Keywords: Sparse design, Pharmacokinetic (PK) , Bioequivalence
This poster presents a power comparison between the Pharmacokinetic (PK) Bioequivalence traditional study design and sparse study design. Two PK study designs, parallel design and 2-way crossover design, are explored here. The power comparison was carried out for two different sample sizes 24 and 48, and three different coefficient of variation (CV) 10%, 20%, and 30%. The power calculation was carried out for the equivalence test in the PK study where the usual 90% confidence interval for the ratio of geometric means should be between the bioequivalence limits of [0.80, 1.25].
Results: (1) The sparse designs demonstrate same power trend as the traditional design such as the power decreases when the sample size decreases, the CV increases, and the true ratio of µT/µR is close to 0.80 and/or 1.25. (2) The power for the sparse design is always lower than the traditional design.
Conclusion: The complexity and large sample size requirement should be carefully considered when using a sparse study design.