration, with unclustered water molecules existing at low water contents, whereas clusters form at intermediate water contents. The transition from water clusters to unclustered water molecules can be expected to change water dependence of pharmaceutical properties, such as rates of degradation. We conclude that a mechanistic understanding of the impact of water on the stability of amorphous pharmaceuticals would require systematic studies of water distribution and clustering, while such investigations are lacking. PMID:24824578

Authelin, Jean-Rene; MacKenzie, Alan P; Rasmussen, Don H; Shalaev, Evgenyi Y

2014-09-01

136

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

137

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

138

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

PubMed Central

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

Kurtzman, Gary

2005-01-01

139

Introduction: Institutional corruption and the pharmaceutical policy.  

PubMed

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

Rodwin, Marc A

2013-01-01

140

The impact of the cox-2 inhibitor issue on perceptions of the pharmaceutical industry: content analysis and communication implications.  

PubMed

The field of risk communication has its roots in the environmental, chemical, space, and nuclear arenas. As a number of these sectors have now vastly improved their communication strategies, attention is being placed on sectors that have been more problematic as of late. Examples of such sectors, include the food industries and the pharmaceutical/health sector. This article focuses on how large, multinational pharmaceutical companies can better communicate risks by analysis of one specific case, namely, that of the Cox-2 controversy.(1) For purposes of this article, risk communication is best described as "the flow of information and risk evaluations back and forth between academic experts, regulatory practitioners, interest groups and the general public," and "big pharma" refers to the more traditional R & D-based, innovative pharmaceutical companies. PMID:17710597

Lofstedt, Ragnar E

2007-01-01

141

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

142

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

143

Drug Companies Drop South Africa Suit  

NSDL National Science Digital Library

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

De Nie, Michael W.

2001-01-01

144

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

145

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

2014-12-01

146

INTERNATIONAL PERCEPTIONS OF THE UK CHEMISTRY RESEARCH BASE  

E-print Network

Medical Research Council INTERNATIONAL PERCEPTIONS OF THE UK CHEMISTRY RESEARCH BASE Chemistry on the campuses of the world's research universities." "Research Universities: Their Value to Society Extends Well advances in many areas. Chemistry research underpins a wide range of activities that benefit society

147

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

148

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

149

The Status of Mirror Research Based on a Workshop in  

E-print Network

The Status of Mirror Research Based on a Workshop in Berkeley, CA. Sept. 8-9, 2008 25 Participants eliminates neoclassical radial transport · Large end expansion enables high electron temperature · Central by Deuterium Neutral Beams 10 #12;recent achievements max 60% nf 5x1019 m-3 11 GDT Central Beta Reaches 60

150

Research-Based Learning: Teaching Development through Fieldschools  

ERIC Educational Resources Information Center

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

Guinness, Patrick

2012-01-01

151

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

152

Alcohol and your health Research-based information from the  

E-print Network

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

Bandettini, Peter A.

153

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

154

Visualization Research Based on Cognitive Design Maneesh Agrawala  

E-print Network

Visualization Research Based on Cognitive Design Principles Maneesh Agrawala UC Berkeley 635 Soda for the article "Design Prin- ciples for Visual Communication," Communications of the ACM, April 2011 Appendix Designing visualization systems based on cognitive design principles is not a new methodology. Visualization

Agrawala, Maneesh

155

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

Federal Register 2010, 2011, 2012, 2013

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

2011-08-18

156

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

157

Market Research Company Description  

E-print Network

Market Research Company Description: A company focused on developing web-based graphical development - Market research for enterprise and education adoption - Plan and execute a company-wide ping of industries. Short Project Name: New Target Market Research, Analysis, & Proposal Project Description

Dahl, David B.

158

Microbial factories for recombinant pharmaceuticals  

PubMed Central

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

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

2009-01-01

159

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

160

Cardiff School of Pharmacy and Pharmaceutical Sciences  

E-print Network

Cardiff School of Pharmacy and Pharmaceutical Sciences Undergraduate Degree Programme www.cardiff.ac.uk/phrmy our #12;Cardiff School of Pharmacy and Pharmaceutical Sciences Friendly One of the Top UK Schools in Pharmacy World-leading "One of the best institutions in Britain . . . this powerhouse of academic

Davies, Christopher

161

Emerging Issues: Pharmaceuticals and Patents1  

Microsoft Academic Search

This article analyses the Intellectual Property Rights (IPR) debate on pharmaceuticals, an issue introduced by TRIPS, a World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights. This debate, particularly when focused on pharmaceutical products related to emerging global pandemics such as HIV\\/AIDS, opposes contrasting views: the need to protect the individual right of patent owner of

Cristina de Albuquerque Possas

162

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

163

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

164

A monitoring system for contaminated pharmaceutical processes  

Microsoft Academic Search

The automation of contaminated processes in the pharmaceutical industry is a crucial point of interest for manufacturers. The areas where the active pharmaceutical ingredients are penetrated the entire production room must be secured very careful, to avoid any healthy damage of the employees. Examples for dangerous ingredients in high concentration are insulin and antiplatelet agents (blood thinner). These can be

I. O. Maga

2008-01-01

165

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

166

Pharmaceutical care in Kuwait: hospital pharmacists' perspectives.  

PubMed

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

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

2014-12-01

167

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

168

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

169

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

170

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

171

2nd International China BioPharmaceutical Symposium.  

PubMed

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

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

2009-03-01

172

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

173

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

174

The Use of Astronomy in Research Based Science Education  

NASA Astrophysics Data System (ADS)

NOAO facilities in Tucson and Kitt Peak support ``The Use of Astronomy in Research Based Science Education" (RBSE), a teacher enhancement program funded through the National Science Foundation's Directorate for Education and Human Resources. This four-year project offers a research experience to middle and high school teachers via a summer workshop with extension to the classroom during the academic year. Research-based education is designed to teach science as it is practiced, and is a proven method for effective science education. RBSE is currently in its second year of operation; and results from our 1997 and 1998 programs will be presented. We are seeking mentors from around the nation for teachers who have been accepted into the 1999 program. Mentors are nearby astronomers willing to spend a few hours a month helping RBSE teachers implement the RBSE program in their classroom.

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

1999-05-01

175

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

176

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

177

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

NASA Astrophysics Data System (ADS)

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

Wu, Huiquan; Khan, Mansoor

2012-08-01

178

[Annual lifelong learning program for pharmaceutical care practice by the Gifu Pharmaceutical University].  

PubMed

Knowledge and techniques involved in medical affairs have been steadily advancing. The lifelong learning programs supported by Gifu Pharmaceutical University are introduced. The 3 unique programs consist of (1) a lifelong learning program concerning recent medical topics provided by our university, (2) a reeducation program containing some lectures and practices concerning the most advanced knowledge and techniques on pharmacy and medicine, provided by co-organization of 3 public universities (Nagoya City University, University of Shizuoka, and Gifu Pharmaceutical University), and (3) an annual lifelong learning program promoted by Gifu Pharmaceutical University Pharmacy. Gifu Pharmaceutical University Pharmacy accommodates 100 prescriptions daily from hospitals. The annual lifelong learning programs held by our pharmacy have comprehensively provided practical knowledge and techniques on newly developed medicines, pharmaceutical care practice, pharmacotherapy, community pharmaceutics, and so on, for the last 10 years. Pharmacists should have full responsibility for pharmacotherapy as health care workers. The pharmacists should make a concerted effort to understand pharmacotherapy through pharmaceutical care practice by cooperation with community pharmacists, hospital pharmacists, and pharmaceutical associations. Our lifelong learning program has contributed to the improvement of pharmaceutical skills and communication among pharmacists, medical doctors, and other health care workers. PMID:21212611

Sugiyama, Tadashi; Horiuchi, Tadashi; Tsuchiya, Teruo

2011-01-01

179

Spectroscopy in pharmaceutical development: an overview  

NASA Astrophysics Data System (ADS)

Spectroscopic techniques play a key role in the everyday work of the pharmaceutical analyst. In addition to the normal use of the various spectroscopies for simple, routine analyses, a pharmaceutical analytical chemist might use spectroscopy to perform a host of additional functions. These might include, for example, the characterization of a polymorphic substance by either X-ray diffraction or nuclear magnetic resonance spectroscopy, the identification of a foreign material in a tablet dosage form by infrared microspectroscopy, or the selection of a wavelength for liquid chromatographic analysis by photodiode array ultraviolet-visible spectroscopy. The following presentation is meant to acquaint the non-pharmaceutical chemist with some of the ways spectroscopy is utilized in the pharmaceutical analysis research and development laboratory.

Scypinski, Stephen; Murari, Ramaswamy; Grant, Anne; Ng, Sammy

1992-08-01

180

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...

181

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

182

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

183

Pharmaceutical salt formation guided by phase diagrams.  

E-print Network

??Salt formation is frequently employed to improve the solubility and bioavailability of pharmaceutical compounds. Solid-Liquid-Equilibrium (SLE) phase diagram that serves as the foundation for designing… (more)

Lam, Ka Wing

2009-01-01

184

Toxic effect of pharmaceuticals on methanogenesis.  

PubMed

Pharmaceuticals present in sewage may inhibit the biological processes in a sewage treatment plant. In this work, the toxic-effect of six pharmaceuticals (carbamazepine, sulfamethoxazole, propranolol hydrochloride, diclofenac sodium, ofloxacin and clofibric acid) on the anaerobic digestion process is assessed. Acetoclastic methanogenes are the most sensitive group of microorganisms participating in the anaerobic digestion process. Appropriate toxicity tests for these microorganisms were then based on assessing the impact of pharmaceuticals on the specific methanogenic activity (SMA) of the anaerobic biomass. The toxicity was expressed by the IC80 and IC50 values, i.e. the concentration at which bioactivity was 80% and 50% of the control, respectively. Results showed that the pharmaceuticals tested caused a mild inhibition to the methanogenes in most cases, related directly to the tendency of the compounds to adsorb on the anaerobic biomass. PMID:15497866

Fountoulakis, M; Drillia, P; Stamatelatou, K; Lyberatos, G

2004-01-01

185

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

186

MULTIFUNCTIONAL AND STIMULI-SENSITIVE PHARMACEUTICAL NANOCARRIERS  

PubMed Central

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

Torchilin, Vladimir

2011-01-01

187

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

188

Toxic effect of pharmaceuticals on methanogenesis  

Microsoft Academic Search

Abstract Pharmaceuticals present in sewage,may inhibit the biological processes in a sewage,treatment plant. In this work, the toxic-effect of six pharmaceuticals (carbamazepine, sulfamethoxazole, propranolol hydrochloride, diclofenac sodium, ofloxacin and clofibric acid) on the anaerobic digestion process is assessed. Acetoclastic methanogenes,are the most sensitive group of microorganisms participating in the anaerobic digestion process. Appropriate toxicity tests for these microorganisms,were then based

M. fountoulakis; P. drillia; K. Stamatelatou; G. Lyberatos

189

The Use of Astronomy in Research Based Science Education  

NASA Astrophysics Data System (ADS)

NOAO facilities in Tucson and Kitt Peak support "The Use of Astronomy in Research Based Science Education" (RBSE), a Teacher Enhancement Program funded through the National Science Foundation's Directorate for Education and Human Resources. This four-year project offers a research experience to middle and high school teachers during summer workshops with extension to the classroom during the academic year. Results from our 1997 Pilot Program will be presented. Mentors are sought for teachers from around the nation who have been accepted into the 1998 program. Mentors are astronomers willing to spend a few hours a month helping RBSE teachers implement the program in their local classroom.

Jacoby, Suzanne H.; Lockwood, Jeffrey F.; McCarthy, Donald W.

1998-05-01

190

Experiences of new faculty implementing research-based instructional strategies  

NSDL National Science Digital Library

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

Dancy, Melissa H.; Henderson, Charles R.

2012-04-25

191

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

192

Marketing norm perception among medical representatives in Indian pharmaceutical industry.  

PubMed

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

2012-03-01

193

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

PubMed

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

Dew, Kevin; Davis, Amy

2014-01-01

194

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

195

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

196

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

197

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

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

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

198

78 FR 17763 - Housatonic Railroad Company, Inc., Maybrook Railroad Company, and Housatonic Transportation...  

Federal Register 2010, 2011, 2012, 2013

...Housatonic Railroad Company, Inc., Maybrook Railroad Company, and Housatonic Transportation Company--Intra-Corporate Family Transaction Exemption Housatonic Railroad Company, Inc. (HRRC), Maybrook Railroad Company (MRC),...

2013-03-22

199

Current Practices for DNA Sample Collection and Storage in the Pharmaceutical Industry, and Potential Areas for Harmonization: Perspective of the I-PWG  

Microsoft Academic Search

Collection and storage of DNA samples in clinical drug development programs are an important investment for the pharmaceutical industry to allow efficient evaluation of observed variability in drug response. To enable collection and future use of samples, individual companies must define (i) processes to collect specimens worldwide, (ii) whether collection is optional or mandatory, (iii) conditions and duration of sample

M A Franc; A W Warner; N Cohen; P M Shaw; P Groenen; A Snapir

2011-01-01

200

"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

"New Jersey is the pharmaceutical capital of the country and Rutgers is at the center of it all in getting to know the companies and the people now," he points out. New Jersey is truly the medicine chest, The State University of New Jersey, has turned a geographic advantage into a unique, new MBA

Lin, Xiaodong

201

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

PubMed

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

Epstein, Richard J

2007-10-01

202

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

203

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

PubMed Central

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

Lexchin, J; Holbrook, A

1994-01-01

204

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

205

HARVARD ESPRESSO COMPANY  

NSDL National Science Digital Library

HARVARD ESPRESSO COMPANY brings you a fine selection of gourmet coffees from around the world roasted to perfection by the Torrefazione Coloiera of Vancouver, BC. While you are drinking your brew, check out the artists of the month.

