Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions.

J Clin Pharmacol

Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.

Published: December 2020

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http://dx.doi.org/10.1002/jcph.1760DOI Listing

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