Bioequivalence and Bioavailability Forum • The unknown x

The unknown x [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2010-05-06 15:26 (5884 d 07:47 ago) – Posting: # 5312
Views: 41,799

Dear Dave, dear All,

this question is not solely to you Dave, but I must have an entry point.

After looking closer at the SAS code I'm sitting here and wondering about the analysis of the I_ij which covers the first part

(Y_T-Y_R)²

of the linearized scaled ABE criterion.
Does anyone know what this ominous x in the code is and where it comes from :confused:

.

"[snip] -----
From the dataset IGLM2 (or IOUT2), calculate the following:

IGLM2: pointest=exp(estimate);

       x=estimate**2-stderr**2;

       boundx=(max((abs(LowerCL)),(abs(UpperCL))))**2;

[/snip] -----".

See on page 5 or 8 of the FDA Progesterone DRAFT guidance.

—
Regards,

Detlew

Complete thread:

Reference scaled BE - FDA (and FARTSSIE update) ddubins 2010-04-26 20:28 [RSABE / ABEL]
- 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 code d_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 xd_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