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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.
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For more information see International scientific guidelines adopted in Australia.