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 ...

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 ...

Stability evaluation occurs at various stages during the development of a drug product. At early development stages, it is used to select formulations and packaging configurations that are most likely ...

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 ...

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers. According to market ...