Accelerated Predictive Stability (APS) Regulatory Strategies

Abstract The application and the global regulatory reception to the use of APS approaches for the assignment of storage conditions, packaging configurations, and use periods/expiry for solid oral dosage forms are discussed. Clinical stability programs are designed to support and underwrite drug product use period assignments for specified storage conditions and packaging configurations. Some Health Authorities require a proposed clinical use period in the clinical trial applications (CTAs). The use of APS studies enables the justification of an initial use period, storage conditions, and packaging configuration based on tailored and science-based accelerated stability studies. The regulatory reception and feedback on the use of APS data in regulatory submissions will be discussed. Opportunities for the application of similar approaches for drug products in the initial marketing applications (MAs) and postapproval applications will be discussed. Some of these examples include, but are not limited to, changes to commercial packaging and minor changes to drug product composition and processes.