title: Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.
abstract: 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.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: C
authors.initials: C
authors.lastname: Wagner
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: P
authors.initials: P
authors.lastname: Zhao
authors.affiliation: Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Pan
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: V
authors.initials: V
authors.lastname: Hsu
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: J
authors.initials: J
authors.lastname: Grillo
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Huang
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
authors.forename: V
authors.initials: V
authors.lastname: Sinha