Biowaiver monographs for immediate release solid oral dosage forms: Diclofenac sodium and diclofenac potassium A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs . This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO).
dc.contributor.author | Chuasuwan, B. | en_US |
dc.contributor.author | Binjesoh, V. | en_US |
dc.contributor.author | Polli, James E. | en_US |
dc.contributor.author | Zhang, H. | en_US |
dc.contributor.author | Amidon, Gordon L. | en_US |
dc.contributor.author | Junginger, H. E. | en_US |
dc.contributor.author | Midha, Kamal K. | en_US |
dc.contributor.author | Shah, V. P. | en_US |
dc.contributor.author | Stavchansky, S. | en_US |
dc.contributor.author | Dressman, Jennifer B. | en_US |
dc.contributor.author | Barends, D. M. | en_US |
dc.date.accessioned | 2009-03-03T20:09:02Z | |
dc.date.available | 2010-05-07T17:40:09Z | en_US |
dc.date.issued | 2009-04 | en_US |
dc.identifier.citation | Chuasuwan, B.; Binjesoh, V.; Polli, J.E.; Zhang, H.; Amidon, G.L.; Junginger, H.E.; Midha, K.K.; Shah, V.P.; Stavchansky, S.; Dressman, J.B.; Barends, D.M. (2009). "Biowaiver monographs for immediate release solid oral dosage forms: Diclofenac sodium and diclofenac potassium A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs . This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO). ." Journal of Pharmaceutical Sciences 98(4): 1206-1219. <http://hdl.handle.net/2027.42/61873> | en_US |
dc.identifier.issn | 0022-3549 | en_US |
dc.identifier.issn | 1520-6017 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/61873 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=18752289&dopt=citation | en_US |
dc.description.abstract | Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1206–1219, 2009 | en_US |
dc.format.extent | 170251 bytes | |
dc.format.extent | 3118 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.subject.other | Chemistry | en_US |
dc.subject.other | Food Science, Agricultural, Medicinal and Pharmaceutical Chemistry | en_US |
dc.title | Biowaiver monographs for immediate release solid oral dosage forms: Diclofenac sodium and diclofenac potassium A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs . This article reflects the scientific opinion of the authors and not the policies of regulating agencies, the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO). | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | 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 | Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland ; Research and Development Institute, The Government Pharmaceutical Organization, Bangkok, Thailand | en_US |
dc.contributor.affiliationother | Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland ; Faculty of Pharmacy, Rangsit University, Pathumtani, Thailand | en_US |
dc.contributor.affiliationother | Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland | en_US |
dc.contributor.affiliationother | AstraZeneca Pharmaceuticals LP, Wilmington, Delaware | en_US |
dc.contributor.affiliationother | Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand | en_US |
dc.contributor.affiliationother | University of Saskatchewan, Saskatoon, Saskatchewan, Canada | en_US |
dc.contributor.affiliationother | International Pharmaceutical Federation FIP, The Hague, The Netherlands | en_US |
dc.contributor.affiliationother | Pharmaceutical Division, College of Pharmacy, University of Texas at Austin, Austin, Texas | en_US |
dc.contributor.affiliationother | Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt, Germany | en_US |
dc.contributor.affiliationother | RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands ; RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Telephone: 31-30-2744209; Fax: 31-30-2744462. | en_US |
dc.identifier.pmid | 18752289 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/61873/1/21525_ftp.pdf | |
dc.identifier.doi | 10.1002/jps.21525 | en_US |
dc.identifier.source | Journal of Pharmaceutical Sciences | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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