Safety and general pharmacology

Dedicated facilities comprising specific housing equipped with video monitoring and tailored computer systems. These enable a large variety of study designs with rodent and non-rodent species, to be performed. All material and software have been validated according to GLP standards 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 using animals (dog, non-human primate and mini-pig) via specific approaches dedicated to the assessment of cardiovascular and respiratory functions by external telemetry and minimally invasive telemetry combined with Functional Observational Battery. With a wealth of experience in pharmacology and toxicology, CIT can be considered as the ideal partner for in vivo screening tests, as well as pathological, mutant and transgenic models. In the recent years, pathological models have been developed in a wide range of species and our expertise enables us to develop customized chronic pathology in vivo models.

1. ICH S7A – Core Battery Studies (CNS)

 

Central Nervous system

  • Irwin test and Functional Observation Battery (FOB) in rodents
  • FOB 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 non rodents (including primates, dogs and minipigs)
  • Telemetry in rodents
  • 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 measurement
  • Gastric emptying and secretion test
  • 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 Arrhythmogenic Profile

In vivo

  • Evaluation of QT prolongation by telemetry in conscious animals: (dogs, primates, minipigs and guinea-pig)
  • Hypokalemic sensitised models (guinea pigs and dogs)
  • Combined ECG and respiratory evaluations 

 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

 

4. Safety pharmacology endpoints in toxicology

Central nervous system

  • FOB in non-rodents

  • Irwin test and FOB in rodents.

Cardiovascular system (CV)

  • External Telemetry in non rodents (including primates, dogs and minipigs).
  • Minimally invasive telemetry in non rodents.

 

Respiratory system

  • Respiratory function in non rodents by external telemetry.
  • Whole body plethysmography in conscious rats.

 

 Combining the evaluation of three functions in regulatory toxicology

 

 5. Early safety pharmacology screening battery for QT lengthening and Cardiovascular toxicity assessment

In vivo

  • Anaesthetized model: guinea-pig
  • Conscious model: guinea-pig with external telemetry device held in place by a jacket.

 

In vitro

  • Human Ether a go-go Related Gene (hERG) assay.

 

6. Other pharmacological tests

 

General Pharmacology

  • Ototoxicity evaluation by Auditory Brainstem Response (ABR),
  • Sepsis model in mice (LPS) and primates (E. coli)
  • Wound Healing
  • Gastric emptying in NHPs
  • Effect on triglyceride metabolism
  • Other tests upon request

 

Disease models

  • Hypo K+
  • TdP models
  • Cardiac hypertrophy
  • Myocardial infarction,
  • Hypertension
  • Diabetes
  • Hypercholesterolemia 
  • Transgenic models
  • Other diseases upon request.

Juvenile models                                    

 

Our Partners
New toxicity assessment using human and embryonnic stem cells New efficacy models

Stay informed

 

© All rights reserved to CIT  | Conception 2exVia with MasterEdit©