Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

I. INTRODUCTION A. Objectives of the Guideline This guideline is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the ICH Q1A(R) Harmonised Tripartite guideline on Stability Testing of New Drug Substances and Products (hereafter referred to as the parent guideline).