Bioequivalence and Bioavailability Forum

❝ 2. Some people claim that extreme standardization (BMI, …) will also help to reduce CV_intra. I strongly doubt that since the between- and within-variance components are mutually independent.

I would assume that volunteers with very constant everyday habits, including sleeping, diet (!), GI-transit time etc. etc. have reduced intraindivdual variability. Maybe do a BE-study in a monastery as proof-of-concept?

For your in vitro dissolution testing you don't mix within one experiment (!) basket and paddle employing various rotation speeds, use flasks of different volumes, different buffers, temperatures etc. pp. to reduce variability, or? So why shouldn't high standardization work with your in vivo dissolution system, too?