ANVISA - SABE [Design Issues]

posted by Samaya B – India, 2015-04-27 12:03 (3581 d 17:13 ago) – Posting: # 14741
Views: 8,109

Dear Sundar,

ANVISA accepts SABE design for highly variable drug products.
We have recently submitted a protocol for a HVDP using full repliacted design for ANVISA review. Along with a protocol, you can submit literature references showing >30% ISCV.

Widening criteria for confidence interval remained same as that of EU guidance.

Hope this would be helpful.

Thanks.


Regards,
Samaya.

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,665 registered users;
83 visitors (0 registered, 83 guests [including 10 identified bots]).
Forum time: 04:17 CET (Europe/Vienna)

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

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