493
Views
1
CrossRef citations to date
0
Altmetric
Research Article

Fit-For-Purpose Biomarker Immunoassay Qualification and Validation: Three Case Studies

, , , , , , , , , & show all
Pages 2329-2340 | Received 01 Jul 2016, Accepted 19 Sep 2016, Published online: 07 Oct 2016

References

  • Hay M , ThomasDW, CraigheadJL, EconomidesC, RosenthalJ. Clinical development success rates for investigational drugs. Nat. Biotechnol. 32 (1), 40–51 (2014).
  • Tan DS , ThomasGV, GarrettMDet al. Biomarker-driven early clinical trials in oncology: a paradigm shift in drug development. Cancer J. 15 (5), 406–420 (2009).
  • Backen AC , CummingsJ, MitchellC, JaysonG, WardTH, DiveC. ‘Fit-for-purpose’ validation of searchlight multiplex elisas of angiogenesis for clinical trial use. J. Immunol. Methods342 (1–2), 106–114 (2009).
  • Chau CH , RixeO, McleodH, FiggWD. Validation of analytic methods for biomarkers used in drug development. Clin. Cancer Res. 14 (19), 5967–5976 (2008).
  • Cummings J , RaynaudF, JonesL, SugarR, DiveC. Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs. Br. J. Cancer103 (9), 1313–1317 (2010).
  • Cummings J , WardTH, DiveC. Fit-for-purpose biomarker method validation in anticancer drug development. Drug Discov. Today15 (19–20), 816–825 (2010).
  • Desilva B , SmithW, WeinerRet al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (11), 1885–1900 (2003).
  • Jani D , AllinsonJ, BerishaFet al. Recommendations for use and fit-for-purpose validation of biomarker multiplex ligand binding assays in drug development. AAPS J. 18 (1), 1–14 (2016).
  • Khan MU , BowsherRR, CameronMet al. Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development. Bioanalysis7 (2), 229–242 (2015).
  • Lee JW , DevanarayanV, BarrettYCet al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2), 312–328 (2006).
  • Lee JW , HallM. Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877 (13), 1259–1271 (2009).
  • Lee JW , WeinerRS, SailstadJMet al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm. Res. 22 (4), 499–511 (2005).
  • US FDA . Guidance for industry. Bioanalytical method validation. www.fda.gov.
  • Brookes K , CummingsJ, BackenAet al. Issues on fit-for-purpose validation of a panel of elisas for application as biomarkers in clinical trials of anti-angiogenic drugs. Br. J. Cancer102 (10), 1524–1532 (2010).
  • Lin M , LassmanME, WeinerR, LaterzaOF. Development and fit-for-purpose validation of a LC–MS/MS assay for fibrinogen peptide a quantitation in human plasma. Bioanalysis6 (13), 1759–1766 (2014).
  • Ni YG , YuanX, NewittJAet al. Development and fit-for-purpose validation of a soluble human programmed death-1 protein assay. AAPS J. 17 (4), 976–987 (2015).
  • Gregg EO , MinetE, McewanM. Urinary biomarkers of smokers’ exposure to tobacco smoke constituents in tobacco products assessment: a fit for purpose approach. Biomarkers18 (6), 467–486 (2013).
  • Robas NM . Use of pd biomarkers to drive dose selection and early clinical decision making. Bioanalysis4 (20), 2485–2497 (2012).
  • Jia G , EricksonRW, ChoyDFet al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients. J. Allergy Clin. Immunol. 130 (3), 647–654.e10 (2012).
  • Huang YJ , NariyaS, HarrisJMet al. The airway microbiome in patients with severe asthma: associations with disease features and severity. J. Allergy Clin. Immunol. 136 (4), 874–884 (2015).
  • Choy DF , HartKM, BorthwickLAet al. Th2 and th17 inflammatory pathways are reciprocally regulated in asthma. Sci. Transl. Med. 7 (301), 301ra129 (2015).
  • Maude SL , BarrettD, TeacheyDT, GruppSA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 20 (2), 119–122 (2014).
  • EMA . Committee for Medicinal Products for Human Use (CHMP). Guideline on bioanalytical method validation. London, UK (2011). www.ema.europa.eu.
  • Andreasson U , Perret-LiaudetA, van Waalwijk van DoornLJC. A practical guide to immunoassay method validation. Front. Neurol. 6, 179 (2015).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.