Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.
作者： C Wagner , P Zhao , Y Pan , V Hsu , J Grillo
DOI: 10.1002/PSP4.33
关键词:
摘要: The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role PBPK in drug development regulation. Representatives from industry, academia, regulatory agencies discussed issues within plenary panel discussions. This report summarizes discussions provides current perspectives application different areas, including its utility, predictive performance, reporting for submissions.
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