Understanding the importance of stress degradation studies

December 4, 2018
Stress testing is a fundamental requirement in all drug development programs. It provides evidence of the effect of environmental factors of the quality of a drug substance or product. You don’t want to wait to find out what will happen to your product when exposed to temperature, humidity, light etc.
Steve Baertschi joined us for our Impurities Day to discuss what stability testing is and why it is important.
Stress Degradation: Going from Stress Degradation to a Stability-Indicating Method
One question we get asked frequently: how many stress tests should be conducted? What degradants should be investigated further? Steve Baertschi shared with us a great case study of stress testing 15 compounds, and how his team defined ‘major’ degradants. Watch it here:
Read the ICH guidelines on stability testing: https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
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