ppt课件-bioanalyticalmethodsvalidationforpharmacokineticsstudies.pptVIP

ECVPT Bioanalytical methods validation for pharmacokinetic studies P.L. Toutain Toulouse Feb. 2008 Validation methods Selective and sensitive analytical methods for the quantitative determination of drugs and their metabolites (analytes) are critical for successful performance of PK and bioequivalence studies Validation methods Validation of analytical methods includes all the procedures recommended to demonstrate that a particular method, for a given matrix, is reliable and reproducible Validation methods A priori validation: Pre-study validation for analytical method development and method e