Montes Tirado, Efraín

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    Design and analysis of an accelerated stability test for an in-vitro diagnostic product with lot-to-lot variation
    (2009) Montes Tirado, Efraín; Artiles León, Noel; College of Engineering; Hernández Rivera, William; González Barreto, David; Department of Industrial Engineering; Ríos López, Isabel
    This work presents a research project performed in Abbott’s Diagnostics Division in Puerto Rico with the purpose of providing an empirical rather than a simulation based method for applying Arrhenius kinetics theory to a set of data gathered from an accelerated stability study of three lots for a quantitative immunoassay reagent kit (i.e. an in-vitro diagnostic product). Four models where developed to relate product content, time and temperature, and they where compared in terms of their ability to fit well the accelerated stability data, the significance of the model parameters considered, and their reliability for extrapolation purposes. These models included the Arrhenius classical approach, a polynomial function, and two nonlinear modifications of the Arrhenius life-temperature equation for a zero and first order kinetic reaction. The Arrhenius nonlinear model for a zero-order reaction was selected as the most appropriate to estimate degradation by means of an accelerated stability test since it provided relevant statistics and compliance with the underlying assumptions of the Arrhenius Life-Temperature relationship. Finally, a validation procedure was developed for the most appropriate model selected, which is based on prediction intervals to contain m individual future observations. This procedure could be used routinely to compare degradation patterns of future lots at elevated temperatures and conclude if the lots have similar degradation patterns as the previous good lots from where the prediction intervals where developed.