Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Autor: Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Kim MJ; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Li Z; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., DiLiberti CE; Montclair Bioequivalence Services, LLC, Montclair, New Jersey, USA., Au J; Optimum Therapeutics LLC, Carlsbad, California, USA., Hooker A; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Ducharme MP; Learn and Confirm Inc., Bois Franc, St-Laurent, Canada., Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2018 Jul; Vol. 104 (1), pp. 27-30. Date of Electronic Publication: 2018 Mar 30.
DOI: 10.1002/cpt.1065
Abstrakt: On October 2 nd and 3 rd , 2017, the US Food and Drug Administration (FDA) hosted a public workshop titled "Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review." 1 This report summarizes Session 2 of the public workshop: "Model Informed Drug Development and Review for Generic Products." The session focused on the application of quantitative methods and modeling in modernizing the generic drug development and review.
(© 2018 American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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