%0 Journal Article %1 Cummings.2008 %A Cummings, J. %A Ward, T. H. %A Greystoke, A. %A Ranson, M. %A Dive, C. %D 2008 %J Br.J.Pharmacol. %K & Adherence Agents Animals Antineoplastic Assay Biomarkers Cell Clinical Control Death Drug Enzyme-Linked Europe Evaluation Guideline Guidelines Humans Immunosorbent Keratin-18 Laboratories Mass Pharmacological Preclinical Proteins Quality Reproducibility Research Results Spectrometry Terminology Topic Trials analysis as drug effects jurisprudence legislation methods of pharmacology protein standards therapeutic use %N 4 %P 646-656 %T Biomarker method validation in anticancer drug development %U PM:17876307 %V 153 %X 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 subjects entered into clinical trials of new investigational agents, laboratories conducting these analyses become subject to the Clinical Trials Regulations. While these regulations are not specific in their requirements of research laboratories, quality assurance and in particular assay validation are essential. This review, therefore, focuses on a discussion of current thinking in biomarker assay validation. Five categories define the majority of biomarker assays from 'absolute quantitation' to 'categorical'. Validation must therefore take account of both the position of the biomarker in the spectrum towards clinical end point and the level of quantitation inherent in the methodology. Biomarker

@article{Cummings.2008, abstract = {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 subjects entered into clinical trials of new investigational agents, laboratories conducting these analyses become subject to the Clinical Trials Regulations. While these regulations are not specific in their requirements of research laboratories, quality assurance and in particular assay validation are essential. This review, therefore, focuses on a discussion of current thinking in biomarker assay validation. Five categories define the majority of biomarker assays from 'absolute quantitation' to 'categorical'. Validation must therefore take account of both the position of the biomarker in the spectrum towards clinical end point and the level of quantitation inherent in the methodology. Biomarker }, added-at = {2010-02-05T11:28:39.000+0100}, author = {Cummings, J. and Ward, T. H. and Greystoke, A. and Ranson, M. and Dive, C.}, biburl = {https://www.bibsonomy.org/bibtex/21afa190aeb2d73879b9d1e0dd290a8ee/kanefendt}, interhash = {f95fbf056d41553ef843171232f1d657}, intrahash = {1afa190aeb2d73879b9d1e0dd290a8ee}, journal = {Br.J.Pharmacol.}, keywords = {& Adherence Agents Animals Antineoplastic Assay Biomarkers Cell Clinical Control Death Drug Enzyme-Linked Europe Evaluation Guideline Guidelines Humans Immunosorbent Keratin-18 Laboratories Mass Pharmacological Preclinical Proteins Quality Reproducibility Research Results Spectrometry Terminology Topic Trials analysis as drug effects jurisprudence legislation methods of pharmacology protein standards therapeutic use}, number = 4, pages = {646-656}, timestamp = {2010-02-05T11:28:53.000+0100}, title = {Biomarker method validation in anticancer drug development}, url = {PM:17876307}, volume = 153, year = 2008 }