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Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report
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 baseddoi:10.1089/jamp.2011.0968 pmid:22413806 fatcat:6zi3hrfmovajtiu6w75hwbq6xm