Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

Author:

Selen Arzu,Cruañes Maria T.,Müllertz Anette,Dickinson Paul A.,Cook Jack A.,Polli James E.,Kesisoglou Filippos,Crison John,Johnson Kevin C.,Muirhead Gordon T.,Schofield Timothy,Tsong Yi

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference5 articles.

1. Guidance for Industry Q8(R2) Pharmaceutical development, 2009 (ICH Q8 (R2)). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf .

2. Gray VA. Meeting report: University of Wisconsin/AAPS/FDA Workshop Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit. Dissolution Technologies. 2009;16(4):35–9.

3. Dickinson PA, Lee WW, Stott PW, Townsend AI, Smart JP, Ghahramani P, et al. Clinical relevance of dissolution testing in quality by design. AAPS J. 2008;10(2):380–90.

4. Müllertz A. Biorelevant dissolution media, biotechnology. Pharmaceutical aspects. Arlington: AAPS; 2007. p. 151–77.

5. Benet LZ, Wu CY. Using a biopharmaceutics drug disposition classification system to predict bioavailability and elimination characteristics of new molecular entities. Somerset: NJDMDG; 2006.

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