Theophylline ER 450 mg study design [Design Issues]

posted by Ramesh Ramalingam  – India, 2018-10-18 05:16 (939 d 11:39 ago) – Posting: # 19463
Views: 1,447

Dear Members,

Based on literature reference, Theophylline is a narrow therapeutic index drug. As per USFDA recommendation if the drugs falls under narrow therapeutic index, the BE study should be a fully replicated crossover design in order to:
• Scale bioequivalence limits to the variability of the reference product; and
• Compare test and reference products within-subject variability.

But respective molecule OGD (which was issued on 2010) Draft guidelines recommending two-way cross-over study design.

Could you please suggest the study design whether it should be two-period, two-way crossover design or four period, fully replicated design.


Regards,
Ramesh

Complete thread:

Activity
 Admin contact
21,460 posts in 4,486 threads, 1,514 registered users;
online 5 (0 registered, 5 guests [including 2 identified bots]).
Forum time: Friday 16:56 UTC (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

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