ICH Q1A(R2) Stability Testing of New Drug Substances and Products
ICH Q1A(R2) Step 4 February 2003Stability Testing of New Drug Substances and ProductsDescription:This Guideline provides recommendations on stabilitytesting protocols including temperature, humidity and trial duration forclimatic Zone I and II. Furthermore, the revised document takes into accountthe requirements for stability testing in Climatic Zones III and IV in order tominimise the different storage conditions for submission of a global dossier.谢谢您的分享，金币已奖励!
页:
[1]