European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development

Bioanalysis

Volumn 4, Issue 15, 2012, Pages 1883-1894

  Timmerman, Philip ^a   Herling, Christian ^b   Stoellner, Daniela ^c   Jaitner, Birgit ^c   Pihl, Susanne ^d   Elsby, Karen ^e   Henderson, Neil ^e   Barroso, Begona ^c   Fischmann, Stephanie ^f   Companjen, Arjen ^c   Versteilen, Amanda ^c   Bates, Stewart ^g   Kingsley, Clare ^c   Kunz, Ulrich ^h  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b NOVO NORDISK A S   (Denmark)

^c Novartis ^*  (United Kingdom)

^d H LUNDBECK A S   (Denmark)

^e ASTRAZENECA   (United Kingdom)

^f ABBOTT LABORATORIES   (United States)

^g GLAXOSMITHKLINE   (United Kingdom)

^h BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

ANALYSIS; ANALYTIC METHOD; ASSAY; BIOMARKER BIOANALYSIS; CLASSIFICATION; CONTROLLED STUDY; DECISION SUPPORT SYSTEM; DECISION TREE; DRUG DEVELOPMENT; EUROPE; INTERPERSONAL COMMUNICATION; LIMIT OF QUANTITATION; PHARMACODYNAMICS; REVIEW; SAMPLE; SCIENTIST;

ANIMALS; BIOMARKERS, PHARMACOLOGICAL; DRUG DISCOVERY; EUROPE; EVALUATION STUDIES AS TOPIC; GOVERNMENT REGULATION; HUMANS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 84865723412     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.164     Document Type: Review

References (10)

1. 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 (Pubitemid 46296546)
2. 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
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 (Pubitemid 43237862)
4. DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method Validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11), 1885-1900 (2003 (Pubitemid 37449466)
5. Dijksman J, Timmerman P, Abbott R et al. 'Less is more': Defining modern bioanalysis. Bioanalysis 4(6), 633-642 (2012
6. Houghton R, Horro Pita C, Ward I et al. Generic approach to validation of small-molecule LC-MS/MS biomarker assays. Bioanalysis 1(8), 1365-1374 (2009
7. Biomarker Definitions Working Group. Biomarkers and surrogate end points: Preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69, 89-95 (2001
8. Danhof M, Alvan G, Dahl SG, Kuhlmann J, Paintaud G. et al. Mechanism-based pharmacokinetic-pharmacodynamic modeling - a new classification of biomarkers. Pharm. Res. 22(9), 1432-1437 (2005 (Pubitemid 41215882)
9. Lesko L, Atkinson A. Use of biomarkers and surrogate end points in drug development and regulatory decision making. Annu. Rev. Pharmacol. Toxicol. 41, 347-366 (2001 (Pubitemid 32390116)
10. Kuhlmann J. The Applications of Biomarkers in Early Clinical Drug Development to Improve Decision-Making Processes. In: Appropriate dose selection - How to optimize clinical drug development. Venitz J, Sittner W (Eds). Springer, Berlin, Germany, 29-45 (2007).