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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

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[DOI] [PMC free article] [PubMed] [Google Scholar] 187.Alehagen U., Johansson P., Aaseth J., Alexander J., Surowiec I., Lundstedt-Enkel K., Lundstedt T

Front Neurosci 17:1134080 Climent E, Pascual M, Renau-Piqueras J, Guerri C (2002) Ethanol exposure enhances cell death in the developing cerebral cortex: role of brain-derived neurotrophic factor and its signaling pathways