| FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | 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. | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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