Overview
- Introduces new associations to established topics such as, quantitative proteomics in the context of immunhistochemistry (IHC) assays and tissue biobanking for personalized medicine
- Comprehensive review of traditional validation methods i.e. cell-based assays and mass spectrometry
- Defines the business and market of biomarkers through commercial biomarker assay kits and biomarker CRO services
- Includes supplementary material: sn.pub/extras
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 21)
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Table of contents (19 chapters)
Keywords
About this book
Editors and Affiliations
About the editors
Marian Kelley is a leading expert in biotherapeutic drug development from biomarker application to assay analysis. She is the president and founder of MKelley Consulting, LLC, a company that provides bioanalytical support in drug development including validation of biomarker methods, immunogenicity and pharmacokinetic studies, and cell-based assays. Marian was the founding secretary of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG); she co-chaired the Workshop on Assay Reproducibility for Incurred Samples held in Crystal City; and most recently, she leads the L1 global harmonization team on Run Acceptance for LBA resulting in a published white paper. Kelley is coauthor or coeditor of over 30 publications. She is also an extensively experienced trainer in validation of methods and quality control.
Bibliographic Information
Book Title: Translating Molecular Biomarkers into Clinical Assays
Book Subtitle: Techniques and Applications
Editors: Russell Weiner, Marian Kelley
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-3-319-40793-7
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2016
Hardcover ISBN: 978-3-319-40792-0Published: 30 August 2016
Softcover ISBN: 978-3-319-82185-6Published: 14 June 2018
eBook ISBN: 978-3-319-40793-7Published: 22 August 2016
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XIII, 212
Number of Illustrations: 8 b/w illustrations, 16 illustrations in colour