Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in ...

Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering. This training is designed for ...

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development. The stability of clinical trial materials, regardless of the trial ...

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best ...

Experts have hailed the proposed draft Schedule M guidelines placing significant emphasis on stability testing compared to the existing Schedule M. This marks a commendable stride in aligning with ...