Most regulatory agencies now request that women be enrolled into the clinical studies as early in Phase II as possible. Since thalidomide, reproduction, and teratology studies have been required prior to enrollment of large numbers of women in clinical studies. In some cases, depending upon the proposed indication for the drug, postmenopausal or otherwise reproductively incapable women can be used. However, the timing of the enrollment of women needs to be understood well in advance so that the lack of appropriate non-clinical reports does not hinder clinical development.
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