Bioequivalence and Bioavailability Forum • ICH M13A published

ICH M13A published [Design Issues]

posted by ElMaestro – Denmark, 2024-07-31 16:14 (263 d 21:59 ago) – Posting: # 24114
Views: 2,943

Hi Zuzana,

the ICH document was written in a generic fashion, it does not take into consideration specific cases like yours. This fully justifies a deviation from the guidance. It is for that reason that I think EU regulators would suggest to dose as per SmPC and not as per ICH guidance if you ask for scientific advice. So that is what I would lean towards.

Gut feeling only.

—
Pass or fail!
ElMaestro

Complete thread:

Fed conditions → timing of meal zuzanna 2024-07-31 07:54 [Design Issues]
- ICH M13A Helmut 2024-07-31 09:14
  - ICH M13A zuzanna 2024-07-31 10:32
    - ICH M13A published Helmut 2024-07-31 12:21
      - ICH M13A published zuzanna 2024-07-31 13:47
        
        ICH M13A publishedElMaestro 2024-07-31 14:14
        
        ICH M13A published zuzanna 2024-08-01 12:49
        
        ICH M13A published qualityassurance 2024-08-02 05:09
        
        ICH M13A published ElMaestro 2024-08-02 15:14
        ICH M13A published zuzanna 2024-08-03 21:16
        
        ICH M13A published qualityassurance 2024-08-05 12:45