Drugs between Research and Regulations

Proceedings of the 5th International Meeting of Pharmaceutical Physicians Munich, October 14–17, 1984

C. Steichele, U. Abshagen, J. Koch-Weser (Herausgeber)

Buch | Softcover

XII, 206 Seiten

2012 | 1. Softcover reprint of the original 1st ed. 1985
Steinkopff (Verlag)
978-3-642-54132-2 (ISBN)

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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.

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.

Erscheint lt. Verlag	22.12.2012
Zusatzinfo	XII, 206 p. 4 illus.
Verlagsort	Heidelberg
Sprache	englisch
Maße	170 x 244 mm
Gewicht	394 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Medizin / Pharmazie ► Pharmazie
Schlagworte	Cancer • clinical trial • Drug • drug development • drug safety • Lipide • Rauwolfia • Research • Toxicity
ISBN-10	3-642-54132-1 / 3642541321
ISBN-13	978-3-642-54132-2 / 9783642541322
Zustand	Neuware