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

posted by jag009  – NJ, 2020-03-04 20:25 (1703 d 00:22 ago) – Posting: # 21204
Views: 3,970

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:

UA Flag
Activity
 Admin contact
23,278 posts in 4,889 threads, 1,656 registered users;
75 visitors (0 registered, 75 guests [including 13 identified bots]).
Forum time: 20:48 CET (Europe/Vienna)

Science without epistemology is –
insofar as it is thinkable at all –
primitive and muddled.    Albert Einstein

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