Recommendations on: Internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

Bioanalysis

Volumn 3, Issue 12, 2011, Pages 1323-1332

  Lowes, Steve ^a   Jersey, Jim ^b   Shoup, Ronald ^c   Garofolo, Fabio ^d   Savoie, Natasha ^d   Mortz, Ejvind ^e   Needham, Shane ^f   Caturla, Maria Cruz ^g   Steffen, Ray ^h   Sheldon, Curtis ⁱ   Hayes, Roger ^j   Samuels, Tim ^k   Di Donato, Lorella ^l   Kamerud, John ^m   Michael, Steve ⁿ   Lin, Zhongping ^o   Hillier, Jim ^p   Moussallie, Marc ^q   De Souza Teixeira, Leonardo ^r   Rocci, Mario ^s   Buonarati, Mike ^t   Truog, James ^u   Hussain, Saleh ^v   Lundberg, Richard ^w   Breau, Alan ^x   Zhang, Tianyi ^x   Jonker, Jianine ^y   Berger, Neil ^z   Gagnon Carignan, Sofi ^aa   Nehls, Corey ^ab   Nicholson, Robert ^ab   Hilhorst, Martijn ^ac   Karnik, Shane ^ad   De Boer, Theo ^ae   Houghton, Richard ^af   Smith, Kirk ^ag   Cojocaru, Laura ^ah   Allen, Mike ^ai   Harter, Tammy ^aj   Fatmi, Saadya ^ak   Sayyarpour, Farhad ^al   Vija, Jenifer ^am   Malone, Michele ^an   Heller, Dennis ^ao   more..

^a Advion BioSciences Inc   (United States)

^b Agilux Laboratories   (United States)

^c AIT Bioscience LLC   (United States)

^d INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

^e Alphalyse A/S   (Denmark)

^f Alturas Analytics   (United States)

^g Anapharm Europe SL   (Spain)

^h BIOANALYTICAL SYSTEMS INC   (United States)

ⁱ CELERION   (United States)

^j Cetero Research   (United States)

^k CHARLES RIVER LABORATORIES   (United States)

^l CIRION BioPharma Research   (Canada)

^m Covance ^*  (United States)

ⁿ Late Stage Developmental Services Covance Inc   (United States)

^o Frontage Laboratories   (United States)

^p Gen Probe Life Sciences   (United Kingdom)

^q Huntingdon Life Sciences New Jersey   (United States)

^r ICF   (Brazil)

^s ICON Development Solutions   (United States)

^t Intertek   (United States)

^u JCL Bioassay USA   (United States)

^v Lambda Therapeutic Research   (Canada)

^w MEDTOX Laboratories   (United States)

^x MPI RESEARCH   (United States)

^y PAREXEL INTERNATIONAL   (United States)

^z Pharma Medica   (Canada)

^aa PharmaNet Canada   (Canada)

^ab Pharmaceutical Product Development   (United States)

^ac PRA HEALTH SCIENCES   (United States)

^ad Pyxant Labs   (United States)

^ae QPS   (Netherlands)

^af Quotient Bioresearch Ltd   (United Kingdom)

^ag Smithers Viscient   (United States)

^ah Tandem Labs   (United States)

^ai Tandem Labs   (United States)

^aj Unilab York Bioanalytical Solutions   (United Kingdom)

^ak Warnex Bioanalytical   (Canada)

^al WIL RESEARCH LABORATORIES   (United States)

^am Protein Bioanalysis Group   (United States)

^an Worldwide Clinical Trials   (United States)

^ao XENOBIOTIC LABORATORIES INC   (United States)

more..

Author keywords

bioanalysis; bioanalytical CRO; bioanalytical guidelines; bioanalytical harmonization; bioanalytical issues; GCC; Global CRO Council

Indexed keywords

ARTICLE; BLOOD; CALIBRATION; CHEMICAL ANALYSIS; CHEMICAL REANALYSIS; CONDITIONING; CONSENSUS DEVELOPMENT; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULAR BIOLOGY; MOLECULAR STABILITY; PRACTICE GUIDELINE; REGULATORY MECHANISM; SAMPLING; SENSITIVITY ANALYSIS; STANDARDIZATION; VALIDATION PROCESS;

BIOPHARMACEUTICS; CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG STABILITY; INTERNATIONAL COOPERATION; QUALITY CONTROL; REFERENCE STANDARDS;

EID: 79959421480     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.135     Document Type: Article

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