Bioequivalence and Bioavailability Forum

Dear members,

I want to share here a debatable approach for run acceptance from bioanalytical lab end.

If blank sample and zero standard have more that 20% peak area of LLOQ sample, can we consider second lowest standard as revised LLOQ for batch acceptance?

Can Sample Concentration below revised LLOQ be reanalyzed considering pass batch?

What can be the associated consequences other than analytical end?

Please share some papers or links if anybody have related to this approach.

Why we can't go for this?


Thanks & Regards,
Shreyas Goswami.