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

Fang, Lanyan (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
Kim, Myong-Jin (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
Li, Zhichuan (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
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Wang, Yaning (author)
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA
DiLiberti, Charles E. (author)
Montclair Bioequivalence Serv LLC, Montclair, NJ USA
Au, Jessie (author)
Optimum Therapeut LLC, Carlsbad, CA USA
Hooker, Andrew, 1973- (author)
Uppsala universitet,Institutionen för farmaceutisk biovetenskap
Ducharme, Murray P. (author)
Learn & Confirm Inc, St Laurent, PQ, Canada
Lionberger, Robert (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
Zhao, Liang (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
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 (creator_code:org_t)
2018-03-30
2018
English.
In: Clinical Pharmacology and Therapeutics. - : Wiley. - 0009-9236 .- 1532-6535. ; 104:1, s. 27-30
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  • Journal article (peer-reviewed)
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  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

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