Epidemiological Concepts in Clinical Pharmacology

1. Front Matter

   Pages I-XII

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2. Opening Remarks

   • H. Kewitz

   Pages 1-1

3. The Thalidomide Hypothesis: How It Was Found and Tested

   • W. Lenz

   Pages 3-10

4. Reasons for the Successes and Failures of Specific Models in Drug Epidemiology

   • Samuel Shapiro

   Pages 11-22

5. Methodological Concepts: What Could We Know and What Should We Know in Drug Epidemiology?

   • K. Überla

   Pages 23-33

6. The Design of Case-Control Studies

   • H. J. Jesdinsky

   Pages 34-42

7. Methodological Evaluation of Studies in Drug Epidemiology

   • Olli P. Heinonen

   Pages 43-49

8. Problems with International Evaluation of Drug Risks

   • Åke Liljestrand

   Pages 50-56

9. Drug Utilization Studies — an Instrument in Drug Research

   • P. K. M. Lunde, M. Andrew, I. Baksaas

   Pages 57-72

10. Observational Cohort Study in General Practice: Differences and Equivalences Among Analgesics for Treatment of Colic Pain

    • H. Kewitz, G. Härter, U. Feldmann, G. Kreutz, M. Nitz, E. Unger

    Pages 73-86

11. Oxprenolol in Myocardial Infarction Survivors: Brief Review of the European Infarction Study Results in the Light of Other Beta-Blocker Post Infarction Trials

    • R. Schröder

    Pages 87-99

12. The Epidemiological Evaluation of Major Upper Gastrointestinal Bleeding in Relation to Aspirin Use

    • Micha Levy

    Pages 100-104

13. The Role of Pharmacogenetics in Drug Epidemiology

    • I. Roots, G. Heinemeyer, N. Drakoulis, D. Kampf

    Pages 105-118

14. Possibilities and Limitations of a Modified Spontaneous ADR Monitoring System Available to Practitioners in Germany

    • Ellen Weber

    Pages 119-124

15. Prescription of Psychotropic Drugs in Germany

    • B. Müller-Oerlinghausen, L. G. Schmidt

    Pages 125-137

16. The Benefit-Risk Evaluation of Drugs by Health Authorities in the Federal Republic of Germany

    • Gottfried Kreutz

    Pages 138-142

17. Postmarketing Surveillance of Drugs: Visions of the Future

    • Olli S. Miettinen

    Pages 143-147

18. Closing Remarks

    • H. Kewitz

    Pages 148-148

Clinical pharmacology is not primarily characterized by a particular methodology, but rather by the aims it pursues. Cooperation with scientists in other fields is thus essential. The symposium "Epidemiological Concepts in Clinical Pharmacology" (November 28-29, 1985) was organized by the Institute of Clinical Pharmacology of the Free University of Berlin to acknowledge the increasing impact of epidemio­ logical methods and thinking on clinical pharmacology. The editors are glad that all the presentations of the leading experts can now be made available to a broader rea­ dership. Neither the symposium itself nor publication of the proceedings would have been possible without the generous support received from the Paul-Martini-Stif­ tung and from the Free University of Berlin. To these institutions we owe deep grati­ tude. The expert guidance we received from Dr. Ute Heilmann of Springer-Verlag is also gladly acknowledged. Berlin, November 1986 H.Kewitz I. Roots K. Voigt Contents Opening Remarks 1 H.Kewitz ..... The Thalidomide Hypothesis: How It Was Found and Tested W.Lenz ............................. . 3 Reasons for the Successes and Failures of Specific Models in Drug Epidemiology S. Shapiro ... . . . . . . . . . . . . . . . . . . . . . . . . . .. . . 11 . . . Methodological Concepts: What Could We Know and What Should We Know in Drug Epidemiology K. Obeda. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 . . . . . . The Design of Case-Control Studies H.J.Jesdinsky ............ . . ........ 34 Methodological Evaluation of Studies in Drug Epidemiology O. P. Heinonen. . . . . . . . . . . . . . . . . . . . . . . .. . . 43 . . . . . Problems with International Evaluation of Drug Risks A. Liljestrand ....................... . . . . . . .. . . 50 Drug Utilization Studies -an Instrument in Drug Research P. K. M. Lunde, M. Andrew, I. Baksaas . . . . . . . . . . . . . . .. . . 57 . .

• drug
• drug research
• pharmacology
• research

• Institute of Clinical Pharmacology, Klinikum Steglitz of the Free University of Berlin, Berlin 45, Federal Republic of Germany

  Helmut Kewitz, Ivar Roots, Karlheinz Voigt

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