Bioequivalence and Bioavailability Forum

PE outside the acceptance range [Study Assessment]

posted by aanrin – United Arab Emirates, 2015-07-27 14:18 (3981 d 19:38 ago) – Posting: # 15151
Views: 11,777

Thanks for the reply.

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?

Complete thread:

Esmeprazole Gastro resistant tablet BE study aanrin 2015-07-27 11:45
- PE outside the acceptance range Helmut 2015-07-27 12:14
  - PE outside the acceptance rangeaanrin 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 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 [Study As­sess­ment]

Complete thread:

PE outside the acceptance range [Study Assessment]