Pre-clinical evaluation of contraceptive steroids: regulatory requirements and scientific expectations. 1986

G Zbinden

The development of new contraceptive steroids placed great pressures on regulatory agencies. There was insufficient time to develop a novel pre-clinical safety evaluation, hence their toxicity in animals was assessed as with other drugs. The approach of regulatory agencies to toxicity and carcinogenicity testing of these steroids are discussed and evaluated.

UI MeSH Term Description Entries
D003278 Contraceptives, Oral, Hormonal Oral contraceptives which owe their effectiveness to hormonal preparations. Hormonal Oral Contraceptive,Hormonal Oral Contraceptive Agent,Contraceptive Agents, Estrogen,Contraceptive Agents, Oral, Hormonal,Hormonal Oral Contraceptive Agents,Oral Contraceptive Agents, Hormonal,Oral Contraceptives, Hormonal,Contraceptive, Hormonal Oral,Contraceptives, Hormonal Oral,Estrogen Contraceptive Agents,Hormonal Oral Contraceptives,Oral Contraceptive, Hormonal
D004353 Drug Evaluation, Preclinical Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications. Drug Screening,Evaluation Studies, Drug, Pre-Clinical,Drug Evaluation Studies, Preclinical,Drug Evaluations, Preclinical,Evaluation Studies, Drug, Preclinical,Evaluation, Preclinical Drug,Evaluations, Preclinical Drug,Medicinal Plants Testing, Preclinical,Preclinical Drug Evaluation,Preclinical Drug Evaluations,Drug Screenings,Screening, Drug,Screenings, Drug
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia

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