Respiratory safety assessment identifies potential adverse effects of test articles on lung function, before clinical trials, reducing the likelihood of failure in later stages
Pulmonary physiology is assessed at therapeutic and supratherapeutic exposure levels
Vivo Respiratory Safety Assessment - Methodology
Species: Rats, Guinea Pigs, Rabbits, Pigs
Timeline: 24 hours in-live, 1 week analysis
Vivo Respiratory Safety Assessment - Readouts & Application
Readouts:
Plethysmography
Pulmonary PV loop analysis
Intrapleural pressure telemetry
Application:
Respiratory safety assessment is necessary for regulatory submission. ICH guidelines S7A provide a framework for the methodology.