کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8994341 | 1114390 | 2005 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Interâ and intralaboratory variation of in vitro diffusion cell measurements: An international multicenter study using quasiâstandardized methods and materials
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
In 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 interâ and intralaboratory variation in diffusion cell measurements caused by factors other than skin. This was attained through the use of an artificial (silicone rubber) rateâlimiting 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 (60â±â27 μg cmâ2 hâ1, nâ=â25, range 27-101) were in agreement with the standardized calculations of MP flux (60â±â21 μg cmâ2 hâ1, 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. Intralaboratory 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 nonskinârelated variability in diffusion cell measurements. It is clear that further developments of in vitro methodologies for measuring skin absorption are required. © 2005 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 94:632-638, 2005
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 94, Issue 3, March 2005, Pages 632-638
Journal: Journal of Pharmaceutical Sciences - Volume 94, Issue 3, March 2005, Pages 632-638
نویسندگان
R.P. Chilcott, N. Barai, A.E. Beezer, S.I. Brain, M.B. Brown, A.L. Bunge, S.E. Burgess, S. Cross, C.H. Dalton, M. Dias, A. Farinha, B.C. Finnin, S.J. Gallagher, D.M. Green, H. Gunt, R.L. Gwyther, C.M. Heard, C.A. Jarvis, J. Hadgraft,