Dedicated facilities with specific housing and tailored computer systems allow a large variety of study designs with rodent and non-rodent species. All material and software have been validated following GLP guidance in order to fulfil ICH requirements. Studies can be conducted with standard or non standard designs (see general toxicology for species and routes of administration).
Safety pharmacology end-points are also available in regulatory toxicity studies via specific approaches (external telemetry, non rodent Functional Observation Battery for example).
In the view of our experience in pharmacology and toxicology, CIT can be considered as the ideal partner for in vivo screening tests, pathological, mutant and transgenic models. In the recent years, we developed several pathological models in a wide range of different species. Our expertise enables us to develop customized chronic pathological in vivo models.
| 1. ICH S7A – Core Battery Studies (CNS) |
Central Nervous system |
Irwin test and Functional Observation Battery (FOB) in rodents |
Specific detailed observation in non-rodents |
Locomotor Activity (actimetry for rats or telemetry for all species) |
Motor coordination (rotarod test) |
Hexobarbital-induced sleeping time |
Cardiovascular system (CV) |
Telemetry in rodents |
Telemetry in non rodents (including primates and minipigs) |
Orthostatic hypotension in dogs (tilt model) |
Anaesthetized preparations |
Respiratory system |
Whole body plethysmography in conscious rats and guinea-pigs |
2. ICH S7A - Supplemental studies |
Renal function |
Diuresis and ionic clearances |
Gastro-intestinal system |
Charcoal transit time |
Gastric emprying and secretion |
Ulcer induction in rodents |
Endocrine system |
Glucose tolerance test |
ACTH stimulation test |
Lipid Metabolism |
Uterotrophic assay |
Coagulation |
Bleeding time |
Thrombosis models |
3. ICH S7B - QT Prolongation and Arhythmogenic Profile |
In vitro |
Human Ether a go-go Related Gene (hERG) assay |
Purkinje fibres or papillary muscles action potential duration |
Available under GLP conditions through partnerships |
In vivo |
QT prolongation evaluation by telemetry in conscious animals: (guinea pigs, dogs, primates and minipigs) |
Hypokalemic sensitised models (guinea pigs and dogs) |
Combined ECG and respiratory evaluations |
Map
Short term, tolerance and in-vitro toxicology