| Literature DB >> 22413806 |
Carole Evans1, David Cipolla, Tim Chesworth, Eva Agurell, Richard Ahrens, Dale Conner, Sanjeeva Dissanayake, Myrna Dolovich, William Doub, Anders Fuglsang, Afredo García Arieta, Michael Golden, Robert Hermann, Günther Hochhaus, Susan Holmes, Paul Lafferty, Svetlana Lyapustina, Parameswaran Nair, Dennis O'Connor, David Parkins, Ilse Peterson, Colin Reisner, Dennis Sandell, Gur Jai Pal Singh, Marjolein Weda, Patricia Watson.
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.Mesh：
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Year: 2012 PMID： 22413806 DOI： 10.1089/jamp.2011.0968
Source DB: PubMed Journal: J Aerosol Med Pulm Drug Deliv ISSN： 1941-2711 Impact factor: 2.849