Bioequivalence and Bioavailability Forum • TSD Japonica…

TSD Japonica… [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2014-07-22 19:50 (3948 d 18:23 ago) – Posting: # 13292
Views: 12,962

Dear Detlew,

❝ […] not quite clear to me if this meets the "Addonionsis Japonica" in all respects.

No, it doesn’t. That’s why I called it misuse. Thoughtlessly I edited my post not being aware of your answer already posted. I’ve set the futility criterion to extreme values, but I was aware that still some studies might simply stop.

❝ At least it is not what Wonnemann et al. simulated. No futility criterion was used by them if I read the paper correct […]

Yes, you do.

❝ Seems the story goes further (just befor your quote):

❝ "If bioequivalence cannot be demonstrated because of an insufficient number, an add-on subject study can be performed ..."

Oh no!

❝ If one reads this, it may call for some criteria what an insufficient number is. Knowing Potvin et al. TSD's this may be interpreted as call for some power calculation step after 'stage 1'.

Seems so. The terminology is consistent, since in the preceding sentence the guidance asks for a “sufficient” number of subjects in planning the sample size.

❝ Knowing Potvin et al. TSD's this may be interpreted as call for some power calculation step after 'stage 1'.

If one wants to find a suitable adjustment avoiding inflation the only difference to Potvin & Co. would be restricting n₂ to ≥n₁/2.

❝ In power.2stage.GS() the criterion for continuing to stage 2 is:

❝ - not BE in the first stage

❝ - and result was not futile (via a PE or CI criterion)

For the latter case I used 0.01/100, but the former may still hit.

—
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Helmut Schütz

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Science Quotes

Complete thread:

EMA: α-inflation – the suspicion begins to mount Helmut 2014-07-21 02:04
- EMA: α-inflation – the suspicion begins to mount ElMaestro 2014-07-21 09:24
  - Why simulate a simple AB|BA at all? Helmut 2014-07-21 16:14
    - Why simulate a simple AB|BA at all? ElMaestro 2014-07-21 20:50
      - Fancy smoothing? Helmut 2014-07-21 23:13
        
        Arbitrary smoothing? d_labes 2014-07-22 08:43
        
        Noise… Helmut 2014-07-22 13:31
        
        TSD Japonica… d_labes 2014-07-22 16:06
        
        TSD Japonica…Helmut 2014-07-22 17:50
        
        Noise debugged d_labes 2014-07-24 13:47
        
        Noise debugged Helmut 2014-07-24 15:07
        
        Shit happens d_labes 2014-07-24 16:09
      - Commentary d_labes 2014-07-22 08:18
        
        Commentary nobody 2014-09-15 08:24
        
        Commentary Helmut 2014-09-15 10:12
      - IBE/PBE = Two-Stage Helmut 2014-09-29 03:33
        
        IBE/PBE = Two-Stage ElMaestro 2014-09-29 15:16
        
        Sequential Design = Inflation likely… Helmut 2014-09-30 15:03