Bioequivalence and Bioavailability Forum • EMA guideline: no way...:

EMA guideline: no way...: [Design Issues]

posted by mittyri – Russia, 2019-12-07 21:58 (1153 d 21:02 ago) – Posting: # 20959
Views: 5,375

Dear Osama,

❝ 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?

I doubt that something exists at the moment.
Please also see the related discussion and cites of EMA guideline.

—
Kind regards,
Mittyri

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