title: Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
abstract: The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified.
authors.affiliation: Catalent Pharma Solutions, Research Triangle Park, NC 27709, USA. carole.evans@catalent.com
authors.forename: Carole
authors.initials: C
authors.lastname: Evans
authors.forename: David
authors.initials: D
authors.lastname: Cipolla
authors.forename: Tim
authors.initials: T
authors.lastname: Chesworth
authors.forename: Eva
authors.initials: E
authors.lastname: Agurell
authors.forename: Richard
authors.initials: R
authors.lastname: Ahrens
authors.forename: Dale
authors.initials: D
authors.lastname: Conner
authors.forename: Sanjeeva
authors.initials: S
authors.lastname: Dissanayake
authors.forename: Myrna
authors.initials: M
authors.lastname: Dolovich
authors.forename: William
authors.initials: W
authors.lastname: Doub
authors.forename: Anders
authors.initials: A
authors.lastname: Fuglsang
authors.forename: Afredo
authors.initials: A
authors.lastname: García Arieta
authors.forename: Michael
authors.initials: M
authors.lastname: Golden
authors.forename: Robert
authors.initials: R
authors.lastname: Hermann
authors.forename: Günther
authors.initials: G
authors.lastname: Hochhaus
authors.forename: Susan
authors.initials: S
authors.lastname: Holmes
authors.forename: Paul
authors.initials: P
authors.lastname: Lafferty
authors.forename: Svetlana
authors.initials: S
authors.lastname: Lyapustina
authors.forename: Parameswaran
authors.initials: P
authors.lastname: Nair
authors.forename: Dennis
authors.initials: D
authors.lastname: O'Connor
authors.forename: David
authors.initials: D
authors.lastname: Parkins
authors.forename: Ilse
authors.initials: I
authors.lastname: Peterson
authors.forename: Colin
authors.initials: C
authors.lastname: Reisner
authors.forename: Dennis
authors.initials: D
authors.lastname: Sandell
authors.forename: Gur Jai Pal
authors.initials: GJ
authors.lastname: Singh
authors.forename: Marjolein
authors.initials: M
authors.lastname: Weda
authors.forename: Patricia
authors.initials: P
authors.lastname: Watson
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols / Q000493:pharmacokinetics*; D001682:Biological Availability; D002170:Canada; D004335:Drug and Narcotic Control; D058995:Dry Powder Inhalers; D005060:Europe; D006801:Humans; D008168:Lung / Q000378:metabolism*; D036501:Metered Dose Inhalers; D008962:Models, Theoretical; D010316:Particle Size; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000336:Aerosols