Publication: Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine
Issued Date
2006-01-01
Resource Type
ISSN
15206017
00223549
00223549
Other identifier(s)
2-s2.0-33646594458
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Pharmaceutical Sciences. Vol.95, No.5 (2006), 974-984
Suggested Citation
E. Jantratid, S. Prakongpan, J. B. Dressman, G. L. Amidon, H. E. Junginger, K. K. Midha, D. M. Barends Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine. Journal of Pharmaceutical Sciences. Vol.95, No.5 (2006), 974-984. doi:10.1002/jps.20614 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/23913
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine
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.