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The past several years have seen an evolution in the obligations of pharmaceuticalcompanies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceuticalcompanies, 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 pharmaceuticalcompanies 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 pharmaceuticalcompanies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceuticalcompanies 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
This article is concerned with the establishment of the Brazilian pharmaceutical industry. It addresses some issues of relevance to social-economic history, such as the emergence of the public health system, procedures for combating infectious disease, the relations between disinfection campaigns and the chemical industry, serotherapy and the production of serums and vaccines by public research institutions and private pharmaceuticalcompanies. Focusing on the private pharmaceutical industry in Brazil, with special reference to the Instituto Pinheiros - Produtos Terapêuticos S.A., this article highlights the relations between scientists technology and product development. It also considers the debate which involved the scientific community and some governmental research institutions for public health policy development in the state of São Paulo. PMID:16683337
...Drug-Related Supply Promotion by PharmaceuticalCompany Sales Representatives at VA...Drug-Related Supply Promotion by PharmaceuticalCompany Sales.'' Copies of comments...under which sales representatives from pharmaceuticalcompanies promoting drugs and...
Integration of clinical and preclinical pharmacology in pharmaceuticalcompanies could be improved by several key recommendations: Companies should ensure that there is an adequate pool of trained clinical pharmacologists and preclinical pharmacologists. Training should include topics that allow clinical pharmacologists to be cognizant of the methods, issues and challenges faced by the preclinical pharmacologists and vice versa. Companies should incentivize such integration internally by aligning objectives and metrics/incentives. In academic medicine and the NHS there should be support for involvement of clinical pharmacologists in basic academic research and industrial R & D and new ways of facilitating and incentivizing preclinical pharmacologists and clinical pharmacologists to move between these various environments should be sought. PMID:22360450
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 pharmaceuticalcompany 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
Structured interviews with eight leading Japanese pharmaceuticalcompanies and industry data show that drug discovery in the Japanese companies occurs predominantly in-house. In contrast, European and US pharmaceuticalcompanies rely more on alliances with university-based start-ups and other biotechnology companies for drug discovery. Personnel policies in the Japanese companies are still geared to on-the-job training for lifetime employment and the
Background. In Pakistan, there is no mechanism to monitor the drug promotional campaign by pharmaceutical industry despite the fact that there is enough evidence that irrational pharmacotherapy is increasingly encountered even in the developed countries due to unethical practices of pharmaceutical promotion. Objectives. To audit the drug promotional claims made by the pharmaceuticalcompanies in Pakistan. Methods. Drug promotional pamphlets
Dileep Kumar Rohr; Anwarul Hassan Gilani; Kamal Memon; Ghazala Perven; Muhammad Talha Khan; Hina Zafar; Rakesh Kumar
Objective To examine the opinions of Libyan doctors regarding the quality of drug information provided by pharmaceuticalcompany representatives (PCRs) during detailing visits. Method An anonymous survey was conducted among 1,000 doctors from selected institutes in Tripoli, Benghazi and Sebha. Doctors were asked questions regarding the quality of information provided during drug-detailing visits. Results A questionnaire return rate of 61% (608 returned questionnaires out of 1,000) was achieved. The majority (n=463, 76%) of surveyed participants graded the quality of information provided as average. Approximately, 40% of respondents indicated that contraindications, precautions, interactions and adverse effects of products promoted by PCRs were never or rarely mentioned during promotional visits, and 65% of respondents indicated that an alternative drug to the promoted product was never or rarely mentioned by the representatives. More than 50% of respondents (n=310, 51%) reported that PCRs were not always able to answer all questions about their products. Only seven respondents (1%) believed that PCRs never exaggerated the uniqueness, efficacy or safety of their product. The majority of respondents (n=342, 56%) indicated that verbal information was not always consistent with written information provided. Seven per cent of respondents (n=43) admitted that they did not know whether or not the verbal information provided by PCRs was consistent with written information. Conclusion Doctors believe that the provision of drug information by PCRs in Libya is incomplete and often exaggerated. Pharmaceuticalcompanies should ensure that their representatives are trained to a standard to provide reliable information regarding the products they promote.
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 pharmaceuticalcompanies. 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.
Strategies for designing nonclinical safety evaluation programs for pharmaceutical products of biotechnology, the types of studies conducted, and the reasons for their inclusion were identified through a questionnaire-based survey of 37 pharmaceutical and biotechnology companies. The majority of respondents were already using International Conference on Harmonization (ICH) guidance, then available only in draft, when choosing which studies to include; a
|Interviews with participants in research and development in a pharmaceuticalcompany explored the use of organizational learning mechanisms to create knowledge. Results indicate that dynamic learning capability is embedded in and influenced by company culture, existing skills and competence, capacity for continuous change, and leadership.…
Ingelgard, Anders; Roth, Jonas; Shani, A. B. (Rami); Styhre, Alexander
Summary Today, pharmaceuticalcompanies are at a crossroads. Price discounts, shrinking margins, reductions in market exclusiv- ity, product commoditization ? as well as Part 11 validation compliance ? repre- sent new challenges for pharmaceuticalcompanies of all sizes. Equally daunting are pressures on the supply chain. It is not enough to simply deliver the right ac- tive ingredient. It must
Purpose – The current good manufacturing practices (cGMP) are followed in the pharmaceutical sector to ensure that products are consistently produced and controlled to the appropriate quality standards as required by the marketing agencies. The purpose of this paper is to share improvement experiences due to implementation of lean principles combined with cGMP in a pharmaceuticalcompany. Design\\/methodology\\/approach – To
Aim To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.Design and Setting Fifty-one medical Sydney specialists were asked to collect all gifts, offers, invitations, and items received from pharmaceuticalcompanies
Paul M. McNeill; Ian H. Kerridge; Catherine Arciuli; David A. Henry; Graham J. Macdonald; Richard O. Day; Suzanne R. Hill
While pharmaceuticalcompanies provide abundant health and medical information on their Web sites, little is known about consumers' perceptions of pharmaceuticalcompanies as a health information source and the impact of pharmaceutical Web sites on health-related attitudes and behaviors. Findings from this study suggest that a pharmaceuticalcompany can be perceived to be just as credible as a government health
Objectives To examine the interaction between general practitioners and pharmaceuticalcompany representatives. Design Qualitative study of 13 consecutive meetings between general practitioner and pharmaceutical representatives. A dramaturgical model was used to inform analysis of the transcribed verbal interactions. Setting Practice in south west England. Participants 13 pharmaceuticalcompany representatives and one general practitioner. Results The encounters were acted out in six scenes. Scene 1 was initiated by the pharmaceutical representative, who acknowledged the relative status of the two players. Scene 2 provided the opportunity for the representative to check the general practitioner's knowledge about the product. Scene 3 was used to propose clinical and cost benefits associated with the product. During scene 4, the general practitioner took centre stage and challenged aspects of this information. Scene 5 involved a recovery strategy as the representative fought to regain equilibrium. In the final scene, the representative tried to ensure future contacts. Conclusion Encounters between general practitioners and pharmaceutical representatives follow a consistent format that is implicitly understood by each player. It is naive to suppose that pharmaceutical representatives are passive resources for drug information. General practitioners might benefit from someone who can provide unbiased information about prescribing in a manner that is supportive and sympathetic to the demands of practice. What is already known on this topicPharmaceutical representatives influence physicians' prescribing in ways that are often unacknowledged by the physicians themselvesMeetings with pharmaceutical representatives are associated with increased prescribing costs and less rational prescribingWhat this study addsMeetings between pharmaceutical representatives and general practitioners follow a consistent format that is implicitly understood by each playerGeneral practitioners may cooperate because representatives make them feel valued
Background Pharmaceuticalcompanies 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 pharmaceuticalcompanies 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 pharmaceuticalcompanies (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 pharmaceuticalcompanies for information. Randomized and observational studies evaluating information from pharmaceuticalcompanies 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 pharmaceuticalcompany 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 pharmaceuticalcompanies 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 pharmaceuticalcompanies. Please see later in the article for the Editors' Summary
Spurling, Geoffrey K.; Mansfield, Peter R.; Montgomery, Brett D.; Lexchin, Joel; Doust, Jenny; Othman, Noordin; Vitry, Agnes I.
Interaction of pharmaceuticalcompanies (PC) with healthcare services has been a reason for concern. In medicine, awareness of the ethical implications of these interactions have been emphasized upon, while this issue has not been highlighted in dentistry. This study undertook a cross-sectional rapid assessment procedure to gather views of dentists in various institutions towards unethical practices in health care and pharmaceutical industry. The purpose of this study was to assess the need for the formulation and implementation of guidelines for the interaction of dentists with the pharmaceutical and device industry in the best interest of patients. A group of 209 dentists of Lahore including faculty members, demonstrators, private practitioners and fresh graduates responded to a questionnaire to assess their attitudes and practices towards pharmaceuticalcompanies’ marketing gifts. The study was conducted during 2011 and provided interesting data that showed the pharmaceutical industry is approaching private practitioners more frequently than academicians and fresh graduates. Private practioners accepted the gifts but mostly recognized them as unethical (over 65%). Both groups considered sponsoring of on-campus lectures as acceptable (over 70%). Respondents are not fully aware of the ethical demands which are imperative for all health care industries, and there is a dire need of strict guidelines and code of ethics for the dentist’s interaction with the pharmaceutical and device industry so that patient interest is protected.
Tahir, Shaila; Rafique, Adeela; Ghafoor, Farkhanda; Saleem, Akif; Khan, Amanullah
Many people today question whether global pharmaceuticalcompanies operate with a universal set standard for crisis management or if cultural values influence their decisions regardless of external pressures. Because of technology, continental borders no longer obstruct intercultural communication. The result of increasing scientific advances leaves no organization impervious to both true problems and false rumors spread by the media. An
Purpose – Describes a team-building training session for ten members of the UK medical affairs and regional medical advisors division of international pharmaceuticalcompany Takeda. Design\\/methodology\\/approach – Explains the reasons for the session, the form it took and the results it achieved. Findings – Details two activities – sculpting a horse's head from a block of ice and designing, making
Purpose – The purpose of this paper is to investigate the wealth effects of the issuance of guidelines by the Office of Inspector General (OIG) to encourage pharmaceutical manufacturers to use internal controls or self-regulation “to efficiently monitor adherence to applicable statutes, regulations, and program requirements” in their marketing to the physicians. Design\\/methodology\\/approach – The authors employ a standard event-study
While pharmaceuticalcompanies provide abundant health and medical information on their Web sites, little is known about consumers' perceptions of pharmaceuticalcompanies as a health information source and the impact of pharmaceutical Web sites on health-related attitudes and behaviors. Findings from this study suggest that a pharmaceuticalcompany can be perceived to be just as credible as a government health agency, and that Web site interactivity and consumer involvement with online health information affect the persuasive effects of the pharmaceuticalcompany's message. Implications for future research and for the role of pharmaceuticalcompanies in health communication are discussed. PMID:21347942
In Italy, the process of power decentralization to Regional Governments has particularly affected pharmaceutical care policies. Regions are experimenting with various strategies to govern drugs utilization and expenditure, and differentiating their approaches, leading to an ever-changing and complex institutional scenario. Pharmaceuticalcompanies have created new professional roles, the Regional Affairs Managers (RAM), with the mandate to monitor the different regional contexts and measures, and to establish relationships with the public actors in charge of pharmaceutical policies. This analysis shows how public affairs/lobbying actions at regional level and the creation of a solid political competence within companies are still in an early phase. The activities carried out by RAMs remain limited to an exchange of information and only rarely are perceived by Regional public servants (RRs) as giving support to their work or influence decisions. The interaction with RAMs is often seen as little relevant and still too concentrated on products and a marketing/commercial approach rather than on broader issues of interest to RRs who need to manage the pharmaceutical care system at large. The level of acceptance of this type of activity is also variable and RRs' attitudes alternate between diffidence, polite tolerance, and openness to a constructive dialogue about pharmaceuticals and their management in a regional healthcare system. PMID:18384907
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.
Bawazir, Saleh A.; Alkudsi, Mohammed A.; Al Humaidan, Abdullah S.; Al Jaser, Maher A.; Sasich, Larry D.
Purpose Only 53% and 63% of studies and clinical trials results presented at congresses are published. Company-sponsored trial results\\u000a are being posted on publicly accessible Web sites. We analyzed the public availability (publication or posting on a Web site)\\u000a rate, time to publication, and factors predicting public availability of results of studies sponsored by a pharmaceutical\\u000a company.\\u000a \\u000a \\u000a \\u000a \\u000a Methods This was a retrospective
Rafael Dal-Ré; Alejandro Pedromingo; Manuel García-Losa; Juan Lahuerta; Rafael Ortega
Objective Drugs, as commercial products, are subject to diverse marketing methods including promotional activities. Although the legal\\/ethical aspects of promotional activities have been discussed in a limited manner, the patient has remained the neglected variable of this equation. The goal of our study, therefore, is to investigate the patients’ opinion on the promotional activities of pharmaceuticalcompanies.Method A descriptive study was conducted
...requested by the VA employee. (3) Marketing to students. Pharmaceuticalcompany representatives are prohibited from marketing to medical, pharmacy, nursing and other health profession students, including residents. Exceptions may be...
The Turkish Pharmaceutical Manufacturers Association-Ilaç Endüstrisi Isverenler Sendikasi (IEIS) set guidelines for pharmaceuticalcompanies when designing their websites in 2003. The objective of this study is to evaluate whether pharmaceuticalcompany websites comply with these guidelines. The list of all the national and international pharmaceuticalcompanies active in Turkey is obtained from Farmalist Vademecum. We evaluated each site in terms of availability of drug advertisement, mail address, e-mail address, telephone number, fax number, update information, indication of target group, links, references, information, appropriate content for the intended target group, disclaimer stating the given information is only for health care professionals, disclaimer stating the given information cannot replace a health care professional, responsible body for the website design. The search was done throughout February 2005. We used x(2) test and Fisher's exact x(2) tests for statistical analysis. Of the 82 pharmaceuticalcompanies active in Turkey, 51 had a website eligible for evaluation. Of the 51 companies, 34 (66.7%) were national and 17 (33.3%) were international. Eighteen companies had drug advertisement on the home page of their websites (64.7%). Of the total companies majority had mail address (89.2%); telephone number (89.2%); fax number (84.3%); links (66.7%); and appropriate content for the health care professionals (62.7%). The frequency of having update information and a separate pharmacist/physician information part was higher among international pharmaceuticalcompany websites compared to the national ones. These differences were statistically significant (p < 0.05). As a result of the evaluation, the majority of the pharmaceuticalcompanies failed to comply wholly with the guidelines set by IEIS when designing their website on the Internet. PMID:16430388
In this paper overt repositioning of pharmaceutical and biotechnology companies in relation to patients and the wider public between 1990 and 2002 is analysed. It is proposed that this repositioning is linked to their success in gaining public acceptance of their use of genetics-based technologies to develop novel products. It is argued that this has helped biopharmaceutical companies to avoid
This study estimates the proportion of essential drugs out of all drugs offered for sale in six regions of the developing world by the 20 largest European pharmaceuticalcompanies. The total number of drugs offered for sale by the 20 companies is estimated from citations in the most important drug compendia in each region for 1988 and 1989. Essential drugs
One hundred and ninety-seven new chemical entities (NCEs) were investigated in man for the first time between 1964 and 1980 by the seven UK-owned pharmaceuticalcompanies. Thirty-five of these NCEs have been marketed and 137 withdrawn from further research and development. There was an increase in the number of NCEs investigated each year, but this was counter-balanced by an increase in the number rejected. Development times increased from about 4.5 years in the 1960s to 9 years in the 1970s with an accompanying reduction in the effective patent life.
Background Many patients’ and consumers’ organizations accept drug industry funding to support their activities. As drug companies and patient groups move closer, disclosure become essential for transparency, and the internet could be a useful means of making sponsorship information accessible to the public. This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceuticalcompanies, focusing on their websites. Methodology/Principal Findings Patient and consumer groups were selected from those stated to be sponsored by a group of pharmaceuticalcompanies on their websites. The websites were examined using two forms with principal (name of drug companies providing funds, amount of funding) and secondary indicators of transparency (section where sponsors are disclosed, update of sponsorship). Principal indicators were applied independently by two reviewers to the patient and consumer groups’ websites. Discordances were solved by discussion. One hundred fifty-seven Italian patient and consumer groups and 17 drug companies were considered. Thirteen drug companies (76%) named at least one group funded, on their Italian websites. Of these, four (31%) indicated the activities sponsored and two (15%) the amount of funding. Of the 157 patient and consumer groups, 46 (29%) named at least one pharmaceuticalcompany as providing funds. Three (6%) reported the amount of funding, 25 (54%) the activities funded, none the proportion of income derived from drug companies. Among the groups naming pharmaceuticalcompany sponsors, 15 (33%) declared them in a dedicated section, five (11%) on the home page, the others in the financial report or other sections. Conclusions/Significance Disclosure of funds is scarce on Italian patient and consumer groups’ websites. The levels of transparency need to be improved. Disclosure of patient and consumer groups provided with funds is frequent on Italian pharmaceuticalcompanies’ websites, but information are often not complete.
In the industrialized world, the negative image that many people (including politicians) have of pharmaceuticalcompanies not only makes the life for those working in this field more difficult, in a sense it is a road block. Without an improvement in communication between the public world and the pharmaceutical industry, one can foresee this industry steadily becoming a more difficult environment to work in. There is a clear need for knowing more about all the work done inside these companies before a new drug is approved (it is not all about marketing…). That society has no understanding of the ever-increasing costs of new drugs is also related to this lack of understanding of how tricky and cumbersome the process is to take a new idea for treating a certain disease to production of a marketed drug. With a relatively small investment of money, but with an investment of much good will, brain power, and trust, it should be possible to bring all relevant parties together and make a change.
|The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceuticalcompanies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…
The objective of this study was to comprehend the pricing differentiation of essential drugs between the local pharmaceuticalcompanies (LPC) and multinational pharmaceuticalcompanies (MNC) of Bangladesh. Thirty five (35) essential drug prices were collected from a local drug directory, namely Bangladesh National Formulary 2006. The mean and standard deviation of the prices of drugs belonging to all therapeutics categories
Objectives To examine the frequency of pharmaceuticalcompany representative (PCR) interactions with doctors in Libya and review possible associations between these interactions and the personal and practice setting characteristics of doctors. Method An anonymous survey questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. Results A questionnaire return rate of 61% (608 returned questionnaires) was achieved. Most respondents (94%) reported that they had been visited by PCRs at least ‘once’ in the last year. Fifty per cent of respondents met with PCRs at least once a month, and 20% at least once a week. The following characteristics were significantly associated with meeting with a representative more than once a week: age, gender (male > female), years of practice, being a specialist (other than an anaesthesiologist) or working in private practice. Ninety-one per cent of doctors reported that they had received at least one kind of relationship gift during the last year. Printed materials (79%), simple gifts (73%) and drug samples (69%) were the most common relationship products given to respondents. Reimbursements or sponsored items were reported by 33% of respondents. Physician specialists were more likely to receive drug samples or sponsored items than residents, general practitioners, anaesthesiologists or surgeons (P<0.01). Participants working in private practice alone or in both sectors were more likely to receive printed materials, simple gifts or free samples from PCRs than doctors working in the public sector (P<0.05). Conclusion Libyan doctors are frequently visited by PCRs. Doctors, working in private practice or specialist practice, are especially targeted by promotional activities. An agreed code of conduct for pharmaceutical promotion in Libya between doctors and PCRs should be created.
Objective To describe how pharmaceuticalcompanies cater to the material needs of doctors. Design Case report of memoirs. Setting Facilities that have nothing to do with medicine, somewhere in the Arabian peninsula. Patient population Random sample of doctors. Interventions Promotion by the pharmaceutical industry. Main outcome measures Short term outcomes were travel, pleasure, amusement, and gifts, and long term outcomes were the market share of specific companies. Results Short term outcomes were heterogeneous, underlying the diversity of the means employed by the pharmaceutical industry to subvert, divert, and influence medical practice. Overall, 200 doctors were dressed in white gowns, a doctor in preventive medicine quoted Hippocrates in favour of smoking, a senior doctor became a poet, a doctor trying to understand the Methods section of a poster paper wondered whether he should have been sunbathing at the beach instead, and two women doctors were kidnapped by Bedouin warriors. Long term outcomes on the sales of the company drugs are pending but are likely to be most favourable. Conclusions Eat, drink, be merry, and boost prescriptions.
This Energy Consumption Guide shows the results of a survey of the UK Pharmaceutical Industry undertaken in 1992 in conjunction with the Association of the British Pharmaceutical Industry (ABPI). The survey was questionnaire based and the companies who re...
