Abstract
This chapter serves as an introduction to the terms and definitions of biomarkers as well as the validation assay process which includes: a standard curve, validation samples, accuracy and precision (reproducibility), limits of quantification, parallelism, dilution linearity, specificity and interference, stability, and normal range. Different biomarkers exist for the various stages of the drug discovery and development process. The main objective of this chapter is to introduce concepts that will facilitate the successful use of biomarkers in drug development—from selection, to validation, and then implementation.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Biomarkers Definitions Working Group (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69(3):89–95
Woodcock J, Woosley J (2008) The FDA critical path initiative and its influence on new drug development. Annu Rev Med 59:1–12
Kola I, Landis J (2004) Can the pharmaceutical industry reduce the attrition rates? Nat Rev Drug Discov 3:711–716
Miller KJ, Bowsher RR, Celniker A, Gibbons J, Gupta S, Lee JW, Swanson SJ, Smith WC, Weiner RS (2001) Workshop on bioanalytical methods validation for macromolecules: summary report. Pharm Res 18(9):1373–1383
Lee JW et al (2006) Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23(2):312–328
Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R (2007) Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res 24(10):1962–1973
DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, Khan M, Tacey R, Hill H, Celniker A (2003) Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 20(11):1885–1900
US FDA (2013) Draft guidance for industry bioanalytical method validation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf
Ray CA, Bowsher RR, Smith WC, Devanarayan V, Willey MB, Brandt JT, Dean RA (2005) Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum. J Pharm Biomed Anal 36(5):1037–1044
Green LJ, Marder P, Ray C, Cook CA, Jaken S, Musib LC, Herbst RS, Carducci M, Britten CD, Basche M, Eckhardt SG, Thornton D (2006) Development and validation of a drug activity biomarker that shows target inhibition in cancer patients receiving enzastaurin, a novel protein kinase C-beta inhibitor. Clin Cancer Res 12(11 Pt 1):3408–3415
Engelberts I, Möller A, Schoen GJ, van der Linden CJ, Buurman WA (1991) Evaluation of measurement of human TNF in plasma by ELISA. Lymphokine Cytokine Res 10(1–2):69–76
Palandra J, Finelli A, Zhu M, Masferrer J, Neubert H (2013) Highly specific and sensitive measurements of human and monkey interleukin 21 using sequential protein and tryptic peptide immunoaffinity LC-MS/MS. Anal Chem 85(11):5522–5529
Biancotto A, Feng X, Langweiler M, Young NS, McCoy JP (2012) Effect of anticoagulants on multiplexed measurement of cytokine/chemokines in healthy subjects. Cytokine 60(2):438–446
Salven P, Orpana A, Joensuu H (1999) Leukocytes and platelets of patients with cancer contain high levels of vascular endothelial growth factor. Clin Cancer Res 5(3):487–491
Scaltriti M, Baselga J (2006) The epidermal growth factor receptor pathway: a model for targeted therapy. Clin Cancer Res 12:5268–5272
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Ray, C. (2016). Fit-for-Purpose Validation. In: Weiner, R., Kelley, M. (eds) Translating Molecular Biomarkers into Clinical Assays . AAPS Advances in the Pharmaceutical Sciences Series, vol 21. Springer, Cham. https://doi.org/10.1007/978-3-319-40793-7_1
Download citation
DOI: https://doi.org/10.1007/978-3-319-40793-7_1
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-40792-0
Online ISBN: 978-3-319-40793-7
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)