Rapid development of complex generics: Achieving in vitro Q3 bioequivalence through the application of physicochemical characterization methods

In the face of increasing pressure on health care access and costs, regulators such as the US FDA are actively seeking ways to enable the rapid development and launch of new generic medicines. Within this, there has been significant focus on complex products, such as OINDP (Orally Inhaled and Nasal Drug Products) and topical creams, where the delivery method and site of action makes bioequivalence assessments difficult using traditional in vivo approaches. As a result, many off-patent complex drug products are not subject to generic competition. The US FDA has therefore committed to providing improved scientific and regulatory clarity with respect to complex generic drug approvals, leading to the publication of product-specific guidance documents which outline the requirements for assessing in vitro bioequivalence by considering physicochemical (Q3) equivalence. This webinar will consider the workflows associated with evaluation of physicochemical (Q3) bioequivalence with reference to the measurement solutions offered by Malvern Panalytical.

In this webinar, we will introduce a toolbox of physicochemical analysis techniques which are increasingly being employed to assist with the evaluation of physicochemical (Q3) bioequivalence for complex generic drug products in vitro. Example case studies will be shared, including data on topical cream and nasal spray formulations.