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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.
Jean D, Naik K, Milligan L, Hall S, Mei Huang S, Isoherranen N, Kuemmel C, Seo P, Tegenge MA, Wang Y, Yang Y, Zhang X, Zhao L, Zhao P, Benjamin J, Bergman K, Grillo J, Madabushi R, Wu F, Zhu H, Zineh I. Jean D, et al. Among authors: wu f. CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1271-1275. doi: 10.1002/psp4.12706. Epub 2021 Sep 18. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34536337 Free PMC article. No abstract available.
Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.
Lee J, Feng K, Conti DS, Walenga R, Wientjes M, Wang H, Newman B, Han L, Dhapare S, Bielski E, Babiskin A, Wu F, Donnelly M, Kim MJ, Jiang W, Luke MC, Fang L, Zhao L. Lee J, et al. Among authors: wu f. Clin Pharmacol Ther. 2022 Nov;112(5):982-989. doi: 10.1002/cpt.2553. Epub 2022 Mar 7. Clin Pharmacol Ther. 2022. PMID: 35133652 Review.
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