R. Fares & P. Champeroux, ERBC FOB test and respiratory...Read More
The nonclinical safety assessment for marketing approval of a pharmaceutical usually includes pharmacology studies, general toxicity studies, toxicokinetic and nonclinical pharmacokinetic studies, reproduction toxicity studies or genotoxicity studies. Other nonclinical studies to assess phototoxicity, immunotoxicity, juvenile animal toxicity and abuse liability should be conducted on a case-by-case basis (ICH guideline M3(R2)).
Respiratory and cardiovascular systems and CNS are among the vital organ systems that should be studied in safety pharmacology core battery test for small molecules as for large molecules usually in 2 species, rodents and non-rodents.
The DECRO solution permits to simultaneously record respiratory parameters, ECG and activity in socially-housed animals (rats and minipigs) in a non-invasive approach by jacketed external telemetry.
The solution enables Standard Safety Pharmacology Respiratory studies enhanced with cardiac and spontaneous activity endpoints, as stand-alone studies or combined with CNS evaluation (FOB/Irwin tests) in one single study.
In addition to satisfying ICH S7A for respiratory function and FOB with the ability to be ambulatory and collect data for 24 hours, the simultaneous collection of HR and activity aid in the interpretation of any changes the test article may produce.
DECRO solution can therefore be deployed in GLP and non GLP safety pharmacology (stand-alone) or toxicology (incorporation of safety pharmacology endpoints) studies.
Fields of applications:
- Integrated physiology for early-stage or pre-regulatory studies (DRF)
- Access to cardiorespiratory safety and CNS (spontaneous activity) parameters in a toxicology study
- Repro-TOX studies (juvenile minipigs for the 1st week of age)
- Pharmacological effects of small molecules or biological compounds or of active metabolites with long kinetics