European experiences with equivalence determinations for inhaled products will be the main focus of the workshop co-organized by ISAM and IPAC-RS. Canadian and US perspectives will also be represented. The program includes presentations from several regulatory agencies, academia and industry, as well as interactive breakout sessions on such topics as
鈥� Design of Equivalence Studies.
鈥� In Vivo Tests (PK, PD, Biomarkers).
鈥� "In Vitro Only" Equivalence.
鈥� Device Design Similarity and Testing Needed to Support Device Changes.
鈥� Design of Equivalence Studies.
鈥� In Vivo Tests (PK, PD, Biomarkers).
鈥� "In Vitro Only" Equivalence.
鈥� Device Design Similarity and Testing Needed to Support Device Changes.
