With food administration [Design Issues]

posted by dshah  – India/United Kingdom, 2022-01-20 12:49 (319 d 03:37 ago) – Posting: # 22735
Views: 871

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

Complete thread:

UA Flag
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
12 visitors (0 registered, 12 guests [including 6 identified bots]).
Forum time: 16:27 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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