Amlodipine/Valsartan [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2023-09-12 08:48 (78 d 03:07 ago) – Posting: # 23717
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Hi Bebac user,

❝ The combination of Amlodipine and valsartan was published as two periods crossover but after checking the variability of Valsartan, it had more than 30%. Therefore, should I in those cases design this study as replicated or un-replicated?

There is no product-specific guidance of the EMA and the FDA recommends 2×2×2 crossovers (fasting and fed). Any replicated design can be assessed for (conventional, unscaled) average bioequivalence. However, if you aim at reference-scaling, I would be wary to base the sample size on the CVw of a 2×2×2 design because the CVwR is unknown (see this article).

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