Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring

Author:

Stewart J.,Breslin W. J.,Beyer B. K.,Chadwick K.,De Schaepdrijver L.,Desai M.,Enright B.,Foster W.,Hui J. Y.,Moffat G. J.,Tornesi B.,Van Malderen K.,Wiesner L.,Chen C. L.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference19 articles.

1. ICH. ICH Harmonized Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for the Conduct of Human Trials and Marketing Authorization for Pharmaceuticals M3(R2). 2009.

2. UK MHRA. Clarification of contraceptive wording in clinical trials (version 2, amended 21 May 2010). 2010.

3. Ng EW, Chiruvolu P, Levy GF, Allan BR, Wyszynski DF. Contraception language in informed consent forms: a survey of biopharmaceutical companies. Drug Inform J. 2012;46:329–335.

4. UK MHRA. Recommendations related to contraception and pregnancy testing in clinical trials. Advisory non-binding guidance supported by national competent authorities represented at the CTFG-meeting in Rome 2014-09-15. 2014.

5. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: Department of Reproductive Health, WHO; 2010.

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