Drugs between Research and Regulations

1. Front Matter

   Pages I-XII

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2. Chronic Concern on Chronic Toxicity Studies

   1. Chronic toxicity tests, current problems and possible solutions

      • G. Zbinden

      Pages 1-6

   2. What can be gained from a retrospective analysis of chronic toxicity studies?

      • Stuart R. Walker

      Pages 7-11

   3. The role of carcinogenicity studies in risk assessment

      • E. Fröhlich, R. Hess

      Pages 13-19

   4. Alternatives to chronic toxicity studies

      • Rolf Baß, Peter Grosdanoff, Toni Lehnert

      Pages 21-26

3. Clinical Trials and Medical Practice

   1. What good are clinical trials?

      • Peter J. Fell

      Pages 27-38

   2. Clinical guidelines — a help or a hindrance?

      • M. N. G. Dukes

      Pages 39-44

   3. Clinical trials in the natural environment

      • Louis Lasagna

      Pages 45-49

   4. Clinical trials and the general practitioner

      • Paolo E. Lucchelli

      Pages 51-56

   5. Clinical trials and chronic diseases

      • G. Fülgraff

      Pages 57-63

   6. Alternatives to clinical trials in post-marketing research on drug effects

      • Olli S. Miettinen

      Pages 65-68

4. The Future of Long-Term Intervention and Prevention Studies

   1. The future of long-term intervention and prevention studies — methodological aspects

      • Frederick H. Epstein

      Pages 69-76

   2. Lessons for the future from long-term studies with beta blockers and hypolipidaemic agents

      • J. D. Fitzgerald

      Pages 77-87

   3. Rauwolfia derivatives and breast cancer: how do we know when we have the answers?

      • C. R. B. Joyce

      Pages 89-107

   4. The organisation of long-term intervention and prevention studies

      • Michael D. Rawlins

      Pages 109-112

5. New Biostatical Concepts for Clinical Trials

   1. The explanatory and pragmatic approaches in clinical trials

      • D. Schwartz, M. H. Pejovic

      Pages 113-120

   2. Alternatives to classical randomized trials

      • Marvin Zelen

      Pages 121-129

   3. Data quality assurance with particular regard to protocol violations

      • O. Vanderbeke, R. Blomer

      Pages 131-137

6. Clinical Trials in Children

   1. The need of clinical drug trials in children

      • Dietrich Reinhardt

      Pages 139-149

   2. Ethical restrictions in clinical trials in children

      • Lars O. Boréus

      Pages 151-155

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.

• Rauwolfia
• cancer
• clinical trial
• drug
• drug development
• drug safety
• lipide
• research
• toxicity

• ICI-Pharma Arzneimittelwerk Plankstadt, Heidelberg, Germany

  C. Steichele

• Boehringer Mannheim GmbH, Mannheim 31, Germany

  U. Abshagen

• F. Hoffmann-La Roche & Co. Ltd., Basel, Switzerland

  J. Koch-Weser

Policies and ethics