"For methods that employ sample extraction, the recovery (extraction efficiency) should be evaluated."
Who knows from recent discussions whether protein precipitation is considered "sample extraction" or not?
Sample extraction includes everything you do to your sample. Actually, protein precipitation would be the most critical part to check in your methods as this will determine the recovery of your analytes.
Andreu, you can just dilute and inject the sample. Do you consider dilution as a "sample extraction"?
Yes, to do. You need to check if your analytes ara soluble in the dilution solvent otherwise this can have an impact in recovery. But here you are talking about protein precipitation, to me it seems is even more critical since this is not a dilute and shoot approach.
Ok, I see your point. The reason why I opened this discussion is the statement from the ICH M10. Which methods in bioanalysis do not employ sample extraction? Just direct injection of any biosample?
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