Bioequivalence and Bioavailability Forum • PE outside the acceptance range

PE outside the acceptance range [Study Assessment]

posted by Helmut – Vienna, Austria, 2015-07-27 14:22 (3527 d 15:43 ago) – Posting: # 15152
Views: 10,088

Hi Aan,

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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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

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