PCS method qualification

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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.

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf