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where yijk is the response from the kth time point of the ith batch and the jth package of a drug product, xijk is the sampling time at which the yijk response was obtained, ij is the intercept for the ith batch and the jth package, ij is the degradation rate of the ith batch and the jth package, and ijk is the random error assumed to be independently and normally distributed with zero mean and constant variance 2. Chen et al. [11] show that there are 16 different models of Equation (52); however, these models reduce to 9. The general procedure consists in identifying the class of model that is associated to a given assay information. Once the model is determined, the appropriate procedure is implemented to determine the shelf life of the drug product. Chen et al. [11] established the procedure for estimating the shelf life. Identi cation of Analysis of Covariance Model A general procedure, based on regression analysis, to identify the analysis-of-covariance model that applies to a given set of assay results to determine the shelf life is introduced here. We call this procedure the regression model with indicator variables for testing poolability of batches and packages. To introduce the fundamental concepts and facilitate the understanding, we consider rst a simple case, second a general model, and nally the methodology as an example. Suppose we have three batches and the corresponding indicator variables model is de ned as yij = 0 + 1u1 + 2 u2 + xij ( 1 + 1u2 + 2 u2 ) + eij (53) create barcode in ms word 2007 Get Barcode Software - Microsoft Store
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