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RegisterPE outside the acceptance range [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2015-07-27 14:36 (3527 d 15:22 ago) – Posting: # 15154
Views: 10,060
Hi Aan,
Exactly. BTW, MHRA follows EMA’s GLs.
Why should they (i.e., ignoring their own rules)?
Esomeprazole exhibits a pronounced food effect (reduced BA). Although dosing in the fasted state is recommended in the innovator product’s label/SmPC in a generic application you have to show BE for both fasting/fed conditions. I don’t know on which side your product failed (upper = less food effect or lower = higher food effect). Even in the former case, the test product is not similar to the reference, but “better”. In some legislations you could opt for a “hybrid application” which would require an additional clinical study.
❝ As per the regulatory requirements and guidelines for modified release tablet both fasting and fed study is recommended (MHRA, USFDA etc).
Exactly. BTW, MHRA follows EMA’s GLs.
❝ Regulatory agency - MHRA UK, canada, MOH UAE. will they accept the study if fasting meets the criteria and the fed study fails.
Why should they (i.e., ignoring their own rules)?
Esomeprazole exhibits a pronounced food effect (reduced BA). Although dosing in the fasted state is recommended in the innovator product’s label/SmPC in a generic application you have to show BE for both fasting/fed conditions. I don’t know on which side your product failed (upper = less food effect or lower = higher food effect). Even in the former case, the test product is not similar to the reference, but “better”. In some legislations you could opt for a “hybrid application” which would require an additional clinical study.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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 rangeHelmut 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 rangeHelmut 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