Stability Assessment for Shipment of API and Drug Products
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns.
This webinar will explore approaches to assessing stability of biologic APIs and small-molecule drug products throughout expected product shipment. Two subject-matter experts, Vladimir Golynskiy and Geoff Carr will address questions about regulatory requirements, stability studies, and shipping studies.