206

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

PubMed

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

Erices, Rainer; Frewer, Andreas; Gumz, Antje

2014-10-23

207

The Virtual Oil Company  

SciTech Connect

In anticipation of continuing declines in upstream activity levels over the next fifteen years, the Virtual Oil Company model articulates a vision of fewer, leaner, but financially stronger firms that concentrate only on their core competencies, and through well-structured partnering arrangements, outsource the rest. Freed from the {open_quotes}clutter{close_quotes}, these leading companies will be in better position to focus on those opportunities that offer the potential for renewed reserve and revenue growth.

Garibaldi, C.A.; Haney, R.M.; Ross, C.E.

1995-12-31

208

The virtual oil company  

SciTech Connect

In anticipation of continuing declines in upstream activity levels over the next 15 years, the virtual oil company model articulates a vision of fewer, leaner, but financially stronger firms that concentrate only on their core competencies and outsource the rest through well-structured partnering arrangements. Freed from the ``clutter,`` these leading companies will be in better position to focus on those opportunities that offer the potential for renewed reserve and revenue growth.

Garibaldi, C.A.; Haney, R.M.; Ross, C.E. [Arthur D Little, Houston, TX (United States)

1995-09-01

209

Educating Inquiry-Oriented Teachers: Students' Attitudes and Experiences towards Research-Based Teacher Education  

ERIC Educational Resources Information Center

In this article, we will discuss research-based teacher education as an organizing theme of teacher education. We will report the results of two surveys in which students expressed their attitudes towards the research-based approach and their experiences of research-based teacher education. The construct validity of the inventory was tested using…

Byman, Reijo; Krokfors, Leena; Toom, Auli; Maaranen, Katriina; Jyrhama, Riitta; Kynaslahti, Heikki; Kansanen, Pertti

2009-01-01

210

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

PubMed Central

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

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

2012-01-01

211

Southern Company`s standby generator program  

SciTech Connect

Alabama Power Company (APCO) continues to look for ways to improve customer satisfaction and enact demand-side management programs. The decision was made to evaluate the availability of customer-owned generators in order to meet these objectives. The idea was to utilize customer-owed standby generators (SG) as we would a peaking plant and to pay the customer credits based on the cost of the construction of peaking capacity plants. It was felt that if APCO could utilize this capacity to offset the construction of peaking capacity, then these costs would be passed on to our customers.

Swartz, S.

1995-12-01

212

[Quality improvement potential in the pharmaceutical industry].  

PubMed

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

Nusser, Michael

2007-01-01

213

Pharmaceutical logistics in the European theater.  

PubMed

This article describes the responsibilities and objectives of the pharmacy officer for the U.S. Army Medical Materiel Center, Europe. Pharmacists' experiences and knowledge offer advantages in the ordering, storage, and distribution of medical materiel. Exploitation of new technology and a customer-focused attitude encourage a working environment that capitalizes on pharmaceutical expertise. The use of temperature monitors, enhanced automation opportunities, expired drug return credits, and other customer-focused initiatives exemplify pharmacists' value to military medical logistics organizations. An overview of the pharmaceutical pipeline to U.S. military and State Department customers in the European theater is provided. PMID:10544621

Spain, J

1999-10-01

214

Radiostability of pharmaceuticals under different irradiation conditions  

NASA Astrophysics Data System (ADS)

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

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

2005-02-01

215

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

216

NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS  

EPA Science Inventory

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

217

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

218

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

219

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

220

A Preliminary Ecotoxicity Study of Pharmaceuticals in the Marine Environment  

Microsoft Academic Search

Environmental fates and effects of pharmaceuticals in the aquatic environment have been the focus of recent research in environmental ecotoxicology. Worldwide studies of common over-the-counter pharmaceuticals have reported detectable levels in the aquatic environment, but there are few studies examining impacts on marine habitats. These drugs can affect the functions of various vertebrates and invertebrates. The stability of two pharmaceuticals,

Amy Mei Fun Choong; Serena Lay-Ming Teo; Jo Lene Leow; Hwee Ling Koh; Paul Chi Lui Ho

2006-01-01

221

Effects of pharmaceuticals on Daphnia survival, growth, and reproduction  

Microsoft Academic Search

Pharmaceuticals have been globally detected in surface waters, and the ecological impacts of these biologically-active, ubiquitous chemicals are largely unknown. To evaluate the aquatic toxicity of individual pharmaceuticals and mixtures, we performed single species laboratory toxicity tests with Daphnia magna, a common freshwater zooplankton. We conducted acute (6-day) and chronic (30-day) exposure pharmaceutical bioassays and evaluated survivorship and morphology of

Colleen M. Flaherty; Stanley I. Dodson

2005-01-01

222

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

223

Introduction The essence of pharmaceutical materi-  

E-print Network

, which shows the progression from crystal engineering of active phar- maceutical ingredients (APIs pharmaceutical application in- clude the design of custom materials with specific physical and chemical Higuchi and his contemporaries. In 1953, Higuchi reported studies on the influence of electrolytes, p

Elliott, James

224

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

225

Applications of Nanotechnology to Pharmaceutical Product Development  

E-print Network

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

Fisher, Frank

226

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

227

Strategy Formation in Pharmaceutical Drug Discovery  

Microsoft Academic Search

Advances in scientific knowledge and technology have significantly changed the process of pharmaceutical drug discovery over the last two centuries. Accompanying these changes has been the increasing popularity of research into the formation and change of organisational strategy. Despite the popularity of the two research areas, organisational strategy and drug discovery, there is almost no information about the defining strategies

Christos Tsinopoulos

228

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

229

Direct to Consumer Advertising in Pharmaceutical Markets  

Microsoft Academic Search

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

Kurt R. Brekke; Michael Kuhn

2005-01-01

230

Welfare Effects of Pharmaceutical Informative Advertising  

Microsoft Academic Search

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

Paris Cleanthous

2011-01-01

231

Direct to consumer advertising in pharmaceutical markets  

Microsoft Academic Search

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

Kurt R. Brekke; Michael Kuhn

2006-01-01

232

Pharmaceutical Advertising and Medicare Part D  

Microsoft Academic Search

Critics continue to charge that Part D provided windfall profits to pharmaceutical manufacturers, at the expense of patients. While there is little doubt that Part D has increased the profitability of drugs sold to Part D beneficiaries, this may help or harm patients. The key question is how firms have responded to the increased profit opportunities, and how this has

Neeraj Sood; Darius Lakdawalla

2010-01-01

233

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

234

The role of UHPLC in pharmaceutical development.  

PubMed

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

Chesnut, Stephen M; Salisbury, John J

2007-05-01

235

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...

236

Pharmaceuticals, Hormones, and Other Organic Wastewater  

E-print Network

processes (via wastewater treatment plants, or domestic septic systems), which often are not designedPharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999 as biogenic hormones are released directly to the environment after passing through wastewater treatment

237

Pharmaceutical quality of anthelmintics sold in Kenya  

Microsoft Academic Search

Nine anthelmintic products purchased in pharmacies and from agricultural merchants in Kenya were tested for pharmaceutical quality. The concentration of active drug was compared with the claim on the label, and the variability of several products was tested between batches and between bottles within the same batch. All the products purchased claimed to contain levamisole but its mean (sd) concentration

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

1998-01-01

238

Are pharmaceutical patents protected by human rights?  

Microsoft Academic Search

The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect

J Millum

2008-01-01

239

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

ERIC Educational Resources Information Center

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

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

2010-01-01

240

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

PubMed

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

Meffert, Jeffrey J

2009-01-01

241

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

242

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

243

Company Town Shutdown.  

ERIC Educational Resources Information Center

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

Turnage, Martha A.

244

The Timken Company  

Microsoft Academic Search

The acquisition of Torrington, Inc., from Ingersoll-Rand, Inc., required a strategy that met both the investment and financing objectives of the Timken Company. The case provides an excellent example of the principle that investment and financing decisions can be considered independently. Because of Timken's need to have a sequential financing strategy, the case illustrates the complexities of managing large investment

Kenneth Eades; Ali Erarac

245

Garden Variety Coffee Company  

E-print Network

Garden Variety Coffee Company Hiroba Nippon Got Fries? Icy's Subway Pitas, Wraps, Fruit Smoothies Residences Dairy Shell Mac's Backstreet KFC Super SamPit Coffee Church Church Pizza BoosterPanago Liquor-0001) - Fruit Smoothies, Sandwiches, Salads Safeway Pizza Hut Taco Time - Grocery Store - Pizza, Salads

Wismath, Stephen

246

Sunshine Power Company MEA  

NSDL National Science Digital Library

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

Kerri Caudill

2012-08-03

247

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

248

Effect of pharmaceutical excipients on the stability of trichlormethiazide tablets under humid conditions.  

PubMed

The stability of trichlormethiazide (TCM) and the drug in the nine products available on the market (the original tablet (B) and 8 generic tablets (G1-G8)) were investigated under humid conditions. TCM was non-hygroscopic and was not degraded under humid conditions. Drug degradation in aqueous ethanol was accelerated with increased water concentration, and the drug stability in buffer solution was improved with decreased pH. TCM decomposition was not detected in each unwrapped tablet at low relative humidity. However, rapid degradation was observed for products G1 and G2, while product B and G7 showed higher stability at high relative humidity. The stability of products G1 and G2 decreased with increasing humidity. The same results were observed for the tablets in press-through packages (PTP), but the degradation rate was much slower than tablets without PTP packages. These results suggested that the adsorbed moisture by excipients cause TCM degradation. Various pharmaceutical excipients are added to TCM tablets and these vary between different pharmaceutical companies. Intact drug and pharmaceutical excipients, including lactose, microcrystalline cellulose, corn starch, hydroxypropylcellulose (HPC), low substituted HPC (L-HPC), calcium stearate, and light anhydrous silicic acid, were mixed, and the sample mixtures were stored in humid conditions. It was found that the TCM content decreased significantly in a binary mixture of TCM/HPC 1 : 1. PMID:19952441

Teraoka, Reiko; Matsushima, Yuki; Sugimoto, Isao; Inoue, Kana; Morita, Shin-ya; Kitagawa, Shuji

2009-12-01

249

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

250

Biological treatment of pharmaceutical wastewater from the antibiotics industry.  

PubMed

Pharmaceutical wastewater generated by an antibiotics (penicillin) company was treated by aerobic membrane bioreactors (MBRs) and sequencing batch reactors (SBRs). At a low organic loading rate of 0.22 kg-COD m(-3)d(-1), both types of reactors were capable of treating the wastewater such that the treated effluent met the discharge regulation except for the total dissolved solids. However, when the loading rate was increased to 2.92 kg-COD m(-3)d(-1), foaming issues resulted in unstable performance. Overall, the MBRs achieved better solid removal but the SBRs performed better in regards to the degradation of aromatic compounds, as determined by UV absorbance (UVA). Finally, ozonation was applied on two different streams and showed promise on the strong stream - that corresponds to the formulation effluent and contains most of the biorefractory compounds. Ozonation successfully reduced the UVA, lowered the pH and increased the biochemical oxygen demand : chemical oxygen demand (BOD5 : COD) ratio of the strong stream. However, it was less efficient on the effluent having undergone pre-treatment by a biofilter due to a lack of selectivity towards refractory compounds. PMID:24569287

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

2014-01-01

251

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

252

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

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

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

253

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

PubMed Central

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.

2013-01-01

254

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

255

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

256

Controlling pharmaceutical crystallization with designed polymeric heteronuclei.  

PubMed

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

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

2015-01-21

257

Performance and data interpretation of the in vivo comet assay in pharmaceutical industry: EFPIA survey results.  

PubMed

In genotoxicity testing of pharmaceuticals the rodent alkaline comet assay is being increasingly used as a second in vivo assay in addition to the in vivo micronucleus assay to mitigate in vitro positive results as recommended by the ICH S2(R1) guideline. This paper summarizes a survey suggested by the Safety Working Party of European Medicines Agency (EMA), and conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) to investigate the experience among European pharmaceutical companies by conducting the in vivo comet assay for regulatory purpose. A special focus was given on the typology of the obtained results and to identify potential difficulties encountered with the interpretation of study data. The participating companies reported a total of 147 studies (conducted in-house or outsourced) and shared the conclusion on the comet assay response for 136 studies. Most of the studies were negative (118/136). Only about 10% (14/136 studies) of the comet assays showed a positive response. None of the positive comet assay results were clearly associated with organ toxicity indicating that the positive responses are not due to cytotoxic effects of the compound in the tissue examined. The number of comet assays with an equivocal or inconclusive response was rare, respectively <1% (1/147 studies) and 2% (3/147 studies). In case additional information (e.g. repeat assay, organ toxicity, metabolism, tissue exposure) would have been available for evaluation, a final conclusion could most probably have been drawn for most or all of these studies. All (46) negative in vivo comet assays submitted alongside with a negative in vivo micronucleus assay were accepted by the regulatory authorities to mitigate a positive in vitro mammalian cell assay following the current ICH S2 guidance. The survey results demonstrate the robustness of the comet assay and the regulatory acceptance of the current ICH S2 guidance. PMID:25435358

van der Leede, Bas-Jan; Doherty, Ann; Guérard, Melanie; Howe, Jonathan; O'Donovan, Mike; Plappert-Helbig, Ulla; Thybaud, Véronique

2014-12-01

258

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

259

Amphibole content of cosmetic and pharmaceutical talcs.  

