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At least 613 records · Page 34Linked to original sources
PubMed1997

The PMAC code of marketing practices: time for improvement? Pharmaceutical Manufacturers Association of Canada.

In this issue (see pages 351 to 356) Dr. Joel Lexchin proposes reforms that could help the Pharmaceutical Manufacturers Association of Canada (PMAC) adapt its Code of Marketing Practices to changing times. The PMAC code reflects the ethical concerns of drug manufacturers and speaks to the need for high standards in promotional activities. The code is a commendable beginning, but it does not go far enough in ensuring ethical practice. The PMAC should take this opportunity to address the concerns raised by Lexchin. For example, proactive assessment of advertising would improve the current system.

Advertising↗
PubMed1990

[How and when to create a pediatric file for authorization to market a new drug. A proposal of the SNIP clinical group (National Syndicate of Pharmaceutical Industry)].

In order to recommend the pediatric use of a new drug, the registration file should include several types of studies. Existing data on toxicological and pharmacological studies in animal and human have to be thoroughly examined. In addition, the splitting potential of single doses to be adapted to the child should be studied, according to the galenic formula. In all cases, the clinical file should have one pharmacokinetic study on acute intake of one or several doses in the specific age bracket. When the efficacy of a drug has been demonstrated in adults for the same disease, and if the results are extrapolated to children, the file should include one or several open studies designs in order to assess the tolerability. On the contrary, for example when the disease is different in or specific for children, one or several double blind randomized studies against reference treatment are necessary. All those studies should show the therapeutical value of the drug, and should allow precise recommendations for the dosages, depending on the body weight and/or the body surface compatible with the galenic formula.

Child↗
PubMed2000

[Career opportunities for female and male physicians in the pharmaceutical industry].

INTRODUCTION: Pharmaceutical medicine is not only a mainstay in clinical drug development and marketing of drugs in pharmaceutical industry but also a challenging alternative to the clinic and outpatient practice for physicians. Since most of them have only a vague notion of what a career in this sector of industry involves, this paper attempts to display the scope of opportunities and responsibilities for physicians and to answer some of the most frequently asked questions. JOB PROFILES: Areas for physicians are preclinical research, clinical research, drug safety, biometry, scientific relations, marketing and sales departments, working as company physician, training of sales representatives, health policy and project management. Earnings, continued and postgraduate training, job changing as well as possibilities of information on a career in the pharmaceutical industry are described. CONCLUSION: Despite the wide range of job profiles, a physician is still a physician in the pharmaceutical industry: his or her aim is to help patients and relieve their suffering through ethical and innovative therapeutic research. This aim is achieved through committed involvement in the development and marketing of new, effective and safe drugs.

Career Choice↗
PubMedDate not supplied

Clinical research: the influence of the pharmaceutical industry.

OBJECTIVE: The aim of the investigation is to throw light on the influence of the pharmaceutical industry on clinical research in Norway. The files of the five regional medical research ethics committees, which contain the application forms and the protocols of all the research projects on humans, were used as source for the statistics. The projects were first classified and registered in two groups: pharmacology/pharmacotherapy and others. Then the pharmacology/pharmacotherapy group was divided into projects sponsored or initiated by the industry and others. RESULTS: In the 3 years 1988-1990, the yearly average number of projects was 360. Sixty-two percent of the projects were pharmacology/pharmacotherapy; seventy-nine percent of these projects were conducted by the industry. The corresponding figures for the year 1997 were 747, 40% and 68%, respectively. We have not been able to find similar statistics from other countries. CONCLUSION: Our conclusion is that research in pharmacology/pharmacotherapy should be more independent of industry.

Drug Industry↗
PubMed2004

Commentary on "European collaboration in trials of new agents for children with cancer" by Ablett et al.

Recent progress in establishing a European network to conduct paediatric oncology phase I/II clinical trials calls attention to the challenges facing researchers developing new agents for children with cancer. These challenges include: ensuring that effective infrastructures are in place to safely and efficiently conduct early phase clinical trials in children while meeting all ethical and regulatory requirements associated with such trials; obtaining timely access to new agents from pharmaceutical sponsors for both preclinical testing and for phase I and phase II testing; and effectively prioritizing new agents for evaluation in children so that those agents most likely to benefit children with specific cancers are brought forward for clinical testing. The use of public funds to develop and maintain clinical trials infrastructures devoted to paediatric oncology drug development can help in addressing these challenges and can facilitate the timely paediatric evaluation of new agents, thereby contributing to the goal of identifying more effective treatments for children with cancer.

