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Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceuticalcompanies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceuticalcompanies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma. PMID:24291787
Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan
Pakistani pharmaceutical industry is synchronized by various legal perspectives to make certain the health of people of Pakistan but unfortunately rising population, inflation and people's wish to have money to burn leads to unethical practices so as in Pharmaceuticalcompanies of Pakistan. Keeping in view the rising trend of unethical drug promotional activities in Pharmaceutical industry, a prior study was
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.
Although access to medicines is a vital feature of the right to the highest attainable standard of health ("right to health"), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceuticalcompanies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on Business and Human Rights and places the human rights responsibilities of pharmaceuticalcompanies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for PharmaceuticalCompanies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for PharmaceuticalCompanies consider the specific human rights responsibilities of one sector (pharmaceuticalcompanies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceuticalcompanies, with particular attention to patent-holding pharmaceuticalcompanies. Adopting a right-to-health "lens," the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceuticalcompanies' policies, and provide standards in relation to which pharmaceuticalcompanies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceuticalcompanies and hold them publicly accountable for their human rights responsibilities. PMID:22789042
Background Pharmaceuticalcompany representatives likely influence the prescribing habits and professional behaviour of physicians. Objective The objective of this study was to systematically review the effects of interventions targeting practising physicians’ interactions with pharmaceuticalcompanies. Eligibility criteria We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceuticalcompanies. Data sources The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. Appraisal and synthesis methods We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Results Of 11?189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceuticalcompanies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a ‘collaborative approach’ between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceuticalcompanies (by restricting free samples, promotional material, and meetings with pharmaceuticalcompany representatives) on prescription behaviour. Limitations We identified too few studies to allow strong conclusions. Conclusions Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians’ prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceuticalcompanies.
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
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
Purpose – The purpose of this paper is to contribute to the literature on emerging multinationals by studying the internationalization strategies of two established companies in the Indian pharmaceutical industry: Ranbaxy and Wockhardt. Design\\/methodology\\/approach – The study utilizes a longitudinal case-study approach to capture Ranbaxy's and Wockhardt's dynamic internationalization patterns. An extensive literature review using recently published works, government documents,
BACKGROUND: Pharmaceuticalcompany representatives (PCRs) influence the prescribing habits and professional behaviour of physicians. However, the skills for interacting with PCRs are not taught in the traditional medical school curriculum. We examined whether an innovative, mandatory workshop for third year medical students had immediate effects on knowledge and attitudes regarding interactions with PCRs. METHODS: Surveys issued before and after the
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
Objectives Adherence to safer nonsteroidal anti-inflammatory drug (NSAID) prescribing strategies remains low, despite their acceptance as markers of high-quality care and their aggressive dissemination. This study describes the taxonomy of methods used by pharmaceuticalcompanies to influence physicians’ NSAID prescribing behaviors and elicits physicians’ perceptions of and counter-balances to these influences. Study Design In-depth interviews analyzed using the constant comparative method of qualitative data analysis. Methods Qualitative interviews were conducted with physicians representing various clinical specialties. Interviews were transcribed and coded inductively using grounded theory. Recruitment was stopped at 25 participants after the attainment of thematic saturation, when no new concepts emerged from ongoing analysis of consecutive interviews. Results Physicians described a variety of influences that shaped their NSAID prescribing behaviors, including detailing and direct contact with pharmaceutical representatives, requests from patients inspired by direct-to-consumer advertisements, and marketing during medical school and residency training. Physicians described practice guidelines, peer-reviewed evidence and opinions of local physician experts as important counterweights to pharmaceuticalcompany influence. Local physician experts interpreted and provided context for new clinical evidence, practice guidelines and NSAID related marketing. Conclusions The social and communicative strategies used by pharmaceuticalcompanies can be adapted to improve physicians’ adoption of guidelines for safer NSAID prescribing. The communicative interactions between local experts and other physicians who prescribe NSAIDs may be the critical target for future interventions to promote safer NSAID prescribing.
Naik, Aanand D.; Woofter, Aaron L.; Skinner, Jessica M.; Abraham, Neena S.
As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called “high-tech” industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry’s major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceuticalcompanies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts’ opinion was designed and delivered to 11 pharmaceuticalcompanies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company.
Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali
As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called "high-tech" industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry's major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceuticalcompanies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts' opinion was designed and delivered to 11 pharmaceuticalcompanies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company. PMID:24250532
Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali
Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceuticalcompanies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceuticalcompanies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceuticalcompanies extend comprehensive measures against counterfeit and illicit trading. PMID:24492224
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.
Many medicines currently available on the market are simply too expensive for millions around the world to afford. Many medicines available in the developing world are only available to a small percentage of the population due to economic inequities. The profit-seeking behavior of pharmaceuticalcompanies exacerbates this problem. In most cases, the price reductions required to make drugs affordable to a broader class of people in the developing world are not offset by the resultant increase in sales volume. Simply stated, in most of the developing world, it is more profitable to sell drugs to the very wealthy at high prices than it is to sell cheaper drugs to a greater number of people. As a result, medicines remain unaffordable for the vast majority of people in many parts of the world. While this might be an acceptable outcome for certain commodities, such as luxury goods, it is completely unacceptable for life-saving medicines. Therefore, in order to effectively address the global lack of access to medicines, the role pharmaceuticalcompanies play in the international intellectual property regime must be critically examined. PMID:22789043
Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceuticalcompanies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceuticalcompanies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceuticalcompanies who wish to register and supply medicines to African countries. Methods: This cross-sectional descriptive pilot study was conducted across pharmaceuticalcompanies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceuticalcompanies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and efficacy of medicines. The experience of pharmaceuticalcompanies indicated that country specific regulatory requirements are a barrier to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific labeling were cited as key problems. Conclusion: Pharmaceuticalcompanies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI).
Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceuticalcompanies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceuticalcompanies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine. PMID:24799811
Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceuticalcompanies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceuticalcompanies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine.
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 are defined as drugs listed on the 1988 version of the World Health Organization's (WHO) essential drugs list or equivalent to WHO essential drugs. Only 482, or 16% of a total of 3021 cited drugs were essential drugs or equivalent to an essential drug. The proportion for each company ranged from a low of 5.4% to a maximum of 39.0%. A high proportion, 41.7%, of the 2539 non-essential drugs cited in the compendia contained two or more active ingredients, compared to only 9.5% of the essential drugs. The results indicate that European pharmaceuticalcompanies have yet to focus their drug marketing efforts in developing countries on the essential drugs recommended by the WHO. The ethical responsibility of the pharmaceuticalcompanies is discussed, particularly in respect to their sales on the private market. PMID:8211308
Background A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceuticalcompanies and their incentives. Methods As part of a cross-sectional survey, a validated questionnaire previously used for assessing attitude of medical students towards pharmaceutical industry, was modified, pre-tested and distributed among consenting clinical year students at DUHS and AKU. Questions included acceptability of pharmaceutically sponsored gifts, events and tuition fee, and their impact on future prescription. Responses were graded as agree, disagree or neutral which were then scored according to the AMSA guidelines of ethical conduct. Results Out of a total of 353 targeted students 303 responded, corresponding to a response rate of 85.8%. Responses indicated that 42.7% students believed in no interaction with drug companies during medical school. However, 81% of students favored pharmaceutical sponsorship of student-body events/seminars at medical colleges. More than one-third of the students were comfortable receiving gifts from drug companies. Overall, the results of this study offer an interesting comparison between the students of a private medical school (AKU) and a public medical school (DUHS); AKU students exhibited a greater degree of mistrust towards drug information provided by pharmaceuticalcompanies compared to DUHS students (p?=?0.040). Furthermore, when asked if there was a need to incorporate guidelines in the undergraduate curriculum with regard to interaction with drug companies, 84.2% students at AKU agreed, compared to 54.9% at DUHS. Medical student Attitude Scores are more or less similar to each other independent of their various demographical differences. Conclusion This study highlights that medical students in our population have a high level of acceptability towards incentives offered by pharmaceutical industry and that formal guidance regarding the subject should be incorporated into medical curriculum.
In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceuticalcompanies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention. PMID:24092398
Background The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceuticalcompanies. A regulatory letter represents the FDA’s first official notification to a pharmaceuticalcompany that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8?±?45.6, during the Bush Administration (2001–2008) it was 120.4?±?33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0?±?17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3?±?36.4), Bush (29.5?±?16.2) and Obama (41.7?±?11.1). Conclusions Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceuticalcompanies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.
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
Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceuticalcompanies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them.
This article looks at the spatial distribution of patent activity among publicly traded companies in the U.S. pharmaceutical industry. Data for two time periods show that patent introductions tend to favor the Northeast. Significant locational variations are uncovered in the innovation performance of firms in this industry. These variations are hypothesized to reflect the localized economic conditions that characterize Porter’s
Since 2002, the Leem (French Association of PharmaceuticalCompanies) has conducted a survey every two years to update the attractiveness of France for international clinical trials. Thirty companies (68% of the French market) have participated in this 6(th) survey which involved 79 countries, a greater number of Phases I/II, II and III studies (420 versus 352 in 2010), a relatively stable number of included patients (246,895 versus 249,704 in 2010) and a greater number of centers (32,965 versus 24,337 in 2010). The evolution of time-lines for the go-ahead by French Authorities is heterogeneous (shorter time-lines by the French National Agency of Drug and Health Products Safety [ANSM] but longer time-lines by Research Ethics Comittees [CPP]). The time-lines for first hospital contracts remain stable. France ranks at an average position among European countries in regards to quantitative and qualitative data, and its state-of-art in early stages is still recognized. Its good performance in oncology and orphan diseases are major assets of competitiveness. PMID:23484655
Background Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors’ concurrent publications. Methods The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceuticalcompanies during the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. Results These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. Conclusions With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database.
Superparamagnetic iron oxide (SPIO) nanoparticles are a relatively large class of contrast agents for magnetic resonance imaging. According to their biodistribution, distinct classes of SPIO nanoparticles have been investigated for clinical applications either as macrophage imaging agents or blood pool agents. Contrast agents which are pharmaceutics followed the same development rules as therapeutic drugs. Several drawbacks such as clinical development difficulties, organization of market access and imaging technological developments have limited the widespread use of these products. SPIO nanoparticles that are composed of thousands iron atoms providing large T2* effects are particularly suitable for theranostic. Stem cell migration and immune cell trafficking, as well as targeted SPIO nanoparticles for molecular imaging studies are mainly at the stage of proof of concept. A major economic challenge in the development of molecular imaging associated with a therapeutic treatment/procedure is to define innovative business models compatible with the needs of all players taking into account that theranostic solutions are promising to optimize resource allocation and ensure that expensive treatments are prescribed to responding patients. PMID:23633290
Drug-induced prolongation of the QT interval is having a significant impact on the ability of the pharmaceutical industry to develop new drugs. The development implications for a compound causing a significant effect in the ‘Thorough QT/QTc Study'—as defined in the clinical regulatory guidance (ICH E14)—are substantial. In view of this, and the fact that QT interval prolongation is linked to direct inhibition of the hERG channel, in the early stages of drug discovery the focus is on testing for and screening out hERG activity. This has led to understanding of how to produce low potency hERG blockers whilst retaining desirable properties. Despite this, a number of factors mean that when an integrated risk assessment is generated towards the end of the discovery phase (by conducting at least an in vivo QT assessment) a QT interval prolongation risk is still often apparent; inhibition of hERG channel trafficking and partitioning into cardiac tissue are just two confounding factors. However, emerging information suggests that hERG safety margins have high predictive value and that when hERG and in vivo non-clinical data are combined, their predictive value to man, whilst not perfect, is >80%. Although understanding the anomalies is important and is being addressed, of greater importance is developing a better understanding of TdP, with the aim of being able to predict TdP rather than using an imperfect surrogate marker (QT interval prolongation). Without an understanding of how to predict TdP risk, high-benefit drugs for serious indications may never be marketed.
This article has two objectives. It firstly provides a general framework for variables that influence R&D (Research and Development) localisation by pharmaceutical and biotech companies. The analysis of R&D localization includes both in-house R&D and contracted R&D. Following a systematic literature search, these variables were classified into four distinct categories: regulatory environment, institutional framework, national systems of innovation and local development and specialisation. The authors highlight that some of these factors directly depend on the action of public administrations (e.g., patent protection, price regulation, public investments in research, and incentives to private companies); others are indirectly influenced by public policies (e.g., GDP growth rate, infrastructures). This theoretical framework was used to analyse the Italian case-study. Pros and cons of the Italian context were investigated from the point of view of multinational pharmaceuticalcompanies and the Italian Association of Biotech Companies. Interviews were chosen as the most appropriate data gathering technique given the exploratory nature of the study of the Italian context. The paper is divided into five parts. A brief introduction provides figures showing that Europe has been loosing positions compared with other Continents and the same has occurred in Italy compared with other EU countries. The second one illustrates the methodology. The third one is focused on variables affecting R&D localisation. In the fourth section the Italian case-study is discussed. Theoretical and empirical findings are summarised and discussed in the conclusions. PMID:16824641
The supply chain represents the critical link between the development of new product and the market in pharmaceutical industry. Over the years, improvements made in supply chain operations have focused largely on ways to reduce cost and gain efficiencies in scale. In addition, powerful regulatory and market forces have provided new incentives for pharmaceutical firms to basically rethink the way they produce and distribute products, and also to re-imagine the role of the supply chain in driving strategic growth, brand differentiation and economic value in the health continuum. The purpose of this paper is to formulate basic factors involved in risk analysis of pharmaceutical industry, and also determine the effective factors involved in suppliers selection and their priorities. This paper is based on the results of literature review, experts’ opinion acquisition, statistical analysis and also using MADM models on data gathered from distributed questionnaires. The model consists of the following steps and components: first factors involved in to supply chain risks are determined. Based on them a framework is considered. According the result of statistical analysis and MADM models the risk factors are formulated. The paper determines the main components and influenceial factors involving in the supply chain risks. Results showed that delivery risk can make an important contribution to mitigate the risk of pharmaceutical industry.
SUMMARY In this paper we explore the possible reasons why medical papers reporting clinical trials sponsored by the pharmaceutical industry often analyse repeated measures data at certain key time-points instead of employing sophisticated models of repeated measures proposed by many statisticians. A survey indicated that the priority reason in the industry for having repeated measures in clinical trials is to
Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceuticalcompany that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceuticalcompany in August 2002. PMID:12437486
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
India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fully-fledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets. PMID:15527398
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
Background: Since 1995, every member-country of the World Trade Organization (WTO) has agreed to honor a 20-year patent-life, from the date of a pharmaceuticalcompany's application for the patent, in the country of application. Patent protection retards competitive imitation of an invented product. This kind of protection is particularly important for pharmaceuticals, because pharmaceuticals that are not derived from biotechnology
Community Clinical Oncology Program Celebrates 20 Years of Research 20-Year CCOP ResearchBasesResearchBases develop and implement the cancer prevention and control clinical trials of the CCOP program. The following ResearchBases have been a continuous
...500-1] Axcess International, Inc., Gamma Pharmaceuticals, Inc., Innovex...securities of Axcess International, Inc. because...securities of Gamma Pharmaceuticals, Inc. because...above-listed companies....
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
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An international project team (including members from US, Canada and UK) was formed from a number of interested biopharmaceutical\\u000a companies and regulatory authorities to conduct a cross-organisation collaboration exercise. The results of the first comparison\\u000a with eight different organisations that used instruments of the same equipment model, the same reagents, and the same methodology\\u000a has been reported previously . This
Brian Nunnally; Ketaki Patel; Mingfang Hong; Xinfeng Zhang; Shao-Xiong Wang; Brenda Rener; Angelia Reed-Bogan; Oscar Salas-Solano; Wendy Lau; Michel Girard; Heather Carnegie; Virginia Garcia-Cañas; K. C. Cheng; Ming Zeng; Margaret Ruesch; Ronald Frazier; Claudia Jochheim; Kshama Natarajan; K. Michael Jessop; Mansoor Saeed; Frank Moffatt; Seth Madren; Serigne Thiam; Kevin Altria
The shortening of patent life periods, generic competition and public health policies, among other factors, have changed the operating context of the pharmaceutical industry. In this work we address a dynamic allocation\\/planning problem that optimises the global supply chain planning of a pharmaceuticalcompany, from production stages at primary and secondary sites to product distribution to markets. The model explores
Rui T. Sousa; Songsong Liu; Lazaros G. Papageorgiou; Nilay Shah
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
In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. PMID:24986349
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
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.
NCI Community Oncology Research Program (NCORP) Updated Frequently Asked Questions on ResearchBases Request for Application (RFA) Select a category by clicking on its title below. How to search the content of the FAQs: Click on the FAQ Category you
The RFA, in Section IV, # 2, under Budget for Entire Period, states, "NCORP ResearchBase affiliation agreements MUST be included." But this is not reiterated or mentioned in the NCORP Program Guidelines.
Short term toxicity studies are conducted in animals to provide information on major adverse effects typically at the maximum tolerated dose (MTD). Such studies are important from a scientific and ethical perspective as they are used to make decisions on progression of potential candidate drugs, and to set dose levels for subsequent regulatory studies. The MTD is usually determined by parameters such as clinical signs, reductions in body weight and food consumption. However, these assessments are often subjective and there are no published criteria to guide the selection of an appropriate MTD. Even where an objective measurement exists, such as body weight loss (BWL), there is no agreement on what level constitutes an MTD. A global initiative including 15 companies, led by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), has shared data on BWL in toxicity studies to assess the impact on the animal and the study outcome. Information on 151 studies has been used to develop an alert/warning system for BWL in short term toxicity studies. The data analysis supports BWL limits for short term dosing (up to 7days) of 10% for rat and dog and 6% for non-human primates (NHPs). PMID:23602904
Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).
Pharmaceutical analysis is incorporated into the pharmaceutics component of the undergraduate curriculum at the University of Wisconsin. Many collaborative demonstrations, lectures, and laboratory experiments can illustrate the close relationship between analysis and modern pharmacy practice. (Author/LBH)
Pharmaceutical engineering is the branch of engineering devoted to the application of engineering concepts, scientific principles, and codes of practice to develop processes and scale-up criteria for drug manufacturing and pharmaceutical operations, including the operation of industrial facilities for pharmaceutical production. Pharmaceutical engineering is a new engineering area in the academic world. Because of its proximity to many pharmaceuticalcompanies,
Piero M. ARMENANTE; Joseph J. MANFREDI; Maureen A. HOWLEY; Steven A. OSTROVE
Problem statement: The pharmaceutical industry is a major contributor to industrial wastes globally. Effluents from this industry are usually discharged into the environment and when not properly handled and disposed, they affect both hum an health and the environment. Approach: This study evaluated the mutagenic potentials of effluen ts from six pharmaceuticalcompanies in the Lagos province of Nigeria using
A. Akintonwa; O. Awodele; A. T. Olofinnade; C. Anyakora; G. O. Afolayan; H. A. B. Coker
The animal health pharmaceutical industry has proactively reported on the volumes of member company antimicrobial active ingredients sold in the U.S. At the individual company level, reporting of finished product distribution data to the FDA is a regulatory requirement, with applications to surveillance and pharmacovigilance. An accounting of product manufactured is done for purposes of good business practices, as well as marketing analyses. Additional applications of antimicrobial usage data might include use in risk assessments, such as for the FDA's Center for Veterinary Medicine Guidance for Industry #152 for the evaluation of the microbiological safety of antimicrobials intended for use in food animals. Compilation of national usage data will be a complex undertaking, hindered by issues such as confidentiality, auditing, field use practice variations, population dynamics (e.g. disease incidence, market conditions for poultry and livestock production), and generic usage. The amounts or volumes in pounds should be considered relative to the large number of animals under husbandry in the United States. Large volumes might seem impressive unless put into proper context. Until such time as a clearly defined application of national usage data is agreed, it is recommended that local usage programs will provide more useful information to perpetuate prudent antimicrobial use in animals. PMID:16266763
In this paper we explore performance measurement practices in the pharmaceutical industry with particular focus on the inscribing (or ‘tracing’) of pharmaceutical representatives (‘drug reps’) responsible for the promotion of prescription medications to general practitioners and other healthcare professionals. We draw upon Latour’s sociology of translation to explore performance measures in the organizational field of pharmaceuticalcompanies operating in France.
In many developed countries, isolation of human pharmaceutical proteins from milk of genetically modified animals is currently a priority. One of the first commercial pharmaceuticals obtained from the milk of transgenic goats, an anticoagulant antithrombin III, developed by Genzyme Transgenic Corporation, an American biotechnological company, will appear on the pharmaceutical market in the nearest future. In this review, we discuss
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…
Today's revolutionary genomics research is the key to the search for tomorrow's new drugs. Over the next 10 to 20 years, there could be 15 times the number of therapeutic agents that there are today. With these scientific advances, optimal drug therapy becomes an even more significant component of health care. Canada's Research-BasedPharmaceuticalCompanies have proposed a therapeutic management system designed to make the optimum use of health care while controlling costs. The proposal is based on the disease management approach, applied first to diseases that are the most widespread in the population and that represent the highest costs for the health care system. The concept involves comparing the best available practices with the care provided and making the necessary adjustments to improve patients' health in line with the most cost effective approach. Preliminary results from similar programs underway in Canada, such as those in the field of asthma treatment, suggest that they can lead to improvements in the quality of care and represent a step forward in comparison with measures focusing only on cutting costs. The future will bring new challenges in achieving optimal drug therapy as genomics leads to tailor-made medications, necessitating changes in drug plan policies and reimbursement. With personalized treatment regimens and an increased understanding of how to prevent and treat diseases, optimal drug therapy can be taken to a new level. Quality of life can be further improved, more lives can be saved and the health care system can be saved more money while providing the best possible treatments. PMID:11586380
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.
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
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
The chosen companies were selected from a highly competitive field of applicants by an independent panel of experts from venture capital firms, bio-pharmaceutical and medical device companies, based on their strength of research, impact on cancer, product development, and market potential.
Progenics Pharmaceuticals is developing GMK vaccine (a ganglioside conjugate vaccine coupled to keyhole limpet hemocyanin and formulated with the adjuvant QS-21), licensed from the Memorial Sloan-Kettering Cancer Center, for the potential treatment of melanoma and other cancers , . It was previously under co-development with Bristol-Myers Squibb, but in May 2001, all rights to the GMK vaccine were returned to Progenics . It was the first of a new class of ganglioside conjugate vaccine evaluated by Progenics . GMK vaccination induces antibodies against GM2 ganglioside capable of specifically killing melanoma cells. Melanoma patients with antibodies against GM2 ganglioside have significantly improved disease-free and overall survival compared to antibody-negative subjects. The vaccine is undergoing two phase III trials, the first comparing GMK to high-dose IFNalpha in melanoma patients with more serious disease and at a high risk of relapse, and the second, in collaboration with the European Organization for Research and Treatment of Cancer, comparing GMK (14 doses of GMK over three years) to no treatment other than close monitoring of malignant melanoma patients at immediate risk of relapse . In February 1999, Lehman Brothers predicted that the vaccine had a 50% probability of reaching market, with an estimated first launch date in 2002. The analysts predicted potential peak sales in 2008 of $150 million in the US and $100 million in the rest of the world at that time . In January 2000, Lehman Brothers expected that an NDA filing would take place in 2002, with possible launch of the vaccine in 2003. In addition, Lehman Brothers estimated potential peak sales at $500 million . In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of GMK and PRO-542 in 2002 . In July 2001, Ladenburg Thalmann predicted a $257 million market potential for GMK in the US, with the non-US market equivalent to the US market. A launch date of 2005 in the US, with a worldwide launch in 2006, was estimated . PMID:12054067
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.