PubMed Central

Pharmaceutical and cosmetic-grade talcs were examined for asbestiform amphibole content using a new density-optical method. Talcs under the Food and Drug Administration are not regulated as to asbestos content; however, all talcs were well below the level mandated by the Occupational Safety and Health Administration for industrial talcs. Only one was found to contain an amphibole particle size distribution typical of asbestos. Images FIGURE 1. FIGURE 5. FIGURE 7. PMID:1659533

Blount, A M

1991-01-01

260

Bioceramics and pharmaceuticals: A remarkable synergy  

NASA Astrophysics Data System (ADS)

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

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

2007-09-01

261

Paying for pharmaceutical registration in developing countries.  

PubMed

Fees charged by drug regulatory authorities (DRAs) may be used as a policy instrument to speed up regulatory approval, to encourage retention of quality staff and to stimulate introduction of generics versus new chemical entities. Often, the cost recovery function of these registration fees is not related to the true cost of the pharmaceutical regulatory process. In this paper, we scaled new drug registration fees of various DRAs to indices of economic development - the GNP per capita and the total government health expenditure per capita. Based on our analyses of 34 countries, most DRA registration fees for new drug applications for developing/non-OECD countries are less than the current GNP/capita of that country or are about US dollars 5000 for each US dollars 1000 spent per capita on healthcare. At present, each US dollars 1000 new drug registration fee for the developing/non-OECD countries analyzed corresponds to a total pharmaceutical market share of about US dollars 85 million. Our analyses further suggest little relationship between DRA registration fees and drug approval times in developing countries. The situation is complex, however, as policy tradeoffs are important to consider. Differential registration fees, presumably designed to encourage locally produced versus imported products, may violate international trade regulations. Moreover, certain DRA registration fees may provide perverse incentives for the pharmaceutical industry. Developing countries should require that DRA registration fees be based on accurate accounting of the cost of services provided. At present levels, these fees could be increased without disincentive to the pharmaceutical industry. For new drug registration fees, our analyses suggest that developing countries could charge between 1-5 times their GNP per capita or between US dollars 17000 and US dollars 80000 for each US dollars 1000 spent per capita on healthcare. PMID:12917265

Kaplan, Warren A; Laing, Richard

2003-09-01

262

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

263

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

264

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

265

Human resource management and knowledge management: enhancing knowledge sharing in a pharmaceutical company  

Microsoft Academic Search

There is a gap in understanding the implications for human resource management practices of the rising interest in managing knowledge (Scarbrough and Carter, 2000). As a response, this paper takes an organizational learning perspective to reflect more critically upon the problems of managing knowledge. In particular, it highlights employees' unwillingness to share knowledge with others as crucial in determining the

Graeme Currie; Maire Kerrin

2003-01-01

266

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

E-print Network

to a class of drugs called neuraminidase inhibitors. They do not elimi- nate the virus, but they reduce its by inhaler, which is not very practical if a patient's breathing is impaired. But both neuraminidase

Cai, Long

267

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

PubMed Central

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

Abiola, Sara; Colgrove, James

2012-01-01

268

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

269

Agglomeration tendency in dry pharmaceutical granular systems.  

PubMed

The agglomeration tendency of dry pharmaceutical mixtures containing various concentrations of Xylitab 100 (Xylitol), calcium carbonate precipitated (CCP) and magnesium stearate (MgSt) was evaluated statistically as a function of mixing time. A Ro-Tap tester was employed to mix the three pharmaceutical components, and the agglomerates formed were measured with respect to their weight and size. An experimental design was devised and applied to structure and then statistically analyze the results. Xylitab was found not to be influential in the formation of agglomerates, but aided in deagglomeration when mixed with other components. CCP and MgSt formed agglomerates over time and showed positive interactions favouring agglomeration. The agglomerates started to fracture when they reached a critical size, at which stage the particles' attraction forces (cohesion forces) were weaker than both gravity and inertia. It has been shown and quantitatively demonstrated that the mixing time and ingredient concentrations of a three-component pharmaceutical mixture can affect agglomeration tendency. PMID:16797949

Lachiver, Emilie DesRosiers; Abatzoglou, Nicolas; Cartilier, Louis; Simard, Jean-Sébastien

2006-10-01

270

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

271

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.

272

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

PubMed

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

Paluzzi, Joan E

2012-01-01

273

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

274

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

275

Life Cycle Analysis within Pharmaceutical Process Optimization and Intensification: Case Study of Active Pharmaceutical Ingredient Production.  

PubMed

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

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

2014-12-01

276

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

PubMed

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

Giermaziak, Wojciech

2014-04-01

277

COORDINATING ON LOWER PRICES: PHARMACEUTICAL PRICING  

E-print Network

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

Sadoulet, Elisabeth

278

The Appreciation and Realisation of Research-Based Teacher Education: Finnish Students' Experiences of Teacher Education  

ERIC Educational Resources Information Center

Finnish pupils have scored well on international comparative students' achievement tests. Apparently, this is the main reason for the current wide international interest in the Finnish teacher education system and its research-based approach. The aim of this article is to describe student teachers' perspectives on the research-based approach. We…

Jyrhama, Riitta; Kynaslahti, Heikki; Krokfors, Leena; Byman, Reijo; Maaranen, Katriina; Toom, Auli; Kansanen, Pertti

2008-01-01

279

Prevalence and Implementation Fidelity of Research-Based Prevention Programs in Public Schools. Final Report  

ERIC Educational Resources Information Center

This report presents descriptive information about the prevalence and quality of implementation of research-based programs from the Study of the Implementation of Research-Based Programs to Prevent Youth Substance Abuse and School Crime. The study found that, while schools reported implementing a large number of prevention programs during the…

Crosse, Scott; Williams, Barbara; Hagen, Carol A.; Harmon, Michele; Ristow, Liam; DiGaetano, Ralph; Broene, Pamela; Alexander, Debbie; Tseng, Margaret; Derzon, James H.

2011-01-01

280

Accelerated aging: prediction of chemical stability of pharmaceuticals.  

PubMed

Methods of rapidly and accurately assessing the chemical stability of pharmaceutical dosage forms are reviewed with respect to the major degradation mechanisms generally observed in pharmaceutical development. Methods are discussed, with the appropriate caveats, for accelerated aging of liquid and solid dosage forms, including small and large molecule active pharmaceutical ingredients. In particular, this review covers general thermal methods, as well as accelerated aging methods appropriate to oxidation, hydrolysis, reaction with reactive excipient impurities, photolysis and protein denaturation. PMID:15778049

Waterman, Kenneth C; Adami, Roger C

2005-04-11

281

Company profile: Spider stories.  

PubMed

SpiderBiotech is a biotech company that has carried out extensive research and development on peptide-based anti-infectives, with five people involved in R&D activities and a strong network of industrial and academic partners experienced in the field of anti-infectives. SpiderBiotech has also created a proprietary library of bioactive peptides and lipopeptides (both linear and dendrimeric) active against bacterial and viral infections. At the moment they have two ongoing projects: the most advanced is focused on the development of a panel of peptide based antibiotics. The second project is related to novel antiviral drugs to treat acyclovir resistant Herpes virus infections. PMID:18504017

Giuliani, Andrea

2008-06-01

282

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

Microsoft Academic Search

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

Antonio Peinado; Jonathan Hammond; Andrew Scott

2011-01-01

283

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

284

Influence of sewage and pharmaceuticals on soil microbial function.  

PubMed

Although sewage effluent application to land is a common approach to recycle water and provide nutrients to plants, bioactive pharmaceuticals contained in sewage may change soil quality by affecting soil microbial communities. Establishing causal effects, however, is difficult, because trace levels of pharmaceuticals are confounded with other effluent constituents. Therefore, two originally similar soil microbial communities, one irrigated in situ with sewage effluent for 12 years and another nonirrigated, were exposed to high levels of acetaminophen, aspirin, carbamazepine, chlorpromazine, and tetracycline. The objectives of the current study were to determine the influence of high levels of pharmaceuticals on several soil microbial properties, the effect that prolonged effluent irrigation with ambient levels of pharmaceuticals had on soil microbial function, and how this effect would change in response to pharmaceutical exposure. Several pharmaceuticals, at high exposure levels, imposed stress on the soil microbial community as judged by increased CO(2) respiration, decreased biomass carbon, and altered substrate utilization affinities. Prolonged effluent irrigation, which altered the genetic fingerprint of the microbial community, also mitigated the response that exposure to pharmaceuticals had on the microbial community and enabled degradation of the antimicrobial salicylic acid after aspirin exposure. In conclusion, prolonged irrigation with sewage effluent containing pharmaceuticals at ambient levels influenced the microbial community so that they were able to better cope with sudden exposure to high levels of pharmaceuticals. PMID:21312249

Gielen, Gerty J H P; Clinton, Peter W; Van den Heuvel, Michael R; Kimberley, Mark O; Greenfield, Laurie G

2011-05-01

285

Capillary electrophoresis for the analysis of small-molecule pharmaceuticals.  

PubMed

This paper reviews the application of CE to the analysis of small-molecule pharmaceuticals. The areas of pharmaceutical analysis covered are enantiomer separation, the analysis of small molecules such as amino acids or drug counter-ions, pharmaceutical assay, determination of related substances and physicochemical measurements such as log P and pK(a) of compounds. The different electrophoretic modes available and their advantages for pharmaceutical analysis are described. Recent applications of CE for each subject area are tabulated with electrolyte details. PMID:16786477

Altria, Kevin; Marsh, Alex; Sänger-van de Griend, Cari

2006-06-01

286

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

287

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

288

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

289

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

290

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

291

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

292

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

Federal Register 2010, 2011, 2012, 2013

...Controlled Substances, Notice of Registration, Halo Pharmaceutical, Inc. By Notice dated...Register on August 7, 2012, 77 FR 47114, Halo Pharmaceutical, Inc., 30 North Jefferson...and determined that the registration of Halo Pharmaceutical, Inc., to...

2012-12-21

293

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

Federal Register 2010, 2011, 2012, 2013

...Controlled Substances, Notice of Registration; Halo Pharmaceutical Inc. By Notice dated December...Register on December 14, 2011, 76 FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson...and determined that the registration of Halo Pharmaceutical Inc. to manufacture...

2012-03-20

294

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

E-print Network

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

Gleeson, Joseph G.

295

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

Federal Register 2010, 2011, 2012, 2013

...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

296

Old Yet New--Pharmaceuticals from Plants  

NASA Astrophysics Data System (ADS)

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

Houghton, Peter J.

2001-02-01

297

US Pharmaceutical Innovation in an International Context  

PubMed Central

Objectives. We explored whether the United States, which does not regulate pharmaceutical prices, is responsible for the development of a disproportionate share of the new molecular entities (NMEs; a drug that does not contain an active moiety previously approved by the Food and Drug Administration) produced worldwide. Methods. We collected data on NMEs approved between 1992 and 2004 and assigned each NME to an inventor country. We examined the relation between the proportion of total NMEs developed in each country and the proportion of total prescription drug spending and gross domestic product (GDP) of each country represented. Results. The United States accounted for 42% of prescription drug spending and 40% of the total GDP among innovator countries and was responsible for the development of 43.7% of the NMEs. The United Kingdom, Switzerland, and a few other countries innovated proportionally more than their contribution to GDP or prescription drug spending, whereas Japan, South Korea, and a few other countries innovated less. Conclusions. Higher prescription drug spending in the United States does not disproportionately privilege domestic innovation, and many countries with drug price regulation were significant contributors to pharmaceutical innovation. PMID:20403883

Wang, Steven; Hebert, Paul; Carpenter, Daniel; Anderson, Gerard

2010-01-01

298

Towards a healthy use of pharmaceuticals.  

