Advances in validation, risk and uncertainty assessment of bioanalytical methods

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 4, 2011, Pages 848-858

  Rozet, E ^a   Marini, R D ^a   Ziemons, E ^a   Boulanger, B ^b   Hubert, Ph ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b Arlenda sa   (Belgium)

Author keywords

Bioanalytical method validation; Incurred sample reproducibility; Measurement uncertainty; Results accuracy; Standard curve

Indexed keywords

ACCURACY; ANALYTIC METHOD; BINDING ASSAY; CALIBRATION; ELECTROPHORESIS; EXPERIMENTAL DESIGN; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIGAND BINDING; LIMIT OF QUANTITATION; MASS SPECTROMETRY; METHODOLOGY; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; RELIABILITY; REPRODUCIBILITY; REVIEW; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; UNCERTAINTY; VALIDATION PROCESS;

ANIMALS; CALIBRATION; CHEMISTRY TECHNIQUES, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; EQUIPMENT DESIGN; HUMANS; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; RISK; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955480549     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.12.018     Document Type: Review

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