International scientific guideline: Lapatinib film-coated tablet 250mg product specific bioequivalnce guidance

About this guideline

TGA adopted date: 15 Jul 2019

Overseas effective date: 15 Jul 2019

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.