Bioequivalence and Bioavailability Forum • [Opinion] Should the 90% CI for GMR be required to encompass 1

[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by bebac_fan – US, 2018-03-29 16:57 (1304 d 11:41 ago) – Posting: # 18617
Views: 8,449

Dear John

» So basically he's questioning the validity of FDA's 20% window on BE then...

Actually, I am questioning the validity of FDA's Swr scaled 10% window on BE for NTID.

If a GMR of 1.1 is clinically relevant (i.e. a test should be sensitive for this), and the NTID with a Swr of .22 will pass by ABE, this is a failure IMO.

Thanks,
BF

Complete thread:

[Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43 [RSABE / ABEL]
- [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:07
  - [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 19:23
    - [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:44
      - [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 20:05
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-28 21:25
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 21:59
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 23:03
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 23:57
        
        Black Swan again mittyri 2018-04-05 17:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 Helmut 2018-03-28 23:57
  - [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 13:46
  - [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 16:52
    - [Opinion] Should the 90% CI for GMR be required to encompass 1bebac_fan 2018-03-29 16:57
      - [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 19:55
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 20:30
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 21:22
        
        Paper & Presentations Helmut 2018-03-30 01:33
        
        Donald Schuirmann’s opinion Helmut 2018-04-10 14:41