Bioequivalence and Bioavailability Forum

ICH M13A published [Design Issues]

posted by zuzanna – Poland, 2024-08-01 14:49 (46 d 15:40 ago) – Posting: # 24121
Views: 1,333

Hi ElMaestro,

Thanks for sharing your thoughts, it sounds really reasonable.

There is one more problem - in this case, the first sampling point was scheduled for 20 minutes.

The subjects should eat their meal within 30 minutes and I am afraid that moving this point to 40 minutes may be associated with the risk of a high "Cmax at first sampling point" number

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 publishedzuzanna 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