Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification

Validation of high-resolution echocardiography and magnetic resonance imaging vs. high-fidelity catheterization in experimental pulmonary hypertension

(2010) Dalia Urboniene et al.   AMERICAN JOURNAL OF PHYSIOLOGY-LUNG CELLULAR AND MOLECULAR PHYSIOLOGY

A Systematic Approach to Preclinical and Clinical Safety Biomarker Qualification Incorporating Bradford Hill's Principles of Causality Association

(2010) R K Chetty et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs

(2010) J A DiMasi et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Research at the interface of industry, academia and regulatory science

(2010) William B Mattes et al.   NATURE BIOTECHNOLOGY

Urinary biomarkers trefoil factor 3 and albumin enable early detection of kidney tubular injury

(2010) Yan Yu et al.   NATURE BIOTECHNOLOGY

Urinary clusterin, cystatin C, β2-microglobulin and total protein as markers to detect drug-induced kidney injury

(2010) Frank Dieterle et al.   NATURE BIOTECHNOLOGY

Next-generation biomarkers for detecting kidney toxicity

(2010) Joseph V Bonventre et al.   NATURE BIOTECHNOLOGY

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

(2010) Frank Dieterle et al.   NATURE BIOTECHNOLOGY

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

(2010) Frank D Sistare et al.   NATURE BIOTECHNOLOGY

Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies

(2010) Vishal S Vaidya et al.   NATURE BIOTECHNOLOGY

EU Framework 6 Project: Predictive Toxicology (PredTox)—overview and outcome

(2010) Laura Suter et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Plasma MicroRNAs as Sensitive and Specific Biomarkers of Tissue Injury

(2009) O. F. Laterza et al.   CLINICAL CHEMISTRY

Circulating microRNAs, potential biomarkers for drug-induced liver injury

(2009) K. Wang et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Electrochemiluminescent immunoassay for rat skeletal troponin I (Tnni2) in serum

(2009) Deqin Sun et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

The carcinoGENOMICS project: Critical selection of model compounds for the development of omics-based in vitro carcinogenicity screening assays

(2008) M VINKEN et al.   MUTATION RESEARCH-REVIEWS IN MUTATION RESEARCH

Strategic Approach to Fit-for-Purpose Biomarkers in Drug Development

(2007) John A. Wagner   Annual Review of Pharmacology and Toxicology

Cardiac troponin is the most effective translational safety biomarker for myocardial injury in cardiotoxicity

(2007) Peter James O’Brien   TOXICOLOGY