A multistep validation process of biomarkers for preclinical drug development

被引：0
作者：
W M Freeman
G V Bixler
R M Brucklacher
C-M Lin
K M Patel
H D VanGuilder
K F LaNoue
S R Kimball
A J Barber
D A Antonetti
T W Gardner
S K Bronson
机构：
[1] Functional Genomics Core Facility,Department of Pharmacology
[2] Penn State College of Medicine,Department of Cellular & Molecular Physiology
[3] Penn State College of Medicine,Department of Ophthalmology
[4] Penn State College of Medicine,undefined
[5] Penn State College of Medicine,undefined
来源：
The Pharmacogenomics Journal | 2010年 / 10卷
关键词：
biomarker; drug development; preclinical; gene expression; diabetic retinopathy;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Biomarkers that can be measured in preclinical models in a high-throughput, reproducible manner offer the potential to increase the speed and efficacy of drug development. Development of therapeutic agents for many conditions is hampered by the limited number of validated preclinical biomarkers available to gauge pharmacoefficacy and disease progression, but the validation process for preclinical biomarkers has received limited attention. This report defines a five-step preclinical biomarker validation process and applies the process to a case study of diabetic retinopathy. By showing that a gene expression panel is highly reproducible, coincides with disease manifestation, accurately classifies individual animals and identifies animals treated with a known therapeutic agent, a biomarker panel can be considered validated. This particular biomarker panel consisting of 14 genes (C1inh, C1s, Carhsp1, Chi3l1, Gat3, Gbp2, Hspb1, Icam1, Jak3, Kcne2, Lama5, Lgals3, Nppa, Timp1) can be used in diabetic retinopathy pharmacotherapeutic research, and the biomarker development process outlined here is applicable to drug development efforts for other diseases.
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页码：385 / 395
页数：10
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