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Translating molecular biomarkers into clinical assays[electronic resource] :techniques and applications /

紀錄類型:	書目-電子資源 : Monograph/item
杜威分類號:	610.72
書名/作者:	Translating molecular biomarkers into clinical assays : techniques and applications // edited by Russell Weiner, Marian Kelley.
其他作者:	Weiner, Russell.
出版者:	Cham : : Springer International Publishing :, 2016.
面頁冊數:	xi, 212 p. : : ill., digital ;; 24 cm.
Contained By:	Springer eBooks
標題:	Biochemical markers.
標題:	Biomedicine.
標題:	Pharmaceutical Sciences/Technology.
標題:	Pharmacy.
ISBN:	9783319407937
ISBN:	9783319407920
內容註:	Foreword -- Fit-For-Purpose Validation -- Biomarkers in Drug Discovery and Development: Pre-Analytical and Analytical Considerations -- Biomarker Discovery -- Application of Quantitative Biomeasures in Early Drug Discovery -- Biomarkers in discovery and preclinical phase during drug development -- Incorporating clinical biomarkers into clinical trials -- Perspectives on Tissue Biobanking for Personalized Medicine -- The role of commercial biomarker assay kits in preclinical and clinical trials kits -- Quantification of protein biomarkers using liquid chromatography tandem mass spectrometry -- LC/MS methods for small Molecule biomarkers -- Cell-based Assays -- New Technologies for Cellular Analysis -- Flow cytometry methods for the Clinical Development of Immunomodulatory Biologics -- Key mass spectrometry techniques used in clinical biomarker research -- Clinical Genomic Biomarker Assay Development: Technologies and Issues -- Implementation of Immunohistochemistry assays for clinical trial sample analyses -- Strategic Approach to Outsourcing Clinical Biomarker Assays through CRO Relationships -- In situ hybridization (ISH) in Clinical Biomarker Development.
摘要、提要註:	This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers, and it also provides critical analyses of various new validation methods for practitioners and researchers.
電子資源:	http://dx.doi.org/10.1007/978-3-319-40793-7

Translating molecular biomarkers into clinical assays[electronic resource] :techniques and applications /
Translating molecular biomarkers into clinical assaystechniques and applications /[electronic resource] :edited by Russell Weiner, Marian Kelley. - Cham :Springer International Publishing :2016. - xi, 212 p. :ill., digital ;24 cm. - AAPS advances in the pharmaceutical sciences series,2210-7371. - AAPS advances in the pharmaceutical sciences series..

Foreword -- Fit-For-Purpose Validation -- Biomarkers in Drug Discovery and Development: Pre-Analytical and Analytical Considerations -- Biomarker Discovery -- Application of Quantitative Biomeasures in Early Drug Discovery -- Biomarkers in discovery and preclinical phase during drug development -- Incorporating clinical biomarkers into clinical trials -- Perspectives on Tissue Biobanking for Personalized Medicine -- The role of commercial biomarker assay kits in preclinical and clinical trials kits -- Quantification of protein biomarkers using liquid chromatography tandem mass spectrometry -- LC/MS methods for small Molecule biomarkers -- Cell-based Assays -- New Technologies for Cellular Analysis -- Flow cytometry methods for the Clinical Development of Immunomodulatory Biologics -- Key mass spectrometry techniques used in clinical biomarker research -- Clinical Genomic Biomarker Assay Development: Technologies and Issues -- Implementation of Immunohistochemistry assays for clinical trial sample analyses -- Strategic Approach to Outsourcing Clinical Biomarker Assays through CRO Relationships -- In situ hybridization (ISH) in Clinical Biomarker Development.

This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers, and it also provides critical analyses of various new validation methods for practitioners and researchers.

ISBN: 9783319407937

Standard No.: 10.1007/978-3-319-40793-7doiSubjects--Topical Terms:

431086
Biochemical markers.

LC Class. No.: R853.B54

Dewey Class. No.: 610.72

Translating molecular biomarkers into clinical assays[electronic resource] :techniques and applications /
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