2009 White Paper on Recent Issues in Regulated Bioanalysis from the 3rd Calibration and Validation Group Workshop

Bioanalysis

Volumn 2, Issue 1, 2010, Pages 53-68

  Savoie, Natasha ^a   Garofolo, Fabio ^a   Van Amsterdam, Peter ^b   Booth, Brian P ^c   Fast, Douglas M ^d   Lindsay, Michael ^e   Lowes, Steve ^f   Masse, Robert ^g   Mawer, Louise ^h   Ormsby, Eric ⁱ   Phull, Rupinder ^j   Rocci, Mario L ^k   Vallano, Patrick T ^l   Yin, Xia ^e  

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

^b Solvay Pharmaceuticals Inc   (Netherlands)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^e Apotex Inc   (Canada)

^f Advion BioSciences Inc   (United States)

^g Anapharm Canada   (Canada)

^h MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

ⁱ HEALTH CANADA   (Canada)

^j Barr Pharmaceuticals Inc   (United States)

^k ICON PLC   (United Kingdom)

^l Formulation Development Services   (India)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; DRUG;

ANALYSIS; ARTICLE; BIOANALYSIS; BIOEQUIVALENCE; BLOOD ANALYSIS; CALIBRATION; DRUG ANALYSIS; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GAS CHROMATOGRAPHY; GOOD CLINICAL PRACTICE; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; METHODOLOGY; QUALITY CONTROL; REPRODUCIBILITY; VALIDATION STUDY; CHEMICAL ANALYSIS; REVIEW; STANDARD;

CHEMISTRY TECHNIQUES, ANALYTICAL; HUMANS; PHARMACEUTICAL PREPARATIONS; VALIDATION STUDIES AS TOPIC;

EID: 79951769600     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.09.134     Document Type: Article

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