| Literature DB >> 1493710 |
A Jordan1.
Abstract
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.Entities:
Keywords: Americas; Animals, Laboratory; Biology; Cancer; Chromosome Abnormalities; Clinical Research; Clinical Trials; Contraception; Contraception Research; Contraceptive Agents--pharmacodynamics; Contraceptive Methods--pharmacodynamics; Developed Countries; Diseases; Family Planning; Female Contraception; Government Agencies; In Vitro; Injectables--pharmacodynamics; Male Contraception; Metabolic Effects; Neonatal Diseases And Abnormalities; Neoplasms; North America; Northern America; Oral Contraceptives; Oral Contraceptives, Combined; Organizations; Physiology; Reproduction; Research Methodology; Reversibility; Steroid Metabolic Effects; United States
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Year: 1992 PMID: 1493710 DOI: 10.1016/0010-7824(92)90114-9
Source DB: PubMed Journal: Contraception ISSN: 0010-7824 Impact factor: 3.375