Pre-clinical evaluation of contraceptive steroids: regulatory requirements and scientific expectations.
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.
D000818:Animals; D003278:Contraceptives, Oral, Hormonal / Q000633:toxicity*; D004353:Drug Evaluation, Preclinical
D003278:Contraceptives, Oral, Hormonal