Bioequivalence and Bioavailability Forum

Dear all,

I have questions about calibration curve and precision.
I generally see that 5 calibration curves were used to establish the curve and five consecutive days were used to determine between-day precision.

But I don't see in US guidance how many calibration curves are needed in validation step. So, are 3 calibration curves acceptable if they follow the criteria in establishment of calibration curve?

"At least 4 out of six non-zero standards meet the criteria including LLOQ...
<= 20% deviation of LLOQ, 15% deviation of other than LLOQ"

For between-day precision, is between-day precision from 3 days (each day 6 repeats) measurement acceptable?

"In the guidance, at least 5 determiantions should be used to find precision..." Is this mean at least 5 day determination?

Thank in advance

Sarawut