2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections

Bioanalysis

Volumn 3, Issue 18, 2011, Pages 2081-2096

  Garofolo, Fabio ^a   Rocci Jr , Mario L ^b   Dumont, Isabelle ^a   Martinez, Suzanne ^a   Lowes, Steve ^c   Woolf, Eric ^d   Van Amsterdam, Peter ^e   Bansal, Surendra ^f   Barra, Ariadna Cristina Gomes ^g   Bauer, Ronald ^h   Booth, Brian P ⁱ   Carrasco Triguero, Montserrat ^j   Desilva, Binodh ^k   Dunn, John ^l   Gallicano, Keith ^m   Gouty, Dominique ⁿ   Ho, Stacy ^o   Hucker, Richard ^p   Jemal, Mohammed ^k   Katori, Noriko ^q   Le Blaye, Olivier ^r   Lee, Jean ^s   Li, Wenkui ^t   Michael, Steve ^u   Nehls, Corey ^v   Nicholson, Robert ^v   Ormsby, Eric ^w   Tang, Daniel ^x   Viswanathan, C T ⁱ   Weiner, Russell ^d   Young, Graeme ^y   more..

^a Algorithme Pharma Inc   (Canada)

^b ICON Development Solutions   (United States)

^c Advion BioSciences Inc   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e Chemical Design and Synthesis Unit   (Netherlands)

^f HOFFMANN LA ROCHE INC   (United States)

^g Agencia Nacional de Vigilancia Sanitaria Brazil   (Brazil)

^h AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j GENENTECH INC   (United States)

^k BRISTOL MYERS SQUIBB   (United States)

^l GLAXOSMITHKLINE   (United States)

^m Watson Laboratories   (United States)

ⁿ Intertek   (United States)

^o GENZYME CORPORATION   (United States)

^p PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^q NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^r AFSSAPS   (France)

^s AMGEN INC   (United States)

^t NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^u 206 Carnegie Center   (United States)

^v Pharmaceutical Product Development   (United States)

^w HEALTH CANADA   (Canada)

^x Frontage Laboratories   (China)

^y GLAXOSMITHKLINE   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; COUNTERION; MONOCLONAL ANTIBODY; TAMOXIFEN; WARFARIN;

ACCURACY; ANALYSIS; BLOOD ANALYSIS; BLOOD SAMPLING; CALIBRATION; CONFERENCE PAPER; DILUTION; DRIED BLOOD SPOT TECHNOLOGY; GOOD LABORATORY PRACTICE; HEMATOCRIT; HEMOLYSIS; HUMAN; IMMUNOGENICITY; LIQUID CHROMATOGRAPHY; METABOLITE; MOLECULAR STABILITY; NONHUMAN; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; STANDARDIZATION; VALIDATION PROCESS;

CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRIED BLOOD SPOT TESTING; DRUG INDUSTRY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; MASS SPECTROMETRY; PHARMACEUTICAL PREPARATIONS; TECHNOLOGY TRANSFER; TISSUE ARRAY ANALYSIS; VALIDATION STUDIES AS TOPIC;

EID: 80053292992     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.192     Document Type: Conference Paper

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