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Model-Informed Drug Development and Review for Generic Products: Summary Of FDA Public Workshop
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
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2018 (English)In: Clinical Pharmacology and Therapeutics, ISSN 0009-9236, E-ISSN 1532-6535, Vol. 104, no 1, p. 27-30Article in journal (Refereed) Published
Abstract [en]

On October 2nd and 3rd, 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.

Place, publisher, year, edition, pages
2018. Vol. 104, no 1, p. 27-30
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-361536DOI: 10.1002/cpt.1065ISI: 000434960300015PubMedID: 29603191OAI: oai:DiVA.org:uu-361536DiVA, id: diva2:1252201
Conference
2nd Workshop of International-Transporter-Consortium on Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review, OCT 02-03, 2017, US Food & Drug Adm, National Harbor, Maryland, USA.
Note

Correction in: Clinical Pharmacology & Therapeutics. DOI: 10.1002/cpt.1207

Available from: 2018-10-01 Created: 2018-10-01 Last updated: 2018-10-01Bibliographically approved

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Hooker, Andrew

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