safety pharmacology 

ICH S7A and S7B guidelines for the conduct of safety pharmacology evaluations recommend a core battery of studies on three vital organ systems (cardiovascular, respiratory and central nervous system) to assess the potential risks of novel pharmaceuticals for human use. Charles River can customize safety pharmacology studies to the individual needs of both your program and your compound. We have established ICH core battery tests and supplementary safety pharmacology models (detailed below) to meet current regulatory requirements and provide meaningful data to accurately drive your decision-making process. We continually invest in the most scientifically robust, state-of-the-art equipment to support cost- and animal-efficient study designs. Our three safety pharmacology facilities feature dedicated telemetry suites, surgical capabilities and custom-built cardiovascular laboratories equipped with one-way viewports and closed-circuit television to allow remote observation of the animals without disrupting data collection. We have validated the use of ECG pattern recognition software to increase the sensitivity of our ECG analyses.

To learn more about incorporating these safety pharmacology technologies into your program, click here to contact an expert.

Related Information

• Webinar Replay - Jacketed External Telemetry (JET) with Blood Pressure: Continuous Collection of Key Cardiovascular Data in Repeat-Dose Studies (Available only in The Source℠. Click here to log in or click here to register.)
• Safety Pharmacology: Problem Solved Case Study (Available only in The Source℠. Click here to log in or click here to register.)