title: Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.
abstract: 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.
authors.affiliation: Univerisity of Maryland School of Pharmacy, Baltimore, MD, 21201, USA. jpolli@rx.umaryland.edu
authors.forename: James E
authors.initials: JE
authors.lastname: Polli
authors.forename: Bertil S I
authors.initials: BS
authors.lastname: Abrahamsson
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
authors.forename: Gordon L
authors.initials: GL
authors.lastname: Amidon
authors.forename: John M
authors.initials: JM
authors.lastname: Baldoni
authors.forename: Jack A
authors.initials: JA
authors.lastname: Cook
authors.forename: Paul
authors.initials: P
authors.lastname: Fackler
authors.forename: Kerry
authors.initials: K
authors.lastname: Hartauer
authors.forename: Gordon
authors.initials: G
authors.lastname: Johnston
authors.forename: Steve L
authors.initials: SL
authors.lastname: Krill
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lipper
authors.forename: Waseem A
authors.initials: WA
authors.lastname: Malick
authors.forename: Vinod P
authors.initials: VP
authors.lastname: Shah
authors.forename: Duxin
authors.initials: D
authors.lastname: Sun
authors.forename: Helen N
authors.initials: HN
authors.lastname: Winkle
authors.forename: Yunhui
authors.initials: Y
authors.lastname: Wu
authors.forename: Hua
authors.initials: H
authors.lastname: Zhang
mesh_terms: D001702:Biopharmaceutics / Q000145:classification* / Q000331:legislation & jurisprudence; D003226:Congresses as Topic; D015195:Drug Design; D016568:Drugs, Generic / Q000737:chemistry / Q000145:classification / Q000493:pharmacokinetics; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic