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RegisterEsmeprazole Gastro resistant tablet BE study [Study Assessment]
Dear Sir/Madam,
The following BE study results for Esmeprazole Gastro resistant tablet
Fed Study - The Test to Reference ratio of geometric LSmeans for the Cmax was outside the acceptance range of 80 to 125% and the corresponding 90% confidence interval was also outside the widened range of 75 to 133%. The Test to Reference ratio of geometric LSmeans for the AUCT and AUC∞ were within the acceptance range of 80 to 125%, however, their corresponding 90% confidence intervals were outside this range.
Fasting Study - meets all criterias and found to be bioequivalent.
Please advice me whether the product will be accepted as generic by the regulatory authority if the fed study fails but fasting study is succesful.
Wityh Regards
Aan
Edit: Category changed. [Helmut]
The following BE study results for Esmeprazole Gastro resistant tablet
Fed Study - The Test to Reference ratio of geometric LSmeans for the Cmax was outside the acceptance range of 80 to 125% and the corresponding 90% confidence interval was also outside the widened range of 75 to 133%. The Test to Reference ratio of geometric LSmeans for the AUCT and AUC∞ were within the acceptance range of 80 to 125%, however, their corresponding 90% confidence intervals were outside this range.
Fasting Study - meets all criterias and found to be bioequivalent.
Please advice me whether the product will be accepted as generic by the regulatory authority if the fed study fails but fasting study is succesful.
Wityh Regards
Aan
Edit: Category changed. [Helmut]
Complete thread:
- Esmeprazole Gastro resistant tablet BE studyaanrin 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 story Ohlbe 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