Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
Wu F, Mousa Y, Raines K, Bode C, Tsang YC, Cristofoletti R, Zhang H, Heimbach T, Fang L, Kesisoglou F, Mitra A, Polli J, Kim MJ, Fan J, Zolnik BS, Sun D, Zhang Y, Zhao L.
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CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):585-597. doi: 10.1002/psp4.12907. Epub 2023 Jan 4.
CPT Pharmacometrics Syst Pharmacol. 2023.
PMID: 36530026
Free PMC article.
Review.