This empirical study of five pharmaceuticalcompanies in India demonstrates the significance of inferential statistics in analyzing and solving complex business problems. The accounting technique of ratio analysis has been used in conjunction with the techniques of inferential statistics to draw inferences regarding short-term solvency of the companies selected for the study. Beside the main liquidity ratios, the relevant turnover
This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceuticalcompanies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceuticalcompanies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. PMID:22789039
The author explores the predominant strategic characteristics of fourteen multinational corporations eleven of which are among the twenty largest pharmaceutical firms world-wide. She shows that, while no dominant pattern emerges with respect to strategic choices, firms with a US focus appear less likely to be involved with diversification than their global dispersion counterparts, which are more likely to use a
With substantial fixed costs of drug development, more common conditions can support more products. If additional pharmaceutical products are beneficial, they will attract greater consumption and promote better health, e.g. greater longevity. We ask how market size measured by condition prevalence affects consumption and longevity. We document in condition cross sections that both the tendency to use a drug and
Whether physicians ought to interact with pharmaceutical sales representatives (reps) is a question worthy of careful ethical analysis. The issue presents a challenge to both professional integrity and time management. Empirical data suggest that interactions with pharmaceutical reps increase the chances that the physician will act contrary to duties owed to the patient. Ideally, a physician might both interact with reps and also do the research necessary to counteract the commercial bias in their messages. But a physician who actually did that research would, in turn, be devoting a good deal of time that might better be spent in other activities. The counterargument, that one is obligated to see representatives to obtain free samples to best serve one’s patients, can be shown in most practice settings not to be compelling. Physicians ought to refuse to visit with representatives as a matter of both professional integrity and sensible time management.
With an aging population and increased prevalence of chronic diseases, such as obesity and diabetes mellitus, drug reforms are needed across Europe to ensure the continued provision of comprehensive healthcare. It is also a challenge, with the limited resources available, to fund new innovative drugs that significantly improve patient health. Recent national and regional reforms in Sweden have moderated the rate of increase in drug expenditure, despite increased volumes of drug use and the launch of new, expensive drugs. National reforms include the adoption of economic principles when assessing the value and subsequent reimbursement of new and existing drugs, as well as reforms to obtain low prices for generic drugs. Regional reforms aim to encourage the rational use of medicines through the establishment of drug and therapeutic committees, development of guidelines, academic detailing, continuous benchmarking of prescribing patterns, and financial incentives. Some of these reforms provide examples to other European countries, whilst others duplicate existing measures. As such, we believe other European countries can benefit from an analysis of the Swedish reforms. We believe the pharmaceutical industry can also benefit from this analysis by working with key regional payers involved with developing and implementing the reforms as they moderate and refine their future activities, including finding acceptable ways of introducing new expensive drugs. PMID:18563945
Despite the fact that both men and women carry the human papillomavirus (HPV) and jointly contribute to its status as an epidemic, the promotion of Gardasil, a vaccine that blocks infection from four strains of HPV, has largely been designated as a women's-only health issue. The following case study contributes to ongoing efforts in the field of health communication to identify problematic assumptions informing contemporary health policy and practices. Specifically, I analyze how Merck Pharmaceuticals, the creator of Gardasil, strategically imbues direct-to-consumer advertisements with contradiction to preserve traditional notions of both women and medicine. I found that three gendered dialectics characterize Merck's efforts to invoke complacency among female consumers: public/secret, education/ignorance, and structured/individualist. In the case of the HPV vaccination, the implications of these dialectics are the perpetuation of complacency among female audiences that threatens both the success of this particular technology and the overall status of women and health. In line with conclusions offered by Thompson (2010a ), this study extends a call for health and communication scholars to continue to deconstruct dominant medical discourses and presents possibilities for re-storying narratives that mediate women's experiences with health. PMID:23402269
Introduction In 1998 a pharmaceuticalcompany published its Web site to provide: an institutional presence multifunctional information to primary customers and general public a new way of access to the company a link to existing company-sponsored sites a platform for future projects Since the publication, some significant integration have been added; in particular one is a primary interactive service, addressed to a selected audience. The need has been felt to foster new projects and establish the idea of routinely considering the site as a potential tool in the marketing mix, to provide advanced services to customers. Methods Re-assessment of the site towards objectives. Assessment of its perception with company potential suppliers. Results The issue "web use" was discussed in various management meetings; the trend of use of Internet among the primary customers was known; major concerns expressed were about staffing and return of investment for activities run in the Web. These perceptions are being addressed by making the company more comfortable by: Running the site through a detailed process and clear procedures, defining A new process of maintenance of the site, involving representatives of all the functions. Procedures and guidelines. A master file of approved answers and company contacts. Categories of activities (information, promotion, education, information to investors, general services, target-specific services). Measures for all the activities run in the Web site Specifically for the Web site a concise periodical report is being assessed, covering 1. Statistics about hits and mails, compared to the corporate data. Indication of new items published. Description by the "supplier" of new or ongoing innovative projects, to transfer best practice. Basic figures on the Italian trend in internet use and specifically in the pharmaceutical and medical fields. Comments to a few competitor sites. Examples of potential uses deriving from other Web sites. Discussion The comparatively low use of Internet in Italy has affected the systematic professional exploitation of the company site. The definition of "anarchic" commonly linked to the Web by local media has lead to the attempt to "master" and "normalize" the site with a stricter approach than usual: most procedures and guidelines have been designed from scratch as not available for similar activities traditionally run. A short set of information has been requested for inclusion in the report: its wide coverage will help to receive a flavour of the global parallel new world developing in the net. Hopefully this approach will help to create a comfortable attitude towards the medium in the whole organisation and to acquire a working experience with the net.
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
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-basedpharmaceutical and biotechnology companies. PhRMA member companies invested an estimated $44.5 billion in 2007 for innovative biomedical research to
An international project team (including members from US, Canada and UK) has been formed from a number of interested biopharmaceutical\\u000a companies and regulatory authorities to conduct a cross-organisation collaboration exercise. The results from this exercise\\u000a demonstrate the robustness of CE-SDS across eight different organisations that used instruments of the same equipment model,\\u000a the same reagents, and the same methodology. Data
B. Nunnally; S. S. Park; K. Patel; M. Hong; X. Zhang; S.-X. Wang; B. Rener; A. Reed-Bogan; O. Salas-Solano; W. Lau; M. Girard; H. Carnegie; V. Garcia-Cañas; K. C. Cheng; M. Zeng; M. Ruesch; R. Frazier; C. Jochheim; K. Natarajan; K. Jessop; M. Saeed; F. Moffatt; S. Madren; S. Thiam; K. Altria
Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development. PMID:21569250
Drug prices have been a conspicuous political issue in much of recent history, but no more so than during health care reform debates in 1993 and 1994.This paper investigates possible effects of political activity on pharmaceutical prices, with a particular focus on the health care reform period. It evaluates the extent to which pharmaceuticalcompanies slowed the rates at which
Drug prices have been a conspicuous political issue in much of recent history, but no more so than during health care reform debates in 1993 and 1994. This paper investigates possible effects of political activity on pharmaceutical prices, with a particular focus on the health care reform period. It evaluates the extent to which pharmaceuticalcompanies slowed the rates at
GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada. PMID:15298072
The report examines the competitive position of the European pharmaceuticalcompanies and industries, and compares them with the pharmaceuticalcompanies and industries in other parts of the world, particularly the US. Over the last two decades, the industry has experienced some important structural changes, mainly driven by technological and institutional shocks that have affected all the stages of its value
Alfonso Gambardella; Luigi Orsenigo; Fabio Pammolli
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 pharmaceuticalcompanies 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
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.
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
What are the trends in the global competitiveness of the Indian pharmaceutical industry? Where does this industry stand when compared to global peers on pharmaceutical value-added, productivity, research and development and trade performance? What are the new strategies that Indian pharmaceuticalcompanies are adopting to become global players? These questions are addressed in this paper. It is found that strategic
What are the trends in the global competitiveness of the Indian pharmaceutical industry? Where does this industry stand when compared to global peers on pharmaceutical value-added, productivity, research and development and trade performance? What are the new strategies that Indian pharmaceuticalcompanies are adopting to become global players? These questions are addressed in this paper. It is found that strategic
Summary Pharmaceuticalcompanies are capitalising on the advent of the internet and the development of new media forms to promote their products. electronic detailing, interactive websites, email prompts and viral marketing campaigns using social networking sites such as y ouTube, mySpace and Facebook are among the tools being used. Such campaigns are targeting both health professionals and the general public.
Pharmaceuticalcompanies 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 pharmaceuticalcompany's drug discovery data. We provide an analysis of the principal
Many pharmaceuticalcompanies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceuticalcompanies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceuticalcompanies with pipeline gaps to bring new pharmaceuticals to the clinician. PMID:19041620
... regulations, including falsification of documents and manipulation of samples. ... using the Bioanalytical Electronic Raw Data Audit Plan (provided by ... More results from www.fda.gov/drugs/drugsafety
Given the large percentage of Internet users who search for health information online, pharmaceuticalcompanies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceuticalcompanies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceuticalcompany influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
The feasibility of the commercial manufacturing of pharmaceuticals in space is examined. The method of obtaining pharmaceuticalcompany involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the...
A technical analysis on the feasibility of commercial manufacturing of pharmaceuticals in space is presented. The method of obtaining pharmaceuticalcompany involvement, laboratory results of the separation of serum proteins by the continuous flow electro...
Mission statement is a managerial tool which has the power of directing the behaviour in a company. The important question we can ask is whether the existence of a mission statement is associated with company performance or not. Findings of different studies exploring this relationship are not very conclusive. In our researchbased on a sample of 394 Slovenian companies
In Italy the price setting of medicines reimbursed by the National Health Service is regulated at the central level by AIFA, the national regulatory authority. Prices of non reimbursed medicines are indeed freely established, with some limitations, by pharmaceuticalcompanies. To contain pharmaceutical expenditure and rationalise the whole sector the following measures have been introduced in the past years: a threshold to public pharmaceutical expenditure (PPE); a reference price system (RPS) for off-patent medicines; a pay-back mechanism as an alternative to price cut. In 2008 Italy launched a reform of the pharmaceutical expenditure governance system with the aim to introduce stability and promote development and competitiveness in the pharmaceutical sector. PMID:18566845
Folino-Gallo, Pietro; Montilla, Simona; Bruzzone, Mario; Martini, Nello
Through this lesson and its associated activity, students explore the role of biomedical engineers working for pharmaceuticalcompanies. 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.
|A survey of 99 pharmaceuticalcompanies concerning their organization and use of project management techniques for research and development found that the industry is using project management increasingly in a variety of ways for better business planning and operations. (MSE)|
Introduction of the new Pharmaceutical Benefits Board (LFN; 1 October 2002) has markedly changed the principles of pricing and reimbursement of drugs in Sweden. The Board is required to make decisions based on information on cost-effectiveness, and pharmaceuticalcompanies must submit economic evaluations when relevant as part of their applications for reimbursement. This study examined experience to date regarding the
In the United States, government has played a limited role in containing the costs of pharmaceuticals. There are no price controls, no national drug formularies, no universal cost-sharing policies, and perhaps most important, no national coverage of prescription drugs. Rather, pharmaceutical cost containment was historically left to private insurers and managed care companies, while consumers paid out of pocket for
Purpose – This paper aims to analyze the present trends in pharmaceutical innovation and the impact of generic competition. Design\\/methodology\\/approach – A secondary research was conducted to collect data related to new drug approvals of various classes over previous years; trends of investment in research and development; and the pipeline of new drug products of pharmaceuticalcompanies. Findings – While
This paper offers a discussion to the question of why there are pressures on developing countries for introducing and\\/or reinforcing patent protection to pharmaceutical drugs. Patent protection is an important component of a complex strategy developed by the research and development intensive pharmaceutical drug companies of industrial countries to meet market competition. For legal and economic reasons, patents are fundamental
Organizational literature heralds the value of team learning but does not provide a research-based description of it. This article describes a model of team learning that was derived empirically from case studies in two companies, one with a cross section of employees in a petrochemical company and the second in a data-processing unit that had been reorganized into self-managed teams
Elizabeth Kasl; Victoria J. Marsick; Kathleen Dechant
\\u000a The pharmaceutical marketplace is dominated by large multinational companies, competing worldwide, with a global presence\\u000a in branded products. Retaining marketshare requires standards of product quality and reliability close to 100%, attained at\\u000a sustainable cost. Wholesalers and final customers expect reliability and quality from pharmaceuticalcompanies, which face\\u000a an increasing challenge to achieve such standards. Reliable production plans are critical to
|Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…
Pharmaceutical analysis simply means analysis of a pharmaceutical(s). Webster's dictionary defines a pharmaceutical as a medicinal drug. It is generally known that a pharmaceutical is a chemical entity of therapeutic interest. A more appropriate term for a pharmaceutical is active pharmaceutical ingredient (API) or active ingredient. In colloquial terms, it is simply referred to as “active”; the use of this
|It is known that interaction between pharmaceuticalcompanies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceuticalcompany representatives and increasingly accept their gifts.…
A collaborative, researchbased laboratory experiment in mathematical modelling was included in a bioprocess engineering laboratory module, taught as part of an interdisciplinary program in biotechnology. The class was divided into six groups of three students and given the task of investigating a novel diafiltration process that is currently the focus of international research. Different aspects of the problem were
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 pharmaceuticalcompany can better understand the conscious and unconscious consumer's thoughts and tailor specific marketing messages. PMID:23346245
It is known that interaction between pharmaceuticalcompanies and medical professionals may lead to corruption of professional\\u000a values, irrational use of medicine, and negative effects on the patient–physician relationship. Medical students frequently\\u000a interact with pharmaceuticalcompany representatives and increasingly accept their gifts. Considering the move toward early\\u000a clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the
... Pharmaceutical Working Groups. Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. Individual Working Group Members. -. -. ... More results from www.fda.gov/drugs/developmentapprovalprocess/manufacturing
Under the TRIPS agreement, WTO members are required to enforce product patents for pharmaceuticals. The debate about the merits of this requirement has been extremely contentious. Many low income economies claim that patent protection for pharmaceuticals will result in substantially higher prices for medicines, with adverse consequences for the health and well-being of their citizens. On the other hand, research-based
Shubham Chaudhuri; Pinelopi K. Goldberg; Panle Jia Barwick
Patents and patent valuation have raised tremendous concerns from the research-basedpharmaceutical industry for a long time. Questions about the valuation of drug patent portfolios, the assessment of research and development (R&D) performance or innovation output, and the competitive position of different firms in the industry all tend to revolve around the basic question of pharmaceutical patent valuation. This article
A double case study applying action research methodology was conducted in two pharmaceutical preparation manufacturers in the Netherlands in order to improve their manufacturing systems by implementing time-based manufacturing (TBM) practices. Following the diagnosis phase, the situation of each Company was analysed and suitable improvement interventions were selected for implementation in the Case Companies. At the end of the action
Asia is becoming a centre of gravity for global business. As a result of this, there is a growing interest in investment in this area, and pharmaceuticalcompanies are not an exception. The old research and development investment model of the Western Big Pharma companies is starting to fall apart with the well-publicised reduction of new chemical entities productivity. Big
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 pharmaceuticalcompany, 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.
The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceuticalcompanies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers. PMID:22392783
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 pharmaceuticalcompanies. 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
Seeks to address issues associated with lifelong learning from the perspective of teaching and curriculum practice in the areas of mathematics and technology in an Australian pharmaceutical manufacturing enterprise. Its aim is to reflect on research-based innovative course delivery in the field specified to indicate possibilities in education for lifelong learning. Following discussion of lifelong learning, issues important to the
The aim was to obtain information on the use of financial instruments hedging the Serbian large and medium-sized enterprises, as well as to detect any differences between the characteristics of companies that use them or not used. Survey researchesbased on telephone interviews with financial or accounting managers with a stratified random sample of 101 Serbian companies and conducted in
NOAO facilities will be used in support of ``Teacher Leaders in ResearchBased Science Education" (TLRBSE), a new Teacher Retention and Renewal program that will be funded through the National Science Foundation's Directorate for Education and Human Resources. The goal of TLRBSE is to provide professional development for secondary teachers of mathematics and science in an effort to support novice teachers beginning their careers as well as to motivate and retain experienced teachers. Within the context of astronomy, TLRBSE will develop master teachers who will mentor a second tier of novice teachers in the exemplary method of research-based science education, a proven effective teaching method which models the process of inquiry and exploration used by scientists. Participants will be trained through a combination of in-residence workshops at Kitt Peak National Observatory and the National Solar Observatory, a distance-learning program during the academic year, interaction at professional meetings and mentor support from teacher leaders and professional astronomers. A total of 360 teachers will participate in the program over five years.
Rector, T. A.; Jacoby, S. H.; Lockwood, J. F.; McCarthy, D. W.
NOAO facilities will be used in support of ``Teacher Leaders in ResearchBased Science Education" (TLRBSE), a new Teacher Retention and Renewal program that will be funded through the National Science Foundation's Directorate for Education and Human Resources. The goal of TLRBSE is to provide professional development for secondary teachers of mathematics and science in an effort to support novice teachers beginning their careers as well as to motivate and retain experienced teachers. Within the context of astronomy, TLRBSE will develop master teachers who will mentor a second tier of novice teachers in the exemplary method of research-based science education, a proven effective teaching method which models the process of inquiry and exploration used by scientists. Participants will be trained through a combination of in-residence workshops at Kitt Peak National Observatory and the National Solar Observatory, a distance-learning program during the academic year, interaction at professional meetings and mentor support from teacher leaders and professional astronomers. A total of 360 teachers will participate in the program over five years.
Rector, T. A.; Jacoby, S. H.; Lockwood, J. F.; McCarthy, D. W.
In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceuticalcompanies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. PMID:18633728
In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceuticalcompanies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products.
This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.
This paper examines how equitable, differentiated pricing can improve access to and affordability of medicines, particularly in low- and middle-income countries, and how governments and supranational agencies can create an environment that enables pharmaceuticalcompanies to operate a sustainable business model benefitting all key stakeholders. Using value-based pricing techniques in combination with a non-linear function that captures national income parameters
This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four
Laura Magazzini; Fabio Pammolli; Massimo Riccaboni
Examines excellence in three major pharmaceuticalcompanies: Merck, Lilly, and Glaxo. Provides an overview of recent trends in the health care industry. Shows that, although all three companies are facing tough competition and strict cost-containment pressures, they continue to develop innovative strategies for increasing the quality of their product offering. Analyses Merck’s recent acquisition of Medco and its implications; also
Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceuticalcompanies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they need vision as well as commitment regarding the unique requirements of the industry. PMID:18972973
The paper addresses the industrial profiles for production of selected packaging materials, for which technology is available with Yugoslav companies, who have been producing these materials for the needs of Yugoslav pharmaceutical industry. This means th...
The perceptions of U.S. biotechnology and pharmaceuticalcompanies 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 biologi...
In an effort to assess medical liaison trends across the pharmaceutical industry, two surveys of medical liaison managers were previously administered and published. The intent of these surveys was to identify overall approaches used by pharmaceuticalcompanies in defining and managing the medical liaison role. We conducted this third survey to focus on areas identified by the initial survey participants
J. Lynn Bass; Christopher M. Marrone; Craig Klinger
|OBJECTIVE: To analyze the educational and ethical issues involved in interactions between departments of psychiatry and the pharmaceutical industry. METHODS: The author analyzes the history of attitudes toward pharmaceuticalcompanies, various conflicting ethical principles that apply, and areas of confluence and conflict of interest between…
|A discussion of clinical trials in the pharmaceutical industry describes typical processes and administrative issues, then presents a case in which a foreign pharmaceuticalcompany negotiated with a university for sponsorship of a multicenter clinical trial of a new drug therapy. Problems and important considerations in clinical trials are…
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In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceuticalcompany concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. PMID:23339876
A method for making and identifying processed botanical materials as being of a pharmaceutical grade for use in clinical settings and patient treatment. The method utilizes fingerprints of the processed botanical material with respect to bioactivity and/or composition to establish whether the material meets previously established pharmaceutical grade requirements. The method is applicable to processed botanical materials, such as plant extracts, powders and the like which are used in medicinal applications.
