Biochemical markers and the FDA Critical Path: How biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development

被引：106

作者：

Karsdal, M. A. ^{[1
]}

Henriksen, K. ^{[1
]}

Leeming, D. J. ^{[1
]}

Mitchell, P. ^{[2
]}

Duffin, K. ^{[2
]}

Barascuk, N. ^{[1
]}

Klickstein, L. ^{[3
]}

Aggarwal, P. ^{[4
]}

Nemirovskiy, O. ^{[4
]}

Byrjalsen, I. ^{[1
]}

Qvist, P. ^{[1
]}

Bay-Jensen, A. C. ^{[1
]}

Dam, E. B. ^{[1
]}

Madsen, S. H. ^{[1
]}

Christiansen, C. ^{[1
]}

机构：

[1] Nord Biosci AS, DK-2730 Herlev, Denmark

[2] Eli Lilly & Co, Indianapolis, IN 46285 USA

[3] Novartis, Basel, Switzerland

[4] Pfizer, St Louis, MO USA

来源：

BIOMARKERS | 2009年 / 14卷 / 03期

关键词：

Neoepitope; biomarker; FDA; critical path; translational science; OLIGOMERIC MATRIX PROTEIN; BONE-MINERAL DENSITY; EARLY POSTMENOPAUSAL WOMEN; SURROGATE END-POINTS; OSTEOARTHRITIS STRUCTURAL ARTHRITIS; HORMONE REPLACEMENT THERAPY; DESTRUCTIVE JOINT DISEASES; RANDOMIZED CLINICAL-TRIAL; C-TERMINAL TELOPEPTIDES; COLLAGEN TYPE-I;

D O I：

10.1080/13547500902777608

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

The aim of this review is to discuss the potential usefulness of a novel class of biochemical markers, neoepitopes, in the context of the US Food and Drug Administration (FDA) Critical Path Initiative, which emphasizes biomarkers of safety and efficacy as areas of pivotal interest. Examples of protein degradation fragments - neoepitopes - that have proven useful for research on bone and cartilage are collagen type I and collagen type II degradation products, respectively. These markers have utility in the translational approach, as they can be used to estimate safety and efficacy in both preclinical models and clinical settings. Biochemical markers of tissue degradation may provide optimal tools, which in combination with other techniques, prove essential to drug discovery and development.

引用

页码：181 / 202

页数：22