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Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

We have adopted this International Scientific Guideline - EMA/CHMP/83874/2014

Last updated

About this guideline

Overseas effective date:  1 July 2016

Replaces: CHMP/EWP/225/02 Note for guidance on the evaluation of the Pharmacokinetics of medicinal products in patients with impaired renal function (adopted by TGA 24 November 2004)

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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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