Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

Stability studies are used to assess the shelf life of a product by storing samples under differing conditions, typically as defined by regulatory authorities, and then testing samples taken from ...

Pharmaceuticals need to be assessed for stability to support the assigned shelf life. Therefore, when analysing stability samples obtained from these studies, analytical methods are required which are ...

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies. It is ...

What are stability indicating methods? Why do we use stability indicating methods? How could it help solve problems and what answers could it give? When do we use stability indicating methods? What ...