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Wyszukujesz frazę ""Raines, Kimberly"" wg kryterium: Autor


Wyświetlanie 1-6 z 6
Tytuł:
Impact of the US FDA “Biopharmaceutics Classification System” (BCS) Guidance on Global Drug Development
Autorzy:
Mehta, Mehul U.
Uppoor, Ramana S.
Conner, Dale P
Seo, Paul
Vaidyanathan, Jayabharathi
Volpe, Donna A.
Stier, Ethan
Chilukuri, Dakshina
Dorantes, Angelica
Ghosh, Tapash
Mandula, Haritha
Raines, Kimberly
Dhanormchitphong, Pariban
Woodcock, Janet
Yu, Lawrence X
Pokaż więcej
Źródło:
Molecular Pharmaceutics; December 2017, Vol. 14 Issue: 12 p4334-4338, 5p
Periodyk
Tytuł:
Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
Autorzy:
Wu F; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Maryland, Silver Spring, USA.
Mousa Y; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Maryland, Silver Spring, USA.
Raines K; Office of New Drug Products (ONDP), Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA, Maryland, Silver Spring, USA.
Bode C; Absorption Systems LLC, Pennsylvania, Eaton, USA.
Tsang YC; Apotex Inc., Ontario, Toronto, Canada.
Cristofoletti R; University of Florida, Florida, Gainesville, USA.
Zhang H; Office of Bioequivalence, OGD, CDER, U.S. FDA, Maryland, Silver Spring, USA.
Heimbach T; Merck & Co., Inc., New Jersey, Rahway, USA.
Fang L; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Maryland, Silver Spring, USA.
Kesisoglou F; Merck & Co., Inc., New Jersey, Rahway, USA.
Mitra A; Janssen Research & Development, New Jersey, Raritan, USA.
Polli J; University of Maryland, Maryland, College Park, USA.
Kim MJ; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Maryland, Silver Spring, USA.
Fan J; Office of Clinical Pharmacology, Office of Translational Sciences, CDER, U.S. FDA, Maryland, Silver Spring, USA.
Zolnik BS; Office of New Drug Products (ONDP), Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA, Maryland, Silver Spring, USA.
Sun D; University of Michigan, Michigan, Ann Arbor, USA.
Zhang Y; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Maryland, Silver Spring, USA.
Zhao L; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Maryland, Silver Spring, USA.
Pokaż więcej
Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 May; Vol. 12 (5), pp. 585-597. Date of Electronic Publication: 2023 Jan 04.
Typ publikacji:
Journal Article; Review
MeSH Terms:
Research Report*
Models, Biological*
Humans ; Therapeutic Equivalency ; Computer Simulation
Czasopismo naukowe
    Wyświetlanie 1-6 z 6

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