Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir
dc.contributor.author | Arnal, J. | en_US |
dc.contributor.author | Gonzalez-Alvarez, I. | en_US |
dc.contributor.author | Bermejo, M. | en_US |
dc.contributor.author | Amidon, Gordon L. | en_US |
dc.contributor.author | Junginger, H. E. | en_US |
dc.contributor.author | Kopp, S. | 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 | 2008-12-01T20:59:49Z | |
dc.date.available | 2010-01-05T16:59:13Z | en_US |
dc.date.issued | 2008-12 | en_US |
dc.identifier.citation | Arnal, J.; Gonzalez-Alvarez, I.; Bermejo, M.; Amidon, G.L.; Junginger, H.E.; Kopp, S.; Midha, K.K.; Shah, V.P.; Stavchansky, S.; Dressman, J.B.; Barends, D.M. (2008). "Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir." Journal of Pharmaceutical Sciences 97(12): 5061-5073. <http://hdl.handle.net/2027.42/61316> | en_US |
dc.identifier.issn | 0022-3549 | en_US |
dc.identifier.issn | 1520-6017 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/61316 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=18425814&dopt=citation | en_US |
dc.description.abstract | Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were also taken into consideration in order to ascertain whether a biowaiver can be recommended. According to the Biopharmaceutics Classification System (BCS) and considering tablet strengths up to 400 mg, aciclovir would be BCS Class III. However, in some countries also 800 mg tablets are available which fall just within BCS Class IV. Aciclovir seems not to be critical with respect to a risk for bio in equivalence, as no examples of bio in equivalence have been identified. It has a wide therapeutic index and is not used for critical indications. Hence, if: (a) the test product contains only excipients present in aciclovir solid oral IR drug products approved in ICH or associated countries, for instance as presented in this article; and (b) the comparator and the test product both are very rapidly dissolving , a biowaiver for IR aciclovir solid oral drug products is considered justified for all tablet strengths. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:5061–5073, 2008 | en_US |
dc.format.extent | 152563 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: Aciclovir | 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 | Facultad de Farmacia, Universidad de Valencia, Burjassot 46100, Valencia, Spain | en_US |
dc.contributor.affiliationother | Facultad de Farmacia, Universidad de Valencia, Burjassot 46100, Valencia, Spain | en_US |
dc.contributor.affiliationother | Facultad de Farmacia, Universidad de Valencia, Burjassot 46100, Valencia, Spain | en_US |
dc.contributor.affiliationother | Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand | en_US |
dc.contributor.affiliationother | World Health Organization, Geneva, Switzerland ; This article reflects the scientific opinion of the authors and not the policies of regulating agencies. | en_US |
dc.contributor.affiliationother | University of Saskatchewan, Saskatoon, Saskatchewan, Canada | en_US |
dc.contributor.affiliationother | International Pharmaceutical Federation FIP, Den Haag, 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 am Main, 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 | 18425814 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/61316/1/21392_ftp.pdf | |
dc.identifier.doi | http://dx.doi.org/10.1002/jps.21392 | en_US |
dc.identifier.source | Journal of Pharmaceutical Sciences | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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