By Joanne S. Eglovitch
Published in: Regulatory Focus
Published on: April 17, 2025
The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline consolidates the existing five stability guidelines into one and addresses new topics such as stability considerations for advanced therapies, bracketing and matrixing, stability modeling, and stability considerations for reference materials and novel excipients.
Compliance • Guidances • Quality • Regulatory • Study Design
