TY - JOUR
T1 - Taking a deep breath
T2 - Evidence-based approaches to respiratory safety assessment
AU - Kremer, John J.
AU - Bridgland-Taylor, Matt
AU - Clark, Matt
AU - Rolf, Mike G.
AU - Traebert, Martin
AU - Friedrichs, Gregory S.
N1 - Publisher Copyright:
© 2025 Elsevier Inc.
PY - 2025/6
Y1 - 2025/6
N2 - 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.
AB - 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.
KW - Perspective
KW - Respiratory
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=105004193893&partnerID=8YFLogxK
U2 - 10.1016/j.vascn.2025.107744
DO - 10.1016/j.vascn.2025.107744
M3 - Artículo
AN - SCOPUS:105004193893
SN - 1056-8719
VL - 134
JO - Journal of Pharmacological and Toxicological Methods
JF - Journal of Pharmacological and Toxicological Methods
M1 - 107744
ER -