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RegisterOmeprazole Capsule Multiple Dose/Steady State BE Requirement [Design Issues]
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!
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:
- Omeprazole Capsule Multiple Dose/Steady State BE RequirementMei San 2017-12-07 03:52 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Omeprazole Capsule Multiple Dose/Steady State BE Requirement Neve 2017-12-07 07:52
- Omeprazole Capsule Multiple Dose/Steady State BE Requirement Relaxation 2017-12-07 15:50
- Omeprazole Capsule Multiple Dose/Steady State BE Requirement Neve 2017-12-07 07:52
Ing. Helmut Schütz