Bioequivalence and Bioavailability Forum

Dear All,

Query is with reference to Oxcarbazepine Tablet BE study Submission to Health Canada.

As per literature Oxcarbazepine is highly variable with respect to Cmax and ISCV is more than 30%. As per Health Canada “A drug product may be considered a HVDP [highly variable drug product] if the within-subject coefficient of variation (CV) of the AUC [area under the concentration versus time curve] for the reference product is greater than 30.0%.” As per Health Canada Oxcarbazepine is not highly variable. BE study need to be performed with two-way cross over design without expanding confidence interval. In Pilot two way cross over study (N:14) there is very high variability with respect to Cmax parameter for both test & reference product (T/R ratio: 111, ISCV: 43%). Due to which unable decide sample size for Pivotal BE study. To counter high variability in Pilot two-way crossover BE study i have following proposal.

- Pilot BE Study with full replicate design. Calculate sample size for pivotal two way Cross over study design based on this study.

Can you let us know your feedback on this proposal?


With regards
AB661

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Edit: Category changed; see also this post #1. [Helmut]