Omeprazole Capsule Multiple Dose/Steady State BE Requirement [Design Issues]

posted by Mei San – Malaysia, 2017-12-07 04:52 (2304 d 06:13 ago) – Posting: # 18038
Views: 3,247

Dear all,

Just wonder if multiple dose BE is required for omeprazole capsule?

As I'm aware of the EMA MR dosage BE guideline, only single dose fasting & single dose fed studies are required for delayed release multiple unit formulation.

However, some sponsors did perform the multiple dose studies as shown in public assessment report.

Kindly advise. Thanks!

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
109 visitors (0 registered, 109 guests [including 9 identified bots]).
Forum time: 11:06 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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