The follow-up of the spontaneous activity of a subject in...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.
The DECRO solution permits to simultaneously record respiratory parameters, ECG and activity in socially-housed rats in a non-invasive approach by jacketed telemetry.
This solution enables Standard Safety Pharmacology Respiratory studies enhanced with cardiac and spontaneous activity endpoints, providing additional contextualization and screening capabilities. It can be deployed in safety pharmacology (stand-alone) or toxicology (incorporation of safety pharmacology endpoints) studies.
In addition to satisfying ICH S7A for respiratory function 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.
Fields of applications:
- Integrated physiology for early-stage or pre-regulatory studies
- Access to cardiorespiratory safety and CNS (spontaneous activity) parameters in a toxicology study
- Repro-TOX studies (juvenile minipigs)
- Pharmacological effects of small molecules or biological compounds or of active metabolites with long kinetics