Folyadek es gazkromatografias modszerek validalasa a bioanalitikai munka soran

Róna Kálmán, Ary Kornélia, Vereczkey László

Research output: Short survey

Abstract

The authors discuss the validation of bioanalytical methods used to generate data for bioavailability, bioequivalence and pharmacokinetics studies. The basis of this manuscript is a consensus on the requirements for bioanalytical validation, which has been reached by a panel of experts at the Washington Conference Report. In this paper it is attempted to suggest approaches to validation parameters both for the method and assay to be evaluated, namely specificity/selectivity, linearity, LOQ/LOD, accuracy, prescision, recovery and stability.

Translated title of the contributionValidation of gas and liquid chromatographic methods in the bioanalytical laboratory
Original languageHungarian
Pages (from-to)51-57
Number of pages7
JournalActa pharmaceutica Hungarica
Volume67
Issue number2-3
Publication statusPublished - jan. 1 1997

ASJC Scopus subject areas

  • Pharmaceutical Science

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