Study Design with long half life [Design Issues]

posted by Pankaj – India, 2010-03-21 17:30 (5940 d 10:02 ago) – Posting: # 4950
Views: 4,544

Dear All,

Planning to design a BABE protocol on a molecule with Tmax around 1-1.5 hours and T-half of around 550 hours.
Can we go for parallel truncated design for the molecule? Does all the regulatories (US/EU/ANVISA) accept such kind of design for BABE studies?
Kindly Suggest.

Thanks in advance.

Regards,

Pankaj

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
117 visitors (0 registered, 117 guests [including 9 identified bots]).
Forum time: 04:32 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

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