Bioequivalence and Bioavailability Forum • Yummz

Yummz [Design Issues]

posted by ElMaestro – Denmark, 2010-08-24 17:09 (5768 d 03:36 ago) – Posting: # 5825
Views: 6,827

Ahoy,

❝ "In case the study is to be performed during fed conditions, the timing

❝ of administration of the drug product in relation to food intake is

❝ recommended to be according to the SmPC of the originator product. If no

❝ specific recommendation is given in the originator SmPC, it is recommended

❝ that subjects should start the meal 30 minutes prior to administration of

❝ the drug product and eat this meal within 30 minutes."

Assuming it takes at least 5 minutes to get from the breakfast area and into the clinic or dosing room, I propose the following mandatory paragraph in all new protocols in section 4.7.1.43.8.18::

"Persons not capable of inhaling 5 donuts, a bagel with cream cheese, 2 bowls of Honey Crust Loop Bomb Speed Wafers with whole milk, a half water melon, and 16 oz. of orange juice, in 25 minutes while reading the Bangalore Gazette or Toronto Times are excluded."

—
Pass or fail!
ElMaestro

Complete thread:

Timing of high-fat breakfast Dr Andrew Leary 2010-08-24 12:13 [Design Issues]
- It's breakfast time d_labes 2010-08-24 13:00
  - YummzElMaestro 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 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