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The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing. It will include, A comprehensive review of ICH guidance, Pitfalls in stability testing, ...

The requirement to formulate biologics in a safe and stable form, and the known propensity for these molecules to aggregate, has led to the need for rigorous stability characterization of these ...

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 testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

This article looks at the use of bracketing and matrixing to lower the number of stability samples required and, consequently, reduce the cost of sample production, testing and management. There is a ...

New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, ...