Khwaja; Tasneem A. (Newport Beach, CA); Friedman; Elliot P. (Montecito, CA)
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
|Three issues are discussed: (1) conflict between the pharmaceutical industry and academe; (2) how and why some companies contract their research efforts to colleges; and (3) how colleges can increase their percentage of industry monies available for contract research. (Author/MSE)|
The absence of government regulation in the US has left pharmaceuticalcompanies free to set their own prices based on a number of market considerations. Historically, these have included not only ingredient, research and development costs, but also advertising, the drug's marginal effectiveness, competition, and market size. However, within the last two decades, two parallel trends have combined to bring
Background Press releases are a popular vehicle to disseminate health information to the lay media. While the quality of press releases issued by scientific conferences and medical journals has been questioned, no efforts to assess pharmaceutical industry press releases have been made. Therefore, we sought to systematically examine pharmaceuticalcompany press releases about original research for measures of quality. Methodolgy/Principal Findings Press releases issued by the ten top selling, international pharmaceuticalcompanies in the year 2005 were selected for evaluation. A total of 1028 electronic press releases were issued and 235 were based on original research. More than half (59%) reported results presented at a scientific meeting. Twenty-one percent of releases were not explicit about the source of original data. While harms or adverse events were commonly cited (76%), study limitations were rarely noted (6%). Almost one-third (29%) of releases did not quantify study results. Studies presented in abstract form were subsequently published within at least 20 months in 53% of cases. Conclusions Pharmaceuticalcompany press releases frequently report basic study details. However, readers should be cautioned by the preliminary nature of the data and lack of identified limitations. Methods to improve the reporting and interpretation of drug company press releases are desirable to prevent misleading media coverage.
This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceuticalcompanies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity. PMID:23896384
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 pharmaceuticalcompanies 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.
Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative. PMID:18048307
Databases held by regulatory agencies and by pharmaceuticalcompanies may be used to detect safety signals. We compared the utility of a company safety database with those from two large regulatory authority databases in assessing potential safety signals in order to understand how the different sources may be used. Proportional reporting ratios (PRRs) were calculated from the company database for
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…
|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…
After the turn to market oriented economy a lot of drugs were authorized for sale in the East European countries. Because of the limited resources of these countries, mainly generic or brand generic products were licensed. The number of the patented drugs on the market could be used as measure of the market attractiveness to the R&D producers. The study shows the analysis of the innovativeness of the Bulgarian drug market comparing the registration and the patient activity of the producers. The number of the authorized products for five years period (1990-2000) and share of the patented products were investigated. During the observed period the number of newly authorized pharmaceuticals increased almost seven times from 800 (650 INN) to 6000 (2000 INN) dosage forms. The prevailing part of the newly registered drugs was found to be brand generics and possess only trade name protection. The share of drugs that are patented is less than five percent of all newly registered medicines, and among the fifty most commonly prescribed and sold medicines between 1996-2000, only 0.5 percent of drugs were patented. Obviously the Bulgarian pharmaceutical market is very competitive but not that attractive for most of the R&D producers. In general the registration of the patent protected products is increasing during the years and especially after harmonization of the related legislation with the EU requirements. The patent activity of the pharmaceuticalcompanies regarding newly authorized drugs is influenced by the structure of morbidity and population. During the last two years the patent activity is increasing and is oriented mainly towards the protection of newly authorized drugs or pharmaceutical forms and obligatory registration of trademarks for the privatized Bulgarian pharmaceutical manufacturers. PMID:14677267
Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810. PMID:21797049
Most major pharmaceuticalcompanies have employed grid computing to expand their compute resources with the intention of minimizing additional financial expenditure. Historically, one of the issues restricting widespread utilization of the grid resources in molecular modeling is the limited set of suitable applications amenable to coarse-grained parallelization. Recent advances in grid infrastructure technology coupled with advances in application research and redesign will enable fine-grained parallel problems, such as quantum mechanics and molecular dynamics, which were previously inaccessible to the grid environment. This will enable new science as well as increase resource flexibility to load balance and schedule existing workloads. PMID:18598912
The challenges of developing new medicines are well known. Effective application of clinical pharmacology expertise is vital to the successful evaluation of potential new medicines. In drug development, this depends on effective integration of diverse skills. Many of these are currently in short supply, but through innovative partnerships between industry and academia there is an opportunity to reinvigorate the discipline by nurturing these key skills to the benefit of both partners. Specific areas of focus should be experimental medicine, modelling and simulation, and translational skills.
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The establishment of an effective product information unit in a large pharmaceuticalcompany, such as Lederle Laboratories, a division of American Cyanamid Company, involves a collaboration of various human and technical resources needed to efficiently process a high volume of medical information. Special consideration must be given towards developing good avenues of communication, both outside of and within the parent
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
This paper investigates the strategic and organizational changes which two major Swiss pharmaceuticalcompanies have implemented in order to respond to the challenges related to a slowing of innovation and increasing oligopolistic rivalry. Introducing cross-functional project teams, the companies mainly accelerated the development process. These project teams are overlaying structures which complement the functional and geographical organizational units. Common project
This paper seeks to explain why some pharmaceuticalcompanies are observed to withdraw their products before patents are expired and simultaneously introduce new patented (competing) products. Given the specific nature of drug markets, the companies in fact increase the entry cost of the potential generic drug manufacturers and thereby lessen competition for new drugs. The paper determines the optimal date
Human pharmaceuticals are widely used and can reach surface waters, where they have the potential to exert biological effects on aquatic non-target organisms. Due to the high number of pharmaceutical drugs used in human medicine throughout the world, it is necessary to select the pharmaceuticals to search for, prior to implementing any environmental measurements and any extensive environmental risk assessment
Pharmaceuticals and their metabolites can reach water bodies through sewage systems, industrial discharges, effluents from sewage treatment plants (STPs), aquaculture, and livestock farming. Pharmaceuticals include a hundred substances which are very different as regards chemical–physical properties and environmental behavior, although they may have strong biochemical activities. At present, pharmaceuticals can reach water concentrations of ng L to µg L and
Polymer conjugation is of increasing interest in pharmaceutical chemistry for delivering drugs of simple structure or complex compounds such peptides, enzymes and oligonucleotides. For long time drugs, mainly with antitumoral activity, have been coupled to natural or synthetic polymers with the purpose of increasing their blood permanence time, taking advantage of the increased mass that reduces kidney ultrafiltration. However only
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.
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
The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceuticalcompanies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning.
Worker exposure to estrogens were studied at the Ortho Pharmaceutical Corporation (SIC-2834) in Raritan, New Jersey, on June 20, 1978. The company was under consideration for inclusion in a NIOSH study of the health effects of occupational estrogen exposu...
Interactions between physicians and detailers (even when legitimate ones) raise scientific and ethical questions. In Portugal little thinking and discussion has been done on the subject and the blames for bribery have monopolized the media. This work intended to review what has been said in medical literature about these interactions. How do physicians see themselves when interacting with pharmaceuticalcompanies and their representatives? Do these companies in fact change their prescriptive behaviour, and, if so, how do they change it? How can physicians interact with detailers and still keep their best practice? A Medline research, from 1966 till 2002, was performed using the key-words as follows. A database similar to Medline but concerning medical journals published in Portugal, Index das Revistas Médicas Portuguesas, was also researched from 1992 to 2002. Pharmaceuticalcompanies are profit bound and they allot promoting activities, and detailing in particular, huge amounts of money. Most physicians hold firmly to the belief that they are able to resist and not be influenced by drug companies promotion activities. Nevertheless, all previous works on literature tell us the opposite. Market research also indicates that detailers effectively promote drug sales. Various works also suggest that the information detailers provide to physicians may be largely incorrect, even comparing it to the written information provided by the pharmaceuticalcompanies they work for. The frequency at which portuguese physicians (especially family physicians) contact with pharmaceutical sales representatives is higher than the frequency reported in countries where the available studies come from (namely, Canada and the United States of America). This may put portuguese physicians at a higher risk, making it imperative that work and wide debate are initiated among the class. PMID:16202335
The Pharmaceutical Management Branch (PMB) deployed a new and improved mechanism for ordering investigational agents. Agents should now be ordered online. The Online Agent Order Processing (OAOP) application provides online agent ordering, order status review, FedEx tracking information, and assistance with selecting information that typically resulted in processing delays with faxed order requests (e.g. correct protocol number, correct investigator number and current shipping address, agent NSC number and agent strength and formulation).
Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy. PMID:15861928
Traulsen, Janine Morgall; Almarsdóttir, Anna Birna
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
Advocates of drug price restrictions in the U.S. argue that pharmaceuticalcompanies operate in an unregulated market, free to charge whatever price the market will bear. The pharmaceutical industry insists that these large profits are justified for investments toward discovering new life saving medicines. As innovation wanes, marketing costs soar, and drug profits rise, public interest advocates and state leaders are challenging this justification. This article examines current problems associated with the ability to procure affordable medicines, and examines mounting tensions between the federal government and the states, particularly regarding the states' ability to negotiate lower prices with drug manufacturers in light of the recent Medicare changes. It provides a brief survey of efforts underway to secure affordable pharmaceuticals for state's residents, addressing the history and feasibility of using compulsory licensing for producing affordable life-saving drugs with respect to public health, constitutional, eminent domain, and anti-trust issues. PMID:17242532
In India same drug molecules are sold under different brand names by different pharmaceuticals. To persuade the physicians to prescribe their brands pharmaceuticals engage in marketing techniques like giving samples, gifts, sponsoring travel etc. Many countries are striving to reduce the impact of incentives on prescription behaviour. This study explores the influence of pharmaceutical marketing on the prescription practices of doctors in India. There were 103 study subjects - 50 doctors and 53 sales personnel. Data collection was done by a self administered questionnaire. Data were collected on 36 variables which were supposed to influence prescription. The effectiveness of the promotional strategies on prescription behaviour was marked in a seven point Likert scale ranging from "not at all effective" (score=1) to "extremely effective" (score=7). Open ended questions were used to collect qualitative data. Good rapport with the doctor, launch meetings, reputation of the company, quality of the drug and brand names significantly influenced prescription behaviour, while direct mailers, advertisements in journals and giving letter pads and other brand reminders were less effective. Commonly used method of giving samples was not among the twenty most effective methods influencing prescription. Product quality and good company are still factors that influence prescription. Pharmaceutical marketing influences the choice of brands by a physician. The more expensive strategies involved in public relations are more effective. Sending mails and journal advertisements are less effective strategies. How expensive marketing strategies affect cost of the medicines has to be explored further. PMID:24000508
This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians’ relationships with patients/subjects and pharmaceuticalcompanies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceuticalcompanies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.
A meeting convened between Vice President Al Gore and executives of leading pharmaceuticalcompanies to determine means of accelerating efforts to develop vaccines, therapeutics, and microbicides for people with HIV. Gore explained that the administration will work with pharmaceuticalcompanies to determine the long-term effectiveness of drugs approved by the Food and Drug Administration (FDA), work with international groups to increase investment in vaccine development, help develop new microbicides for women with HIV, and identify promising areas of AIDS research. According to advocates, the Clinton Administration has made great strides in improving and accelerating the FDA's drug approval process. The next goal of the pharmaceutical research agenda should be to include consumer advocates in the decision-making process. PMID:11363414
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 pharmaceuticalcompanies. This article analyzes the interrelation of the far-reaching but spatially selective international expansion of R&D and technology of a major Swiss
The outsourcing of medical research has become a strategic imperative in the global pharmaceutical industry. Spurred by the\\u000a challenges of competition, the need for speed in drug development, and increasing domestic costs, pharmaceuticalcompanies\\u000a across the globe continue to outsource critical parts of their value chain activities, namely contract clinical research and\\u000a drug testing, to sponsors across the globe, typically
...Monongahela Power Company, West Penn Power Company, The Potomac Edison Company, PJM Interconnection, L.L.C.; Notice of Filing...Monongahela Power Company, West Penn Power Company, The Potomac Edison Company (collectively, the Designated FirstEnergy...
Fibromyalgia syndrome is a debilitating pain disorder of unknown origins and a paradigmatic contested illness. As with other contested illnesses, the reality of fibromyalgia is disputed by many physicians. Thus, millions of individuals who are diagnosed with fibromyalgia must cope with chronic symptoms as well as medical and public skepticism. In this context, the U.S. Federal Drug Administration's approval of Lyrica, the first prescription medication specifically for the management of fibromyalgia, is of considerable interest. In this paper I examine the cultural logic whereby the existence (and marketing) of an officially approved prescription medication for a condition lends support to the biomedical existence of the condition itself. I label this logic pharmaceutical determinism and argue that it represents an important new phase in the proliferation of contested illness diagnoses. Using the case of Lyrica, I describe the role that pharmaceuticalcompanies and pharmaceuticals themselves play in promoting and legitimating contested diagnoses and validating those who are so diagnosed. Through a narrative analysis of the Lyrica direct-to-consumer advertising campaign and the responses of fibromyalgia sufferers to the introduction and marketing of Lyrica, I demonstrate the symbiotic relationship between the interests of the pharmaceutical industry, contested illness legitimization, and medicalization. I also provide a gender analysis of this relationship, foregrounding how contested illnesses continue to be shaped by their feminization in a cultural context that equates women with irrationality. Finally, I address the consequences and limitations of relying on the pharmaceutical industry for illness validation. PMID:21840638
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…
Despite longstanding recognition, in Britain and elsewhere, of the problems of relating research to nursing practice and education, the authors found no previous research on nurse educators' understandings of the term ‘research-based nurse education’ (RBNE). In a cooperative inquiry, four nurse educators with varying lengths of experience in different kinds of educational institutions explored their understandings of the term and
Introduction: The aim of this project was to develop and evaluate a research-based dramatic production for the purpose of transferring knowledge about traumatic brain injury (TBI) to health care professionals, managers, and decision makers. Methods: Using results drawn from six focus group discussions with key stakeholders (consumers, informal…
Colantonio, Angela; Kontos, Pia C.; Gilbert, Julie E.; Rossiter, Kate; Gray, Julia; Keightley, Michelle L.
Research is an integral element of the work of higher education institutions, underpinning not only academics' responsibilities in developing intellectual skills and personal reputations, but contributing to the status of an organisation. Whilst formalised approaches are adopted for developing research, there is a growing trend towards informal groupings or communities of practice. This research, based on interviews with members of
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…
Formulating design guidelines from research results can potentially offer two advantages: available empirical knowledge is distilled into a readily accessible form, and practitioners can judge the authority of those guidelines for themselves, but a case history demonstrates that challenges confront the developer of research-based guidelines for Web site design, First, few studies of people using the Web have yet been
Although international students studying in New Zealand desire and expect contact with their domestic peers, the level of cross?national interactions remains generally low. This paper describes an initiative to promote more and better intercultural understanding within a target group of students having similar needs and interests in a higher education setting. A research?based teaching approach progressively increased student engagement with
The diverse population of students in grades 1- 3 at a suburban elementary school has created a challenge for teachers when differentiating instruction in reading. The purpose of this doctoral project study was to explore the lived experiences of these teachers as they have acquired research-based instructional strategies in reading that support…
Three perspectives on the redesign and implementation of a master's level social studies seminar are offered. Research-based writing was used to build information literacy skills and foster teachers' professionalism. Assessments indicate that students improved research and writing skills, increased their sense of teaching efficacy, and enhanced…
McMillen, Paula S.; Garcia, Jesus; Bolin, David A.
|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…
|The experience and science expertise of these award-winning authors makes this easy-to-use guide a teacher's treasure trove. This latest edition to the popular What Successful Teachers Do series describes 75 research-based strategies and outlines best practices for inquiry-oriented science. Each strategy includes a brief description of the…
Glasgow, Neal A.; Cheyne, Michele; Yerrick, Randy K.
|Introduction: The aim of this project was to develop and evaluate a research-based dramatic production for the purpose of transferring knowledge about traumatic brain injury (TBI) to health care professionals, managers, and decision makers. Methods: Using results drawn from six focus group discussions with key stakeholders (consumers, informal…
Colantonio, Angela; Kontos, Pia C.; Gilbert, Julie E.; Rossiter, Kate; Gray, Julia; Keightley, Michelle L.
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
Contents: The role of plastics in packaging of pharmaceuticals; Types of plastic materials used in packaging of pharmaceuticals; Properties of plastics and their applications in the pharmaceutical industry; Factors having a bearing on the choice of correc...
The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceuticalcompanies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceuticalcompanies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. PMID:23744524
Lipworth, Wendy; Montgomery, Kathleen; Little, Miles
Pharmaceutical policy is a global concern. It has become a hot political topic in most countries – developed as well as developing – and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it
As part of achieving national environmental goals, the Swedish Government commissioned an official report from the Swedish Medical Products Agency on environmental effects of pharmaceuticals. Considering half-lives\\/biodegradability, environmental occurrence, and Swedish sales statistics, 27 active pharmaceutical ingredients were selected for environmental hazard and risk assessments. Although there were large data gaps for many of the compounds, nine ingredients were identified
Carina Carlsson; Anna-Karin Johansson; Gunnar Alvan; Kerstin Bergman; Thomas Kühler
Context Controversy exists over the fact that physicians have regular contact with the pharmaceutical industry and its sales representatives, who spend a large sum of money each year promoting to them by way of gifts, free meals, travel subsidies, spon- sored teachings, and symposia. Objective To identify the extent of and attitudes toward the relationship between physicians and the pharmaceutical
The current practice of characterization and control of impurities in pharmaceuticals is reviewed with emphasis on issues specific to the generic industry. Case studies are discussed to demonstrate that generic pharmaceuticals are therapeutically equivalent to the branded product, even though the color, size, shape, and excipients utilized may not be identical. PMID:17196702
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 . 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 . A further grant of $2.7 million was awarded in August 1998 for the clinical evaluation of PRO-542 and other anti-HIV therapies . Progenics is collaborating with the Aaron Diamond AIDS Research Center (ADARC) in New York and the Center for Disease Control and Prevention in Atlanta . 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 . 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 . 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 . PMID:11249748
During more than a decade of direct-to-consumer advertising (DTC) of pharmaceuticals in the United States, several highly controversial and contested disease states have been promoted to affect diagnostic and prescribing outcomes that are favorable to a company's branded drug. Influencing medical diagnosis is essential to the branding of a disease, which helps to protect pharmaceutical intellectual property and assures higher profits for drug companies. Enormous marketing as well as medical resources are deployed to ensure that new diagnoses of disease states are recognized. While much work has been done investigating the marketing processes necessary to shape and define diagnoses for many of these new disease states, such as Premenstrual Dysphoric Disorder (PMDD), the promotion of self-diagnosis within pharmaceutical marketing campaigns garner little sociological attention. This article reviews and analyzes branded disease awareness campaigns sponsored by pharmaceuticalcompanies that employ self-diagnostic "tools". By using the example of one specific disease state, PMDD, I illustrate how the marketing of self-diagnosis transforms the patient into a consumer in order to achieve the aims of a drug company. This example is contextualized within the larger theoretical framework on the sociology of diagnosis. Consideration is given to how the marketing of self-diagnosis goes beyond Jutel's (2009) description of diagnosis as being the "classification tool of medicine" and becomes a marketing tool to construct a well-educated consumer who will demand medical diagnoses inline with a drug company's objectives. PMID:21835526
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 , . Phase I trials for epilepsy and PD have been completed, and dose-finding studies for both indications had commenced in March 2001 . 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 , . 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 . PMID:11572661
During the past few years, there have been rapid changes in the pharmaceutical uses of nitroglycerin. New dosage forms and new delivery systems have become available, which have resulted in potential confusion to all concerned with the proper use of these systems. The goal of this review is to prevent confusion and to bring all the relevant information together. The various analytical techniques available for quality control of the dosage forms and for the study of the pharmacokinetics are reviewed, with the intent of enabling the reader to identify pertinent references rapidly. The interaction of nitroglycerin with packaging and plastic delivery devices is also reviewed so that the reader can make informed choices. Finally, the clinical pharmacy and pharmacokinetics are reviewed so as to bring the reader up to date in that area. After reading this article, the areas of nitroglycerin research that still need to be explored should be apparent.
In 1995 a new research-based fisheries outreach program called Fishing in the Parks began as a university-agency-organization collaboration. The focus of this effort was to understand outreach program participants and to assess whether this program effectively reached the targeted novice-angler segment of families with young children. In 1995 and 1996, surveys were administered to 2,374 adult and youth program participants,
The people of Anadys are committed to advancing patient care by discovering, developing, and commercializing novel and powerful anti-infective medicines. Anadys is focused on the discovery and development of small molecule therapeutics for the treatment of infectious disease, including hepatitis C and bacterial infections. The company's lead program for the treatment of hepatitis C is currently in Phase IB testing. Anadys also has a broad portfolio of antiviral and antibacterial programs directed at novel targets, intervention points and mechanisms of action. With an integrated suite of technologies and capabilities, including Riboproteomics, ATLAS and structure-based drug design through a world-class medicinal chemistry team, Anadys is capable of quickly optimizing lead compounds for use in preclinical and clinical testing. The company's goal is to build a strong and continual pipeline of novel and powerful drug candidates directed to advance patient care. PMID:12831329
Ortho Pharmaceutical Corporation of New Jersey spent $125,000 to achieve almost $390,000 in energy savings in an aggressive effort to control energy costs and consumption. Despite the addition of a 212,000-square-foot building, the company's energy consumption increased only two per cent over 1982 levels. Energy costs have grown 17% to $2.2 million during the period. Among the projects were space conditioning and air handling retrofits, relamping, an automatic boiler blowdown system, and boiler oxygen trim controls. 1 figure.
