Bioequivalence and Bioavailability Forum • EMA Steady State Fed Study breakfast

EMA Steady State Fed Study breakfast [Regulatives / Guidelines]

posted by Jay – India, 2015-06-02 14:43 (3685 d 22:59 ago) – Posting: # 14895
Views: 9,493

Dear All,

As per EMA GL on MR products, for the Steady state studies of MR products under fed condition, the meal to be given prior to dosing is mentioned as "standard Meal", while in single dose fed studies it is stated as high fat meal.

So how should standard meal be around total of 700-800 kcal meal!!

Please provide your views on the same

Regards,
Jay

Complete thread:

EMA Steady State Fed Study breakfastJay 2015-06-02 12:43 [Regulatives / Guidelines]
- EMA Steady State Fed Study breakfast jag009 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