Timing is Everything: Biomarkers for Early Detection of Preclinical Toxicology Events
Now On Demand | Hosted by AAPS
Small molecule biomarkers represent dynamic indicators of adverse effects in the setting of drug exposure and can provide an early warning of drug toxicity prior to histopathological changes. Nontargeted measurement of small molecule biomarkers in preclinical samples can lead to the discovery of early biomarkers that are associated with late-stage toxicity outcomes. The ability to detect biomarkers of adverse drug changes early can support better and faster go/no-go decision making to optimize the time, cost, and ultimate success of drug development programs.
This presentation explores the use of next-generation mass spectrometry for small molecule biomarker discovery (“metabolomics”) to enable the early detection of toxicology and safety events in preclinical studies, and to better predict and mitigate late-stage toxicity in clinical studies.
- The dynamic characteristics of small molecule biomarkers and how they can be leveraged to detect drug-induced toxic events long before histopathological changes.
- How discovery metabolomics can be used to reduce the time, size, and number of preclinical studies needed to support candidate drugs through human clinical trials.
- The use of rapid small molecule profiling to monitor safety biomarkers that can be used to detect and track toxicity events in real time and potentially guide adjustments in drug dosing regimens.