Literature DB >> 19521568

Searching for 'omic' biomarkers.

David Lin1, Zsuzsanna Hollander, Anna Meredith, Bruce M McManus.   

Abstract

Cardiovascular diseases impose enormous social and economic burdens on both individual citizens and on society as a whole. Clinical indicators such as high blood pressure, blood cholesterol and obesity have had some utility in identifying those who are at increased risk of cardiovascular events. However, there remains an urgent need for sensitive and specific indicators, preferably acquired through minimally invasive means, to help stratify patients for more personalized health care. As such, there has been a steadily growing interest in searching for 'omic' biomarkers of cardiovascular diseases. Historically, the transition of cardiac biomarker discovery to implementation has been a lengthy and somewhat unregulated process. Recent technological advancements, as well as concurrent efforts by regulatory agencies such as the Food and Drug Administration (United States) and Health Canada to establish policies and guidelines in the 'omic' arena, have helped propel the discovery and validation of biomarkers forward. The present paper provides perspective on current strategies in the biomarker development pathway, as well as the potential limitations associated with each step from discovery to clinical uptake. Canadian biomarker studies now underway illustrate the possibilities for assessment of risk, diagnosis, prognosis and response to therapy, and for the drug discovery process.

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Year:  2009        PMID: 19521568      PMCID: PMC2787011          DOI: 10.1016/s0828-282x(09)71048-7

Source DB:  PubMed          Journal:  Can J Cardiol        ISSN: 0828-282X            Impact factor:   5.223


  41 in total

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Review 5.  Process map proposal for the validation of genomic biomarkers.

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6.  Biomarker qualification pilot process at the US Food and Drug Administration.

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Journal:  AAPS J       Date:  2007-03-23       Impact factor: 4.009

Review 7.  The FDA critical path initiative and its influence on new drug development.

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Review 8.  Accelerating drug development using biomarkers: a case study with sitagliptin, a novel DPP4 inhibitor for type 2 diabetes.

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Journal:  AAPS J       Date:  2008-08-07       Impact factor: 4.009

9.  Several conditions causing elevation of serum CK-MB and CK-BB.

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10.  Design of early validation trials of biomarkers.

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  2 in total

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2.  Reliability of serum metabolite concentrations over a 4-month period using a targeted metabolomic approach.

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  2 in total

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