The pharmaceuticals we humans use to treat illness and disease typically enter the aquatic environment via the sewer network and wastewater treatment works. Understanding the risks posed to the aquatic environment by these chemicals requires an understanding of the concentrations that exist in the environment and whether they are sufficiently high to have adverse effects on aquatic organisms. The main source of pharmaceuticals to wastewater treatment works is pharmaceuticals used by the general population. Only a small contribution is believed to come from hospitals. The predicted environmental concentrations of pharmaceuticals suggest that certain pharmaceuticals may pose a risk to the environment, but measurement of the actual concentrations present in effluents and recipient waters suggest that sophisticated wastewater treatment is effective for significantly reducing effluent concentrations, and that environmental concentrations of pharmaceuticals, in the Oslo Fjord, for example, are generally low. Humans also excrete the metabolites of the pharmaceuticals that they have used and these too may be released into the environment, sometimes in greater concentrations than the parent drug. The occurrence of most pharmaceuticals and their metabolites in the environment poses little acute environmental risk. However, the effects of long-term chronic exposure to these compounds are still poorly understood and the long-terms risks to the environment are still not clear. What is clear is that certain pharmaceuticals pose a greater environmental risk than others, and that where possible this knowledge should be used to inform users of more environmentally friendly alternatives. PMID:22669389
Grung, Merete; Langford, Katherine; Thomas, Kevin V
In an apprenticeship-style course that mimics experiences in research laboratories and better reflects trends in educational reform, students perform team projects through collaboration with corporate research institutions. This research-based, student-ce
This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceuticalcompanies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient. PMID:17970244
This is the web site home for the Teacher Leaders in ResearchBased Science Education (TLRBSE) program supported by the National Optical Astronomy Observatory. It is designed to retain and renew middle and high school teachers of science by integrating the best practices of ResearchBased Science Education with the process of mentoring. The program involves teachers in research while also building leadership skills and pedagogical tools.
Unimed Pharmaceuticals announced the beginning of a phase II trial to test the safety and efficacy of Androgel-DHT (dihydrotestosterone gel) for treating HIV wasting syndrome and low testosterone levels in AIDS patients. The gel delivers the hormone by being absorbed into the skin. The company has also notified the FDA that this product qualifies for orphan drug designation for treating weight loss in AIDS patients. PMID:11363535
The content and organization of Poland's system of pharmaceutical education is described. Tables are presented of the subjects of the basic studies curriculum and the following areas of specialization: applied pharmacy, pharmaceutical analysis, clinical analysis, drug technology, herbal pharmacy, and bioanalysis and environmental studies. (SW)
Recombinant DNA technology has now made it possible to produce proteins for pharmaceutical applications. Consequently, proteins produced via biotechnology now comprise a significant portion of the drugs currently under development. Isolation, purification, formulation, and delivery of proteins represent significant challenges to pharmaceutical scientists, as proteins possess unique chemical and physical properties. These properties pose difficult stability problems. A summary of
Mark C. Manning; Kamlesh Patel; Ronald T. Borchardt
Pharmacogenomic Innovative Solutions Ltd (PGXIS) was established in 2007 by a group of pharmacogenomic (PGx) experts to make their expertise available to biotechnology and pharmaceuticalcompanies. PGXIS has subsequently established a network of experts to broaden its access to relevant PGx knowledge and technologies. In addition, it has developed a novel multivariate analysis method called Taxonomy3 which is both a data integration tool and a targeting tool. Together with siRNA methodology from CytoPathfinder Inc., PGXIS now has an extensive range of diverse PGx methodologies focused on enhancing drug development. PMID:21919604
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
With respect to special characteristics of pharmaceutical industry and lack of reported performance measure, this study tries to design an integrated PM model for pharmaceuticalcompanies. For generating this model; we first identified the key performance indicators (KPIs) and the key result indicators (KRIs) of a typical pharmaceuticalcompany. Then, based on experts? opinions, the identified indicators were ranked with respect to their importance, and the most important of them were selected to be used in the proposed model; In this model, we identified 25 KPIs and 12 KRIs. Although, this model is mostly appropriate to measure the performances of pharmaceuticalcompanies, it can be also used to measure the performances of other industries with some modifications. We strongly recommend pharmaceutical managers to link these indicators with their payment and reward system, which can dramatically affect the performance of employees, and consequently their organization`s success.
Shabaninejad, Hosein; Mirsalehian, Mohammad Hossein; Mehralian, Gholamhossein
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The aim of this article is to present the development of the pharmaceutical industry in Syria using national and international public data sources. At the end of the 80ies, the pharmaceutical industry in Syria was very poor, covering 6% of the national needs. In less than 20 years, with the government support in terms of legal frame and strategic political engagement, the Syrian pharmaceutical industry finally covered almost 90% of the national needs, in terms of drugs, and exported drugs in around 52 Arabian countries. Beyond covering the local market, the main added values of this huge development consisted in exporting drugs in amount of 150 million dollars per year and providing jobs for 17000 Syrian people, out of which around 85% are women. Strong and weak points of the pharmaceutical sector are taken into consideration in the article and further interventions to support a sustainable development are proposed by the author. PMID:20945828
The aim of this article is to present the development of the pharmaceutical industry in Syria using national and international public data sources. At the end of the 80ies, the pharmaceutical industry in Syria was very poor, covering 6% of the national needs. In less than 20 years, with the government support in terms of legal frame and strategic political engagement, the Syrian pharmaceutical industry finally covered almost 90% of the national needs, in terms of drugs, and exported drugs in around 52 Arabian countries. Beyond covering the local market, the main added values of this huge development consisted in exporting drugs in amount of 150 million dollars per year and providing jobs for 17000 Syrian people, out of which around 85% are women. Strong and weak points of the pharmaceutical sector are taken into consideration in the article and further interventions to support a sustainable development are proposed by the author.
In recent years, special educators' roles and responsibilities have undergone significant transformations deriving from both internal and external sources. This article initially reviews some of the reform movements that have sought to bring research-based practices into the classroom, particularly for students considered exceptional or at-risk. Although these reforms have changed both special and general education, they may not have necessarily
The invention relates to a pharmaceutical dosage form, preferably with controlled release of a pharmacologically active compound (A) contained therein, the pharmaceutical dosage form very preferably being tamper-resistant and most preferably having a breaking strength B.sub.1 of at least 500 N in direction of extension E.sub.1 and having a breaking strength B.sub.2 of less than 500 N in direction of extension E.sub.2.
\\u000a Nonprofit scientific, professional, and trade organization consisting of more than 140 firms engaged primarily in the manufacture\\u000a of prescription pharmaceutical, medical device, and diagnostic products; these firms account for more than 90% of US industry\\u000a sales of human dosage drugs; globally, by 2002 the 10 largest drug firms accounted for 48% of pharmaceutical sales worldwide\\u000a (1985: 20%); 8 of 10
Electronic detailing (e-detailing) means using digital technology by pharmaceuticalcompanies as a means of relaying information about pharmaceutical products to physicians. This study addresses the factors that could affect the decision of physicians to adopt e-detailing technology. Based on the theoretical foundations of technology adoption models, Rogers' work on diffusion of innovations could be useful to study physicians' adoption of
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…
Over the last 15 years, the pricing and other competitive strategies of pharmaceuticalcompanies have been altered by revolutionary developments in information technology, new state drug substitution laws, federal legislation, and the emergency of market ...
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. PMID:23902642
The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceuticalcompanies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.
Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceuticalcompanies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceuticalcompanies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction. PMID:24772685
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)
An Indian pharmaceuticalcompany has introduced its own brand of Lamivudine (3TC) to the Indian and overseas market. Cipla is offering Lamivir at a price that is less than half that of Glaxo. Lamivir is priced at $1.20 for each 150 mg tablet, compared with $2.80 to $5.80 for Glaxo's Epivir. PMID:11367089
Some otherwise desirable oil compositions derived from natural sources are characterized by an unpleasant odor. Fractions or combinations of such oils may also be so characterized. Stable, deodorized oils may be prepared by adding an amount of a deodorizing agent effective to substantially reduce the odor of the derived oil composition, fraction or combination thereof to that oil composition, fraction or combination. The pharmaceutical topical compositions of the present invention contain these stable, deodorized oil compositions and exhibit enhanced penetration properties and achieve enhanced patient response. The improved pharmaceutical compositions of the present invention may be used to manage pain and/or to treat the underlying ailments. Methods of making such topical pharmaceutical compositions are also discussed.
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
Pharmaceuticals have greatly improved health in developing countries, but many people in developing countries do not obtain even inexpensive pharmaceuticals and little pharmaceutical R&D is oriented toward products needed by developing countries, such as a malaria vaccine. Access to existing products could be improved by facilitating differential pricing, for example by subsidizing donation programs, and reforming health care delivery. R&D
Raman spectroscopy may be implemented through a microscope to provide fine scale axial and lateral chemical maps. The molecular structure of many drugs makes Raman spectroscopy particularly well suited to the investigation of pharmaceutical systems. Chemometric methods currently used to assess bulk Raman spectroscopic data are typically applied to Raman mapping data from pharmaceuticals; few reports exist where the spatial information inherent to a mapped dataset is used for the calculation of chemical maps. Both univariate and multivariate methods have been applied to Raman mapping data to determine the distribution of active pharmaceutical ingredients (APIs) in tablets, solid dispersions for increased solubility and controlled release devices. The ability to axially (depth) profile using Raman mapping has been used in studies of API penetration through membranes, cellular uptake of drug delivery liposomes, and initial API distribution and subsequent elution from coatings of medical devices. New instrumental developments will increase the efficiency of Raman mapping and lead to greater utilisation of Raman mapping for analyses of pharmaceutical systems. PMID:21194560
Provisions in the Australia-United States Free Trade Agreement (AUSFTA) may threaten the Australian Pharmaceutical Benefits Scheme (PBS), the "gold standard" of such programs worldwide. If Australia postpones passing of the US Free Trade Agreement Implementation Bill in the Senate, there will be opportunity for broader interests in both the United States and Australia to carefully study the agreement. The provisions of AUSFTA relating to the PBS are supposed to promote transparency, but the pharmaceutical manufacturers themselves (who are demanding transparency) do not reveal the content of their submissions to the Pharmaceutical Benefits Advisory Committee, or disclose all their financial relationships with researchers and policymakers. In AUSFTA, the "public health" language of affordable prescription drugs is missing and is replaced by language supporting "pharmaceutical innovation". Debate as to whether AUSFTA will force significant changes to the PBS, including higher drug prices, is currently under way in Australia. Perhaps the appropriate target of reforms should be the excessive US drug prices, and not the economically efficient Australian drug prices. PMID:15347274
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.
The need for a global medical information group at Eli Lilly and Company was identified in 1994. As a result, the Global Medical Information (GMI) Department was formed. GMI began the globalization process by benchmarking other pharmaceuticalcompanies and by surveying Lilly affiliate medical information groups. GMI then initiated a global medical information conference which validated the globalization plans, identified
Jennifer L. Riggins; Kevin J. Ferguson; Sheila I. Miller; Elaine Gorham
A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceuticalcompanies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceuticalcompanies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceuticalcompanies (1956 to 1970s). In this period, many Japanese pharmaceuticalcompanies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceuticalcompanies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceuticalcompanies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans. PMID:11613536
Recent ICH recommendations on test procedures and acceptance criteria for new drug substances of synthetic chemical origin and new drug products produced from them (Q6A) sets the frame for registration of new chemical entities. These requirements are automatically applied by all pharmaceuticalcompanies to products in late developmental phases. Furthermore, and justifiably so, they do not provide any guideline for setting specifications other than those for residual solvents and residues of heavy metal catalysts. During development of new chemical entities, ICH requirements represent a minimum beyond which additional testing has to be carried out in order to accumulate a body of scientific data which may ultimately permit simplified testing. This information is furthermore needed for drafting of registration files. This presentation will provide information on salt and polymorph selection, as well as morphology of particles. The need for more sophisticated techniques for assay of trace impurities by LC/MS will be illustrated with examples of alkylating agents. Complementary information from techniques such as CE, orthogonal to HPLC, is often needed to ensure absence of additional impurities. Finally, beyond compendial characterisation of hydroxypropylmethylcellulose, a commonly used excipient, by size exclusion chromatography with triple detection will be described. PMID:16158995
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
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.
There are a variety of oral and topical pharmaceutical agents for the treatment of osteoarthritis. To date there is no pharmacologic agent proved to prevent disease progression. This article focuses primarily on the medications used for symptomatic relief and palliation of pain. The article reviews the medications' mechanisms of action and the available efficacy literature, as well as indications, contraindications, and common adverse effects. PMID:22632707
The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus. PMID:19167054
Government policy debates on pharmaceutical pricing often turn on whether higher drug prices fund greater company-financed R&D spending. In the US, debate breaks down because each side uses a different measure of R&D spending, and the measures are far apart. Government agencies, Congress and consumer groups use government-generated survey data from the National Science Foundation (NSF), and the pharmaceutical industry uses survey data from the Pharmaceutical Research and Manufacturers of America (PhRMA). This issue is also relevant to academic work because some studies use NSF data, and others use PhRMA data. This article illustrates the pros and cons of these survey data series, and offers a more reliable, comprehensive and replicable alternative series, based on Compustat data. PMID:19014202
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
Deliquescence is a first order phase transition from solid to solution that occurs at a relative humidity (RH) that is characteristic to the crystalline compound. Such dissolution of active pharmaceutical ingredients and excipients can lead to detrimental physical and chemical instabilities. Furthermore, in systems containing more than one deliquescent component, the RH of the solid-solution transition will be lowered, leading to some level of dissolution at unexpectedly low RH conditions. Deliquescence lowering is independent of the ratio of the deliquescent components and therefore is of concern for any formulation containing two or more deliquescent compounds. Because chemical reactions occur much more readily in solution, deliquescence will enhance the degradation of labile APIs. RH fluctuations will lead to cycles of deliquescence and efflorescence (crystallization), which will contribute to particle agglomeration and caking. This review will address the phenomenon of deliquescence, the significance of deliquescence to pharmaceutical systems, measurement techniques, the kinetics and thermodynamics of deliquescence, the behavior of mixtures of deliquescent compounds (including phase diagrams and thermodynamics of binary systems), and consequences of deliquescence on chemical and physical stability. PMID:19895256
The healthcare burden is increasing in both the developed and the developing world and there is widespread acceptance that the historical pharmaceutical business model is not sustainable. In order to meet the healthcare challenge, companies and academia need to develop new business models to increase the probability of success and decrease the cost of failure. New partnerships have already emerged in the area of neglected diseases and other models for diseases of the developed world are emerging. PMID:21464073
Previous estimates of the potential value of higher plants in tropical forests for Pharmaceuticals are too high because analysts\\u000a mistakenly used gross revenues to value drugs instead of net revenues. Correcting this error, we estimate each new drug is\\u000a worth an average $94 million to a private drug company and $449 million to society as a whole. Given recent experience
The integrity of, and public respect for, clinical research and professional education is endangered by inadequate attention\\u000a to possible conflicts of interest and conflicts of commitment. All funding sources carry some risk of encouraging “incentive\\u000a bias,” and no reasonable critics have proposed doing away with pharmaceuticalcompany sponsorship of research and training.\\u000a Several have urged the pharmaceutical industry to assume
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 selection and study of candidate products, and their production requirements is presented. Antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon were studied. Production mass balances for antihemophilic factor, beta cells, and erythropoietin were compared for space verus ground operation.
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
The Pharmaceutical Assets Portal aims to facilitate industry-academic collaborations for discovery of new indications for compounds no longer being developed by pharmaceuticalcompanies, through eliminating barriers to access such compounds. The Portal’s enabling infrastructure includes a national investigator database; a Foci-of-Expertise browser; a material transfer agreement template; and a funding partner. Whereas the goal of creating a shared compound repository remains to be achieved, the Portal has established a mechanism to facilitate future drug repositioning opportunities.
Purpose Pain is a common physiological reaction. The development and sale of medication against pain is a main focus of pharmaceutical\\u000a companies, with total sales of prescription analgesics amounting to US$50 billion in 2009. In this market, advertising is\\u000a necessary. One way to market both new and old drugs is through direct physician-to-pharmaceutical sales representative (PSR)\\u000a contact. PSRs see themselves ideally
Christoph L. Lassen; Kirstin Fragemann; Tobias Klier; Nicole Meyer; Bernhard M. Graf; Christoph H. R. Wiese
The invention relates to methods of screening mixtures containing a pharmaceutical compound and an excipient to identify properties of the pharmaceutical compound/excipient combination that retard solid-state nucleation. The invention further relates to increasing the solubility, dissolution and bioavailability of a drug with low solubility in gastric fluids conditions by combining the drug with a precipitation retardant and an optional enhancer.
This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceuticalcompanies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceuticalcompanies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceuticalcompanies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly. PMID:11214458
The process of developing pharmacological treatments for alcohol use disorder is notoriously complex and challenging. The path to market is long, costly, and inefficient. One way of expediting and reducing the drug development process is through collaborations-building partnerships among government, academia, pharmaceutical and biotechnology companies, healthcare organizations and advocacy groups, and the patients (end consumers) themselves. By forging collaborations, particularly with pharmaceuticalcompanies, the alcohol treatment field stands to reap benefits in generating new medications for use in mainstream treatment settings. At the same time, there are certain caveats that should be considered, particularly by academic researchers, before entering into such partnerships. This commentary examines the advantages and caveats of government and academia collaborations with pharmaceuticalcompanies. PMID:24689461
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.
