Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 5, 2011, Pages 869-877

  Valentin, Marie Anne ^a   Ma, Shenglin ^b   Zhao, An ^b   Legay, François ^a   Avrameas, Alexandre ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Novartis Institutes for Biomedical Research   (China)

Author keywords

Bioanalytical study plan; Endogenous biomarker; Feasibility study; Immunoassay; Parallelism; Validation

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CLINICAL ASSESSMENT; CORRELATION ANALYSIS; DECISION MAKING; ENZYME LINKED IMMUNOSORBENT ASSAY; FEASIBILITY STUDY; IMMUNOASSAY; PRIORITY JOURNAL; QUALITY CONTROL; SAMPLE;

AUTOMATION; BIOLOGICAL MARKERS; BIOMEDICAL RESEARCH; CALIBRATION; CHEMISTRY TECHNIQUES, ANALYTICAL; DECISION SUPPORT TECHNIQUES; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOASSAY; PROTEINS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SPECIMEN HANDLING;

EID: 79956075204     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.03.033     Document Type: Article

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