1. Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
- Author
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Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, García Arieta A, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lyapustina S, Nair P, O'Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJ, Weda M, and Watson P
- Subjects
- Administration, Inhalation, Biological Availability, Canada, Drug and Narcotic Control, Dry Powder Inhalers, Europe, Humans, Metered Dose Inhalers, Models, Theoretical, Particle Size, Therapeutic Equivalency, United States, United States Food and Drug Administration, Aerosols pharmacokinetics, Lung metabolism
- 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.
- Published
- 2012
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