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Mei San ☆ Malaysia, 2017-12-07 04:52 (3118 d 13:47 ago) Posting: # 18038 Views: 5,114 |
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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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Neve ☆ India, 2017-12-07 08:52 (3118 d 09:48 ago) (edited on 2017-12-07 10:41) @ Mei San Posting: # 18039 Views: 4,330 |
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❝ Just wonder if multiple dose BE is required for omeprazole capsule? Normally, Single dose fasting and fed studies are required. ❝ some sponsors did perform the multiple dose studies as shown in public assessment report. Reason may be, omeprazole has time-dependent kinetics (omeprazole auto-inhibits its metabolism). Hence, according to Guidance on the investigation of Bioavailability and Bioequivalence, a steady state study is required due to this time dependency. |
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Relaxation ★ Germany, 2017-12-07 16:50 (3118 d 01:49 ago) @ Neve Posting: # 18041 Views: 4,273 |
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Hello everybody. Just a short input as I do not fully agree with the answer. ❝ Normally, Single dose fasting and fed studies are required. ❝ Reason may be, omeprazole has time-dependent kinetics (omeprazole auto-inhibits its metabolism). ❝ Hence, according to Guidance on the investigation of Bioavailability and Bioequivalence, a ❝ steady state study is required due to this time dependency. Would it be possible to point to the guideline you are referring and maybe the page? I mean, I could follow that argument if the task was to clarify the pharmacokinetics of a product. But in case of bioequivalence I fail to understand the need for a study at steady-state (and also fail to find that requirement in the guidelines I am aware of). OK, if this was a prolonged release formulation, but, um, do such formulations for omeprazole exist  . |
Ing. Helmut Schütz