Bioequivalence and Bioavailability Forum • Emesis in Steady state BE studies

Emesis in Steady state BE studies [Design Issues]

posted by dk – India, 2014-03-20 12:44 (4478 d 02:36 ago) – Posting: # 12678
Views: 5,111
(edited on 2014-03-20 14:14)

Hi,

I have a question regarding withdrawal criteria in case of emesis in a steady state BE study.

we are planning to conduct a multi site BE study. As per Protocol, subjects will have to consume tablets from Day 1 to Day 8 and then crossed over for other Product. Post-dose PK sampling is planned on Day 8 and and Day 16. we have kept withdrawal criteria if the subjects vomits within 2 times of median Tmax after dosing on Day 8 and 16. However we are not sure if the same withdrawal criteria has to be applied for other days as well i.e. on Day 1 to 7 and Day 9 to day 15. Could somebody please provide answer for this. Also please provide the reference for the same.

Thanks a lot for the help.

Kind Regards
DK

Edit: Category changed. [Helmut]

Complete thread:

Emesis in Steady state BE studiesdk 2014-03-20 11:44 [Design Issues]
- Emesis in Steady state BE studies Tina 2014-03-20 15:34
  - Emesis in Steady state BE studies krish 2014-03-21 05:07
    - Emesis in Steady state BE studies dk 2014-03-21 05:37
  - Emesis in Steady state BE studies dk 2014-03-21 05:31