Meals in fast and fed studies [Regulatives / Guidelines]

posted by Ayman Rabayah – Jordan, 2020-03-03 08:48 (809 d 20:27 ago) – Posting: # 21192
Views: 1,744

Hi Helmut and colleagues

We need to put clear criteria for meal consumption in BE studies, specifically, meals in fasting studies and meals (besides the high fat breakfast) in fed studies? Subjects are dosed and then 4-5hrs later they're provided lunch, later perhaps a snack, dinner, etc. Depending on the Tmax of the drug, the meal after 4hrs from the dose could affect absorption. Subjects have a variety of food requirements; A tall man might require more food than a small man. Should subjects "be made" to eat 100% of their meal (for consistency between subjects) or is it fine for them to eat 75% or even less? How about later meals after 2xTmax? They won't affect absorption, so could subjects eat as much or as little as they want? Do we care about any meal but the high fat breakfast in fed studies?

looking forward to hear from you
Thank you

Complete thread:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Sunday 06:15 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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