Pharmaceuticals in conjunction with nanoparticle delivery systems are growing towards new heights. The aim of this review is to gain a thorough understanding of different types and characteristics of nanoparticle based delivery systems, important properties of delivery systems, pharmaceutical ingredient loading and release in the nanoparticle delivery systems. In this review, we have also highlighted about the promising pharmaceutical deliveries like brain targeted delivery, ocular delivery, oral delivery, dermal and transdermal delivery, cancer chemotherapy, vaccine delivery, nucleic acids delivery and delivery system coupling to implants. A snapshot of the nanoparticle mediated drug deliveries which are commercially available and ongoing clinical trials have been provided. PMID:23747865
This study applied artificial neural networks to explore the influences of the quantitative and qualitative patent indicators upon corporate market value in the US pharmaceutical industry. The results showed that US pharmaceuticalcompanies should not concentrate most of their R&D resources on one particular technological field, but create wider technological capabilities to avoid missing new technological opportunities and to decrease
Contents: General characteristics of the Italian pharmaceutical industry; Regulations governing the registration of medicinal specialties; Technical requirements for registration of medicinal specialties. Evaluation of the application for marketing author...
The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry. PMID:19152846
ONO-5046 (sivelestat) is a competitive inhibitor of human neutrophil elastase from Ono Pharmaceutical, which is awaiting FDA approval for the treatment of pulmonary fibrosis and idiopathic interstitial pneumonia . An NDA was filed in Japan in September 1998 . It is in phase II trials for the treatment of acute circulatory failure . It is also being investigated as a potential treatment of arthritis . In animal models of asthma, sivelestat decreased the level of hemorrhage and protein extravasation into the bronchoalveolar lavage fluid after the administration of a 40 mg/kg injection of phorbol myristate acetate . The compound also inhibited the growth of human lung cancer cell lines in SCID mice . Sivelestat inhibits gastric lesion formation in rats subjected to water immersion restraint stress. Low oral bioavailability in vivo is due to extensive hepatic first-pass metabolism. Endotoxin-induced lung injury in rabbits was attenuated by pretreatment with sivelestat . In 1996, analysts at Yamaichi estimated sivelestat would be launched in Japan between 1998/9 and peak annual sales would be less than 5 billion yen . PMID:16107941
From the pharmacopoeial standpoint, gels, together with ointments, creams, pastes, cataplasmata, and medicated plasters, rank among the group of topical semisolid preparations applied to the skin. They are bicoherent systems composed of the internal phase made of a polymer producing a coherent three-dimensional net-like structure, which fixes the liquid vehicle as the external phase. Intermolecular forces bind the molecules of the solvent to a polymeric net, thus decreasing the mobility of these molecules and producing a structured system with increased viscosity. The physical and chemical bonds binding the particles of the internal phase provide a relatively stable structure, which can originate by swelling of solid polymers, or by decreasing the solubility of the polymer in a solution. An important group of gels used in pharmacy are hydrophylic gels, or hydrogels, usually made of hydrophyilc polymers, which under certain conditions and polymer concentration, jellify. Attention of pharmaceutical research now concentrates primarily on hydrophilic gels, as this dosage form seems to be prospective for the development of modern drugs based on systems with prolonged and controlled release of active ingredients. PMID:15895965
Radio frequency identification (RFId) technology promises to offer both a more efficient and accurate tracking and tracing of goods, as well as a reduction in thefts and counterfeiting in the pharmaceutical supply chain. Attracted by this opportunity, numerous companies that are carrying out pilot projects in this supply chain are focusing on item-level applications. Unfortunately, these applications remain somewhat futuristic
Giovanni Miragliotta; Alessandro Perego; Angela Tumino
Multinational companies in the life science sector are heavily influenced by government policies and regulations and in turn attempt to influence these actors nationally and internationally. This paper focuses on recent and on-going research, principally on the agro-biotechnology and, to a lesser extent, on the pharmaceutical industries, covering the evolution of policy and regulation in Europe, how policies are influenced
To measure the use of alternatives to in vivo mammalian toxicity studies dur- ing drug research and development, the Japan Pharmaceutical Manufacturers Association (JPMA) distributed a questionnaire to its 99 member companies, of which 85 responded and 50 (59%) of them had some experiences in using alter- natives to in vivo mammalian toxicity studies. The results show alternative methods have
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 pharmaceuticalcompanies for hormone therapies (HT). To unravel this question, a qualitative content analysis of web sites for FDA-approved hormone therapies
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 pharmaceuticalcompanies for hormone therapies (HT). To unravel this question, a qualitative content analysis of web sites for FDA-approved hormone therapies
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
Innovations in chemistry and biology have generated multiple products and built significant revenue streams in the pharmaceutical industry. However, the complex and multi-disciplinary process of drug discovery and drug development makes it difficult to identify specific core competencies within a company. There is a need to better identify and manage sources of innovation that lead to new markets as ever-increasing
Indian pharmaceutical sector is currently witnessing faster introduction of new drugs, with shorter life cycles, given the intense competition. Often, pharma companies fail to strategically align their sales force with brands to gain the competitive edge. Personal selling literature too is silent on this front. This study for the first time, suggests a new conceptual framework to align sales career
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 pharmaceuticalcompanies 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
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 pharmaceuticalcompanies for hormone therapies (HT). To unravel this question, a qualitative…
|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 pharmaceuticalcompanies for hormone therapies (HT). To unravel this question, a qualitative…
|This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment…
Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of 'acquiescent' and 'investigative' norms of regulatory trust, I demonstrate how investigative norms of regulatory trust-which deter pharmaceuticalcompanies from assuming that their data analyses will be accepted without independent de-construction-drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy. PMID:18649014
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.
Since 2011, Germany's Pharmaceutical Market Restructuring Act has mandated that all newly introduced drugs are subject to an assessment of their benefits in relation to a comparator, typically the current standard treatment. For drugs found to have some additional benefit, the manufacturer and the statutory health insurers negotiate a price. For drugs found to have no additional benefit, their price is set in reference to the price of the comparator. This new system is intended to reduce spending on expensive new drugs that are no more effective than existing treatments, while encouraging pharmaceuticalcompanies to invest in innovative drugs that improve health outcomes. The German experience provides lessons for the United States, where comparative effectiveness research is publicly funded but public insurance programs are limited in their ability to use its findings to make coverage or pricing decisions. PMID:24171232
The huge amount of information, the big number of scientists and their efforts, labs, man/hrs, fund, companies all and others factors build the success of the amazing new branch of genetic engineering the 'protein engineering' (PE). It concerns with the modification of protein structure/function(s) or building protein from scratch. The engineered proteins usually have new criteria(s). Engineering proteins can be mediated on the level of genes or proteins. PE fined its way in different important sectors including industrial, pharmaceutical and medicinal ones. Aspects about PE and its applications will be discussed with this review. The concept, tools, and the industrial applications of the protein, engineered proteins and PE will be under focus. In order to get up to date knowledge about the applications of PE in basic protein and molecular biology, several examples are discussed. PE can play a significant role in different industrial and pharmaceutical sectors if used wisely and selectively. PMID:23261751
The news from South Africa yesterday was both good and bad for AIDS activists. Lawyers for a group of over 39 major pharmaceuticalcompanies 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.
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 pharmaceuticalcompanies 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.
...false Condition of participation: Pharmaceutical services. 482.25 Section 482...25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the...
...false Condition of participation: Pharmaceutical services. 482.25 Section 482...25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the...
The US Department of Energy's (DOE) Office of Industrial Technologies (OIT) sponsors research and development (R D) to improve the energy efficiency of American industry and to provide for fuel flexibility. The pharmaceutical industry generates considerable amounts of wastewater that require extensive treatment before they are released. A common method of disposal is aerobic biological treatment, but this method is energy intensive and expensive. An alternative process--anaerobic digestion--costs less, saves energy, generates less sludge requiring disposal, and produces a usable fuel--methane. OIT and HydroQual, Inc., with Merck Co. recently completed a joint project that demonstrated the anaerobic biological treatment of wastewaters generated by the pharmaceutical industry. The objectives of the project were to demonstrate how the anaerobic biological process and the resulting energy savings can apply to the pharmaceutical industry and how effective and beneficial the process is to sludge management operations at pharmaceutical plants. This technical case study provides an overview of the DOE-HydroQual-Merck R D project and highlights the field tests done on pilot-scale anaerobic wastewater treatment units at a pharmaceutical plant. This document makes field test and data analysis results available to other researchers and private industry. It discusses project status; summarizes field-test efforts; and reviews potential technology impacts in terms of commercial applications, benefits, and full-scale system economics. 5 figs., 1 tab.
Risk communication is central to the risk management strategy of a pharmaceuticalcompany. Pharmaceuticalcompanies 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 pharmaceuticalcompany 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
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.
On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act, which is the government's most comprehensive legislation regarding pediatric research to date. The Act offers pharmaceuticalcompanies a six-month exclusivity term in return for their agreement to conduct pediatric tests on drugs. It also provides public funding and organizes private funding to help conduct pediatric research on those drugs that pharmaceuticalcompanies opt not to test in children. This Note reviews the history of pediatric research and traces the development of the Best Pharmaceuticals for Children Act's unique incentive and public funding structure. The Note contends that, while the Act is comprehensive and promotes important pediatric studies, its incentive structure forces consumers and taxpayers to bear the costs of testing pharmaceuticals in children instead of the manufacturers who research, develop, and market those drugs. Congress should consider mandating pediatric studies in any future enactment of the legislation. PMID:16594116
The solid-state characteristics play an important role during the development and manufacture of medicinal products, because they may influence the effectiveness, stability as well as the processibility of pharmaceutical systems. The amorphous state is critical in determining the solid-state physical and chemical properties of many pharmaceutical dosage forms. The main reason of the growing interest toward amorphous materials is the need to improve the bioavailability of compounds with poor aqueous solubility. However the disordered structure of higher energy state assures increased solubility and faster dissolution rate, the amorphous state is a non-equilibrium state. Materials often go through spontaneous transformations towards lower energy equilibrium states. PMID:18986089
All aspects of life took place on company land. Every mine had its own town, laid one after another along the tracks that brought people and supplies in and out. Coal camps, were densely populated semi-urban areas, with a company store, pool halls, and rows of cookie-cutter houses. But the populations of the coalfields were always changing. A constant flow
According to the logics of the efficient capital investment, the management of the investment of the saving capital in the company’s assets must conclude, on the end of the financial year, with a plus of real value (NPV > 0). From this point of view, in this paper we suggest the usage of an investment valuation model for the assessment
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...
A UNIDO publication on the use of plastics in pharmaceutical industry is presented and covers: (1) packaging of pharmaceuticals with particular reference to plastics; plastic packaging materials for other consumer goods; (2) the production of containers f...
This guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present ...
... key findings of a new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) that focuses ... 2013, PhRMA joined with the European Federation of Pharmaceutical Industries and Associations (EFPIA) in adopting joint Principles ...
Text Version... Page 14. Certificate of a Pharmaceutical Product* (CPP) Application ... The CPP also contains information about the pharmaceutical regulatory or ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
|There is a growing emphasis in adult basic education on research-based reading instruction. Using Kruidenier's (2002) framework of principles and trends, we describe research-based techniques found during a visit to an adult basic education program. We also describe how the program moved to research-based instruction, and the factors that seem…
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
The limited availability of published physical and dielectric property data for pharmaceutical powders hinders the design of processing systems, particularly dryers. In this study, the physical properties (solubility and boiling point) and dielectric properties, in terms of temperature rise, dielectric constant, and dielectric loss factor, of selected pharmaceutical powders were measured. The pharmaceutical actives, paracetamol and aspirin, and selected common
ObjectiveThe role of a clinical pharmacist is often seen simply as the supplier of prescribed medicines and their clinical and pharmaceutical knowledge is seldom recognised. Prescribing errors are common1 and feedback of errors improves both patient safety and future prescribing and raises standards in patient care. This study sets out to record clinical interventions made by pharmacists on the neonatal
In this report the state of the art with respect to PVC as pharmaceutical packaging material is described. A general introduction into the applications of PVC is followed by a description of its production process. The metabolic effects of the monomer of PVC, vinyl chloride and of the most commonly used plasticizer diethylhexylphthalate are mentioned. Special attention is given to
Mechanical activation has become a phenomenon of general significance in pharmaceutics. This report describes the extent of activation induced by relevant processes. With the use of the Eyring equation the transformation of structurally stored energy into chemical energy and the implied free enthalpy as well as the excess free enthalpy (activity) were evaluated from the rate of an indicator reaction.
This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes. PMID:10234068
A study of physicochemical and biological treatment of pharmaceutical wastewater by the activated sludge process was performed in an oxidation ditch. The physicochemical study using different coagulants revealed that all the coagulants used are not effective and their doses required were very high for COD reduction. In the biological oxidation study, it was found that the wastewater could be processed
Noting the increasing public attention on healthcare, Korean society has shown greater attention to the significance of the health technology (HT) development. In order to promote HT competitiveness, the role of research-based hospitals (RBHs), in producing new ideas as well as utilizing final outcomes, has grown increasingly significant. Despite high quality healthcare professionals, state-of-the-art equipment, and well-developed information technology, few hospitals in Korea are successful leaders in HT development. In order to understand HT research and development (R&D) programs in Korea as well as hospital-based R&D investment performance, this paper has analyzed a recent three-year R&D investment of the Korean government. In addition, a survey on how to promote RBHs in Korea has been proceeded through adopting the Delphi method. Several model cases of RBHs abroad have also been studied to understand key success factors in formulating a development model of RBHs in Korea. This paper proposes suggestions for the promotion of RBHs in Korea: systematic reform related to the hospitals, reinforcement of the infrastructure of the hospitals, empowering human resources and policy framework to support the hospitals.
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 PharmaceuticalCompanies, Medical Associations and Hospitals throughout the world.
Today many companies build online communities in order to retain existing customers by identifying their needs and beliefs as well as to attract potential clients. Company online communities also enable conversations between visitors and dialogue between visitors and representatives of companies. Exploring why visitors visit companies' online communities is very important for companies to be able to optimize the benefits
Over the past 20 years, an estimated $1 billion has been spent in research and development of stroke therapeutics; however, this huge investment has failed to produce a clinically efficacious drug with the exception of the thrombolytic agent Activase (tPA). This sobering reality has been the subject of numerous reflections by renowned leaders in stroke research with special focus on the most recent failed clinical trials. The validity of the neuroprotection strategy has been questioned and efforts to substantially modify the quality of stroke research have been examined. The consistent failures of the pharmaceutical industry to develop a neuroprotective drug for ischemic stroke have had a major impact on the assessment of stroke as an attractive therapeutic area for drug discovery. Many pharmaceuticalcompanies have scaled down their stroke programs, reflecting skepticism about the prospect of contemporary stroke drug discovery strategy based on neuroprotective agents. In this article, we present a Translational Medicine perspective on critical issues that the pharmaceutical industry and the academic community encounter but often ignore during stroke therapeutic development. This Translational Medicine framework offers a systematic analysis of the possible deficiencies that likely underwrote the colossal failure of clinical trials with neuroprotective drugs. In addition, we offer a biomarker-based system that aims at providing "proof of concept" along the discovery and development pipeline, which if implemented along early preclinical and clinical development phases, might significantly reduce risks and enable success. PMID:19064772
Fosamprenavir, a Vertex Pharmaceuticals phosphate ester prodrug of the HIV protease inhibitor amprenavir, is under development by GlaxoSmithKline (GSK; formerly Glaxo Wellcome) for the potential treatment of HIV infection in adults and children. By November 2000, it was in phase III trials; a third phase III trial was initiated in April 2001. In October 2001, GSK expected filing in both the EU and US in 2002. In January 2002, Vertex anticipated an NDA filing during the second half of 2002. Fast-track status for fosamprenavir was received by Glaxo Wellcome in December 1999. As of January 2002, enrollment was complete for two of the three phase III trials, and an NDA was expected to be filed during 2002. Fosamprenavir was first synthesized at Vertex as part of a collaboration with Glaxo Wellcome and by 1999, it was being developed by Glaxo Wellcome as part of an ongoing agreement between the two companies. In September 2000 and January 2001, Merrill Lynch predicted a 2002 launch, with sales of pounds sterling 50 million in 2002, rising to pounds sterling 150 million in 2004. PMID:12054084
The influence of direct-to-consumer advertising and physician promotions are examined in this study. We further examine some of the ethical issues which may arise when physicians accept promotional products from pharmaceuticalcompanies. The data revealed that direct-to-consumer advertising is likely to increase the request rates of both the drug category and the drug brand choices, as well as the likelihood
This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical-company-sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates three significant ways that institutional corruption can occur in the research process. First, conflicts of norms between pharmaceuticalcompanies, universities, and affiliated teaching hospitals can result in compromises and self-censorship. Second, normal behavior is shaped through routine interactions. Unethical behaviors can be (or can become) normal behaviors when they are produced and reproduced through a network of social interactions. Third, funding arrangements can create networks of dependency that structurally distort the independence of the academic researcher in favor of the funder's interests. More broadly, the case study demonstrates how the social organization approach deepens our understanding of the practice of ethics. PMID:24088153
Pharmaceutical production and distribution constitute big business. For the companies the rewards can be substantial. Rates of return on drug company investments tend to be higher than many other manufacturing enterprises. But reward is only one side of the story. There is also the issue of social risk, the focus of this article. Social risk for pharmaceutical production is especially pronounced. An ineffective or, worse, dangerous drug, can have dire consequences for the population at large. For this reason, there is elaborate government regulation and oversight of drug safety and risk. These systems, especially in the US and Europe, will be the main focus of this paper. The two systems will be described, and then compared and contrasted in terms of their framing of social risk and actions governments take to limit it. Systems elsewhere, especially in the developing world, are increasing in relative importance and these will be briefly discussed as well. Ethical issues that have arisen in these various systems will be surfaced and analysed. The paper will close with some conclusions and suggestions for further research. PMID:21406340
Pharmaceuticalcompanies 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
Volatile pollutants such as hydrocarbons have, during many years, been analysed in small concentrations in air, water, food, pharmaceutical solutions, and human blood and tissues. It has also been shown that such substances have unexpected consequences for cell cultures and scientific experiments. These substances also accumulate in patients receiving haemodialysis and these patients are exposed to quite high concentrations. The knowledge of the toxicity of such compounds has led to the development of maximum limit concentrations with the aim to decrease the exposure of humans. This paper discusses the problems of human exposure in general and especially through pharmaceutical solutions, and the possibilities of eliminating such compounds with the aim of decreasing the exposure as a hygienic challenge.
