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Asia-inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler.
Lu H, Klopp-Schulze L, Mukker JK, Li D, Kuroki Y, Bolleddula J, Terranova N, Goteti K, Gao W, Strotmann R, Dong J, Venkatakrishnan K. Lu H, et al. Among authors: gao w. Clin Transl Sci. 2024 Oct;17(10):e70050. doi: 10.1111/cts.70050. Clin Transl Sci. 2024. PMID: 39445632 Free PMC article. Review.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. Among authors: gao w. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
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