PubMed

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

Laporte, J R

1985-01-01

299

Removal of pharmaceuticals and fragrances in biological wastewater treatment  

Microsoft Academic Search

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

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

2005-01-01

300

Uptake of human pharmaceuticals by plants grown under hydroponic conditions  

Microsoft Academic Search

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

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

2010-01-01

301

Application of Fourier Transform Infrared Spectrophotometry in Pharmaceutical Drugs Analysis  

Microsoft Academic Search

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

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

2010-01-01

302

Pharmaceutical Cocrystallization: Engineering a Remedy for Caffeine Hydration  

E-print Network

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

de Gispert, Adrià

303

Tackling Corruption in the Pharmaceutical Systems Worldwide with Courage and  

Microsoft Academic Search

Poor drug access continues to be one of the main global health problems. Global inequalities in access to pharmaceuticals are caused by a number of variables including poverty, high drug prices, poor health infrastructure, and fraud and corruption — the latter being the subject of this article. There is growing recognition among policy makers that corruption in the pharmaceutical system

Conviction JC Cohen; M Mrazek; L Hawkins

2007-01-01

304

Pharmaceutical Concern and Prioritization Framework for Aquatic Life Effects  

EPA Science Inventory

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

305

75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop  

Federal Register 2010, 2011, 2012, 2013

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

2010-03-31

306

A Risk Modeling Framework for the Pharmaceutical Industry  

Microsoft Academic Search

This conceptual paper seeks to advance a theoretical discussion on risk modeling and how it is used within the context of business process modeling. It discusses developments in risk modeling and then shows how they have been applied to the USA pharmaceutical industry. The pharmaceutical industry is a particularly interesting example in that it is bound on one side by

Warren Adis

2007-01-01

307

Fate and mobility of pharmaceuticals in solid matrices  

Microsoft Academic Search

The sorption and mobility of six pharmaceuticals were investigated in two soil types with different organic carbon and clay content, and in bacterial biomass (aerobic and anaerobic). The pharmaceuticals examined were carbamazepine, propranolol, diclofenac sodium, clofibric acid, sulfamethoxazole and ofloxacin. The sorption experiments were performed according to the OECD test Guideline 106. The distribution coefficients determined by this batch equilibrium

Panagiota Drillia; Katerina Stamatelatou; Gerasimos Lyberatos

2005-01-01

308

Pharmaceuticals as Neuroendocrine Disruptors: Lessons Learned from Fish on Prozac  

Microsoft Academic Search

Pharmaceuticals are increasingly detected in a variety of aquatic systems. One of the most prevalent environmental pharmaceuticals in North America and Europe is the antidepressant fluoxetine, a selective serotonin reuptake inhibitor (SSRI) and the active ingredient of Prozac. Usually detected in the range below 1 ?g\\/L, fluoxetine and its active metabolite norfluoxetine are found to bioaccumulate in wild-caught fish, particularly

Jan A. Mennigen; Pamela Stroud; Jake M. Zamora; Thomas W. Moon; Vance L. Trudeau

2011-01-01

309

The Chemical and Pharmaceutical Industry Susan Brench (1984)  

E-print Network

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

Goldschmidt, Christina

310

Significance of pharmaceutical excipients in prescribed medicines: a case report  

PubMed Central

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

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

2014-01-01

311

Astronaut William Gregory works with pharmaceutical experiments on middeck  

NASA Technical Reports Server (NTRS)

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

1995-01-01

312

STANDARD INSURANCE COMPANY A Stock Life Insurance Company  

E-print Network

STANDARD INSURANCE COMPANY A Stock Life Insurance Company 900 SW Fifth Avenue Portland, Oregon 97204-1282 (503) 321-7000 CERTIFICATE: GROUP ACCIDENTAL DEATH AND DISMEMBERMENT INSURANCE Policyholder will be insured as provided by the terms of the Group Policy. If your coverage is changed by an amendment

Oklahoma, University of

313

STANDARD INSURANCE COMPANY A Stock Life Insurance Company  

E-print Network

STANDARD INSURANCE COMPANY A Stock Life Insurance Company 900 SW Fifth Avenue Portland, Oregon 97204-1282 (503) 321-7000 CERTIFICATE: GROUP ACCIDENTAL DEATH AND DISMEMBERMENT INSURANCE Policyholder has been issued to the Policyholder. We certify that you will be insured as provided by the terms

Oklahoma, University of

314

STANDARD INSURANCE COMPANY A Stock Life Insurance Company  

E-print Network

STANDARD INSURANCE COMPANY A Stock Life Insurance Company 900 SW Fifth Avenue Portland, Oregon 97204-1282 (503) 321-7000 CERTIFICATE GROUP LIFE INSURANCE Policyholder: State of Oklahoma ex rel A Group Policy has been issued to the Policyholder. We certify that you will be insured as provided

Oklahoma, University of

315

STANDARD INSURANCE COMPANY A Stock Life Insurance Company  

E-print Network

STANDARD INSURANCE COMPANY A Stock Life Insurance Company 900 SW Fifth Avenue Portland, Oregon 97204-1282 (503) 321-7000 CERTIFICATE GROUP LONG TERM DISABILITY INSURANCE Policyholder: University to the Policyholder. We certify that you will be insured as provided by the terms of your Employer's coverage under

Pilyugin, Sergei S.

316

STANDARD INSURANCE COMPANY A Stock Life Insurance Company  

E-print Network

STANDARD INSURANCE COMPANY A Stock Life Insurance Company 900 SW Fifth Avenue Portland, Oregon 97204-1282 (503) 321-7000 CERTIFICATE GROUP SHORT TERM DISABILITY INSURANCE Policyholder: University to the Policyholder. We certify that you will be insured as provided by the terms of your Employer's coverage under

Meyers, Steven D.

317

Staging Ethics: The Promise and Perils of Research-based Performance  

Microsoft Academic Search

While performance can be an effective vehicle for knowledge transmission, Christina Sinding, Lisa Schwartz, and Matthew Hunt examine the ethical blind spots that can sometimes emerge in research-based performance.

Christina Sinding; Lisa Schwartz; Matthew Hunt

2011-01-01

318

Staging Ethics: The Promise and Perils of Research-based Performance  

Microsoft Academic Search

:While performance can be an effective vehicle for knowledge transmission, Christina Sinding, Lisa Schwartz, and Matthew Hunt examine the ethical blind spots that can sometimes emerge in research-based performance.

Christina Sinding; Lisa Schwartz; Matthew Hunt

2011-01-01

319

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

Cancer.gov

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

320

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

PubMed Central

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

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

2010-01-01

321

Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters  

PubMed Central

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

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

2014-01-01

322

Extraction characterization and evaluation of selected mucilage as pharmaceutical excipient.  

PubMed

Natural polymers have been used in different pharmaceutical formulations. They are easily available, non-toxic, biodegradable and cost effective to be used as pharmaceutical excipient. In present investigation mucilage was extracted from fruit of Hibiscus esculentus and further characterized to be used as pharmaceutical excipient. Tablets were prepared using four different concentrations (6.6%, 13.3%, 20%, 26.66%) of Hibiscus esculentus mucilage and potato starch to evaluate binding properties of mucilage. Results obtained from the micromeritic characterization and flow behavior showed that Hibiscus esculentus mucilage is a good candidate to be used as pharmaceutical excipient. Tablets prepared using mucilage showed relatively lesser friability than prepared with starch. It was found that release of drug from tablets prepared with mucilage was less as compared to prepared with starch. Findings of the different results easily predict the fact that mucilage obtained from Hibiscus esculentus has characteristics to be used as pharmaceutical excipient. PMID:22046826

Malviya, Rishabha

2011-01-01

323

Membrane bioprocesses for pharmaceutical micropollutant removal from waters.  

PubMed

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

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

2014-01-01

324

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

E-print Network

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

Hou, Billy

2011-01-01

325

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

E-print Network

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

Imai, Hiroshi

326

IRRIGATION FOR VACCINE PRODUCTION IN PHARMACEUTICAL TOBACCO  

Technology Transfer Automated Retrieval System (TEKTRAN)

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

327

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

PubMed

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

Taylor, David; Senac, Thomas

2014-11-01

328

Real Estate Development Company Description  

E-print Network

Real Estate Development Company Description: The largest specialty family footwear retailer America, the Caribbean and South America. Short Project Name: Competitive Analysis - Real Estate Positions to assist them in making recommendations for how our company should develop its real estate strategy

Dahl, David B.

329

Survival skills in downsizing company  

Microsoft Academic Search

Unfortunately, many of us will be in companies that are downsizing at some point in our careers. Often such reductions in staff at companies create a work environment that is less than optimal. However, the guidelines discussed by the author are intended to help you in maintaining gainful employment during the process. These guidelines deal with downsizing situations where the

K. W. Tracy

2003-01-01

330

HR/Organizational Company Description  

E-print Network

HR/Organizational Company Description: One of the world's leading companies in the field of health, but foster a culture and environment so the millennial generation can succeed. Key Deliverables 1. Analyze adapt our current culture to fit the needs of the new generation of the workforce, or a way to implement

Dahl, David B.

331

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

PubMed

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

Syrycki, Marek

2002-01-01

332

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

PubMed

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

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

2015-01-01

333

Quantitative risk modelling for new pharmaceutical compounds.  

PubMed

The process of discovering and developing new drugs is long, costly and risk-laden. Faced with a wealth of newly discovered compounds, industrial scientists need to target resources carefully to discern the key attributes of a drug candidate and to make informed decisions. Here, we describe a quantitative approach to modelling the risk associated with drug development as a tool for scenario analysis concerning the probability of success of a compound as a potential pharmaceutical agent. We bring together the three strands of manufacture, clinical effectiveness and financial returns. This approach involves the application of a Bayesian Network. A simulation model is demonstrated with an implementation in MS Excel using the modelling engine Crystal Ball. PMID:16257374

Tang, Zhengru; Taylor, Mark J; Lisboa, Paulo; Dyas, Mark

2005-11-15

334

Marine Polysaccharides in Pharmaceutical Applications: An Overview  

PubMed Central

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

Laurienzo, Paola

2010-01-01

335

Pharmaceutical Particle Engineering via Spray Drying  

PubMed Central

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

2007-01-01

336

Cancer nanoimmunotherapy using advanced pharmaceutical nanotechnology.  

PubMed

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

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

2014-11-01

337

The ethics and economics of pharmaceutical pricing.  

PubMed

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

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

2015-01-01

338

Pharmaceutical Advertising and Medicare Part D  

PubMed Central

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

Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

2013-01-01

339

Pharmaceutical advertising and Medicare Part D.  

PubMed

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

Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

2013-12-01

340

The pharmaceutical death-ride of dihydroartemisinin  

PubMed Central

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

2010-01-01

341

Pharmaceutical quality of anthelmintics sold in Kenya.  

PubMed

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

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

1998-04-11

342

VALUING TRIAL DESIGNS FROM A PHARMACEUTICAL PERSPECTIVE USING VALUE-BASED PRICING.  

PubMed

Our aim was to adapt the traditional framework for expected net benefit of sampling (ENBS) to be more compatible with drug development trials from the pharmaceutical perspective. We modify the traditional framework for conducting ENBS and assume that the price of the drug is conditional on the trial outcomes. We use a value-based pricing (VBP) criterion to determine price conditional on trial data using Bayesian updating of cost-effectiveness (CE) model parameters. We assume that there is a threshold price below which the company would not market the new intervention. We present a case study in which a phase III trial sample size and trial duration are varied. For each trial design, we sampled 10?000 trial outcomes and estimated VBP using a CE model. The expected commercial net benefit is calculated as the expected profits minus the trial costs. A clinical trial with shorter follow-up, and larger sample size, generated the greatest expected commercial net benefit. Increasing the duration of follow-up had a modest impact on profit forecasts. Expected net benefit of sampling can be adapted to value clinical trials in the pharmaceutical industry to optimise the expected commercial net benefit. However, the analyses can be very time consuming for complex CE models. © 2014 The Authors. Health Economics published by John Wiley & Sons Ltd. PMID:25204721

Breeze, Penny; Brennan, Alan

2014-09-01

343

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

PubMed Central

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

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

2014-01-01

344

Assessment of the pharmaceutical market in Poland after accession to the European Union.  

PubMed

The Republic of Poland joined the European Union (EU) on 1 May 2004. The EU accession brought new opportunities to the Polish health care system and the pharmaceutical market. However, there are still barriers to overcome such as bureaucracy, lack of transparency in pricing and reimbursement, decision-making processes, the short period of data exclusivity, respect for intellectual property rights, favorisation of local companies and low health care investment. Additionally, drug costs outpace overall economic development, a trend which is universally valid for almost all EU countries and which forms one of the most serious factors in health care expenditure. A systematic cost-effective assessment, the so-called fourth hurdle (after quality, efficacy and safety), of prescription drugs seems a necessity in most EU countries. The Polish Ministry of Health has defined aims for the future health care system in the National Drug Policy 2004-2008, including health economical criteria and instruments. However, it is to be expected that for some time there will be more a reimbursement hurdle instead of a fourth hurdle in controlling drug expenditure. This review focuses on the Polish pharmaceutical market with special consideration of the history of the Polish health care system. It will highlight the present situation of the Polish health care system after EU accession and provide an outlook to its possible future. PMID:17186200

Willert, Patricia L

2007-12-01

345

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

PubMed Central

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

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

2011-01-01

346

[Studies on the food allergenic proteins contained in pharmaceutical excipients].  

PubMed

Most drugs contain pharmaceutical excipients. These are pharmacologically inactive substances used as vehicles for the active ingredients of a medication. Some of these pharmaceutical excipients are produced from allergenic foods (e.g., milk, egg, peanut, soybean, and sesame) and removing proteins completely from such excipients is difficult. Therefore, if individuals with food allergy consume drugs containing allergenic food-derived excipients, eliminating the risk of developing specific allergic symptoms induced by them may not be possible. We determined the levels of proteins in pharmaceutical excipients and ethical drugs (inhalants and injections) by spectrophotometric analyses. The level of protein in the pharmaceutical excipient lactose in each sample was approximately 1 mg/g. In the case of oils from soybeans, peanuts, and sesame in pharmaceutical excipients, proteins were detected in the range 7-9 microg/g sample. We also determined levels of allergenic proteins in pharmaceutical excipients and ethical drugs using commercial enzyme-linked immunosorbent assay systems. The milk proteins in lactose were detected in the range 1.39-13.07 microg/g. The results of this study suggest that physicians, patients with food allergies, pharmacists, and healthcare providers must pay attention to presence of potential impurities those may cause allergic symptoms in pharmaceutical products. PMID:23243989

Sakai, Shinobu; Adachi, Reiko; Miyazaki, Tamaki; Aso, Yukio; Okuda, Haruhiro; Teshima, Reiko

2012-01-01

347

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

PubMed

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

Sihn, Kyu-Hwan

2013-12-01

348

Pharmaceutical sciences' manpower supply and internal rate of return.  

