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Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

2015; Nature Portfolio; Volume: 4; Issue: 4 Linguagem: Inglês

10.1002/psp4.33

ISSN

2163-8306

Autores

Christian Wagner, Ping Zhao, Y. Pan, Vicky Hsu, Joseph A. Grillo, S-M Huang, Vikram Sinha,

Tópico(s)

Pharmaceutical studies and practices

Resumo

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 of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions.

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