Kroneld, R. (Department of Medicine, University of Turku (Finland))
Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures. PMID:10309721
The presence of drugs in the environment, principally in water, can be detected analytically. Although concentrations detected are very low, their presence raises the issue of the impact on the natural medium and human health. In the first part of this review, we attempt to answer some of the most frequently asked questions: why are drugs found in the environment? where do they come from? is there a health hazard? In the second part, we describe measures taken by the pharmaceutical industry to protect the environment. Action is taken to control waste from production sites but also to coordinate the efforts of the pharmaceutical profession via CYCLAMED. Collection and reuse of unused drugs is also discussed. PMID:14639188
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
In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like "pakwa jambu phala varna," varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta. PMID:22131745
In rural communities, cable companies owned by telephone companies supply basic service at a lower price than comparable cable companies not owned by telephone companies. The lower price (approximately $1.20 per month) appears to be due to lower costs and economies of scope rather than to any anti-competitive actions or cross subsidies. In addition, the monthly price of basic service
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 pharmaceuticalcompanies 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. PMID:15979678
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 pharmaceuticalcompanies 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 pharmaceuticalcompanies. PMID:17710597
Purpose – The purpose of this study is to use an approach that helps the pharma industry develop and structure communications that provide buyers and sellers with a better procedure to drive decisions to buy\\/sell stocks. Messages related to pharmaceuticalcompanies and their products were collected from many sources. Design\\/methodology\\/approach – An experimental design was employed to evaluate communication concepts
Howard Moskowitz; Samuel Rabino; Alex Gofman; Daniel Moskowitz
Rapid advancement of genomics, genetic and bioinformatic technologies have paved the way for an explosion of opportunities in pharmacogenomics, which is reflected by the growing number of biomarkers in the 'personalized medicine cabinet'. AKESOgen, Inc. (GA, USA) has been established to meet and champion these needs. AKESOgen, Inc. is a biomarker, genomics and pharmacogenomics contract research organization that services the academic, pharmaceutical, biotechnology and agricultural sectors. AKESOgen, Inc. performs biomarker profiling and genomics services utilizing different types of markers (e.g., DNA, RNA and methylation) for the research and development market. AKESOgen, Inc. establishes and validates biomarkers in the clinical trials arena and provides expertise in biobanking. PMID:22909201
Over the past two years, the US pharmaceutical and biotechnology industries were preparing themselves for passage of some type of health-reform legislation with a clear appreciation—and concern—about the enormous impact any law would be likely to have on the structure and viability of the research-based industry. Now, with final passage in March 2010 of the Patient Protection and Affordable Care
The management imperatives for pharmaceutical care concern themselves with complexity, while leadership imperatives are concerned with effecting change. Both "species" of action are needed to support the paradigm shift associated with pharmaceutical care. Pharmacy managers must be the architects and engineers of the new dimensions of complexity associated with pharmaceutical care while also serving as zealots of change for pharmaceutical care within their departments and hospitals. In the final analysis, departments of pharmacy do not practice pharmaceutical care. They are, however, the borne fruit of pharmacy managers and leaders who provide for an appropriate environment inclusive of resources and systems necessary for individual pharmacists to make the commitment to making pharmaceutical care a reality. PMID:10128744
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
Taxol, a unique diterpene anticancer compound derived from the bark of the Taxus brevifolia (Pacific yew) tree, induces cytotoxicity by a novel mechanism of action. An antimicrotubule agent, Taxol promotes the formation and stabilization of the tubulin polymer unlike other anticancer agents that induce microtubule disassembly. Because of its poor aqueous solubility, Taxol is formulated as a solution in 50% Cremophor EL and 50% dehydrated alcohol, USP. The Cremophor EL and dehydrated alcohol vehicle used in the formulation of Taxol creates some interesting challenges for its preparation and administration. The pharmaceutical concerns associated with the preparation and administration of Taxol are discussed. PMID:7912520
Adams, J D; Flora, K P; Goldspiel, B R; Wilson, J W; Arbuck, S G; Finley, R
The qualitative and quantitative capabilities of ion mobility spectrometry (IMS) as a comprehensive and powerful tool in workplace air monitoring have been demonstrated on the example of a Spanish pharmaceuticalcompany. The developed IMS based procedure is capable of detecting and determining in air samples the active pharmaceutical ingredients (APIs) manipulated and/or produced in this pharmaceutical industry. Sensitivity, in the ng-pg range, selectivity, possibly to provide results in near real time, and reduction of analysis costs are the most important properties that ratify IMS as a serious alternative in occupational exposure assessment. The possibility of false positives by drift time interferences and false negatives by competitive ionization and also desorption process interferences has been deeply evaluated. Moreover, chemometric strategies based on self-modeling curve resolution (SMCR) have been applied to obtain qualitative and quantitative individual component information from overlapped peaks. The IMS procedure has been successfully applied to evaluate the concentration of APIs (nimesulide, dexketoprofen, deflazacort) handled by the pharmaceuticalcompany employees in the making of tablets and granulates, and control measures have been suggested in accordance. PMID:22500648
To date there are no German or international standards for the analysis of pharmaceuticals in waters. The efficiency of the analytical methods—predominantly LC-MS\\/MS and GC-MS—used for trace analysis of pharmaceuticals is proved for the first time by proficiency tests using natural waters.Two proficiency tests for up to 11 different groups of pharmaceuticals in river water and waste water were carried
The current state and outlooks of the development of the flow-injection analysis of medicinal substances in pharmaceuticals and biological fluids are considered. The role of chemical, photochemical and enzymatic reactions of derivatization in the flow-injection determination of pharmaceuticals is outlined. The role of detection methods in improving the selectivity and sensitivity of the flow-injection analysis of pharmaceuticals and expanding its
... Among topics to be addressed: pharmaceutical development, chemistry, manufacturing and controls (CMC), manufacturing and quality operations ... More results from www.fda.gov/drugs/developmentapprovalprocess/manufacturing
... Suitability Petitions. -. Office of Generic Drugs - Generic Pharmaceutical Association (GPhA) Board of Directors Quarterly Meetings. -. ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved
... for Pharmaceutical Science and Clinical Pharmacology scheduled for October 30, 2013 is cancelled due the government shutdown because FDA's ... More results from www.fda.gov/advisorycommittees/calendar
This paper analyses a large, longitudinal database on inter-firm R&D partnerships formed in the high-tech pharmaceutical biotechnology industry since 1975. Our research indicates an overall growth in the number of annually, newly established R&D partnerships where research partners consistently prefer contractual partnerships to equity-based alliances. In the networks that develop through these R&D partnerships, small, entrepreneurial biotechnological companies take a
On May 10, 2007, three executives of the pharmaceuticalcompany Purdue Pharma pled guilty in federal court to misleading doctors\\u000a and patients about the risk of addiction and potential for abuse of OxyContin. Additionally, Purdue Pharma paid over $600\\u000a million in fines and other payments to the United States government and the Commonwealth of Virginia. The drug OxyContin was\\u000a first
This article presents experience from the practice of a successful pharmaceuticalcompany 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
|This book is intended as an introduction to the television program, "The Electric Company," designed to help teach reading to children in grades 2-4 who are experiencing difficulty. Contents include: Sidney P. Marland, Jr.'s preface, "A Significant New Teaching Tool"; Joan Ganz Cooney's "Television and the Teaching of Reading"; and Barbara…
Pharmaceuticals enter aquatic environments in unchanged form or as metabolites. Little is known about their potential hormonal activity, which is of particular interest due to potential long-term effects on fertility and reproduction in aquatic organisms. Moreover, there is a need to assess the combined activity of pharmaceutical mixtures. In this study, 37 pharmaceuticals have been analysed in vitro for estrogenic
This study examines what is generally regarded to be the most important measure of innovation in the pharmaceutical industry—the extent to which new drugs are developed and marketed by pharmaceutical firms. Pharmaceutical industry output, as measured by new chemical entity (NCE) approvals in the United States since the 1962 Amendments to the Federal Food, Drug, and Cosmetic Act of 1938,
|Those disciplines in the pharmaceutical sciences where critical manpower shortages now exist or will occur are identified by 34 pharmaceutical manufacturers in response to a request by the American Foundation for Pharmaceutical Education, which awarded fellowships in four critical areas. High priority needs are appended. (JMD)|
We describe two optical methods for in vitro drug trials on living cells and cell cultures. Response of each single target cell to drug impact is measured as the change of cell functional and structural state by photothermal imaging and the changes of cell viability is controlled with Laser Viability Test. Both photothermal methods are sensitive to specific cell reaction but although to reaction of general origin. High sensitivity of the methods allows to use minor amounts of drug and cell materials. Pharmaceutical applications are illustrated with the results of in vitro experiments being obtained for human living blood cells.
What can explain the longevity gap between a company that survives for centuries--the Swedish company Stora, for example, which is more than 700 years old--and the average corporation, which does not last 20 years? A team at Royal Dutch/Shell Group explored that question. Arie de Geus, a retired Shell executive, writes about the team's findings and describes what he calls living companies-organizations that have beaten the high mortality rate of the average corporation. Many companies die young, de Geus argues, because their policies and practices are based too heavily on the thinking and language of economics. Their managers focus on producing goods and services and forget that the organization is a community of human beings that is in business--any business--to stay alive. In contrast, managers of living companies consider themselves to be stewards of a long-standing enterprise. Their priorities reflect their commitment to the organization's long-term survival in an unpredictable world. Like careful gardeners, they encourage growth and renewal without endangering the plant they are tending. They value profits the same way most people value oxygen: as necessary for life but not the purpose of it. They scuttle assets when necessary to make a dramatic change in the business portfolio. And they constantly search for new ideas. These managers also focus on developing people. They create opportunities for employees to learn from one another. Such organizations are suited for survival in a world in which success depends on the ability to learn, to adapt, and to evolve. PMID:10165449
Founded in 2009 and headquartered in Glasgow, Scotland, UK, Sistemic Ltd has developed from a thought in the minds of four scientists into a company working globally to play its part in delivering the exciting opportunities for improvements in human health presented by cell therapies and regenerative medicine products (jointly referred to as the CT industry). Sistemic is now working in all corners of the world with some of the industry's leading companies to ensure that the products that they are developing, which will undoubtedly change the way we treat some of the major diseases and conditions currently placing a large burden on healthcare systems, including diabetes, dementia and cardiovascular disease, are as safe and efficacious as possible. Sistemic is also working to ensure that these products can be produced at a cost that will not lead to potentially transformational treatments being an additional financial burden on our already overburdened healthcare systems. Sistemic is using its revolutionary and IP-protected SistemQC™ (UK) technology to enhance understanding of characterization, process optimization and potency of CT products. The company is using the diagnostic power of miRNAs, a set of approximately 2000 ncRNAs that regulate a large percentage of the total gene expression of a cell. miRNAs are often present in a cell- and tissue-specific way that, at least in some cases, accounts for the phenotypic differences between cell types. These differences in miRNA expression can be interpreted by the miRNA profile and it is interpreting the instructive power of these profiles that underpin Sistemic's knowledge bases, giving CT companies a more comprehensive understanding of their cell populations with respect to their identity and functional capabilities. This knowledge is being used by companies to characterize, process, optimize and assess the efficacy of cell products. PMID:23998750
A research-based framework for teaching science is a heuristic tool used to help preservice teachers conceptualize many complexities of teaching while making explicit the strategy to use a research-based body of professional knowledge to inform instructional decision-making (Clough, 2003, Paper presented at the annual meeting of the Association…
|Purpose: This paper seeks to present a theoretical framework with the aim of contributing to improved understanding of how reflection can provide a mechanism to integrate research-based knowledge with the pre-existing practice-based knowledge. Design/methodology/approach: The paper begins with an explanation of important concepts: research-based…
Increasing the accurate use of research-based practices in classrooms is a critical issue. Professional development is one of the most practical ways to provide practicing teachers with training related to research-based practices. This study examined the effects of in-service plus follow-up coaching on first grade teachers' accurate delivery of…
Kretlow, Allison G.; Cooke, Nancy L.; Wood, Charles L.
This article offers a rationale for research-based professionalism, especially in the contexts of schooling and teacher education. It also explores some of the problematic contextual issues facing those wanting to develop research-based professionalism – work overload, stress, excessive accountability, lack of adequate funding. Despite these problems, the article argues, the cultivation and pursuit of professional curiosity are essential if teachers
|This study proposes a research-based teacher selection protocol. The protocol is intended to offer school district hiring authorities a tool to identify teacher candidates with the behaviors expected to predict effective teaching. It is hypothesized that a particular series of research-based interview questions focusing on teaching behaviors in…
Research supports using research-based comprehension strategies; however, comprehension strategy instruction is not highly visible in basal reading programs or classroom instruction, resulting in many students who struggle with comprehension. A content analysis examined which research-based comprehension strategies were presented in five elementary school basal readers and how the basals suggest that the strategies be taught. The analysis found that two
...Drug Enforcement Administration Roots Pharmaceuticals, Inc.; Revocation of Registration...issued an Order to Show Cause to Roots Pharmaceuticals, Inc. (Registrant), of American...Registration BR9610571, issued to Roots Pharmaceuticals, Inc., be, and it hereby...
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
The chemistry tests to verify of the quality of bulk Pharmaceutical Waters underwent substantial changes with the implementation of USP 23 in 1996. These qualitative tests were replaced with modern, quantitative, instrument-based tests such as conductivity and total organic carbon (TOC). The acceptance of these changes was not without its problems, but the resulting changes have improved Pharmaceutical Water quality
The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding
Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals. PMID:10945918
The presence of human pharmaceutical compounds in surface waters is an emerging issue in environmental science. In this study the occurrence and behavior of human pharmaceuticals in a variety of wastewater treatment processes is reviewed. Although some groups are not affected by sewage treatment processes others are amenable to degradation, albeit incomplete. While water purification techniques such as granular activated
The modern pharmaceutical development facility is vastly different from previous designs. In this review, the authors describe the trends and types of facility currently used in the development of pharmaceutical products, and discuss some of the trends that will shape those facilities of the future. PMID:10498921
|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…
The scope of this study was directed to examine different wastewater treatment technologies (activated sludge, trickling filter, nanofiltration, reverse osmosis) at full-scale facilities in Arizona and California leading to indirect potable reuse and their capability to remove pharmaceuticals. Additionally, the fate of selected pharmaceuticals was studied during soil-aquifer treatment (SAT) at sites where secondary and tertiary treated effluents are used
During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose of the conference was to promote the 'Integration of Systems Approaches into Pharmaceutical Sciences' in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA, the meeting was attended by 75 industrial and some 45 academic participants. PMID:18602464
Westerhoff, Hans V; Mosekilde, Erik; Noe, Christian R; Clemensen, Anne Marie
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 pharmaceuticalcompanies have been employing these technologies in order to detain illegitimate drugs in their supply chain. PMID:23641326
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 pharmaceuticalcompanies have been employing these technologies in order to detain illegitimate drugs in their supply chain.
Pharmaceuticalcompanies 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.
Pharmaceuticalcompanies 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
|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 researchbased 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
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 researchbased 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
Background There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceuticalcompanies 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 pharmaceuticalcompanies 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.
The Software Engineering (SE) industry is experiencing the effects of strong globalization. The world is changing rapidly in many areas including financial, technological, economic, and political, but the structures of SE companies are also changing. This means that companies are becoming closer to each other, and geographical distance and national borders are losing their meaning. Because of this globalization, companies
Purpose – The purpose of this study is to investigate the degree of knowledge of competitive intelligence in Tunisian companies. Design\\/methodology\\/approach – This exploratory study was conducted using semi-in-depth interviews and focus group with six executives in six companies in Tunisia. Three sectors were chosen for this study: communication technologies, manufacturing and commercial retailing. These companies are prevalent in Tunisia
Marketing costs exceed 30% of revenues for the pharmaceutical industry, with over 90% of the effort aimed at physicians. Although there are currently unprecedented numbers of regulatory activities focusing on relationships between the pharmaceutical industry and the medical profession, such legislation is often unrecognized or flouted. The potential influence, although minimized by both parties, must not be ignored. Physicians and drug companies will need to re-evaluate their responsibilities to their patients and their shareholders, and both groups should assume proactive and guidance roles in the transformation. PMID:17481979
McFadden, David W; Calvario, Elizabeth; Graves, Cynthia
Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally <1 microg/L. Four pharmaceuticals (methadone, oxycodone, butalbital, and metaxalone) in samples of NY3 effluent had median concentrations ranging from 3.4 to >400 microg/L. Maximum concentrations of oxycodone (1700 microg/L) and metaxalone (3800 microg/L) in samples from NY3 effluent exceeded 1000 microg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 microg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847
Phillips, Patrick J; Smith, Steven G; Kolpin, D W; Zaugg, Steven D; Buxton, Herbert T; Furlong, Edward T; Esposito, Kathleen; Stinson, Beverley
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.
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.
Text Version... 6 Page 7. Pharmaceutical Quality Systems “A Common Thread to Tech Transfer” ... Knowledge Management Quality Risk Management PQS elements ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
Text Version... mistake has never tried anything new.” -ALBERT EINSTEIN P11: Continual Improvement of the Pharmaceutical Quality System By Erin McCaffery ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development.
Enick, O.V. [Department of Biological Sciences, Simon Fraser University, Burnaby, BC, V5A 1S6 (Canada)], E-mail: email@example.com; Moore, M.M. [Department of Biological Sciences, Simon Fraser University, Burnaby, BC, V5A 1S6 (Canada)], E-mail: firstname.lastname@example.org
The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...
... to another); (2) receive presentations from the Office of Pharmaceutical Science (OPS) on the scientific and regulatory challenges of Transdermal ... More results from www.fda.gov/advisorycommittees/calendar
Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared ...
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, pro...
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, Samuel
Contents: Issues and considerations--(Note by the secretariat of UNIDO and report of the working group); Selected background papers--(Choice and adaptation of appropriate technology for the production of pharmaceuticals in developing countries, provision ...
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
Text Version... Process Improvement ... P9: Pharmaceutical Quality System Elements: Continual Improvement of the Process (CAPA) By Juan Andres Page 2. ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess
The major purpose of this article is to emphasize the need for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Economic incentives for drug discovery and development clash with societal needs for low-cost pharmaceuticals in the United States and all over the world. The Hatch-Waxman Act of 1984 was enacted to promote public health by balancing the interests of brand name and generic companies. Patent protection, which provides a monopoly for a limited time, is aimed to provide such incentives. Creation of patents requires the interaction between scientists and lawyers, an endeavor made difficult by the differing intellectual spheres of their respective disciplines. Therefore, in the first place, a thorough understanding of patent fundamentals among pharmaceutical scientists will help them work more efficiently with patent attorneys. Second, it will enable them to appreciate the strengths and weaknesses of individual patents, which is critical in developing strategies amidst the ongoing patent tug-of-war between brand-name and generic companies. PMID:16353948
\\u000a The pharmaceutical industry has passed a consolidation phase, which is delayed in comparison to other industries, but it follows\\u000a the same mechanics. Whereas the primary consolidation most often can be seen in the form of elevated M&A transactions, the\\u000a far-reaching secondary transformation also affects the value chain and the business model of the (pharmaceutical) industry\\u000a itself. Like in other industries,
Interventional radiologists employ a wide variety of drugs on a daily basis to improve patient experiences and outcomes during interventional procedures. The expectation is for the interventionalist to be well-versed in all pharmaceuticals used in the interventional suite. In this article, the authors review the following classes of common miscellaneous pharmaceutical agents used in interventional radiology: vasodilators, vasoconstrictors, antiemetics, bowel antiperistalsis agents, and prothrombotics.
Oppenheimer, Jason; Ray, Charles E.; Kondo, Kimi L.
Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales\\u000a and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the\\u000a time-to-peak-sales of pharmaceutical brands. We develop a growth model that includes these two variables as well as control\\u000a variables for
Marc Fischer; Peter S. H. Leeflang; Peter C. Verhoef
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
The aim of the present study is to analyse the spatio-temporal dynamics underlying Spanish pharmaceutical expenditure increases. We suggest alternative ways to resolve the problem of identifying exogenous and endogenous spatial spillover in a seemingly unrelated regression framework, while parametric instability is captured using linear time trends in the coefficients. The results highlight the need of considering these dynamic aspects in the pharmaceutical expenditure analysis.
Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming's discovery of penicillin in a common mold, in 1928, and the subsequent development—prompted by World War II injuries—of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies
This paper provides a sketch of the emerging role of the pharmaceutical salesman, or 'detail man', in the growth years of the American post-World War II pharmaceutical industry. Using training manuals, trade literature, in-house company newsletters, memoirs, and a variety of other published sources, the paper follows the delicate tactics employed by salesmen and their managers in their attempts to recast drug salesmanship as a 'professional service' fulfilling vital functions within medical education. As they worked to legitimate their presence in the nation's hospitals and clinics, particular emphasis was given to precise management of the etiquette of doctor-salesman interaction. Ultimately, the techniques employed by mid-century salesmen and their managers were to prove successful in generating a widespread acceptance of the industry representative within the clinical spaces of hospital and clinic. Indeed, many of the practices of market research and market strategy employed across the pharmaceutical industry today have their origins in the practices of the individual detail man. Exploration of the postwar pharmaceutical salesman as an overlooked historical 'type' provides significant insights into the intersection of medicine and the consumer marketplace during the later 20th century. PMID:15298001
Aviir, Inc. is a venture-funded biotechnology company developing and commercializing laboratory tests to provide personalized information to physicians and patients, with the goal of preventing cardiovascular disease and metabolic syndromes. Leveraging advanced research, Aviir developed and launched MIRISK VP™, a risk assessment test to better identify individuals at risk of a heart attack. Aviir also offers an extensive menu of other cardiovascular and metabolic tests through its Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Efforts are likewise focused on expanding genomics testing capability to address sudden cardiac death attributed to inherited cardiovascular diseases. This completes their integrated precision diagnostics approach that combines biomarker immunoassays with genomic and transcription analysis, along with core clinical chemistry to deliver a comprehensive personal health solution. PMID:23394387
Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. PMID:12461710
Beauchamp, Tom L; Jennings, Bruce; Kinney, Eleanor D; Levine, Robert J
The bromination of five selected pharmaceuticals (metoprolol, naproxen, amoxicillin, phenacetin, and hydrochlorothiazide) was studied with these compounds individually dissolved in ultra-pure water. The apparent rate constants for the bromination reaction were determined as a function of the pH, obtaining the sequence amoxicillin>naproxen>hydrochlorothiazide?phenacetin?metoprolol. A kinetic mechanism specifying the dissociation reactions and the species formed for each compound according to its pK(a) value and the pH allowed the intrinsic rate constants to be determined for each elementary reaction. There was fairly good agreement between the experimental and calculated values of the apparent rate constants, confirming the goodness of the proposed reaction mechanism. In a second stage, the bromination of the selected pharmaceuticals simultaneously dissolved in three water matrices (a groundwater, a surface water from a public reservoir, and a secondary effluent from a WWTP) was investigated. The pharmaceutical elimination trend agreed with the previously determined rate constants. The influence of the main operating conditions (pH, initial bromine dose, and characteristics of the water matrix) on the degradation of the pharmaceuticals was established. An elimination concentration profile for each pharmaceutical in the water matrices was proposed based on the use of the previously evaluated apparent rate constants, and the theoretical results agreed satisfactorily with experiment. Finally, chlorination experiments performed in the presence of bromide showed that low bromide concentrations slightly accelerate the oxidation of the selected pharmaceuticals during chlorine disinfection. PMID:21906777
Benitez, F Javier; Acero, Juan L; Real, Francisco J; Roldan, Gloria; Casas, Francisco
...EL11-19-000] Southern California Edison Company, Pacific Gas and Electric Company...PURPA),\\1\\ Southern California Edison Company (SCE), Pacific Gas and Electric...Electric Company, Southern California Edison Company, and San Diego Gas &...
This paper analyses a large database on inter-firm R&D cooperation formed in the pharmaceutical biotechnology industry during the period 1985 - 1998. The results indicate that network size largely grows, whereas the density of the network declines during the periods. In the network analysis that emphasizes individual structural positions, the empirical results show that small biotechnological companies had a crucial
Developing countries are a fertile testing ground for the research and development of new drug products. Recently, Western pharmaceuticalcompanies expanded their overseas drug testing from India and Africa to the former Soviet Union, where doctors in need of reliable income conduct clinical trials on subjects seeking access to medical care. Although U.S. government agencies monitor clinical drug trials sponsored
The article series provides an account in words and pictures of the Danish pharmaceutical industry's products from the earliest times until about 1950. Part 1 deals with products from Nordisk Insulinlaboratorium, founded in 1923, and Novo Terapeutisk Laboratorium, founded in 1925. The two companies were competitors for many years and became two of the world's leading insulin producers. In 1989 they joined forces, merging to become Novo Nordisk A/S, today one of the world's leading biotech companies. The article chronicles the earliest decades of development and progress in insulin production, illustrated with photos of several types of consumer packaging. In 1923 Nordisk Insulinlaboratorium marketed Insulin "Leo" tablets, from which patients had to make their own sterile solution for injection two to three times a day, because the solution was unstable. Ready-to-use solutions gradually came on the market, and formulations with prolonged duration, so-called protamin-insulins, were developed in the 1930s. Insulin "Leo" Retard was marketed in 1936, and its basic properties were maintained and further developed in step with research breakthroughs well into the 1980s. Novo Terapeutisk Laboratorium's first insulin was Insulin Novo in 1925, and at the same time one of the company founders developed Novo-sprøjten (the Novo Syringe) for individual dosage from a special ampoule. The syringe was further developed over the years and was the prototype for the NovoPen launched in 1985 as well as for later advanced dosage systems. Starting in 1938 Novo Terapeutisk Laboratorium marketed Zink-Protamin-Insulin Novo and products based on other insulin derivatives in the 1940s. The era concludes with Insulin Novo Lente from 1952 as well as suspensions of amorphous and crystalline zinc-insulin. Ever since, insulin treatments for diabetes have been the focus of intensive development throughout the global marketplace and continue to be so. PMID:18548941
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 pharmaceuticalcompanies, 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
The company town is often an ephemeral phenomenon on the landscape. When the mine or factory closes, the town closes too, and its houses are removed or left to decay. A few company towns survive the removal of their economic base. Haydenville, in the Hocking Valley of southeast Ohio, has physically changed little since the boom days of the clay
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 pharmaceuticalcompanies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance. PMID:22694032
Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed. We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant. As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy. PMID:21233424
Rothman, Sheila M; Raveis, Victoria H; Friedman, Anne; Rothman, David J
Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed. We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant. As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy.
Raveis, Victoria H.; Friedman, Anne; Rothman, David J.
Pharmaceuticals are often excreted from patients as the parent compound or as active metabolites. Some of these compounds have been found in the environment. However, the environmental concentrations of the majority of pharmaceuticals and their metabolites are not known. The re...
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?
The Conference on Plant-Made Pharmaceuticals was an inaugural event organized by Molecular Farming Association Inc, a non-profit organization created in 2000 to support the emergence of plant-made biopharmaceuticals and plant-factory companies. The meeting was sponsored by the Government of Canada, the Gouvermement du Québec and the Société Générale de Financement, along with 20 companies involved in plant-made pharmaceuticals and related activities. Although there was very little discussion of new biopharmaceuticals under development with these systems, this was the first meeting where participants could survey the entire breadth of technologies and approaches that are being taken to produce biopharmaceuticals in transgenic plants. Participants also heard about the technical, manufacturing and regulatory issues confronting transgenic plant expression systems, as well as from 'new technology' companies that hav not previously presented in a public forum. There was a clear sense emerging from the meeting that the hurdles currently facing the industry will be overcome and that transgenic plant systems will eventually move into the mainstream of biopharmaceutical manufacturing technologies. PMID:12841207
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. Pharmaceuticalcompanies 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 pharmaceuticalcompanies. The potential reasons for this and some challenges and possible solutions are discussed. PMID:22819210
Ataman, Ozlem U; Sambrook, Sally J; Wilks, Chris; Lloyd, Andrew; Taylor, Amanda E; Wedge, Stephen R
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.
HMGB1, outside of a cell, is a trigger of inflammation and a stimulus for tissue reconstruction; the balance may depend on the complexes it forms with other molecules. HMGB1 is the prime example of a danger signal that originates from the damaged self rather than from invading pathogens. HMGB1 is released by cells that die traumatically and is secreted by cells destined to die and by activated cells of the innate immunity system. As a danger signal, HMGB1 is expected to trigger inflammation, but recent reports indicate that pure recombinant HMGB1 has no proinflammatory activity and only acts as a chemoattractant and a mitogen. However, HMGB1 forms highly inflammatory complexes with ssDNA, LPS, IL-1beta, and nucleosomes, which interact with TLR9, TLR4, IL-1R, and TLR2 receptors, respectively. Thus, HMGB1 has dual activities, solo or in company; I speculate that this may serve our body's necessity to sacrifice or reconstruct tissues as required by the presence or absence of pathogens. PMID:19414536
...Notice of Application; Johnson Matthey Pharmaceutical Materials, Inc. Pursuant to Sec. 1301...on November 15, 2012, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Service, 25 Patton Road, Devens,...
Managers usually associate ergonomics with occupational health and safety and related legislation, not with business performance. In many companies, these decision makers seem not to be positively motivated to apply ergonomics for reasons of improving health and safety. In order to strengthen the position of ergonomics and ergonomists in the business and management world, we discuss company strategies and business
|This book was designed to serve as a guide for the small and medium-sized firm establishing a systematic training pattern for the first time, and to the larger company for whom it will act as a useful check list. The guide examines the kind of information required and the ways in which actual companies have arrived at their training requirements…
Food, Drink and Tobacco Industry Training Board, Croydon (England).
|On July 30, 2002, President George W. Bush signed the Sarbanes-Oxley Act of 2002 into law. The legislation was crafted by the United States Congress to address issues related to accounting improprieties which came to light during the Enron scandal. The specific purpose of the legislation was "To protect investors by improving the accuracy and…
With an aging population and increased prevalence of chronic diseases, such as obesity and diabetes mellitus, drug reforms are needed across Europe to ensure the continued provision of comprehensive healthcare. It is also a challenge, with the limited resources available, to fund new innovative drugs that significantly improve patient health. Recent national and regional reforms in Sweden have moderated the
Bjorn Wettermark; Brian Godman; Karolina Andersson; Lars L. Gustafsson; Alan Haycox; Vittorio Bertele
Objective: Glaxo Wellcome becomes aware of prenatal exposures to its medications as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all Glaxo Wellcome medicines has been developed. For specific products there are prospective pregnancy registries. Study Design: The registries are observational, case-registration, and follow-up studies designed to detect evidence of teratogenicity associated
Robbin Reiff-Eldridge; Cindy R. Heffner; Sara A. Ephross; Patricia S. Tennis; Alice D. White; Elizabeth B. Andrews
The Japanese standards relating to the Care and Management of Laboratory Animals and Relief of Pain was revised on June 1, 2006, based on the amendment of the Japanese Law for Humane Treatment and Management of Animals, which added the \\
The aim of this paper is to assess whether cost containment has been affected by recent pharmaceutical reimbursement reforms that have been introduced in the Spanish health care system over the period 1996-2002, under the conservative Popular Party Government. Four main reimbursement policies can be observed in the Spanish pharmaceutical market after 1996, each of them largely unintegrated with the other three. First, a second supplementary negative list of excluded pharmaceutical products was introduced in 1998. Second, a reference pricing (RP) system was introduced in December 2000, with annual updating and enlargement. Third, the pharmacies' payment system has moved from the traditional set margin on the consumer price to a margin that varies according to the consumer price of the product, the generic status of the product, and the volume of sales by pharmacies. And fourth, general agreements between the government and the industry have been reached with cost containment objectives. In the final section of this paper, we present an overall assessment of the impact of these pharmaceutical reimbursement policies on the behaviour of the agents in the pharmaceutical market. PMID:14720633
'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines.
'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113
As one of its aspects, the process of European integration has an influence on the legal orders of the Member States, which is often referred to in the literature as the europeization of law. Upon Poland's accession to the structures of the European Union, there have also been radical changes to the Polish legal system. According to the concept of the sources of law in the Polish Constitution and to the judicial decisions of the European Court of Justice, Community law now takes priority over national law, even over acts of parliament. Pharmaceutical law represents one of the areas where the harmonization process has been taking place. It shapes the principles and the manner according to which medicinal products are approved for marketing, the conditions of clinical trials, as well as the conditions of drug manufacture and advertisement. It also determines the rules of trading in medicinal products, the running of pharmaceutical wholesalers and pharmacies, as well as the duties and rights of the Pharmaceutical Inspectorate. This paper provides a summary of research on the impact of Community law on Polish pharmaceutical law, i.e. on the europeization process, and on the consequences of this process for the Polish pharmaceutical market and for research and development. PMID:20369799
The innovative practical course was developed to improve the students' ability to acquire pharmaceutical care skills. The primary components of the course were in-school training using small group discussions and hospital experience including identification, analysis, prevention and resolution of drug-therapy problems, patient counseling on their medications and diseases, and interaction with medical team. Specific objectives of the research were to (1) compare students' performance before and after the course, (2) measure students' perceptions of their pharmaceutical care skills before and after the course, (3) determine students' perception of the value of the course. Statistical comparison of pre-test and post-test grades indicated both a retention and acquiring pharmaceutical care skills. A pre-course and post-course survey instrument was designed to measure students' perception of their pharmaceutical care skills. Perception of most of the items of the survey was significantly improved at the end of the course. Overall, the majority of students were highly satisfied with the course. In conclusion, the present study demonstrates that the innovative pharmaceutical care practical course was successfully introduced. PMID:17041786
Complete Genomics Inc. is a life sciences company that focuses on complete human genome sequencing. It is taking a completely different approach to DNA sequencing than other companies in the industry. Rather than building a general-purpose platform for sequencing all organisms and all applications, it has focused on a single application - complete human genome sequencing. The company's Complete Genomics Analysis Platform (CGA™ Platform) comprises an integrated package of biochemistry, instrumentation and software that sequences human genomes at the highest quality, lowest cost and largest scale available. Complete Genomics offers a turnkey service that enables customers to outsource their human genome sequencing to the company's genome sequencing center in Mountain View, CA, USA. Customers send in their DNA samples, the company does all the library preparation, DNA sequencing, assembly and variant analysis, and customers receive research-ready data that they can use for biological discovery. PMID:21345140
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 pharmaceuticalcompanies 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.
The occurrence and fate of pharmaceuticals in landfills has been largely neglected. Once discarded in municipal solid waste (MSW), pharmaceuticals within a landfill may undergo degradation, adsorption, or enter the leachate and eventually exit the landfill. The active pharmaceutical ingredient (API) concentration of MSW was predicted using available statistics on medication usage and directly measured by a MSW composition study. Estimation calculations resulted in a potential concentration of APIs from 7.4 to 45 mg/kg of MSW, varying with the percentage of dispensed medications assumed to become unused. Direct measurement resulted in the collection of 22 APIs comprising a total of 22,910 mg. This resulted in a final concentration of 8.1 mg/kg within MSW. Additionally, 45 empty medication containers were collected which potentially contained 33 differing APIs upon disposal. PMID:18599201
Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers. PMID:7211890
Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.
|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…
To date, there has been very little research-based mathematics curriculum for talented elementary students. Yet the gifted education and mathematics literature suggest support for curriculum that is both enriched and accelerated with a focus on developing conceptual understanding and mathematical thinking. Project M3: Mentoring Mathematical Minds is a 5-year Javits research grant project designed to create curriculum units with these
M. Katherine Gavin; Tutita M. Casa; Jill L. Adelson; Susan R. Carroll; Linda Jensen Sheffield; Ann Marie Spinelli
|The purpose of this research study was to identify "how" effective superintendents use the research-based leadership responsibilities/practices outlined in Marzano and Waters' (2006) meta-analysis that significantly and positively impact student achievement. A second purpose of this research was to find challenges that superintendents face in…
The purpose of this article was to illuminate for early childhood teacher practitioners how guided reading, as a research-based approach to reading instruction, could address the challenges of early reading instruction. The early years are the focus for the prevention of reading difficulties and research conducted over the past two decades has…
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…
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.
|We describe the development and implementation of research-based learning tools such as the Quantum Interactive Learning Tutorials and peer-instruction tools to reduce students' common difficulties with issues related to measurement in quantum mechanics. A preliminary evaluation shows that these learning tools are effective in improving students'…
|Building on an earlier 2008 summary prepared for OECD by Marlene Scardamalia and Carl Bereiter, this paper by Gesa S. E. van den Broek provides a more extensive discussion of approaches described as "researchbased innovation." "Fostering Communities of Learning" is a constructivist approach in which teachers help students discover important…
This paper recounts the investigative journey of a small group of faculty and graduate students at the University of British Columbia who extensively employed research-based theatre methods to collaboratively and performatively explore three distinct but related contexts that represent critical "moments" in the professional lives of educators and…
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
|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…
|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
|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…
|The article argues that, when judged on the basis of the strength of its researchbase, J. Renzulli's three-ring conception of giftedness is of questionable validity. Research on all three bases of the definition (above average general ability, task commitment, creativity) is reviewed. (Author/DB)|
|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…
|At last, a truly helpful, practical guide for K-4 teachers who want to ensure that their approach to teaching young English language learners is based on research and grounded in proven classroom practices. The authors of ASCD's best-selling book "Research-Based Methods of Reading Instruction, Grades K-3" explain how you can help the English…
|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.
|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…
Cognitive antecedents of alcohol consumption have been identified and psychologists have provided research-based recommendations regarding the content of persuasive communication designed to reduce health-endangering drinking. Yet, there has been little research into the correspondence between such recommendations and the content of publicly available health education leaflets. This study assessed the extent to which messages in leaflets designed to reduce alcohol
Charles Abraham; Lorraine Southby; Sabine Quandte; Barbara Krahé; Winfried van der Sluijs
The clinical laboratory plays an important part in the development of new pharmaceutical agents. The nature of this role will vary depending on the stage of clinical development of the drug and the goals of a particular investigation. Therefore, it may be appropriate to conduct and interpret clinical trial laboratory tests differently from the standard methods used in routine clinical analysis. The training and background of laboratory directors are important in providing both prospective and on-site management of laboratory testing during pharmaceutical clinical trials. PMID:7624909
WHO has a constitutional mandate to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products". The Organization collaborates closely with national nomenclature committees to select a single name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical. To avoid confusion, which could jeopardize the safety of patients, trade-marks should neither be derived from INNs nor contain common stems used in INNs. Recent developments in pharmacological research and biotechnology are challenges for the nomenclature committee. New schemes and concepts are being developed, for example, for naming monoclonal antibodies and other recombinant compounds.
... 6 2013-01-01 2012-01-01 true Parent company. 583.15 Section 583.15 Banks...SAVINGS AND LOAN HOLDING COMPANIES Â§ 583.15 Parent company. The term parent company means any company which directly or...
This guidance is intended to alert pharmaceutical manufacturers of finished products, pharmacy compounders, repackers, and suppliers to the potential risk of melamine contamination in pharmaceutical components. In September 2008, FDA received reports from...
Contents: Restrictive clauses in the licensing agreements with special reference to the pharmaceutical industry in developing countries; Control of restrictive clauses most frequently used in the licensing agreements in the pharmaceutical industry --an ov...
The report examines the current and future international competitiveness of the U.S. pharmaceutical industry, focusing on the manufacturers of pharmaceutical preparations. Forces and trends that will influence the future international environment of the p...
Potential exposure to active pharmaceutical ingredients (APIs) in the aquatic environment is a subject of ongoing concern. We recently estimated maximum likely potency-normalized exposure rates at the national level for several hundred commonly used human prescription pharmaceut...
...Project No. 2680-105] Consumers Energy Company, Detroit Edison Company; Notice of Application Accepted for Filing, Soliciting...2011. d. Applicants: Consumers Energy Company & Detroit Edison Company. e. Name of Projects: Ludington Pumped...
...Railroad Company--Trackage Rights Exemption-- BNSF Railway Company BNSF Railway Company (BNSF), pursuant to a written trackage...owned, indirect subsidiary of Canadian National Railway Company, over BNSF's Thayer South...
... Permissible bank holding company activities of savings and loan holding companies... Savings and Loan Holding Company Activities and Acquisitions Â§ 238.54 Permissible bank holding company activities of savings and loan holding...
...Surety Companies Acceptable on Federal Bonds: Amendment--Liberty Mutual Insurance Company AGENCY: Bureau of the Fiscal Service...underwriting limitation for the following company has been amended: Liberty Mutual Insurance Company (NAIC 23043), which was...
...treatment of a mutual insurance holding company as an insurance company...that is a mutual insurance holding company will be conducted in...treatment of mutual insurance holding companies under Section 203...Washington, DC 20429. Hand Delivery/Courier:...
Background to the debate The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The “Human Rights Guidelines for PharmaceuticalCompanies in relation to Access to Medicines” include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceuticalcompanies and access to medicines.
In recent years, increasing attention has been paid to the trace-level contamination of pharmaceuticals in the water environment all over the world. Considering a large number of pharmaceuticals used, it is crucial to establish a priority list of pharmaceuticals that should be monitored and/or treated first. In the present study, we developed a ranking system based on the pharmaceutical consumption, removal performance in the wastewater treatment plants (WWTPs) and potential ecological effects, and applied to the situation of China. 39 pharmaceuticals, which had available consumption data and also been reported previously in the WWTPs of China, were selected as candidate pharmaceuticals. Among them, seventeen pharmaceuticals were considered as priority pharmaceuticals, out of which, erythromycin, diclofenac acid and ibuprofen, had the high priority. Compared with other literatures, we found that some pharmaceuticals given concerns to globally should also be included in the priority list in China; while some pharmaceuticals, not mentioned in other literatures, such as cefalexin, ketoconazole, should be also given prior consideration in China. Among all the therapeutic classes, antibiotics, which were grossly abused in China, contributed the most to the priority pharmaceuticals. However, priority antibiotics accounted for only 32% of candidate antibiotics, while 71% and 100% of the candidate anti-inflammatory and antilipidemic respectively were identified as the priority pharmaceuticals, indicating that antibiotics might be overanxiously considered in the previous studies on their behaviors in the WWTPs of China. PMID:22591850
There are numerous observations of pharmaceuticals (or their metabolites) as contaminants in wastewater, surface water and groundwater. This implies a potential for indirect human exposure to pharmaceuticals via drinking water supplies. Various effect benchmarks may be employed in an evaluation of the significance of such indirect exposure. In this study a comparison was made between reported concentrations of pharmaceuticals in
Simon Webb; Thomas Ternes; Michel Gibert; Klaus Olejniczak
Although pharmaceutical counterfeiting incidents can be traced back thousands of years, it has been downplayed and even dismissed by pharmaceutical manufacturers in the past. That has changed. Pharmaceutical firms are newly dedicated to eradicate counterfeits globally and spending more money on anticounterfeiting efforts than ever before. The confluence of three factors seems to have drastically changed the existing paradigm for
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
Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the
Younghee Kim; Jinyong Jung; Myunghyun Kim; Alistair B. A. Boxall; Kyungho Choi
A survey of 500 respondents from Beijing, China, was conducted to investigate their perceptions of the functions and consequences of pharmaceutical advertising and their medical decisions. Results indicated that Chinese consumers held a very positive attitude toward advertising in general, as well as toward pharmaceutical advertising in particular. Pharmaceutical advertising was most readily accepted as information for brand differentiation and
In this survey chapter on pricing and reimbursement in U.S. pharmaceutical markets, we first provide background information on important federal legislation, institutional details regarding distribution channel logistics, definitions of alternative price measures, related historical developments, and reasons why price discrimination is highly prevalent among branded pharmaceuticals. We then present a theoretical framework for the pricing of branded pharmaceuticals, without and
In many developed countries, the physician\\/pharmaceutical sales representative relationship has increasingly become the focus of ethical questions. Given this context, the purpose of the present study was to determine the ethical dilemmas faced by pharmaceutical sales representatives in Turkey in their relations with physicians, and to identify possible solutions. Through an investigator-designed questionnaire, the ethical problems perceived by 215 pharmaceutical
BACKGROUND: Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the
Habibat A Garuba; Jillian C Kohler; Anna M Huisman
Pharmaceutical research has been likened metaphorically to the game of chess. Comparing these endeavors in moderate detail identifies similarities between them, but also important differences. For example, chess is played by individuals against one another, while pharmaceutical research—at least as usually perceived—is conducted by scientific teams. Drawing a comparison between pharmaceutical research and chess exemplifies the role metaphors can play
This report describes a scoping study conducted in order to establish whether pharmaceutical compounds may be present in UK estuaries. Surface water samples collected from five UK estuaries were analysed for the presence of 14 pharmaceutical compounds selected from the priority lists of the UK Environment Agency and the Oslo and Paris Commission (OSPAR). The pharmaceutical compounds\\/metabolites clofibric acid, clotrimazole,
Objective: There were three objectives to this study: to establish New Zealand community pharmacists' level of understanding of the pharmaceutical care process; to determine their attitudes to the concept of pharmaceutical care; and to determine the barriers to commencing pharmaceutical care practice. Comparisons were made between proprietors (pharmacy owners) and employees, males and females, and younger and older pharmacists. Method:
This manual for pharmaceutical supply systems planning in developing countries is the seventh volume in a series of works known collectively as the International Health Planning Methods Series. The series provides AID advisors and national health official...
Novel pharmaceutical compositions containing an active substance of formula (I), wherein R.sub.1, R.sub.2 and R.sub.3, which are the same or different are H, CH.sub.3 or C.sub.2 H.sub.5. The compositions have useful antiradical and/or antilipoperoxidative and/or hepatotropic properties.
Joyeux; Michel (Varangeville, FR); Mortier; Francois (Malzeville, FR)
Functions of educational specialists, including educational psychologists, in the field of pharmaceutical education are discussed. The functions considered range from a general educational consultant to evaluator of an innovative program. Requirements for functioning effectively within a pharmacy school are also examined. The compensation…
Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. PMID:23581664
Water treatment can reduce the concentrations of most contaminants. Ozone was evaluated at pilot and full scale, and found to readily reduce the estrogenicity of wastewater effluent. Free chlorine was found to be highly effective for the oxidation of phenolic steroids and acidic pharmaceuticals, while it was ineffective for ketone steroids (i.e., progesterone and testosterone). UV at typical disinfection doses
Exploiting a rich panel data set on anti-ulcer drug prescriptions, we measure the effects of uncertainty and learning in the demand for pharmaceutical drugs. We estimate a dynamic matching model of demand under uncertainty in which patients learn from prescription experience about the effectiveness of alternative drugs. Unlike previous models, we allow drugs to have distinct symptomatic and curative effects,
Exploiting a rich panel data set on anti-ulcer drug prescriptions, we measure the ef- fects of uncertainty and learning in the demand for pharmaceutical drugs. We estimate a dynamic matching model of demand under uncertainty in which patients learn from prescription experience about the effectiveness of alternative drugs. Unlike previous models, we allow drugs to have distinct symptomatic and curative
The pharmaceutical industry, though global in nature, remains fragmented in practice. This paper explores current trends which will increase the internationalization of the industry: biotechnology, efficiency of licensing, standards of quality, and postmarketing activities. Harmonization and the future European registration system are, of course, crucial, and this discussion assumes their success.
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
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
Decision trees are among the most popular of the new statistical learning methods being used in the pharmaceutical industry for predicting quantitative structure-activity relationships. This article reviews applications of decision trees in drug discovery research and extensions to the basic algorithm using hybrid or ensemble methods that improve prediction accuracy. PMID:16454756
The legume family Fabaceae has numerous taxa with tremendous potential for nutraceuticals and pharmaceuticals that have only recently started to be investigated. This family is the third largest family of flowering plants with approximately 650 genera and nearly 20,000 species. Species in this fam...
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…
India occupies the top-most position in the use of herbal drugs. This publication endeavours to give an idea of the extent of use of herbal drugs or their crude extractives, by the pharmaceutical concerns of India in their preparations. This will incident...
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
Phytoremediation of selected pharmaceuticals (diclofenac, ibuprofen, and acetaminophen) using Armoracia rusticana and Linum usitatissimum cell cultures and by hydroponically cultivated Lupinus albus, Hordeum vulgaris, and Phragmites australis plants in laboratory conditions is described. During in vitro experiments, the best results for acetaminophen were achieved using Armoracia rusticana hairy root cultures, where 100% of the starting amount was removed from the
Jan Kotyza; Petr Soudek; Zden?k Kafka; Tomáš Van?k
|The need for research administrators to understand and appreciate the pharmaceutical industry's research and development environment is discussed, using examples from Canada. The research administrator's role in the technology transfer process and implications for faculty are examined. Ways to build closer school-industry ties are discussed.…
|Areas in which pharmacy educators and practitioners can collaborate to hasten pharmacy curriculum development are outlined, including: state and regional centers for operationalizing the pharmaceutical care concept; training, formal resource programs for pharmacists; research advisory boards; public education; links with medical community;…
Multilateral and bilateral trade agreements have become important vehicles by which US multinational corporations, through close collaboration with government officials, are striving, amongst other objectives, for increasingly stringent global intellectual property protection (GIPP), particularly over what they term “innovative” pharmaceuticals. This chapter explores the evolution and structural dynamics of GIPP. It particularly considers the hypothesis that GIPP represents a corporate-driven
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
The pharmaceutical development of chiral drugs requires the activities of many different research and development groups. Guidelines which help to coordinate the activities of these groups and assist in the successful development of compounds with either single or multiple chiral centers are outlined and discussed. PMID:9884183
Williams, R C; Riley, C M; Sigvardson, K W; Fortunak, J; Ma, P; Nicolas, E C; Unger, S E; Krahn, D F; Bremner, S L
'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
The aim of this paper is to analyse empirically entry decisions by generic firms into markets with tough regulation. Generic drugs might be a key driver of competition and cost containment in pharmaceutical markets. The dynamics of reforms of patents and pricing across drug markets in Spain are useful to identify the impact of regulations on generic entry. Estimates from
Clays are ubiquitous substances, some of which (talcum, kaolinite, smectites, fibrous clays) have been used since very ancient times for their therapeutic effects. This chapter focuses on the use of fibrous clays (sepiolite and palygorskite or attapulgite) as active components and\\/or excipients in pharmaceutical formulations and cosmetics. In particular, they exhibit antidiarrhoeal and antacid activity when administered orally as solid
Alberto López-Galindo; César Viseras; Carola Aguzzi; Pilar Cerezo
With increasing frequency and concentration pharmaceuticals have been identified in surface waters across the world. They enter the environment through improper disposal, incomplete metabolism and in run-off from production sites. Diuretics are drugs that aid in the treatment of numerous diseases by increasing urinary excretion. Due to their frequency of use and their documented environmental presence this subclass was selected
AS DR. JOEL LEXCHIN MAKES PAINFULLY OBVIOUS in this issue (see pages 351 to 356), reg- ulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be re- garded by manufacturers as the cost of doing business, and any regulatory body
Knowledge intensive sectors, such as the pharmaceutical, have typically to face the problem of dealing with heterogeneous and vast amounts of information. In these scenarios integration, discovery and an easy access to knowledge are the most important fac tors. The use of semantics to classify meaningfully the information and to bridge the gap between the d ifferent representations that different
Pectin has a long history of use in the food industry and is now extensively studied for pharmaceutical and cosmetic applications. The rationale for the development of pectin derived colon-specific drug delivery systems is the unique biostability of pectin in the human gastrointestinal tract, where...
Because pharmaceutical markets function poorly, the patent system does not effectively stimulate drug research and development. Instead, it induces large amounts of research into drugs with relatively little incremental therapeutic value, while providing inadequate incentives to innovate in some areas of great therapeutic value. At the same time, patents result in high prices which exclude many users from access to
This work explores the factors that spur firms’ propensity to enter in international markets. Among the whole population of Spanish firms active in the pharmaceutical sector (over the period 1995-2004), we identify those firms that have entered the US market by assessing whether they have filed at least a trademark in the US Patents and Trademarks Office. By means of
Fabrizio Cesaroni; Marco S. Giarratana; Ester Martínez-Ros
\\u000a This chapter presents a general overview of pharmaceutically used polymers with respect to their physicochemical characteristics\\u000a and factors affecting drug delivery abilities. Pharmaceutical polymers, chemical structure, and properties are discussed for\\u000a their applications in controlled drug release systems. An additional focus is on new polymers (dendrimers, hyperbranched polymers),\\u000a considering their chemical versatility, uniqueness, and future implications. Problems associated with controlled
Identifying a dosing regimen for recommended use is one of the more difficult tasks in pharmaceutical development and has major therapeutic and economic consequences. In the clinical phase of pharmaceutical development, pharmacokinetic-pharmacodynamic (PK/PD) models are used to characterize the relationship between drug exposure and clinical outcome. When adherence to the prescribed drug dosage is known, true dose-response can be validly estimated, while non-compliance with the nominal prescribed dosage causes unintended variability in actual drug exposure and ensuing difficulty in determining dose-response. The purpose of this manuscript is to provide an overview of the important role that adherence plays in the interpretation of clinical studies for pharmaceutical development, to summarize the challenges in utilizing currently available tools for assessing adherence, to characterize the attributes of an ideal adherence marker, and to describe the utilization of a networked system having an ingestible sensor for direct confirmation of pharmaceutical utilization in drug development studies. The positive detection accuracy of this networked system when compared to direct ingestion is 99.3% [95%CI: 0.977, 0.999]. A direct measure of pharmaceutical utilization in pharmaceutical studies provides the means to examine the temporal patterns of drug response that are engendered by patients' actual dosing patterns, and to characterize more accurately exposure-response relationships. Materials and methods are available to accomplish these goals. PMID:22487008
Fraudulent or abusive sales and marketing practices by pharmaceuticalcompanies can result in costly overutilization of products that are increasingly paid for by government healthcare programs and may result in adverse health and safety consequences to the patient-beneficiaries of those programs. Federal enforcement efforts in this area are largely modeled on those used to combat white-collar crime, with cases taking years to reach conclusion. This approach overlooks the impact on patients who receive unnecessary care or are denied access to appropriate care during the course of the investigation. Many states are beginning to regulate certain pharmaceutical sales and marketing practices, but state-by-state regulation ignores the importance of a uniform federal regulatory and enforcement approach in an area already occupied by federal law. This Article explores current federal and state efforts to limit overutilization, fraud, and abuse in the sale and marketing of prescription drugs, and illustrates the merits of an expanded role for the U.S. Food and Drug Administration (FDA) to regulate pharmaceutical sales and marketing practices. This approach borrows lessons learned from the FDA's efficient and effective regulatory and enforcement methods and maintains a careful balance between the interests of patient-beneficiaries, the government and industry. PMID:17002233
The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied - though by no means solved - in financial accounting than in medicine. This article analyzes pharmaceuticalcompany manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information. PMID:24088151
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.
Traumatic brain injury often results in physical, behavioral, and cognitive impairments perceived by health care practitioners to limit or exclude clients' full participation in treatment decision making. We used qualitative methods to evaluate the short- and long-term impact of "After the Crash: A Play About Brain Injury," a research-based drama designed to teach client-centered care principles to brain injury rehabilitation staff. We conducted interviews and observations with staff of two inpatient neurorehabilitation units in Ontario, Canada. Findings demonstrate the effectiveness of the play in influencing practice through the avoidance of medical jargon to improve clients' understanding and participation in treatment; newfound appreciation for clients' needs for emotional expression and sexual intimacy; increased involvement of family caregivers; and avoidance of staff discussions as if clients were unaware. These findings suggest that research-based drama can effect reflexivity, empathy, and practice change to facilitate a client-centered culture of practice in brain injury rehabilitation. PMID:22941919
This paper presents a systematic approach to the development of a set of research-based ageing- centred web design guidelines (SilverWeb Guidelines). The approach included an initial extensive literature review in the area of human–computer interaction and ageing, the development of an initial set of guidelines based on the reviewed literature, a card sorting exer- cise for their classification, an affinity
Panayiotis Zaphiris; Sri Hastuti Kurniawan; Mariya Ghiawadwala
Of 100,374 persons living in Maui County, Hawaii, 58 percent are Asians and Pacific Islanders, and 39 percent are Caucasians. By contrast, a visual survey of the nursing staff of two home care agencies showed approximately 85 percent Caucasians and 15 percent People of Color. A research-based, Cross-Cultural Training (CCT) was conducted to educate home care nurses about the beliefs,
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
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
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.
There are two major issues that have potential for positive interactions between the industry and clinical pharmacy. These are drug selection and reimbursement, and clinical research. The first issue embodies the drug prescribing process, which has been, until recently, almost the sole purview of physicians. For this reason, pharmaceutical manufacturers have marketed their products primarily to this group. Changes are occurring; other licensed practitioners, including clinical pharmacists, are gaining prescribing authority. Schools of pharmacy have trained several thousand clinical pharmacists over the past decade, while the pharmacology component of medical education and the time devoted to clinical therapeutics either has stagnated or declined during the same period. Meanwhile, drug information has increased and the need to monitor drug selection to curtail costs has widened the opportunities for clinical pharmacists to exert an influence. The pharmaceutical industry needs to recognize the role clinical pharmacists play in drug selection. Drug selection decisions obviously influence drug reimbursement decisions, which influence drug sales, which influence profits. Clinical research is the backbone of a company's financial success and is becoming technologically sophisticated. Companies are becoming aware that many clinical pharmacists are able to collect and analyze clinical drug data as well as, or possibly better than, physicians. Clinical pharmacists can play a significant role in monitoring the safety and efficacy of marketed drugs. Good postmarketing surveillance data collection systems need to be developed. PMID:6692740
In Europe, company cars are offered by employers as fringe benefits to their employees at a lower price than employees pay in the car market, mainly due to favourable taxation of company cars. We analyse the welfare effects of favourable taxation of company cars for the Netherlands. The estimated annual welfare costs of the distortionary taxation of company cars are
Every single company or institution wants to utilize its resources in the most efficient way. In order to do so they have to be have good structure. The new way to analyze company structure by utilizing existing within company natural social network and example of its usage on Enron company are presented in this paper.
There is a wide range of applications of confocal Raman microscopy in pharmaceutical development. It is a powerful tool to probe the distribution of components within a formulation, to characterize homogeneity of pharmaceutical samples, to determine solid state of drug substances and excipients and to characterize contaminations and foreign particulates. The information obtained by confocal Raman microscopy is extremely useful, sometimes even crucial, for drug substance design, for the development of solid and liquid formulations, as a tool for process analytics and for patent infringements and counterfeit analysis. In this chapter, those aspects and applications will be presented, focusing on solid drug formulations. This chapter will also reveal the advantages and demonstrate the synergies of Raman mapping as compared to similar imaging methods such as SEM/EDX, NIR and MIR imaging.
This symposium focuses on the management of genotoxic impurities in the synthesis of pharmaceuticals. Recent developments in both Europe and United States require sponsors of new drug applications to develop processes to control the risks of potential genotoxic impurities. Genotoxic impurities represent a special case relative to the International Conference on Harmonisation Q3A/Q3B guidances, because genotoxicity tests used to qualify the drug substance may not be sufficient to demonstrate safety of a potentially genotoxic impurity. The default risk management approach for a genotoxic impurity is the threshold of toxicological concern unless a more specific risk characterization is appropriate. The symposium includes descriptions of industry examples where impurities are introduced and managed in the synthesis of a pharmaceutical. It includes recent regulatory developments such as the "staged threshold of toxicological concern" when administration is of short duration (eg, during clinical trials). PMID:19966139
Bercu, Joel P; Dobo, Krista L; Gocke, Elmar; McGovern, Timothy J
|Many proven research-based instructional strategies have been developed for introductory college-level physics. Significant efforts to disseminate these strategies have focused on convincing individual instructors to give up their traditional practices in favor of particular research-based practices. Yet evidence suggests that the findings of…
In the pharmaceutical industry, some tests for quality assurance before, during and after the manufacture of a drug product involve a two-stage sampling technique. We propose statistical testing procedures in a two-stage sampling problem with large within-class sample sizes. We also derive a two-stage sampling plan by minimizing the expected squared volume (or the generalized variance) of the confidence region related to the test. We present two examples to illustrate the proposed methods. PMID:8296110
The bromination of five selected pharmaceuticals (metoprolol, naproxen, amoxicillin, phenacetin, and hydrochlorothiazide) was studied with these compounds individually dissolved in ultra-pure water. The apparent rate constants for the bromination reaction were determined as a function of the pH, obtaining the sequence amoxicillin>naproxen?hydrochlorothiazide?phenacetin?metoprolol. A kinetic mechanism specifying the dissociation reactions and the species formed for each compound according to its pKa
F. Javier Benitez; Juan L. Acero; Francisco J. Real; Gloria Roldan; Francisco Casas
Silicone elastomer (in the form of a flexible rod) is one of the materials currently tested for use in analytical extraction\\u000a techniques and passive sampling devices. We investigated the applicability of this material for the enrichment of selected\\u000a polar pharmaceuticals (antipyrine, carbamazepine, diclofenac, ibuprofen, bezafibrate) from water. Time-resolved batch extraction\\u000a tests (up to five weeks in duration) were performed in stirred
Albrecht Paschke; Janine Brümmer; Gerrit Schüürmann
In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy as a health care profession, as well as what it means when we view pharmaceutical policy in the context of the health sector labour market, is discussed. The authors also discuss how factors external to the profession are affecting its purpose and realm of practice, including the current trend in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental in developing new and expanding roles for the profession, sometimes inspired by external events, but often as a result of their own prerogative. The pharmacy profession is encouraged to take a leading role in forming and contributing to policy, in this way making visible its contribution to society in general and public health in particular. If not, the profession will forever be reacting to policy and will remain at the mercy of policymakers and other strong actors in society. PMID:16341741
Objective: To assess the opinions and practice patterns of obstetrician-gynaecologists on acceptance and use of free drug samples and other incentive items from pharmaceutical representatives.Methods: A questionnaire was mailed in March 2003 to 397 members of the American College of Obstetricians and Gynecologists who participate in the Collaborative Ambulatory Research Network.Results: The response rate was 55%. Most respondents thought it
M A Morgan; J Dana; G Loewenstein; S Zinberg; J Schulkin
Biomagnetic methods have been designed for a wide range of applications. Recently, such methods have been proposed as alternatives\\u000a to scintigraphy for evaluating of a number of pharmaceutical processes in vitro as well as under the influence of gastrointestinal physiological parameters. In this review, physical characterization as\\u000a well as the most recent applications of Superconducting Quantum Interference Device (SQUID), Anisotropic
Luciana A. Corá; Madileine F. Américo; Ricardo B. Oliveira; Cristina H. R. Serra; Oswaldo Baffa; Raul C. Evangelista; Giselle F. Oliveira; José Ricardo Aruda Miranda
Newborns are a particularly vulnerable population. The response to a drug in terms of efficacy and toxicity varies widely from one newborn to another. Inter-individual variation in drug response is strongly affected by the patient's biochemical state at the time of therapy, as reflected by his metabolic phenotype, which in turn results from the interaction of both genetic and non-genetic factors. These factors contribute to the difficulties in accurate drug prescribing and dosing and to the increased risk of adverse drug reactions in the neonatal population. Metabolomics has been found to be particularly suitable for pharmaceutical Research & Development, with a range of successful applications that include preclinical safety evaluation of drug candidates, predicting the metabolism and toxicity of a drug based on the analysis of a pre-dose metabolic profile (pharmacometabolomics), and identification of drug-related alterations in metabolic pathways. Pharmacometabolomics is a rapidly developing field which refers to the direct measurement of metabolites in an individual's body fluids to predict or evaluate the metabolism of pharmaceuticals. The implementation of metabolomic techniques in pharmaceutical research has the potential to greatly enhance our understanding of mechanisms of drug effects, of undesirable drug reactions and of the biological processes underlying individual variations in drug response phenotypes. A more extensive clinical use of metabolomics could be a decisive step towards personalized drug therapy, with the ultimate aim to match the right drug to the right patient. Some applications of metabolomics in pharmaceutical research are discussed, with special focus on clinical use in Neonatology. PMID:23025765
Antonucci, Roberto; Pilloni, Maria Dolores; Atzori, Luigi; Fanos, Vassilios
The historical uses of ion-exchange resins and a summary of the basic chemical principles involved in the ion-exchange process are discussed. Specific applications of ion-exchange resins are provided. The utility of these agents to stabilize drugs are evaluated. Commonly occurring chemical and physical incompatibilities are reviewed. Ion-exchange resins have found applicability as inactive pharmaceutical constituents, particularly as disintegrants (inactive tablet
Electrostatics continues to play an important role in pharmaceutical aerosols for inhalation. Despite its ubiquitous nature, the charging process is complex and not well understood. Nonetheless, significant advances in the past few years continue to improve understanding and lead to better control of electrostatics. The purpose of this critical review is to present an overview of the literature, with an emphasis on how electrostatic charge can be useful in improving pulmonary drug delivery. PMID:23919475
Wong, Jennifer; Chan, Hak-Kim; Kwok, Philip Chi Lip
Although there is much controversy in the economic literature about how advertising affects market competition, little is\\u000a known about the effect of advertising on product innovation. We examined the relationship between advertising expenditures\\u000a and the research and development activities of pharmaceutical firms using empirical data from eight therapy areas. This study\\u000a finds that detailing advertising may have a significant positive
A simple, precise, fast and low-cost differential pulse polarographic (DPP) method for determination of lornoxicam in pharmaceutical formulations has been proposed. The results have been compared with those of high performance liquid chromatography (HPLC) method. Mean values and standard deviations calculated by ten determinations were 8.10 ± 0.12 mg for DPP and six determinations were 8.02 ± 0.08 mg for
The Journal continues its profiles of state owned oil companies with a return to the Persian Gulf, South America, and a first time look at the state oil company of Romania, one of Eastern Europe`s most active and oldest producers. The government of Kazakhstan`s activities are also covered in this report. These profiles detail the organization of the companies, with emphasis on upstream and downstream operations. Support functions, though essential to a company, are not covered in detail. Company projects and capabilities are only described in this report when necessary to put the company in perspective. Following are the profiles of state companies for Bahrain, Kuwait, Romania, and Venezuela.
