Challenges with Developing In Vitro Dissolution Tests for Orally Inhaled Products (OIPs)

Author:

Riley Trevor,Christopher David,Arp Jan,Casazza Andrea,Colombani Agnes,Cooper Andrew,Dey Monisha,Maas Janet,Mitchell Jolyon,Reiners Maria,Sigari Nastaran,Tougas Terrence,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

Reference47 articles.

1. US FDA CDER. Guidance for Industry: Dissolution testing of immediate release solid oral dosage forms. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070237.pdf (1997). Accessed 4 Oct 2011.

2. US FDA CDER. Guidance for Industry: Extended release oral dosage forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070239.pdf (1997). Accessed 4 Oct 2011.

3. US FDA CDER. Draft guidance: metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing and controls documentation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070573.pdf (1998). Accessed 4 Oct 2011.

4. US FDA CDER. Nasal spray and inhalation solution, suspension, and spray drug products chemistry, manufacturing, and controls documentation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070575.pdf (2002). Accessed 4 Oct 2011.

5. Joint EMA and Health Canada Guidance. Pharmaceutical quality of inhalation and nasal products. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/chem/inhalationnas-eng.php (2006);

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