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 contribution||Validation of gas and liquid chromatographic methods in the bioanalytical laboratory|
|Number of pages||7|
|Journal||Acta pharmaceutica Hungarica|
|Publication status||Published - Jan 1 1997|
ASJC Scopus subject areas
- Pharmaceutical Science