Back to Search
Start Over
Recent Successes in the Identification, Development, and Qualification of Translational Biomarkers
- Source :
- Toxicologic Pathology. 43:62-69
- Publication Year :
- 2014
- Publisher :
- SAGE Publications, 2014.
-
Abstract
- The development of novel safety or efficacy biomarkers has increasingly been used to improve safety monitoring and minimize attrition during drug development; however, for new biomarkers, the failure rate can equal or exceed that of new chemical entities. Drug-induced kidney injury is recognized to occur throughout the drug development process, with histopathology considered to be the gold standard for preclinical toxicologic screening. Renal biomarkers used clinically are primarily biomarkers of renal function and are considered insensitive for the detection of drug-induced kidney injury during first-in-man studies, particularly for compounds known to induce renal injury in preclinical species. Recent efforts by public–private partnerships have led to unprecedented success in the identification, development, and qualification of several new translatable biomarkers of kidney injury in the rat. To optimize the chance of success in current and future biomarker efforts in preclinical species and man, selection and development of biomarkers should emphasize biological considerations including marker variability and biology in both health and disease. The research to support the qualification of novel renal safety markers for routine use in the clinical setting is currently underway, and results from this work are greatly anticipated.
- Subjects :
- Male
medicine.medical_specialty
Drug Evaluation, Preclinical
Disease
Pharmacology
Kidney
Toxicology
Pathology and Forensic Medicine
Dogs
Renal injury
Toxicity Tests
Kidney injury
Animals
Humans
Medicine
Biomarker discovery
Intensive care medicine
Molecular Biology
business.industry
Cell Biology
Rats
medicine.anatomical_structure
Drug development
Biomarker (medicine)
Female
Kidney Diseases
Identification (biology)
business
Biomarkers
Subjects
Details
- ISSN :
- 15331601 and 01926233
- Volume :
- 43
- Database :
- OpenAIRE
- Journal :
- Toxicologic Pathology
- Accession number :
- edsair.doi.dedup.....8d11f3b4ada302667ba9e192ac1cb180