Bioequivalence and Bioavailability Forum • FDA’s aggregate BE for NTIDs: example

FDA’s aggregate BE for NTIDs: example [RSABE / ABEL]

posted by jag009 – NJ, 2013-01-15 00:04 (4503 d 16:55 ago) – Posting: # 9844
Views: 14,873

Hi Helmut,

Stuck at the last one..

❝ 3. upper CL: 1.0453 (passed)

Did you get these values for std dev of T and R? I pulled them from PROC MIXED when running the unscaled BE steps as suggested by the warfarin guidance:

S_WT2=0.003281; S_WR2=0.02483

Turning brain dead on Monday (5pm->home time)... Can't get the 90% CI.

John

Complete thread:

FDA’s aggregate BE for NTIDs: example Helmut 2013-01-13 15:54 [RSABE / ABEL]
- 404 d_labes 2013-01-13 19:06
  - URL corrected Helmut 2013-01-13 20:49
    - URL corrected jag009 2013-01-14 21:09
      - THX! Helmut 2013-01-14 21:50
        
        THX! jag009 2013-01-14 21:53
        
        Home stretch Helmut 2013-01-14 22:07
        
        Home stretch jag009 2013-01-14 22:24
        
        estimate K2K 2013-01-16 04:48
        
        only a typo in John’s code Helmut 2013-01-16 14:00
        
        only a typo in John’s code K2K 2013-01-17 04:46
- FDA’s aggregate BE for NTIDs: examplejag009 2013-01-14 23:04
  - Variances from ABE: different model Helmut 2013-01-15 15:41
    - Variances from ABE: different model jag009 2013-01-15 17:58
      - Variances from ABE: different model Helmut 2013-01-15 18:09
        
        Variances from ABE: different model jag009 2013-01-15 18:17
        
        Yep. Almost there. Helmut 2013-01-15 23:30
        
        Yep. Almost there. jag009 2013-01-16 16:14
        
        Done Helmut 2013-01-20 12:58
        
        Variances from ABE: different model jag009 2013-01-15 18:19
        
        Variances from ABE: different model Helmut 2013-01-15 18:29
        
        Variances from ABE: different model jag009 2013-01-15 19:49
        Variances from ABE: different model jag009 2013-01-16 19:35
        
        Variances from ABE: different model Helmut 2013-01-16 19:39