Best Practices for Integrating ICH Q1A with Real-Time and Accelerated Stability Studies
The ICH Q1A(R2) guideline remains the cornerstone for stability testing of new drug substances and products. However, real-world challenges often arise in implementing its principles during both real-time and accelerated studies. This guide provides step-by-step best practices to help pharmaceutical professionals effectively integrate ICH Q1A with various stability approaches, ensuring both scientific robustness and regulatory…