Bioequivalence and Bioavailability Forum

Hi Ken,

❝ I would say the first thing is to make sure the equipment and reagents you use have been validated by the vendor (in Europe we have a CE-marking that is supposed to show this). Performing yourself a full validation the same way you would do it for a bioanalytical method would be a challenge (difficult to prepare well standardised calibration and QC samples for these endogeneous substances), but you can at least check the precision of your method using pooled samples at low and high levels. Use commercial QCs during routine sample analysis.

Agree with Ohlbe. I ran a antihypertive PK/PD study using holter monitor for 24 hour BP monitoring and the devices were validated and calibrated by the vendor.

John