SAFETY REGULATORY PACKAGE
Porsolt’s broad expertise and years of preclinical pharmacology experience makes us the ideal partner to conduct your GLP Safety Pharmacology experiments. Porsolt offers safety studies in both in vitro and in vivo models with facilities, procedures, materials and software, that are validated to GLP standard.
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SAFETY REGULATORY PACKAGE
Behavioral Pharmacology Studies
Behavioral Pharmacology Studies for investigating abuse and dependence potential : Abuse and dependence potential is investigated as part of a GLP safety pharmacology package
| Conditioned place preference | Rat |
| Drug discrimination | Rat |
| Non-precipitated withdrawal(option: telemetry) | Rat |
| Self-administration (initiation) | Rat |
| Self-administration (substitution) | Rat |
Core Battery [ICH S7]
The safety pharmacology core battery investigates the effects of a test substance on vital functions, including the cardiovascular, respiratory and central nervous systems.
CARDIOVASCULAR ACTIVITY RECORDING
IN VITRO MODELS| hERG channel | HEK 293 cells |
| Purkinje fiber | Rabbit – Dog |
CARDIOVASCULAR STUDIES IN CONSCIOUS ANIMALS
| Arterial blood pressure, heart rate and ECG | Mouse – Rat – Dog - Guinea-pig – Mini-pig |
CENTRAL NERVOUS SYSTEM STUDIES
| Activity meter | Mouse – Rat |
| Primary observation (Irwin) | Mouse – Rat |
| Rotarod | Mouse – Rat |
RESPIRATORY STUDIES
| Airway function (whole body plethysmography) | Mouse – Rat - Guinea-pig |
Formulation Analysis
Formulation analysis is an essential part of GLP safety studies, when accuracy of dose concentrations is critical.
Porsolt’s vast portfolio of models and services for different indications also allows us to provide a comprehensive follow-up analysis of your project as part of a larger development program.
Method transfer or development
Method validation:
- specificity - accuracy
- linearity - precision,…
Stability evaluation
(stock and dosing formulations)
Adsorption evaluation
(for in vitro studies)
Formulation analysis:
- concentration verification
- homogeneity of formulations
Supplemental Studies
The effects of a test substance on other important physiological functions, beyond Central Nervous, Cardiovascular and Respiratory Systems, should be assessed.
| Autonomic nervous system | Rat |
| Cardiovascular studiesin anesthetized animals | Multiple species |
| Gastrointestinal system | Multiple species |
| Renal function | Mouse – Rat |
| Cardiomyocytes | iCell²® |
| Spontaneously beating right atrium | Guinea-pig – Rabbit |
| Stimulated left atrium | Guinea-pig – Rabbit |
