Определение объема выборки для исследований биоэквивалентности с использованием компьютерного моделирования

Standard design for drug bioequivalence study aimed at reducing the intra-individual variance is provided by randomized crossover 2 × 2 investigation. Determination of the sample set volume for this bioequivalence investigation is an import part of experiment planning and must be reliably justified. The present work was aimed at implementation and validation of an algorithm for determining the necessary volume of sample set for bioequivalence investigation using numerical simulations. The proposed algorithm is based on the procedure of determination of the statistical test power for the known number of observations, variance, and preset value of the permissible first-order error level.