PubMed

A pharmacy student has many career options upon graduation. These options include graduate education in one of the pharmaceutical sciences and a retail pharmacy position. The attractive salaries offered by chain pharmacies play an important role in the recent graduate's career decision-making process. The purpose of this study is to provide a comparative assessment of the internal rate of return (IRR) for different pharmaceutical science career options as related to chain-store pharmacist earnings. Additionally, this study analyzes the effect of the IRR on the applicant pool size and composition for graduate study in pharmaceutical sciences. Income/age profiles were developed using public domain income data derived from salary surveys sponsored by professional associations. Based on these income/age profiles, IRRs were estimated for the pharmaceutical science disciplines, clinical pharmacy, pharmaceutics, medicinal chemistry, and pharmacy administration, and further differentiated for industry versus academic careers. The IRRs are the highest for Pharm.D.'s in academic careers (16.0%), followed by pharmaceutical scientists employed by pharmaceutical industry (8.13%). The IRR of pharmaceutical scientists in academia is lower than the return of other financial investment vehicles. Other authors have established a relationship between the IRR of a profession and a rise or decline in the applicant pool. The IRRs calculated here imply that this association can also be observed for the pharmaceutical scientist applicant pool. Low IRRs should result in a declining applicant pool. However, the last decade has shown an increase of 66% in the number of Ph.D.'s granted, while the percentage of Ph.D.'s granted to nonpharmacists or non-Americans has not increased significantly over the same time period.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2062796

Hartzema, A G; Perfetto, E

1991-06-01

349

Removal of Pharmaceutical Residues by Ferrate(VI)  

PubMed Central

Background Pharmaceuticals and their metabolites are inevitably emitted into the waters. The adverse environmental and human health effects of pharmaceutical residues in water could take place under a very low concentration range; from several µg/L to ng/L. These are challenges to the global water industries as there is no unit process specifically designed to remove these pollutants. An efficient technology is thus sought to treat these pollutants in water and waste water. Methodology/Major Results A novel chemical, ferrate, was assessed using a standard jar test procedure for the removal of pharmaceuticals. The analytical protocols of pharmaceuticals were standard solid phase extraction together with various instrumentation methods including LC-MS, HPLC-UV and UV/Vis spectroscopy. Ferrate can remove more than 80% of ciprofloxacin (CIP) at ferrate dose of 1 mg Fe/L and 30% of ibuprofen (IBU) at ferrate dose of 2 mg Fe/L. Removal of pharmaceuticals by ferrate was pH dependant and this was in coordinate to the chemical/physical properties of pharmaceuticals. Ferrate has shown higher capability in the degradation of CIP than IBU; this is because CIP has electron-rich organic moieties (EOM) which can be readily degraded by ferrate oxidation and IBU has electron-withdrawing groups which has slow reaction rate with ferrate. Promising performance of ferrate in the treatment of real waste water effluent at both pH 6 and 8 and dose range of 1–5 mg Fe/L was observed. Removal efficiency of ciprofloxacin was the highest among the target compounds (63%), followed by naproxen (43%). On the other hand, n-acetyl sulphamethoxazole was the hardest to be removed by ferrate (8% only). Conclusions Ferrate is a promising chemical to be used to treat pharmaceuticals in waste water. Adjusting operating conditions in terms of the properties of target pharmaceuticals can maximise the pharmaceutical removal efficiency. PMID:23409029

Jiang, JiaQian; Zhou, Zhengwei

2013-01-01

350

76 FR 66709 - Trunkline Gas Company, LLC, Sea Robin Pipeline Company, LLC; Notice of Application  

Federal Register 2010, 2011, 2012, 2013

...CP12-5-000] Trunkline Gas Company, LLC, Sea Robin Pipeline Company, LLC; Notice of Application...Trunkline Gas Company, LLC (Trunkline) and Sea Robin Pipeline Company, LLC (Sea Robin), together referred to as Applicants, both...

2011-10-27

351

78 FR 35360 - Surety Companies Acceptable on Federal Bonds: Terminations-American Economy Insurance Company...  

Federal Register 2010, 2011, 2012, 2013

...DEPARTMENT OF THE TREASURY Fiscal Service Surety Companies Acceptable on Federal Bonds: Terminations-- American Economy Insurance Company (NAIC 19690); American States Insurance Company (NAIC 19704); General Insurance Company of...

2013-06-12

352

Review of pharmaceutical applications of N-methyl-2-pyrrolidone.  

PubMed

N-Methyl-2-pyrrolidone (NMP) or Pharmasolve is very strong solubilizing agent and it has important applications in different fields of industry. This review presents NMP physicochemical characteristics, application especially in pharmaceutical sciences, pharmacokinetic and toxicity. Characteristics of NMP such as physicochemical properties, solubilization efficacy, toxicity and adverse effects were compared with other common solvents used in the pharmaceutical industries. This review reveals that NMP is an acceptable pharmaceutical solvent and its efficacy, toxicity, and side effects are comparable with other common solvent. PMID:21486529

Jouyban, Abolghasem; Fakhree, Mohammad A A; Shayanfar, Ali

2010-01-01

353

Strategies for strengthening patent protection of pharmaceutical inventions in light of federal court decisions.  

PubMed

In this article, a brief history of patent law is presented, along with recent changes in its interpretation that are relevant in securing patents in the current landscape. Specific patent examples are presented to illustrate key issues. For example, the case of KSR International Co. v. Teleflex, Inc. is an important recent decision by the United States Supreme Court, which developed a more flexible definition of the teaching-suggestion-motivation (TSM) test in determining obviousness, which negates patentability. Although KSR case involved a mechanical invention, the ruling in this case has had implications in other areas of patent law, particularly as it applied to pharmaceutical and chemical inventions. It has had a significant impact on the outcome of patent prosecution at the United States Patent and Trademark Office (USPTO), as well as in defending patents in federal courts. If an invention is obvious to try and there are a finite number of predictable solutions in the prior art, then the invention will be considered obvious by current standards. Bayer Schering Pharma AG v. Barr Laboratories, Inc is presented as a case in which the court of appeals has applied the KSR standard of obviousness in invalidating a formulation patent claim, in which a finite number of options were available to the formulator. Unlike the formulation patent example, patents covering new molecules have survived challenges more successfully. In The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the court of appeals for the Federal Circuit determined that the invention of risedronate was unobvious, although it was a mere positional isomer of a prior bisphosphonate. However in Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., the court of appeals judged against the innovator company when there was a clearer case of predictable prior art. Finally, Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. presents an example of a case at the Federal Circuit where topiramate was more easily defended, because the scientist had at his disposal a great number of unpredictable options and the results were clearly surprising. In light of these and other court decisions the USPTO has established new guidelines for patent examinations going forward that this article describes. PMID:20615184

Pillai, Xavier; Kinney, William A

2010-01-01

354

A field study on 8 pharmaceuticals and 1 pesticide in Belgium: removal rates in waste water treatment plants and occurrence in surface water.  

PubMed

Only recently, attention has been drawn towards the occurrence of pharmaceuticals in the environment. In recent years many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in waste water, surface water, ground water and in soil. In this study, we demonstrate the applicability of a previously developed LC-MS/MS method by evaluating in waste water and surface water samples from Belgium the occurrence of 8 pharmaceuticals and 1 pesticide (flubendazole, pipamperone, rabeprazole, domperidone, ketoconazole, itraconazole, cinnarizine, miconazole and propiconazole). Removal rates in five public waste water treatment plants were assessed. Introduction of several compounds into the aquatic environment by discharge of effluent could be demonstrated. For several compounds, the highest concentrations (up to 35.6 microg/l for pipamperone) were observed in the effluent of a WWTP receiving water from chemo-pharmaceutical and other industrial companies. The occurrence of these compounds in the aquatic environment was assessed by analyzing 16 surface water samples, taken from various locations. Four pharmaceuticals (flubendazole, pipamperone, domperidone and cinnarizine) could be detected in at least one sample at low concentrations (up to 26.4 ng/l). The pesticide propiconazole was found in comparable concentrations (up to 85.9 ng/l) as in effluent, suggesting potential introduction by direct seepage of water from rural grounds. The highest concentrations of flubendazole, pipamperone, domperidone, propiconazole and cinnarizine (up to 961.3 ng/l) were observed in a sample, taken near the discharge of a WWTP receiving water from chemo-pharmaceutical and other industries. An initial environmental risk assessment was done based on these results. PMID:20471061

Van De Steene, Jet C; Stove, Christophe P; Lambert, Willy E

2010-07-15

355

Eastern Kodak Company  

SciTech Connect

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

Y.S. Tyan

2009-06-30

356

The valuation of construction companies  

E-print Network

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

Sassine, Edmond, 1980-

2004-01-01

357

Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 continuous manufacturing symposium.  

PubMed

This white paper focuses on equipment, and analytical manufacturers' perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:821-831, 2015. PMID:25448273

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

2015-03-01

358

Achieving business and operational excellence in the pharmaceutical industry  

E-print Network

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

Coffey, Shonna (Shonna Marie)

2008-01-01

359

Study of polymeric film bonding for pharmaceutical applications  

E-print Network

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

Cardell, Alyse (Alyse Christine)

2011-01-01

360

Three essays on the development and diffusion of pharmaceutical innovations  

E-print Network

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

Azoulay, Pierre

2001-01-01

361

Computer-aided rational solvent selection for pharmaceutical crystallization  

E-print Network

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

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

2010-01-01

362

The business case for continuous manufacturing of pharmaceuticals  

E-print Network

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

Wilburn, Kristopher Ray

2010-01-01

363

Exploration of parameters for the continuous blending of pharmaceutical powders  

E-print Network

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

Lin, Ben Chien Pang

2011-01-01

364

Business models for information commons in the pharmaceutical industry  

E-print Network

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

Bharadwaj, Ragu

2009-01-01

365

3 HPLC instrumentation in pharmaceutical analysis: Status, advances, and trends  

Microsoft Academic Search

This chapter presents an overview of current trends in high-pressure liquid chromatography (HPLC) instrumentation focusing on recent advances and features relevant to pharmaceutical analysis. Operating principles of HPLC modules (pump, detectors, autosampler) are discussed with future trends.

Michael W. Dong

2005-01-01

366

Analytical Pharmaceutical Chemistry--Bridging Disciplines and Interests  

ERIC Educational Resources Information Center

Because of their interest and expertise in the analysis of drugs in biological fluids, analytical pharmaceutical chemists can contribute significantly to interdisciplinary research and teaching efforts. Suggestions for such efforts are described. (Author/LBH)

Smith, Robert V.

1977-01-01

367

Hydroxyalkyl phosphine compounds for use as diagnostic and therapeutic pharmaceuticals  

DOEpatents

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

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

1999-03-02

368

Decomposition of persistent pharmaceuticals in wastewater by ionizing radiation  

NASA Astrophysics Data System (ADS)

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

Kimura, Atsushi; Osawa, Misako; Taguchi, Mitsumasa

2012-09-01

369

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

E-print Network

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

Li, Wu, M. Eng Massachusetts Institute of Technology

2009-01-01

370

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

EPA Science Inventory

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

371

Experimental Design and Inferential Modeling in Pharmaceutical Crystallization  

E-print Network

. Braatz. 160 January 2001 et al., 19991, the ratio of the nucleated crystal mass to seed crystal massExperimental Design and Inferential Modeling in Pharmaceutical Crystallization Timokleia seed type, seed amount, temperature, solvent ratio, addition time, and agitation intensity

Braatz, Richard D.

372

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS (PPCPS) AS ENVIRONMENTAL POLLUTANTS  

EPA Science Inventory

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

373

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS: DIVERSE GALAXY OF ENVIRONMENTAL POLLUTANTS  

EPA Science Inventory

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

374

Recent trends and future of pharmaceutical packaging technology  

PubMed Central

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

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

2013-01-01

375

Framework for the determination of yield limits In pharmaceutical operations  

E-print Network

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

Liow, Yuh Han John

2010-01-01

376

[New pharmaceuticals in treatment of chronic dust bronchitis].  

PubMed

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

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

2007-01-01

377

Chemical ecology: a view from the pharmaceutical industry.  

