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Additional resources for A First Course in Probability, 5th Ed scanned + Solutions Manual

Example text

The relationship among the total uncorrected sum of squares, the sum of squares due to regression, and the sum of squares of residuals is the same as that for the linear regression model with intercept. 1). , I, h = 0, 1. C. P. (1995). Statistical Design and Analysis in Pharmaceutical Science. Marcel Dekker, New York. 2 Statistical Analysis and Prediction 33 follows a central t distribution with J − 1 degrees of freedom. 32) where tα/2,J −1 is the (α/2)th upper quantile of a central t distribution with J − 1 degrees of freedom.

As a result, a full factorial design consists of 33 = 27 combinations. If each combination is to be tested at the time intervals of 0, 3, 6, 9, 12, 18, 24, 36, and 48 months for a 4-year stability study, there are a total of 270 (3 × 3 × 3 × 10) assays. , a complete factorial design is used), a substantial expense is involved. Besides, it is in the best interest of the pharmaceutical companies that a longer shelf-life can be claimed by testing fewer batches for strength-by-package combinations within a short period of time.

When there is a significant batch-to-batch variation, a typical approach is to consider so-called stability analysis with fixed effects model (Chow and Liu, 1995). This fixed effects model may not be appropriate because statistical inference about the expiration dating period obtained can only be made to the batches under study and cannot be applied to future batches. As indicated in the FDA stability guidelines, the batches used in longterm stability studies for establishment of drug shelf-life should constitute a random sample from the population of future production batches.

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A First Course in Probability, 5th Ed scanned + Solutions Manual by Sheldon Ross

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