A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

Lutz Müller, Robert J. Mauthe, Christopher M. Riley, +21

Regulatory Toxicology and Pharmacology

BiochemistryDrug ResistanceMedicineDrug PurityToxicology Testing +8

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

Frank Dieterle, Frank D. Sistare, Federico Goodsaid, +62

Nature Biotechnology

Translational MedicineUrologyRenal FunctionMedicineKidney Failure +7

Biological Qualification of Biomarkers of Chemical-Induced Renal Toxicity in Two Strains of Male Rat

Ernie Harpur, Daniela Ennulat, David Hoffman, +10

Toxicological Sciences

Renal PathologyRenal InflammationPathologyKidney InjuryToxicological Mechanism +27

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

Frank D. Sistare, Frank Dieterle, Sean P. Troth, +34

Nature Biotechnology

Drug SafetyPredictive ToxicologyPreclinical Drug EvaluationSafety BiomarkersPharmacology +8

Evaluation of Novel Biomarkers of Nephrotoxicity in Two Strains of Rat Treated with Cisplatin

Jean‐Charles Gautier, Björn Riefke, Jakob Walter, +10

Toxicologic Pathology

Renal LesionsRenal PathologyRenal InflammationPathologyOxidative Stress +17

MicroRNA-122: A Novel Hepatocyte-Enriched in vitro Marker of Drug-Induced Cellular Toxicity

Richard Kia, Lorna Kelly, Rowena Sison‐Young, +22

Toxicological Sciences

Cell Culture MediaImmunologyCell DeathPathologyHepatotoxicity +19

Normal Ranges and Variability of Novel Urinary Renal Biomarkers in Sprague-Dawley Rats

Jean‐Charles Gautier, Thierry Gury, Magali Guffroy, +4

Toxicologic Pathology

Renal PathologyRenal InflammationMultiple AssaysSingleplex AssaysRenal Function +17

Comparison between Male and Female Sprague-Dawley Rats in the Response of Urinary Biomarkers to Injury Induced by Gentamicin

Jean‐Charles Gautier, Thierry Gury, Magali Guffroy, +5

Toxicologic Pathology

Renal PathologyRenal InflammationReproductive EndocrinologyInflammationRenal Function +22

Biomarkers of Collecting Duct Injury in Han-Wistar and Sprague-Dawley Rats Treated with N-Phenylanthranilic Acid

Graham R. Betton, Daniela Ennulat, David Hoffman, +3

Toxicologic Pathology

Renal PathologyRenal InflammationOxidative StressInflammationGlomerulonephritis +25

Differential expression and ciprofibrate induction of hepatic UDP-glucuronyltransferases for thyroxine and triiodothyronine in Fischer rats

Theo J. Visser, Ellen Kaptein, Ernie Harpur

Biochemical Pharmacology

HepatologyBiochemistryDifferential ExpressionMedicineLiver Physiology +10