Intersection-union Tests in Dissolution Proole Testing

For k = 1; : : : ; p, let t k denote the time points at which dissolution prooles are collected , and let X ik and Y jk represent the proportion of drug dissolved from dosage unit i for the reference drug and for dosage unit j for the test drug respectively, We assume that the samples are drawn from independent multivariate p normal populations with mean vectors X and Y respectively and the same variance covariance matrix. We consider the problem of testing H 0 : where is a xed constant. An easy to implement size intersection-union test (IUT) is presented for this problem and power comparisons are made by means of simulations between the procedures recommended by the FDA and the IUT given. A method of sample size calculation for the IUT is presented.