A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 877, Issue 23, 2009, Pages 2235-2243

  Boulanger, Bruno ^a   Rozet, Eric ^b   Moonen, François ^c   Rudaz, Serge ^d   Hubert, Philippe ^b  

^a UCB PHARMA   (Belgium)

^b CIRM   (Belgium)

^c UNIVERSITY OF LIÈGE   (Belgium)

^d UNIVERSITY OF GENEVA   (Switzerland)

Author keywords

Acceptance criteria; Accuracy; Decision rule; Fit for purpose; Risk; Tolerance interval; Total error; Validation

Indexed keywords

ACCEPTANCE CRITERIA; ACCURACY; DECISION RULE; FIT-FOR-PURPOSE; TOLERANCE INTERVAL; TOTAL ERROR; VALIDATION;

RISK ANALYSIS;

ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; BINDING ASSAY; BIOASSAY; DECISION MAKING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; LIGAND BINDING; MEDICAL SOCIETY; MOLECULAR SIZE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; SIMULATION; VALIDATION PROCESS;

BIOLOGICAL ASSAY; CHEMISTRY, ANALYTICAL; CONGRESSES AS TOPIC; GUIDELINES AS TOPIC; VALIDATION STUDIES AS TOPIC;

EID: 67650476312     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2009.06.019     Document Type: Article

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