Product quality research institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: Final report on a statistical procedure for determining equivalence-Reference-Cited by-同舟云学术

Product quality research institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: Final report on a statistical procedure for determining equivalence

Published:2007-10 Issue:4 Volume:8 Page:
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Christopher David,Adams Wallace,Amann Anthony,Bertha Craig,Byron Peter R.,Doub William,Dunbar Craig,Hauck Walter,Lyapustina Svetlana,Mitchell Jolyon,Morgan Beth,Nichols Steve,Pan Ziqing,Pal Singh Gur Jai,Tougas Terrence,Tsong Yi,Wolff Ron,Wyka Bruce

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/content/pdf/10.1208/pt0804090.pdf

Reference24 articles.

1. FDA/CDER. Draft guidance for industry: bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. Food and Drug Administration Web site. 1999; Available at: http://www.fda.gov/cder/guidance/2070DFT.pdf. Accessed March 28, 2007.

2. Tsong Y. Statistical comparison of particle size distribution profiles. 2004; Available at: http://pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/DC01-475116-v2-Yi_Tsong_Statistical_Archive_PQRI_Profile_Comparisons.DOC. Accessed June 22, 2007.

3. Tsong Y. Profile analysis of cascade impactor data: proposed FDA approach. Presentation to OINDP Subcommittee of the Advisory Committee for Pharmaceutical Science. Rockville, MD: US Pharmacopeia; April 26, 2000. Available at: http://www.fda.gov/ohrms/dockets/ac/00/slides/3609s1e.ppt. Accessed October 19, 2006.

4. United States Pharmacopeial Convention. Chapter 601. Aerosols, metered-dose inhalers, and dry powder inhalers. In:USP30-NF25. Rockville, MD: USP; 2007:220–240.

5. DeLuca PP, Lyapustina S. Product Quality Research Institute reports.AAPS PharmSciTech [serial online]. 2007;8:article 6.

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