Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Abstract The Biopharmaceutics Classification System (BCS), developed in the 1990s for oral immediate release drugs, is utilized by R&D scientists and regulators to streamline product development and regulatory approval timelines. This elegant, science-based approach is based on three in vitro pa...

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Bibliographic Details
Main Authors: Jayne E. Hastedt, Per Bäckman, Andrew R. Clark, William Doub, Anthony Hickey, Guenther Hochhaus, Phil J. Kuehl, Claus-Michael Lehr, Peter Mauser, Jason McConville, Ralph Niven, Masahiro Sakagimi, Jeffry G. Weers
Format: Article
Language:English
Published: SpringerOpen 2016-01-01
Series:AAPS Open
Subjects:
BCS
Physical pharmacy
Physicochemical characterization
Particle dissolution
Lung dose
Dose number
Online Access:http://link.springer.com/article/10.1186/s41120-015-0002-x

Internet

http://link.springer.com/article/10.1186/s41120-015-0002-x

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