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. |
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| 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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| ISSN: | 1573-904X |
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| DOI: | 10.1007/s11095-025-03846-y |
