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A Prototypical Process for Creating Evidentiary Standards for Biomarkers and Diagnostics
Author(s) -
Altar CA,
Amakye D,
Bounos D,
Bloom J,
Clack G,
Dean R,
Devanarayan V,
Fu D,
Furlong S,
Hinman L,
Girman C,
Lathia C,
Lesko L,
Madani S,
Mayne J,
Meyer J,
Raunig D,
Sager P,
Williams SA,
Wong P,
Zerba K
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100451
Subject(s) - food and drug administration , clinical pharmacology , process (computing) , engineering ethics , key (lock) , medicine , management science , business , process management , computer science , pharmacology , engineering , computer security , operating system
A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative. 1 This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America (PhRMA) committees and tested at a workshop in collaboration with the Food and Drug Administration and academia. With some necessary refinements, this could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose. Clinical Pharmacology & Therapeutics (2008); doi: 10.1038/sj.clpt.6100451