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Inpharma Weekly

, Volume 937, Issue 1, pp 3–3 | Cite as

Women in clinical trials

addressing the critical issues
  • Lee Barradell
Newsletter Article

Abstract

Women of childbearing potential can now be included in early clinical trials in the US, following a change to the study design guidelines of the FDA. This should allow the determination of pharmacodynamic and pharmacokinetic criteria that are specific to this gender. Hopefully, this will result in more effective treatment regimens. However, news of these changes will be met with a mixed response by trial organisers and drug manufacturers, who are now faced with a new set of legal and ethical problems. Discussion of these took place at the 95th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics [ New Orleans, US; March 1994 ].

Keywords

Drug Manufacturer Ethical Problem Ethical Review Board Early Clinical Trial Childbearing Potential 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© Adis International Ltd 1994

Authors and Affiliations

  • Lee Barradell

There are no affiliations available

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