stabilitys与tudyofICH.pptVIP

Stability Testing Definition-定义 Stability: The capacity of a product to remain within specifications to ensure its identity, strength, quality and purity throughout the retest or expiry date. Stability studies should include long term stability study, accelerated stability study, intermediate stability study (if appropriate) and photostability testing (if appropriate). The choice of test conditions should follow ICH guidelines Q1A, Q1B, Q1C and Q1E. 稳定性：指产品保持其物理、化学、生物学稳定性及其疗效和安全性的能力。药品稳定性试验包括长期稳定性试验、加速稳定性试验及中间试验（必要时），光照试验（必要时）。稳定性试验应遵从ICH 指南 Q1A，Q1B, Q1C及Q1E。 ICH Q1A(R2) -Principle Genera