Narrow therapeutic index drug [RSABE / ABEL]

posted by Mahesh M – India, 2014-01-02 11:32 (4563 d 14:05 ago) – Posting: # 12124
Views: 7,809

Hello all,

My query is regarding the narrow therapeutic index drugs
  1. To demonstrate BE study on narrow therapeutic index drug: Two treatment, four period fully replicated design is more appropriate? (US FDA).
  2. 90 % CI should be 90-111.11 %?
Eg. Draft guidance of Tacrolimus clearly mention about design and bioequivalence criteria but what’s about other NTI drugs like Sirolimus, Everolimus etc.

Kindly suggest
Regards
Mahesh

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
246 visitors (0 registered, 246 guests [including 28 identified bots]).
Forum time: 02:37 CEST (Europe/Vienna)

When you meet the Buddha, you kill him;
when you meet the patriarchs, you kill them.    Wumen Huikai

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