Fast & fed in one study (alternative) [Design Issues]

posted by jag009  – NJ, 2020-03-04 19:25 (317 d 05:05 ago) – Posting: # 21204
Views: 1,924

Hi,

» What happens if T is BE to R under fasting and fed but T has much more food effect than R? Will "nice-to-know" become "but-now-I-know-so-you-are-fucked"? What's your experience from regulation perspective?

With FDA → In general they don't care but if they look at your data and see that you borderline past fed (or fast), then they might raise an issue.

J

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,488 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 00:31 CET (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

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