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in vitro & in vivo Safety Assessment Studies
Safety pharmacology studies are required to assess the impact of your new candidate on human biological systems prior to the clinical testing phase. As your dedicated testing partner, our expert team works with you to conduct in vitro and in vivo safety pharmacology studies that quickly and accurately assess your candidate’s potential for toxicity across major therapeutic areas including CNS, cardiovascular, respiratory, gastrointestinal, and renal systems.
Expert Safety Pharmacology & Toxicology Testing
From non-GLP safety screening assays to expert safety pharmacology study designs, our toxicology programs can be tailored to fit your specific project and needs – for both small- or large-molecule compounds.
Non-GLP Cardiovascular Safety Screening Assays
- Guinea pig QT assay
- Rat telemetry studies
- SHR studies for cardiovascular efficacy
- EKG and indirect blood pressure in canines and Non-Human Primates (NHPs)
- hERG assay
Safety Pharmacology Studies
- Functional Observational Battery (FOB) studies in rats and mice
- CNS system evaluation in mice, rats, canines and NHPs
- Cardiovascular telemetry studies in conscious canines, NHPs and minipigs
- Jacketed External Telemetry (JET) in conscious canines and NHPs
- Respiratory system studies in conscious rats and mice (head-out plethysmographs), canines and NHPs
- hERG assay
- Gastrointestinal motility studies in rats and mice
Renal function in rats
How We Work
Our Safety Pharmacology experts have decades of experience conducting safety assessment studies for drug development. Working as an extension of your team, we design a safety study around your specific data and timeline requirements, and with the right selection of assays. We then provide regulatory support to help you stay ahead of any relevant guidance. All to ensure your candidate can advance through its development lifecycle without risk of delay or retesting.
Your Global Partner for Toxicology
As part of our mission to seamlessly deliver high-quality data that enables high-quality drug candidates, you’ll have access to our world-class safety assessment center in Suzhou, China, where we invest in the most advanced technology for data acquisition and processing – and utilize the Ponemah® Software platform for data collection and assimilation.
We also work with the International Conference on Harmonization International (ICH), complying with requirements and providing clarifications needed to advance your program successfully.