Strategies for Intermediate Condition Justification in Absence of Accelerated Stability Data
Strategies for Intermediate Condition Justification in Absence of Accelerated Stability Data How to Justify Intermediate Stability Conditions When Accelerated Data Is Unavailable Stability testing is a critical part of pharmaceutical development, guiding the determination of shelf life and appropriate storage conditions. While ICH Q1A(R2) outlines the importance of accelerated testing (typically at 40°C/75% RH), there…