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SAFETY PHARMACOLOGY
Covering the main areas mandated by ICH S7 Guidelines, NOTOX recommends a core set of studies for the evaluation of effects of compounds on the central nervous system (CNS), as well as cardiovascular and respiratory function.
Types of safety pharmacology studies required depend largely on the mode of action of the test material. NOTOX has established safety pharmacology models to meet current regulatory requirements for the core tests and, if indicated, follow-up studies in each area.These include startle response and learning and memory studies for the CNS, as well as additional cardiovascular and respiratory tests, and can also include supplemental studies like evaluation of renal and immune functions.
The core tests include:
Covering the main areas mandated by ICH S7 Guidelines, NOTOX recommends a core set of studies for the evaluation of effects of compounds on the central nervous system (CNS), as well as cardiovascular and respiratory function. Types of safety pharmacology studies required depend largely on the mode of action of the test material. NOTOX has established safety pharmacology models to meet current regulatory requirements for the core tests and, if indicated, follow-up studies in each area.These include startle response and learning and memory studies for the CNS, as well as additional cardiovascular and respiratory tests, and can also include supplemental studies like evaluation of renal and immune functions.
The core tests include:
- Central nervous system studies: Modified Irwin Screen. For validation of the Irwin test, amphetamine and chlorpromazine are used as positive controls.
- Cardiovascular studies in conscious, unrestrained animals via telemetry. Evaluation of heart rate, blood pressure and ECG are implemented. In addition the in vitro hERG assay is performed. This assay is validated using HEK239 cells with E-4031 as positive control.
- Respiratory evaluations for routine parameters, such as respiratory rate and tidal volume. Carbachol and clonidine are used to validate the respiratory safety test, using a head-out plethysmograph set-up.
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 Immunotoxicity studies (flyer) | |
| Safety Pharmacology studies (flyer) | |
| A head-out plethysmography set-up for respiratory safety assessment (poster) | |
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