Bioequivalence and Bioavailability Forum 12:17 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

FDA: RSABE for NTID [RSABE / ABEL]

posted by Jay - India, 2018-04-02 06:28  - Posting: # 18628
Views: 1,865

Thanks, John for the reply...

I would like to understand that how come the study passing in ABE within 80% to 125%, low T/R and low ISCV would not meet the BE criteria of scaled average bioequivalence.

As we generally proceed with scaled approach when the ISCV is high (more than 30%) and would not meet BE criteria with ABE approach.

Please let me know your views on the same.

Regards,
Jay

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,187 posts in 4,084 threads, 1,308 registered users;
online 11 (1 registered, 10 guests [including 6 identified bots]).

In these days, a man who says a thing cannot be done
is quite apt to be interrupted by some idiot doing it.    Elbert Green Hubbard

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed