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dc.contributor.authorChilcott, Robert
dc.contributor.authorBarai, N
dc.contributor.authorBeezer, A. E.
dc.contributor.authorBrain, S I
dc.contributor.authorBrown, Marc
dc.contributor.authorBunge, A L
dc.contributor.authorBurgess, S E
dc.contributor.authorCross, S
dc.contributor.authorDalton, C H
dc.contributor.authorDias, M
dc.contributor.authorFarinha, A
dc.contributor.authorFinnin, B C
dc.contributor.authorGallagher, S J
dc.contributor.authorGreen, D M
dc.contributor.authorGunt, H
dc.contributor.authorGwyther, R L
dc.contributor.authorHeard, C.M.
dc.contributor.authorJarvis, C A
dc.contributor.authorKamiyama, F
dc.contributor.authorKasting, G B
dc.contributor.authorLey, E E
dc.contributor.authorLim, S T
dc.contributor.authorMcnaughton, G S
dc.contributor.authorMorris, A
dc.contributor.authorNazemi, M H
dc.contributor.authorPellett, M A
dc.contributor.authorDu Plessis, J
dc.contributor.authorQuan, Y S
dc.contributor.authorRaghavan, S L
dc.contributor.authorRoberts, M.
dc.contributor.authorRomonchuk, W
dc.contributor.authorRoper, C S
dc.contributor.authorSchenk, D
dc.contributor.authorSimonsen, L
dc.contributor.authorSimpson, A
dc.contributor.authorTraversa, B D
dc.contributor.authorTrottet, L
dc.contributor.authorWatkinson, A
dc.contributor.authorWilliams, F.M.
dc.contributor.authorWilkinson, S C
dc.contributor.authorYamamoto, A
dc.contributor.authorHadgraft, J.
dc.date.accessioned2012-03-21T12:00:34Z
dc.date.available2012-03-21T12:00:34Z
dc.date.issued2005-03
dc.identifier.citationChilcott , R , Barai , N , Beezer , A E , Brain , S I , Brown , M , Bunge , A L , Burgess , S E , Cross , S , Dalton , C H , Dias , M , Farinha , A , Finnin , B C , Gallagher , S J , Green , D M , Gunt , H , Gwyther , R L , Heard , C M , Jarvis , C A , Kamiyama , F , Kasting , G B , Ley , E E , Lim , S T , Mcnaughton , G S , Morris , A , Nazemi , M H , Pellett , M A , Du Plessis , J , Quan , Y S , Raghavan , S L , Roberts , M , Romonchuk , W , Roper , C S , Schenk , D , Simonsen , L , Simpson , A , Traversa , B D , Trottet , L , Watkinson , A , Williams , F M , Wilkinson , S C , Yamamoto , A & Hadgraft , J 2005 , ' Inter- and intralaboratory variation of in vitro diffusion cell measurements : An international multicenter study using quasi-standardized methods and materials ' , Journal of Pharmaceutical Sciences , vol. 94 , no. 3 , pp. 632-638 . https://doi.org/10.1002/jps.20229
dc.identifier.issn0022-3549
dc.identifier.otherPURE: 628500
dc.identifier.otherPURE UUID: 9e9cd70e-7cb5-4487-ab71-7968a25bfdbc
dc.identifier.otherWOS: 000227414800017
dc.identifier.otherScopus: 20144388993
dc.identifier.urihttp://hdl.handle.net/2299/8015
dc.description.abstractIn vitro measurements of skin absorption are an increasingly important aspect of regulatory studies, product support claims, and formulation screening. However, such measurements are significantly affected by skin variability. The purpose of this study was to determine inter- and intralaboratory variation in diffusion cell measurements caused by factors other than skin. This was attained through the use of an artificial (silicone rubber) rate-limiting membrane and the provision of materials including a standard penetrant, methyl paraben (MP), and a minimally prescriptive protocol to each of the 18 participating laboratories. "Standardized" calculations of MP flux were determined from the data submitted by each laboratory by applying a predefined mathematical model. This was deemed necessary to eliminate any interlaboratory variation caused by different methods of flux calculations. Average fluxes of MP calculated and reported by each laboratory (60 +/- 27 mug cm(-2) h(-1), n = 25, range 27-101) were in agreement with the standardized calculations of MP flux (60 +/- 21 mug cm(-2) h(-1), range 19-120). The coefficient of variation between laboratories was approximately 35% and was manifest as a fourfold difference between the lowest and highest average flux values and a sixfold difference between the lowest and highest individual flux values. Intra-laboratory variation was lower, averaging 10% for five individuals using the same equipment within a single laboratory. Further studies should be performed to clarify the exact components responsible for nonskin-related variability in diffusion cell measurements. It is clear that further developments of in vitro methodologies for measuring skin absorption are required. (C) 2005 Wiley-Liss, Inc.en
dc.format.extent7
dc.language.isoeng
dc.relation.ispartofJournal of Pharmaceutical Sciences
dc.subjectmethyl paraben
dc.subjectin vitro
dc.subjectskin absorption
dc.subjectpercutaneous penetration
dc.subjectsilicone rubber membrane
dc.subjectinterlaboratory variation
dc.subjectintralaboratory variation
dc.subjectHUMAN-SKIN
dc.subjectPERCUTANEOUS-ABSORPTION
dc.subjectRAT SKIN
dc.subjectINVITRO
dc.subjectPENETRATION
dc.subjectINVIVO
dc.subjectVALIDATION
dc.subjectPERMEATION
dc.subjectMODEL
dc.titleInter- and intralaboratory variation of in vitro diffusion cell measurements : An international multicenter study using quasi-standardized methods and materialsen
dc.contributor.institutionHealth & Human Sciences Research Institute
dc.contributor.institutionDepartment of Pharmacy
dc.description.statusPeer reviewed
dcterms.dateAccepted2005-03
rioxxterms.versionofrecordhttps://doi.org/10.1002/jps.20229
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue


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