A gamma process modeling approach for the comparison of dissolution profiles.

In this paper, we propose a stochastic gamma process model for assessing the similarity of two dissolution profiles. Based on the proposed stochastic model, we utilize the difference factor and similarity factor to test the similarity of two dissolution profiles based on bootstrap confidence intervals. The performances of the proposed methods are compared with a multivariate test procedure via Monte Carlo simulation studies. The proposed testing methods are shown to be powerful and effectively controlling the error rate. The proposed model provides a simple yet useful alternative parametric statistical model for assessing the similarity of two dissolution profiles. All the methods are illustrated with a numerical example.