SerhiiP
☆    

Ukraine,
2022-01-20 10:20
(820 d 11:18 ago)

Posting: # 22734
Views: 1,819
 

 With food administration [Design Issues]

Post reply
Dear Members,

I have a question here.

If SmPC only states that the medicine should be taken with food, does this means we should administer medicine with food(and wich timings that is?), or do we administer immideately after food?
Just couldn't find any answer about that :confused:.

Thanks!
 
dshah
★★  

India/United Kingdom,
2022-01-20 12:49
(820 d 08:48 ago)

@ SerhiiP
Posting: # 22735
Views: 1,572
 

 With food administration

Post reply
Dear SerhiiP!
As per the EMA guideline-"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."
Please find the guideline here.
Regards,
Dshah
 
UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,661 registered users;
110 visitors (0 registered, 110 guests [including 7 identified bots]).
Forum time: 22:38 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5