Theory and application of microbiological assay pdf

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theory and application of microbiological assay pdf

Theory And Application Of Microbiological Assay by William Hewitt

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Published 17.01.2019

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Theory and application of Microbiological Assay

Demonstration of equivalent amounts of the same active pharmaceutical ingredient API between generic and innovator products pharmaceutical equivalence is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. Physicochemical methods are preferred instead of biological assays to determine concentration of drugs in biological fluids, but it does not permit direct quantification of potency. Here, we report a microbiological assay using large plates designed to determine potency and concentration of pharmaceutical-grade antibiotics for injection and a statistical method to assess the in vitro equivalence of generic products with respect to the innovator. The assay is based on the concentration-dependent variation of the inhibitory effect of antibiotics on reference bacteria B. We compared the parameters of 22 generic products amikacin 4, gentamicin 15, and vancomycin 3 products against the innovator and the reference powder by Overall Test for Coincidence of the Regression Lines Graphpad Prism 5.

Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. Some chapters discuss the test organisms and solutions, wherein test solutions are the final dilutions at a series of two or more concentrations that have been prepared from reference standard and unknown for application to the test system.
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  1. Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities.

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