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

posted by Mei San – Malaysia, 2017-12-07 04:52 (1936 d 13:17 ago) – Posting: # 18038
Views: 3,055

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!

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