Bioequivalence and Bioavailability Forum

PE outside the acceptance range [Study Assessment]

posted by Helmut – Vienna, Austria, 2015-07-27 14:14 (3527 d 16:05 ago) – Posting: # 15150
Views: 10,073

Dear Aan,

❝ Fed Study - The Test to Reference ratio of geometric LSmeans for the Cmax was outside the acceptance range of 80 to 125%…

OK, that’s the end of the story – even for the least restrictive (i.e., Canadian) requirement.

❝ 90% confidence interval was also outside the widened range of 75 to 133%.

❝ Please advice me whether the product will be accepted as generic by the regulatory authority if the fed study fails but fasting study is succesful.

In the future please tell us which regulatory agency you are aiming at. Requirements differ around the globe. A (prespecified!) widened acceptance range of 75–133% is rarely applicable nowadays.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Esmeprazole Gastro resistant tablet BE study aanrin 2015-07-27 11:45 [Study Assessment]
- PE outside the acceptance rangeHelmut 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 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]