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

posted by Ohlbe – France, 2018-10-01 15:30 (1205 d 18:00 ago) – Posting: # 19353
Views: 2,215

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.


Complete thread:

 Admin contact
21,831 posts in 4,567 threads, 1,553 registered users;
online 14 (0 registered, 14 guests [including 6 identified bots]).
Forum time: Wednesday 08:31 CET (Europe/Vienna)

Research under a paradigm must be a particularly effective way
of inducing paradigm change.    Thomas S. Kuhn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz