Published: Springer, 2019
Description:
1 online resource (xxi, 642 pages) : illustrations (chiefly color)
Contents:
“…IVDs and FDA marketing authorizations: a general overview of FDA approval process of an IVD
companion diagnostic device in oncology -- Quality control of immunohistochemical and in situ hybridization predictive biomarkers for patient treatment: experience from international guidelines and international quality control schemes -- Use of
companion diagnostics (CDx) and predictive biomarkers for cancer targeted therapy:
clinical applications in precision medicine -- Policy issues in the
clinical development and use of predictive biomarkers for molecular targeted therapies -- Role of central laboratories in research, validation, and application of predictive biomarkers -- Part V: Precision medicine
clinical trials and FDA-approved targeted therapies -- Prominent precision medicine
clinical trials in oncology around the world -- Precision medicine
clinical trials: successes and disappointments, challenges and opportunities--lessons learnt -- FDA-approved targeted therapies in oncology.…”
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