Safety Biomarkers in Preclinical Development
| Autor: | Dominique Brees, Vito G. Sasseville, Keith Mansfield |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Clinical Trials as Topic
medicine.medical_specialty Pathology Clinical Drug-Related Side Effects and Adverse Reactions General Veterinary business.industry Drug discovery Drug Evaluation Preclinical Pharmacology Biomarkers Pharmacological Translational Research Biomedical Clinical trial Drug Discovery Animals Humans Medicine Biomarker (medicine) Biomarker discovery business Preclinical toxicology Intensive care medicine |
| Zdroj: | Veterinary Pathology. 51:281-291 |
| ISSN: | 1544-2217 0300-9858 |
| DOI: | 10.1177/0300985813505117 |
| Popis: | The identification, application, and qualification of safety biomarkers are becoming increasingly critical to successful drug discovery and development as companies are striving to develop drugs for difficult targets and for novel disease indications in a risk-adverse environment. Translational safety biomarkers that are minimally invasive and monitor drug-induced toxicity during human clinical trials are urgently needed to assess whether toxicities observed in preclinical toxicology studies are relevant to humans at therapeutic doses. The interpretation of data during the biomarker qualification phase should include careful consideration of the analytic method used, the biology, pharmacokinetic and pharmacodynamic properties of the biomarker, and the pathophysiology of the process studied. The purpose of this review is to summarize commonly employed technologies in the development of fluid- and tissue-based safety biomarkers in drug discovery and development and to highlight areas of ongoing novel assay development. |
| Databáze: | OpenAIRE |
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