PubMed Central

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

Caporale, L H

1995-01-01

378

Solid-State NMR Studies of Pharmaceutical Systems  

Microsoft Academic Search

High?and low?resolution solid?state nuclear magnetic resonance (SSNMR) applications to the study of pharmaceuticals are reviewed. Examples are shown involving the use of mono?and bidimensional SSNMR techniques based on different nuclear interactions and the measurement of several nuclear parameters, such as chemical shifts, line widths, and relaxation times (T1, T2, T1?). The systems investigated include pure active pharmaceutical ingredients (APIs), substances

Marco Geppi; Giulia Mollica; Silvia Borsacchi; Carlo Alberto Veracini

2008-01-01

379

Understanding and Predicting Pharmaceutical Product ShelfLife  

Microsoft Academic Search

\\u000a Pharmaceutical products are assigned a shelf-life which determines the time when a product is considered to be safe and effective\\u000a under a relevant storage condition. A number of factors are used to assign that shelf-life. Among these factors are the chemical\\u000a stability of the active pharmaceutical ingredient (API) in its dosage form, and specifically whether any degradation products\\u000a are potentially

Kenneth C. Waterman

380

Pharmaceuticals' sorptions relative to properties of thirteen different soils.  

PubMed

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

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

2015-04-01

381

Uptake of human pharmaceuticals by plants grown under hydroponic conditions.  

PubMed

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

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

2010-03-01

382

QSTR modelling of the acute toxicity of pharmaceuticals to fish  

Microsoft Academic Search

Extensive use of pharmaceuticals as human and veterinary medication raises concerns for their adverse effects on non-target organisms. The purpose of this study was to employ multiple linear regression (MLR) to predict the toxicities of a diverse set of pharmaceuticals to fish. The descriptor pool consisted of about 1500 descriptors calculated using Dragon 5.4, Spartan 06 and Codessa 2.2 software.

G. Tugcu; M. Türker Saçan; M. Vracko; M. Novic; N. Minovski

2012-01-01

383

Chronic aquatic environmental risks from exposure to human pharmaceuticals  

Microsoft Academic Search

This paper reviews current information on the chronic aquatic toxicity of human pharmaceuticals and how it should be measured. Chronic toxicitytests withCyanobacteria are likelyto besensitive surrogates for bothalgae andother unicellular organisms,although possibly not for higher plants. In contrast, there is little evidence of a general need to perform chronic aquatic invertebrate tests for all human pharmaceuticals, although further acute-to-chronic ratio

Mark Crane; Chris Watts; Tatiana Boucard

2006-01-01

384

Oxidation of pharmaceutically active compounds by a ligninolytic fungal peroxidase  

Microsoft Academic Search

Pharmaceuticals are an important group of emerging pollutants with increasing interest due to their rising consumption and\\u000a the evidence for ecotoxicological effects associated to trace amounts in aquatic environments. In this paper, we assessed\\u000a the potential degradation of a series of pharmaceuticals: antibiotics (sulfamethoxazole), antidepressives (citalopram hydrobromide\\u000a and fluoxetine hydrochloride), antiepileptics (carbamazepine), anti-inflammatory drugs (diclofenac and naproxen) and estrogen\\u000a hormones

Gemma Eibes; Gianfranco Debernardi; Gumersindo Feijoo; M. Teresa Moreira; Juan M. Lema

2011-01-01

385

Drug Policy Down Under: Australia's Pharmaceutical Benefits Scheme  

PubMed Central

Australia has had a government subsidized universal system of pharmaceutical provision for 50 years. The Pharmaceutical Benefits Scheme (PBS) consumes around 14 percent of total government health care expenditures and has grown substantially in both range of drugs covered, and expenditure since it was first introduced in 1950. It incorporates patient copayments (with differentials for the general population compared with concessional beneficiaries). Prior to listing a drug on the PBS it is subject to a rigorous cost-effectiveness analysis. PMID:15229996

Duckett, Stephen J.

2004-01-01

386

Transferring pharmaceuticals into the gas phase  

NASA Astrophysics Data System (ADS)

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

Christen, Wolfgang; Krause, Tim; Rademann, Klaus

2008-11-01

387

Glycosylation profiles of therapeutic antibody pharmaceuticals.  

PubMed

Recombinant antibodies specific for human targets are often used as therapeutics and represent a major class of drug products. Their therapeutic efficacy depends on the formation of antibody complexes resulting in the elimination of a target molecule or the modulation of specific signalling pathways. The physiological effects of antibody therapeutics are known to depend on the structural characteristics of the antibody molecule, specifically on the glycosylation which is the result of posttranslational modifications. Hence, production of therapeutic antibodies with a defined and consistent glycoform profile is needed which still remains a considerable challenge to the biopharmaceutical industry. To provide an insight into the industries capability to control their manufacturing process and to provide antibodies of highest quality, we conducted a market surveillance study and compared major oligosaccharide profiles of a number of monoclonal antibody pharmaceuticals sampled on the Swiss market. Product lot-to-lot variability was found to be generally low, suggesting that a majority of manufacturers have implemented high quality standards in their production processes. However, proportions of G0, G1 and G2 core-fucosylated chains derived from different products varied considerably and showed a bias towards the immature agalactosidated G0 form. Interestingly, differences in glycosylation caused by the production cell type seem to be of less importance compared with process related parameters such as cell growth. PMID:21745568

Wacker, Christoph; Berger, Christoph N; Girard, Philippe; Meier, Roger

2011-11-01

388

Direct to consumer advertising in pharmaceutical markets.  

PubMed

We study effects of direct-to-consumer advertising (DTCA) in the prescription drug market. There are two pharmaceutical firms providing horizontally differentiated (branded) drugs. Patients differ in their susceptibility to the drugs. If DTCA is allowed, this can be employed to induce (additional) patient visits. Physicians perfectly observe the patients' type (of illness), but rely on information to prescribe the correct drug. Drug information is conveyed by marketing (detailing), creating a captive and a selective segment of physicians. First, we show that detailing, DTCA and price (if not regulated) are complementary strategies for the firms. Thus, allowing DTCA induces more detailing and higher prices. Second, firms benefit from DTCA if detailing competition is not too fierce, which is true if investing in detailing is sufficiently costly. Otherwise, firms are better off with a ban on DTCA. Finally, DTCA tends to lower welfare if insurance is generous (low copayments) and/or price regulation is lenient. The desirability of DTCA also depends on whether or not the regulator is concerned with firms' profit. PMID:16280182

Brekke, Kurt R; Kuhn, Michael

2006-01-01

389

Pharmaceutically active secondary metabolites of marine actinobacteria.  

PubMed

Marine actinobacteria are one of the most efficient groups of secondary metabolite producers and are very important from an industrial point of view. Many representatives of the order Actinomycetales are prolific producers of thousands of biologically active secondary metabolites. Actinobacteria from terrestrial sources have been studied and screened since the 1950s, for many important antibiotics, anticancer, antitumor and immunosuppressive agents. However, frequent rediscovery of the same compounds from the terrestrial actinobacteria has made them less attractive for screening programs in the recent years. At the same time, actinobacteria isolated from the marine environment have currently received considerable attention due to the structural diversity and unique biological activities of their secondary metabolites. They are efficient producers of new secondary metabolites that show a range of biological activities including antibacterial, antifungal, anticancer, antitumor, cytotoxic, cytostatic, anti-inflammatory, anti-parasitic, anti-malaria, antiviral, antioxidant, anti-angiogenesis, etc. In this review, an evaluation is made on the current status of research on marine actinobacteria yielding pharmaceutically active secondary metabolites. Bioactive compounds from marine actinobacteria possess distinct chemical structures that may form the basis for synthesis of new drugs that could be used to combat resistant pathogens. With the increasing advancement in science and technology, there would be a greater demand for new bioactive compounds synthesized by actinobacteria from various marine sources in future. PMID:23958059

Manivasagan, Panchanathan; Venkatesan, Jayachandran; Sivakumar, Kannan; Kim, Se-Kwon

2014-04-01

390

Pharmaceutical Point of View on Parenteral Nutrition  

PubMed Central

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

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

2013-01-01

391

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

PubMed

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

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

2014-04-01

392

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

PubMed Central

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

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

2014-01-01

393

Improving studentsâ understanding of quantum measurement. II. Development of research-based learning tools  

NSDL National Science Digital Library

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

Zhu, Guangtian; Singh, Chandralekha

2012-05-16

394

Studies of Confidence in Software Cost Estimation Research Based on the Criterions MMRE and PRED  

E-print Network

Studies of Confidence in Software Cost Estimation Research Based on the Criterions MMRE and PRED@menzies.us Jan 19, 2009 ABSTRACT Confidence in cost estimation is different than model accuracy. It is related PRED, which unlike MMRE has received relatively little investigation. Keywords Cost Estimation; Cost

Menzies, Tim

395

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

ERIC Educational Resources Information Center

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

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

2009-01-01

396

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

ERIC Educational Resources Information Center

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

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

2013-01-01

397

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

ERIC Educational Resources Information Center

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

Wieman, Carl; Deslauriers, Louis; Gilley, Brett

2013-01-01

398

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

ERIC Educational Resources Information Center

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

Jääskelä, Päivikki; Nissilä, Pia

2015-01-01

399

Targeting Reading Fluency for ESL Students: A Research Based and Practical Application  

ERIC Educational Resources Information Center

Fluency in reading refers to the speed and ease with which we read, according to the Government Partnership for Reading Publications. You might ask, "Why should fluency be taught?" According to "Research-Based Principles for Adult Basic Education Reading Instruction," National Fluency Government Partnership for Reading from 2007 "Students who are…

Brady, Evangeline Christina; Kritsonis, William Allan

2008-01-01

400

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

ERIC Educational Resources Information Center

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

Wills, Alison

2003-01-01

401

On Improving the University Research Base: The Technical University of Lisbon Case in Perspective  

ERIC Educational Resources Information Center

This article examines the challenges faced by a Portuguese technical university that is striving to develop its research base within a developing science, technology and higher education system. The paper identifies lack of resources, and also organizational factors, as particular challenges. These include faculty inbreeding, career structures and…

Horta, Hugo

2008-01-01

402

Research-Based Guidelines and Strategies to Train Teachers for Parent Involvement.  

ERIC Educational Resources Information Center

This paper discusses the development of research-based guidelines and strategies for training both inservice and preservice elementary school educators in parent involvement. These guidelines provide information that should effectively develop teachers' knowledge, understanding, and skills regarding communication with parents and strengthening the…

Williams, David L., Jr.; Chavkin, Nancy Feyl

403

Strategic approaches to cancer control research in NCI-funded research bases.  

PubMed

Although the Community Clinical Oncology Program (CCOP) of the National Cancer Institute (NCI) has always encouraged research on cancer prevention and control issues, the clinical cooperative groups and cancer centers that serve as CCOP "research bases" were not required to conduct cancer control research until June 1987. This article draws upon case studies of six cooperative groups and two cancer centers to examine how CCOP research bases have defined cancer control research to be compatible with their missions, restructured roles and relationships to facilitate protocol development and implementation, and routine cancer control research to make prevention and control studies an accepted component of their scientific programs. Three "deliberate" or "emergent" strategies are found to be associated with the earlier resolution of problems and more rapid assimilation of cancer control studies into research base agendas. These strategies include (1) proactive planning, such as the early formation of a Cancer Control Research Committee (CCRC) and the identification of "idea champions" to promote cancer prevention and control research; (2) a staged approach to defining and introducing cancer control research; and (3) the creation of multiple "bridging" mechanisms to link cancer prevention and control studies with ongoing research activities. Research bases were most successful in building investigator commitment to cancer control research when they framed research questions within an accepted scientific paradigm, sought out and supported investigators with an interest in cancer prevention and control questions, created CCRCs with broadly representative memberships, and widely publicized ideas for prevention and control studies. PMID:1473121

McKinney, M M; Warnecke, R B; Kaluzny, A D

1992-01-01

404

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

ERIC Educational Resources Information Center

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

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

405

Lift, Squeeze, Stretch, and Twist: Research-Based Inquiry Physics Experiences (RIPE) of Energy for Kindergartners  

ERIC Educational Resources Information Center

This study examines changes in kindergarten students' understanding of energy after participating in a series of lessons developed using an inquiry-based early childhood science teaching model: Research-based Inquiry Physics Experiences (RIPE). The lessons addressed where objects get their energy and what they use their energy to do, and how…

Van Hook, Stephen J.; Huziak-Clark, Tracy L.

2008-01-01

406

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

ERIC Educational Resources Information Center

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

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

2011-01-01

407

Removing Vestiges: Research-Based Strategies To Promote Inclusion, December 2000.  

ERIC Educational Resources Information Center

This document contains four articles that provide research-based strategies to promote diversity in the higher education community. Diversity programming at many community colleges tends to be event-centered, whether those events are annual, such as Native American Awareness Month, or incidental, like responses to high-profile hate crimes.…

Kee, Arnold M., Ed.

2000-01-01

408

The Research-Based Model Partnership Education Program: A 4-Year Outcome Study.  

ERIC Educational Resources Information Center

Evaluated the four-year outcome of the Research-Based Model Partnership in Education Program, an after-school tutoring and adaptive-skills training program for mostly low-achieving, low-income African-American students. Computerized school records provided academic and social data. Results indicated that four-year participants had higher grade…

Tucker, Carolyn M.; Herman, Keith C.; Reid, Alaycia D.; Keefer, Nikki L.; Vogel, David L.

