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RegisterPE outside the acceptance range: end of the story [Study Assessment]
Aanrin,
You're not answering Helmut's comments (lower or higher food effect compared to the reference ?). Regulators want bioequivalence to be demonstrated both fasted and fed. It is not. Based on the information you provided up to now, that's the end of the story.
You're not answering Helmut's comments (lower or higher food effect compared to the reference ?). Regulators want bioequivalence to be demonstrated both fasted and fed. It is not. Based on the information you provided up to now, that's the end of the story.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Esmeprazole Gastro resistant tablet BE study aanrin 2015-07-27 11:45 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PE outside the acceptance range Helmut 2015-07-27 12:14
- PE outside the acceptance range aanrin 2015-07-27 12:18
- PE outside the acceptance range Helmut 2015-07-27 12:22
- PE outside the acceptance range aanrin 2015-07-27 12:27
- PE outside the acceptance range Helmut 2015-07-27 12:36
- PE outside the acceptance range aanrin 2015-08-24 09:08
- PE outside the acceptance range: end of the storyOhlbe 2015-08-24 13:34
- PE outside the acceptance range Shuanghe 2015-08-24 15:43
- PE outside the acceptance range aanrin 2015-08-24 09:08
- PE outside the acceptance range Helmut 2015-07-27 12:36
- PE outside the acceptance range aanrin 2015-07-27 12:27
- PE outside the acceptance range Helmut 2015-07-27 12:22
- PE outside the acceptance range aanrin 2015-07-27 12:18
- PE outside the acceptance range Helmut 2015-07-27 12:14
Ing. Helmut Schütz