ABSTRACT
The guidance on the evaluation and statistical analysis of stability data provided in the parent guideline is brief in nature and limited in scope. The basic concepts of stability data evaluation are the same for single- versus multifactor studies and for full- versus reduced-design studies. Data for all attributes should be presented in an appropriate format, and an evaluation of such data should be included in the application. Extrapolation is the practice of using a known dataset to infer information about future data. Extrapolation to extend the retest period or shelf life beyond the period covered by long-term data can be proposed in the application, particularly if no significant change is observed at the accelerated condition. Regression analysis is considered an appropriate approach to evaluating the stability data for a quantitative attribute and establishing a retest period or shelf life.
