Bioequivalence

Demonstration of bioequivalence between different pharmaceutical formulations is regularly required for supporting Marketing Authorization Applications in the EU. As frequent in industry practice, as common is the mistake to consider bioequivalence studies “simple and routine”, blinded by the quite standardized approach followed by various service providers present on the market.

AccepTher, by regarding bioequivalence as integrated part of product development, individually tailored according to the regulatory strategy for each product, comes to fill in a gap typically established when studies are “simply” outsourced. We consult our clients to identify the optimal clinical development strategy for their products intended for “abridged” filing, by starting from assessment of whether a biowaiver can be applied for, until proposing, preparation and submission and/or managing execution of the complete Clinical Development Plan.

Upon a wide experience of preparing and submission of a Clinical Trial Applications in Europe, pharmacokinetic and statistical analyses and writing of Study Reports, AccepTher provides these services through its experts. AccepTher assumes, nevertheless, to act as a single contact point for Sponsors on bioequivalence, based on working experience with the key CROs, both providing integrated solutions and offering focused services (i.e. clinical or analytical); as well as to “simply” ensure project management of studies sponsored by its clients.