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

No way! But... [Design Issues]

posted by wienui – Germany, Oman, 2019-12-07 04:01 – Posting: # 20955
Views: 2,232
(edited by wienui on 2019-12-07 06:47)

Dear all,

» So here two answers - theoretically there is no problem to use all data, but regulatory authorities can bann you for it. (IMHO)

I also agree about this as a previous acadmic person, but as a regulator, which regulatory supportive Guidelines (EMA & FDA) reasons, can I rely on it to be able to use data from study subjects who didn't completed all study periods?

Best regards,
Osama

—
Cheers,
Osama

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