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

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Behavioral Pharmacology Studies for investigating abuse and dependence potential : Abuse and dependence potential is investigated as part of a GLP safety pharmacology package

IN VIVO MODELS >
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
EX-VIVO MODELS
Purkinje fiber Rabbit – Dog
IN VIVO MODELS

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.

IN VIVO MODELS
Autonomic nervous system Rat
Cardiovascular studiesin anesthetized animals Multiple species
Gastrointestinal system Multiple species
Renal function Mouse – Rat
EX-VIVO MODELS
Cardiomyocytes iCell²®
Spontaneously beating right atrium Guinea-pig – Rabbit
Stimulated left atrium Guinea-pig – Rabbit

Porsolt

Z.A. de Glatigné
53940 Le Genest-Saint-Isle, France
Telephone +33 2 43 69 36 07

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