Taking a deep breath: Evidence-based approaches to respiratory safety assessment

Modernization of the necessity and conduct of nonclinical respiratory assays should be undertaken to enhance their translational impact for clinical outcomes, optimize animal and development costs, and ultimately strengthen regulatory relevance. This manuscript offers a perspective on why the International Conference on Harmonization (ICH) S7A mandated respiratory assay should be updated, offering a potential streamlined approach for putative therapeutics with minimal expected risks, and recommendations on more rigorous, supplemental investigations of respiratory safety hazards.