Extrapolating Shelf Life Using ICH Q1E Recommendations
Regulatory authorities often accept shelf life extrapolation based on well-documented stability data—provided the approach complies with ICH Q1E recommendations. In this article, we provide a detailed, regulatory-focused tutorial on how to extrapolate shelf life using statistical principles outlined by ICH Q1E and accepted by global agencies like the USFDA. ➀ What Is Shelf Life Extrapolation?…
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