Folyadek es gazkromatografias modszerek validalasa a bioanalitikai munka soran

Translated title of the contribution: Validation of gas and liquid chromatographic methods in the bioanalytical laboratory

Róna Kálmán, Ary Kornélia, L. Vereczkey

Research output: Contribution to journalArticle

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.

Original languageHungarian
Pages (from-to)51-57
Number of pages7
JournalActa Pharmaceutica Hungarica
Volume67
Issue number2-3
Publication statusPublished - Mar 1997

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Gases
Therapeutic Equivalency
Biological Availability
Pharmacokinetics

ASJC Scopus subject areas

  • Pharmaceutical Science

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Folyadek es gazkromatografias modszerek validalasa a bioanalitikai munka soran. / Kálmán, Róna; Kornélia, Ary; Vereczkey, L.

In: Acta Pharmaceutica Hungarica, Vol. 67, No. 2-3, 03.1997, p. 51-57.

Research output: Contribution to journalArticle

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