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Description
The FDA guidance published in 1993 left the decision of including women of childbearing potential up to the researchers, IRBs, and women enrolling in the trial.34 In 1998, the FDA provided an updated guidance on the topic mandating sponsors to understand sex differences in PK, safety, and pharmacological response
[DOI] [PubMed] [Google Scholar] 76.Ayala A., Muoz M.F., Argelles S

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