PCS method qualification

2 posts / 0 new
Last post
Rajiv Dua
Rajiv Dua's picture
PCS method qualification

Ques- For Preclinical material stability testing (early developmental stage), are the stability indicating methods needs to be qualified?

Dr. Analytical
Dr. Analytical's picture
You should ask a regulatory

You should ask a regulatory consultant for more information, but I believe some validation will be required at the pre-clinical stage.

For example, the FDA web site offers many Guidance documents, such as this one, that implies that method validation is required for pre-clinical studies.