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RegisterFDA Recommendation on Matrix Effect Determination in CC Assay [Bioanalytics]
Dear Scopy,
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.
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.
❝ 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.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- FDA Recommendation on Matrix Effect Determination in CC Assay Obinoscopy 2018-10-01 14:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA Recommendation on Matrix Effect Determination in CC AssayOhlbe 2018-10-01 15:30
- FDA Recommendation on Matrix Effect Determination in CC Assay ElMaestro 2018-10-01 16:30
- Reducing matrix effects Ohlbe 2018-10-01 17:20
- FDA Recommendation on Matrix Effect Determination in CC Assay ElMaestro 2018-10-01 16:30
- FDA Recommendation on Matrix Effect Determination in CC AssayOhlbe 2018-10-01 15:30
Ing. Helmut Schütz