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

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

posted by Helmut – Vienna, Austria, 2013-01-13 16:54 (4504 d 23:40 ago) – Posting: # 9834
Views: 16,123

Dear all,

I tried to implement FDA’s aggregate BE according to the warfarin guidance in Phoenix/WinNonlin 6.3. For a discussion see also this thread. In order to demonstrate BE a study has to pass three criteria:

RSABE based on θ=[ln(1.11111)/0.1]²: crit. bound ≤0.
unscaled ABE: 90% CI within 80.00–125.00%.
comparison of σ_WT with σ_WR: upper 95% CL of s_WT/s_WR ≤2.5.

For an example data set (20kB xls) I got:

critbound: -0.0098283 (passed)
CI: 93.90–103.35% (passed)
upper CL: 1.0453 (passed)

Can you check in your installation – or other software – whether I screwed up?^*

I did. Not for the first time. See this post. Ergo:
upper CL: 0.68427 (passed)

—
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Helmut Schütz

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Complete thread:

FDA’s aggregate BE for NTIDs: exampleHelmut 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: example jag009 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