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

M A Karsdal, K Henriksen, D J Leeming, P Mitchell, K Duffin, N Barascuk, L Klickstein, P Aggarwal, O Nemirovskiy, I Byrjalsen, P Qvist, A C Bay-Jensen, E B Dam, S H Madsen, C Christiansen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: 2009-May
OriginalsprogEngelsk
TidsskriftBiomarkers
Vol/bind14
Udgave nummer3
Sider (fra-til)181-202
Antal sider21
ISSN1354-750X
DOI
StatusUdgivet - 1. maj 2009

Fingeraftryk

Critical Pathways
Biomarkers
United States Food and Drug Administration
Degradation
Pharmaceutical Preparations
Essential Drugs
Safety
Collagen Type II
Cartilage
Collagen Type I
Proteolysis
Bone
Tissue
Research
Proteins

Citer dette

Karsdal, M A ; Henriksen, K ; Leeming, D J ; Mitchell, P ; Duffin, K ; Barascuk, N ; Klickstein, L ; Aggarwal, P ; Nemirovskiy, O ; Byrjalsen, I ; Qvist, P ; Bay-Jensen, A C ; Dam, E B ; Madsen, S H ; Christiansen, C. / 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. I: Biomarkers. 2009 ; Bind 14, Nr. 3. s. 181-202.
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title = "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",
abstract = "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.",
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Karsdal, MA, Henriksen, K, Leeming, DJ, Mitchell, P, Duffin, K, Barascuk, N, Klickstein, L, Aggarwal, P, Nemirovskiy, O, Byrjalsen, I, Qvist, P, Bay-Jensen, AC, Dam, EB, Madsen, SH & Christiansen, C 2009, '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', Biomarkers, bind 14, nr. 3, s. 181-202. https://doi.org/10.1080/13547500902777608

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. / Karsdal, M A; Henriksen, K; Leeming, D J; Mitchell, P; Duffin, K; Barascuk, N; Klickstein, L; Aggarwal, P; Nemirovskiy, O; Byrjalsen, I; Qvist, P; Bay-Jensen, A C; Dam, E B; Madsen, S H; Christiansen, C.

I: Biomarkers, Bind 14, Nr. 3, 01.05.2009, s. 181-202.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - 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

AU - Karsdal, M A

AU - Henriksen, K

AU - Leeming, D J

AU - Mitchell, P

AU - Duffin, K

AU - Barascuk, N

AU - Klickstein, L

AU - Aggarwal, P

AU - Nemirovskiy, O

AU - Byrjalsen, I

AU - Qvist, P

AU - Bay-Jensen, A C

AU - Dam, E B

AU - Madsen, S H

AU - Christiansen, C

PY - 2009/5/1

Y1 - 2009/5/1

N2 - 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.

AB - 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.

KW - Biological Markers

KW - Critical Pathways

KW - Drug Design

KW - United States

KW - United States Food and Drug Administration

U2 - 10.1080/13547500902777608

DO - 10.1080/13547500902777608

M3 - Journal article

VL - 14

SP - 181

EP - 202

JO - Biomarkers

JF - Biomarkers

SN - 1354-750X

IS - 3

ER -