Bioequivalence and Bioavailability Forum

❝ If a predose (without IS) shows a very high concentaration, as per the

❝ bioanalysit it is due to back calculation of analyte area, the analyte area

❝ is less than 20% compared to the Standard A.

Dear Alhas,

What ever your analysts said seems to be absolutely correct. How come one can estimate the concentration of the drug in a blank (predose sample) with out Internal standard.
Check the area at the RT of analyte and IS and it should meet your SOP criteria, If it meets then you can accept the data and no need to perform reanalysis.