Tiered approach into practice: Scientific validation for chromatography-based assays in early development - A recommendation from the European Bioanalysis Forum

Bioanalysis

Volumn 7, Issue 18, 2015, Pages 2387-2398

  Timmerman, Philip ^a   White, Stephen ^b   Mcdougall, Stuart ^c   Kall, Morten A ^d   Smeraglia, John ^e   Fjording, Marianne Scheel ^f   Knutsson, Magnus ^g  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b GLAXOSMITHKLINE   (United Kingdom)

^c Covance ^*  (United Kingdom)

^d H LUNDBECK A S   (Denmark)

^e UCB PHARMA   (Belgium)

^f NOVO NORDISK A S   (Denmark)

^g Ferring Pharmaceuticals AS   (Denmark)

Author keywords

early clinical development; early preclinical development; European Bioanalysis Forum; metabolites; scientific validation; tiered approach; tissue analysis; urine analysis

Indexed keywords

ARTICLE; BLOOD ANALYSIS; CALIBRATION; CHROMATOGRAPHY; DILUTION; DRUG DISTRIBUTION; DRUG EXCRETION; EXTRACTION; GOOD LABORATORY PRACTICE; HUMAN; LIQUID CHROMATOGRAPHY; METABOLITE; NONHUMAN; QUALITY CONTROL; STANDARD; TANDEM MASS SPECTROMETRY; TISSUE HOMOGENATE; URINALYSIS;

EID: 84943558350     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.15.168     Document Type: Article

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