Bioequivalence and Bioavailability Forum

Hi Ken,

❝ (i) Is ISR necessary for pilot study ?

FDA? No. But for us if the assay is newly developed then we would ask the lab to do ISR (yes for a pilot study) just to make sure things are okay.

John

Dear Ken,

❝ (i) Is ISR necessary for pilot study ?

I agree with John: I would say it is not mandatory, but if you want to be on the safe side, you can run some ISR samples to make sure there is no big problem with your method before you use it in the pivotal study.

❝ (2) For BE study using pharmacodynamic parameters, for example measurement of serum glucose level performed by pathology lab, what are the parameters to be performed in method validation ? The instrument and approach used for glucose determination in pathology lab is different from analytical lab. Limited (2 levels) standard reagents are used and no QC samples.

QC samples are commercially available (but they usually have rather large acceptance ranges).

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.