Carrasquillo-Luna, Carla J.

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    Statistical techniques for testing batch to batch variability and accelerated testing
    (2011) Carrasquillo-Luna, Carla J.; Ramírez Beltrán, Nazario D.; College of Engineering; Carlo, Héctor J.; Hernández Rivera, William; Department of Industrial Engineering; Lu, Kejie
    The purpose of stability studies is to determine the shelf life of drug products. The period between the date of manufacture and expiration date of a given product is known as the shelf life, and consequently the shelf life indicates the period of time during which the consumer can expect the product to be safe and effective. A minimum of three batches is required to perform stability studies. If batch-to-batch variability is small then the batches can be analyzed as one batch, assuming that they come from a single population. This result is determined by testing the batches for equality of slopes and intercepts of the linear degradation rate. However, if a test shows that the batches cannot be combined, then the expiration date should be based on the minimum of the expiration dates obtained from analyzing each batch separately. This project presents ANCOVA (Analysis of Covariance), and the Indicator Variables method, both methods were used to identify and evaluate with the help of simulation techniques if multiple batches can be considered as coming from the same population. Initially it was thought that Indicator Variables would overcome ANCOVA but the simulation results indicate that ANCOVA is superior to Indicator Variables. It is then recommended to use ANCOVA to test variability between batches. Accelerated studies were also analyzed in this project. The drug investigated is stored under high temperatures to accelerate the degradation and thus allows the rate constants to be determined in a shorter period of time. Temperature is the most common acceleration factor used because its relationship with drug degradation is characterized by the Arrhenius equation.