Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report

Carole Evans, David Cipolla, Tim Chesworth, Eva Agurell, Richard Ahrens, Dale Conner, Sanjeeva Dissanayake, Myrna Dolovich, William Doub, Anders Fuglsang, Afredo García Arieta, Michael Golden (+14 others)
2012 Journal of Aerosol Medicine  
Executive Summary T he European regulatory approach to determining equivalence of locally acting orally inhaled products (OIPs) recommends a stepwise demonstration of equivalent product performance via in vitro tests, failing that-via pharmacokinetic (PK) safety plus PK pulmonary deposition or lung imaging studies, and failing that-via pharmacodynamic (PD) or clinical studies. North American regulatory approaches do not allow equivalence determinations based
doi:10.1089/jamp.2011.0968 pmid:22413806 fatcat:6zi3hrfmovajtiu6w75hwbq6xm