Bioequivalence and Bioavailability Forum 16:22 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

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

posted by Mei San - Malaysia, 2017-12-07 03:52  - Posting: # 18038
Views: 1,379

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,619 posts in 3,961 threads, 1,212 registered users;
online 23 (1 registered, 22 guests [including 17 identified bots]).

I’m not a pessimist,
I’m just a well informed optimist.    José Saramago

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed