Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

Bioanalysis

Volumn 4, Issue 6, 2012, Pages 651-660

  Boterman, Mark ^a   Doig, Mira ^b   Breda, Massimo ^c   Lowes, Steve ^d   Jersey, Jim ^e   Shoup, Ronald ^f   Garofolo, Fabio ^g   Dumont, Isabelle ^g   Martinez, Suzanne ^g   Needham, Shane ^h   Caturla, Maria Cruz ⁱ   Couerbe, Philippe ^j   Guittard, Joelle ^k   Maltas, John ^l   Lansing, Tim ^m   Bhatti, Masood ⁿ   Schiebl, Christine ^o   Struwe, Petra ^o   Sheldon, Curtis ^o   Hayes, Roger ^p   Sangster, Timothy ^q   Pattison, Colin ^q   Bouchard, Johanne ^j   Goodwin, Lee ^r   Islam, Rafiq ^s   Segers, Rudi ^t   Lin, Zhongping ^u   Hillier, Jim ^v   Garofolo, Wei ^w   Zimmer, Dieter ^x   Folguera, Lois ^x   Zimmermann, Thomas ^x   Pawula, Maria ^y   Moussallie, Marc ^z   De Souza Teixeira, Leonardo ^aa   Rocha, Thais ^aa   Tang, Daniel ^ab   Jardieu, Paula ^ac   Truog, James ^ad   Lin, Jenny ^ad   Lundberg, Richard ^ae   Cox, Chris ^af   Breau, Alan ^ag   Bigogno, Chiara ^ah   Schoutsen, Dick ^ad   Dilger, Carmen ^ai   Bouhajib, Mohammed ^aj   Levesque, Ann ^ak   Gagnon Carignan, Sofi ^ak   Nicholson, Robert ^al   Jenkins, Rand ^al   Lin, Ming Hung ^ad   Karnik, Shane ^am   De Boer, Theo ^an   Houghton, Richard ^ao   Green, Rachel ^ao   DeMaio, William ^ap   Sable, Romuald ^aq   Smith, Kirk ^ar   Siethoff, Christoph ^as   Cojocaru, Laura ^at   Allen, Mike ^au   Harter, Tammy ^av   Fatmi, Saadya ^aw   Sayyarpour, Farhad ^ax   Malone, Michele ^ay   Best, Stuart ^az   Fang, Xinping ^ba   more..

^a ABL   (Netherlands)

^b ABS Laboratories   (United Kingdom)

^c Accelera   (Italy)

^d Advion BioSciences Inc   (United States)

^e Agilux Laboratories   (United States)

^f AIT Bioscience   (United States)

^g Algorithme / Simbec   (Canada)

^h Alturas Analytics   (United States)

ⁱ Anapharm Europe   (Spain)

^j SOLVO BIOTECHNOLOGY   (Hungary)

^k Avogadro   (France)

^l BASi   (United Kingdom)

^m BioAgilytix Labs   (United States)

ⁿ BioPharma Services   (Canada)

^o CELERION   (United States)

^p Cetero Research   (United States)

^q Charles River   (United Kingdom)

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

^s EMD Millipore   (United States)

^t Eurofins Medinet Inc   (Germany)

^u Frontage Laboratories   (United States)

^v Gen Probe Life Sciences   (United Kingdom)

^w Global CRO Council (GCC)   (Canada)

^x Harlan   (Switzerland)

^y HUNTINGDON LIFE SCIENCES   (United Kingdom)

^z Huntingdon Life Sciences   (United States)

^aa ICF   (Brazil)

^ab ICON APAC   (China)

^ac ICON Development Solutions   (United States)

^ad JCL BIoassay USA ^*  (Taiwan)

^ae MEDTOX Laboratories   (United States)

^af Millipore BioPharma Services   (United Kingdom)

^ag MPI RESEARCH   (United States)

^ah NiKem Research   (Italy)

^ai Nuvisan GmbH   (Germany)

^aj Pharma Medica Research Inc   (Canada)

^ak PharmaNet Canada   (Canada)

^al Pharmaceutical Product Development   (United States)

^am Pyxant Labs   (United States)

^an QPS Netherlands BV   (Netherlands)

^ao Quotient Bioresearch Ltd   (United Kingdom)

^ap Ricerca Inc   (United States)

^aq SGS   (Belgium)

^ar Smithers Viscient   (United States)

^as Swiss BioQuant AG   (Switzerland)

^at Tandem Labs   (United States)

^au Tandem Labs   (United States)

^av Unilabs   (France)

^aw Warnex Bioanalytical   (Canada)

^ax WIL RESEARCH LABORATORIES   (United States)

^ay Worldwide Clinical Trials   (United States)

^az Xceleron Ltd   (United Kingdom)

^ba XENOBIOTIC LABORATORIES INC   (United States)

more..

Author keywords

EMA; European Medicines Agency; FDA; matrix selection; reference standards; stability

Indexed keywords

ACCURACY; ANALYTIC METHOD; BIOEQUIVALENCE; CALIBRATION; CHROMATOGRAPHY; GOOD CLINICAL PRACTICE; GOOD LABORATORY PRACTICE; HUMAN; LIGAND BINDING; LIMIT OF QUANTITATION; NONHUMAN; PARALLEL DESIGN; PRACTICE GUIDELINE; REFERENCE VALUE; REPRODUCIBILITY; REVIEW; STANDARD; THERMOSTABILITY; VALIDATION PROCESS;

BIOLOGICAL ASSAY; CALIBRATION; DRUG STABILITY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REFERENCE STANDARDS;

EID: 84859127820     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.18     Document Type: Review

References (11)

1. EMA. Guideline on Bioanalytical Method Validation. EMA, Committee for Medicinal Products for Human Use (CHMP), London, UK (2011).
2. Premkumar N, Lowes S, Jersey J et al. Formation of a Global Contract Research Organization Council for Bioanalysis. Bioanalysis 2(11), 1797-1800 (2010).
3. Global CRO council leads to APA opening to CROs! Bioanalysis 3(4), 357 (2011).
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6. th GCC Closed Forum at EBF - Bioanalysis (2012) (In Press).
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9. Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Workshop/Conference Report. AAPS J. 9(1), E30-E42 (2007).
10. EMA. Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins. EMA, Committee for Medicinal Products for Human Use (CHMP), London, UK (2007).
11. Global CRO Council. www.global-cro-council.org