Advanced Level Mathematics: Statistics 1 by Steve Dobbs

By Steve Dobbs

Written to compare the contents of the Cambridge syllabus. facts 1 corresponds to unit S1. It covers illustration of information, variations and combos, chance, discrete random variables and the conventional distribution.

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Won (1992) indicated that stability data of levothyroxine sodium exhibit a biphasic first-order degradation profile with an initial fast degradation rate followed by a slower rate. To compensate for the initial accelerated degradation, some pharmaceutical companies use an overage of active ingredient in their formulation, which can lead to occasional instances of superpotency. 3 Impurities The USP-NF defines an impurity as any component of a drug substance (excluding water) that is not the chemical entity defined as the drug substance.

Thus, accelerated testing is also known as stressed testing. , 5, 50 or 75◦ C), humidity of 75% or greater, exposure to various wavelengths of electromagnetic radiation, and storage in an open container. , a few months). Based on the degradation data observed, the kinetic parameters of the reaction rate can be estimated. A predicted shelf-life under marketplace storage conditions can then be obtained by extrapolation. Note that the extrapolation from stressed testing conditions to ambient conditions is usually done based on established relationships between kinetic parameters and storage conditions.

2000) studied the size and power of the f 2 similarity factor for assessment of similarity based on the method of moments and the method of bootstrap. More details regarding the statistical methods for assessment of similarity between dissolution profiles in terms of f 2 similarity factor are given in the last chapter of this book. 9 Mean Kinetic Temperature Haynes (1971) pointed out that changes in the actual field storage temperature could cause the reaction rate constant of some drug products to change according to the Arrhenius relationship.

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