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An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this art...

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Shranjeno v:
Bibliografske podrobnosti
izdano v:Clin Cancer Res
Main Authors: Beaver, Julia A., Tzou, Abraham, Blumenthal, Gideon M., McKee, Amy E., Kim, Geoffrey, Pazdur, Richard, Philip, Reena
Format: Artigo
Jezik:Inglês
Izdano: 2016
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC5354944/
https://ncbi.nlm.nih.gov/pubmed/27993967
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1158/1078-0432.CCR-16-1098
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