Bioequivalence and Bioavailability Forum • It's breakfast time

It's breakfast time [Design Issues]

posted by Dr Andrew Leary – Ireland, 2010-08-25 16:52 (5779 d 21:53 ago) – Posting: # 5831
Views: 6,705

Greetings, Pavidus!

❝ I would do the BE after high-fat breakfast.

❝ Is this correct?

In my view, you are correct.

Do we need any more evidence that (aspects of) the new GL are insane? There are very few SmPCs that specify the particular meal to be taken before or with or after the drug in question. So now we have no choice but to go for a meal composition which pushes variability to the maximum. Which Europeans (apart from some of my fellow Irishmen) eat a breakfast of 800 to 1000 calories with 50% fat?

Kind regards

Andrew

Complete thread:

Timing of high-fat breakfast Dr Andrew Leary 2010-08-24 12:13
- It's breakfast time d_labes 2010-08-24 13:00
  - Yummz ElMaestro 2010-08-24 15:09
    - Yummz Dr Andrew Leary 2010-08-24 16:22
    - Reading matters Helmut 2010-08-24 16:34
  - It's breakfast time Dr Andrew Leary 2010-08-24 16:20
    - It's breakfast time Pavidus 2010-08-25 14:11
      - It's breakfast timeDr Andrew Leary 2010-08-25 14:52
        
        It's breakfast time ElMaestro 2010-08-25 15:14
        It's breakfast time Ohlbe 2010-08-25 16:07
        
        It's breakfast time Dr Andrew Leary 2010-08-25 16:15
      - It's breakfast time Dr_Dan 2010-08-25 15:33
        
        It's breakfast time Dr_Dan 2010-08-25 15:49
        
        It's breakfast time Helmut 2010-08-25 16:22
        
        It's breakfast time Pavidus 2010-08-26 10:02