Translating Molecular Biomarkers into Clinical Assays
Techniques and Applications
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Beschreibung
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.
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.
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
Autor*in
Russell Weiner
Themen in »Translating Molecular Biomarkers into Clinical Assays«
Biomarker pharmacokinetics FDA bioanalysis target engagement