Clinically Relevant In Vitro Testing of Orally Inhaled Products—Bridging the Gap Between the Lab and the Patient-Reference-Cited by-同舟云学术

Clinically Relevant In Vitro Testing of Orally Inhaled Products—Bridging the Gap Between the Lab and the Patient

Published:2016-05-12 Issue:4 Volume:17 Page:787-804
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Mitchell Jolyon P.,Suggett Jason,Nagel Mark

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/s12249-016-0543-x.pdf

Reference89 articles.

1. Tougas TP, Christopher D, Mitchell JP, Strickland H, Wyka B, Van Oort M, et al. Improved quality control metrics for cascade impaction measurements of orally inhaled drug products (OIPs). AAPS PharmSciTech. 2009;10(4):1276–85.

2. United States Food and Drug Administration. Center for Drug Evaluation and Research (CDER): draft guidance for industry metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing, and controls documentation. 1998.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 10 Oct 2015.

3. 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 10 Oct 2015.

4. European Medicines Agency: 2006 EMEA/CHMP/QWP/49313/2005 Corr. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003568.pdf . Accessed 10 Oct 2015.

5. US Pharmacopeial Convention: United States Pharmacopeia 38/National Formulary 33, Chapter <601> Aerosols, nasal sprays, metered-dose inhalers, and dry powder inhalers. Rockville, MD, 2015.

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