1998-01-01

409

Reading Instruction for Diverse Classrooms: Research-Based, Culturally Responsive Practice  

ERIC Educational Resources Information Center

This practical, teacher-friendly book provides indispensable guidance for implementing research-based reading instruction that is responsive to students' diverse cultural and linguistic backgrounds. Structured around the "big five" core topics of an effective reading program--phonemic awareness, phonics, fluency, vocabulary, and comprehension--the…

McIntyre, Ellen; Hulan, Nancy; Layne, Vicky

2010-01-01

410

Using Research Based Assessment Tools in Professional Development in Current Electricity  

ERIC Educational Resources Information Center

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

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

2007-01-01

411

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

ERIC Educational Resources Information Center

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

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

2009-01-01

412

Research-Based Educational Practices for Students with Autism Spectrum Disorders  

ERIC Educational Resources Information Center

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

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

2011-01-01

413

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

E-print Network

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

Nebraska-Lincoln, University of

414

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

ERIC Educational Resources Information Center

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

Rosenshine, Barak

2012-01-01

415

Shadow Communications Inc. Virtual Education Company  

E-print Network

. Through the use of Virtual Human Agents (VHAs), the company facilitates natural language dialogue between SE Hawthorne Rd # 103 Gainesville, FL 32641-7560 For more information abou this UF startup company, the company has two products that are required curricula at four U.S. medical schools. The company

Jawitz, James W.

416

Company Information on the World Wide Web  

Microsoft Academic Search

Used in conjunction with more traditional business reference resources, the World Wide Web can help fill out a company' s picture. Corporate Web presences may range from single-page company descriptions to multi-layered sites that take fuller advantage of the Web' s immense capacity and interactive nature. Maintained primarily to promote and advertise a company' s products and services, company sites

Joseph A. Larose

1997-01-01

417

Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medications.  

PubMed

Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of "seeding" trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it's not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. PMID:21327723

Lexchin, Joel

2012-06-01

418

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

Pharmacy Practice I 4 Pharmacy Practice II 4 Pharmacy Practice III 4 Pharmaceutics in Pharmacy Practice 1 Pharmacy Informatics 2 Study Design 2 Drug Information 2 Gross Anatomy 3 Total Units Cardiovascular Organ System 5 Laboratory Medicine 2 Microbiology 5 Pharmacy Topics in Endocrinology 2 Electives

Gleeson, Joseph G.

419

Pharmacy Practice I 4 Pharmacy Practice II 4 Pharmacy Practice III 4 Pharmaceutics IBiopharmaceutics 3 Pharmaceutics IIDosage Forms and Pharmaceutics III  

E-print Network

Pharmacy Practice I 4 Pharmacy Practice II 4 Pharmacy Practice III 4 Pharmaceutics Biostatistics 3 Physical Chemistry 5 Pharmacological Biochemistry 4 Law and Ethics 2 Histology 2 Pharmacy Informatics 3 Concepts in Pharmacy Practice 1 Gross Anatomy 3 Total Units 17 Total Units 16 Total Units 18

Gleeson, Joseph G.

420

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

E-print Network

is owned by 9 major railroads. · Manage various national railcar pools · Goal: Provide safe, reliable cars 11 © Copyright 2008 TTX Company : : CONFIDENTIAL 11 Railroads efficiently move freight Transportation, equipment tended to derail. (Wheelbase limit ~10m) · Some genius invented a very short, small "car" called

Barkan, Christopher P.L.

421

Limited Liability Companies in Kansas  

E-print Network

provisions of the Act as they relate to the creation, ment Editor of the Wayne Law Review, arzd an LL.M,~~~~ Haward operation and dissolution of an LLC in Kansas. 1 shall Lalo School (1970) Prior to entering not attempt to discuss the taxation of LLCs...Limited Liability Companies in Kansas* by Edwin W. Hecker Jr. About the Author T he Kansas Limited Liability Company Act (the Act)' EDWN W. HECKER-[R. is a professor at the Unitlersi(y of Kansas School of is now over three years old and has...

Hecker, Edwin W. Jr.

1994-01-01

422

Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development.  

PubMed

Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in te MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries. PMID:19797857

Sasaki, Madoka; Hinotsu, Shiro; Kawakami, Koji

2009-10-01

423

Pharmaceutical Consultation in UAE Community Pharmacies  

PubMed Central

In recent years, the focus of pharmacists as traditional drug dispensers has shifted to more active and participative role in risk assessment, risk management, and other medication related consultation activities. Pharmacy profession is evolving steadily in the United Arab Emirates (UAE). Pharmacists in UAE are so much occupied in their administrative and managerial duties that dispensing is mostly attended to by pharmacy technicians. Pharmacist-led patient counseling is limited to the dosage and frequency of medications and rarely adverse reactions and drug interactions with other medications. Therefore we decided to perform quantitative questionnaires study to explore the role of pharmacist in patient counseling in UAE, the evaluation of pharmacist's opinion on patient counseling and the potential determinants of personal consultation. Results show the frequency and nature of inquiries received by pharmacist. Five to twenty inquires per month are received from patient, most of them related to drug prescription and dose recommendation. Thirty nine percent of pharmacists received inquiries from doctors, most of them related to the dose and mode of action. Ninty two percent of the pharmacists agreed that patient counseling is their professional responsibility. About 82% of pharmacists agreed that counseling will increase their sales and enhance the reputation of their pharmacies. Seventy percent of pharmacists mentioned that they need to undergo training for effective counseling while 46% of pharmacists felt that more staff in the pharmacies would have a positive influence on patient compliance to medication therapies and patient safety. The potential determinants of personal consultation show that 52% of participants trusted pharmacist and 55% considered the pharmacist as a friend. Forty eight percent of participants visited the pharmacy for medical recommendation while 30% for drug compounding, 72% agreed that pharmacist conducts full instruction while 31% agreed about full investigation. In conclusion, reorganization of the pharmacist's activities may improve pharmaceutical consultations. Pharmacists must be exposed to recent trends in drug therapy, dosage forms, dosage, adverse effects and interaction. This will go a long way in providing rational use of drugs to the patients and improve their quality of life. PMID:22707824

Hamoudi, N. M.; Shirwaikar, A. A.; Ali, H. S.; Al Ayoubi, E. I.

2011-01-01

424

CORE CONCERT DANCE COMPANY SUMMER  

E-print Network

CORE CONCERT DANCE COMPANY SUMMER INTENSIVE 2005 What: A week long day camp taught by current CORE registration form along with $25 non-refundable deposit to: UGA Department of Dance Attn: CORE Summer Intensive Earmarked: CORE Summer Dance Intensive Balance of tuition ($200) is due by May 30th . Name

Arnold, Jonathan

425

Speed Dating Listing Company Name  

E-print Network

Management Inc. Road Construction Southwest, Inc. Rock Gap Engineering LLC Royal Consulting Inc. Sanbros, Inc. Alpha Restoration & Construction Services, LLC AmeriCom Automation Services, Inc. ATI Security Inc. Avisco, Inc. B&D Industries, Inc. Ballew Construction Company, Inc. Blue Skies Consulting LLC

426

Natural gas annual 1993 supplement: Company profiles  

SciTech Connect

The Natural Gas Annual provides information on the supply and disposition of natural gas to a wide audience including industry, consumers, Federal and State agencies, and educational institutions. This report, the Natural Gas Annual 1993 Supplement: Company Profiles, presents a detailed profile of 45 selected companies in the natural gas industry. The purpose of this report is to show the movement of natural gas through the various States served by the companies profiled. The companies in this report are interstate pipeline companies or local distribution companies (LDC`s). Interstate pipeline companies acquire gas supplies from company owned production, purchases from producers, and receipts for transportation for account of others. Pipeline systems, service area maps, company supply and disposition data are presented.

Not Available

1995-02-01

427

75 FR 41524 - Cranston Print Works Company, Webster Division, Webster, MA; Cranston Print Works Company...  

Federal Register 2010, 2011, 2012, 2013

...TA-W-64,198A] Cranston Print Works Company, Webster Division, Webster, MA; Cranston Print Works Company, Corporate Offices...applicable to workers of Cranston Print Works Company, Webster Division, Webster, Massachusetts. The...

2010-07-16

428

77 FR 553 - Surety Companies Acceptable on Federal Bonds: Termination; Western Bonding Company  

Federal Register 2010, 2011, 2012, 2013

...Companies Acceptable on Federal Bonds: Termination; Western Bonding Company AGENCY: Financial Management Service, Fiscal Service...Certificate of Authority issued by the Treasury to Western Bonding Company (NAIC 13191) under 31 U.S.C. 9305 to...

2012-01-05

429

77 FR 11529 - Louisville Gas and Electric Company; Kentucky Utilities Company; Notice of Petition for...  

Federal Register 2010, 2011, 2012, 2013

...Energy Regulatory Commission [Docket No. EL12-27-000] Louisville Gas and Electric Company; Kentucky Utilities Company; Notice...Commission) Rules of Practice and Procedure, 18 CFR 385.207, Louisville Gas and Electric Company and Kentucky Utilities...

2012-02-27

430

78 FR 72672 - Owensboro Municipal Utilities v. Louisville Gas and Electric Company, Kentucky Utilities Company...  

Federal Register 2010, 2011, 2012, 2013

...EL13-79-000] Owensboro Municipal Utilities v. Louisville Gas and Electric Company, Kentucky Utilities Company; Notice of Filing Take notice that on November 22, 2013, Louisville Gas and Electric Company and Kentucky Utilities...

2013-12-03

431

Quantitative analysis of caffeine applied to pharmaceutical industry  

NASA Astrophysics Data System (ADS)

The direct determination of some compounds like caffeine in pharmaceutical samples without sample pretreatment and without the separation of these compounds from the matrix (acetyl salicylic acid, paracetamol,…) is very worthwhile. It enables analysis to be performed quickly and without the problems associated with sample manipulation. The samples were diluted directly in KBr powder. We used both diffuse reflectance (DRIFT) and transmission techniques in order to measure the intensity of the peaks of the caffeine in the pharmaceutical matrix. Limits of detection, determination, relative standard deviation and recovery using caffeine in the same matrix as in the pharmaceutical product are related. Two methods for the quantification of caffeine were used: calibration line and standard addition techniques.

Baucells, M.; Ferrer, N.; Gómez, P.; Lacort, G.; Roura, M.

1993-03-01

432

Production of Pharmaceutical Proteins in Solanaceae Food Crops  

PubMed Central

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

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

2013-01-01

433

High-pressure biotechnology in medicine and pharmaceutical science  

PubMed Central

High-pressure (HP) biotechnology is an emerging technique initially applied for food processing and more recently in pharmaceutical and medical sciences. Pressure can stabilize enzymes and modulate both their activity and specificity. HP engineering of proteins may be used for enzyme-catalyzed synthesis of fine chemicals, pharmaceuticals, and production of modified proteins of medical or pharmaceutical interest. HP inactivation of biological agents is expected to be applicable to sterilization of fragile biopharmaceuticals, or medical compounds. The enhanced immunogenicity of some pressure-killed bacteria and viruses could be applied for making new vaccines. Finally, storage at subzero temperatures without freezing is another potential application of HP for cells, animal tissues, blood cells, organs for transplant, and so forth. PMID:12488614

2001-01-01

434

A Course Introducing the Principles of Pharmaceutical Care  

PubMed Central

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

Chirico, Mark J.

2010-01-01

435

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

PubMed Central

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

Pignato, Alyssa

2014-01-01

436

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

Microsoft Academic Search

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

Stefania Zerbinati; Vangelis Souitaris; Nathalie Moray

2012-01-01

437

Occurrence of veterinary pharmaceuticals in the aquatic environment in Flanders  

NASA Astrophysics Data System (ADS)

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

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

2009-04-01

438

Research-based assessment affordances and constraints: Perceptions of physics faculty  

E-print Network

To help faculty use research-based materials in a more significant way, we learn about their perceived needs and desires and use this information to suggest ways for the Physics Education Research community to address these needs. When research-based resources are well aligned with the perceived needs of faculty, faculty members will more readily take them up. We used phenomenographic interviews of ordinary physics faculty and department chairs to identify four families of issues that faculty have around research-based assessments (RBA). First, many faculty are interested in using RBAs but have practical needs around how to do so: how to find them, which ones there are, and how to administer them. They want help addressing these needs. Second, at the same time, many faculty think that RBAs are limited and don't measure many of the things they care about, or aren't applicable in their classes. They want assessments to measure skills, perceptions, and specific concepts. Third, many faculty want to turn to commu...

Madsen, Adrian; Martinuk, Mathew "Sandy"; Bell, Alexander; Sayre, Eleanor C

2015-01-01

439

Simultaneous determination of sitagliptin and metformin in their pharmaceutical formulation.  

PubMed

Two simple, accurate, and rapid methods were developed for simultaneous determination of sitagliptin phosphate and metformin hydrochloride in their pharmaceutical formulation. The first is a TLC method coupled with densitometry. The second is an HPLC method using a C18 column. The selectivity of the proposed methods was checked using laboratory-prepared mixtures. The proposed methods were successfully applied to the analysis of sitagliptin phosphate and metformin hydrochloride in bulk form and in their pharmaceutical formulation without interference from other additives. PMID:23767354

Rezk, Mamdouh R; Riad, Safa'a M; Mahmoud, Ghada Y; Abdel Aleem, Abdel-Aziz El Bayoumi

2013-01-01

440

Multivariate Equivalence Tests for Use in Pharmaceutical Development.  

