Amlodipine/Valsartan [Design Issues]
❝ 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).
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