Validation of a computer software program for statistical analysis of accelerated stability studies on biological standards

Long-term stability is an essential requirement for biological measurement standards and it has been evaluated by applying the Arrhenius model to the data obtained from accelerated thermostability studies. A computer program DEGTEST suited to a mainframe computer has been used for evaluating the stability of biological standards for more than a decade. This paper describes the validation of a computer program executable in a personal computer Microsoft® Windows® XP environment for the analysis of accelerated thermostability study data.