Even a cursory survey of this article suggests that the pharmaceutical sciences are being rapidly transformed under the influence of both the new technologies and sciences and the economic imperatives. Of particular importance are scientific and technological advances that may greatly accelerate the critical process of discovery. The possibility of a drug discovery process built around the principles of directed diversity, self-reproduction, evolution, and self-targeting suggests a new paradigm of lead discovery, one based quite directly on the paradigms of molecular biology. Coupled with the principles of nanotechnology, we may contemplate miniature molecular machines containing directed drug factories, circulating the body and capable of self-targeting against defective cells and pathways -- the ultimate "drug delivery machine." However, science and technology are not the only factors that will transform the pharmaceutical sciences in the next century. The necessary reductions in the costs of drug discovery brought about by the rapidly increasing costs of the current drug discovery paradigms means that efforts to decrease the discovery phase and to make drug development part of drug discovery will become increasingly important. This is likely to involve increasing numbers of "alliances," as well as the creation of pharmaceutical research cells -- highly mobile and entrepreneurial groups within or outside of a pharmaceuticalcompany that are formed to carry out specific discovery processes. Some of these will be in the biotechnology industry, but an increasing number will be in universities. The linear process from basic science to applied technology that has been the Western model since Vannevar Bush's Science: The Endless Frontier has probably never been particularly linear and, in any event, is likely to be rapidly supplanted by models where science, scientific development, and technology are more intimately linked. The pharmaceutical sciences have always been an example of use-directed basic research, but the relationships between the pharmaceutical industry, small and large, and the universities seems likely to become increasingly developed in the next century. This may serve as a significant catalyst for the continued transformation of universities into the "knowledge factories" of the 21st century. Regardless, we may expect to see major changes in the research organizational structure in the pharmaceutical sciences even as pharmaceuticalcompanies enjoy record prosperity. And this is in anticipation of tough times to come. PMID:10084422
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
The aim of this paper is to empirically analyse the responses by general practitioners to promotional activities for ethical drugs by pharmaceuticalcompanies. Promotion can be beneficial as a means of providing information, but it can also be harmful in the sense that it lowers price sensitivity of doctors and it merely is a means of maintaining market share, even when cheaper, therapeutically equivalent drugs are available. A model is estimated that includes interactions of promotion expenditures and prices and that explicitly exploits the panel structure of the data, allowing for drug specific effects and dynamic adjustments, or habit persistence. The data used are aggregate monthly GP prescriptions per drug together with monthly outlays on drug promotion for the period 1994-1999 for 11 therapeutic markets, covering more than half of the total prescription drug market in the Netherlands. Identification of price effects is aided by the introduction of the Pharmaceutical Prices Act, which established that Dutch drugs prices became a weighted average of the prices in surrounding countries after June 1996. We conclude that GP drug price sensitivity is small, but adversely affected by promotion. Ltd. PMID:15945041
Windmeijer, Frank; de Laat, Eric; Douven, Rudy; Mot, Esther
Occupation-induced skin reactions are not infrequently observed in the pharmaceutical industry. Workers may come in contact with irritant substances and also with chemically reactive intermediates or drugs that may be potential sensitizers. The skin lesions can be located at the site of contact, usually the hands, although airborne reactions on exposed and even nonexposed areas (eg, by particles trapped under clothing) are not uncommon. Generalized reactions may occur due to inhalation or transcutaneous absorption. An accidental exposure to a highly allergenic compound may cause a chemical burn, followed by primary sensitization and allergic contact dermatitis. The pharmaceutical contact allergens belong to many different pharmacologic classes. If several cases of contact dermatitis occur in multiple individuals in the same company, then the working conditions are implicated and should be changed to prevent their recurrence. Measures to be taken include dust control, installation of closed filter equipment, and keeping the workers informed about the potential risks associated with the manipulation of the chemicals. PMID:22014988
Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceuticalcompany owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future. PMID:1877607
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
Government agencies and members of the educational research community have petitioned for research-based curricula. The ambiguity of the phrase "research-based", however, undermines attempts to create a shared research foundation for the development of, and informed choices about, classroom curricula. This article presents a framework for the…
The pharmaceuticals and pharmaceutical metabolites salicylic acid, paracetamol, clofibrinic acid, and methotrexate were examined with regard to their biological degradability and toxicity toward algae,Daphnia,fish embryos, luminescent bacteria, ciliates, and the fish cell line BF-2. The EC50values calculated for the most sensitive organismic test (all except cell cultures) in each case were for salicylic acid, 37 mg\\/L (fish embryos); for paracetamol,
K.-P. Henschel; A. Wenzel; M. Diedrich; A. Fliedner
Interest in the physiologic and pharmacologic role of bioactive compounds present in plants has increased dramatically over the last decade. Of particular interest in relation to human health are the classes of compounds known as the phytoestrogens, which embody several groups of non-steroidal estrogens, including isoflavones and lignans that are widely distributed within nature. The impact of dietary phytoestrogens on normal biologic processes was first recognized in sheep. Observations of sheep grazing on fields rich in clover and cheetahs fed high soy diets in zoos suggested that flavonoids and related phytochemicals can affect mammalian health. Endogenous estrogens have an important role not only in the hypothalamic-pituitary-gonadal axis, but also in various non-gonadal systems, such as cardiovascular systems, bone, and central nervous systems, and lipid metabolism. There have been several clinical studies of hormone replacement therapy (HRT) in post-menopausal women to examine whether HRT has beneficial effects on the cardiovascular system, bone fractures, lipid metabolism, and Alzheimer's disease. In addition, estrogen contributes to the development of some estrogen-dependent cancers, such as breast cancer and prostate cancer and the number of patients with these cancers is increasing in developed countries. Although recent mega-studies showed negative results for classical HRT in the prevention of some of these diseases, the molecules that interact with estrogen receptors are candidate drugs for various diseases, including hormone-dependent cancers. This review focuses on the molecular properties and pharmaceutical potential of phytoestrogens. PMID:16543667
OSI-774 (formerly CP-358774), a quinazoline derivative, is an orally active epidermal growth factor receptor (EGFR) inhibitor which was originally under joint development by Pfizer and OSI Pharmaceuticals (formerly Oncogene Science) for the potential treatment of cancer (eg, ovarian, non-small cell lung cancer (NSCLC) and head and neck). It is being evaluated in phase II trials , . On 8 January 2001, OSI announced that it had signed an agreement with Roche and Genentech for the global co-development and marketing of OSI-774. The agreement with Genentech covers the United States, that with Roche the rest of the world , . In June 2000, OSI gained all development and marketing rights for OSI-774 following Pfizer's merger with Warner-Lambert . In September 2000, Pfizer transferred the IND dossierfor OSI-774 to OSI ahead of the timeline agreed in the June 2000 development and marketing rights agreement . The phase II trials will assess OSI-774 both as a single agent and in combination with existing chemotherapy regimens . Phase III trials are expected to be initiated in 2001 . In October 2000, Lehman Brothers predicted that OSI-774 would move into pivotal trials in thefirst half of 2001 and that the drug would be launched in 2003. The analysts also estimated worldwide sales of US $66 million, $285 million and $461 million in 2003, 2004 and 2005, respectively, and peak sales in excess of US $500 million . PMID:11816847
In February 1997, the Canadian National Forum on Health presented its recommendations for a pharmaceutical policy for Canada. These recommendations include moving towards a universal coverage, publicly funded drug plan; support for reference-based pricing as a method of containing drug plan costs; and requiring that pharmaceuticalcompanies turn over a portion of their research funds to the national research granting
There are two assumptions that are taken for granted in the pharmaceutical industry today. Firstly, that we can generate an unprecedented amount of drug-related information along the research and development (R&D) pipeline, and secondly, that researchers are more connected to each other than they have ever been, owing to the internet revolution of the past 15 years or so. Both of these aspects of the modern pharmaceuticalcompany have brought many benefits to the business. However, the pharmaceutical industry is currently under fire due to allegations of decreased productivity despite significant investments in R&D, which if left to continue at the present pace, will reach almost US 60 billion dollars by 2006. This article explores the role of knowledge in the industry and reviews recent developments and emerging opportunities in the field of knowledge management (KM) as it applies to pharmaceutical R&D. It is argued that systematic KM will be increasingly necessary to optimize the value of preceding advances in high-throughput approaches to R&D, and to fully realize the anticipated increase in productivity. The application of KM principles and practices to the business can highlight opportunities for balancing the current reliance on blockbuster drugs with a more patient-centric focus on human health, which is now becoming possible. PMID:15892246
THe so-called "New German Medicine", initially propagated in the health policy of the National Socialist Party, promoted greater use of phytotherapeutic and homeopathic drugs by the medical community. In response, the "Reichsfachschaft der pharmazeutischen Industrie e. V." (Association of Pharmaceutical Industry of the Reich") was obliged to pursue a carefully chosen double strategy, given that the members of the Association were both manufacturers of natural remedies and manufacturers of allopathic drugs.However, the fact that I.G. Farben completely ignored the "New German Medicine" suggests that the large chemical-pharmaceutical manufacturers did not take this policy very seriously. The only documents pertaining to increased research in the area of natural remedies stem from the medium-sized manufacturers Knoll and Schering. In the case of both companies it is noteworthy that they worked towards obtaining a scientific foundation for the developed preparates, and that they employed conventional methods of chemical analysis and proof of activity. THe growth of the classical manufacturers of natural remedies, such as the company Willmar Schwabe was, as far as any growth at all could be observed, significantly smaller than had been theoretically postulated. There is no casual relationship between any commercial success during the period in which the Nazis were in power and today's commercial prosperity.Moreover, from the viewpoint of the pharmaceutical industry, the "New German Medicine" seems to have passed its zenith before 1936, when the 4-year plan for war preparation entered into force. PMID:16025629
This article sheds a light on the Vietnamese pharmaceutical market. The progress that has been made in the recent years following the opening of the Vietnamese regime to the western world, although not easy, brought a certain number of opportunities for domestic firms and foreign investors. The pharmaceutical Vietnamese industry started to emerge at the beginning of the 1990s. Although, the consumption of drugs is low, it does reach the sum of $ 5.5 per capita. As the majority of these products are imported, foreign companies tend to dominate the market both in volume and in diversity. The state has always played an important role with the implementation of a strict price control strategy and most national drug companies remain state-owned. The production and consumption of drugs were also largely influenced by state policies as the latter also control hospitals. In the second half of the eighties, the progressive liberalisation of the country allowed private drug pharmacies to appear and advertisement campaigns became legal. Because the lack of specific products like antibiotics was clear, the government increased the flow of imports, including private imports by citizens. Sources of imports have become more diverse, although France remains an important source of supply. Fournier, Lipha and Pierre Fabre are among the French drug manufacturers located in Vietnam. Other foreign companies include from India, South Korea, Thailand and Germany. Joint ventures were also created with French and Japanese companies. The import of medical materials is subjected to authorisations from the Ministry of Health and the Ministry of Foreign Trade as it is necessary to obtain a licence to do so. Licences are issued on the basis of the production of drugs that do not currently exist on the local market. But Vietnam also exports pharmaceutical products to Laos, Cambodia, and Cuba. Local resources constitute an important source of new products and have stirred a strong interest among pharmaceutical researchers. A strong decentralisation process characterises the pharmaceutical sector, with pharmacies in the provinces and districts while wholesalers remain located in Hanoi and Saigon. The presence of many middlemen has contributed to an increase in prices. Today, a concentration of pharmacies is still noted in inner cities while the suburbs and the villages still have difficulties supplying drugs for inhabitants. Solutions have been implemented such as the opening of new pharmacies and additional professional training for pharmacists. Prices were lowered while the quality of the supply chain was improved. Local production is encouraged as hospitals are prompted to prescribe Vietnamese products. The modernisation of the Vietnamese pharmaceutical industry is also visible through the importation of medical materials and an increase in the number of private hospitals financed with both the help of local and foreign investors, mainly through joint-ventures, most often in Saigon and Hanoi. The renovation of local hospitals was also possible with the help of France and Japan. Columbia Gia Dinh International, located in Saigon, is one of the very few US/Vietnamese medical institutions created with a local partner, the Gia Dinh hospital. The recovery of the economy will accelerate the creation of new projects designed to improve local medical infrastructures. Other private companies, some of which are based in Singapore, have been specifically designed to deliver care to expatriates working in Vietnam. Insurance coverage has been provided in Vietnam since in 1992. Other improvements concern the implementation of "Good Manufacturing Practices" (GMP) and "Good Laboratory Practices" and "Good Storage Practices". Most norms were implemented at the end of the 90s in joint companies linking foreign investors and local partners or in independent foreign drug manufacturers based in Vietnam. Special areas were created to receive high tech investments in the medical and pharmaceutical field. Prices should diminish as competition o
Otsuka Pharmaceuticals in collaboration with Bristol-Myers Squibb is developing aripiprazole, a dual dopamine autoreceptor agonist and postsynaptic D2 receptor antagonist, for the potential treatment of psychoses including schizophrenia , . A regulatory filing for schizophrenia in the US was submitted at the end of 2001 . The compound entered phase III trials in Japan in 1995 . Although presynaptic dopamine autoreceptor agonists may be efficacious in the treatment of schizophrenia, they may also potentially increase the risk for exacerbation of psychosis through stimulation of postsynaptic dopaminergic receptors , , . However, earlier neuropharmacology studies have shown that aripiprazole can act as a presynaptic D2 agonist while displaying an antagonistic effect at the postsynaptic D2 receptors , , , , . In animal models, aripiprazole inhibits the apomorphine-induced stereotypy, without causing catalepsy , . Moreover, in contrast to classical antipsychotics that produce disabling movement disorders, aripiprazole does not cause an upregulation of D2 receptors or an increase in expression of the c-fos mRNA in the striatum, in agreement with the low risk for extrapyramidal side effects (EPS) during aripiprazole treatment , , , . Collectively, aripiprazole is an important atypical antipsychotic candidate with a favorable safety profile. Moreover, the mechanism of action of aripiprazole differentiates it from both typical and atypical antipsychotics and hence, may provide important leads for pharmacotherapy of schizophrenia and other psychotic disorders. In January 2000, Lehman Brothers predicted peak sales of aripiprazole could reach US $500 million . In February 2001, Credit Suisse First Boston predicted sales of US $403 million in 2005 . PMID:12054061
The Research-Based Web Design and Usability Guidelines (Guidelines) developed by the Communication Technologies Branch (CTB) of the National Cancer Institute (NCI) in the U.S. Department of Health and Human Services. The guidelines were developed to assis...
The Partnership for Reading is pleased to present 'Research-Based Principles for Adult Basic Education Reading Instruction.' The Partnership, an initiative of the National Institute for Literacy, the U.S. Department of Education, the National Institute of...
...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...
Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceuticalcompanies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing. PMID:19408179
Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David
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.
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
Using survey data from 364 employees of four mid-sized pharmaceuticalcompanies in India, we tested the relationship between propensity to trust and the three components of organizational commitment. Standardized measures of propensity to trust and organizational commitment were administered after creating temporal separation in data collection to control common source variance. Results supported most hypotheses. Propensity to trust was found
This commentary offers an overview of some current trends of the pharmaceutical industry drawing on examples taken from the analysis of four companies (Pfizer, Merck, Novo Nordisk, Crucell). The very brief analysis looks at diversification paths, pipeline management strategies, generic competition as well as corporate social responsibility policies. PMID:21782941
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…
Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.
As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing. PMID:9800720
The pharmaceutical sector is a part of today's economy in which the relationship between patents and competition has been receiving increasing attention. The European Commission's inquiry into this sector adds to the ongoing debate. Its Preliminary Report, published in November 2008, explains and quantifies a number of practices adopted by individual companies operating in the sector. The Report focuses on two strands of interplay between pharmaceuticalcompanies. The first focus is on competition between originator and generic companies and the second relates to competition among originators themselves. The Report's observations on the former provide us with some important insights into the potential ways of raising barriers to the timely entry of cheaper, off-patent products, while scrutiny of the latter adds to our understanding of the current rate of introducing new innovative products into the market. The study is completed by a number of observations on the sector's regulatory framework. The presentation below follows the order of findings described in the Report. PMID:20107914
Individualized health management is one of the most exciting challenges facing health care marketing today. Greater access to health information has empowered consumers to take more control of their health needs, creating a whole new landscape for marketers, manufacturers, and service providers. Customization is the key to creating marketing campaigns that successfully target today's health-conscious consumers. Drawing on individualized market intelligence and available genetic information, pharmaceuticalcompanies are learning to tailor products to meet the needs of this growing market. PMID:11291513
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
This paper provides empirical evidence on the leading factors affecting the prices of new pharmaceuticals, both at introduction and after 4, 6, and 8 years. Most important is the extent of therapeutic advance embodied in a new product. For drugs which represent important therapeutic gains, launch prices can be two or three times those of existing drugs used for the
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…
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 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.
Taste masking is an important factor in the development of oral dosage forms containing bitter active pharmaceutical ingredients. Currently numerous techniques are being applied to overcome this problem. Realizing this, several researchers and pharmaceuticalcompanies are now engaged in developing novel techniques to address the problem of taste masking evident by numerous patents filed in this area in recent times. In this review the most recent patents for taste masking are discussed and how these patents overcome the limitations of conventional approaches of taste masking is also highlighted. Novel techniques based on some recent patents such as nanohybrid, melt extrusion, non-complex cyclodextrin compositions and off taste masking are providing new realms to taste masking of bitter drugs. The present article also provides an overview of various patented platform technologies based on different techniques/mechanisms employed for taste masking. The unique features and principles of taste-masking approaches used in various patented technologies are also discussed. A better understanding of these new patents and patented technologies will help researchers and pharmaceutical industries to select the appropriate platform, or to develop innovative products with improved taste masking properties. PMID:24499438
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 electrophoresis process, the selection and study of candidate products, and their production requirements is described. The candidate products are antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon. Production mass balances for antihemophelic factor, beta cells, and erythropoietin were compared for space versus ground operation. A conceptual description of a multiproduct processing system for space operation is discussed. Production requirements for epidermal growth factor of alpha-1-antitrypsin and interferon are presented.
The pharmaceutical industry is accountable on the one hand to its shareholders and on the other to the community at large. These two obligations can, in principle, be met. However, the industry has developed practices that do not consider society, including excessive or inappropriate pricing of drugs, an indifference to the needs and limitations of the developing world, an imbalance between true innovation and promotional activity, interference with clinical investigations, and efforts to mould medical thinking and priorities as a means to enlarge the market. In such respects, the pharmaceutical industry must now be called to order. The industry has shown itself to be sufficiently resilient to adapt to change if society insists on it. However, to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society's public-health interests. PMID:12457804
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
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.
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review. PMID:24854893
Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet
Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer’s V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceuticalcompanies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India.
Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer's V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceuticalcompanies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India. PMID:24826027
With the advent of the Internet, the World Wide Web and social networking systems, a number of collaborative environments have been developed that support efforts in online science education. This paper examines the basic aspects of online collaboration, describes two differing types of collaborative environments currently used, and discusses the elements of successful collaborative environments for online projects that enable research-based science education.
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.
Knudsen, Lisbeth E. [Institute of Public Health, University of Copenhagen, Blegdamsvej 3, DK2100 Copenhagen O (Denmark)
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.
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
Would you ever think Illinois could ever be a leading oil-producing state? The Ohio Oil Company, now known as Marathon Refinery in Robinson thought Illinois was a good place to pump oil. The company was originally established in 1887 in northwestern Ohio by a group of independent oil producers who appointed Henry M. Ernst as president. The company grew rapidly
Over the last 20 years, the number of publications outlining the advances in design strategies, growing techniques, and characterization of cocrystals has continued to increase significantly within the crystal engineering field. However, only within the last decade have cocrystals found their place in pharmaceuticals, primarily due to their ability to alter physicochemical properties without compromising the structural integrity of the active pharmaceutical ingredient (API) and thus, possibly, the bioactivity. This review article will highlight and discuss the advances made over the last 10 years pertaining to physical and chemical property improvements through pharmaceutical cocrystalline materials and, hopefully, draw closer the fields of crystal engineering and pharmaceutical sciences.
BACKGROUND The relationship between physicians and the pharmaceutical industry is controversial because of the potential for conflicts of interest. However, little empirical evidence exists on the extent of physician participation in activities sponsored by pharmaceuticalcompanies. OBJECTIVES To determine the prevalence of participation of internal medicine physicians in clinical trials and lectures sponsored by pharmaceuticalcompanies and to describe factors that are associated with such participation. DESIGN, SETTING, AND PARTICIPANTS We conducted a cross-sectional regional survey of 1,000 Maryland internal medicine physicians between February 2000 and January 2001 in order to measure the prevalence of physician participation in pharmaceutical-sponsored clinical trials and lectures. We also collected economic and demographic information to examine potential associations between physician characteristics and engagement in such activities. RESULTS Of 835 eligible physicians 444 (53%) responded, of whom 37% reported engaging in pharmaceutical-sponsored clinical trials and/or lectures to supplement their incomes. In our multivariable analysis, subspecialists versus generalist physicians (odds ratio [OR], 1.85; 95% confidence interval [CI], 1.14 to 2.99), physicians in private group-single specialty and academic practice versus physicians in solo practice (OR, 2.30; 95% CI, 1.19 to 4.44 and OR, 2.56; 95% CI, 1.17 to 5.61, respectively), and physicians with higher versus lower annual incomes (OR, 1.22; 95% CI, 1.04 to 1.44) had a greater odds of participation in these activities. Additionally, physicians dissatisfied with their income had a 140% greater odds of participation (OR, 2.36; 95% CI, 1.45 to 3.83) than those who were satisfied with their income. CONCLUSIONS A substantial number of internists engage in pharmaceutical industry-sponsored clinical trials and/or lectures in an effort to supplement their incomes. Physician dissatisfaction with income appears to partially explain such participation.
Ashar, Bimal H; Miller, Redonda G; Getz, Kelly J; Powe, Nell R
Total Electron Yield (TEY) oxygen K-edge NEXAFS detects the presence of strongly adsorbed water molecules on poloxamer-coated pharmaceutical actives, which provides a useful spectroscopic indicator for bioavailability. The results are supported by complementary XPS measurements. Carbon K-edge spectra obtained in a high-pressure NEXAFS cell were used in situ to establish how a polymer coating spread on a drug surface by using humidity induced dispersion of the coating. Finally, we demonstrate how combined Carbon and Oxygen K-edge measurements can be used to characterize amorphous surface layers on micronised crystals of a drug compound.
Murray Booth, A.; Braun, Simon; Lonsbourough, Tom; Purton, John; Patel, Sunil; Schroeder, Sven L. M.
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
Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceuticalcompanies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceuticalcompanies was refined by expert opinions extracted from result of questionnaires.
Objectives: The aim of this study was to investigate originator pharmaceuticalcompanies' practices in relation to health technology assessment (HTA) and the views and perceptions of their executives on the importance of HTA in pricing and reimbursement of medicines in Greece. Methods: A qualitative study was performed, using individual semi-structured interviews based on an interview schedule with open-ended questions. The target population was market access departments' executives of originator pharmaceuticalcompanies. Our target sample consisted of sixteen executives, of whom ten agreed to participate. Saturation point was reached after eight interviews. Data were audio recorded, transcribed verbatim, and analyzed using content analysis. Results: Participants considered HTA as a very important complementary tool for decision making in health policy, particularly in the field of pharmaceuticals and medical devices. They believed that, in Greece, HTA could be institutionalized for the reimbursement mechanism of medicines under certain conditions relating to current health policy-making attitudes and conditions pertaining in the country. They considered that there are many constraints which must be overcome as well as opportunities to be exploited. Conclusions: Decisions in pharmaceutical policy should be scientifically substantiated and HTA should be institutionalized primarily for reimbursement decisions. Development of guidelines for conducting pharmaco-economic evaluation, change in health policy goals, recording of cost and epidemiological data, and broader participation of all stakeholders in HTA decision-making processes are suggested as prerequisites for a successful implementation of HTA in Greece. PMID:24806287
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
The physical, emotional, and financial costs of caring for patients with chronic, nonhealing leg wounds are substantial. In fiscal year 2001, the home care department of a large Veterans Affairs medical center in the Pacific Northwest spent nearly half of its annual budget on veterans needing wound care. In this article, the authors describe a practice improvement project designed to improve the wound care management of homebound veterans with chronic, nonhealing lower extremity wounds using a research-based protocol and consultation by a certified wound care specialist, as well as the effect of this program on home care expenditures. PMID:18019117
As a normal part of the drug development process, U.S. pharmaceuticalcompanies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the "common rule" if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients' rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceuticalcompanies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo-controlled clinical trials may adversely impact drug development. PMID:12481798
Scarcity of health care resources draws attention to the expenditure on pharmaceuticals, as drugs are considered to be one of the major growth drivers of health care spending. This article assesses the Hungarian expenditure on pharmaceuticals by taking into account the economic status of the country and benchmarks from other OECD countries with special focus on indicators of Visegrad V4 countries (Czech Republic, Slovakia, Poland and Hungary). Our results highlight the heterogeneity of pharmaceutical expenditure data derived from different indicators among observed countries. Pharmaceutical spending is relatively higher in middle-income countries, mainly due the price convergence of innovative drug's, on contrary manpower cost of health care services are adjusted to local price levels, therefore the price differential of health care services between middle income and developed countries is greater. International trends of the global pharmaceutical market are also valid in Hungary. Increased private funding, mainly out of pocket payments above the average of V4 countries, has been the major growth driver of pharmaceutical expenditure recently in Hungary. Increased private pharmaceutical expenditure was mainly derived from the severe cost-containment measures in 2006. The annual growth rate of the National Health Insurance Fund's pharmaceutical budget for drug reimbursement was 1.37% in real terms between 1994 and 2009. This is much beneath the expansion of global pharmaceutical market. Consequently, cost-containment of public pharmaceutical spending was very successful in the last fifteen years, and the burden of market growth has been shifted to households. Public health programmes, investment into preventive care, with consideration on unfavourable Hungarian morbidity and mortality indicators, however, necessitate the increase of public pharmaceutical budget. In order to improve the allocative efficiency of health care spending, available resources should be spent only on effective, cost-effective, economically affordable medicines. PMID:21404477
In August 1999, the US Food and Drug Administration (FDA) approved Apri, a new oral contraceptive from Duramed Pharmaceuticals. Apri is available at approximately 30% less than the retail cost of comparable pills and is the first substitutable product equivalent to Ortho-Cept and Desogen, both of which contain 30 mcg of ethinyl estradiol and 150 mcg of desogestrel. Duramed, a longtime manufacturer of generic pharmaceuticals, has gained FDA approval for other women's health products in the last 2 years, including 1) medroxyprogesterone acetate tablets for treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance, 2) estropipate tablets for treatment of vasomotor symptoms of menopause and prevention of osteoporosis, and 3) estradiol tablets. In March 1999, Duramed also gained FDA approval for Cenestin, a conjugated estrogen drug product that is made of 9 synthetic estrogen components derived from a compound obtained from plant material. This drug is safe for short-term use in treating vasomotor symptoms such as hot flashes and sweating associated with menopause. PMID:12295619
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
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
Astronaut William G. Gregory, pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour during the STS-67 mission. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical, but also biotechnology, cell biology, fluids, and crystal growth investigation
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…
Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. Purpose: The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. Methodology: This paper represents a thorough literature review of the multifaceted sources including: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). Discussion: In the thirty years pharmaceuticalcompanies have consistently developed and launched new medicines, bringing hope to sick or – at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceuticalcompanies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceuticalcompanies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Conclusion: Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and eliminating a major source of the industry’s profits. Still, there is plenty of room for improvement in the medications people take while there is no shortage of human suffering to alleviate. It is doubtful whether big pharmaceutical firms will be able to pursue these goals within the old model of developing exclusive new drugs that can be sold further in the future. In the past, medicines for the ailments that were never before addressed, like anti-cholesterol or anti-depression drugs were developed. Currently, and in the future, it is expected that only blockbuster modifications will be developed. This phenomenon is expected to create market saturation, which will significantly reduce profits. The business model that drove the major drug makers’ success is not working anymore. Pharmaceuticalcompanies must create new ways and to bring new ideas. The survivors will be those that market strategies supported by innovative approaches and winning capabilities.
Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company’s medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field.
Atrial fibrillation is one of the most common long-lasting arrhythmias of the heart. It leads to an increase in morbidity and a substantial reduction in quality of life in most patients. Therefore, an early and adequate therapy strategy and prevention of comorbidities of atrial fibrillation are demanding. There is no controversy about the pharmaceutical treatment as the first choice and gold standard in atrial fibrillation patients. As there is no evidence that frequency control is superior to rhythm control or vice versa, therapy strategies should depend on the clinical status and comorbidities of the individual patient. However, adequate anticoagulation for prevention of thromboembolism should be performed in every patient, even after conversion of atrial fibrillation into sinus rhythm. PMID:18629452
Sinha, Anil-Martin; Brachmann, Johannes; Schmidt, Martin
An analysis of the politics of Bangladesh pharmaceutical policy in the 1980s shows how significant health policy reforms in developing countries depend on political conditions both inside and outside the country. Bangladesh's drug policy of 1982 illustrates that governments can sometimes change public policy in ways unfavourable to multinational corporations, while the failed health policy reform of 1990 shows that reforms unfavourable to powerful domestic interest groups can be more difficult to achieve, even contributing to a government's downfall. The case provides evidence of basic changes in how the international agenda for health policy is set, especially the growing role of non-governmental organizations in international agencies and national policy debates. Understanding the political patterns of policy reform in Bangladesh has important implications for strategies to affect health policy in developing countries. PMID:15726775
Objective To describe the sources of internal company documents used in public health and healthcare research. Methods We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. Results Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceuticalcompanies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceuticalcompany documents, but the search retrieved an impractical number of citations for review. Conclusions Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for research, indicating a need for funding for this type of research and well-indexed and curated repositories to provide researchers with ready access to the documents.
Wieland, L. Susan; Rutkow, Lainie; Vedula, S. Swaroop; Kaufmann, Christopher N.; Rosman, Lori M.; Twose, Claire; Mahendraratnam, Nirosha; Dickersin, Kay
Studies in the field of forensic pharmacology and toxicology would not be complete without some knowledge of the history of drug discovery, the various personalities involved, and the events leading to the development and introduction of new therapeutic agents. The first medicinal drugs came from natural sources and existed in the form of herbs, plants, roots, vines and fungi. Until the mid-nineteenth century nature's pharmaceuticals were all that were available to relieve man's pain and suffering. The first synthetic drug, chloral hydrate, was discovered in 1869 and introduced as a sedative-hypnotic; it is still available today in some countries. The first pharmaceuticalcompanies were spin-offs from the textiles and synthetic dye industry and owe much to the rich source of organic chemicals derived from the distillation of coal (coal-tar). The first analgesics and antipyretics, exemplified by phenacetin and acetanilide, were simple chemical derivatives of aniline and p-nitrophenol, both of which were byproducts from coal-tar. An extract from the bark of the white willow tree had been used for centuries to treat various fevers and inflammation. The active principle in white willow, salicin or salicylic acid, had a bitter taste and irritated the gastric mucosa, but a simple chemical modification was much more palatable. This was acetylsalicylic acid, better known as Aspirin®, the first blockbuster drug. At the start of the twentieth century, the first of the barbiturate family of drugs entered the pharmacopoeia and the rest, as they say, is history. PMID:21698778
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
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
The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual difficulties of pharmaceutical development, pharmaceuticals made by plants have achieved pertinent milestones albeit slowly compared to other pharmaceutical production systems and are now at the cusp of reaching the consumer. Though the current economic climate begs for cautious investment as opposed to trail blazing, it is perhaps a good time to look to the future of plant-made pharmaceutical technology to assist in planning for future developments in order not to slow this technology’s momentum. To encourage continued progress, we highlight the advances made so far by this technology, particularly the change in paradigms, comparing developmental timelines, and summarizing the current status and future possibilities of plant-made pharmaceuticals.
Thomas, David R.; Penney, Claire A.; Majumder, Amrita; Walmsley, Amanda M.
Clinical trials constitute large, complex, and resource intensive activities for pharmaceuticalcompanies. Accurate prediction of patient enrollment would represent a major step forward in optimizing clinical trials. Currently models for patient enrollment that are both accurate and fast are not available. We present a discrete event model of the patient enrollment process that is accurate and uses relatively small CPU
Bernard M. McGarvey; Nancy J. Dynes; Burch C. Lin; Wesley H. Anderson; James P. Kremidas; James C. Felli
Clinical trials constitute large, complex, and resource in- tensive activities for pharmaceuticalcompanies. Accurate prediction of patient enrollment would represent a major step forward in optimizing clinical trials. Currently models for patient enrollment that are both accurate and fast are not available. We present a discrete event model of the pa- tient enrollment process that is accurate and uses relatively
Bernard M. Mcgarvey; Nancy J. Dynes; Burch C. Lin; Wesley H. Anderson; James P. Kremidas; James C. Felli
CEO and President Adrian Adams described Auxilium Pharmaceuticals as "the same as a Big Pharma company, only smaller." This 'specialty biopharmaceutical company' has transformed itself in the last 6 to 9 months to become the "leading men's healthcare franchise with a broad and diverse product portfolio." All of this has led to a very busy 2013, which began with the USD 600 million acquisition (Q2) and integration of Actient Pharmaceuticals, the licensing of avanafil (Stendra™) for erectile dysfunction and ended with the approval of collagenase Clostridium histolyticum (Xiaflex®) in Peyronie's disease. From a portfolio of 2 products at the beginning of 2013, Auxilium ended the year with 12. PMID:24696871
The state of the art in flow-chemiluminescence (flow-CL) technique for automated pharmaceutical analysis is reviewed. Flow-CL approaches have become powerful and promising tools for pharmaceutical screening in recent years due to their simplicity, low cost and high sensitivity. Because of these advantages, these methods have been widely used for pharmaceutical analysis in recent years. The literature reviewed covers papers of analytical interest that appeared between 2007 and mid-2012 and have been divided into several sections based on fundamental types of CL systems employed. Furthermore, entries have been summarized alphabetically in tabular form giving details of analytical figures of merit of the methods. PMID:23124900
Can the pharmaceutical industry learn anything from other powder processing industries? Although essential regulatory processes have ensured that the pharmaceutical industry is a leader in quality assurance, they have also led to a conservative approach to process technology. Conservatism is advantageous when the dosage form and profit margins are stable; however, for most other industries, form, price and quality of product are all subject to fickle customer requirements. Other powder industries have used a sequential questioning approach to elicit new technical responses to change. Perhaps the time is ripe for this to be introduced to the pharmaceutical industry? PMID:10996571
Despite the efforts of the medical community, as well as promotional efforts by pharmaceuticalcompanies, relatively few women in the US have heard of emergency contraceptives (ECs). Gynetics, marketer of Preven, plans to file a new drug application for a levonorgestrel EC by the end of 1999, with an anticipated approval in the second half of 2000. Women's Capital Corp., marketer of Plan B, is also aiming for a national commercial launch of its product. According to a recently published acceptability study, women will use ECs when they are made available. A survey among 235 women at 13 Kaiser Permanente medical offices in San Diego, California, regarding their experiences with ECs showed that 91% were satisfied with ECs, and 97% said they would use ECs for emergencies only--dispelling fears that women would forego use of ongoing contraception. About 70% of the women who participated in the study were using a contraceptive method when they requested ECs. PMID:12295558
Pharmaceuticalcompanies provide the majority of financial support for staging the American Academy of Family Physicians (AAFP) Annual Scientific Assembly. In return they are allowed to dominate the physical and mental environment. The assembly is opulent and entertaining, but undoubtedly much of the expense is passed to the health care consumer in the form of high-priced brand-name prescription drugs. Additionally, public perception of such spectacles threatens the image that the AAFP has been careful to nurture--that family physicians are the ultimate advocates for our patients and, by extension, the health care-consuming public. Family physicians and our representative AAFP must recognize our complicity with and vulnerability to media forces. We must further adjust our role, not only to avoid the appearance of impropriety but to rededicate ourselves to our science, our intellectual basis, and ultimately our patients. PMID:16823679
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…
The Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (academicians, scientists, regulators, industrialists, venture capitalists) who shared their views on the forces that might determine how the pharmaceutical sciences will look in 2020. The commentary here provides a summary of major research activities that will drive drug discovery and development, enabling technologies for pharmaceutical sciences, paradigm shifts in drug discovery, development and regulations, and changes in education to meet the demands of academia, industry and regulatory institutions for pharmaceutical sciences in 2020. PMID:20107875
The relations between healthcare professionals and pharmaceutical laboratories can influence treatment choices. Increasingly, nurses are a target for a visit from a medical representative. The French National Authority for Health supports professionals in their reception of medical information. PMID:24839688
A rationale for defining "clinical pharmaceutical scientist" is developed along with an outline of the aims and purposes of a training program for him. Postdoctoral (PharmD) fellowships are described as the most effective training method. (LBH)
Meetings & Events Investigators' - Site Coordinators' Opportunity for Research Excellence (I-SCORE) Workshop March 20-21, 2014 Poster Presentations – Full List « Previous | Next » MRIGlobal Pharmaceutical Development and Repository Management Jonathan
Pharmaceutical manufacturers generate a variety of wastes during manufacturing, maintenance, and housekeeping operations which can be reduced or minimized through source reductIon and recycling. he typical waste streams are spent fermentation broths, process liquors, solvents, eq...
The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environme...
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 ...
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
In recent years, the Spanish government has been battling to keep pharmaceutical expenditures under control. Its measures include control of prices, introduction of a "negative list" of drugs no longer reimbursed, increased cost-sharing, and introduction of overall budgets for pharmaceutical expenditures. Although the average prices of old pharmaceutical products declined by 39 percent over the last 15 years and consumption in value increased by only 10 percent, real pharmaceutical expenditures in Spain increased by 264 percent over that period. The main reason for the continuing rise in these expenditures and the failure of cost-containment measures is the introduction of new, more expensive drugs, which often fail to offer any real therapeutic advantages over products already on the market. This situation is exacerbated by a lack of effective demand-side measures such as budgets for doctors and lack of a generics market. PMID:11109184
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.
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 ...
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.
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 ?g/L. Four pharmaceuticals (methadone, oxycodone, butalbital, and metaxalone) in samples of NY3 effluent had median concentrations ranging from 3.4 to >400 ?g/L. Maximum concentrations of oxycodone (1700 ?g/L) and metaxalone (3800 ?g/L) in samples from NY3 effluent exceeded 1000 ?g/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 ?g/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.
The development of research-based active-learning instructional methods in physics has significantly altered the landscape of U.S. physics education during the past 20 years. Based on a recent review [D.E. Meltzer and R.K. Thornton, Am. J. Phys. 80, 478 (2012)], we define these methods as those (1) explicitly based on research in the learning and teaching of physics, (2) that incorporate classroom and/or laboratory activities that require students to express their thinking through speaking, writing, or other actions that go beyond listening and the copying of notes, or execution of prescribed procedures, and (3) that have been tested repeatedly in actual classroom settings and have yielded objective evidence of improved student learning. We describe some key features common to methods in current use. These features focus on (a) recognizing and addressing students' physics ideas, and (b) guiding students to solve problems in realistic physical settings, in novel and diverse contexts, and to justify or explain the reasoning they have used.
Abstract Pharmaceuticals present in sewage,may inhibit the biological processes in a sewage,treatment plant. In this work, the toxic-effect of six pharmaceuticals (carbamazepine, sulfamethoxazole, propranolol hydrochloride, diclofenac sodium, ofloxacin and clofibric acid) on the anaerobic digestion process is assessed. Acetoclastic methanogenes,are the most sensitive group of microorganisms participating in the anaerobic digestion process. Appropriate toxicity tests for these microorganisms,were then based
M. fountoulakis; P. drillia; K. Stamatelatou; G. Lyberatos
This chapter presents the current state of die compaction modelling in the pharmaceutical industry. The topic is introduced\\u000a with a review of the particular features of pharmaceutical powder formulations. The operation of rotary production presses\\u000a is described together with experimental procedures developed to characterise die-fill and high-speed compression. The experimental\\u000a techniques described in Chapters 4–8 are employed to characterise the
The detailed knowledge of the human genome has not fulfilled its promise as yet. It seems fair to say that we are far from treating existing diseases by therapeutic interventions developed on the basis of genetic knowledge. However, pharmacogenetics has shown to be useful in improving our understanding of pharmacotherapy. Industry is starting to embed this knowledge in the design of innovative drugs and there are three important areas of interest: safety, efficacy and target identification. Application of pharmacogenetics e.g. in patient selection are leading to the direction of more personalised medicine. The future will bring more of such applications. However, current knowledge also leads to a more integrated approach of pharmacogenetics as part of systems biology, providing an even more complete image of reality surrounding disease and therapy, including for example environmental factors and behaviour. In addition, collaborative efforts with academic partners are very much welcomed by the pharmaceutical industry and are expected to have a synergistic effect on progression in this field. PMID:20205665
Raaijmakers, Jan A M; Koster, Ellen S; Maitland-van der Zee, Anke-Hilse
Livestock animals have made a significant contribution to human health and well-being throughout humankind's history. A significant contribution of farm animals to human health are the longstanding use of bovine and porcine for production of insulin (for treatment of diabetes), gelatin (for pharmaceutical and other purposes), as well as horse and sheep antibody against natural venoms, toxins, drugs and microbial peptides. Gelatin being the biggest animal protein consumed in human health, follows with antibodies fragments. The chronic problem of animal-derived therapeutics, especially those of high molecular weight, is the immunogenicity induction in addition to their biosafety. However, the invertebrates and lower vertebrates donate the human being a several crucial emergency saving life small-peptides or their analogs such as Refludan, Prialt, Exendin. Not only, but the farm animals are enormously using as models for novel surgical strategies, testing of biodegradable implants and sources of tissue replacements, such as skin and heart valves. Recently, they are being harnessing as bioreactor for production of biopharmaceutical related products through gene farming with efficiency far greater than any conventional microbial or cell-culture production systems. Only 16 transgenic cows would be covering the worldwide needs from human growth hormone. The transgenic, especially animal, technology would be solving a several biopharmaceutical products disadvantages, such as cost, biosafety, immunogenicity and the availability dimensions. PMID:19591041
Pressed by an impressive series of corruption scandals and by a change of attitude towards cost-containment, the Italian pharmaceutical sector's regulatory environment was radically changed in 1994. Regulatory power was concentrated on a national technical body (CUF) and a new set of measures was taken, including a nationwide drug expenditure budget, a redefinition of both the positive list and the cost-sharing rules, and new price-setting models. As a result, in the period 1993-1996, nominal expenditures decreased by about L 1600 billion (ECU 83.6 billion at 1997 exchange rate), that is from 13.3% to 11.0% of current National Health Service (NHS) expenditure. While in the 1980s Italy was one of the most generous countries in funding pharmaceuticals, it is now one of the most parsimonious. Although the overall pharmaceutical market shrank in 1994 and 1995, a substantial part of NHS drug-bill savings resulted from cost-shifting from the public sector to patients, mainly because physicians have not aligned their prescribing behaviour to the new positive list. The new Italian approach to containing pharmaceutical costs has been certainly effective, at least in the short run. However, new relevant issues are emerging regarding the fall of NHS pharmaceutical coverage, the centralised nature of the Italian pharmaceutical policy and the gap between scientific based policies and actual prescribing behaviours. PMID:10187653
Rejection of four pharmaceutical compounds, carbamazepine, diclofenac, ibuprofen and naproxen, by forward osmosis (FO) membranes was investigated in this study. For the first time, the rejection efficiency of the pharmaceutical compounds was compared between commercial cellulose triacetate (CTA) based membranes and thin film composite (TFC) polyamide based membranes. The rejection behavior was related to membrane interfacial properties, physicochemical characteristics of the pharmaceutical molecules and feed solution pH. TFC polyamide membranes exhibited excellent overall performance, with high water flux, excellent pH stability and great rejection of all pharmaceuticals investigated (>94%). For commercial CTA based FO membranes, hydrophobic interaction between the compounds and membranes exhibited strong influence on their rejection under acidic conditions. The pharmaceuticals rejection was well correlated to their hydrophobicity (log D). Under alkaline conditions, both electrostatic repulsion and size exclusion contributed to the removal of deprotonated molecules. The pharmaceuticals rejection by CTA-HW membrane at pH 8 followed the order: diclofenac (99%)>carbamazepine (95%)>ibuprofen (93%) ? naproxen (93%). These results can be important for FO membrane synthesis, modification and their application in water purification. PMID:22640821
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
Company command currently has responsibilities that were once at the battalion or brigade command level, but now have been pushed down to the company level. This research identified 35 company command competencies required for successful performance in th...
D. Forrest, H. M. Wolters, K. O. Moriarty, L. A. Ford, M. J. Cullen
Scholarly attention to pharmaceuticalcompanies' ability to sustain research and development (R&D) productivity has increased as they increasingly handle business challenges. Furthermore, the deterioration of R&D productivity has long been considered a major cause of mergers and acquisitions (M&As). This study attempts to investigate quantitatively the possible causes of the deterioration and the relationship between the deterioration and M&As by examining the Japanese pharmaceutical industry. Japan from 1980 to 1997 is an ideal case because of the availability of official data, but more importantly the significant changes in its business environment at the time. Using the Malmquist Index and data envelopment analysis, we measured the deterioration of R&D productivity from 1980 to 1997 based on a sample of 15 Japanese companies. Two lessons can be learned from Japan's case. First, to sustain R&D productivity over the long term, companies should use licensing activities and focus on the dominant therapeutic franchises. Second, if a company fails significantly to catch up with the benchmark, it is likely to pursue an M&A or seek an alternative way to improve R&D productivity. These findings appear similar to the current situation of the global pharmaceutical industry, although Japan pursued more licensing activities than M&A to improve R&D productivity. PMID:24647159
Background Commercial sources of information are known to have greater influence than scientific sources on general practitioners' (GPs) prescribing behavior in under developed and developing countries. The study aimed to determine the self-reported impact of pharmaceutical promotion on the decision-making process of prescription of GPs in Eastern Turkey. Methods A cross-sectional, exploratory survey was performed among 152 GPs working in the primary health centers and hospitals in Erzurum province of Eastern Turkey in 2006. A self-administered structured questionnaire was used. The questionnaire included questions regarding sociodemographics, number of patients per day, time per patient, frequency of sales representative visits to GPs, participation of GPs in training courses on prescribing (in-service training, drug companies), factors affecting prescribing decision, reference sources concerning prescribing and self-reported and self-rated effect of the activities of sales representatives on GPs prescribing decisions. Results Of 152 subjects, 53.3% were male and 65.8% were working at primary health care centers, respectively. Mean patient per day was 58.3 ± 28.8 patients per GP. For majority of the GPs (73.7%), the most frequent resource used in case of any problems in prescribing process was drug guides of pharmaceuticalcompanies. According to self-report of the GPs, their prescribing decisions were affected by participation in any training activity of drug companies, frequent visits by sales representatives, high number of patient examinations per day and low year of practice (p < 0.05 for all). Conclusion The results of this study suggest that for the majority of the GPs, primary reference sources concerning prescribing was commercial information provided by sales representatives of pharmaceuticalcompanies, which were reported to be highly influential on their decision-making process of prescribing by GPs. Since this study was based on self-report, the influence reported by the GPs may have been underestimated.
Vancelik, Serhat; Beyhun, Nazim E; Acemoglu, Hamit; Calikoglu, Oksan
The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceuticalcompany who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose. PMID:15154832
A realist conceptualization of interests is proposed in opposition to the fashionable view that interests, objectivity and reality are merely social constructs, and that sociological analyses should be confined to discourse, actor-networks and micro-contextual practices. The objective interests of pharmaceuticalcompanies in profit-maximization, and of patients/public health in the optimisation of drugs' benefit-risk ratios, can be empirically validated. The relationship between those interests and pharmaceutical regulation is best characterised by 'neo-liberal corporate bias' at the macro- and meso-levels. How such bias manifests itself at the micro-social level of science-based pharmaceutical testing and regulatory decision making is examined using a realist sociology of scientific knowledge, which appreciates that assessment of the validity of techno-scientific knowledge claims is essential for their sociological explanation. Commercial interests are shown to have biased science away from the interests of public health, in favour of industry. International comparisons of drug regulation demonstrate that drug injuries are not necessarily an inevitable by-product of pharmaceutical progress because some countries have fewer drug safety problems than others. Similarly, the lowering of techno-scientific standards for drug safety testing is not an inevitable cost of faster development of therapeutically valuable medicines, but a consequence of the internationalization of neo-liberal corporate bias. PMID:18761508
A treatability study of pharmaceutical wastewater from El-Nasr Pharmaceutical and Chemical Company, South-East of Cairo, was carried out. The company discharges both industrial (6000 m(3)/d) and municipal wastewater (128 m(3)/d) into a nearby evaporation pond without any treatment. The generated raw wastewater is characterized by high values of COD (4100-13,023), TSS (20-330 mg/L), and oil grease (17.4-600 mg/L). In addition, the presence of refractory compounds decreases BOD/COD ratio (0.25-0.30). Analysis of raw wastewater confirmed that pre-treatment is required prior to discharge into public sewers to comply with the Egyptian Environmental laws and regulations. The obtained results indicated that the refractory compounds and their by-products cannot be readily removed by biological treatment and always remain in the treated effluent or adsorbed on the sludge flocs. The application of Fenton oxidation process as a pre-treatment improved the removal of pharmaceuticals from wastewater and appears to be an affective solution to achieve compliance with the law legislation with respect to discharge in a determined receptor medium. PMID:19195782
Badawy, Mohamed I; Wahaab, Rifaat A; El-Kalliny, A S
Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company's medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field. PMID:24826035
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...
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
...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales)...
...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales)...
...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,...
