Simone De Rosa
Comparison of Parametric and Non-parametric Approaches for Accuracy of Quantitative Microbiological Methods.
Rel. Mauro Gasparini, Edwin R. Van Den Heuvel. Politecnico di Torino, Master of science program in Mathematical Engineering, 2019
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Abstract
Quantitative microbiological methods are aimed at counting the number of microorganisms in a sample. They are extremely important in the pharmaceutical industry to ensure drug safety: indeed, bacteria and toxins produced by microorganisms could contaminate medicines, which may harm humans if the contamination remains undetected. Many new technologies are being developed to measure the microbial content in a sample: they are generally called rapid methods because they provide much quicker results than compendial methods, which are standardized methods and need up to 14 days to produce a result. Rapid methods need to be validated before being practically used and accuracy is one of the parameters which needs to be evaluated during validation.
Essentially, the accuracy of the rapid method is evaluated by comparing its expected measurement to the expected measurement of a compendial method
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