Bioequivalence and Bioavailability Forum • Partial replicate design and FDA ABE code

Partial replicate design and FDA ABE code [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2010-04-28 11:47 (5907 d 11:45 ago) – Posting: # 5252
Views: 41,961

Hi Dave,

❝ ❝ D. Labes:

❝ ❝ BTW: What is missing is explicit code for ABE evaluation for the partial replicate design ...

❝

❝ The explicit code for this is on the last page (page 9) of the progesterone guidance. It's just the unscaled approach. You can use that method for both 4-period and 3-period designs.

(underlined by me)

I do not believe that. We have experimented with the FDA code on partial replicate design here in the forum and got some strange results. See f.i. here and here.
IMHO this is due to the fact that the intra-subject variance for Test is not identifiable in this design.

BTW: Regarding the sample size question of my very dear friend KR have a look into this tread.

—
Regards,

Detlew

Complete thread:

Reference scaled BE - FDA (and FARTSSIE update) ddubins 2010-04-26 20:28
- Reference scaled ABE - FDA d_labes 2010-04-27 08:58
  - Reference scaled ABE - FDA ElMaestro 2010-04-27 13:39
    - Factor 2 is unbiased d_labes 2010-04-27 14:30
    - Biased bonus from MoM d_labes 2010-05-04 12:10
      - Biased bonus from MoM ElMaestro 2010-05-04 12:54
        
        Mixed MoM d_labes 2010-05-04 14:40
        
        Mixed MoM ElMaestro 2010-05-04 15:08
        
        R and G, CSH and UN d_labes 2010-05-05 10:42
        
        A sailor gets confused ElMaestro 2010-05-05 11:49
        
        Confused V/Z matratzen and tips d_labes 2010-05-05 14:49
        
        superb post! ElMaestro 2010-05-05 21:32
        
        Gambling with UN d_labes 2010-05-06 11:00
        
        Mixed MoM yjlee168 2010-05-05 09:12
- Reference scaled BE - FDA (and FARTSSIE update) KR 2010-04-27 13:14
- Reference scaled BE - EMA Helmut 2010-04-27 14:58
  - Reference scaled BE - EMA ddubins 2010-04-27 17:52
    - Partial replicate design and FDA ABE coded_labes 2010-04-28 09:47
    - Reference scaled BE - EMA Helmut 2010-04-28 14:46
    - Switching - null sWR d_labes 2010-05-04 14:04
- The unknown x d_labes 2010-05-06 13:26
  - The unknown x jdetlor 2010-09-28 17:22
    - Unknown x corrected? d_labes 2010-10-01 12:14
      - Unknown x corrected? Qilex 2016-09-21 12:25
        
        Official unknown x d_labes 2016-09-21 13:22