Log in
RegisterPE outside the acceptance range [Study Assessment]
Hi Helmut,
Thanks for your kind reply.please find my comments below for your advice.
From the results obtained from the BE studies the reference product achieves mean AUCt values as high as 3377.07 ng·h/ml in fasting conditions and as low as 1382.98 ng·h/ml in fed condition.
Based on the Reference product’s claim in the SmPC, stating that decreased and delayed absorption of esomeprazole due to food effect has no significant influence on its clinical efficacy, then the clinical efficacy should be guaranteed within the range 3377.07 – 1382.98 ng·h/ml.
In another word, the mean AUCt values of the Test product are well within the reference product range 3377.07 – 1382.98 ng·h/ml. Therefore, the clinical efficacy of the test product should be guaranteed when it was taken under fed condition.
So in this case a additional clinical study is required ? or the same BE study is enough for the submission to the regulatory as Generic.?
Thanks for your kind reply.please find my comments below for your advice.
From the results obtained from the BE studies the reference product achieves mean AUCt values as high as 3377.07 ng·h/ml in fasting conditions and as low as 1382.98 ng·h/ml in fed condition.
Based on the Reference product’s claim in the SmPC, stating that decreased and delayed absorption of esomeprazole due to food effect has no significant influence on its clinical efficacy, then the clinical efficacy should be guaranteed within the range 3377.07 – 1382.98 ng·h/ml.
In another word, the mean AUCt values of the Test product are well within the reference product range 3377.07 – 1382.98 ng·h/ml. Therefore, the clinical efficacy of the test product should be guaranteed when it was taken under fed condition.
So in this case a additional clinical study is required ? or the same BE study is enough for the submission to the regulatory as Generic.?
Complete thread:
- Esmeprazole Gastro resistant tablet BE study aanrin 2015-07-27 11:45
![[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 rangeaanrin 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 rangeaanrin 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