Omeprazole reference = HVDP [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2016-04-07 14:57 (3229 d 04:14 ago) – Posting: # 16170
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Hi wienui,

❝ 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? ;-) 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.


    References
  1. 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.
  2. 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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