Conference report: Aaps and us fda crystal city v meeting on quantitative bioanalytical method validation and implementation: Feedback from the ebf

Bioanalysis

Volumn 6, Issue 6, 2014, Pages 729-732

  Smeraglia, John ^a   McDougall, Stuart ^b   Elsby, Karen ^c   Companjen, Arjen ^d   White, Stephen ^e   Golob, Michaela ^f   Brudny Kloeppel, Margarete ^g   Amsterdam, Peter Van ^h   Timmerman, Philip ⁱ  

^a UCB PHARMA   (Belgium)

^b UK   (United Kingdom)

^c ASTRAZENECA   (United Kingdom)

^d CRUCELL HOLLAND BV   (Netherlands)

^e GLAXOSMITHKLINE   (United Kingdom)

^f Merck Serono Grafing ^*  (Germany)

^g BAYER PHARMA AG   (Germany)

^h Chemical Design and Synthesis Unit   (Netherlands)

ⁱ JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

BINDING ASSAY; CHROMATOGRAPHY; CLINICAL PRACTICE; DECISION MAKING; DIAGNOSTIC KIT; FOOD AND DRUG ADMINISTRATION; INFORMATION PROCESSING; LIGAND BINDING; PRACTICE GUIDELINE; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; REVIEW; VALIDATION PROCESS; VALIDITY; BIOASSAY; GOVERNMENT REGULATION; HUMAN; PROCEDURES; UNITED STATES; VALIDATION STUDY;

BIOLOGICAL ASSAY; CHROMATOGRAPHY; GOVERNMENT REGULATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VALIDATION STUDIES AS TOPIC;

EID: 84898715802     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.17     Document Type: Review

References (7)

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7. Lee JW, Vishwanathan CT, Yu Chen B et al. Fit-for purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006).