ABSTRACT
INTRODUCTION As described in chapter 1, stress testing is the main tool that is used to predict stability-related problems, develop analytical methods, and identify degradation products and pathways. Stability-related issues can affect many areas, including the following:
• Analytical methods development • Formulation and packaging development • Appropriate storage conditions and shelf-life determination • Safety/toxicological concerns • Salt selection/polymorph screening • Manufacturing/processing parameters • Absorption, distribution, metabolism, and excretion (ADME) studies • Environmental assessment
It is worth discussing briefl y each of these stability-related areas.
