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 ...

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 ...

Stability testing is required to demonstrate the pharmaceutical product meets its acceptance criteria throughout its lifetime and to gain regulatory approval to extend a previously approved shelf life ...

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 ...

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 ...