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  5. Analysis of problems of the Bioanalytical Method Validation used for pharmacological and clinical researches

Analysis of problems of the Bioanalytical Method Validation used for pharmacological and clinical researches

V. Dobrova, L. Maloshtan
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In this work the problems of the Bioanalytical Method Validation used for pharmacological and clinical researches are considered. Analysis of modern normative base affecting the questions of development of validation processes have been done. There was showed that unlike modern production processes, which, in most, are regulated and documented in accordance with the system of the International standards of the ISO series 9000, laboratory researches are conducted without the proper systematization and standardization. Approaches to creation of plans of validatsii bioanaliticheskih methods are offered.