Bioequivalence and Bioavailability Forum • Almighty oracle's mysterious saying

Almighty oracle's mysterious saying [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2015-07-24 10:23 (3429 d 05:03 ago) – Posting: # 15140
Views: 29,265

Dear Helmut!

❝ Parturient montes, nascetur ridiculus mus. Horace (Ars poetica, Ep.II.3, 139)

Full ACK

As every Pythia's saying: Mysterious!
Nowhere in the scABEL method there is an term utilizing the 'uncertainty' of the variability of the reference.
Contrary to the FDA RSABE which has such a term.
That's the reason why both 3-period designs (TRR|RTR|RRT or TRT|RTR) require similar numbers of subjects.

And deeming 12 subjects as sufficient to 'control' that 'uncertainty' is at least strange (politely spoken):

library(PowerTOST)

CVCL(CV=0.3, df=12-2, "2-sided")

 lower CL  upper CL 

0.2072921 0.5513299

From no widening up to cap on widening!

But the net effect is of course pleasing :cool:

—
Regards,

Detlew

Complete thread:

3 period full replicate Dr_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 sayingd_labes 2015-07-24 08:23