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Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products

We have adopted this International Scientific Guideline - EMA/CHMP/594085/2015 

Last updated

About this guideline

Overseas effective date: 1 February 2017

Replaces: CPMP/EWP/2655/99 Points to Consider on Pharmacokinetics and Pharmacodynamics in the Development of Antibacterial Medicinal Products (adopted by TGA 19 April 2001)

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.
  • 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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