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Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms

We have adopted this International Scientific Guideline - EMA/CHMP/EWP/280/96 Corr 1

Last updated

About this guideline

Overseas effective date: 1 June 2015

Replaces: CPMP/EWP/280/96 Corr. Note for Guidance on Modified Release Oral and Transdermal dosage forms: Section II (Pharmacokinetic and Clinical Evaluation) (corrected version adopted by TGA 1 June 2014)

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics

TGA annotations:

For multiple strengths of generic TDDS products, bioequivalence studies should be performed at least on the lowest and highest strengths versus the corresponding innovator products. If an applicant considers that this is unnecessary in a particular case, a justification for not submitting bioequivalence data should be submitted in accordance with the ARGPM guidance on Biopharmaceutic studies.

  • 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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