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Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

We have adopted this International Scientific Guideline - CHMP/EWP/89249/2004 

Last updated

About this guideline

Overseas effective date:  31 July 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.
  • 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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