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PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.

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Title: PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.
Authors: Wu F; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Tsakalozou E; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Burckart GJ; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, MD, USA., Žakelj R; Lek Pharmaceuticals d.d., a Sandoz Company, Ljubljana, Slovenia., Gaohua L; Bristol Myers Squibb, Princeton, NJ, USA., Sagawa K; Pfizer Global Research and Development, Groton, CT, USA., Lukacova V; Simulations Plus, Inc., Lancaster, CA, USA., Vaithiyalingam S; Regulatory Affairs, Cipla LTD, Warren, NJ, USA., Fan J; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, MD, USA., Fotaki N; University of Bath, Bath, UK., Patel N; Certara UK Ltd, Sheffield, S1 2BJ, UK., Fang L; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA. Lanyan.Fang@fda.hhs.gov.
Source: Pharmaceutical research [Pharm Res] 2025 May; Vol. 42 (5), pp. 847-855. Date of Electronic Publication: 2025 Mar 26.
Publication Type: Journal Article
Journal Info: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.
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  Data: <searchLink fieldCode="AU" term="%22Wu+F%22">Wu F</searchLink>; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Tsakalozou+E%22">Tsakalozou E</searchLink>; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Burckart+GJ%22">Burckart GJ</searchLink>; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Žakelj+R%22">Žakelj R</searchLink>; Lek Pharmaceuticals d.d., a Sandoz Company, Ljubljana, Slovenia.<br /><searchLink fieldCode="AU" term="%22Gaohua+L%22">Gaohua L</searchLink>; Bristol Myers Squibb, Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Sagawa+K%22">Sagawa K</searchLink>; Pfizer Global Research and Development, Groton, CT, USA.<br /><searchLink fieldCode="AU" term="%22Lukacova+V%22">Lukacova V</searchLink>; Simulations Plus, Inc., Lancaster, CA, USA.<br /><searchLink fieldCode="AU" term="%22Vaithiyalingam+S%22">Vaithiyalingam S</searchLink>; Regulatory Affairs, Cipla LTD, Warren, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Fan+J%22">Fan J</searchLink>; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Fotaki+N%22">Fotaki N</searchLink>; University of Bath, Bath, UK.<br /><searchLink fieldCode="AU" term="%22Patel+N%22">Patel N</searchLink>; Certara UK Ltd, Sheffield, S1 2BJ, UK.<br /><searchLink fieldCode="AU" term="%22Fang+L%22">Fang L</searchLink>; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA. Lanyan.Fang@fda.hhs.gov.
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  Data: <searchLink fieldCode="JN" term="%228406521%22">Pharmaceutical research</searchLink> [Pharm Res] 2025 May; Vol. 42 (5), pp. 847-855. <i>Date of Electronic Publication: </i>2025 Mar 26.
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