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. 2020 Dec:60 Suppl 2:S26-S33. doi: 10.1002/jcph.1760.

¹ 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.
² Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, New York, USA.

No abstract available

Keywords: bioequivalence; drug delivery; generic drug; intrauterine; physiologically based pharmacokinetics (PBPK); vaginal.

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