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

posted by jag009  – NJ, 2020-03-04 19:25 (468 d 13:28 ago) – Posting: # 21204
Views: 2,239

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
21,523 posts in 4,499 threads, 1,523 registered users;
online 6 (1 registered, 5 guests [including 4 identified bots]).
Forum time: Wednesday 09:53 CEST (Europe/Vienna)

Don’t undertake a project
unless it’s manifestly important
and nearly impossible.    Edwin H. Land

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