FDA Recommendation on Matrix Effect Determination in CC Assay [Bioanalytics]

posted by Ohlbe – France, 2018-10-01 15:30 (1029 d 09:55 ago) – Posting: # 19353
Views: 2,117

Dear Scopy,

» I am going through the FDA BMV guideline and I noticed they didn't give any specific guidance on how to validate that a Chromatographic Assay method is free from Matrix Effect.

True. I find this is a real gap in their new Guidance. There was nothing about it in the 2001 Guidance, and not much more here, though matrix effects are a real pain in the quadrupole and can be dangerous.

» Why is this so? Could it be that there are different school of thoughts on how to evaluate matrix effect and the FDA is trying not to take sides?

No idea. I know that the FDA is trying not to be overly prescriptive, but they are giving much more details on other aspects of method validation.

We'll see what makes it into the ICH draft.


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