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

posted by Helmut Homepage – Vienna, Austria, 2020-03-05 12:50 (1904 d 10:25 ago) – Posting: # 21206
Views: 4,546

Hi Shuanghe,

❝ 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"?


By “much more” you mean that the 90% CI is entirely outside the 80-125% limits, right? This means only that you have to forget the idea of a hybrid application.
Everything else (CI overlapping the limits) is indecisive and would not worry me. Even if you are completely outside (T demonstrated a larger food effect than R) – since both fasting and fed passed BE – stay with the generic pathway and you should be fine.

❝ What's your experience from regulation perspective?


Nil – also for the “nice” case. Though the EMA stated in various conferences to welcome such a hybrid application, I haven’t seen one so far. Any experience from the members?

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,678 registered users;
47 visitors (0 registered, 47 guests [including 9 identified bots]).
Forum time: 00:15 CEST (Europe/Vienna)

Being really good at C++ is like being really good
at using rocks to sharpen sticks.    Thant Tessman

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