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Volumn 81, Issue 24, 2009, Pages 9841-9848
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Acceptance criteria for method equivalency assessments
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Author keywords
[No Author keywords available]
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Indexed keywords
ACCEPTANCE CRITERIA;
ASSAY METHODS;
CONTROL REQUIREMENTS;
CRITICAL COMPONENT;
DRUG SUBSTANCES;
EXACT ALGORITHMS;
PROCESS CAPABILITIES;
PROCESS CONTROL STRATEGIES;
PRODUCT-LIFE-CYCLE;
QUALITY BY DESIGNS;
TOLERANCE INTERVAL;
BIOASSAY;
PROCESS CONTROL;
ALGORITHM;
ANALYTIC METHOD;
CLINICAL ASSESSMENT;
CONTROL STRATEGY;
DECISION MAKING;
DRUG DETERMINATION;
HUMAN;
METHOD EQUIVALENCE;
MONITORING;
PROCESS CONTROL;
QUALITY CONTROL;
REVIEW;
RISK FACTOR;
SAMPLE SIZE;
CHEMISTRY TECHNIQUES, ANALYTICAL;
DRUG INDUSTRY;
HUMANS;
PHARMACEUTICAL PREPARATIONS;
QUALITY CONTROL;
RISK ASSESSMENT;
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EID: 72449162520
PISSN: 00032700
EISSN: None
Source Type: Journal
DOI: 10.1021/ac901944t Document Type: Review |
Times cited : (43)
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References (17)
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