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

posted by Shuanghe  – Spain, 2020-03-04 16:13 (512 d 20:18 ago) – Posting: # 21203
Views: 2,291

Dear Helmut

» If T shows a substantially lower food effect than R that’s good for the patients. However, if you want to state that in the label/SmPC (“can be taken with or without food”) you have to switch from a generic to a hybrid application. The EMA welcomes that. Whether the additional clinical studies are worth the efforts is another story.

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?

All the best,
Shuanghe

Complete thread:

Activity
 Admin contact
21,592 posts in 4,514 threads, 1,532 registered users;
online 14 (0 registered, 14 guests [including 4 identified bots]).
Forum time: Friday 13:31 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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