PubMed

Abstract Statistical equivalence analyses are well established parts of many studies in the biomedical sciences. Also in pharmaceutical development and manufacturing equivalence testing methods are required in order to statistically establish similarities between machines, process components or complete processes. This article presents a choice of multivariate equivalence testing procedures for normally distributed data as generalizations of existing univariate methods. In all derived methods, variability is interpreted as nuisance parameter. The use of the proposed methods in pharmaceutical development is demonstrated with a comparative analysis of dissolution profiles. PMID:24896319

Hoffelder, Thomas; Gössl, Rüdiger; Wellek, Stefan

2014-06-01

441

75 FR 6791 - Surety Companies Acceptable on Federal Bonds-Termination: Trinity Universal Insurance Company  

Federal Register 2010, 2011, 2012, 2013

...DEPARTMENT OF THE TREASURY Fiscal Service Surety Companies Acceptable on Federal Bonds--Termination: Trinity Universal Insurance Company AGENCY: Financial Management Service, Fiscal Service, Department of the Treasury....

2010-02-10

442

Preventing Drug Use among Children and Adolescents: A Research-Based Guide for Parents, Educators, and Community Leaders. Second Edition  

ERIC Educational Resources Information Center

In 1997, the National Institute on Drug Abuse (NIDA) published the first edition of "Preventing Drug Use among Children and Adolescents: A Research-Based Guide" to share the latest NIDA-funded prevention research findings with parents, educators, and community leaders. The guide introduced the concept of "research-based prevention" with questions…

Robertson, Elizabeth B.; David, Susan L.; Rao, Suman A.

2003-01-01

443

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

E-print Network

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

Singh, Mahender Pal, 1965-

2005-01-01

444

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

E-print Network

In the pharmaceutical industry, the conventional tablet manufacturing process, a batch-based process based on solid powder handling, presents challenges such as inhomogeneous blending between Active Pharmaceutical Ingredients ...

Kim, Won, S.M. Massachusetts Institute of Technology

2010-01-01

445

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

EPA Science Inventory

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

446

Source characterization of nervous system active pharmaceutical ingredients in healthcare wastewaters  

EPA Science Inventory

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

447

77 FR 47114 - Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical Inc.  

Federal Register 2010, 2011, 2012, 2013

...Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical Inc. Pursuant to Sec. 1301.33(a), Title...Regulations (CFR), this is notice that on July 6, 2012, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany,...

2012-08-07

448

78 FR 51210 - Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical, Inc.  

Federal Register 2010, 2011, 2012, 2013

...Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical, Inc. Pursuant to Sec. 1301.33(a), Title...Regulations (CFR), this is notice that on July 8, 2013, Halo Pharmaceutical, Inc., 30 North Jefferson Road,...

2013-08-20

449

Theoretical and experimental investigation of particle interactions in pharmaceutical powder blending  

E-print Network

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

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

2007-01-01

450

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

EPA Science Inventory

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

451

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

Federal Register 2010, 2011, 2012, 2013

...AGENCY [FRL-9197-7] Best Management Practices for Unused Pharmaceuticals...comments on a draft guidance document entitled, Best Management Practices for Unused Pharmaceuticals...facilities. EPA expects that this document will help reduce the...

2010-09-08

452

78 FR 56977 - Axcess International, Inc., Gamma Pharmaceuticals, Inc., Innovex, Inc, Knight Energy Corp...  

Federal Register 2010, 2011, 2012, 2013

...COMMISSION [File No. 500-1] Axcess International, Inc., Gamma Pharmaceuticals, Inc., Innovex, Inc, Knight Energy Corp...current and accurate information concerning the securities of Gamma Pharmaceuticals, Inc. because it has not filed any...

2013-09-16

453

Endocrine Active Chemicals, Pharmaceuticals, and Other Chemicals of Concern in Surface Water, Wastewater-  

E-print Network

Endocrine Active Chemicals, Pharmaceuticals, and Other Chemicals of Concern in Surface Water. Cloud State University, University of St. Thomas, and the University of Colorado Endocrine Active 21, 2009. #12;Endocrine Active Chemicals, Pharmaceuticals, and Other Chemicals of Concern in Surface

454

Concentrations and mass loadings of cardiovascular pharmaceuticals in healthcare facility wastewaters  

EPA Science Inventory

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

455

Approved Module Information for PH2502, 2014/5 Module Title/Name: Pharmaceutical  

E-print Network

by microbes, disinfection and sterilisation, testing and evaluation of sterility and preservation of pharmaceuticals, disinfectants and preservatives discussed in the lecture course. Pharmacogenetics: diagnosis and treatment. The module illustrates pharmaceutically relevant aspects of disinfectants

Neirotti, Juan Pablo

456

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

Federal Register 2010, 2011, 2012, 2013

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

2013-09-23

457

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

Federal Register 2010, 2011, 2012, 2013

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

2011-06-29

458

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

Federal Register 2010, 2011, 2012, 2013

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

2012-01-11

459

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

Federal Register 2010, 2011, 2012, 2013

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

2010-03-08

460

78 FR 58314 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

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

2013-09-23

461

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

Federal Register 2010, 2011, 2012, 2013

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

2012-07-20

462

Pharmaceuticals in Surface Waters and Potential Transfer to Irrigated Food Crops  

EPA Science Inventory

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

463

Frontline: A Company of Soldiers  

NSDL National Science Digital Library

A number of documentaries have paid close to attention to various aspects of the current military conflict in Iraq, but this recent documentary by the people at Frontline warrants special notice. In November 2004, a production team documented the day-to-day realities of the soldiers of the 1-8 Cavalary's Dog Company in South Baghdad. The actual filming began three days after the Falljuah campaign was launched, and as such the production acquired a rather intense and moving aspect heightened by these encounters and incidents. On this site, visitors can watch the entire program as it appeared on PBS, read a list of FAQ's about the production, and read four fascinating interviews with those in Dog Company. Visitors can also read the notebook of producer Edward Jarvis and offer their own reactions to the program.

464

An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims  

PubMed Central

Objective To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. Methods Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL), and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market. Results In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6%) followed by unsubstantiated efficacy claims (18.6%). Warning letters were primarily directed to manufacturers of cardiovascular (14.6%), anti-microbial (14.6%), and CNS (12.5%) drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%). Conclusions The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health. PMID:24155837

Chatterjee, Satabdi; Patel, Harshali K.; Sansgiry, Sujit S.

465

Recent progress in enzymatic resolution and desymmetrization of pharmaceuticals and their intermediates.  

PubMed

The literature is surveyed from mid-1998 through to August 2000 for examples of the resolution or desymmetrization of existing/potential pharmaceutical entities and pharmaceutical intermediates, and of chiral building blocks for pharmaceutical manufacture. Examples of commercial interest are included with new developments in the art of resolution. PMID:19649905

Pesti, J A; Dicosimo, R

2000-11-01

466

Household Disposal of Pharmaceuticals as a Pathway for Aquatic Contamination in the United Kingdom  

Microsoft Academic Search

Pharmaceuticals are produced and used in increasingly large volumes every year. With this growth comes concern about the fate and effects of these compounds in the environment. The discovery of pharmaceuticals in the aquatic environment has stimulated research in the last decade. A wide range of pharmaceuticals has been found in fresh and marine waters, and it has recently been

Jonathan P. Bound; Nikolaos Voulvoulis

2005-01-01

467

HPLC and LC\\/MS Analysis of Pharmaceutical Container Closure System Leachables and Extractables  

Microsoft Academic Search

The term “leachables” refers to impurities in pharmaceutical products whose origin is the pharmaceutical container closure system in either direct or indirect contact with the formulation. Potential leachables identified through laboratory studies of pharmaceutical container closure system components are referred to as “extractables.” Extractables and leachables are most often chemical additives to plastic and elastomeric container closure system components, or

Daniel L. Norwood; Dennis Jenke; Cristina Manolescu; Scott Pennino; Nelu Grinberg

2009-01-01

468

Antibiotic resistance: a view from the pharmaceutical industry.  

PubMed

The development of new antibiotics has been successful in significantly reducing morbidity and mortality. With increasing use there has occurred an increase in antibiotic resistance but not a parallel increase in new agents with significantly improved spectrum of activity. Without concerted action from the pharmaceutical industry, physicians, academia, health care providers, and governments, the prospects look gloomy. PMID:8994797

Bax, R P

1997-01-01

469

Pharmaceutical Education and Pharmacy Practice in Pakistan and India.  

ERIC Educational Resources Information Center

Visits to colleges of pharmacy and to community and hospital pharmacies revealed that: pharmacy graduates seek employment in the pharmaceutical industry; pharmacy dispensers are PharmD graduates; physicians are the major drug dispensers to patients; little distinction is made between prescription and over-the-counter drugs; and drug laws are…

Blake, Martin I.

1983-01-01

470

General practitioners and pharmaceutical sales representatives: quality improvement research  

Microsoft Academic Search

Background and objective: Interaction between pharmaceutical sales representatives (PSRs) and general practitioners (GPs) may have an adverse impact on GP prescribing and therefore may be ethically questionable. This study aimed to evaluate the interactions between PSRs and GPs in an Australian general practice, and develop and evaluate a policy to guide the interaction.Methods: Doctors’ prescribing, diaries, practice promotional material and

Geoffrey Spurling; Peter Mansfield

2007-01-01

471

Particle generation for pharmaceutical applications using supercritical fluid technology  

Microsoft Academic Search

In the pharmaceutical industry, an even greater number of products are in the form of particulate solids. Their formation, formulation and the control of their user properties are still not well understood and mastered. Since the mid-1980s, a new method of powder generation has appeared involving crystallisation with supercritical fluids. Carbon dioxide is the most widely used solvent and its

Jacques Fages; Hubert Lochard; Jean-Jacques Letourneau; Martial Sauceau; Elisabeth Rodier

2004-01-01

472

[New distribution forms for pharmaceuticals--a logistic perspective].  

PubMed

Pharmaceuticals are an important input in health care. As a complement to other modes of treatment and as a substitute for hospitalisation, they affect the health of individuals and populations. Enormous public financial resources are spent on pharmaceuticals, and halting the growth in expenditures is a political objective. Factors with room for improvement include drug use efficiency, cost-efficient prescription, purchasing prices and distribution. High distribution costs affect prices and, thus, the assessment of product cost vs. utility. Changes in the distribution system may be important, for three reasons: First, increased capital costs call for higher efficiency. Second, increased competition requires improved logistics. And third, information technology has opened up for new supply chain solutions. Direct sales solutions are being considered, and were discussed in a Norwegian public report on the matter, but no final conclusion has been reached. This article discusses changes in the supply of pharmaceuticals and the development of the market. Alternative supply chains are outlined, including what role the postal service may play in a deregulated pharmaceutical market. PMID:9857809

Grund, J; Vartdal, T E

1998-11-10

473

Characterisation of northern Patagonian bentonites for pharmaceutical uses  

Microsoft Academic Search

This paper evaluates the suitability of some smectite-rich samples from northern Patagonia (Argentina) for pharmaceutical use. The clays must comply with some general features before considering their use in pharmacy, including high mineral and chemical purity and the absence of microbial pathogens. Specific characteristics such as sediment volume, swelling power and gel formation are also important for particular applications such

César Viseras Iborra; G. Cultrone; P. Cerezo; C. Aguzzi; M. T. Baschini; J. Vallés; A. López-Galindo

2006-01-01

474

Pharmaceutical Probiotics for the Treatment of Anaerobic and Other Infections  

Microsoft Academic Search

Pharmaceutical probiotics have been used as alternative treatments or preventative therapies for a variety of clinical diseases. The overuse of antibiotics and emergence of multiple-antibiotic resistant pathogens has refocused clinical attention on the field of probiotics. Anaerobic infections which seem to respond well to probiotics are infections which involve the disruption of normal microbial flora. Gastrointestinal infections (travelers' diarrhea, antibiotic-associated

L. V. McFarland; G. W. Elmer

1997-01-01

475

Pharmacies, self-medication and pharmaceutical marketing in Bombay, India  

Microsoft Academic Search

Studies of pharmaceutical practice have called attention to the role played by pharmacists and pharmacy attendants in fostering self-medication and medicine experimentation among the public. Left undocumented is the extent to which clients passively follow the advice of pharmacy personnel or question their motive or expertise. While research has focused on pharmacists and pharmacy attendants as agents encouraging self-medication and

Vinay R. Kamat; Mark Nichter

1998-01-01

476

Pharmaceuticals and PCPs in groundwater: Results from French National screening  

E-print Network

screening campaign in groundwater focused on occurrence of "emerging" organic contaminants with various potential uses and origins. Among the 411 Organic compounds (OC) targeted, 131 pharmaceutical products, 13 life style products and 10 cosmetics have been selected and measured in in 2011 during two sampling

Paris-Sud XI, Université de

477

OVERVIEW OF VOLUNTARY STEWARDSHIP EFFORTS TO ADDRESS PHARMACEUTICAL DISPOSAL  

EPA Science Inventory

This presentation will provide an overview of current federal regulatory guidance for pharmaceutical disposal, currently funded pilot programs for take-back pilot studies, and state programs. The EPA Office of Water's role is to protect our Nation's watersheds and drinking water ...

478

Fate and uptake of pharmaceuticals in soil-plant systems.  

PubMed

Pharmaceuticals have been detected in the soil environment where there is the potential for uptake into crops. This study explored the fate and uptake of p