Clinically Relevant Drug Product Specifications

16:35 - 17:10

Demonstrating clinical relevance of drug product specifications is necessary to unequivocally prove consistent quality of product released to patients. Current practices and challenges towards establishing clinically relevant dissolution specifications for solid oral dosage will be presented along with a discussion on how to ascertain a link between in vitro and in vivo performance for orally inhaled products.

Please note that this will be a remote presentation

Andreas Abend, Director Analytical Sciences, MSD