Safety Pharmacology
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.
Core Battery Studies
Central Nervous System (CNS)
- Functional Observational Battery (FOB)/Modified Irwin Test: mice and rats
- CNS studies in large animals: dogs, non-human primates and minipigs
Cardiovascular System
- Telemetry implanted studies (Blood Pressure + Electrocardiogram + Temperature):
conscious dogs, non-human primates and minipigs - Canine Left Ventricular Pressure (LVP) study
- Jacketed External Telemetry (JET) ECG evaluation: conscious dogs, non-human primates and minipigs and rabbits
- Implanted blood pressure combined with JET ECG evaluation: conscious dogs, non-human primates and minipigs
- SEND data sets
Respiratory System
- Head-out Plethysmography: rats
- Whole Body Plethysmography (WBP): mice and rats
- Face Mask: dogs, minipigs and non-human primates
- SEND data sets
Supplemental Studies
Gastrointestinal Motility
- Studies in mice and rats
Renal System
- Renal function in rats and monkey
Other Studies and Experience
- Guinea pig QT study: non-GLP
- Drug dependence studies in rats
- Sensitivity analysis in dog and non-human primate CV studies
- Qualitative and quantitative ECG evaluation
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.