Description: In this paper the analysis of features of a new method which is developed in the Problem laboratory of morphofunctional researches of the National university of pharmacy is conducted. To identify the sources of uncertainty and assess their impact on the final result of measurements Ishikawa Diagram was built. Taking this into account the estimation indexes and quantitative characteristics have been selected. The validation tests and the results of experimental evaluations was shown.
Keywords: validation, method «in vitro», measurement uncertainty, Ishikawa Diagram, indicators of reproducibility and repeatability