Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

Regulatory Resource: Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in February 2002. This document describes general principles for reduced stability testing and provides examples of bracketing and matrixing designs.

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