Bioequivalence and Bioavailability Forum

Hi Tina,

❝ We recently received an RFI from a EU regulatory body asking whether the vasoconstrictor bioassay complies with the EU bioanalytical guideline.

That's an easy one then. It's a trick question. Just tell them it doesn't

Imagine.... what is a QC sample is in vasoconstrictor assays, how would we do incurred sample re-analysis (yeah right, let's ask the subjects to come back to the clinic for more visits??!?), what about stability and freeze-thaw cycling etc etc.
Just validate the chromamolophystic constrilotractor normally. And pardon me if I am having the terminology slightly wrong .