Chapter 2 - Regulatory Expectations and Industry Practice on Stability Testing

Abstract

The purpose of this chapter is to summarize global regulatory stability guidance and to propose how and when accelerated predictive stability (APS) approaches, such as accelerated stability assessment program (ASAP), can be leveraged in support of regulatory filings. While APS is primarily used as a tool for product development and packaging selection, it also can be used as supportive stability data in regulatory filings and in some cases can be the only stability data provided in the filing. The chapter also introduces the concept of lean stability and how APS can be leveraged as a tool for lean stability strategies.