Reproductive toxicity tests: retrospect and prospect

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 mentione...

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Bibliographic Details
Published inHuman & experimental toxicology Vol. 7; no. 5; pp. 423 - 427
Main Author Sullivan, F M
Format Journal Article
LanguageEnglish
Published England 01.09.1988
Subjects
Abnormalities, Drug-Induced
Animals
Female
Fertility - drug effects
Humans
Male
Pregnancy
Pregnancy, Animal - drug effects
Prenatal Exposure Delayed Effects
Rats
Time Factors
Toxicology - methods
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Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0144-5952
0960-3271
DOI:10.1177/096032718800700507