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 core battery and supplementary safety pharmacology models to meet current regulatory requirements and provide meaningful data to accurately drive your decision-making process.
Benefits of the Charles River Safety Pharmacology Approach
Using our experience to ensure your success. Because every compound is unique, it takes specialized knowledge of regulatory guidance documents to develop the most appropriate safety pharmacology program.
- 25 years of experience interacting with pharm/tox reviewers
- Over 2000 safety pharmacology studies performed since the finalization of the guidelines in 2000
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Conducted studies across the entire range of NCEs and biologics
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Navigator Services: two former FDA reviewers and a world-renowned cardiovascular expert available to offer guidance tailored specifically for your compound
Focusing on your needs. For safety pharmacology studies, timing is critical. Charles River can help you streamline your studies without sacrificing quality or responsiveness.
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Cost-effective solutions to ensure competitive pricing
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Study lead-in times as short as three weeks
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Instrumented colony animals available for quick study starts
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Rapid access to audited draft reports
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On-time reporting history of >98%
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Study updates and data accessibility tailored to your requirements
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Global protocols, reports and statistical templates
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Real-time access to data
S7A Core Battery
Supplemental Studies
Investing for you. At Charles River, we continually invest in the most scientifically robust, state-of-the-art equipment to support cost- and animal-efficient study designs. We have three facilities with 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. Our sites employ the DSI™ Ponemah Physiology Platform (P3P) for respiratory and cardiovascular data analysis, and we are validating the use of ECG pattern recognition software to increase the sensitivity of our ECG analyses. We have also validated the noninvasive DSI JET™ for ECG collection in large animals and are in the process of completing the validation for blood pressure and respiratory measurements. We have implemented High-Definition Oscillometry (HDO) as a state-of-the-art method for the collection of noninvasive blood pressure measurements in toxicology studies.
In 2010, the Safety Pharmacology Society (SPS) acknowledged the need to establish Best Practices guidelines for cardiovascular safety studies. Charles River is keenly aware of technological advances in safety pharmacology data acquisition and analysis and is proactively implementing those aspects of the Best Practices dialogue for which there was a broad consensus. We will continually monitor the evolution of the SPS CV Best Practices guidelines and implement consensus recommendations in our safety pharmacology studies as necessary.
We are committed to maintaining industry-leading services and support to help you carry out a successful safety pharmacology program for your important drug products.
Related Information
Webinar Replay - The Inclusion of Safety Pharmacology and DART Endpoints into Chronic Toxicology Studies (June 2010)
Additional information about our Safety Pharmacology capabilities is available in The Source
SM, o
ur new online scientific and educational information center. To register for The SourceSM, please click here. If you are already a member, click here to login.
If you have any questions, please contact us at askcharlesriver@crl.com.