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Contraceptive Steroids

Pharmacology and Safety

  • Book
  • © 1986

Overview

Editors:
  1. A. T. Gregoire

    1. Food and Drug Administration, RockVille, USA

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    You can also search for this editor in PubMed   Google Scholar

  2. Richard P. Blye

    1. National Institutes of Health, Bethesda, USA

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    You can also search for this editor in PubMed   Google Scholar

Part of the book series: The Plenum Behavior Therapy Series (PBTS)

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Table of contents (22 chapters)

  1. Front Matter

    Pages i-xiii
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  2. Opening Remarks

    1. Opening Remarks

      • Solomon Sobel, William Andrews
      Pages 1-2

  3. Oral Contraceptives and the Occurrence of Disease: Clinical Overview

    1. Oral Contraceptives and the Occurrence of Disease

      • Bruce Stadel
      Pages 3-41

  4. Comparative Metabolism, Pharmacokinetics and Pharmacology of Steroid Contraceptives

    1. Front Matter

      Pages 43-45
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    2. The Role of Pharmacokinetics in Preclinical Safety Studies of Synthetic Sex Steroids

      • Michael Humpel, B. Dusterberg, S. Beier, J. Schuppler, P. Gunzel, W. Elger
      Pages 47-65

    3. Pharmacokinetics of Contraceptive Steroids in Humans

      • Uwe Goebelsmann
      Pages 67-111

    4. Species Differences in Metabolism of Contraceptive Steroids

      • Kenneth Fotherby
      Pages 113-122

    5. Steroids of One Class Can Mimic, Inhibit and Potentiate the Biological Effects of Other Steroid Classes When Administered at High Doses

      • C. Wayne Bardin, Olli A. Janne
      Pages 123-143

    6. Mechanism of Action of Estrogen and its Relationship to Toxicological Assessment

      • James H. Clark
      Pages 145-161

    7. Endocrine Effects of Systemic, Steroidal Contraceptives

      • Richard A. Edgren
      Pages 163-178

    8. Hepatotoxicity of Oral Contraceptives

      • Kamal Ishak
      Pages 179-201

    9. New Steroidal Contraceptives, Implications for Toxicological Models

      • Gerhard Zbinden
      Pages 203-210

    10. Summary

      • Egon Diczfalusy
      Pages 211-212

  6. Effects of Contraceptive Steroids on Coagulation and Lipid Metabolism

    1. Front Matter

      Pages 269-269
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    2. Introduction

      • Heinz Berendes
      Pages 271-272
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Keywords

About this book

One of the United States Food and Drug Administration's most difficult tasks is the assessment of risk-benefit ratios for a broad spectrum of therapeutic and prophylactic drugs. Furthermore, it is now widely recog­ nized that no drug, chemical or even natural substance is completely devoid of risk. Nowhere has this issue been the subject of more controversy than with steroidal contraceptive drugs. Regulated as a special class of products because of their prophylactic use in healthy individuals for prevention of pregnancy rather than for treatment of disease, steroid contraceptives drugs undergo more extensive animal safety tests than any other pharmaceutical agent. This view also contemplates the availability of alternative contraceptive measures posing fewer risks, but the use of less effective methods must take into consideration the hazards associated with pregnancy itself. In April 1983, the Food and Drug Administration and the National Insti­ tutes of Health in cooperation with the World Health Organization, the Population Council, and the Agency for International Development sponsored a three-day workshop to evaluate current guidelines for preclinical safety studies of contraceptive drugs in light of our extensive knowledge of the side effects of marketed products. The meeting included presenta­ tions by experts in the fields of comparative metabolism, pharmacokinetics, pharmacology, carcinogenicity, toxicology, coagulation, lipid metabolism, epidemiology and pathology at a meeting of the Fertility and Maternal Health Drugs Advisory Committee of the National Center for Drugs and Biologics, Food and Drug Administration.

Editors and Affiliations

  • Food and Drug Administration, RockVille, USA

    A. T. Gregoire

  • National Institutes of Health, Bethesda, USA

    Richard P. Blye

Bibliographic Information

  • Book Title: Contraceptive Steroids

  • Book Subtitle: Pharmacology and Safety

  • Editors: A. T. Gregoire, Richard P. Blye

  • Series Title: The Plenum Behavior Therapy Series

  • DOI: https://doi.org/10.1007/978-1-4613-2241-2

  • Publisher: Springer New York, NY

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media New York 1986

  • Softcover ISBN: 978-1-4612-9313-2Published: 15 April 2013

  • eBook ISBN: 978-1-4613-2241-2Published: 13 March 2013

  • Edition Number: 1

  • Number of Pages: XIII, 395

  • Number of Illustrations: 56 b/w illustrations

  • Topics: Pharmacology/Toxicology, Public Health, Tree Biology

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