FDA: RSABE for NTID [RSABE / ABEL]

posted by Jay – India, 2018-04-02 06:28  – Posting: # 18628
Views: 3,017

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
19,688 posts in 4,178 threads, 1,352 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 19:05 CEST

An expert is one who knows more and more
about less and less.    Nicholas Murray Butler

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