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The Future of Predictive Safety Evaluation

In Two Volumes Volume 2

  • A. N. Worden
  • D. V. Parke
  • J. Marks

Table of contents

  1. Front Matter
    Pages i-viii
  2. Molecular Aspects of Toxicology

    1. Front Matter
      Pages 1-1
    2. D. V. Parke
      Pages 3-38
  3. Preclinical: in Vivo and Combined Approaches

    1. Front Matter
      Pages 39-39
    2. A. N. Worden, S. R. Walker
      Pages 57-64
    3. A. B. G. Lansdown
      Pages 77-106
    4. A. J. Dewar
      Pages 107-128
    5. J. H. Weisburger
      Pages 129-152
  4. Nutrition and Toxicological Prediction

    1. Front Matter
      Pages 153-153
    2. D. L. Frape
      Pages 155-162
    3. D. L. Frape
      Pages 163-173
    4. D. L. Frape
      Pages 175-183
    5. D. L. Frape
      Pages 185-195
    6. D. L. Frape
      Pages 197-200
    7. D. L. Frape
      Pages 209-236
  5. Applied Aspects

  6. Back Matter
    Pages 307-312

About this book

Introduction

Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten­ tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi­ tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com­ pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.

Keywords

cancer clinical trial drug drug safety neurotoxicity research toxicity toxicology

Editors and affiliations

  • A. N. Worden
    • 1
  • D. V. Parke
    • 2
  • J. Marks
    • 3
  1. 1.Cantab GroupCambridgeEngland
  2. 2.Department of BiochemistryUniversity of SurreyGuildfordEngland
  3. 3.Director of Medical StudiesGirton CollegeCambridgeEngland

Bibliographic information

  • DOI https://doi.org/10.1007/978-94-009-3201-2
  • Copyright Information Springer Science+Business Media B.V. 1987
  • Publisher Name Springer, Dordrecht
  • eBook Packages Springer Book Archive
  • Print ISBN 978-94-010-7936-5
  • Online ISBN 978-94-009-3201-2
  • Buy this book on publisher's site