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

posted by ElMaestro  – Belgium?, 2018-10-01 14:30 (791 d 17:38 ago) – Posting: # 19355
Views: 1,950

Hello both,

is there any method published anywhere which can be realistically thought to have no matrix effect?
Not just absence of mentioned effect, but truly verified absence of one and how would one go about proving it?

If you had a gun pointed to your head and someone asks you to develop an LC-MS/MS method without matrix effect for, say, Duloxetine or Simvastatin where would you start?

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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