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
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
Pharmaceutical analysis comprises a large amount of the casework in forensic controlled substances laboratories. In order to reduce the time of analysis for pharmaceuticals, a Direct Analysis in Real Time ion source coupled with an accurate mass time-of-flight (DART-TOF) mass spectrometer was used to confirm identity. DART-TOF spectral data for pharmaceutical samples were analyzed and evaluated by comparison to standard spectra. Identical mass pharmaceuticals were differentiated using collision induced dissociation fragmentation, present/absent ions, and abundance comparison box plots; principal component analysis (PCA) and linear discriminant analysis (LDA) were used for differentiation of identical mass mixed drug spectra. Mass assignment reproducibility and robustness tests were performed on the DART-TOF spectra. Impacts on the forensic science community include a decrease in analysis time over the traditional gas chromatograph/mass spectrometry (GC/MS) confirmations, better laboratory efficiency, and simpler sample preparation. Using physical identifiers and the DART-TOF to confirm pharmaceutical identity will eliminate the use of GC/MS and effectively reduce analysis time while still complying with accepted analysis protocols. This will prove helpful in laboratories with large backlogs and will simplify the confirmation process. PMID:24770424
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.
The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceuticalcompanies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets. PMID:17853900
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
Objectives To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceuticalcompanies. Design 42 placebo controlled studies of five selective serotonin reuptake inhibitors submitted to the Swedish drug regulatory authority as a basis for marketing approval for treating major depression were compared with the studies actually published (between
Hans Melander; Jane Ahlqvist-Rastad; Gertie Meijer; Björn Beermann
Summary: This paper explores historical and current roles of pharmaceutical industry sponsorship of clinical trials testing radiation therapy combinations with molecularly targeted agents and attempts to identify potential solutions to expediting further combination studies. An analysis of clinical trials involving a combination of radiation therapy and novel cancer therapies was performed. Ongoing and completed trials were identified by searching the (clinicaltrials.gov) Web site, in the first instance, with published trials of drugs of interest identified through American Society of Clinical Oncology, European CanCer Organisation/European Society for Medical Oncology, American Society for Radiation Oncology/European Society for Therapeutic Radiology and Oncology, and PubMed databases and then cross-correlated with (clinicaltrials.gov) protocols. We examined combination trials involving radiation therapy with novel agents and determined their distribution by tumor type, predominant molecular mechanisms examined in combination to date, timing of initiation of trials relative to a novel agent's primary development, and source of sponsorship of such trials. A total of 564 studies of targeted agents in combination with radiation therapy were identified with or without concomitant chemotherapy. Most studies were in phase I/II development, with only 36 trials in phase III. The tumor site most frequently studied was head and neck (26%), followed by non-small cell lung cancer. 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.
Ataman, Ozlem U., E-mail: firstname.lastname@example.org [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Sambrook, Sally J. [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Wilks, Chris [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Lloyd, Andrew [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Global Medicines Development, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom); Taylor, Amanda E. [Yellow Delaney Communications Ltd, Wilmslow, Cheshire (United Kingdom)] [Yellow Delaney Communications Ltd, Wilmslow, Cheshire (United Kingdom); Wedge, Stephen R. [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)] [Innovative Medicines, AstraZeneca, Alderley Park, Macclesfield, Cheshire (United Kingdom)
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
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.
The characteristics of various pharmaceutical dosage forms are influenced by surface properties such as the friction behavior. For example, die wall friction is a key issue in developing a solid dosage form. However, the friction properties are not completely understood mainly because of the lack of fundamental measurements. Herein, the friction behavior of pharmaceutical materials was investigated and compared with their adhesion behavior using atomic force microscopy. The sliding speed causes significant variations in the frictional force. Compared with other materials, lubricant materials showed less distinct differences in friction tests than in adhesion tests, indicating the dependence of the lubricant efficiency on the stress state. The three parameters obtained from the modified Amonton's law, i.e., absolute frictional force, friction coefficient and residual force, showed consistent trends. Overall, the friction behavior was not a direct reflection of the adhesion forces. The intrinsic friction behavior of a single pharmaceutical particle can be quantified using atomic force microscopy. PMID:17442509
Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes. PMID:20210074
Applications of phosphorimetry including solid substrate phosphorescence, liquid medium phosphorescence, low temperature phosphorescence and phosphorescence sensors were reviewed in pharmaceutical analysis. The drugs involved here included the varieties of alkaloid, Chinese traditional medicine, tetracyclines, quinolone, riboflavin, anticancer medicine, naphazoline, naproxen, nafronyl dipyridamole and so on. Solid surface phosphorimetry is characterized by sample volume of microliter grade, simple and fast operation procedures in pharmaceutical analysis. The combination of liquid phosphorescence with flow injection analysis and chemosensing technique has good advantages in fast, continuous and on-line monitoring of medicines. Modified low temperature phosphorimetry still remains its high sensitivity and overcomes some disadvantages in the procedures. Phosphorimetry will be more widely applied to pharmaceutical analysis as the development of sensitive and quenching, energy transfer, derivative and immunization luminescence. PMID:12938353
The pharmaceutical industry plays an active role in policy surrounding the research, discovery and development of new medicines. Along with this commitment, the pharmaceutical industry must also take an active role in helping to ensure that appropriate patients receive access to state-of-the-art scientific advancements. The various players involved in drug development and introduction, including the pharmaceutical industry, clinicians, advocacy groups and regulatory bodies, need to work together to ensure patient access to quality care. While issues such as drug acquisition costs and marketing are often given a high profile, this may cloud perceptions of the industry's commitment to deliver important new medicines to the patients and healthcare systems that need them. PMID:11990688
Sulfobuthylether-beta-cyclodextrin (SBECD) is a substituted derivative of a cyclic oligosaccharide containing seven glucopyranose units, which bear pH-independent negative charges because of sulfonate groups. This derivative has better solubility and toxicological characteristics than the unsubstituted beta-cyclodextrin, and the presence of sulfobuthyl groups opens new dimensions in the interactions acting the part of the complex formation. These create opportunities for the pharmaceutical applications of this compound. Currently six pharmaceutical preparations circulate--moiety of these circulates in Hungary also--which have a composition containing SBECD as pharmaceutical excipient. Out of the main effects of the complex-forming agent the solubility enhancement is utilized in these compositions to achieve the solution of a therapeutic dose in the case of intravascular administration. Available experimental evidences and published patents are indicative of broadening the circle of the applications in point of both technological advantages and dosage forms. PMID:23926650
Background Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". Objective The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. Methods A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. Results The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". Conclusions It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the present time, representative for various work settings, and valid for countries inside and outside of Europe. PMID:24748506
Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E
Background Surgical patients are at risk for preventable adverse drug events (ADEs) during hospitalization. Usually, preventable ADEs are measured as an outcome parameter of quality of pharmaceutical care. However, process measures such as QIs are more efficient to assess the quality of care and provide more information about potential quality improvements. Objective To assess the quality of pharmaceutical care of medication-related processes in surgical wards with quality indicators, in order to detect targets for quality improvements. Methods For this observational cohort study, quality indicators were composed, validated, tested, and applied on a surgical cohort. Three surgical wards of an academic hospital in the Netherlands (Academic Medical Centre, Amsterdam) participated. Consecutive elective surgical patients with a hospital stay longer than 48 hours were included from April until June 2009. To assess the quality of pharmaceutical care, the set of quality indicators was applied to 252 medical records of surgical patients. Results Thirty-four quality indicators were composed and tested on acceptability and content- and face-validity. The selected 28 candidate quality indicators were tested for feasibility and ‘sensitivity to change’. This resulted in a final set of 27 quality indicators, of which inter-rater agreements were calculated (kappa 0.92 for eligibility, 0.74 for pass-rate). The quality of pharmaceutical care was assessed in 252 surgical patients. Nearly half of the surgical patients passed the quality indicators for pharmaceutical care (overall pass rate 49.8%). Improvements should be predominantly targeted to medication care related processes in surgical patients with gastro-intestinal problems (domain pass rate 29.4%). Conclusions This quality indicator set can be used to measure quality of pharmaceutical care and detect targets for quality improvements. With these results medication safety in surgical patients can be enhanced.
de Boer, Monica; Ramrattan, Maya A.; Boeker, Eveline B.; Kuks, Paul F. M.; Boermeester, Marja A.; Lie-A-Huen, Loraine
Biomagnetic methods have been designed for a wide range of applications. Recently, such methods have been proposed as alternatives 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 well as the most recent applications of Superconducting Quantum Interference Device (SQUID), Anisotropic Magnetoresistive (AMR) and AC Biosusceptometry (ACB) in the pharmaceutical research will be explored. Moreover, their current status and how these technologies can be employed to improve the knowledge about the impact of gastrointestinal physiology on drug delivery in association with pharmacokinetic outcomes, termed pharmacomagnetography, will be presented. PMID:20949311
Saltville, Virginia, is a former company town whose main employer, a soda ash plant, shut down on July 1, 1971. The closure of the chemical plant displaced 700 workers, and created a crisis that threatened not only the existence of the town, but of the entire region. In response, Virginia Highlands Community College (VHCC), in cooperation with the…
Pharmaceutical plants manufacture biological products, medicinal chemicals, botanical products, and other pharmaceutical products. EPA identified 466 operating facilities involved in the manufacture of pharmaceutical products. Most of the pharmaceutical i...
In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...
Pharmaceutical industry includes a lot of independent units specialized in synthesis of active substances, their processing as pharmaceutical forms, control of intermediate and final products, storage of all these as well of a lot of adjuvants. In this lo...
The Department of Pharmaceutics at the University of Illinois at Chicago has been carrying out research in pharmaceutical biotechnology that has allowed unique student involvement and promises further interdisciplinary research and instructional activities. (MSE)
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...
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...
Brand-name pharmaceuticalcompanies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called 'pay-for-delay' agreements have arisen ...
The cubane molecule, in which eight carbon atoms are locked in a cubic framework, shows great potential for both military and pharmaceutical applications. Octanitrocubane, with a predicted density of 2.1 g/cc and strain energy of more than 165 kcal/mol, i...
A course in pharmaceutical product merchandising offered at the St. Louis College of Pharmacy incorporated as its three major components the development of a one-page print advertisement, a recorded radio commercial, and a videotape commercial series. Student evaluations were based on performance rather than effort. (MSE)
Psychiatric medication, or psychotropics, are increasingly prescribed for people of all ages by both psychiatry and primary care doctors for a multitude of mental health and/or behavioral disorders, creating a sharp rise in polypharmacy (i.e., multiple medications). This paper explores the clinical reality of modern psychotropy at the level of the prescribing doctor and clinical exchanges with patients. Part I, Geographies of High Prescribing, documents the types of factors (pharmaceutical-promotional, historical, cultural, etc.) that can shape specific psychotropic landscapes. Ethnographic attention is focused on high prescribing in Japan in the 1990s and more recently in the Upper Peninsula of Michigan, in the US. These examples help to identify factors that have converged over time to produce specific kinds of branded psychotropic profiles in specific locales. Part II, Pharmaceutical Detox, explores a new kind of clinical work being carried out by pharmaceutically conscious doctors, which reduces the number of medications being prescribed to patients while re-diagnosing their mental illnesses. A high-prescribing psychiatrist in southeast Wisconsin is highlighted to illustrate a kind of med-checking taking place at the level of individual patients. These various examples and cases call for a renewed emphasis by anthropology to critically examine the "total efficacies" of modern pharmaceuticals and to continue to disaggregate mental illness categories in the Boasian tradition. This type of detox will require a holistic approach, incorporating emergent fields such as neuroanthropology and other kinds of creative collaborations. PMID:24700144
Pressed by an impressive series of corruption scandals and by a change of attitude towards cost-containment, the Italian pharmaceutical sector's regulatory environment was radically changed in 1994. Regulatory power was concentrated on a national technical body (CUF) and a new set of measures was taken, including a nationwide drug expenditure budget, a redefinition of both the positive list and the
A variety of promotional strategies have been used to stimulate sales of pharmaceutical drugs. Traditionally, push techniques have been the predominant means used to encourage physicians to prescribe drugs and thus increase sales. Recently, the traditional push strategy has been supplemented by a pull strategy. Direct-to-consumer advertising is increasingly used to encourage consumers to request advertised drugs from their physicians.
The drug discovery process is far from optimal; only 1 in 10 compounds selected for development successfully reach the clinical trial phase. In an attempt to improve the efficiency of this process, we have applied feature analysis techniques to polypeptide spectral data from the liver of rats that have been exposed to various dosages of pharmaceuticals. Our goal is to
J. Quinn; Lit-Hsin Loo; J. Armitage; H. Cordingley; S. Roberts; P. J. Bugelski; M. Kam; L. Hrebien
The ubiquity of Online Social Networks (OSNs) is creating new sources for healthcare information, particularly in the context of pharmaceutical drugs. We aimed to examine the impact of a given OSN's characteristics on the content of pharmaceutical drug discussions from that OSN. We compared the effect of four distinguishing characteristics from ten different OSNs on the content of their pharmaceutical drug discussions: (1) General versus Health OSN; (2) OSN moderation; (3) OSN registration requirements; and (4) OSNs with a question and answer format. The effects of these characteristics were measured both quantitatively and qualitatively. Our results show that an OSN's characteristics indeed affect the content of its discussions. Based on their information needs, healthcare providers may use our findings to pick the right OSNs or to advise patients regarding their needs. Our results may also guide the creation of new and more effective domain-specific health OSNs. Further, future researchers of online healthcare content in OSNs may find our results informative while choosing OSNs as data sources. We reported several findings about the impact of OSN characteristics on the content of pharmaceutical drug discussion, and synthesized these findings into actionable items for both healthcare providers and future researchers of healthcare discussions on OSNs. Future research on the impact of OSN characteristics could include user demographics, quality and safety of information, and efficacy of OSN usage. PMID:24637141
Wiley, Matthew T; Jin, Canghong; Hristidis, Vagelis; Esterling, Kevin M
'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
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
The pharmaceutical industry faces considerable challenges, both politically and fiscally. Politically, governments around the world are trying to contain costs and, as health care budgets constitute a very significant part of governmental spending, these costs are the subject of intense scrutiny. In the United States, drug costs are also the subject of intense political discourse. This article deals with the
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…
Studies of replacement therapy of diabetes mellitus resulted not only in introduction of series of forms of insulin available\\u000a at pharmaceutical market but also in new insulin analogues, which exhibit better control of blood glucose level. The present\\u000a paper deals with basic tendencies in this field.
D. A. Gusarov; V. D. Gusarova; D. I. Bayramashvili; A. F. Mironov
Confluences of key factors can transform apparently isolated or random events into trends. The ongoing and growing pressures facing the pharmaceutical industry have "tipped" the industry toward a new direction in the choice of which new medicines to develop and how to develop them. We examine the factors that are at the tipping point. PMID:24747228
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...
Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments show that clofibric acid exhibits no degradation and almost no retardation (Rf = 1.1) whereas ibuprofen is biodegraded (> 90 %) under aerobic conditions. Carbamazepine shows no degradation in the soil column experiments but significant retardation under the prevailing conditions. We conclude that clofibric acid will show the transport behavior of a conservative tracer, whereas ibuprofen may be used to characterize the biodegradation potential in the aerobic zone.
This report presents descriptive information about the prevalence and quality of implementation of research-based programs from the Study of the Implementation of Research-Based Programs to Prevent Youth Substance Abuse and School Crime. The study found that, while schools reported implementing a large number of prevention programs during the…
Crosse, Scott; Williams, Barbara; Hagen, Carol A.; Harmon, Michele; Ristow, Liam; DiGaetano, Ralph; Broene, Pamela; Alexander, Debbie; Tseng, Margaret; Derzon, James H.
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.
The purposes of this article are to underscore the importance of using research-based practices to support the needs of all learners in general education settings and to provide teachers with strategies for obtaining research-based practices. Students with diverse learning needs require that teachers utilize more effective and efficient practices…
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…
Background A researchbase should be of sufficient quality and quantity to inform nursing practice. It must allow nurses to access information about clients' needs and to identify effective strategies for meeting those needs. This paper presents the findings of a scoping review of [`]learning disability nursing research'. The review aimed to determine whether there is a researchbase sufficient
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…
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…
Preservice teachers have difficulty incorporating research-based instructional strategies and often revert to those observed during their own school years. This study describes how preservice teachers used a framework of planning, implementation, feedback, and reflection to try research-based teaching practices from their methods courses and…
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
Customers today are being bombarded with an overwhelming array of choices. To alleviate customer frustration, say Steven Cristol and Peter Sealey in Simplicity Marketing, companies should stop creating new brands and product extensions. Better to consolidate product and service functions by following a four R approach: replace, repackage, reposition, and replenish. That's an outmoded, dictatorial view of markets, says Christopher Locke. Far from being stymied by choices, customers are rapidly becoming smarter than the companies that pretend to serve them. In this networked economy, people are talking among themselves, and that changes everything. Locke predicts we'll see a growing number of well-defined micromarkets--groups of customers converging in real time around entertaining and knowledgeable voices--such as NPR's car guys and the Motley Fool investment site. "Micromedia" Web sites will replace traditional advertising because they'll provide credible user-supplied news about products and services. Locke contends that an open exchange of information solves the "problem" of choice much better than manipulative strategies like simplicity or even permission marketing. Companies can participate in micromarkets through what Locke dubs "gonzo marketing." If Ford, for example, discovers that a subset of its employees are organic gardeners, it may offer support to a big independent organic-gardening Web site with donations and employee volunteers. This marketing effort would be driven not by advertising managers but by people with genuine interest in each micromarket, so it would have credibility with customers. With gonzo marketing, both companies and their markets will benefit. PMID:11184973
Bioremediation companies face technical and legal hurdles, which may result in the amalgamation of smaller remedial action companies. New breakthroughs in genetic engineering promise to counteract the specificity problems of microbial consortia.
It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from ?áslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with decreasing adsorption. In all cases (including non contaminated soil sample) biological activity initially increased (1 and 2 day after the pharmaceutical application) and then dropped down on 5th day (Trimetoprim, Clindamycin, Atenolol, Sulfamethoxazol) or 23rd day (Clarithromycin, Metoprolol, Carbamazepin) of soil sample incubation. A closer correlation between the numbers of colony forming unites and degradation rates were not revealed. Acknowledgement: Authors acknowledge the financial support of the Czech Science Foundation (Project No. 13-12477S).
Intramagnetics General Corporation was founded in 1971 as a spin-off from the General Electric Company (GE). IGC is a world leader in superconductivity technology and applications. The US Department of Energy called IGC the United States` top commercial source of low-temperature superconducting wire, and also noted the company`s superior performance in high-temperature superconducting wire. This article discusses the products of the company and its present/future plans. Organizational and commercial information is also presented.
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…
This paper discusses the development of the partnership between Rhône-Poulenc Rorer (RPR) and two patient groups that are dedicated to the care of patients with amyotrophic lateral sclerosis (ALS) or (Lou Gehrig disease): the ALS Association (ALSA) and the Muscular Dystrophy Association (MDA). This partnership covered the preapproval, approval, and postapproval periods in the drug development of Rilutek® (riluzole), which
Reimbursement contracts, in which health insurers receive rebates from drug manufacturers instead of paying the transparent list price, are becoming increasingly common worldwide. Through interviews with policy makers in nine high-income countries, we describe the use of these contracts around the globe and identify related policy challenges and best practices. Of the nine countries surveyed, the majority routinely use confidential reimbursement contracts. This alternative to drug coverage at list prices offers benefits but is not without challenges. Payers face increased administrative costs, difficulties enforcing contracts, and reduced information about prices paid by others. Among the best practices identified, policy makers recommend establishing clear and consistent processes for negotiating contracts with relatively simple rebate structures and transparency to the public about the existence, purpose, and type of reimbursement contracts in place. Policy makers should also work to address undesirable price disparities within their countries and internationally, which may occur as a result of this new pricing paradigm. PMID:23569058
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
Objectives. We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders’ perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry. Methods. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations. Results. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case. Conclusions. Although policymakers acknowledge the utility of manufacturers’ involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.
This thematic collection of four papers explores a number of perspectives on companies in which multiple languages are used. The "organisational" perspective concerns the question of how the presence of or demand for multiple languages in the company is managed--how companies are guided by national and other policies in regard to the use…
The study consisted in collecting financial information for a group of distressed and non-distressed Romanian listed companies during the period 2006–2008, in order to create early warning signals for financial distressed companies using the following methodologies: the Logistic and the Hazard model, the CHAID decision tree model and the Artificial Neural Network model (ANN). For each company a set of
The increased incidence of infections caused by methicillin-resistant strains of Staphylococcus aureus (MRSA) burdens the healthcare systems with significant additional costs. Simple measures such as active MRSA screening can lead to a reduction of infectious events and massive savings. To establish an effective and comprehensive strategy for prevention and eradication of MRSA, the cooperation and networking of all stakeholders in the health care system is necessary. Pharmaceuticalcompanies are part of the health care system; they therefore have a vital and ethical interest that care within the health system will be further optimized and thus continue to remain affordable. The targets of the HIC@RE project demonstrate the interests of the pharmaceutical and health-care research company RIEMSER Arzneimittel AG, so that a sufficient rationale is given for cooperation in this project.
This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor–patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceuticalcompanies and drug suppliers.
Al-Haddad, Mahmoud S.; Hamam, Fayez; AL-Shakhshir, Sami M.