Health Insurance costs in Germany have grown constantly over the last years. This increase of costs is not only observable in the total consideration but also in all single items. An outstanding growth rate exists in the field of pharmaceutical expenses. Detailed analyses of distribution and development of these costs, separated by age and indication groups, are currently only sporadically available and mostly focusing on the Statutory Health Insurance system in Germany. This research article is based on an initial data analysis and focuses on the question how pharmaceutical expenses in a German private health insurance company will develop until the year 2050, if the observed trend of the past years continues in the same way. This analysis focuses on different age groups. The objective is the demonstration of several scenarios, which illustrate the level of influence of different parameters (demographic changes, developments of prices for pharmaceuticals). Based on the cognition of certain effects measures for handling the growing challenge of financing the health system can be deduced. As a result, both demographic changes and price effects have an significant impact on the future development of per capita pharmaceutical expenses. Whereas older age groups will still cause the highest costs, the middle-aged people will show the highest growth rates. This strong cost increase is not sustainable for the German health insurance system. In addition to previous measures of a regulatory health policy (especially improved cost-benefit-assessments) the article shows new approaches for an intensified prevention and health promotion. PMID:22872541
Böcking, W; Tidelski, O; Skuras, B; Bäumler, A; Kitzmann, F
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.
An analysis of the types and costs of drugs imported by seven multinational pharmaceuticalcompanies in Zaire, an underdeveloped country in Africa, reveals that three-fourths of the drugs consisted of expensive and nonessential items. The prices of essential drugs (24 percent of their total imports) were much higher than those of available generic sources (average difference of 300 percent). The importation of nonessential drugs and high prices paid for essential drugs exacerbate the scarcity of needed items because of Zaire's limited supply of hard currency. In addition, two drug firms imported and promoted the sale of aminopyrone-dipyrone analgesic-antipyretics, drugs now rarely used in Western industrialized countries because of potentially fatal complications. Thus, in Zaire, the multinational pharmaceutical industry has an adverse effect on the availability and cost of drugs, as well as on the pattern of drug usage.
As the president of the Chicago-based Female Health Company (FHC), Mary Ann Leeper has surmounted many business challenges, but none has prepared her for what she now faces. As a biochemist, activist, and entrepreneur, Leeper wants nothing more than to slow, if not halt, the spread of HIV\\/AIDS. Leeper has found an inventor who has designed one tool that might
As the president of the Chicago-based Female Health Company (FHC), Mary Ann Leeper has surmounted many business challenges, but none has prepared her for what she now faces. As a biochemist, activist, and entrepreneur, Leeper wants nothing more than to slow, if not halt, the spread of HIV\\/AIDS. Leeper has found an inventor who has designed one tool that might
Most of students come to introductory physics courses with a wrong idea about the way the world works. A set of research-based labs designed to confront these wrong student ideas in a conceptual context would help to asses their performance in the numerical session of the second part of the same physcs lab Results will be shown to measure the efficiency of the this learning technique through the comparison the the result of tye first part of the lab (based on a conceptual perspective) to the result of the second part of the same lab (based on a numerical perspective).
We present the results of the Learning Center for Earth Sciences and Astronomy (LESA). Thai-land organizes a series of research-based astronomical workshops for secondary school students in the country during 2006 present. The goal of LESA is to apply the research-based learn-ing approach to complement astronomy education, which has been included in the national curriculum since 2002, and to let students gain first-hand experience in astronomical research. Realization of research-based astronomical education in Thailand has long been held back by the limited availability of astronomical facilities in the country. We therefore developed work-shop modules for students using professional astronomical data generously made available to us through various collaborations and on-line archives. Two major difficulties we have overcame in developing these modules are, first, to seek research topics that are meaningful, inspiring, and can demonstrate the process of astronomical research with minimal background in astrophysics, and second, to find the software capable of processing large amounts of astronomical data, yet easily accessible for students. Our workshop modules centered on the basic research methods in observational astronomy, including astrometry, photometry, and spectroscopy. Data for these analysis modules were obtained through collaboration with various research groups, such as re-mote robotic telescopes access from the Robotic Optical Transient Search Experiment and the Las Cumbres Observatory Global Telescope Network, archival images from the Catalina Sky Survey, archival spectra from the Observatoire de Haute-Provence, and imaging and spectral data from the Sloan Digital Sky Survey. We adapt the raw data such that they can be accessed and analyzed with freely-available astronomical software such as the Iris or SAOImage ds9 and VSpec for imaging and spectral data, respectively. In each of the past five years, we have organized year-round workshops for students to carry out research projects using these modules and present their work in poster and oral presentations at our annual meetings. Examples of student projects are the search for variable stars and minor planets, light curve analyzes of variable stars and type Ia supernovae, spectral analyzes of stars and galaxies, and exoplanet searches using the radial velocity technique. To date, more than 80 students from 25 schools in Thailand have participated in our workshops. Our results demonstrate the feasibility of adapt-ing astronomical data or remotely available telescopes to carry out research-based education, despite the lack of locally available astronomical infrastructures.
Background A major marketing technique used by pharmaceuticalcompanies is direct-to-physician marketing. This form of marketing frequently employs promotional marketing brochures, based on clinical research, which may influence how a physician prescribes medicines. This study's objective was to investigate whether or not the information in promotional brochures presented to physicians by pharmaceutical representatives is accurate, consistent, and valid with respect to the actual studies upon which the promotional brochures are based. Methods Physicians in five clinics were asked to consecutively collect pharmaceutical promotional brochures and to send them all to a centralized location. The brochures for any class of medication were collected on a continuous basis until 20 distinct promotional brochures were received by a central location. Once the brochure was received, the corresponding original study was obtained. Two blinded reviewers performed an evidence-based review of the article, comparing data that was printed on the brochure to what was found in the original study. Results Among the 20 studies, 75% of the studies were found to be valid, 80% were funded by the pharmaceuticalcompany, 60% of the studies and the corresponding brochures presented patient-oriented outcomes, and 40% were compared to another treatment regimen. Of the 19 brochures that presented the data as graphs, 4 brochures presented a relative risk reduction while only 1 brochure presented an absolute risk reduction. 15% of the promotional marketing brochures presented data that was different from what was in the original published study. Conclusion Given the present findings, physicians should be cautious about drawing conclusions regarding a medication based on the marketing brochures provided by pharmaceuticalcompanies.
Cardarelli, Roberto; Licciardone, John C; Taylor, Lockwood G
Bisphosphonates is a class of chemical compounds finding extensive medical applications against bone disorders including osteoporosis, Pagets' disease, etc. Non-N-containing members include etidronate, clodronate and tiludronate, while N-containing bisphosphonates include active pharmaceutical compounds such as pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate and zoledronate. The present study covers 20 years of analytical research on this group of compounds, focusing on bioanalytical and pharmaceutical QC applications. A wide range of analytical techniques is presented and critically discussed including among others liquid and gas phase separations, electrophoretic, electroanalytical, automated and enzymatic approaches. PMID:18599247
Zacharis, Constantinos K; Tzanavaras, Paraskevas D
Pharmaceutical benefit management companies (PBMs) act as intermediaries between pharmaceutical manufacturers and third-party payors to administer prescription drug benefits. While PBMs have increased in importance in recent years, they have simultaneously become the target of critics, including United States Attorneys and the Federal Trade Commission. This Article gives a brief overview of the federal enforcement environment in which PBMs are conducting business and discusses how PBMs' rebates are negotiated. It then discusses the applicability of the federal Anti-Kickback Statute, which is the likeliest enforcement tool for prosecutors to use against PBMs. The Article concludes by discussing the steps PBMs can take to minimize their liability and provides insight into how effective the federal government will be in building fraud cases against PBMs' current business practices. PMID:12940677
Text Version... The heating system uses standard halogen lamps to ... blood and fluids through dry heat, thus eliminating ... the following tests were conducted: 1. The ... More results from www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts
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.
Various problems concerning the pharmaceutical and personal care products (PPCPs) in the environment of the Eastern European\\u000a countries are described. The main classes of PPCPs in the environment, as well as major occurrence pathways and PPCPs fate,\\u000a are depicted. The influence of specifics of the regional pharmaceutical market, medication consumption culture and pharmaceutical\\u000a waste disposal techniques on environmental pollution with
Rising to the challenge of increased scrutiny of drug quality and safety, seizing the opportunity for development, manufacturing,\\u000a and distribution of pharmaceuticals for the global network and anticipating the rapid growth of the domestic pharmaceutical\\u000a market in the years to come, China, with support from the international community, has been making sweeping changes to improve\\u000a its environment for pharmaceutical R&D.
A multiphase model based on the Mackay-type level II fugacity model has been used to predict the behaviour and final environmental\\u000a concentrations of some of the more consumed pharmaceuticals in Spain. The model takes into account the mean rate of consumption\\u000a of pharmaceuticals, the percentage of pharmaceutical metabolised, the formation of the corresponding glucuronide, which is\\u000a assumed to be hydrolysed
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
...Board [Docket No. FD 35747] Norfolk Southern Railway Company--Lease Exemption--BNSF Railway Company AGENCY: Surface Transportation Board...SUMMARY: On June 26, 2013, Norfolk Southern Railway Company (NSR) filed a petition under 49...
...concluded that, insofar as the Bank Holding Company Act is concerned, a bank holding company may acquire, either directly...question presented. On the other hand, in the Board's view, a bank holding company may not acquire, on...
...concluded that, insofar as the Bank Holding Company Act is concerned, a bank holding company may acquire, either directly...question presented. On the other hand, in the Board's view, a bank holding company may not acquire, on...
Online searching of patents of pharmaceutical composition is generally considered to be very difficult. It is due to the fact that the patent databases include extensive technical information as well as legal information so that they are not likely to have index proper to the pharmaceutical composition or even if they have such index, the scope and coverage of indexing is ambiguous. This paper discusses how patents of pharmaceutical composition are indexed in online databases such as WPl, CA, CLAIMS, USP and PATOLIS. Online searching of patents of pharmaceutical composition are also discussed in some detail.
... Slides for the March 2, 2011 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. Persons ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs
... Associate Director for Research Policy and Implementation. Office of Pharmaceutical Science, CDER, FDA. ... Pfizer Global Research & Development. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs
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
This paper is based on an analysis of R&D globalization of 14 large companies in the electronics and pharmaceutical sectors in Japan. It is based on a systematic analysis of bibliometric data, combined with an analysis of questionnaire data. The authors' findings suggest that in both industries, R&D globalization has gained momentum in the 1990s. They analyzed the R&D activities
Despite the central role played by human capital in entrepreneurship, little is known about how employees in entrepreneurial firms are compensated and incentivized. We address this gap in the literature by studying 18,935 non-CEO compensation contracts across 1,809 privately-held venture-backed companies. Our key finding is that employee compensation varies with the degree to which VCs versus founders control the business.
Business format franchising is becoming an increasingly international activity. From 1971 to 1985, U.S. franchisors added foreign outlets at a rate of 17% per year, almost twice as fast as they added domestic outlets (Aydin and Kacker 1990). As a result, by 1990 more than 350 U.S. companies had more than 32,000 franchised outlets overseas. By 2000, 60% of all
Honda Motor Company of Japan in a four-year period from 1968 to 1872 designed, tested, and mass-produced a stratified charge engine, the CVCC, which in comparison to conventional engines of similar output at the time was lower in CO, HC and NO\\/sub x\\/ emissions and higher in fuel economy. Honda developed the CVCC engine without government assistance or outside help.
We investigated the occurrence and distribution of pharmaceuticals (including antibiotics, estrogens, non-steroidal anti-inflammatory drugs (NSAIDs), beta-blockers, and lipid regulators) in three rivers and in the waste streams of six hospitals and four pharmaceutical production facilities in Taiwan. The most frequently detected pharmaceuticals were acetaminophen, erythromycin-H2O, sulfamethoxazole, and gemfibrozil. NSAIDs were the next most-often detected compounds, with a detection frequency >60%.
Professional guidelines state that higher-order thinking skills are a desirable outcome of pharmacy education. In this context, courses in pharmaceutics at the University of Southern California are taught in a learner-centered manner that requires use of chemical reference sources and interpretation of physicochemical information for drug molecules. To facilitate these activities, a librarian worked with faculty to design a class on reference sources and primary literature. Students believed the librarian instruction was beneficial. After the intervention, faculty fielded fewer information-related questions and the librarian received more sophisticated questions. The class emphasizes the importance of collaboration between librarians and faculty in achieving these results. PMID:22559181
Chatfield, Amy J; Romero, Rebecca M; Haworth, Ian S
This paper takes a critical look at progress and prospects regarding the sociology of pharmaceuticals over the years. Key themes examined include: (i) medicalisation and pharmaceuticalisation; (ii) regulation; (iii) consumption and consumerism; (iv) expectations and innovation. Papers in the monograph are also introduced and discussed in relation to these themes. The paper concludes with some further comments and reflections on progress and prospects in this field, emphasising the continuing importance of sociological engagement with these personal and political issues in the 21(st) century. PMID:18761505
Objective:To determine the nature, frequency and effects of internal medicine bousestaff and faculty contacts with pharmaceutical representatives\\u000a (PRs).\\u000a \\u000a Design and setting:The authors surveyed internal medicine faculty at seven midwest teaching hospitals and housestaff from two of the teaching\\u000a programs. The survey asked about type and frequency of contacts with PRs and behavior that might be related to these contacts.\\u000a T-tests
Nicole Lurie; Eugene C. Rich; Deborah E. Simpson; Jeff Meyer; David L. Schiedermayer; Jesse L. Goodman; W. Paul McKinney
Contents: Message from the Chairman; What Is the AEA; Japanese Section -- Company Listings, Indexes -- Products and Services, Trade Names, Parent to Subsidiary, and Subsidiary to Parent; English Section -- Company Listings; Indexes -- Products and Service...
The data for the Natural Gas Annual 1991 Supplement : Company Profiles are taken from Form EIA-176, (open quotes) Annual Report of Natural and Supplemental Gas Supply and Disposition (close quotes). Other sources include industry literature and corporate annual reports to shareholders. The companies appearing in this report are major interstate natural gas pipeline companies, large distribution companies, or combination companies with both pipeline and distribution operations. The report contains profiles of 45 corporate families. The profiles describe briefly each company, where it operates, and any important issues that the company faces. The purpose of this report is to show the movement of natural gas through the various States served by the 45 large companies profiled.
...Regulatory Commission [Project No. 12693-001] Sutton Hydroelectric Company, LLC Notice of Site Visit On February 6, 2008, Sutton Hydroelectric Company, LLC (Sutton Hydroelectric) filed a notice of intent and a preliminary...
Favorable outcomes from ongoing research at the University of Colorado Boulder on student learning in junior-level electrostatics (E&M I) have led us to extend this work to upper-division electrodynamics (E&M II). We describe here our development of a set of research-based instructional materials designed to actively engage students during lecture (including clicker questions and other in-class activities); and an instrument for assessing whether our faculty-consensus learning goals are being met. We also discuss preliminary results from several recent implementations of our transformed curriculum, plans for the dissemination and further refinement of these materials, and offer some insights into student difficulties in advanced undergraduate electromagnetism.
Baily, Charles; Dubson, Michael; Pollock, Steven J.
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 strategies. This is a tiny fraction of the 33% stopping rate for physics faculty in general [Phys. Rev. ST Phys. Educ. Res. 8, 020104 (2012)PRSTCR1554-9178]. Nearly all of these UBC faculty members who had an opportunity to subsequently use RBIS in other courses (without CWSEI support) did so. We offer speculations for the difference in quitting rates. The direct support of the faculty member by a trained science education specialist in the discipline during the initial implementation of the new strategies is a particularly notable factor.
An important distinction can be made between the science, technology, and society (STS) movement of past years and the domain of socioscientific issues (SSI). STS education as typically practiced does not seem embedded in a coherent developmental or sociological framework that explicitly considers the psychological and epistemological growth of the child, nor the development of character or virtue. In contrast, the SSI movement focuses on empowering students to consider how science-based issues reflect, in part, moral principles and elements of virtue that encompass their own lives, as well as the physical and social world around them. The focus of this paper is to describe a research-based framework of current research and practice that identifies factors associated with reasoning about socioscientific issues and provide a working model that illustrates theoretical and conceptual links among key psychological, sociological, and developmental factors central to SSI and science education.
Zeidler, Dana L.; Sadler, Troy D.; Simmons, Michael L.; Howes, Elaine V.
We present results demonstrating similar distributions of student scores, and statistically indistinguishable gains on two popular research-based assessment tools: the Brief Electricity and Magnetism Assessment (BEMA) and the Conceptual Survey of Electricity and Magnetism(CSEM). To deepen our understanding of student learning in our course environment and of these assessment tools as measures of student learning, we identify systematic trends and differences in results from these two instruments. We investigate correlations of both pre- and post- conceptual scores with other measures including traditional exam scores and course grades, student background (earlier grades), gender, a pretest of scientific reasoning, and tests of attitudes and beliefs about science and learning science. Overall, for practical purposes, we find the BEMA and CSE