Tiered approach: From plan into practice

Bioanalysis

Volumn 6, Issue 5, 2014, Pages 585-586

  Timmerman, Philip ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; DRUG METABOLITE;

ANALYTIC METHOD; DRUG DEVELOPMENT; EDITORIAL; LIMIT OF QUANTITATION; VALIDATION PROCESS; BIOASSAY; PROCEDURES; STANDARDS; TRENDS;

BIOLOGICAL ASSAY;

EID: 84896456830     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.24     Document Type: Editorial

References (6)

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2. Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001
3. Lee J, Devanarayan V, Barrett Y, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006
4. Viswanathan CT, Bansal S, Booth B, et al. Workshop/conference report-quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. AAPS J. 9(1), E30-E42 (2007
5. Timmerman P, Kall M, Gordon B, et al. Best practices in a tiered approach to metabolite quantification: Views and recommendations of the European Bioanalysis Forum. Bioanalysis 2(7), 1185-1194 (2010
6. Booth B. When do you need a validated assay? Bioanalysis 3(24), 2729-2730 (2011