Tuesday, August 31, 2021

New CDER Impact Story on Physiologically Based Pharmacokinetic Modeling of Sertraline Dosing in Pregnancy - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

Physiologically Based Pharmacokinetic Modeling of Sertraline Dosing in Pregnancy

Pregnant women are a special and vulnerable population with respect to drug therapy but have often been excluded from clinical trials. CDER researchers and NCTR collaborators are working to develop quantitative predictive modeling tools to ensure that drug treatment during pregnancy maximizes maternal therapeutic benefit while minimizing fetal risk.

Learn More


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