A Prototypical Process for Creating Evidentiary Standards for Biomarkers and Diagnostics
| Autor: | D Raunig, James T. Mayne, D Fu, Lawrence J. Lesko, S Furlong, P Sager, Robert A. Dean, Glen Clack, CD Lathia, J Bloom, D Amakye, K Zerba, CA Altar, Lois Hinman, C Girman, J Meyer, D Bounos, S Madani, Viswanath Devanarayan, P Wong, SA Williams |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Quality Control
Drug Industry Process (engineering) Drug Evaluation Preclinical Nanotechnology Risk Assessment Biomarkers Pharmacological law.invention Food and drug administration law Animals Humans Medicine Pharmacology (medical) Cooperative Behavior Program Development Pharmacology Clinical Trials as Topic Clinical pharmacology Diagnostic Tests Routine United States Food and Drug Administration business.industry Reproducibility of Results United States Engineering ethics business Biomarkers |
| Zdroj: | Clinical Pharmacology & Therapeutics. 83:368-371 |
| ISSN: | 1532-6535 0009-9236 |
| DOI: | 10.1038/sj.clpt.6100451 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text