Log in
Registersprinkle study [Design Issues]
Dear Mr.Helmut. Thank you so much. 
All these studies are comparing bioavailabilty of intact capsule Vs sprinkled ones.
But according to USFDA requirements, we have to submit the sprinkle studies done with the innovator's and test drug (if i am correct). But our study was passing with routine fed studies (innovator vs test) but failing on upper limits in the sprinkle fed study (innovator vs test).
All these studies are comparing bioavailabilty of intact capsule Vs sprinkled ones.
But according to USFDA requirements, we have to submit the sprinkle studies done with the innovator's and test drug (if i am correct). But our study was passing with routine fed studies (innovator vs test) but failing on upper limits in the sprinkle fed study (innovator vs test).
Complete thread:
- sprinkle study velupharm 2006-07-21 12:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- sprinkle study Helmut 2006-07-21 13:17
- sprinkle studyvelupharm 2006-07-21 16:25
- sprinkle study (USA vs EU) Helmut 2006-07-21 17:58
- sprinkle study (USA vs EU) velupharm 2006-07-24 06:27
- sprinkle study (USA vs EU) Helmut 2006-07-21 17:58
- sprinkle studyvelupharm 2006-07-21 16:25
- sprinkle study Helmut 2006-07-21 13:17
Ing. Helmut Schütz