Bioequivalence and Bioavailability Forum • Study Results

Study Results [Study Assessment]

posted by VSL – India, 2015-04-20 23:46 (3732 d 20:14 ago) – Posting: # 14721
Views: 14,621

Dear All,
Please explain what to do if following results obtained in BE-Study:

Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.
Study is passed in CI but there is significant p-value for treatment/period/sequence

Shall we submit the study to regulatory agencies?
Regards...
VSL

Edit: Category changed. [Helmut]

Complete thread:

Study ResultsVSL 2015-04-20 21:46
- Study Results ElMaestro 2015-04-20 23:47
  - upper CL < PE Helmut 2015-04-21 00:39
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 00:24
  - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
    - PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 17:12
      - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
        
        PE restriction for HVDs/HVDPs Helmut 2015-04-22 16:41
  - GMR outside the limits when using ABEL Averroes 2017-05-19 11:53
    - Regulations ≠ Science Helmut 2017-05-19 14:07
      - Regulations ≠ Science Averroes 2017-05-22 20:51

Admin contact
23,428 posts in 4,929 threads, 1,689 registered users;
57 visitors (0 registered, 57 guests [including 8 identified bots]).
Forum time: 20:00 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere. Marilyn Monroe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz