FREE WEBINAR: From BCS to IVRT
In Vitro Strategies for Biowaivers and Regulatory Decision-Making
Pharmaceutical companies must ensure that any change in formulation, process, or manufacturing site does not compromise product absorption (for oral forms) or release (for topical products). In an increasingly stringent and evolving regulatory landscape, the preparation of a dossier for oral or topical formulations — whether generics or products undergoing variations — requires robust scientific evidence.
During this webinar, our expert Federico Benetti – Executive Director, will present two strategic services specifically designed to address current regulatory requirements:
BCS-based Biowaivers (oral products)
According to ICH M9 and FDA M9, biowaivers can justify bioequivalence without in vivo studies, defining the data needed to classify active substances and ensure consistent safety and efficacy.
Scope of application: applicable to immediate-release oral solid forms and suspensions, including products under development, generics, and post-approval changes.
IVRT – In Vitro Release Test (topical products)
The IVRT study assesses the release rate of the active ingredient from topical formulations. It is essential for comparing generics and reference products through their release profiles and serves as a predictive tool for evaluating performance, manufacturing consistency, and supporting regulatory submissions for topical products.
Scope of application: suitable for semisolid or liquid formulations such as creams, ointments, gels, and lotions intended for skin or mucosal application.
Our Expert
Federico Benetti
Executive Director
Mérieux NutriSciences – Italy
