The Algorithm for the Quantitative Assessment of the Newcastle Disease Vaccine Stability Using the StatPlus Software Package

Resumo

The paper reports the development of the algorithm for the quantitative assessment of stability of the virus vaccine, LaSota strain, against the Newcastle disease (ND) in birds using the StatPlus software package. A mathematical model for the process of the ND virus thermal inactivation has been developed, according to which the temperature dependence of the virus inactivation rate constant is described by a first order kinetic equation. It has been demonstrated that the inactivation rate constant is the measure of vaccine stability. The adequacy of the model was confirmed by the retrospective analysis of K_T values in the industrial and experimental-industrial vaccine batches. We have statistically validated the use of the “7 days–37°C” accelerated aging test for the prediction of the vaccine storage potential within the shelf life period under the recommended conditions (12 months at 4–8°C according to the Product Specifications).