Simultaneous Assessment of the Safety Pharmacology Core Battery in Large Animal Species

Chengelis Christopher, Kearney Kenneth, Atterson Philip

doi:10.14869/toxp.36.0.4145.0

The assessment of the potential adverse effects of new chemical entities requires that CNS, cardiovascular and respiratory function are assessed as part of the core battery as mandated by the ICH S7A guidelines. Currently, the majority of these assessments are conducted as separate studies with the cardiovascular evaluation using a large animal species (commonly the dog or non-human primate) and the CNS and respiratory function studies performed using the rat. The initiative to combine cardiovascular (CV) and respiratory evaluation in the same study is very attractive as it allows reduction of animal use, study cost and time to project completion. Moreover, the increasing global requirements regarding safety assessment of biopharmaceuticals makes the simultaneous evaluation of safety pharmacology end points in an appropriate species, i.e. the non-human primate, an important consideration. Recent advances in respiratory inductance plethysmography (RIP) have allowed us to collect respiratory end-points as detailed in the ICH S7A guidelines in large animals. By combining this technology with the existing technology for cardiovascular data collection along with video monitoring systems, physiological data from freely moving large animal species can be continuously acquired.

Simultaneous Assessment of the Safety Pharmacology Core Battery in Large Animal Species

Description

Journal

Keywords

Details 詳細情報について

Export

Report a problem