Bioequivalence and Bioavailability Forum

Hi everyone,

Just a thought... For BE studies comparing against a GITS/OROS (osmotic pump delivery) tablet which is designed for a 8-12 hr total drug release in-vitro, is there a need to set up the protocol:

1)to monitor for subject who have bowel movement before 12 hours? Example, if subject has a bowel movement before 12 hours, his/her fecal matter should be collected to check for the presence of the GITS/OROS shell. If there is a shell, can we drop the subject?

or

2)Drop subject(s) who has bowel movement(or go for the extreme, diarrhea) before 12 hrs?

Thanks
John