A harmonised guideline for conduct of blood level bioequivalence studies for veterinary chemical products – VICH GL52 is proposed for implementation at Step 7 by August 2016. The APVMA were non-committal in my communications with them late in 2015 about certain implementation aspects of the Guideline. While Australia is not a signatory to VICH, we expect the APVMA will adopt this guideline unconditionally. In preparation, we’ve worked closely with clients and our network of CROs to ensure a seamless transition.
We regularly coordinate animal, quality assurance, analytical and statistical components of bioequivalence studies. If you are considering pharmacokinetics, bioequivalence or tissue residues, please talk to us about it during your concept and planning stages. Formulations are not straight forward, and you cannot assume that ‘similar formulations’ will exert a similar rate and extent of drug absorption in the animal. By applying our integrated services and some lateral thinking, we offer cost-effective in-vitro methodologies to evaluate your formulation prior to the live phase to increase confidence of a successful ‘bioequivalent’ outcome from your study.