FDA requirements for nonclinical testing of contraceptive steroids.
Written guidelines for the preclinical testing of contraceptive steroids have not been revised since 1968 despite the fact that many important changes have been implemented by the FDA's Division of Metabolism and Endocrine Drug Products. This paper describes the new preclinical testing requirements and the rationale for their implementation.
Jordan
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Division of Metabolism and Endocrine Drug Products, Food and Drug Administration.
D000818:Animals; D003278:Contraceptives, Oral, Hormonal / Q000493:pharmacokinetics / Q000633:toxicity; D004305:Dose-Response Relationship, Drug; D004353:Drug Evaluation, Preclinical; D005260:Female; D005298:Fertility / Q000187:drug effects; D000882:Haplorhini; D008297:Male; D051379:Mice; D009152:Mutagenicity Tests; D009369:Neoplasms / Q000139:chemically induced; D051381:Rats; D014481:United States; D014486:United States Food and Drug Administration
D003278:Contraceptives, Oral, Hormonal