BE between one injection vs multiple injection products [Design Issues]

posted by weiguo2122 – 2024-06-26 22:17 (718 d 15:07 ago) – Posting: # 24040
Views: 4,029

Hi, Dear all,
A product A currently is injected weekly for 4 weeks as one treatment term, we would have a slowly release product A (slow-A), which will be injected monthly. Then we would like to access the BE of A injected 4 time vs slow-A injected 1 time. How is this type of BE between one injection vs multiple injection conducted?

Cmax?

sum of AUCA1-4 vs AUC_slow-A?

Is there any guidance from FDA or EMA.

Any help is greatly appreciated.

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
137 visitors (1 registered, 136 guests [including 24 identified bots]).
Forum time: 13:24 CEST (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

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