Translational Medicine and the Value of Biomarker Qualification

The Critical Path Institute’s Approach to Precompetitive Sharing and Advancing Regulatory Science

(2010) R L Woosley et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Towards consensus practices to qualify safety biomarkers for use in early drug development

(2010) Frank D Sistare et al.   NATURE BIOTECHNOLOGY

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

(2010) Federico M. Goodsaid et al.   NATURE REVIEWS DRUG DISCOVERY

Novel Biomarkers of Acute Kidney Toxicity

(2009) F M Goodsaid et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A guidance for renal biomarker lead optimization and use in translational pharmacodynamics☆

(2009) Josef S. Ozer   DRUG DISCOVERY TODAY

Creatinine as the gold standard for kidney injury biomarker studies?

(2009) S. S. Waikar et al.   NEPHROLOGY DIALYSIS TRANSPLANTATION

Genomic and genetic biomarkers of toxicity

(2007) Donna L. Mendrick   TOXICOLOGY