Regulatory Utility of Physiologically Based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report

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Author/s: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

Date:

Journal:CPT: Pharmacometrics & Systems Pharmacology

DOI:10.1002/psp4.12907