Bioequivalence and Bioavailability Forum • ICH M13A published

ICH M13A published [Design Issues]

posted by Helmut – Vienna, Austria, 2024-07-31 14:21 (45 d 08:56 ago) – Posting: # 24111
Views: 1,409

Hi Zuzanna,

❝ but based on your experience/gut feeling, what option would you choose in this case? meal before or after the drug admonistration?

So far I followed the EMA’s GL (i.e., administration according to the SmPC of the originator). Furthermore:

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble. Carl Sagan. The Demon-Haunted World: Science as a Candle in the Dark. (1995)

In the meantime M13A was published. No changes in this respect (page 10):

For a BE study conducted under fed conditions, it is recommended that subjects start the meal 30 minutes before administration of the drug product and completely consume the meal within 30 minutes.

Contrary to us mere mortals who have to maintain a version control of documents, agencies (and the ICH!) don’t care. Although the draft is still on the ICH’s server, it’s no more linked on the website.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 publishedHelmut 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