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Questions and Answers: Positions on specific questions addressed to the pharmacokinetics working party

We have adopted this International Scientific Guideline - EMA/618604/2008 Rev. 9 

Last updated

About this guideline

Overseas effective date: 2 May 2014

For information: 1 June 2014

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

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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For more information see International scientific guidelines adopted in Australia.

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