Occupational exposure to active ingredients in the pharmaceutical industry has been the subject of very few published studies. Nevertheless, operations involving active powdered drugs or dusty operations potentially lead to operator exposure. The aim of this study was to collect occupational exposure data in the pharmaceutical industry for production processes involving powdered active ingredients. While the possibility of assessing drug exposure from dust level is examined, this article focuses on inhalable dust exposure, without taking chemical risk into account. A total of 377 atmospheric (ambient and personal) samples were collected in nine drug production sites (pharmaceuticalcompanies and contract manufacturing organizations) and the dust levels were assessed. For each sample, relevant contextual information was collected. A wide range of results was observed, both site- and operation-dependent. Exposure to inhalable dust levels varied from 0.01 mg/m(3)to 135 mg/m(3). Though restricted to dust exposure, the study highlighted some potentially critical situations or operations, in particular manual tasks (loading, unloading, mechanical actions) performed in open systems. Simple preventive measures such as ventilation, containment, and minimization of manual handling should reduce dust emissions and workers' exposure to inhalable dust. PMID:24369930
In recent years, the US Food and Drug Administration has encouraged pharmaceuticalcompanies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms. PMID:24311373
Hirshfield, Laura; Giridhar, Arun; Taylor, Lynne S; Harris, Michael T; Reklaitis, Gintaras V
The article presents a reflection on one of the greater challenges which the contemporary State is confronted with, related to guaranteeing the effective application of the fundamental rights, besides having to solve the conflicts that arise due to the rivalry between either fundamental rights or between some of these and others known as second or third generation rights. The conflict between the protection to the intellectual property rights, as in the case of the patents of the pharmaceutical multinationals, and the fundamental right to life is considered. It is observed that the interests of these companies have prevailed, as if the fundamental value to protect was the profit of these multinationals, or their efficiency, and not the right to health of the individuals which bears a direct relation with the right to the life. This situation is aggravated still more when the State, instead of being on the side of the weaker and offering him protection, safeguards the stronger who abuse of their dominant position, exerting the monopoly on the production of many essential medicines. PMID:14658364
Pharmaceutical wastewater generated by an antibiotics (penicillin) company was treated by aerobic membrane bioreactors (MBRs) and sequencing batch reactors (SBRs). At a low organic loading rate of 0.22 kg-COD m(-3)d(-1), both types of reactors were capable of treating the wastewater such that the treated effluent met the discharge regulation except for the total dissolved solids. However, when the loading rate was increased to 2.92 kg-COD m(-3)d(-1), foaming issues resulted in unstable performance. Overall, the MBRs achieved better solid removal but the SBRs performed better in regards to the degradation of aromatic compounds, as determined by UV absorbance (UVA). Finally, ozonation was applied on two different streams and showed promise on the strong stream - that corresponds to the formulation effluent and contains most of the biorefractory compounds. Ozonation successfully reduced the UVA, lowered the pH and increased the biochemical oxygen demand : chemical oxygen demand (BOD5 : COD) ratio of the strong stream. However, it was less efficient on the effluent having undergone pre-treatment by a biofilter due to a lack of selectivity towards refractory compounds. PMID:24569287
Background Strategic Functional-level planning should be aligned with business level and other functional strategies of a company. It is presumed that assimilating the strategies could have positive contribution to business performance, in this regard alignment between marketing strategy and financial strategy seems to be the most important strategies being studied. An empirical work in generic pharmaceutical manufacturing companies for evaluating effect of alignment between these two functions on organizational performance was developed in this paper. Methods All Iranian pharmaceutical generic manufactures listed in Tehran stock market have been tested for period of five years between 2006–2010 and their marketing strategies were determined by using Slater and Olson taxonomy and their financial strategies have been developed by calculating total risk and total return of sample companies for five years based on rate of risk and return in the frame of a 2 × 2 matrix. For the business performance three profitability indices including Q-Tubin (Rate of market value to net asset value), ROA (Return on Asset), ROE (Return on Equity) have been tested. For analysis, a series of one-way ANOVAs as a collection of statistical models within marketing strategies considering financial strategy as independent variable and the three performance measures as dependent variables was used. Results Results show strategic alignment between financial and marketing has significant impact on profitability of company resulting in arise of all three profitability indices. Q tubing’s rate were 2.33,2.09,2.29,2.58 and rate of ROA were 0.21,0.194,0.25,0.22 and rate of ROE were 0.44,0.46,0.45,0.42 for matched strategy types, respectively the rates shown here are more than average meaning that specific type of marketing strategy is fitted with specific type of financial strategy. Conclusion Managers should not consider decisions regarding marketing strategy independently of their financial strategy.
Chitosan has received much attention as a functional biopolymer for diverse applications, especially in pharmaceutics and medicine. Our recent efforts focused on the chemical and biological modification of chitosan in order to increase its solubility in aqueous solutions and absorbability in the in vivo system, thus for a better use of chitosan. This review summarizes chitosan modification and its pharmaceutical/biomedical applications based on our achievements as well as the domestic and overseas developments: (1) enzymatic preparation of low molecular weight chitosans/chitooligosaccharides with their hypocholesterolemic and immuno-modulating effects; (2) the effects of chitin, chitosan and their derivatives on blood hemostasis; and (3) synthesis of a non-toxic ion ligand—D-Glucosaminic acid from Oxidation of D-Glucosamine for cancer and diabetes therapy.
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
The number of couples seeking consultation for infertility problems has steadily increased over the past decade, affecting 10%?15% of the sexually active population. Abnormal semen production, a male factor infertility (MFI), is thought to be the cause of up to 50% of all infertilities in developed countries. There are potentially many different causes of male infertility, including hormonal, anatomical, and secondary to exposure to exogenous substances. In many cases of MFI, a definitive cause for abnormalities is never identified. Recently, the research community has given greater attention to identifying causes of MFI ranging from genetic Y chromosome microdeletions to mechanisms of environmental damage on sperm production. Still evolving, is a clear understanding of how many pharmaceutical medications may cause MFI, which is often treatable and reversible. In this review we will outline the data regarding various pharmaceutical medications that have been investigated as possible causes of MFI.
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
Although not a member of the EU, Norway participates in the European-wide regulatory framework for granting marketing authorization\\u000a to pharmaceutical products. Maximum prices for prescription medicines are determined by the Norwegian Medicines Agency that\\u000a sets pharmacy purchase prices (based on prices in other Northern European countries) and the Ministry of Health that sets\\u000a pharmacy margins. A “discount sharing model” encourages
The Belgian healthcare system has a tradition of access and equity at affordable prices. As in other countries, the system becomes pressured by increasing healthcare costs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement. Nearly all people in Belgium are covered by compulsory health insurance. The system is paid for by social security, the patients and the federal and regional authorities. The part of the consumption of pharmaceuticals that is charged to insurance was about 62.1 billion Belgian francs (BeF), i.e. about 50% of the pharmaceutical market in 1994. Price setting in Belgium has been rather low due to the positive reimbursement list, where the price of a new drug is compared to existing drugs in a comparable therapeutic class (so-called reimbursement criteria). The expenditure on pharmaceuticals is increasing faster than global funding for public health. In order to control drug budgets, different cost-containment measures have been or are being taken, i.e. a mix of price, reimbursement and volume controls. These cost-containment measures are not necessarily in accordance with a health economic approach. This paper suggests the scope for better implementation of pharmacoeconomic evaluation, which can lead to more flexible reimbursement systems in specific indications. Therefore, a formal recognition of the role of objective economic evaluations is needed for both hospital and ambulatory care. This process should be proceeded by improving the understanding and robustness of pharmacoeconomic evaluations. PMID:10165309
Annemans, L; Crott, R; De Clercq, H; Huybrechts, M; Peys, F; Robays, H; Steens, I; Vanschoubroek, K; Winderickx, P
Room temperature phosphorescence was applied to determine nafronyl in pharmaceutical preparations. The linear range of concentration was between 20 and 1000ngml?1. The use of phosphorescence enhancers such as thallium(I) nitrate (external heavy atom), sodium dodecyl sulfate (micellar agent) and sodium sulfite (deoxygenation agent) were studied and optimized to obtain maximum sensitivity and adequate selectivity.Determination was performed in sodium dodecyl sulfate
José A Murillo Pulgar??n; Aurelia Alañón Molina; Pablo Fernández López
A disposable rigid package containing pharmaceutical compositions which protects tablets, capsules, soft shell pills against hard transporting conditions and undesired rupture. The package allows for personal transportation, e.g. in a pocket, and it is easy and convenient to open for people of all level of ability and dexterity. Its design allows for transport as standard mail withstanding temperature fluctuation, vibrations and shocks, mechanical pressure and variation in atmospheric pressure which may occur during transport.
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.
Pharmaceuticalcompanies routinely engage physicians, particularly those with prestigious academic credentials, to deliver "educational" talks to groups of physicians in the community to help market the company's brand-name drugs. Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most academic medical centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking. PMID:22789048
Boumil, Marcia M; Cutrell, Emily S; Lowney, Kathleen E; Berman, Harris A
Coatings are an essential part in the formulation of pharmaceutical dosage form to achieve superior aesthetic quality (e.g., color, texture, mouth feel, and taste masking), physical and chemical protection for the drugs in the dosage forms, and modification of drug release characteristics. Most film coatings are applied as aqueous- or organic-based polymer solutions. Both organic and aqueous film coating bring their own disadvantages. Solventless coating technologies can overcome many of the disadvantages associated with the use of solvents (e.g., solvent exposure, solvent disposal, and residual solvent in product) in pharmaceutical coating. Solventless processing reduces the overall cost by eliminating the tedious and expensive processes of solvent disposal/treatment. In addition, it can significantly reduce the processing time because there is no drying/evaporation step. These environment-friendly processes are performed without any heat in most cases (except hot-melt coating) and thus can provide an alternative technology to coat temperature-sensitive drugs. This review discusses and compares six solventless coating methods - compression coating, hot-melt coating, supercritical fluid spray coating, electrostatic coating, dry powder coating, and photocurable coating - that can be used to coat the pharmaceutical dosage forms. PMID:17510883
As healthcare reform evolves and takes shape, comparative effectiveness research (CER) appears to be one of the central topics on the national healthcare agenda. Over the past couple of years, comparative effectiveness has been explicitly incorporated in more than ten bills. For example, the passage of the American Recovery and Reinvestment Act of 2009 authorized $US1.1 billion for CER. Comparative effectiveness, when costs are formally considered, offers the hope of efficient resource allocation within US healthcare markets. However, the future operationalization and implementation of comparative effectiveness is uncertain, and there exist potentially negative, and unintended, consequences under certain scenarios. One example, and the focus of this article, is pharmaceutical innovation. Incentives for pharmaceutical R&D could be affected if drug development costs increase as a result of firms having to bear, directly or indirectly, the costs of running larger, randomized, head-to-head comparative effectiveness trials. While this may or may not be the case with current and future comparative effectiveness legislation and its subsequent implementation, the potential consequences for pharmaceutical innovation warrant recognition. This is the purpose of the article. To achieve this goal, we develop several models of clinical trial design, drug development costs and R&D investment. By example, we shed light on the causal links between the models and the ways in which industry R&D investment can be affected. PMID:20831295
Vernon, John A; Golec, Joseph H; Stevens, J Stedman
Interest in the public health significance of trace levels of pharmaceuticals in potable water is increasing, particularly with regard to the effects of long-term, low-dose exposures. To assess health risks and establish target concentrations for water treatment, human health risk-based screening levels for 15 pharmaceutically active ingredients and four metabolites were compared to concentrations detected at 19 drinking water treatment plants across the United States. Compounds were selected based on rate of use, likelihood of occurrence, and potential for toxicity. Screening levels were established based on animal toxicity data and adverse effects at therapeutic doses, focusing largely on reproductive and developmental toxicity and carcinogenicity. Calculated drinking water equivalent levels (DWELs) ranged from 0.49 microg/L (risperidone) to 20,000 microg/L (naproxen). None of the 10 detected compounds exceeded their DWEL. Ratios of DWELs to maximum detected concentrations ranged from 110 (phenytoin) to 6,000,000 (sulfamethoxazole). Based on this evaluation, adverse health effects from targeted pharmaceuticals occurring in U.S. drinking water are not expected. PMID:20575537
Bruce, Gretchen M; Pleus, Richard C; Snyder, Shane A
Low levels of pharmaceutical compounds have been detected in aquatic environments worldwide, but their human and ecological health risks associated with low dose environmental exposure is largely unknown due to the large number of these compounds and a lack of information. Therefore prioritization and ranking methods are needed for screening target compounds for research and risk assessment. Previous efforts to rank pharmaceutical compounds have often focused on occurrence data and have paid less attention to removal mechanisms such as human metabolism. This study proposes a simple prioritization approach based on number of prescriptions and toxicity information, accounting for metabolism and wastewater treatment removal, and can be applied to unmeasured compounds. The approach was performed on the 200 most-prescribed drugs in the US in 2009. Our results showed that under-studied compounds such as levothyroxine and montelukast sodium received the highest scores, suggesting the importance of removal mechanisms in influencing the ranking, and the need for future environmental research to include other less-studied but potentially harmful pharmaceutical compounds. PMID:22813724
Dong, Zhao; Senn, David B; Moran, Rebecca E; Shine, James P
Of Russia's 142 million citizens, fewer than 20 million are enrolled in outpatient drug coverage plans. The current government aims to establish universal health insurance including outpatient medicines. Based on the current political and regulatory environment, this report explores pharmaceutical pricing options for Russia that balance greater access to medicines with achieving government plans of boosting local pharmaceutical production. To match innovative medicine prices with their health benefits, in the long run, we suggest that Russia consider adopting value-based pricing, and in the short term, that it introduce direct price negotiations and price drugs according to reference countries that use health technology assessment. Although generic market shares are high, generic medicine prices are higher than they should be. We propose tenders at the manufacturer level for the pricing of high-selling generics, and free pricing for products with sufficient market competition. These policy recommendations are a jumping-off point for further discussion about how pharmaceutical policy could aid this major economy to achieve its population health and health service goals. PMID:24603082
Rudisill, Caroline; Vandoros, Sotiris; Antoun, Joseph George
Background Building appropriate levels of trust in pharmaceuticals is a painstaking and challenging task, involving participants from different spheres of life, including producers, distributors, retailers, prescribers, patients and the mass media. Increasingly, however, trust is not just a national matter, but involves cross-border flows of knowledge, threats and promises. Methods Data for this paper comes from the project 'Tracing Pharmaceuticals in South Asia', which used ethnographic fieldwork and qualitative interviews to compared the trajectories of three pharmaceuticals (Rifampicin, Oxytocin and Fluoxetine) from producer to patient in three sites (north India, West Bengal and Nepal) between 2005-08. Results We argue that issues of trust are crucial in reducing the likelihood of appropriate use of medicines. Unlike earlier discussions of trust, we suggest that trust contexts beyond the patient-practitioner relationship are important. We illustrate these arguments through three case studies: (i) a conflict over ethics in Nepal, involving a suggested revised ethical code for retailers, medical representatives, producers and prescribers; (ii) disputes over counterfeit, fake, substandard and spurious medicines, and quality standards in Indian generic companies, looking particularly at the role played by the US FDA; and (iii) the implications of lack of trust in the DOTS programmes in India and Nepal for the relationships among patients, government and the private sector. Conclusions We conclude that the building of trust is a necessary but always vulnerable and contingent process. While it might be desirable to outline steps that can be taken to build trust, the range of conflicting interests in the pharmaceutical field make feasible solutions hard to implement.
The adsorption of a complex mixture of 12 selected pharmaceuticals to trimethylsilylated mesoporous SBA-15 (TMS-SBA-15) has been investigated by batch adsorption experiments. The adsorption of pharmaceuticals to TMS-SBA-15 was highly dependent on the solution pH and pharmaceutical properties (i.e., hydrophobicity (logKow) and acidity (pKa)). Good log-log linear relationships between the adsorption (Kd) and pH-dependent octanol-water coefficients (Kow(pH)) were then established among the neutral, anionic, and cationic compounds, suggesting hydrophobic interaction as a primary driving force in the adsorption. In addition, the neutral species of each compound accounted for a major contribution to the overall compound adsorption onto TMS-SBA-15. The adsorption kinetics of pharmaceuticals was evaluated by the nonlinear first-order and pseudo-second-order models. The first-order model gave a better fit for five pharmaceuticals with lower adsorption capacity, whereas the pseudo-second-order model fitted better for seven pharmaceuticals having higher adsorption capacity. In the same group of properties, pharmaceuticals having higher adsorption capacity exhibited faster adsorption rates. The rate-limiting steps for adsorption of pharmaceuticals onto TMS-SBA-15 are boundary layer diffusion and intraparticle diffusion including diffusion in mesopores and micropores. In addition, the adsorption of pharmaceuticals to TMS-SBA-15 was not influenced by the change of initial pharmaceutical concentration (10-100?gL(-1)) and the presence of natural organic matter. PMID:23643958
Bui, Tung Xuan; Pham, Viet Hung; Le, Son Thanh; Choi, Heechul
Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India. PMID:18624153
According to 12 may 2011 Reimbursement Act, the new regulations were introduced related to changes in so far in force rules on refunds of official prices and margins for drugs, foodstuffs of special purpose and medical products. After year of functioning of this regulation, in evaluation of the government, law gave measurable financial effects for public payer, sometimes through drastic actions, connected the of reduction of existing profits of manufacturers sector and importers drugs, as well wholesale and retail, both in treatment open and closed. Parallel to research and analysis of effects introduction in life act refund, conducted by government, to target current regulation possible negative phenomena can to be after-effects to regulation, systematically there are conducted analogous study to reputable companies specialized in evaluation and updating market Polish pharmaceutical, such as IMS Health Polska, Pharma Expert, Kamsoft, WHO and European a law firm. In their opinion to reimbursement act is the most serious regulation control system to introduced into Polish order legal, and first time for many years on such a large scale. Thoroughly changed policy of drugs State have important influence for all participants Polish pharmaceutical market, both those directly related to the drug trade, as the functioning doctors and health condition and financial Polish patient. Change in the way prices of drugs is determined as flexible to price formation mechanism, combining drugs similar profile pharmacological in so group limits and dependence of the level of refunds from application drug accordingly characteristics medicinal product, adaptation solutions to new law refund to the existing law about health services, gave measurable financial effect for the public payer. Rationalization expenses to NFZ, as main premise introduction refund act, created to broader than so far possibility to use new molecules of drugs, and the latest medical technology, even if in the revised or new drug programs. Important implications for even Polish image in Europe, especially from the point of view of cohesion policy and application to directive transparency EU have introduction refund act in context to introduction clear, transparent and verifiable procedures used with creating drug pricing mechanisms, foodstuffs of special purpose and medical product. PMID:24868902
Health care automation companies: card transaction processing/EFT/EDI-capable banks; claims auditing/analysis; claims processors/clearinghouses; coding products/services; computer hardware; computer networking/LAN/WAN; consultants; data processing/outsourcing; digital dictation/transcription; document imaging/optical disk storage; executive information systems; health information networks; hospital/health care information systems; interface engines; laboratory information systems; managed care information systems; patient identification/credit cards; pharmacy information systems; POS terminals; radiology information systems; software--claims related/computer-based patient records/home health care/materials management/supply ordering/physician practice management/translation/utilization review/outcomes; telecommunications products/services; telemedicine/teleradiology; value-added networks. PMID:10153839
The objective of this study was to investigate if coexisting compounds could affect the fate of pharmaceuticals in surface water under solar irradiation. The degradation of metronidazole (MET) in the presence of different coexisting pharmaceuticals was investigated in batch experiments with exposure to sunlight. Tinidazole, which has a similar structure to MET, was employed as an analogue. The results indicated that the presence of an analogue with a similar photosensitive group to MET could inhibit the photodegradation of MET. In addition, the effect of coexisting pharmaceuticals with different absorption spectra on the degradation of MET was investigated. The results showed that the effect depended on the degree of overlapping absorption spectra between MET and the coexisting pharmaceuticals. The relationship between the degree of the influence and the ultraviolet absorption spectra of coexisting pharmaceuticals found in this study could give guidance in assessing the fate of pharmaceuticals in environmental water. PMID:22766860
Wu, Bo; Zhang, Ting; Li, Jinxia; Ye, Yong; Chen, Huaixia
ObjectiveTo determine the association between the frequencies of pharmaceutical exposures reported to a poison control center (PCC) and those seen in the emergency department (ED).DesignA statewide population-based retrospective comparison of frequencies of ED pharmaceutical poisonings with frequencies of pharmaceutical exposures reported to a regional PCC. ED poisonings, identified by International Classification of Diseases, Version 9 (ICD-9) codes, were grouped into
Christopher A Naun; Cody S Olsen; J Michael Dean; Lenora M Olson; Lawrence J Cook; Heather T Keenan
Since the introduction about 30 years ago, CE techniques have gained a significant impact in pharmaceutical analysis. The present review covers recent advances and applications of CE for the analysis of pharmaceuticals. Both small molecules and biomolecules such as proteins are considered. The applications range from the determination of drug-related substances to the analysis of counterions and the determination of physicochemical parameters. Furthermore, general considerations of CE methods in pharmaceutical analysis are described. PMID:24395663
Deeb, Sami El; Wätzig, Hermann; El-Hady, Deia Abd; Albishri, Hassan M; de Griend, Cari Sänger-van; Scriba, Gerhard K E
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
\\u000a Service companies have been implementing Lean only in recent years. In this research three third party logistic companies\\u000a and seven companies of the financial sector have been thoroughly interviewed and showed a few interesting aspects on the way\\u000a they implemented Lean. They are implementing Lean in high volume low variety processes and focus on back office activities,\\u000a which are most
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.
The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement. PMID:23656445
Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret
Marketing orientation, still an intriguing concept for many, carries the pledge of superior company performance through the satisfaction of customer's needs. This article draws conclusions from an empirical investigation showing that this relationship does really exist and, in the case of industrial markets, building a marketing orientation it is indeed a significant contributor to the company's performance.
Although not a member of the EU, Norway participates in the European-wide regulatory framework for granting marketing authorization to pharmaceutical products. Maximum prices for prescription medicines are determined by the Norwegian Medicines Agency that sets pharmacy purchase prices (based on prices in other Northern European countries) and the Ministry of Health that sets pharmacy margins. A "discount sharing model" encourages pharmacies to perform parallel import and generic switching by allowing them to keep up to 50% of the difference between maximum price and actual price. The costs of pharmaceuticals in Norway are covered in part by the public budget and in part directly by the patient. Over one-half of pharmaceutical costs are borne by the Norwegian National Insurance Administration through the reimbursement scheme; membership in this program is mandatory, and costs are covered through taxes from employers and employees. Over 90% of reimbursed drug sales are accounted for by the established product list for general reimbursement, but supplementary reimbursement can be granted on the basis of individual patient applications and also to ensure that all patients with serious communicable diseases are given adequate treatment without costs to the patient (e.g., HIV/AIDS, tuberculosis). Patient copayment currently amounts to 36% of the total amount of prescriptions; the maximum per prescription is 48 euros, and total within a single calendar year is 180 euros. Copayments for physician visits, radiology examinations, and laboratory tests, can be included in this amount. The overall system is now undergoing reevaluation, as it has been criticized for being complicated and difficult to comprehend for the users. PMID:15609146
Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL -1 for ciprofloxacin, 28.5-700 ng mL -1 for enoxacin, 29.5-800 ng mL -1 for norfloxacin and 33.5-1000 ng mL -1 for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL -1 for ciprofloxacin, 8.5 ng mL -1 for enoxacin, 9.2 ng mL -1 for norfloxacin and 9.98 ng mL -1 for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method.
