Understanding the Importance of Stress Degradation Studies

December 4, 2018

“Frequently time is of the essence. It is necessary to evaluate, in a short time span, the stability of a product change, and here, the design of stress conditions which will accelerate decomposition in a meaningful way is necessary. This is a difficult task and one very particular to the stability scientist.” J.T Carstensen.

DEFINING STRESS TESTING AND ITS ROLE IN STABILITY: WHAT DOES IT SHOW?

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

COMMON PROBLEMS IN STRESS TESTING OF DRUG PRODUCTS

How to stop stress studies from exploding exponentially

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:

 

 

Watch some of our other videos on stress testing:

Read the ICH guidelines on stability testing: https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

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