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Title: Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine
Authors: E. Jantratid
S. Prakongpan
J. B. Dressman
G. L. Amidon
H. E. Junginger
K. K. Midha
D. M. Barends
Mahidol University
Goethe-Universitat Frankfurt am Main
University of Michigan, Ann Arbor
Leiden/Amsterdam Center for Drug Research
University of Saskatchewan
National Institute of Public Health and the Environment
Keywords: Pharmacology, Toxicology and Pharmaceutics
Issue Date: 1-Jan-2006
Citation: Journal of Pharmaceutical Sciences. Vol.95, No.5 (2006), 974-984
Abstract: Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA) problems were also taken into consideration. On the basis of the overall evidence, a biowaiver can be recommended for cimetidine IR products, provided that the test product contains only those excipients reported in this paper in their usual amounts, and that the test and the comparator drug products both are "rapidly dissolving" as per BCS. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association.
ISSN: 15206017
Appears in Collections:Scopus 2006-2010

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