Antineoplastic Agents↗
PubMed2003

Dairy cattle production in Europe.

The European Union (EU) is a major player on world markets for most dairy products and produces the largest single share of the global market. Dairying is one of the most profitable sectors of EU agriculture. Milk yields per cow have increased steadily in every member state between 1985 and 1997. Overall EU dairy production continues to follow a trend towards increased intensification on a smaller number of larger, more specialised production units. In this paper we highlight the main characteristics of dairy cattle production in the EU, as well as their impact on cow and herd reproductive performances. AI is widely used in areas where there is high input:high output farming and farmers' primary objective is to have each cow produce a calf every 12 months without any particular calving pattern. The use of embryo technologies is increasing and in some areas (e.g. IVP embryo transfers) Europe leads the world. In most areas of Europe, because of both year round calving and ethical or consumer concerns, hormones are mainly used to treat reproductive diseases and not for pharmaceutical control of breeding.

Animals↗
PubMed2005

Challenges and opportunities: what we are learning from the clinical natalizumab experience.

The approval of natalizumab for relapsing forms of multiple sclerosis, and the subsequent voluntary suspension of its use due to an unexpected viral infection, is a cautionary tale of how much we have to learn about how to prioritize and perform the necessary research and development of novel therapeutics for human diseases, the ethics of placebo-controlled trials and the relationships between researchers, regulatory authorities and the pharmaceutical industry.

Antibodies, Monoclonal↗
PubMed1999

Ethical review of regulatory toxicology guidelines involving experiments on animals: the example of endocrine disrupters.

The safety assessment of new chemicals (including medicines, pesticides, food additives, and industrial chemicals) relies on the results of animal experiments. Because the safety of those exposed to these products and the welfare of the experimental animals used are considered critically important, both testing requirements and the welfare of experimental animals are controlled by law. In the U.K., projects that propose to use animals for experimental purposes, including for the testing of chemicals, have been controlled by law for over a century, with the most recent legislation (Animals [Scientific Procedures] Act of 1986) requiring a cost/benefit assessment before it may proceed. New regulations introduced in 1998 will require an ethical review process for all projects from April 1999. Such ethical review will have to take account of the toxicity testing methods and schemes that are required by the legislation aimed at protecting human health. Neither national nor international proposals for toxicity testing methods and schemes are generally subjected to ethical review from the point of protecting animal welfare. The international nature of the chemical and pharmaceutical industry means that testing requirements from one of the major national regulatory agencies (USA, EU, or Japan) or the international organizations (Organization for Economic Co-operation and Development [OECD]or the International Conference on Harmonization [ICH]) have an impact on the testing carried out by industrial organizations in all countries. The recent proposals for screening and testing chemicals to identify endocrine disrupters (ED) from the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC) of the U.S. Environmental Protection Agency (EPA) are used as an example of the interaction between regulatory proposals and animal welfare issues. The current proposals are the most extravagant in the use of animals. Between 0.6 and 1.2 million animals would be required for each 1000 chemicals tested. The EPA, before incorporating them into regulation, is subjecting the recommendations to further review. This will undoubtedly moderate the number of animals actually used from the worst-case calculation. The variables that have the greatest impact on the number of animals required for testing are the prevalence of ED chemicals in the chemicals to be tested, and the sensitivity and specificity of the testing methods. The modeling demonstrates, for example, that increasing the prevalence from 10 to 50% reduces the number of animals used to detect one ED from 10,000 to 2700. Knowledge of the prevalence of EDs in the chemicals to be tested would allow rational selection of tier one screening based on the sensitivity and specificity of the screening tests. The EDSTAC proposals are difficult to justify from an ethical perspective, as equally effective detection rates may be achieved with fewer animals. National and international regulatory testing proposals should be subjected to formal independent ethical review before they are finalized, with a view to improving animal welfare.

Animal Rights↗
PubMed2002

Placebos that harm: sham surgery controls in clinical trials.

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson's disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we find strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson's disease and more broadly in clinical research. Additionally, we believe that these reasons can be generalized to apply to the use of other placebo controls that carry significant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals.

