Biomarker method validation in anticancer drug development

• Published in: British journal of pharmacology Vol. 153; no. 4; pp. 646 - 656
• Main Authors: Cummings, J, Ward, T H, Greystoke, A, Ranson, M, Dive, C
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.02.2008; Nature Publishing; Nature Publishing Group
• Subjects: Animals; anticancer drugs; Antineoplastic Agents - pharmacology; Antineoplastic Agents - therapeutic use; Biological and medical sciences; biomarker; Biomarkers, Pharmacological - analysis; Cell Death - drug effects; clinical trials; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Drug Evaluation, Preclinical - methods; Drug Evaluation, Preclinical - standards; Enzyme-Linked Immunosorbent Assay - standards; Guideline Adherence; Guidelines as Topic; Humans; Keratin-18 - analysis; Laboratories - legislation & jurisprudence; Laboratories - standards; M30 and M65 ELISAs; mass spectrometry; Mass Spectrometry - standards; Medical sciences; method validation; Pharmacology. Drug treatments; Proteins - analysis; Quality Control; Reproducibility of Results; Reviews; Terminology as Topic; Antineoplastic agent; Human; Drug; method validation; Biological marker; Enzyme immunoassay; biomarker; anticancer drugs; Research and development; Clinical trial; M30 and M65 ELISAs; clinical trials; Mass spectrometry; ELISA assay

Over recent years the role of biomarkers in anticancer drug development has expanded across a spectrum of applications ranging from research tool during early discovery to surrogate endpoint in the clinic. However, in Europe when biomarker measurements are performed on samples collected from subject...