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 ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

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 ...

To support global stability practices, fundamental basics must be in place. With regulatory authorities having an increased focus on safety and efficacy, a new drug product often requires at least 10 ...

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 ...

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 ...