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Drug Discovery
Comprehensive Biomarker Discovery and Validation for Clinical Application
Edited by
Péter Horvatovich;
Péter Horvatovich
University of Groningen, Netherlands
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Rainer Bischoff
Rainer Bischoff
University of Groningen, Netherlands
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Hardback ISBN:
978-1-84973-422-6
PDF ISBN:
978-1-84973-436-3
Series:
Drug Discovery Series
No. of Pages:
384
Published online:
17 Jun 2013
Published in print:
10 Jun 2013
Book Chapter
CHAPTER 2: Introduction: Regulatory Development Hurdles for Biomarker Commercialization: The Steps Required to Get a Product to Market
By
Melissa A. Thompson
Melissa A. Thompson
Matrix Clinical Research Management, 59 Pine Street, Peterborough, NH 03458
[email protected]
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Published:10 Jun 2013
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Series: Drug Discovery Series
Page range:
40 - 72
Citation
M. A. Thompson, in Comprehensive Biomarker Discovery and Validation for Clinical Application, ed. P. Horvatovich and R. Bischoff, The Royal Society of Chemistry, 2013, pp. 40-72.
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Taking a product from discovery to commercialization is a complex process. It is a process that requires familiarization and expertise in the regulatory arena and general understanding of quality‐system requirements. This chapter addresses the steps required to get a product to market and the considerations from a regulatory and quality perspective.
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