Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report
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 Sc...
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| Veröffentlicht in: | Journal of aerosol medicine 2012-06, Vol.25 (3), p.117-139 |
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| creator | Evans, Carole Cipolla, David Chesworth, Tim Agurell, Eva Ahrens, Richard Conner, Dale Dissanayake, Sanjeeva Dolovich, Myrna Doub, William Fuglsang, Anders García Arieta, Afredo Golden, Michael Hermann, Robert Hochhaus, Günther Holmes, Susan Lafferty, Paul Lyapustina, Svetlana Nair, Parameswaran O'Connor, Dennis Parkins, David Peterson, Ilse Reisner, Colin Sandell, Dennis Singh, Gur Jai Pal Weda, Marjolein Watson, Patricia |
| description | 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. |
| doi_str_mv | 10.1089/jamp.2011.0968 |
| format | Article |
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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.</description><identifier>ISSN: 1941-2711</identifier><identifier>EISSN: 1941-2703</identifier><identifier>DOI: 10.1089/jamp.2011.0968</identifier><identifier>PMID: 22413806</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Administration, Inhalation ; Aerosols - pharmacokinetics ; Biological Availability ; Canada ; Drug and Narcotic Control ; Dry Powder Inhalers ; Europe ; Health technology assessment ; Humans ; Lung - metabolism ; Metered Dose Inhalers ; Models, Theoretical ; Particle Size ; Therapeutic Equivalency ; United States ; United States Food and Drug Administration</subject><ispartof>Journal of aerosol medicine, 2012-06, Vol.25 (3), p.117-139</ispartof><rights>(©) Copyright 2012, Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-da990353895fce8bd311f81a232c6901632f75cf30ecf151ea5da650afd166873</citedby><cites>FETCH-LOGICAL-c389t-da990353895fce8bd311f81a232c6901632f75cf30ecf151ea5da650afd166873</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22413806$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Evans, Carole</creatorcontrib><creatorcontrib>Cipolla, David</creatorcontrib><creatorcontrib>Chesworth, Tim</creatorcontrib><creatorcontrib>Agurell, Eva</creatorcontrib><creatorcontrib>Ahrens, Richard</creatorcontrib><creatorcontrib>Conner, Dale</creatorcontrib><creatorcontrib>Dissanayake, Sanjeeva</creatorcontrib><creatorcontrib>Dolovich, Myrna</creatorcontrib><creatorcontrib>Doub, William</creatorcontrib><creatorcontrib>Fuglsang, Anders</creatorcontrib><creatorcontrib>García Arieta, Afredo</creatorcontrib><creatorcontrib>Golden, Michael</creatorcontrib><creatorcontrib>Hermann, Robert</creatorcontrib><creatorcontrib>Hochhaus, Günther</creatorcontrib><creatorcontrib>Holmes, Susan</creatorcontrib><creatorcontrib>Lafferty, Paul</creatorcontrib><creatorcontrib>Lyapustina, Svetlana</creatorcontrib><creatorcontrib>Nair, Parameswaran</creatorcontrib><creatorcontrib>O'Connor, Dennis</creatorcontrib><creatorcontrib>Parkins, David</creatorcontrib><creatorcontrib>Peterson, Ilse</creatorcontrib><creatorcontrib>Reisner, Colin</creatorcontrib><creatorcontrib>Sandell, Dennis</creatorcontrib><creatorcontrib>Singh, Gur Jai Pal</creatorcontrib><creatorcontrib>Weda, Marjolein</creatorcontrib><creatorcontrib>Watson, Patricia</creatorcontrib><title>Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report</title><title>Journal of aerosol medicine</title><addtitle>J Aerosol Med Pulm Drug Deliv</addtitle><description>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.