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steichele c. (curatore); abshagen u. (curatore); koch-weser j. (curatore) - drugs between research and regulations

Drugs between Research and Regulations Proceedings of the 5th International Meeting of Pharmaceutical Physicians Munich, October 14–17, 1984

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Dettagli

Genere:Libro
Lingua: Inglese
Editore:

Steinkopff

Pubblicazione: 12/2012
Edizione: Softcover reprint of the original 1st ed. 1985





Trama

Franz Gross died suddenly during preparations for the meeting. He would have taken great pleasure in summarizing in this preface the aims and results of a gathering which so clearly bore his imprint as Chairman of the Scientific Program Committee. His sudden passing away is deeply regretted by all of us: organizers, speakers and participants. We greatly respect him for his exceptional abilities, his impact on science and his qualities as a human being. He provided the impulse for a well balanced and topical scientific program. We therefore dedicate the proceedings of this symposium to his memory. Munich was the fifth in a traditional line of international meetings of pharmaceutical physicians held at three-year intervals, starting in London in 1972 ('International Aspects of Drug Evaluation and Usage'), and followed by Florence in 1975 (,Rationality of Drug Development'), Brussels in 1978 (,Pharmaceutical Medicine - the Future') and Paris in 1981 ('Drug Safety -;- Progress and Controversies'). This 5th meeting discussed improvements in drug development and application and examined the impact of regulatory activities.




Sommario

Chronic Concern on Chronic Toxicity Studies.- Chronic toxicity tests, current problems and possible solutions.- What can be gained from a retrospective analysis of chronic toxicity studies?.- The role of carcinogenicity studies in risk assessment.- Alternatives to chronic toxicity studies.- Clinical Trials and Medical Practice.- What good are clinical trials?.- Clinical guidelines — a help or a hindrance?.- Clinical trials in the natural environment.- Clinical trials and the general practitioner.- Clinical trials and chronic diseases.- Alternatives to clinical trials in post-marketing research on drug effects.- The Future of Long-Term Intervention and Prevention Studies.- The future of long-term intervention and prevention studies — methodological aspects.- Lessons for the future from long-term studies with beta blockers and hypolipidaemic agents.- Rauwolfia derivatives and breast cancer: how do we know when we have the answers?.- The organisation of long-term intervention and prevention studies.- New Biostatical Concepts for Clinical Trials.- The explanatory and pragmatic approaches in clinical trials.- Alternatives to classical randomized trials.- Data quality assurance with particular regard to protocol violations.- Clinical Trials in Children.- The need of clinical drug trials in children.- Ethical restrictions in clinical trials in children.- European Drug Registration.- The role of the EEC in the harmonisation of drug registration.- Clinical trials — European recommendations.- Special Lecture.- The Pharmaceutical Industry — research and responsibility.










Altre Informazioni

ISBN:

9783642541322

Condizione: Nuovo
Dimensioni: 244 x 170 mm Ø 395 gr
Formato: Brossura
Illustration Notes:XII, 206 p. 4 illus.
Pagine Arabe: 206
Pagine Romane: xii


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