Home Forums General Discussion Stability Must Reads Reply To: Stability Must Reads

wichertmm
Participant
Post count: 2

Hi Jacob-

Not books but if you aren’t familiar with the guidance documents from the FDA/ICH you can go to this link and search for stability (or specifications, methods, etc.) and get the FDA/ICH guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

There are other guidance documents as well from the WHO and Health Canada and I think some others. However ICH Q1A (R2), ICH Q5C, ICH Q1E are the most commonly used guidance documents in the US that I can think of right now.

Michelle