New method ensures accurate sample sizes for testing generic drug equivalence.
The article discusses a new method for determining the sample size needed to test if two drugs are bioequivalent. This method can calculate the sample size for multiple pharmacokinetic responses and considers both non-inferiority and non-superiority hypotheses. The current methods often result in either too little or too much power, but this new approach aims to strike a balance. The researchers provide an R code to help calculate the sample size for bioequivalence testing based on their proposed method.