Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.

2.50
Hdl Handle:
http://hdl.handle.net/10029/7597
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
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.
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
Type:
Article
Language:
en
ISSN:
0022-3549
Appears in Collections:
Miscellaneous

Full metadata record

DC FieldValue Language
dc.contributor.authorJantratid, E-
dc.contributor.authorPrakongpan, S-
dc.contributor.authorDressman, J B-
dc.contributor.authorAmidon, G L-
dc.contributor.authorJunginger, H E-
dc.contributor.authorMidha, K K-
dc.contributor.authorBarends, D M-
dc.date.accessioned2007-01-17T15:30:14Z-
dc.date.available2007-01-17T15:30:14Z-
dc.date.issued2006-05-01-
dc.identifier.citationJ Pharm Sci 2006, 95(5):974-84en
dc.identifier.issn0022-3549-
dc.identifier.pmid16557528-
dc.identifier.doi10.1002/jps.20614-
dc.identifier.urihttp://hdl.handle.net/10029/7597-
dc.description.abstractLiterature 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.en
dc.format.extent134083 bytes-
dc.format.mimetypeapplication/pdf-
dc.language.isoenen
dc.titleBiowaiver monographs for immediate release solid oral dosage forms: cimetidine.en
dc.typeArticleen
dc.format.digYES-

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