</description><subject>Administration, Inhalation</subject><subject>Aerosols - pharmacokinetics</subject><subject>Biological Availability</subject><subject>Canada</subject><subject>Drug and Narcotic Control</subject><subject>Dry Powder Inhalers</subject><subject>Europe</subject><subject>Health technology assessment</subject><subject>Humans</subject><subject>Lung - metabolism</subject><subject>Metered Dose Inhalers</subject><subject>Models, Theoretical</subject><subject>Particle Size</subject><subject>Therapeutic Equivalency</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>1941-2711</issn><issn>1941-2703</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNpd0UFLwzAUB_AgipvTq0cJePHSLq9Z0-Y4xtTBRHGKx5KlCetsmy5phX17UzZ38JQH-b3H4_0RugUSAkn5eCuqJowIQEg4S8_QEPgEgigh9PxUAwzQlXNbQhhMGL1EgyiaAE0JG6JqvuuKH1GqWiosTe2KXFnRFr7C2lhsrCjLPS7qjTc5bqzJO9ke_kojRYmF7HWwWE1fxou36Sx4X-F5Z02jRI2_jP12G9Ngqxpj22t0oUXp1M3xHaHPx_nH7DlYvj4tZtNlIGnK2yAXnBMa-zrWUqXrnALoFEREI8k4AUYjncRSU6KkhhiUiHPBYiJ0DoylCR2hh8Ncv--uU67NqsJJVZaiVqZzGRB_Mk5i4J7e_6Nb09nab-cV8CT2FrwKD0pa45xVOmtsUQm79yjrg8j6ILI-iKwPwjfcHcd260rlJ_53efoLuI6D6Q</recordid><startdate>201206</startdate><enddate>201206</enddate><creator>Evans, Carole</creator><creator>Cipolla, David</creator><creator>Chesworth, Tim</creator><creator>Agurell, Eva</creator><creator>Ahrens, Richard</creator><creator>Conner, Dale</creator><creator>Dissanayake, Sanjeeva</creator><creator>Dolovich, Myrna</creator><creator>Doub, William</creator><creator>Fuglsang, Anders</creator><creator>García Arieta, Afredo</creator><creator>Golden, Michael</creator><creator>Hermann, Robert</creator><creator>Hochhaus, Günther</creator><creator>Holmes, Susan</creator><creator>Lafferty, Paul</creator><creator>Lyapustina, Svetlana</creator><creator>Nair, Parameswaran</creator><creator>O'Connor, Dennis</creator><creator>Parkins, David</creator><creator>Peterson, Ilse</creator><creator>Reisner, Colin</creator><creator>Sandell, Dennis</creator><creator>Singh, Gur Jai Pal</creator><creator>Weda, Marjolein</creator><creator>Watson, Patricia</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>201206</creationdate><title>Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report</title><author>Evans, Carole ; Cipolla, David ; Chesworth, Tim ; Agurell, Eva ; Ahrens, Richard ; Conner, Dale ; Dissanayake, Sanjeeva ; Dolovich, Myrna ; Doub, William ; Fuglsang, Anders ; García Arieta, Afredo ; Golden, Michael ; Hermann, Robert ; Hochhaus, Günther ; Holmes, Susan ; Lafferty, Paul ; Lyapustina, Svetlana ; Nair, Parameswaran ; O'Connor, Dennis ; Parkins, David ; Peterson, Ilse ; Reisner, Colin ; Sandell, Dennis ; Singh, Gur Jai Pal ; Weda, Marjolein ; Watson, Patricia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-da990353895fce8bd311f81a232c6901632f75cf30ecf151ea5da650afd166873</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Administration, Inhalation</topic><topic>Aerosols - 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| identifier | ISSN: 1941-2711 |
| ispartof | Journal of aerosol medicine, 2012-06, Vol.25 (3), p.117-139 |
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| subjects | Administration, Inhalation Aerosols - pharmacokinetics Biological Availability Canada Drug and Narcotic Control Dry Powder Inhalers Europe Health technology assessment Humans Lung - metabolism Metered Dose Inhalers Models, Theoretical Particle Size Therapeutic Equivalency United States United States Food and Drug Administration |
| title | Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report |
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