000 03982nam a22004935i 4500
001 978-3-319-40793-7
003 DE-He213
005 20180206182957.0
007 cr nn 008mamaa
008 160822s2016 gw | s |||| 0|eng d
020 _a9783319407937
_9978-3-319-40793-7
050 4 _aRS380
050 4 _aRS190-210
072 7 _aTDCW
_2bicssc
072 7 _aMED072000
_2bisacsh
082 0 4 _a615.19
_223
245 1 0 _aTranslating Molecular Biomarkers into Clinical Assays
_h[recurso electrónico] :
_bTechniques and Applications /
_cedited by Russell Weiner, Marian Kelley.
264 1 _aCham :
_bSpringer International Publishing :
_bImprint: Springer,
_c2016.
300 _aXIII, 212 p. 24 illus., 16 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aAAPS Advances in the Pharmaceutical Sciences Series,
_x2210-7371 ;
_v21
505 0 _aForeword -- 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.
520 _aThis 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.
650 0 _aMedicine.
650 0 _aPharmacy.
650 0 _aPharmaceutical technology.
650 1 4 _aBiomedicine.
650 2 4 _aPharmaceutical Sciences/Technology.
650 2 4 _aPharmacy.
700 1 _aWeiner, Russell.
_eeditor.
700 1 _aKelley, Marian.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9783319407920
830 0 _aAAPS Advances in the Pharmaceutical Sciences Series,
_x2210-7371 ;
_v21
856 4 0 _zLibro electrónico
_uhttp://148.231.10.114:2048/login?url=http://dx.doi.org/10.1007/978-3-319-40793-7
912 _aZDB-2-SBL
942 _cLIBRO_ELEC
999 _c225939
_d225939