All Stories

  1. Response to reader comment on: “Comprehensive genotoxicity and carcinogenicity assessment of molnupiravir”
  2. Do longer duration nonclinical toxicology studies provide predictive clinical safety value? The IQ consortium longer duration nonclinical to clinical translational database
  3. Comprehensive genotoxicity and carcinogenicity assessment of molnupiravir
  4. Magnitude of Urine Albumin and KIM-1 Changes Can be Used to Differentiate Glomerular Injury From Tubular Injury in Rats
  5. Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies
  6. Projecting the impact of an ebola virus outbreak on endangered mountain gorillas
  7. Preclinical characterization and clinical translation of pharmacodynamic markers for MK-5890: a human CD27 activating antibody for cancer immunotherapy
  8. VSV-EBOV vaccine virus lacks horizontal transmission in swine
  9. Development of Pandemic Vaccines: ERVEBO Case Study
  10. Evaluation of 10 Urinary Biomarkers for Renal Safety With 5 Nephrotoxicants in Nonhuman Primates
  11. Vaccine toxicology study overview
  12. 3Rs Concepts for Pathologists
  13. Adversity designation for veterinary pathologists
  14. rVSVΔG-ZEBOV-GP (also designated V920) recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment
  15. An overview of current strategies to assess kidney safety in drug development
  16. Kidney Biomarkers - a historical perspective and future opportunities
  17. Data Visualization in Toxicology Studies
  18. Performance Assessment of New Urinary Translational Safety Biomarkers of Drug-induced Renal Tubular Injury in Tenofovir-treated Cynomolgus Monkeys and Beagle Dogs
  19. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic
  20. Regulatory Forum Opinion Piece*: Imaging Applications in Toxicologic Pathology—Recommendations for Use in Regulated Nonclinical Toxicity Studies
  21. Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective
  22. Rat Urinary Osteopontin and Neutrophil Gelatinase-Associated Lipocalin Improve Certainty of Detecting Drug-Induced Kidney Injury
  23. Evaluation of the Relative Performance of 12 Urinary Biomarkers for Renal Safety Across 22 Rat Sensitivity and Specificity Studies
  24. Recommendations for the Evaluation of Pathology Data in Nonclinical Safety Biomarker Qualification Studies
  25. Topic of Histopathology Blinding in Nonclinical Safety Biomarker Qualification Studies
  26. A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function
  27. Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies
  28. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
  29. Towards consensus practices to qualify safety biomarkers for use in early drug development
  30. Urinary biomarkers trefoil factor 3 and albumin enable early detection of kidney tubular injury
  31. A rapid urine test for early detection of kidney injury
  32. Integrated Pathway Analysis of Rat Urine Metabolic Profiles and Kidney Transcriptomic Profiles To Elucidate the Systems Toxicology of Model Nephrotoxicants
  33. In vivo CXCR4 expression, lymphoid cell phenotype, and feline immunodeficiency virus infection