Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)

Bioanalysis

Volumn 4, Issue 14, 2012, Pages 1723-1730

  Sangster, Timothy ^a   Maltas, John ^b   Struwe, Petra ^c   Hillier, Jim ^d   Boterman, Mark ^e   Doig, Mira ^f   Breda, Massimo ^g   Garofolo, Fabio ^h,i   Caturla, Maria Cruz ^j   Couerbe, Philippe ^k   Schiebl, Christine ^c   Pattison, Colin ^a   Goodwin, Lee ^l   Segers, Rudi ^m   Garofolo, Wei ⁿ   Folguera, Lois ^o   Zimmer, Dieter ^o   Zimmerman, Thomas ^o   Pawula, Maria ^p   Tang, Daniel ^q   Cox, Chris ^r   Bigogno, Chiara ^s   Schoutsen, Dick ⁱ   De Boer, Theo ^t   Green, Rachel ^u   Houghton, Richard ^u   Sable, Romuald ^v   Siethoff, Christoff ^w   Harter, Tammy ^x,y   Best, Stuart ^z   more..

^a Charles River   (United Kingdom)

^b BASi   (United Kingdom)

^c CELERION   (United States)

^d Gen Probe Life Sciences   (United Kingdom)

^e ABL   (Netherlands)

^f ABS Laboratories   (United Kingdom)

^g Accelera   (Italy)

^h Algorithme Pharma/Simbec Research   (Canada)

ⁱ Anapharm Europe ^*  (Netherlands)

^j Anapharm Europe   (Spain)

^k SOLVO BIOTECHNOLOGY   (Hungary)

^l Department of Genetic and Molecular Toxicology   (United Kingdom)

^m Eurofins Medinet Inc   (Germany)

ⁿ Global CRO Council (GCC)   (Canada)

^o Harlan   (Switzerland)

^p HUNTINGDON LIFE SCIENCES   (United Kingdom)

^q ICON APAC   (China)

^r Millipore BioPharma Services   (United Kingdom)

^s NiKem Research   (Italy)

^t QPS Netherlands BV   (Netherlands)

^u Quotient Bioresearch Ltd   (United Kingdom)

^v SGS   (Belgium)

^w Swiss BioQuant AG   (Switzerland)

^x Unilabs   (France)

^y Sanofi Aventis Isotope Chemistry and Metabolite Synthesis Northumberland   (United Kingdom)

^z Xceleron Ltd   (United Kingdom)

more..

Author keywords

consultant; EMA; GCC; GCP

Indexed keywords

BIOLOGICAL MARKER;

ACCURACY; CONFERENCE PAPER; CONSULTATION; GOOD CLINICAL PRACTICE; GOOD LABORATORY PRACTICE; HUMAN; INCURRED SAMPLE REPRODUCIBILITY; LIMIT OF QUANTITATION; NONHUMAN; QUALITY CONTROL; REPRODUCIBILITY; STANDARDIZATION; TREND STUDY; VALIDATION PROCESS;

BIOLOGICAL MARKERS; CALIBRATION; CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG DISCOVERY; EUROPE; HUMANS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SOCIETIES, SCIENTIFIC; VALIDATION STUDIES AS TOPIC;

EID: 84864966396     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.172     Document Type: Conference Paper

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