Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.
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.
Polli
James E
JE
Univerisity of Maryland School of Pharmacy, Baltimore, MD, 21201, USA. jpolli@rx.umaryland.edu
Abrahamsson
Bertil S I
BS
Yu
Lawrence X
LX
Amidon
Gordon L
GL
Baldoni
John M
JM
Cook
Jack A
JA
Fackler
Paul
P
Hartauer
Kerry
K
Johnston
Gordon
G
Krill
Steve L
SL
Lipper
Robert A
RA
Malick
Waseem A
WA
Shah
Vinod P
VP
Sun
Duxin
D
Winkle
Helen N
HN
Wu
Yunhui
Y
Zhang
Hua
H
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
D016568:Drugs, Generic