Controlled Clinical Trials as Topic↗
PubMed1992

[The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry].

BACKGROUND: The objective of this survey was to assess the state of the art of the implementation of Good Clinical Practice in the Spanish Pharmaceutical Industry. METHODS: A questionnaire was sent to the sixty first laboratories according to their sales of ethical products. In the questionnaire there were questions concerning nationality of the company, personnel in clinical research, use and characteristics of standard operating procedures (SOPs), auditing and quality assurance as well as questions in connection with the future implications of SOPs implementation. RESULTS: The level of answer was 42%. Twenty one out of the 24 companies that answered the questionnaire had SOPs implemented. In total 150 clinical research projects were carried out in 1990. One hundred one out of this 150 were performed under GCP. Fourteen companies agreed that with their current structure were able to accomplish 100% of the projects with GCP. The most frequent estimation of cost increase due to GCP was 30% (min. 10%; max. 70%). In overall 26 external audits were performed in 1990. Twenty one laboratories stated that they had not acceptance problems of GCP among the investigators. CONCLUSIONS: The sample seems to be representative of the Spanish pharmaceutical industry attitude with respect to GCP implementation. Although the exigency level was not detailed, around 42% of the clinical trials sponsored by the pharmaceutical industry are performed according to GCP. There is a positive impression as to the possibility to implement GCP as well as to the attitude of the investigators to this respect.

Clinical Trials as Topic↗
PubMed2006

Giving and receiving of gifts between pharmaceutical companies and medical specialists in Australia.

BACKGROUND: This study investigated the 'gift-relationship' between pharmaceutical companies and doctors. METHODS: The study was based on a survey questionnaire of 823 medical specialists from across Australia. The aim of this study was to investigate gifts offered to medical specialists in Australia by pharmaceutical companies, financial support actively sought by medical specialists for activities other than research and to consider what is ethically appropriate. RESULTS: A high percentage of specialists received offers of food (96%), items for the office (94%), personal gifts (51%) and journals or textbooks (50%). Most specialists were invited to product launches, symposia or educational events (75-84%) and 52% received offers of travel to conferences. A high proportion of offers were accepted (66-79%) except invitations to product launches (49%), sponsored symposia (53%) and offers of travel that included partners (27%). Fifteen per cent of specialists requested financial support from pharmaceutical companies for activities and items, including conferences, travel, educational activities, salaries and donations to specific funds. The study outlined guidelines on gifts from pharmaceutical companies and differing standards applying to gifts and grants for travel. We found that, although most gifts and requests for support complied with professional and pharmaceutical industry guidelines, some--including personal gifts, tickets to sporting events, entertainment and travel expenses for specialists' partners--did not. CONCLUSION: To ensure that physicians' judgements are free from real or perceived influence from industry and to maintain public trust, we support a shift towards more conservative standards on gifts and support for travel evident in recent guidelines.

Adult↗
PubMed2026

The AI Revolution: Shaping the Present and Future of Pharmaceutical Research and Development.

The transformative role of artificial intelligence (AI) in the pharmaceutical industry is examined, with a focus on its significant contributions to drug discovery, development, and clinical trial processes. It highlights the inefficiencies and high costs associated with traditional drug development and explores how AI and machine learning (ML) can enhance these processes by analyzing extensive biological datasets. The historical context of AI in pharmaceutical development is examined, noting how advances in computational power and data accessibility have facilitated innovative methodologies, such as predictive analytics and natural language processing. Contemporary trends reveal the integration of AI technologies in drug design, repurposing, and patient response forecasting. This study also addresses the challenges of participant recruitment for clinical trials and proposes AI-driven solutions to optimize patient selection and data management. Furthermore, it discusses AI's role in tailored medicine, emphasizing its potential for advancing precision therapy through targeted drug development and personalized treatment strategies. The importance of digital tools, genomic data analysis, and AI-driven imaging technologies for customizing therapeutic approaches is underscored, along with the regulatory and ethical challenges posed by AI deployment in healthcare. This study illustrates the complexities of AI applications in the pharmaceutical sector, offering insights into both successful and unsuccessful initiatives. The findings suggest that the digitalization of the pharmaceutical industry and enhanced AI integration hold promise for developing safer and more effective therapeutic strategies, while also identifying obstacles to their widespread adoption and optimal functionality.

Artificial intelligence↗