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Webbased Archive of RIVM Publications > Articles and other publications by RIVM employees > Miscellaneous > Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.


Please use this identifier to cite or link to this item: http://hdl.handle.net/10029/7597
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Title: Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.
Authors: Jantratid, E
Prakongpan, S
Dressman, J B
Amidon, G L
Junginger, H E
Midha, K K
Barends, D M
Citation: J Pharm Sci 2006, 95(5):974-84
Issue Date: 1-May-2006
URI: http://hdl.handle.net/10029/7597
DOI: 10.1002/jps.20614
PubMed ID: 16557528
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.
Type: Article
Language: en
ISSN: 0022-3549
Appears in Collections: Miscellaneous

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