qualification and validation - נסיכת המדעים

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Yossi Levy 2011Qualification and validation of analytical and bioanalytical methodsYossi Levy2Method life cycleDevelopmentQualificationValidation Yossi Levy 20113References ICH guidelines for validation of analytical methods: Q2A: Text on validation of analytical procedures Q2B: validation of analytical procedures: methodology ICH draft guideline 1033: Biological assay validation Consensus paper: Recommendations for the Bioanalytical Method validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules (2003), DeSilva et. al. Pharmaceutical Research, Vol. 20, No. 11, November 20034Method development Exploratory process Early development phase check possibility of developing the method Optimization phase once development of method is possible, fine tuning of method s parameters is needed for efficient implementation Examples of parameters: temperature, incubation time, type o

© Yossi Levy 2011 5 Qualification and validation Qualification and validation are two steps in testing the performance of a (bio)analytical procedure/method and

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