Benchmark Your Toxicology Findings Against FDA-Approved Drugs
Drug developers face critical questions before submitting their IND:
- How problematic are our toxicology findings?
- Have similar effects been seen with approved drugs?
- At what exposure multiples were they seen?
- Did they get worse in longer-duration studies?
- Did those findings translate to humans?
TurboToxicology from Resero Analytics provides immediate answers by comparing your study results to those from FDA-approved compounds. This comparative safety profiling approach helps toxicologists, pathologists, and regulatory teams interpret their data with confidence by reducing uncertainty and improving the quality of IND submissions.
Turn FDA Precedent Into Regulatory Confidence
Comparative safety profiling for histopathology, clinical pathology, organ weights, and exposure multiples helps drug developers focus on what’s important by highlighting toxicology findings that fall outside the range observed in approved drugs. This helps:
- Identify which findings fall outside the range seen in approved drugs.
- Flag study results that regulators are most likely to question.
- Gain confidence that many findings are noteworthy but may not be disqualifying.
All comparisons link directly to the original pages in FDA source documents so users can scrutinize the evidence for comparable toxicology findings caused by marketed drugs.
Add Your Company’s Legacy Data for Greater Insight
Drug developers can enrich their experience using TurboToxicology by adding their company’s legacy data. Resero Analytics extracts your company’s legacy data from PDF study reports, files, and APIs, maps them to Controlled Terminology such as CDISC/SEND, and loads them into a secure, searchable environment.
This unlocks:
- Internal benchmarking across development programs
- Consistent and meaningful application of your company’s institutional knowledge
- Continuously expanding safety data repository as new FDA and company studies are added
Built on Data Integrity and Scientific Rigor
All data, whether public or proprietary, undergo controlled extraction, annotation, and quality review. Every finding is searchable, traceable to their original regulatory or proprietary source, and organized for analysis and reporting. Your company’s data remains private and protected, accessible only by your team.
Built for Scientists Across Disciplines
TurboToxicology software is used by toxicologists to weigh the significance of target organ effects and their exposure multiples. Pathologists use it to help determine whether histopathology lesions are treatment-related. Regulatory scientists use it to support safety narratives in Module 2 of IND submissions.
From early discovery through IND-enabling and chronic studies, TurboToxicology empowers scientific teams to analyze, interpret, and report toxicology and pathology data with greater confidence. Comparative safety profiling further enhances its value for compound safety evaluation.
Request a Demo of TurboToxicology from Resero Analytics
Want to know if your findings match FDA-approved drugs? Schedule a live demo of TurboToxicology today and see how comparative safety profiling supports your next IND.