Numerical simulations indicate that neglecting the canonical nonlinearity of glassy-state annealing kinetics in pharmaceutical (and other) glasses leads to good KWW fits to the dependence of enthalpy on annealing time, but with spurious KWW parameters that are affected by nonlinearity. A simplified treatment of nonlinearity that uses the Struik shift factor is found to be a useful approximation for these analyses, and can account for previously reported differences between linear and nonlinear KWW parameters (Kawakami K, Pikal MJ. 2005. J Pharm Sci 94:948-965). PMID:23661359
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
Seventy years ago, the Curtin wartime government introduced legislation for a Pharmaceutical Benefits Scheme (PBS). It was a response to the need to provide access to a wave of antibiotic drugs - sulfonamides, streptomycin, penicillin - to the whole population, not only to the minority able to afford them. The scheme was immediately and successfully opposed by doctors and the conservative opposition, which saw in universal health care an underhand plan to nationalise medicine. There were two High Court challenges, two referendums and a constitutional amendment; but it was not until 1960 that Australians had the comprehensive PBS envisaged by Curtin in 1944. PMID:25047771
Multicomponent reactions – reactions that combine three or more starting materials in one pot to give a single product that contains essentially all of the atoms of the reactants – offer many exciting opportunities for medicinal chemistry. Their most obvious application is in the drug discovery phase, where they can provide efficient access to large numbers of analogs for lead discovery or optimization. By contrast, the inherent 'greenness' of multicomponent reactions makes them of increasing importance in the sustainable production of pharmaceuticals. We will discuss recent advances in both fields as well as general drivers and barriers for the application of multicomponent reactions in a medicinal chemistry context. PMID:24050225
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
Successful drug discovery and development of new therapeutics is a long, expensive multidisciplinary process needing innovation and the integration of smart cutting edge science and technology to overcome the challenges in taking a drug from the bench to the bedside. The research activities of the Pharmaceutical Biochemistry group span the drug discovery and development process, providing an interface that brings together pharmaceutical chemistry, biochemistry, structural biology, computational chemistry and biopharmaceutics. Formulation and drug delivery are brought into play at an earlier stage when facing the perennial challenge of transforming a potent molecule in vitro into a therapeutic agent in vivo. Concomitantly, drug delivery results can be understood at a molecular level. This broad range of interdisciplinary research activities and competences enables us to address key challenges in modern drug discovery and development, provides a powerful collaborative platform for other universities and the pharmaceutical industry and an excellent training platform for pharmacists and pharmaceutical scientists who will later be involved in drug discovery and development. PMID:22867543
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
The Pfizer Healthcare Informatics team conducted a series of guided interviews with 35 Pfizer senior leaders to elicit their understanding, desires, and expectations of how Electronic Health Records (EHR) might be used in the pharmaceutical industry today and/or in the future. The interviews yielded fourteen use case categories comprising 42 specific use cases. The highest priority use cases were “Drug Safety & Surveillance,” “Clinical Trial Recruitment,” and “Support Regulatory Approval.” Fifteen EHR companies were surveyed to assess their functionality against the specified use cases. Self-reported responses from the EHR companies were highest for “Virtual Phase IV Trials” and “Document Management for Clinical Trials.” This research identifies preliminary opportunities for EHR products to provide aggregate, blinded data to address the interests of the pharmaceutical industry. However, further collaboration between the stakeholders will be necessary to ensure the full realization of the opportunities for data re-use.
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.
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
Objective To investigate whether selective serotonin reuptake inhibitor (SSRI) antidepressants are associated with an increased risk of suicide related outcomes in adults. Design Meta-analysis of randomised controlled trials of SSRIs compared with placebo in adults submitted by pharmaceuticalcompanies to the safety review of the Medicines and Healthcare products Regulatory Agency (MHRA). Participants Over 40 000 individuals participating in 477
The hypothesis that pharmaceuticals, with their known syntheses, chemical properties and primary mechanism of action would be an efficient source of new antifouling agents compatible with existing antifouling coating technology was tested. Twenty-three compounds at concentrations from 5 micrograms ml-1 to 40 ng ml-1 were tested for toxicity and inhibition of settlement of barnacle larvae. The compounds had a wide range of solubility in water and covered nine primary mechanisms of action in vertebrates. The upper level of potency was chosen because compounds that are highly potent have greater practical potential. The goal was to find compounds with high inhibition of settlement and low toxicity. Of the 23 compounds tested, 22 had significant effects on barnacle larvae. The variety of chemical structures and their variation in water solubility support the hypothesis that pharmaceuticals that are compatible with existing coatings technology should be considered as antifouling agents. Moreover, factors such as coating compatibility and environmental fate should be addressed early in the development process. PMID:14618722
Triboelectrification of pharmaceutical powders with stainless steel and polymer contact surfaces was investigated. alpha-Lactose monohydrate, from 90 to 125 up to 355-500 microm, was used to quantify electrostatic interactions with negligible powder adhesion to the contact surface. Size fractions down to 53-75 microm alone and in binary mixtures with <10 microm lactose or micronized salbutamol were used to investigate triboelectrification with powder adhered to the contact surface. Triboelectrification was performed in a cyclone charger fitted with interchangeable contact surfaces of steel and polymers, representing the surfaces of pharmaceutical processing and manufacturing equipment, packaging materials and components of dry powder inhaler devices. The results for single component powders showed charge acquisition was inversely related to particle size, where contact surface contamination was negligible. However, with particulate contamination, triboelectrification was more complex due to particle collisions with clean and contaminated contact surfaces. Analysis of adhered and non-adhered powder provided information about changes in composition of two component powders during triboelectrification. Particle size and chemical analyses showed that composition changes of mixtures may be related to powder/contact surface affinity and interparticulate forces for separation of components in a cohesive mix during triboelectrification. PMID:11564540
While the physical properties of pharmaceutical excipients have been well characterized, impurities that may influence the chemical stability of formulated drug product have not been well studied. In this work, the hydroperoxide (HPO) impurity levels of common pharmaceutical excipients are measured and presented for both soluble and insoluble excipients. Povidone, polysorbate 80 (PS80), polyethylene glycol (PEG) 400, and hydroxypropyl cellulose (HPC) were found to contain substantial concentrations of HPOs with significant lot-to-lot and manufacturer-to-manufacturer variation. Much lower HPO levels were found in the common fillers, like microcrystalline cellulose and lactose, and in high molecular weight PEG, medium chain glyceride (MCG), and poloxamer. The findings are discussed within the context of HPO-mediated oxidation and formulating drug substance sensitive to oxidation. Of the four excipients with substantial HPO levels, povidone, PEG 400, and HPC contain a mixture of hydrogen peroxide and organic HPOs while PS80 contains predominantly organic HPOs. The implications of these findings are discussed with respect to the known manufacturing processes and chemistry of HPO reactivity and degradation kinetics. Defining critical HPO limits for excipients should be driven by the chemistry of a specific drug substance or product and can only be defined within this context. PMID:16917844
Wasylaschuk, Walter R; Harmon, Paul A; Wagner, Gabriella; Harman, Amy B; Templeton, Allen C; Xu, Hui; Reed, Robert A
Evolved through the past 60 years, molecular simulations have become one of the most important analytical tools in many theoretical and applied scientific disciplines. This paper provides a brief introduction to molecular simulations as a means of addressing important scientific questions of interest to pharmaceutical scientists. The focus is on fundamental questions such as: (1) Why do simulations work? (2) How to simulate? (3) How to make the results of simulations "real?" (4) Where can simulations be applied? To demonstrate the fundamental rationale of molecular simulations, three perspectives, thermodynamics, statistical mechanics, and general statistics, are compared. The concept of stochasticity is introduced, followed by a brief account of the two major methods used in simulations, molecular dynamics and Monte Carlo simulations. A brief discussion is then given on force fields to indicate their central importance. To facilitate the discussion about possible applications to pharmaceutical systems, the characteristics of molecular simulations are first compared with those of laboratory experiments. Case studies are then introduced to demonstrate the strengths of simulations. Some frequently encountered questions also are presented and discussed. PMID:21491434
Price controls could have a substantial negative effect on pharmaceutical research and development. Extensive research is required before the development costs of a new drug or its benefits are known; most new drug development projects fail, sometimes after substantial financial and time costs. These conditions pose intractable practical problems for the operation of price controls, which cannot rest on objective, predictable standards such as the benefits or costs of individual drugs. In the absence of objective standards, pressure from health care providers and others would create powerful incentives for price regulators to decrease drug prices toward marginal costs of production and distribution, well below levels sufficient to reward innovative research. This downwardly biased price-setting mechanism would apply with particular force to the few successful projects that yield innovative drugs, whose prices would not be set by regulatory authorities until after research expenditures have been incurred and the new drugs are ready to enter the market. Manufacturers will expect price controls to reduce the potential payoffs from breakthrough drugs. This expectation would substantially reduce the incentives to pursue innovative research, as is evident in advanced economies in which price controls are now in force. Once established, price controls for pharmaceuticals, like those for medical services in the Medicare system, would also tend toward complexity and entrenchment of vested interests and could easily become permanent regardless of the harm they cause to patients. PMID:11388819
...Society for Pharmaceutical Engineering Co-Sponsorship Educational...Society of Pharmaceutical Engineering (ISPE), is announcing a...Society for Pharmaceutical Engineering, 600 North Westshore Blvd...registration fees cover the cost of facilities,...
...Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and...Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee...Pharmaceutical Science and Clinical Pharmacology (ACPS-CP) meeting, the...
...Practices for Unused Pharmaceuticals at Health Care Facilities AGENCY: Environmental...Practices for Unused Pharmaceuticals at Health Care Facilities. The guidance is targeted...pharmaceutical disposal practices at health care facilities, prompted by the...
...Notice of Registration; Apertus Pharmaceuticals, LLC By Notice dated June 4, 2012...12, 2012, 77 FR 35058, Apertus Pharmaceuticals, LLC., 331 Consort Drive, St Louis...determined that the registration of Apertus Pharmaceuticals, LLC., to manufacture the...
...Notice of Registration; Cedarburg Pharmaceuticals, Inc. By Notice dated November 5...13, 2012, 77 FR 67676, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton...that the registration of Cedarburg Pharmaceuticals, Inc., to manufacture the...
...TA-W-74,489] Warner Chilcott Pharmaceuticals, Inc. Including On-Site Leased...applicable to workers of Warner Chilcott Pharmaceuticals, Inc., Norwich, New York. The...employment related to the supply of pharmaceutical research and development...
...Substances, Notice of Registration; Halo Pharmaceutical Inc. By Notice dated December 2...December 14, 2011, 76 FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road...determined that the registration of Halo Pharmaceutical Inc. to manufacture the listed...
...Notice of Registration; Morton Grove Pharmaceuticals By Notice dated March 12, 2013...2013, 78 FR 17231, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove...that the registration of Morton Grove Pharmaceuticals to manufacture the listed basic...
...Notice of Registration; Morton Grove Pharmaceuticals By Notice dated September 25, 2012...2012, 77 FR 60144, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove...that the registration of Morton Grove Pharmaceuticals to manufacture the listed basic...
...Notice of Registration; Apertus Pharmaceuticals By Notice dated July 23, 2013, and...31, 2013, 78 FR 46372, Apertus Pharmaceuticals, 331 Consort Drive, St Louis, Missouri...determined that the registration of Apertus Pharmaceuticals to manufacture the listed basic...
... false Condition for coverage-Pharmaceutical services. 416.48 Section 416...416.48 Condition for coverageâPharmaceutical services. The ASC must provide...individual designated responsible for pharmaceutical services. (a) Standard:...
...Notice of Registration; Cedarburg Pharmaceuticals, Inc. By Notice dated January 6...17, 2012, 77 FR 2324, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton...that the registration of Cedarburg Pharmaceuticals, Inc. to manufacture the...
...Schwarz Pharma Manufacturing, Inc. (Pharmaceutical Products); Seymour, IN Pursuant...a special- purpose subzone at the pharmaceutical manufacturing and distribution facility...manufacturing and distribution of pharmaceutical products at the facility of...
...Substances, Notice of Registration, Halo Pharmaceutical, Inc. By Notice dated July 30...August 7, 2012, 77 FR 47114, Halo Pharmaceutical, Inc., 30 North Jefferson Road...determined that the registration of Halo Pharmaceutical, Inc., to manufacture the...
... false Condition for coverage-Pharmaceutical services. 416.48 Section 416...416.48 Condition for coverageâPharmaceutical services. The ASC must provide...individual designated responsible for pharmaceutical services. (a) Standard:...
The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceuticalcompanies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM) regulation in order to achieve "Cara Pembuatan Obat yang Baik" (CPOB) of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO) membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI) as final polisher for controlling conductivity, and finally Ultra Violet (UV) disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.
Poor drug access continues to be one of the main global health problems. Global inequalities in access to pharmaceuticals are caused by a number of variables including poverty, high drug prices, poor health infrastructure, and fraud and corruption — the latter being the subject of this article. There is growing recognition among policy makers that corruption in the pharmaceutical system
To provide an opportunity for pharmacy students to acquire a better understanding of the medical service representative's functions as a member of the pharmaceutical industries' marketing force, a practice experience elective course in pharmaceutical sales was developed at the University of Cincinnati. Course planning and implementation are…
The separation of carboxylic enantiomers in the pharmaceutical field using high-performance liquid chromatographic and capillary electrophoretic techniques is reviewed. The techniques used for chiral separation include diastereomer derivatization, a chiral mobile phase, a chiral stationary phase (high-performance liquid chromatography) and chiral additives (capillary electrophoresis). Practical and conventional separation systems for pharmaceutical applications, such as pharmacokinetics, optical purity testing and stability
Discusses need for social scientific research, clinical social scientists in pharmacy, and specialists in pharmaceutical sociology and the other social sciences. To illustrate, patient noncompliance with drug regimens and the use of sociology to analyze the problem are examined. Includes a sample program in pharmaceutical sociology, course…
Based on the analysis of pharmaceuticals logistics, this paper describes the Internet of Things (IoT) application status in pharmaceuticals warehouse, transportation, quality and safety management. Then the paper in-depth analyzes the main problems and difficulties, such as lack of industry standards, high investment costs, technology started late, lack of industry professionals, information leakage. Finally some countermeasures are given for China
Cabbage (Brassica rapa var. pekinensis) and Wisconsin Fast Plants (Brassica rapa) were chosen for a proof of concept study to determine the potential uptake and accumulation of human pharmaceuticals by plants. These plants were grown hydroponically under high-pressure sodium lamps in one of two groups including a control and test group exposed to pharmaceuticals. The control plants were irrigated with
Patrick A. Herklotz; Prakash Gurung; Brian Vanden Heuvel; Chad A. Kinney
Pharmaceuticals are increasingly detected in a variety of aquatic systems. One of the most prevalent environmental pharmaceuticals in North America and Europe is the antidepressant fluoxetine, a selective serotonin reuptake inhibitor (SSRI) and the active ingredient of Prozac. Usually detected in the range below 1 ?g\\/L, fluoxetine and its active metabolite norfluoxetine are found to bioaccumulate in wild-caught fish, particularly
Jan A. Mennigen; Pamela Stroud; Jake M. Zamora; Thomas W. Moon; Vance L. Trudeau
In this experimental study both biological treatability of pharmaceuticals and their potential toxic effect in biological processes were evaluated. The pharmaceuticals were selected among those that are present at higher concentration in the Italian wastewater treatment plant effluents and widely used as antiulcer (ranitidine), ?-blocker (atenolol) and antibiotic (lincomycin). The present paper is the continuation of a work already presented,[1
ALESSANDRA CARUCCI; GIOVANNA CAPPAI; MARTINA PIREDDA
With the escalating use of pharmaceuticals in health care, there has been increasing anxiety over the potential health risks associated with pharmaceutical waste accumulating in the environment. This research provided nurses in a hospice care facility in Concord, California, with education and training to offer patients a medication disposal service through the use of mail-back envelopes. Over the 6-month study
The removal of seven pharmaceuticals and two fragrances in the biological units of various full-scale municipal wastewater treatment plants was studied. The observed removal of pharmaceuticals was mainly due to biological transformation and varied from insignificant (90% (ibuprofen). However, no quantitative relationship between structure and activity can be set up for the biological transformation. Overall, it can be concluded that
Adriano Joss; Elvira Keller; Alfredo C. Alder; Anke Göbel; Christa S. McArdell; Thomas Ternes; Hansruedi Siegrist
This paper describes an educational project intended to evaluate pharmacy students' abilities to provide direct patient care utilizing the pharmaceutical care process. Fourteen students enrolled in an elective course and provided care for 18 patients throughout spring quarter 1998. There were a total of 61 drug therapy problems identified in this patient population. The Assurance Patient-Centered Pharmaceutical Care Program (version
This review provides some background to infrared spectroscopy including Fourier transform infrared spectroscopy. It is not meant to be complete or exhaustive but to provide the reader with sufficient background for selected applications in pharmaceutical analysis. Fourier transform infrared spectroscopy (FTIR) is a fast and nondestructive analytical method. Associated with chemometrics, it can become a powerful tool for the pharmaceutical
Andrei A. Bunaciu; Hassan Y. Aboul-Enein; Serban Fleschin
Astronaut William G. Gregory, STS-67 pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical but also biotechnology, cell biology, fluids and crystal growth investigations.
Pharmaceutical education and pharmaceutical practice began to diverge in the early twentieth century for socioeconomic reasons and have since grown along separate paths. The movement toward clinical pharmacy, emerging about 1970, may reunite the two but it first faces new challenges. (MSE)
Significance of pharmaceutical formulation (choosing of correct excipients in optimal quantities), effects of glass transition temperature, importance of theoretical modeling of the process, benefits of optimal control, and the advantages of remote monitoring of the process are presented. Experimental and theoretical research and development needs for the freeze-drying of pharmaceutical products are proposed and discussed.
Purpose: The purpose of this paper is to document the ways pharmaceutical representatives learn for work and report attributes of (in)formality and other characteristics of ways of learning perceived as effective and frequently used. Design/methodology/approach: A total of agents 20 from 11 pharmaceutical manufacturers across Canada participated…
Intended for practitioners, this is the first booklet in the Research-Based Practices in Early Reading series published by the Regional Educational Laboratory at Pacific Resources for Education and Learning. The 31-page booklet summarizes research on fluency and fluency instruction and describes strategies for fluency instruction. It also explains…
Communication skills are of great importance for children with developmental disabilities to be functional and independent in their own lives. This paper provides results of a comprehensive literature review on current researched-based intervention strategies that appear effective to increase communication skills for students who have severe…
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.
Changes in the 2004 Individuals With Disabilities Education Improvement Act (IDEA, 2004) opened the door for wide use of response to intervention (RTI) as a model for identifying students with learning disabilities. These legislative changes coincide with recent trends of school-wide reform, in which schools implement research-based instruction…
Harlacher, Jason E.; Walker, Nancy J. Nelson; Sanford, Amanda K.
This study explored two aspects of expanding the use of research-based practices in schools: (a) the extent to which mentor teachers could effectively teach a fellow teacher an instructional practice they had learned the previous year and (b) the extent to which the target practice would be implemented effectively by the partner after instruction…
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.
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…
This report provides research-based answers to questions about literacy development from infancy to age 6, with emphasis on the development of these skills in precocious readers. The question-answer format considers the importance of reading with young children, other activities to help young children learn to read, normal development of reading…
This article presents 10 research-based principles of instruction, along with suggestions for classroom practice. The principles come from (a) research in cognitive science, (b) research on master teachers, and (c) research on cognitive supports. The instructional principles are: (1) Begin a lesson with a short review of previous learning to…
The researchbase on cooperative learning was examined for its applicability to academically talented students. Common types of cooperative learning are described with highlights of the model characteristics as they apply to academically talented students. The models include: Teams-Games-Tournament (TGT); Student Teams Achievement Divisions…
This article examines the challenges faced by a Portuguese technical university that is striving to develop its researchbase within a developing science, technology and higher education system. The paper identifies lack of resources, and also organizational factors, as particular challenges. These include faculty inbreeding, career structures and…
Although there is evidence that literacy deficiencies in adolescents can be remedied with one-to-one tutoring using research-based instructional strategies, a review of current literature provides only limited information on transferring effective instructional strategies to learning environments outside of one-to-one tutoring centers. The authors…
Houge, Timothy T.; Geier, Constance; Peyton, David
This proposal is to amend the undergraduate elementary interdisciplinary curriculum to incorporate a Research-based Inquiry strand throughout the elementary methods for teaching courses in order to provide greater coherence among related topics, and to provide students and faculty the opportunity for increased intellectual interaction and shared inquiry. This will be achieved through reorganization of the courses and the development of
Becky Carr; Jean Madsen; Connie Fournier; Beth McNeill; Robert M. Capraro
"A Focus on Professional Development" is the fourth in the Research-Based Practices in Early Reading Series published by the Regional Educational Laboratory (REL) at Pacific Resources for Education and Learning (PREL). Because reading proficiency is fundamental to student achievement across all subjects and grades, the preparation of the teachers…
Preparing teachers for a research-based professionalism has been the central mission of teacher education in Finland since the mid-1970s. More recently, as a result of such national policy developments as school-based curriculum development and local decision-making, the conception of teachers' work and professionalism has expanded. Drawing on…
Westbury, Ian; Hansen, Sven-Erik; Kansanen, Pertti; Bjorkvist, Ole
This article presents 10 research-based principles of instruction, along with suggestions for classroom practice. These principles come from three sources: (a) research in cognitive science, (b) research on master teachers, and (c) research on cognitive supports. Each is briefly explained in this article. Even though these are three very different…
Evaluated the four-year outcome of the Research-Based Model Partnership in Education Program, an after-school tutoring and adaptive-skills training program for mostly low-achieving, low-income African-American students. Computerized school records provided academic and social data. Results indicated that four-year participants had higher grade…
Tucker, Carolyn M.; Herman, Keith C.; Reid, Alaycia D.; Keefer, Nikki L.; Vogel, David L.
A randomized-trials design was used to evaluate the effectiveness of a preschool mathematics program based on a comprehensive model of research-based curricula development. Thirty-six preschool classrooms were assigned to experimental (Building Blocks), comparison (a different preschool mathematics curriculum), or control conditions. Children were…
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…
Educational reform and financial considerations have emphasized accountability and use of research-based materials and strategies in education. Simultaneously, with growing enrollment in elementary, secondary, and postsecondary ASL programs, the number of commercially marketed materials has grown. Do such materials stand up under scrutiny when…
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…
In recent years cocrystal formation has emerged as a viable strategy towards improving the solubility and bioavailability of poorly soluble drugs. In this review the success of numerous pharmaceutical cocrystals for the improvement of the solubility and dissolution rates of poorly soluble drugs is demonstrated using various examples taken from the literature. The role of crystal engineering principles in the selection of appropriate coformers and the nature of the supramolecular synthons present within the crystals are described. Evidence for improved animal pharmacokinetic data is given for several systems. A summary is provided of our current understanding of the relationship between cocrystal structure and solution phase interactions on solubility as well as those factors that influence overall cocrystal thermodynamic stability. PMID:23207015
Molecular imprinting is a means of introducing sites of specific molecular arrangement into an otherwise uniform polymeric matrix. This is achieved by formation of a pre-polymerisation complex between complementary monomers and the template molecule. Subsequent polymerisation in the presence of a crosslinker, in a porogenic environment, results in the production of a macroporous polymer capable of specific molecular recognition. This paper considers potential roles for molecularly imprinted polymers within a pharmaceutical remit. Applications including controlled release, drug monitoring devices and biological receptor mimetics are discussed. Histamine and ephedrine molecularly imprinted polymers (MIPs) were studied as potential biological receptor mimics whilst a propranolol MIP was investigated for its use as a rate attenuating selective excipient in a transdermal controlled release device. Preliminary studies concerning the preparation of a theophylline selective transcutaneous monitoring device, using a theophylline MIP, are also described. PMID:10675681
Allender, C J; Richardson, C; Woodhouse, B; Heard, C M; Brain, K R
Pharmaceutical industry and physician-investigators are mutually dependent for the development of new drugs and clinical trials of such drugs. Under pressure of increasing market orientation, clinical scientific investigations shift more and more from fundamental to clinical drug trials, the results of which sometimes do not justify the excitement with which they are presented in the scientific and lay press. More room and means should be given to less market oriented studies, addressing more fundamental clinical problems. Financial affiliation with the industry may influence the doctors' mind and the presentation and type of investigation. Apart from this type of intellectual subjection there is a form of financial subjugation of doctors to the industry, by participating in so-called 'postmarketing surveillance studies' which they in fact are not, that have no scientific value whatsoever, but only serve the financial interest of the participating doctor and the industry. PMID:10494304
...Companies Acceptable on Federal Bonds: Regent Insurance Company AGENCY: Financial Management...C. 9305 to the following company: Regent Insurance Company (NAIC 24449...www.fms.treas.gov/c570. Questions concerning this Notice may be...
