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Summary workshop re...
Summary workshop report : bioequivalence, biopharmaceutics classification system, and beyond
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Polli, James E (author)
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- Abrahamsson, Bertil S I (author)
- Uppsala universitet,Institutionen för farmaci
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Yu, Lawrence X (author)
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Amidon, Gordon L (author)
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Baldoni, John M (author)
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Cook, Jack A (author)
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Fackler, Paul (author)
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Hartauer, Kerry (author)
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Johnston, Gordon (author)
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Krill, Steve L (author)
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Lipper, Robert A (author)
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Malick, Waseem A (author)
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Shah, Vinod P (author)
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Sun, Duxin (author)
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Winkle, Helen N (author)
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Wu, Yunhui (author)
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Zhang, Hua (author)
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(creator_code:org_t)
- 2008-08-05
- 2008
- English.
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In: AAPS Journal. - : Springer Science and Business Media LLC. - 1550-7416. ; 10:2, s. 373-379
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https://europepmc.or...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
Keyword
- PHARMACY
- FARMACI
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Polli, James E
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Abrahamsson, Ber ...
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Yu, Lawrence X
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Amidon, Gordon L
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Baldoni, John M
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Cook, Jack A
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show more...
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Fackler, Paul
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Hartauer, Kerry
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Johnston, Gordon
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Krill, Steve L
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Lipper, Robert A
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Malick, Waseem A
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Shah, Vinod P
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Sun, Duxin
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Winkle, Helen N
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Wu, Yunhui
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Zhang, Hua
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmaceutical S ...
- Articles in the publication
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AAPS Journal
- By the university
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Uppsala University