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  5. Statistical methods of tolerability of drugs taking into account the measurement uncertainty

Statistical methods of tolerability of drugs taking into account the measurement uncertainty

V.E. Dobrova, I.A. Zupanets
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Тhe analysis of problems arising in the planning of clinical trial results showed the need for a complex method of statistical evaluation of tolerability of drugs, taking into account aspects of uncertainty of measurements. Three statistical models for assessing the patient (volunteer) in determining the tolerability / safety of drugs were developed. The statistical models can be used depending on the goals and objectives of clinical research. In this way the algorithms estimate the parameters, indicators, and the algorithms for calculating estimates of drug tolerability criteria and an integral parameter – the coefficient of portability were created.
Keywords: algorithms of parameters estimation; statistical models; uncertainty; indices of clinical state, the coefficient of tolerability clinical trials