Bioequivalence and Bioavailability Forum

GMR outside the limits when using ABEL [Study Assessment]

posted by Averroes – Spain, 2017-05-19 13:53 (3320 d 22:00 ago) – Posting: # 17372
Views: 9,808

Dear Helmut,

Recently we performed a full replicate (4-period) study using ABEL for EMA and actually the results shows AUC within 80-125, Cmax within expanded CI but unfortunately GMR fall outside 80-125.

I found in the forum that the GMR constrant is there for political reasons more than for scienfic or statistical reasons. Do you think we could still have an opportunity with European regulatory agencies?

Thanks,

Complete thread:

Study Results VSL 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 ABELAverroes 2017-05-19 11:53
    - Regulations ≠ Science Helmut 2017-05-19 14:07
      - Regulations ≠ Science Averroes 2017-05-22 20:51

GMR outside the limits when using ABEL [Study As­sess­ment]

Complete thread:

GMR outside the limits when using ABEL [Study Assessment]