Evaluating Impurities in New Drugs to Prevent Delays in Development
The Premier Consulting Blog
JULY 9, 2023
During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. What sets this guidance apart from ICH Q3A and ICH Q3B is that it applies to all stages of clinical development, not just to approval.
Let's personalize your content