Repeat analysis and incurred sample reanalysis: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team

AAPS Journal

Volumn 16, Issue 6, 2014, Pages 1167-1174

  Fluhler, Eric ^a   Vazvaei, Faye ^b   Singhal, Puran ^c   Vinck, Petra ^d   Li, Wenkui ^e   Bhatt, Jignesh ^f   De Boer, Theo ^g   Chaudhary, Ajai ^h   Tangiuchi, Masahiro ⁱ   Rezende, Vinicius ^j   Zhong, Dafang ^k  

^a PFIZER INC   (United States)

^b Pharmaceutical Sciences   (United States)

^c Alkem Laboratories Limited   (India)

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^e NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^f Torrent Pharmaceuticals Ltd   (India)

^g Analytical Biochemical Laboratory   (Netherlands)

^h MERCK RESEARCH LABORATORIES   (United States)

ⁱ SCAS BTT Bioanalysis Company Ltd   (South Korea)

^j UNIVERSITY OF SÃO PAULO   (Brazil)

^k SHANGHAI INSTITUTE OF MATERIA MEDICA   (China)

more..

Author keywords

Harmonization; Incurred sample reanalysis; Regulated bioanalysis; Repeat analysis

Indexed keywords

ABOVE THE LIMIT OF QUANTITATION; ANALYTIC METHOD; ARTICLE; ASIA; BELOW THE LIMIT OF QUANTITATION; BIOCOMPATIBILITY; CONSENSUS; DOCUMENTATION; EUROPE; INCURRED SAMPLE REANALYSIS; INFORMATION; INTERNALIZATION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; LOGIC; LOWER LIMIT OF QUANTITATION; MASS SPECTROMETRY; NORTH AMERICA; PRACTICE GUIDELINE; QUALITY CONTROL; RECEPTOR BINDING ASSAY; REINJECTION; REPEAT ANALYSIS; REPORTING; REPRODUCIBILITY; SCIENCE; SOUTH AND CENTRAL AMERICA; STANDARD; TIMING; UPPER LIMIT OF QUANTITATION; CHEMICAL ANALYSIS; COOPERATION; DEVICES; INTERNATIONAL COOPERATION; PROCEDURES; STANDARDS; VALIDATION STUDY;

CHEMISTRY TECHNIQUES, ANALYTICAL; COOPERATIVE BEHAVIOR; INTERNATIONAL COOPERATION; PRACTICE GUIDELINES AS TOPIC; VALIDATION STUDIES AS TOPIC;

EID: 84938812054     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9644-1     Document Type: Article

References (12)

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