Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs)-Reference-Cited by-同舟云学术

Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs)

Published:2009-10-29 Issue:4 Volume:10 Page:1276-1285
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Tougas Terrence P.,Christopher David,Mitchell Jolyon P.,Strickland Helen,Wyka Bruce,Van Oort Mike,Lyapustina Svetlana

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/s12249-009-9312-4.pdf

Reference20 articles.

1. FDA. Guidance for industry PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. 2004. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf . Accessed 4 Aug 2009.

2. FDA CDER. Draft guidance for industry metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing, and controls documentation. 1998. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070573.pdf . Accessed 4 Aug 2009.

3. EP 2.9.18. Preparations for inhalations: aerodynamic assessment of fine particles. Strasbourg: Council of Europe; 2008.

4. USP 31. Chapter <601> aerosols, nasal sprays, metered-dose inhalers, and dry powder inhalers. Rockville: USP; 2008.

5. Health Canada. Pharmaceutical quality of inhalation and nasal products. 2006. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/chem/inhalationnas_e.html (Accessed 4 Aug 2009) and EMEA. 2006 EMEA/CHMP/QWP/49313/2005 Corr. http://www.emea.europa.eu/pdfs/human/qwp/4931305en.pdf (Accessed 4 Aug 2009). Also adopted by Australia: http://www.tga.gov.au/docs/pdf/euguide/qwp/4931305en.pdf . Accessed 4 May 2009.

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