Bioequivalence and Bioavailability Forum • EMA Steady State Fed Study breakfast

EMA Steady State Fed Study breakfast [Regulatives / Guidelines]

posted by jag009 – NJ, 2015-06-19 22:57 (3673 d 16:11 ago) – Posting: # 14967
Views: 7,907

Shouldn't it be the same meal as in the single dose fed study? I recall when I did SS fed study for FDA, the meal was high fat breakfast. I don't think EMA would use different meals.

John

Complete thread:

EMA Steady State Fed Study breakfast Jay 2015-06-02 12:43 [Regulatives / Guidelines]
- EMA Steady State Fed Study breakfastjag009 2015-06-19 20:57
  - EMA Steady State Fed Study breakfast Helmut 2015-06-23 00:25
    - EMA Steady State Fed Study breakfast nobody 2015-06-23 09:11
    - EMA Steady State Fed Study breakfast mmw 2017-08-23 10:00
      - EMA Steady State Fed Study breakfast Helmut 2017-08-23 18:14