...DEPARTMENT OF THE TREASURY Fiscal Service Surety Companies Acceptable on Federal Bonds: Terminations-- American Economy Insurance Company (NAIC 19690); American States Insurance Company (NAIC 19704); General Insurance Company of...
...Fiscal Service Surety Companies Acceptable on Federal Bonds: Darwin National Assurance Company AGENCY: Financial Management Service...issued under 31 U.S.C. 9305 to the following company: Darwin National Assurance Company (NAIC 16624). Business...
...Companies Acceptable on Federal Bonds: Allied World Reinsurance Company AGENCY: Financial...9305 to the following company: Allied World Reinsurance Company (NAIC 22730). Business Address: 199 Water Street, New York, NY 10038....
A construction company that serves a 20-county area of eastern Georgia has as its main source of revenue the manufacture and placement of asphaltic concrete used in road construction. Thanks to a new, multiyear, state-funded highway program, the company is considering the purchase of a new nonportable drum-mix plant needed to expand its asphaltic-concrete manufacturing capacity. Students can explore net
A construction company serving a 20-county area of eastern Georgia has as its main source of revenue the manufacture and placement of asphaltic concrete used in road construction. In response to the demands of a new, multiyear, state-funded highway program, the company needs to expand its manufacturing capacity. Now, in addition to the new portable drum-mix plant (whose price has
The marine environment harbors a number of macro and micro organisms that have developed unique metabolic abilities to ensure their survival in diverse and hostile habitats, resulting in the biosynthesis of an array of secondary metabolites with specific activities. Several of these metabolites are high-value commercial products for the pharmaceutical and cosmeceutical industries. The aim of this review is to outline the paths of marine natural products discovery and development, with a special focus on the compounds that successfully reached the market and particularly looking at the approaches tackled by the pharmaceutical and cosmetic companies that succeeded in marketing those products. The main challenges faced during marine bioactives discovery and development programs were analyzed and grouped in three categories: biodiversity (accessibility to marine resources and efficient screening), supply and technical (sustainable production of the bioactives and knowledge of the mechanism of action) and market (processes, costs, partnerships and marketing). Tips to surpass these challenges are given in order to improve the market entry success rates of highly promising marine bioactives in the current pipelines, highlighting what can be learned from the successful and unsuccessful stories that can be applied to novel and/or ongoing marine natural products discovery and development programs.
The Serotonin Club celebrated its silver jubilee in 2012 with a meeting in Montpellier, France. During the past 25 years, great advances have been made in our understanding of the pharmacology of serotonin receptors and the roles of this neurotransmitter in psychiatric disorders. Most of these advances have involved effective collaborations between academic and industrial scientists. In recent years, however, this picture has changed, as many of the major pharmaceuticalcompanies have pulled out of in-house psychopharmacology research into the major psychiatric disorders, despite an increasing worldwide burden of these disorders and a clear need for improved treatment, particularly in terms of improved efficacy. This Viewpoint investigates the reasons for the decline in industrial involvement and makes proposals as to how future academic research on serotonin function in the brain might reawaken industry interest in serotonin-based research. Briefly, academic preclinical scientists need to alter their experimental approach to research into the psychiatric disorders. This will require a move from a single-target approach to understanding the complex neuronal pathways the cause diverse functional and behavioral outputs, using novel technological advances and the development of animal models with enhanced translational values. It is hoped that such an approach will reveal novel drug targets and thus re-engage the pharmaceutical industry in research that will result in improved human health and social well-being.
This paper studies price determination in pharmaceutical markets using data for 25 countries, 6?years, and a comprehensive list of products from the MIDAS IMS database. A key finding is that the USA has prices that are not significantly higher than those of countries with similar income levels, especially those that are 'lightly regulated'. More importantly, price differences to the US levels increase for 'branded', world top selling, or innovative products, and decrease, regardless of the level of regulation for mature or widely diffused molecules. Because prices for top selling molecules may be easier to perceive and recollect and more important for companies, they may bias the public discussion about international price differences. PMID:23303712
Cloud computing provides information processing power and business services, delivering these services over the Internet from centrally hosted locations. Major technology corporations aim to supply these services to every sector of the economy. Deploying business processes 'in the cloud' requires special attention to the regulatory and business risks assumed when running on both hardware and software that are outside the direct control of a company. The identification of risks at the correct service level allows a good mitigation strategy to be selected. The pharmaceutical industry can take advantage of existing risk management strategies that have already been tested in the finance and electronic commerce sectors. In this review, the business risks associated with the use of cloud computing are discussed, and mitigations achieved through knowledge from securing services for electronic commerce and from good IT practice are highlighted. PMID:20443161
Current drug discovery involves a highly iterative process pertaining to three core disciplines: biology, chemistry, and drug disposition. For most pharmaceuticalcompanies the path to a drug candidate comprises similar stages: target identification, biological screening, lead generation, lead optimization, and candidate selection. Over the past decade, the overall efficiency of drug discovery has been greatly improved by a single instrumental technique, liquid chromatography/mass spectrometry (LC/MS). Transformed by the commercial introduction of the atmospheric pressure ionization interface in the mid-1990s, LC/MS has expanded into almost every area of drug discovery. In many cases, drug discovery workflow has been changed owing to vastly improved efficiency. This review examines recent trends for these three core disciplines and presents seminal examples where LC/MS has altered the current approach to drug discovery.
Ackermann, Bradley L.; Berna, Michael J.; Eckstein, James A.; Ott, Lee W.; Chaudhary, Ajai K.
Removal of seven active pharmaceutical substances (ibuprofen, ketoprofen, naproxen, diclofenac, clofibric acid, mefenamic acid, and gemfibrozil) was assessed by batch experiments, with suspended biofilm carriers and activated sludge from several full-scale wastewater treatment plants. A distinct difference between nitrifying activated sludge and suspended biofilm carrier removal of several pharmaceuticals was demonstrated. Biofilm carriers from full-scale nitrifying wastewater treatment plants, demonstrated considerably higher removal rates per unit biomass (i.e. suspended solids for the sludges and attached solids for the carriers) of diclofenac, ketoprofen, gemfibrozil, clofibric acid and mefenamic acid compared to the sludges. Among the target pharmaceuticals, only ibuprofen and naproxen showed similar removal rates per unit biomass for the sludges and biofilm carriers. In contrast to the pharmaceutical removal, the nitrification capacity per unit biomass was lower for the carriers than the sludges, which suggests that neither the nitrite nor the ammonia oxidizing bacteria are primarily responsible for the observed differences in pharmaceutical removal. The low ability of ammonia oxidizing bacteria to degrade or transform the target pharmaceuticals was further demonstrated by the limited pharmaceutical removal in an experiment with continuous nitritation and biofilm carriers from a partial nitritation/anammox sludge liquor treatment process. PMID:22209263
Falås, P; Baillon-Dhumez, A; Andersen, H R; Ledin, A; la Cour Jansen, J
In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceuticalcompanies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceuticalcompanies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch doctors during the interwar years--from rapprochement towards concerted action. PMID:22586821
Pharmaceutical compounding of capsules is still an important corner stone in today's health care. It allows for a more patient specific treatment plan as opposed to the "one size fits all"-approach, used by the pharmaceutical industry when producing fixed dose finished drug products. However, loss of active pharmaceutical ingredient (API) powder during pharmaceutical capsule compounding can lead to under-dosed finished drug products and annul the beneficiary therapeutic effects for the patient. The amount and location of API loss was experimentally determined during capsule compounding of five different preparations: 10 and 20mg hydrocortisone capsules, 4mg triamcinolone capsules and 0.25mg dexamethasone capsules, using a 10% m/m self-made or commercial trituration. The total API amount present in the five capsule preparations varied between 90.8% and 96.6%, demonstrating that for certain preparations, significant API mass loss occurred during the pharmaceutical compounding of capsules. Swabbing results of the different compounding equipment and working areas indicated the mortar surface as the largest API loss location. An agate mortar accounted for the least amount of API loss, whereas an extensively used porcelain mortar accounted for the highest amount of API loss. Optical microscopy and roughness (Ra) determination by profilometry of the different mortar surfaces revealed a significant influence of the mortar surface wear and tear on the observed API loss. This observation can be explained by physical deformation, or scratch formation, of the relatively soft porcelain mortar surface, in which the API particles can become adsorbed. Furthermore, a small effect of the capsulation device material on the API loss was also observed. The presence of a chemical molecule effect on the API loss was demonstrated through data mining using a set of assay results containing 17 different molecules and 1922 assay values. The 17 median assay values were modeled in function of corresponding molecular descriptors, using stepwise multiple linear regression. The obtained MLR model, containing RDF060m, R6e(+) and R3m(+) variables, explained 92.5% of the observed variability between the 17 median assay values. PMID:24727282
D'Hondt, Matthias; Wynendaele, Evelien; Vandercruyssen, Kirsten; Bauters, Tiene; Vandenbroucke, Johan; Mullens, Steven; Vervaet, Chris; Remon, Jean Paul; De Spiegeleer, Bart
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.
In recent years, spending on prescription drugs contributes substantially to the continuous growth in health expenditure in most Western countries. This increase in spending is influenced by both a rise in the use of existing drugs and by the adoption of new and expensive drugs. Risk-sharing agreements between pharmaceuticalcompanies and health insurers have emerged as insurers began to deny reimbursement of expensive innovative treatments with unfavorable cost-effectiveness ratios. This occurred in cases where the expected budgetary impact was too high or when the long-term effectiveness was questionable. Risk sharing agreements serve the interests of both the insurers and the drug manufacturers. Pharmaceuticalcompanies' interests are to dispel the uncertainties encountered by the health insurers white deciding on drug reimbursement. The insurers are interested in these agreements in order to reduce the budgetary risk while allowing their patients access to innovative drugs. Currently, only a few risk sharing agreements have been implemented, and the scientific literature on such schemes is still sparse. Since the health insurers' interest is to develop mechanisms that will contain health costs, without affecting the insured, it appears that this trend will continue to emerge. It is also likely that the adoption of similar mechanisms in the Israeli National List of Health Services updating process, would improve the accuracy of early estimates of the budgetary impact, and the actual use of the new technologies would be close to early estimates. This article reviews the principles of risk-sharing schemes and issues involved in the actual implementation of such agreements. PMID:22991869
The separation of carboxylic enantiomers in the pharmaceutical field using high-performance liquid chromatographic and capillary electrophoretic techniques is reviewed. The techniques used for chiral separation include diastereomer derivatization, a chiral mobile phase, a chiral stationary phase (high-performance liquid chromatography) and chiral additives (capillary electrophoresis). Practical and conventional separation systems for pharmaceutical applications, such as pharmacokinetics, optical purity testing and stability studies, are described. A comprehensive collection of applications to carboxylic drugs and other carboxylic compounds of pharmaceutical interest is listed in the tables. The characteristics of each enantioseparation method are also discussed briefly. PMID:9832251
Click chemistry refers to a group of reactions that are fast, simple to use, easy to purify, versatile, regiospecific, and give high product yields. While there are a number of reactions that fulfill the criteria, the Huisgen 1,3-dipolar cycloaddition of azides and terminal alkynes has emerged as the frontrunner. It has found applications in a wide variety of research areas, including materials sciences, polymer chemistry, and pharmaceutical sciences. In this manuscript, important aspects of the Huisgen cycloaddition will be reviewed, along with some of its many pharmaceutical applications. Bioconjugation, nanoparticle surface modification, and pharmaceutical-related polymer chemistry will all be covered. Limitations of the reaction will also be discussed.
Innovation, vaccine development, and world-wide equitable access to necessary pharmaceuticals are hindered by current patenting arrangements and the orientation of pharmaceutical research. Plausible alternatives exist, including instituting the right of national or international agencies to act in the public interest and to buy patents selectively with a view to innovation and equitable access. Alternatives could partly or wholly finance themselves and lower pharmaceutical prices globally. Countries, individuals or groups of patients could help promote alternatives by calling into question the current emphasis on commercialization and profit, and by demanding globally equitable arrangements when sharing data that are important for research or when individuals or communities volunteer as research participants. PMID:18771195
As it is often difficult to obtain sufficient numbers of measurements to adequately characterise exposure levels, occupational exposure models may be useful tools in the exposure assessment process. This study aims to refine and validate the inhalable dust algorithm of the Advanced REACH Tool (ART) to predict airborne exposure of workers in the pharmaceutical industry. The ART was refined to reflect pharmaceutical situations. Largely task based workplace exposure data (n = 192) were collated from a multinational pharmaceuticalcompany with exposure levels ranging from 5 × 10(-5) to 12 mg m(-3). Bias, relative bias and uncertainty around geometric mean exposure estimates were calculated for 16 exposure scenarios. For 12 of the 16 scenarios the ART geometric mean exposure estimates were lower than measured exposure levels with on average, a one-third underestimation of exposure (relative bias -32%). For 75% of the scenarios the exposure estimates were, within the 90% uncertainty factor of 4.4, as reported for the original calibration study, which may indicate more uncertainty in the ART estimates in this industry. While the uncertainty was higher than expected this is likely due to the limited number of measurements per scenario, which were largely derived from single premises. PMID:21544304
Mc Donnell, Patricia E; Schinkel, Jody M; Coggins, Marie A; Fransman, Wouter; Kromhout, Hans; Cherrie, John W; Tielemans, Erik L
A variety of promotional strategies have been used to stimulate sales of pharmaceutical drugs. Traditionally, push techniques have been the predominant means used to encourage physicians to prescribe drugs and thus increase sales. Recently, the traditional push strategy has been supplemented by a pull strategy. Direct-to-consumer advertising is increasingly used to encourage consumers to request advertised drugs from their physicians. This research compares the attitudes of two of the most affected participants in the prescriptive sales processes; physicians and pharmaceutical sales representatives. The findings indicate differences between physicians and pharmaceutical sales representatives regarding the efficacy and ethical considerations of various promotional strategies. PMID:16597582
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.
Glass is made of polymeric silica and other minor components, which are necessary for turning the silica into a material more easily moldable and resistant to temperature changes. Glass containers for pharmaceutical usage are classified according to their resistance to a chemical attack, a test carried out in the presence of water and heat. The test is designed to show the released alkalinity, a variable dependent on the amount of sodium oxide, one of the minor components added to the glass mass. In this work, the release of silica from glass by action of constituents from pharmaceutical formulations was investigated. The study included products used in large volumes and usually stored in glass containers. Solutions of amino acids, electrolytes, glucose, oligoelements and others such as heparin and sodium bicarbonate were individually stored in glass containers and heated at 121 degrees C for 30min, as in the water attack test. The test was also carried out only with water, where the pH varied from 2 to 12. The released silicate was measured either by photometry or atomic absorption spectrometry, depending on the nature of the sample. The results showed that silicate is released during the heating cycle even if the contact is with pure water only. The pH exerts a considerable influence on the release, being that the higher the pH, the higher the silica dissolved. An elevated pH, however, is not the only factor responsible for silica dissolution. While in the solutions of NaCl, KCl, Mg Cl2 and ZnSO4 and in most of the amino acids, the concentration of silicate was as high as in pure water (0.1-1.0mg Si/L). In the solutions of sodium acetate, bicarbonate and gluconate, its concentration was much higher, over 30mg Si/L. These results were confirmed by the analysis of commercial products, where in solutions of amino acids the level of silicate ranged from 0.14 to 0.19mg Si/L. On the other hand, calcium gluconate, sodium bicarbonate and potassium phosphate presented silicate levels from 1 to 4mg/L. Although silica is not considered a toxic substance for humans, it is necessary to be aware of its presence in solutions for parenteral nutrition due to the direct introduction into the bloodstream and the large volume usually administrated, even to pre-term infants. PMID:18272302
Bohrer, Denise; Bortoluzzi, Fabiana; Nascimento, Paulo Cícero; Carvalho, Leandro Machado; Ramirez, Adrian Gustavo
We conducted a prospective observational study to (1) determine usage and construct validity of a method to gauge the cognitive impact of information derived from daily e-mail, and (2) describe self-reported impacts of research-based synopses (InfoPOEMs) delivered as e-mail. Ratings of InfoPOEMs using an Impact assessment scale provided (a) data on usage of the impact assessment method, (b) reports of
ROLAND M. GRAD; PIERRE PLUYE; JAY MERCER; BERNARD MARLOW; MARIE-EVE BEAUCHAMP; MICHAEL SHULHA; JANIQUE JOHNSON-LAFLEUR; SHARON WOOD-DAUPHINEE
This article reviews the existing researchbase for child mental health services and policy. It emphasizes the importance\\u000a of research that looks at the overall community-based system of care as the unit of analysis, and stresses the need to maintain\\u000a a systems perspective, even when research is focused on components of the overall system. The review concludes that there\\u000a is
The cognitive impact of a research-based, teacher-delivered sex education programme for 13–15-year olds (SHARE) was evaluated in 25 Scottish schools. The relationship between cognitions targeted by SHARE and the sexual behaviour of teenagers who had first sexual intercourse after receiving sex education was assessed. The belief that there are alternatives to sexual intercourse in romantic\\/sexual relationships and the intention to
The Industry Sector Analyses (I.S.A.) for drugs and pharmaceuticals contains statistical and narrative information on projected market demand, end-users, receptivity of Latin American consumers to U.S. products, the competitive situation - Latin American ...
The invention provides a vaccine including an isolated Als protein family member having cell adhesion activity, or an immunogenic fragment thereof, with an adjuvant in a pharmaceutically acceptable medium. The invention also provides a method of treating ...
A. Ibrahim D. C. Sheppard J. E. Edwards S. G. Filler Y. Fu
...the patients. The institution must have a pharmacy directed by a registered pharmacist or...pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be...
This article outlines a new social reality of global psycho-pharmaceutical prescribing: the pharmaceutical family, or ;phamily.' Ethnographic case studies from Manitoba, Canada (2002 to 2004) show how pharmaceutical emplotment, involving a synergy between cultural and drug scripts, can have uncanny consequences for vulnerable groups, such as Aboriginal children. Observations and interview transcripts of high prescribing doctors are analyzed to understand the prescribing logic of using psychoactive medication, such as methylphenidate, in young Aboriginal children diagnosed with FASD and/or ADHD. Pharmaceutical narratives are presented in order to show how non-compliance to psychotropic prescribing can further marginalize Aboriginal children and is related to the history of colonial practices in Canada. PMID:19293283
The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future.
This research discloses a compound and method of making a compound for use as a diagnostic or therapeutic pharmaceutical comprises a functionalized hydroxyalkyl phosphine ligand and a metal combined with the ligand. 16 figs.
This guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's current thinking on the appropriate regulatory classification of pharmaceutical co-crystal s...
Pharmaceuticals in wastewater were treated by the combined method of activated sludge and ionizing radiation in laboratory scale. Oseltamivir, aspirin, and ibuprofen at 5 ?mol dm-3 in wastewater were decomposed by the activated sludge at reaction time for 4 h. Carbamazepine, ketoprofen, mefenamic acid, clofibric acid, and diclofenac were not biodegraded completely, but were eliminated by ?-ray irradiation at 2 kGy. The rate constants of the reactions of these pharmaceuticals with hydroxyl radicals were estimated by the competition reaction method to be 4.0-10×109 mol-1 dm3 s-1. Decompositions of the pharmaceuticals in wastewater by ionizing radiation were simulated by use of the rate constants and the amount of total organic carbon as parameters. Simulation curves of concentrations of these pharmaceuticals as a function of dose described the experimental data, and the required dose for the elimination of them in wastewater by ionizing radiation can be estimated by this simulation.
Pharmaceuticals from human and veterinary use continually enter the environment through municipal wastewater treatment plants (WWTPs), surface runoff from animal waste, and direct disposal of unused medications. The presence of these chemicals, albeit often at subtherapeutic trac...
To improve the availability of essential drugs for the health requirements of developing countries and to promote industrialization in the Pharmaceutical Sector, UNIDO has prepared a number of publications offering guidance to developing countries in esta...
An issue that began to receive more attention by environmental scientists in the late 1990s was the conveyancy of pharmaceuticals in the environment by way of their use in human and veterinary medical practices and personal care...
Only recently, attention has been drawn towards the occurrence of pharmaceuticals in the environment. In recent years many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in waste water, surface water, ground water and in soil. In this study, we demonstrate the applicability of a previously developed LC-MS/MS method by evaluating in waste water and surface water samples from Belgium the occurrence of 8 pharmaceuticals and 1 pesticide (flubendazole, pipamperone, rabeprazole, domperidone, ketoconazole, itraconazole, cinnarizine, miconazole and propiconazole). Removal rates in five public waste water treatment plants were assessed. Introduction of several compounds into the aquatic environment by discharge of effluent could be demonstrated. For several compounds, the highest concentrations (up to 35.6 microg/l for pipamperone) were observed in the effluent of a WWTP receiving water from chemo-pharmaceutical and other industrial companies. The occurrence of these compounds in the aquatic environment was assessed by analyzing 16 surface water samples, taken from various locations. Four pharmaceuticals (flubendazole, pipamperone, domperidone and cinnarizine) could be detected in at least one sample at low concentrations (up to 26.4 ng/l). The pesticide propiconazole was found in comparable concentrations (up to 85.9 ng/l) as in effluent, suggesting potential introduction by direct seepage of water from rural grounds. The highest concentrations of flubendazole, pipamperone, domperidone, propiconazole and cinnarizine (up to 961.3 ng/l) were observed in a sample, taken near the discharge of a WWTP receiving water from chemo-pharmaceutical and other industries. An initial environmental risk assessment was done based on these results. PMID:20471061
Van De Steene, Jet C; Stove, Christophe P; Lambert, Willy E
Metal leachables from packaging components can affect the safety and efficacy of a pharmaceutical formulation. As liquid formulations continue to contain surfactants, salts, and chelating agents coupled with lower drug levels, the interaction between the formulation and the packaging material becomes more important. This study examines the interaction of commonly used packaging materials with extraction solvents representative of liquid formulations found in the pharmaceutical industry stressed under conditions encountered during accelerated stability studies. PMID:17260898
The occurrence of pharmaceuticals and their metabolites and transformation products in the environment is becoming a matter\\u000a of concern, because these compounds, which may have adverse effects on living organisms, are extensively and increasingly\\u000a used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have\\u000a been detected in many environmental samples worldwide. Their