Q1E: Evaluation of Stability Data

Regulatory Resource: Q1E: Evaluation of Stability Data

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in February 2003. This document extends the main guideline by explaining possible situations where extrapolation of retest periods/shelf-lives beyond the real-time data may be appropriate. Furthermore, it provides examples of statistical approaches to stability data analysis.

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