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

posted by Shuanghe  – Spain, 2020-03-04 16:13 (368 d 23:52 ago) – Posting: # 21203
Views: 2,019

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
21,371 posts in 4,463 threads, 1,495 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 16:05 CET (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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