Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

We have adopted this International Scientific Guideline - EMA/CHMP/458101/2016

Last updated

2 January 2025

Adopted by the TGA : 28 February 2020

Overseas effective date: 1 July 2019

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics

TGA Annotations: Nil

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.
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