Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

We have adopted this International Scientific Guideline - EMEA/CHMP/EWP/147013/2004 Corr

Last updated

27 August 2024

About this guideline

Overseas effective date: 1 January 2007

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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