PE outside the acceptance range [Study Assessment]
Hi Aan,
as mentioned above, please tell us the regulatory agency you want to submit the studies.
Counterquestion: Why did you perform studies in both fasting and fed conditions?
as mentioned above, please tell us the regulatory agency you want to submit the studies.
❝ But the fasting study meets all the criteria. only fed study fails.
❝
❝ So please let me know for Modified release products both fasting and fed study should be successful?
Counterquestion: Why did you perform studies in both fasting and fed conditions?
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Esmeprazole Gastro resistant tablet BE study aanrin 2015-07-27 11:45 [Study Assessment]
- 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 rangeHelmut 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 rangeHelmut 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