The Application of Multiresponse Estimation to Drug Stability Studies

Abstract

This paper focuses on the statistical methodology for the simultaneous analysis of stability data obtained on both parent compound and degradation products. A mathematical model based on kinetic theory is developed to describe both the disappearance of parent compound and appearance of degradation products. Analysis of data obtained from accelerated testing of drug stability is accomplished by extending the kinetic model to include the Arrhenius relationship. A simulated data set generated from parameter estimates obtained from an actual analysis is used as an example to illustrate the statistical techniques.