Bioequivalence and Bioavailability Forum • No way! But...

No way! But... [Design Issues]

posted by Helmut – Vienna, Austria, 2019-12-06 14:47 – Posting: # 20942
Views: 902

Ahoy my capt’n and welcome back to this side of the pond!

» I do not know why there is a regulatory tradition for only using completers …

Those days when studies were evaluated by a paired t-test with a pocket calculator?

» – I would say there is even a potential scientific and ethical advantage of using all period data.

Correct. If we would be allowed (pun!) to use a mixed-effects model. Patterson and Jones argued against this doubtful practice and the ethical implications of discarding data.*

Patterson SD, Jones B. Viewpoint: observations on scaled average bioequivalence. Pharm Stat. 2011;11(1):1–7. doi:10.1002/pst.498.

—
Cheers,
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Should those subjects have only one period data be included in BE analysis? ssussu 2019-12-06 10:58 [Design Issues]
- No way! But... Beholder 2019-12-06 12:36
  - No way! But... ElMaestro 2019-12-06 13:14
    - No way! But...Helmut 2019-12-06 14:47
      - No way! But... PharmCat 2019-12-06 23:46
        
        No way! But... wienui 2019-12-07 04:01
        
        EMA guideline: no way...: mittyri 2019-12-07 20:58
        
        EMA guideline: no way...: wienui 2019-12-09 05:25
        
        Slightly off topic, but related :-) ElMaestro 2019-12-08 01:31
        
        Slightly off topic, but related :-) Shuanghe 2019-12-09 12:00
        Slightly off topic, but related :-) PharmCat 2019-12-09 15:13
        
        Slightly off topic, but related :-) ElMaestro 2019-12-21 15:02
        
        Slightly off topic, but related :-) PharmCat 2019-12-22 01:12
        2.220446e-16 ≈ 0 Helmut 2019-12-22 10:37
        
        The optional tolerance argument ElMaestro 2019-12-23 14:37
        2.220446e-16 ≈ 0 PharmCat 2019-12-24 14:18
        
        Sum of residuals ~ ε Helmut 2019-12-24 14:54
        
        Sum of residuals ~ ε ElMaestro 2019-12-24 15:10
        
        Wrong terminology Helmut 2019-12-28 13:55
        
        Sum of residuals ~ ε PharmCat 2019-12-24 18:40