Denisenko N. Metrological aspects of validation of assay methods of drugs by the method of standard

Українська версія

Thesis for the degree of Candidate of Sciences (CSc)

State registration number

0411U005007

Thesis Registration Form

0411U005007.pdf

Applicant for

Specialization

  • 15.00.03 - Стандартизація та організація виробництва лікарських засобів

13-05-2011

Specialized Academic Board

Д 64.817.01

Essay

The dissertation is devoted to the standardizing of the validation of assay methods by the method of standard. For the first time criteria for validating characteristics with the respect to the requirements for the uncertainty of pharmaceutical analysis method was elaborated. A rational standardized procedure for the validation for the simultaneous evaluation of the characteristics of linearity, precision and accuracy was developed.Scientific approaches to the validation scheme and validation criteria for the characteristics of quantitative analysis by the method of standard were introduced to the general monograph "2.2.N.2 Validation of analytical methods and tests"N SPU 1.2.

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Files

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