International scientific guideline: Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

About this guideline

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Jul 2019

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics

Access this international scientific guideline

For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.