Bioequivalence and Bioavailability Forum • ICH M13A

ICH M13A [Design Issues]

posted by Helmut – Vienna, Austria, 2024-07-31 11:14 (260 d 11:56 ago) – Posting: # 24109
Views: 3,018

Hi Zuzanna,

the ICH M13A was already adopted on 23 July 2024 (step 4). Let’s see when it will appear on the ICH’s website and which changes to the draft have been made. Interesting that the Q&A document is already available.

See for example the EMA’s Bioanalytical Method Validation Guideline of 2011 stating that it was superseded by ICH M10 of 2022.
As long as this does not happen for the BE guideline as well (ICH M13A in step 5 = implemented), it is still applicable.

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Complete thread:

Fed conditions → timing of meal zuzanna 2024-07-31 07:54 [Design Issues]
- ICH M13AHelmut 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 published qualityassurance 2024-08-05 12:45