Bioequivalence and Bioavailability Forum

3 period full replicate [RSABE / ABEL]

posted by Dr_Dan – Germany, 2015-06-24 15:55 (3226 d 22:04 ago) – Posting: # 14974
Views: 31,530

Dear all
From a leading European regulatory authority I just recieved the information that a 3-period full replicate design (two sequences: T-R-T and R-T-R) for a bioequivalence study will not be accepted. The reason is that

for a full replicate design R as well as T need to be replicated and this is only possible with the respective sequences (so TTRR etc.). A 3-period full replicate design would result only in two parallel separate groups (one which – apart from the integrated 2-period crossover– only get Test and the other only Reference); an evaluation would probably only possible as a general 2-period crossover study.

Please excuse the confusing explanation but the text set in italic is the verbal translation from what I received.
My interest is just of academic nature: What should one reply to this attitude?
Looking forward to your replies and to a fruitful discussion.
Kind regards
Dr_Dan

Edit: Category changed from Design Issues. I think this category fits better – especially if one is interested in reference-scaling. [Helmut]

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

3 period full replicateDr_Dan 2015-06-24 13:55 [RSABE / ABEL]
- 3 period full replicate ElMaestro 2015-06-24 14:11
- 3 period full replicate Helmut 2015-06-24 14:29
- 3 period full replicate d_labes 2015-06-24 14:38
  - 3 period full replicate Dr_Dan 2015-06-24 16:43
    - 3 period full replicate Helmut 2015-06-24 18:00
      - 3 period full replicate ElMaestro 2015-06-24 18:11
        
        3 period full replicate Helmut 2015-06-24 18:25
        
        3 period full replicate d_labes 2015-06-25 08:52
        
        3 period full replicate ElMaestro 2015-06-25 10:37
        
        OT d_labes 2015-06-25 11:20
        
        OT ElMaestro 2015-06-25 11:54
        
        OT d_labes 2015-06-25 13:51
    - CVs (borderline OT) Helmut 2015-06-26 13:51
      - CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
        
        Answering an unasked question Helmut 2015-07-02 13:03
        
        Answer to an unasked answer d_labes 2015-07-02 14:21
        
        Bloody typo! Helmut 2015-07-02 14:33
      - CVs (borderline OT) zizou 2015-07-05 19:20
        
        Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
        
        Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
        
        Degrees of freedom 3-period full replicate d_labes 2015-07-06 13:53
        
        Degrees of freedom 3-period full replicate zizou 2015-07-06 17:25
- The almighty oracle has spoken! Helmut 2015-07-23 23:54
  - Almighty oracle's mysterious saying d_labes 2015-07-24 08:23

3 period full repli­cate [RSABE / ABEL]

Complete thread:

3 period full replicate [RSABE / ABEL]