Science Translational Medicine · 2010 · 62 citations · 2 references
PharmacyNephrologyTranslational SciencesClinical PharmacologyRenal PathophysiologyTranslational MedicineAcute Kidney InjuryBiomarker DevelopmentBiomarker ValidationRenal DiseaseTranslational Biomarker ValidationTranslational BiomarkersBiomarker QualificationBiomarker Qualification AssaysBiomarkersClinical Biomarker QualificationClinical Biomarker TranslationEvidence-based Biomarker QualificationRenal Biomarker DiscoveryTranslational Biomarker Development
The gap between development of exploratory biomarkers and their acceptance in drug development and regulatory review is a hurdle in the development of better therapies. The U.S. Food and Drug Administration has developed a regulatory process for biomarker qualification to accelerate the process by which new biomarkers are integrated in the development of therapies.
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Novel Biomarkers of Acute Kidney Toxicity
F M Goodsaid, Melanie Blank, Frank Dieterle et al. · Clinical Pharmacology & Therapeutics · 2009 · 41 citations
Pharmacy, Pharmacology, Toxicology +17