Charles River has established ICH core battery tests and supplementary models to meet current regulatory requirements and provide meaningful data to accurately drive your decision-making process.
Safety pharmacology programs can help further drug development by investigating the potential undesirable effects of a compound on physiological functions in relation to exposure in the therapeutic range and above. As every compound is unique, it takes specialized knowledge of regulatory guidance to develop the most appropriate safety pharmacology program. We can customize your study to address both your program- and compound-specific needs or include our core safety parameters in toxicology studies as an efficient means of meeting regulatory expectations.
Charles River is continually validating state-of-the-art equipment, assays, and experimental techniques to establish and implement industry best practices while improving animal welfare. Purpose-built in vivo safety pharmacology facilities feature dedicated telemetry suites, surgical pharmacology capabilities, and custom-built laboratories that allow for remote observation of the animals without disrupting data collection. Colony rooms expedite study start up times providing meaningful data faster.
- GLP Core Battery Assessments
- A focus on follow-on and/or Supplement Studies
- Comprehensive approach for combining safety pharmacology endpoints within repeat dose toxicology studies
- Integration of assays from in vitro through in vivo for cardiovascular, respiratory, and central nervous systems assessments
- Advanced QT/QTc beat-to-beat assessment to determine arrhythmogenic risk