Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products
dc.contributor.author | Flynn, Gordon L. | en_US |
dc.contributor.author | Sequeira, Joel A. | en_US |
dc.contributor.author | Corbo, Michael | en_US |
dc.contributor.author | Shah, Vinod P. | en_US |
dc.contributor.author | Tenjarla, Srinivas N. | en_US |
dc.contributor.author | Swarbrick, James | en_US |
dc.contributor.author | Yacobi, Avraham | en_US |
dc.contributor.author | Zatz, Joel L. | en_US |
dc.contributor.author | Feldman, Terry G. | en_US |
dc.contributor.author | DeMagistris, David | en_US |
dc.contributor.author | Miran, Deborah R. | en_US |
dc.contributor.author | Franz, Thomas J. | en_US |
dc.contributor.author | Wang, Jonas C. T. | en_US |
dc.contributor.author | Pearce, David M. | en_US |
dc.date.accessioned | 2006-09-08T19:18:16Z | |
dc.date.available | 2006-09-08T19:18:16Z | |
dc.date.issued | 1999-09 | en_US |
dc.identifier.citation | Flynn, Gordon L.; Shah, Vinod P.; Tenjarla, Srinivas N.; Corbo, Michael; DeMagistris, David; Feldman, Terry G.; Franz, Thomas J.; Miran, Deborah R.; Pearce, David M.; Sequeira, Joel A.; Swarbrick, James; Wang, Jonas C. T.; Yacobi, Avaraham; Zatz, Joel L.; (1999). "Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products." Pharmaceutical Research 16(9): 1325-1330. <http://hdl.handle.net/2027.42/41480> | en_US |
dc.identifier.issn | 1573-904X | en_US |
dc.identifier.issn | 0724-8741 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/41480 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=10496646&dopt=citation | en_US |
dc.description.abstract | The FDA recently issued a guidance covering practices of scaleup and post approval changes with semisolids (SUPAC-SS). This guidance outlines the steps that must be taken by a company to maintain certification of its semisolid dermatological products after quantitative changes have been made in their compositions and/or after changes have been made in the sourcing of their key ingredients, in their processing, in their batch sizes, and/or after their site of manufacture has been relocated. A key element within the guidance is a release test to be used to determine if the diffusional release of a drug found in a formulation is the same after changes have been made to the formulation as it was prior to implementing the changes. The AAPS-FDA sponsored workshop was set up to explore this qualifying test. The stated aims of the workshop were: a) to illustrate the methodology and techniques of in vitro release testing, b) to show the sensitivity of in vitro release with respect to manufacturing variables and to variations in components and composition (of specific formulations), c) to recognize in vitro release testing as a useful procedure for SUPAC documentation, d) to highlight and evaluate other applications of in vitro release testing, e) to explore the degree to which in vitro release testing and bioavailability may be related, and f) to evaluate the role of in vitro release testing of topical dosage forms as a tool to improve product quality. | en_US |
dc.format.extent | 1235365 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 | Medical Law | en_US |
dc.subject.other | Pharmacology/Toxicology | en_US |
dc.subject.other | Biochemistry, General | en_US |
dc.subject.other | SUPAC-SS | en_US |
dc.subject.other | FDA Guidances | en_US |
dc.subject.other | Dermatologicals | en_US |
dc.subject.other | Biomedical Engineering | en_US |
dc.subject.other | Pharmacy | en_US |
dc.subject.other | Biomedicine | en_US |
dc.subject.other | Release Testing | en_US |
dc.subject.other | Topical Delivery Systems | en_US |
dc.title | Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products | 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, University of Michigan, Ann Arbor, Michigan | en_US |
dc.contributor.affiliationother | Southern School of Pharmacy, Mercer University, Atlanta, Georgia | en_US |
dc.contributor.affiliationother | AAI, Inc., Wilmington, North Carolina | en_US |
dc.contributor.affiliationother | FDA-Office of Pharmaceutical Science, CDER/OPS ---, HFD 350, 5600 Fishers Lane, Rockville, Maryland, 20857 | en_US |
dc.contributor.affiliationother | Taro Pharmaceuticals, Brampton, Ontario, Canada | en_US |
dc.contributor.affiliationother | Kinetics Corp., Palo Alto, California | en_US |
dc.contributor.affiliationother | College of Pharmacy, Rutgers University, Piscataway, New Jersey | en_US |
dc.contributor.affiliationother | Taro Pharmaceuticals USA, Inc., Hawthorn, New York | en_US |
dc.contributor.affiliationother | Glaxo, Inc., Research Triangle Park, North Carolina | en_US |
dc.contributor.affiliationother | Schering-Plough Research, Kenilworth, New Jersey | en_US |
dc.contributor.affiliationother | R. W. Johnson PRI, Raritan, New Jersey | en_US |
dc.contributor.affiliationother | Johnson & Johnson Consumer Products, Skillman, New Jersey | en_US |
dc.contributor.affiliationother | Miran Consulting, Inc., Lutherville, Maryland | en_US |
dc.contributor.affiliationother | Altana Inc., Melville, New York | en_US |
dc.contributor.affiliationumcampus | Ann Arbor | en_US |
dc.identifier.pmid | 10496646 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/41480/1/11095_2004_Article_303667.pdf | en_US |
dc.identifier.doi | http://dx.doi.org/10.1023/A:1018997520950 | en_US |
dc.identifier.source | Pharmaceutical Research | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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