The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted guidelines developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) for generating blood level bioequivalence studies—VICH GL52 (Bioequivalence).
In addition to VICH GL52 (Bioequivalence) applicants can also refer to the following guidance documents:
- FDA guidance for industry: bioequivalence guideline
- EMA guideline on the conduct of bioequivalence studies for veterinary medicinal products
These guidelines should be read in conjunction with the APVMA’s Part 8 Efficacy and Safety Guidelines.
If proposing to register generic products, please refer to the Guideline for registering generic veterinary chemical products for more information on when bioequivalence data should be submitted.