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RegisterPE outside the acceptance range [Study Assessment]
Hi
As per the regulatory requirements and guidelines for modified release tablet both fasting and fed study is recommended (MHRA, USFDA etc).
Regulatory agency - MHRA UK, canada, MOH UAE. will they accept the study if fasting meets the criteria and the fed study fails.
As per the regulatory requirements and guidelines for modified release tablet both fasting and fed study is recommended (MHRA, USFDA etc).
Regulatory agency - MHRA UK, canada, MOH UAE. will they accept the study if fasting meets the criteria and the fed study fails.
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 rangeaanrin 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 rangeaanrin 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