The types of safety pharmacology studies that are required depend largely on the mode of action of the test material. Charles River recommends a core battery of studies for the evaluation of your test material’s effects on the central nervous system, as well as cardiovascular and respiratory function. We have established safety pharmacology models to meet current regulatory requirements for these core battery tests plus supplementary studies to support your program.
Core Battery Tests
- Central nervous system (CNS) studies in rodents and non-rodents (Functional Observational Battery or Modified Irwin Screen)
- Respiratory evaluations for routine parameters in rodents and nonrodents
- Cardiovascular studies in conscious, unrestrained naïve or non-naïve animals via telemetry or jacket and tether systems
Supplementary Studies
- All main areas mandated by ICH S7 Guidelines
- Additional investigations for CNS, respiratory, and cardiovascular effects
- Renal
- Gastrointestinal
- Muscle and autonomic nervous system function
- Evaluation of endocrine and immune effects
- In vitro hERG and action potential duration assays
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safety pharmacology, safety pharmacology studies, safety pharmacology models, core battery tests, Functional Observational Battery, Modified Irwin Screen, ICH S7 Guidelines
Safety Pharmacology Studies | Preclinical Services | Charles River
The types of safety pharmacology studies required depend largely on the mode of action of the test article. We have established safety pharmacology models to meet current regulatory requirements for both core battery tests and supplementary studies.