Omeprazole reference = HVDP [Design Issues]
Hi wienui,
Regulatory perspective: According to all current guidelines I am aware of, no.
Scientific perspective: Why not?
Omeprazole formulations are already OTC in many countries. Hence, the efficacy/safety profile is established. Many other products were approved with an AR of 70–143% in 2×2 studies in the EU (was recommended as the standard [sic] for Cmax in the 9th draft of the NfG1 following suggestions of Blume et al.2). Following the concept of reference-scaling one has to demonstrate that the reference in the particular study shows a CV of >30%. Given the data in the public domain I would say we can be pretty sure that the reference is a HVDP indeed. Just my two cents.
❝ Could we widen the Cmax rang to 70-143% of HVD (Omeprazole) in a normal (not a replicate) 2x2 crossover BE study.
Regulatory perspective: According to all current guidelines I am aware of, no.
Scientific perspective: Why not?

- References
- Commission of the European Communities, CPMP Working Party on the Efficacy of Medicinal Products. Investigation of Bioavailability and Bioequivalence. Note for Guidance III/54/89-EN, 9th Draft. Brussels: 1991.
- Blume H, Kübel-Thiel K, Reutter B, Siewert M, Stenzhorn G. [Nifedipin: Monographie zur Prüfung der Bioverfügbarkeit/Bioäquivalenz von schnell-freisetzenden Zubereitungen]. Pharm Ztg. 1988;133:389–93. German.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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Complete thread:
- Omeprazole joyjac 2012-05-15 09:22 [Design Issues]
- Omeprazole drgunasakaran1 2012-05-15 09:50
- Omeprazole Helmut 2012-05-15 19:00
- Omeprazole pash413 2012-12-06 18:09
- Cmax at tlast Helmut 2012-12-07 15:29
- Omeprazole, widen of Cmax in a normal crossover design? wienui 2016-04-07 11:00
- Omeprazole reference = HVDPHelmut 2016-04-07 12:57
- Omeprazole pash413 2012-12-06 18:09
- Omeprazole Helmut 2012-05-15 19:00
- Omeprazole drgunasakaran1 2012-05-15 09:50