The role of biomarkers in drug discovery and development has gained precedence over the years. As biomarkers become integrated into drug development and clinical trials, quality assurance and, in particular, assay validation become essential with the need to establish standardized guidelines for analytic methods used in biomarker measurements. New biomarkers can revolutionize both the development and use of therapeutics but are contingent on the establishment of a concrete validation process that addresses technology integration and method validation as well as regulatory pathways for efficient biomarker development. This perspective focuses on the general principles of the biomarker validation process with an emphasis on assay validation and the collaborative efforts undertaken by various sectors to promote the standardization of this procedure for efficient biomarker development
%0 Journal Article
%1 Chau.2008
%A Chau, C. H.
%A Rixe, O.
%A McLeod, H.
%A Figg, W. D.
%D 2008
%J Clin.Cancer Res.
%K Agents Animals Antineoplastic Biological Biomarkers Chemistry Design Drug Evaluation Genome Genomics Human Humans Markers Medical Mice Neoplasms Oncology Outcome Pharmaceutical Pharmacological Preclinical Research Treatment Tumor analysis drug metabolism methods pharmacology therapy
%N 19
%P 5967-5976
%T Validation of analytic methods for biomarkers used in drug development
%U PM:18829475
%V 14
%X The role of biomarkers in drug discovery and development has gained precedence over the years. As biomarkers become integrated into drug development and clinical trials, quality assurance and, in particular, assay validation become essential with the need to establish standardized guidelines for analytic methods used in biomarker measurements. New biomarkers can revolutionize both the development and use of therapeutics but are contingent on the establishment of a concrete validation process that addresses technology integration and method validation as well as regulatory pathways for efficient biomarker development. This perspective focuses on the general principles of the biomarker validation process with an emphasis on assay validation and the collaborative efforts undertaken by various sectors to promote the standardization of this procedure for efficient biomarker development
@article{Chau.2008,
abstract = {The role of biomarkers in drug discovery and development has gained precedence over the years. As biomarkers become integrated into drug development and clinical trials, quality assurance and, in particular, assay validation become essential with the need to establish standardized guidelines for analytic methods used in biomarker measurements. New biomarkers can revolutionize both the development and use of therapeutics but are contingent on the establishment of a concrete validation process that addresses technology integration and method validation as well as regulatory pathways for efficient biomarker development. This perspective focuses on the general principles of the biomarker validation process with an emphasis on assay validation and the collaborative efforts undertaken by various sectors to promote the standardization of this procedure for efficient biomarker development},
added-at = {2010-02-05T11:28:39.000+0100},
author = {Chau, C. H. and Rixe, O. and McLeod, H. and Figg, W. D.},
biburl = {https://www.bibsonomy.org/bibtex/2dfd4f52449dcb63d601aac8725c08f6e/kanefendt},
interhash = {9858fed572840579a2c82f508f1aea1e},
intrahash = {dfd4f52449dcb63d601aac8725c08f6e},
journal = {Clin.Cancer Res.},
keywords = {Agents Animals Antineoplastic Biological Biomarkers Chemistry Design Drug Evaluation Genome Genomics Human Humans Markers Medical Mice Neoplasms Oncology Outcome Pharmaceutical Pharmacological Preclinical Research Treatment Tumor analysis drug metabolism methods pharmacology therapy},
number = 19,
pages = {5967-5976},
timestamp = {2010-02-05T11:28:53.000+0100},
title = {Validation of analytic methods for biomarkers used in drug development},
url = {PM:18829475},
volume = 14,
year = 2008
}