Comparative Toxicology of Hypolipidaemic Fibrates

Comparative Toxicology of Hypolipidaemic Fibrates

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Description

Hypolipidaemic fibrates are a class of drugs developed for the treatment of lipid disorders in man. Toxicology studies have linked them with peroxisome proliferation and, in turn, liver cancer in rodents. This book provides a detailed record of regulatory studies carried out by ICI (now Zeneca) Pharmaceuticals on three fibrates, namely clofibrate, methylclofenapate and clobuzarit. The text constitutes a comprehensive database on the long-term, acute and chronic toxicity of these compounds, documenting the decision-making processes used to determine how important findings should be investigated and when development should be terminated. It also provides a record of the changing standards of toxicological studies required by regulatory authorities in Europe and the United States over a period of 25 years.show more

Product details

  • Hardback | 128 pages
  • 155 x 234 x 6.35mm | 453g
  • Taylor & Francis Ltd
  • London, United Kingdom
  • English
  • references
  • 0748401377
  • 9780748401376

Table of contents

Chapter I Clofibrate: Perilethal Studies; Subacute Toxicity Studies; Oncogenicity Studies - Rat; Oncogenicity Studies - Mice. Chapter II Methylclofenapate: Seven-Year Study - Dog; Interspecies Comparison of Liver Effects; Liver Microsomal Enzyme Studies; Mutagenicity. Chapter III Clobuzarit: Preclinical Toxicity Studies - Marmosets; Teratogenicity Studies/Fertility Studies; Interspecies Comparison of Liver Effects; Concluding Remarks. Appendix: Laboratory Animals, Husbandry and Diets.show more