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

Institutet för molekylärmedicin i Finland

Forskningsoutput: Kapitel i bok/rapport/konferenshandling › Kapitel › Vetenskaplig › Peer review

Sammanfattning

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.

Originalspråk	engelska
Titel på värdpublikation	Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy
Antal sidor	23
Förlag	Wiley
Utgivningsdatum	2010
Sidor	375-398
ISBN (tryckt)	978-0-470-16927-8
Status	Publicerad - 2010
MoE-publikationstyp	A3 Del av bok eller annan forskningsbok

Vetenskapsgrenar

3111 Biomedicinska vetenskaper

Citera det här

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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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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

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

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