About this document
Stability-Indicating Assay Methods Review by Joe Luis Villa Medina is a document available to read on EtoBox.
This document provides a review of the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. It discusses the shortcomings of many published methods in meeting current regulatory requirements and proposes a systematic approach to developing SIAMs that satisfy ICH and regulatory guidelines. The review addresses critical issues like the separation and identification of degradation products, mass balance establishment, stress testing of formulations, developing S
- Author
- Joe Luis Villa Medina
- Language
- EN