Bioequivalence and Bioavailability Forum • ICH M13A published

ICH M13A published [Design Issues]

posted by qualityassurance – 2024-08-05 14:45 (243 d 15:32 ago) – Posting: # 24130
Views: 2,540

Hello Zuzana,

❝ Yes, the challenge is indeed there. The median Tmax is expected to be 1.5h, and the range may start at 40 min or even earlier. I'm afraid to have DLs about the unreliable PK profile with some Tmax at the first sampling points.❝

If you anticipate Tmax at 20 minutes, add other blood collection at 10 minutes. You can collect blood while subjects are having their meal. You can specify this also in protocol. In this way I do not anticipate any DLs.

Regards,
QA

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 published ElMaestro 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 publishedqualityassurance 2024-08-05 12:45