About this document

ICH Q5C Stability Testing Guidelines by Sai Bindu is a document available to read on EtoBox.

The document provides guidelines for stability testing of biological and biotechnological products according to ICH Q5C. It discusses the purposes of stability studies including analytical method development, formulation development, degradation pathway elucidation, expiry date establishment, and comparability assessments. It also describes common degradation pathways for therapeutic proteins such as aggregation, fragmentation, oxidation, deamidation, disulfide bond scrambling, glycation, and disialylation.

Author

Sai Bindu

Language

EN