Bioequivalence and Bioavailability Forum • Unknown x corrected?

Unknown x corrected? [RSABE / ABEL]

posted by Qilex – France, 2016-09-21 14:25 (3565 d 23:13 ago) – Posting: # 16656
Views: 31,702

Hi Detlew

❝ But I'm not quite sure if this applies in our context.

❝ What makes me curious about this is that in the various papers about scaled ABE and also about Individual BE (where (µ_T-µ_R)² is also part of the IBE criterion) there is not any hint of such a 'correction'.

❝ :ponder: .

Any update on the "corrected" x value? The two Lászlós presented a method to "calculate the confidence limits of the reference-scaled SABE by modifying the method of Hyslop et al". The latter method "utilizes Howe's approximation I". The FDA draft guidance on progesterone states that "the method of obtaining the upper confidence bound is based on Howe’s Approximation I".

Hyslop T, Hsuan F, Holder DJ. A small sample confidence interval approach to assess individual bioequivalence. Stat Med 2000;19(20):2885–2897.
Tothfalusi L, Endrenyi L, Arieta AG. Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence. Clin Pharmacokinet 2009;48(11):725–743.
Tothfalusi L, Endrenyi L, Midha KK, et al. Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharm Res 2001;18(6):728–733.

Philippe

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 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 x d_labes 2016-09-21 13:22