Reproductive Toxicity Tests: Retrospect and Prospect

Abstract

1 The design of the classical three segment reproductive test for new drugs is described and the relative merits of the USA/EEC and the Japanese guidelines are discussed. 2 The importance of pharmacokinetic studies in the interpretation of teratology studies and extrapolation to humans is mentioned in relation to caffeine, sodium valproate and cyclophosphamide. 3 Changing ideas on the design of multi-generation studies are reviewed. 4 Recent developments in the fields of behavioural teratology, chemicals in breast milk and transplacental carcinogenesis are described.