Clinical Validation and Biomarkers Translation

David T. S. Lin; Andreas Scherer; Raymond Ng; Robert Balshaw; Shawna Flynn; Paul Keown; Robert McMaster; Bruce McManus

Clinical Validation and Biomarkers Translation

David T. S. Lin, Andreas Scherer, Raymond Ng, Robert Balshaw, Shawna Flynn, Paul Keown, Robert McMaster, Bruce McManus

Suomen molekyylilääketieteen instituutti

Tutkimustuotos: Artikkeli kirjassa/raportissa/konferenssijulkaisussa › Kirjan luku tai artikkeli › Tieteellinen › vertaisarvioitu

Abstrakti

Many of the biomarkers in current clinical use have become accepted via debate, consensus, or merely the passage of time. Biomarkers can no longer become accepted in this way, as they would fail to meet the current regulatory standards of modern medicine. Contemporary biomarkers must be tested in highly regulated human clinical trials. This article focuses on various aspects of discovery, development, clinical validation, and translation of biomarkers.

Alkuperäiskieli	englanti
Otsikko	Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy
Sivumäärä	23
Kustantaja	Wiley
Julkaisupäivä	2010
Sivut	375-398
ISBN (painettu)	978-0-470-16927-8
Tila	Julkaistu - 2010
OKM-julkaisutyyppi	A3 Kirjan tai muun kokoomateoksen osa

Tieteenalat

3111 Biolääketieteet

Siteeraa tätä

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abstract = "Many of the biomarkers in current clinical use have become accepted via debate, consensus, or merely the passage of time. Biomarkers can no longer become accepted in this way, as they would fail to meet the current regulatory standards of modern medicine. Contemporary biomarkers must be tested in highly regulated human clinical trials. This article focuses on various aspects of discovery, development, clinical validation, and translation of biomarkers.",

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T1 - Clinical Validation and Biomarkers Translation

AU - Lin, David T. S.

AU - Scherer, Andreas

AU - Ng, Raymond

AU - Balshaw, Robert

AU - Flynn, Shawna

AU - Keown, Paul

AU - McMaster, Robert

AU - McManus, Bruce

PY - 2010

Y1 - 2010

N2 - Many of the biomarkers in current clinical use have become accepted via debate, consensus, or merely the passage of time. Biomarkers can no longer become accepted in this way, as they would fail to meet the current regulatory standards of modern medicine. Contemporary biomarkers must be tested in highly regulated human clinical trials. This article focuses on various aspects of discovery, development, clinical validation, and translation of biomarkers.

AB - Many of the biomarkers in current clinical use have become accepted via debate, consensus, or merely the passage of time. Biomarkers can no longer become accepted in this way, as they would fail to meet the current regulatory standards of modern medicine. Contemporary biomarkers must be tested in highly regulated human clinical trials. This article focuses on various aspects of discovery, development, clinical validation, and translation of biomarkers.

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KW - Drug development

KW - Biomarkers

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SN - 978-0-470-16927-8

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BT - Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy

PB - Wiley

ER -