Equivalence Considerations for Orally Inhaled Products for Local Action-ISAM/IPAC-RS European Workshop Report

被引：42

作者：

Evans, Carole ^{[1
]}

Cipolla, David ^{[2
]}

Chesworth, Tim ^{[3
]}

Agurell, Eva ^{[4
]}

Ahrens, Richard ^{[5
]}

Conner, Dale ^{[6
]}

Dissanayake, Sanjeeva ^{[7
]}

Dolovich, Myrna ^{[8
]}

Doub, William ^{[9
]}

Fuglsang, Anders ^{[10
]}

Garcia Arieta, Afredo ^{[11
]}

Golden, Michael ^{[12
]}

Hermann, Robert ^{[13
]}

Hochhaus, Guenther ^{[14
]}

Holmes, Susan ^{[15
]}

Lafferty, Paul ^{[16
]}

Lyapustina, Svetlana ^{[17
]}

Nair, Parameswaran ^{[8
]}

O'Connor, Dennis ^{[18
]}

Parkins, David ^{[19
]}

Peterson, Ilse ^{[17
]}

Reisner, Colin ^{[20
]}

Sandell, Dennis ^{[21
]}

Singh, Gur Jai Pal ^{[22
]}

Weda, Marjolein ^{[23
]}

Watson, Patricia ^{[19
]}

机构：

[1] Catalent Pharma Solut, Res Triangle Pk, NC 27709 USA

[2] Aradigm, Hayward, CA USA

[3] AstraZeneca, Macclesfield, Cheshire, England

[4] Swedish Med Prod Agcy, Uppsala, Sweden

[5] Univ Iowa, Iowa City, IA USA

[6] US FDA, Rockville, MD 20857 USA

[7] Mundipharma Res, Cambridge, England

[8] McMaster Univ, Hamilton, ON, Canada

[9] US FDA, St Louis, MO USA

[10] Fuglsang Pharma, Rudolstadt, Germany

[11] Spanish Agcy Med & Hlth Care Prod, Madrid, Spain

[12] Pearl Therapeut, Raleigh, NC USA

[13] Clin Res Appliance, Radolfzell am Bodensee, Germany

[14] Univ Florida, Gainesville, FL USA

[15] GlaxoSmithKline R&D, Res Triangle Pk, NC USA

[16] Med Technol Consulting, Hemel Hempstead, England

[17] Drinker Biddle & Reath, Washington, DC USA

[18] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA

[19] GlaxoSmithKline R&D, Ware, Herts, England

[20] Pearl Therapeut, Morristown, NJ USA

[21] S5 Consulting, Lund, Sweden

[22] AXAR Pharmaceut, Corona, CA USA

[23] Natl Inst Publ Hlth & Environm Rivm, Bilthoven, Netherlands

来源：

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY | 2012年 / 25卷 / 03期

关键词：

inhaler; IVIVC; equivalence; goalposts; pharmacokinetics; pharmacodynamics; in vitro; device; patient handling; DISTRIBUTION APSD METRICS; DRY-POWDER INHALERS; FLUTICASONE PROPIONATE; LUNG DEPOSITION; DOSE-RESPONSE; RELATIVE PRECISION; FULL RESOLUTION; YOUNG-CHILDREN; BIOEQUIVALENCE; BUDESONIDE;

D O I：

10.1089/jamp.2011.0968

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

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.

引用

页码：117 / 139

页数：23

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