Bioequivalence and Bioavailability Forum

Dear ElMaestro,

❝ Shouldn't be an issue from an approval perspective as long as the use of both instruments is protocolled and validated.

Yes we do validate method on both of the instrument.

❝ But it might increase variability and thus the width of the CI.

Here my concern is. i am thinking that till date the evaluation of the same subject data is not evaluated on two different make of instrument. I mean till date none of the CRO (with whom we are working) has done the evaluation of ISR on either instrument. I am worried does the out come of the subject may change if analysed on two different make.

This is the parallel study and inter subject ratio play a roll in this. if the either instrument in not producing reasonably same results, it will be great trouble.

Regards,

Compliance