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

posted by Obinoscopy  – USA, 2018-10-01 14:38 (930 d 20:32 ago) – Posting: # 19351
Views: 2,380

Hi Guys,

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.

All I saw was this:

"Sponsor should ensure that there are no matrix effect throughout the application of the method"

No detail on how this could be achieved was provided.

For Ligand Binding Assays, they did give some hint on how to evaluate Matrix Effect but no Acceptance Criteria was provided.

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?

I personally feel they should have provided a method of evaluating matrix effect. Either they provide that which is in tandem with the EMA or they provide an alternative.

Or what do you think?



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