Best Practices in Evaluating Novel Biomarker Fit for Purpose and Translatability

Research output: Chapter in Book/Report/Conference proceedingChapter

1 Scopus citations


This chapter discusses various tactical aspects to consider when evaluating novel biomarker translatability. The evaluation procedures warrant careful attention in order to leverage the most appropriate traditional and novel biomarkers in the relevant biological matrices. Integration of biomarkers into clinical protocols requires incorporation of biomarker analysis into one of the study objectives. The chapter also describes the use of fit-for-purpose biomarkers in different phases of drug development. When translating a biomarker from preclinical to clinical studies, the species specificity of the assay should be evaluated. Evidence-based protocols for sample collection should be developed and implemented for each biomarker analyzed. When multiple biomarkers are to be analyzed, multiple types of collection containers/tubes may be necessary. The frequency of sample shipments should be determined based on storage space available at the site, stability of samples, and practical factors including personnel time required and cost.

Original languageEnglish (US)
Title of host publicationDrug Discovery Toxicology
Subtitle of host publicationFrom Target Assessment to Translational Biomarkers
Number of pages6
ISBN (Electronic)9781119053248
ISBN (Print)9781119053330
StatePublished - Jan 1 2016


  • Biological matrix selection
  • Biomarkers
  • Drug development
  • Fit-for-purpose testing
  • Human sample collection
  • Sample collection device

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Chemistry(all)
  • Biochemistry, Genetics and Molecular Biology(all)


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