Literature DB >> 1493710

FDA requirements for nonclinical testing of contraceptive steroids.

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


  2 in total

Review 1.  Facts about once-a-month injectable contraceptives: memorandum from a WHO meeting.

Authors: 
Journal:  Bull World Health Organ       Date:  1993       Impact factor: 9.408

Review 2.  Depot-medroxyprogesterone acetate (DMPA) and cancer: memorandum from a WHO meeting.

Authors: 
Journal:  Bull World Health Organ       Date:  1993       Impact factor: 9.408

  2 in total

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