International scientific guideline: Points to consider on the clinical requirements of modified release products submitted as a line extension of an existing marketing authorisation

About this guideline

Overseas effective date: 7 June 2005

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

Access this international scientific guideline

For more information see International scientific guidelines adopted in Australia.

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.