Bioequivalence and Bioavailability Forum • It's breakfast time

It's breakfast time [Design Issues]

posted by Pavidus – 2010-08-25 16:11 (5779 d 00:21 ago) – Posting: # 5829
Views: 6,674

Dear all,
allow me to ask for clarification on this issue using the following example:
exemestane SmPC says: "tablet...preferably after a meal." (i.e. there is no specification if after "high-fat meal", or no).

So I would perform the BE study under fed conditions.

Now, according to the valid GL (page 10):
In studies performed under fed conditions, the composition of the meal is recommended to be according to the SmPC of the originator product. If no specific recommendation is given in the originator SmPC, the meal should be a high-fat

ergo

I would do the BE after high-fat breakfast.
Is this correct?

Thank you in advance.
KR, Pavidus

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 timePavidus 2010-08-25 14:11
      - It's breakfast time Dr 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