Bioequivalence and Bioavailability Forum • Official unknown x

Official unknown x [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2016-09-21 15:22 (3554 d 05:10 ago) – Posting: # 16658
Views: 31,609

Dear Philippe,

❝ Any update on the "corrected" x value?

The first "official" statement regarding the "unknown x" is from a presentation of Donald Schuirmann at "The Global Bioequvalence Harmonization Initiative: EUFEPS/AAPS Second International Conference", Washington, Sep. 15-16, 2016.

Quote from the Handouts:

The statistical approach we use is very similar to that proposed by Tothfalusi, Endrenyi, et al. 2001, with a minor difference (use of an unbiased estimator for (µ_T – µ_R)².)
SAS code to implement the procedure was included in the Draft Guidance on Progesterone (2010).

Thus the user Detlor seems right in his explanation years ago.

—
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 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 xd_labes 2016-09-21 13:22