Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms
dc.contributor.author | Dressman, Jennifer B. | en_US |
dc.contributor.author | Amidon, Gordon L. | en_US |
dc.contributor.author | Shah, Vinod P. | en_US |
dc.contributor.author | Reppas, Christos | en_US |
dc.date.accessioned | 2006-09-08T19:17:04Z | |
dc.date.available | 2006-09-08T19:17:04Z | |
dc.date.issued | 1998-01 | en_US |
dc.identifier.citation | Dressman, Jennifer B.; Amidon, Gordon L.; Reppas, Christos; Shah, Vinod P.; (1998). "Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms." Pharmaceutical Research 15(1): 11-22. <http://hdl.handle.net/2027.42/41462> | en_US |
dc.identifier.issn | 1573-904X | en_US |
dc.identifier.issn | 0724-8741 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/41462 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=9487541&dopt=citation | en_US |
dc.description.abstract | Dissolution tests are used for many purposes in the pharmaceutical industry: in the development of new products, for quality control and, to assist with the determination of bioequivalence. Recent regulatory developments such as the Biopharmaceutics Classification Scheme have highlighted the importance of dissolution in the regulation of post-approval changes and introduced the possibility of substituting dissolution tests for clinical studies in some cases. Therefore, there is a need to develop dissolution tests that better predict the in vivo performance of drug products. This could be achieved if the conditions in the gastrointestinal tract were successfully reconstructed in vitro . The aims of this article are, first, to clarify under which circumstances dissolution testing can be prognostic for in vivo performance, and second, to present physiological data relevant to the design of dissolution tests, particularly with respect to the composition, volume, flow rates and mixing patterns of the fluids in the gastrointestinal tract. Finally, brief comments are made in regard to the composition of in vitro dissolution media as well as the hydrodynamics and duration of the test. | en_US |
dc.format.extent | 1166147 bytes | |
dc.format.extent | 3115 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.language.iso | en_US | |
dc.publisher | Kluwer Academic Publishers-Plenum Publishers; Plenum Publishing Corporation ; Springer Science+Business Media | en_US |
dc.subject.other | Dissolution Test Conditions | en_US |
dc.subject.other | Prediction of in Vivo Performance | en_US |
dc.subject.other | Biochemistry, General | en_US |
dc.subject.other | Dissolution Tests | en_US |
dc.subject.other | Pharmacology/Toxicology | en_US |
dc.subject.other | Medical Law | en_US |
dc.subject.other | Composition of Dissolution Media | en_US |
dc.subject.other | Biomedical Engineering | en_US |
dc.subject.other | Pharmacy | en_US |
dc.subject.other | Biomedicine | en_US |
dc.title | Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms | en_US |
dc.type | Article | en_US |
dc.subject.hlbsecondlevel | Pharmacy and Pharmacology | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | College of Pharmacy, The University of Michigan, Ann Arbor, Michigan, 48109-1065 | en_US |
dc.contributor.affiliationother | Department of Pharmacy, University of Athens, Panepistimiopolis, 157 71, Zografou, Greece | en_US |
dc.contributor.affiliationother | Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, HFD-350, Rockville, Maryland, 20857 | en_US |
dc.contributor.affiliationother | Institut für Pharmazeutische Technologie, Johann Wolfgang Goethe-Universität, Marie-Curie-Str. 9, 60439, Frankfurt am Main, Germany | en_US |
dc.contributor.affiliationumcampus | Ann Arbor | en_US |
dc.identifier.pmid | 9487541 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/41462/1/11095_2004_Article_303766.pdf | en_US |
dc.identifier.doi | http://dx.doi.org/10.1023/A:1011984216775 | en_US |
dc.identifier.source | Pharmaceutical Research | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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