Comparative Toxicology of Hypolipidaemic Fibrates

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.