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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
pharmacology, toxicology and pharmaceutics
Inter- and intralaboratory variation of in vitro diffusion cell measurements: An international multicenter study using quasi-standardized methods and materials
Journal of Pharmaceutical Sciences, Volume 94, No. 3, Year 2005
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Description
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 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 μg cm-2 h-1, n = 25, range 27-101) were in agreement with the standardized calculations of MP flux (60 ± 21 μg 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. 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 nonskin-related variability in diffusion cell measurements. It is clear that further developments of in vitro methodologies for measuring skin absorption are required. © 2005 Wiley-Liss, Inc. and the American Pharmacists Association.
Authors & Co-Authors
Chilcott, Robert
United Kingdom, Salisbury
Defence Science and Technology Laboratory
Barai, N.
United States, Cincinnati
University of Cincinnati Medical Center
Beezer, Anthony E.
United Kingdom, London
University of Greenwich
Brain, S. I.
United Kingdom, Cardiff
An-ex Analytical Services Ltd.
Brown, M. B.
United Kingdom, London
King's College London
Bunce, A. L.
United States, Golden
Colorado School of Mines
Burgess, S. E.
United Kingdom, London
University of Greenwich
Cross, Sheree E.
Australia, Brisbane
The University of Queensland
Dalton, C. H.
United Kingdom, Salisbury
Defence Science and Technology Laboratory
Dias, M.
United Kingdom, Guildford
Disperse Technologies
Farinha, A.
Portugal, Lisbon
Lab. de Estudos Farmacêuticos
Finnin, Barrie C.
Australia, Melbourne
Faculty of Pharmacy and Pharmaceutical Sciences
Gallacher, S. J.
United Kingdom, Cardiff
College of Biomedical and Life Sciences
United Kingdom, Maidenhead
Stiefel Laboratories
Green, D. M.
United Kingdom, London
University of Greenwich
Gunt, H.
United States, Cincinnati
University of Cincinnati Medical Center
Gwyther, R. L.
United Kingdom, Salisbury
Defence Science and Technology Laboratory
Heard, Charles M.
United Kingdom, Cardiff
College of Biomedical and Life Sciences
Jarvis, C. A.
United Kingdom, Cardiff
College of Biomedical and Life Sciences
Kamiyama, F.
Japan, Kyoto
Kyoto Pharmaceutical University
Kasting, G. B.
United States, Cincinnati
University of Cincinnati Medical Center
Ley, E. E.
United States, Golden
Colorado School of Mines
Lim, S. T.
United Kingdom, Cardiff
An-ex Analytical Services Ltd.
McNaughton, G. S.
United Kingdom, Cardiff
College of Biomedical and Life Sciences
Morris, A.
United Kingdom, Cardiff
College of Biomedical and Life Sciences
Nazemi, M. H.
United Kingdom, Cardiff
College of Biomedical and Life Sciences
Pellett, M. A.
United Kingdom, Havant
Wyeth Consumer Hlth. Care
Du Plessis, Jeanetta L.
South Africa, Potchefstroom
North-west University
Quan, Y. S.
Japan, Kyoto
Kyoto Pharmaceutical University
Rachavan, S. L.
United Kingdom, London
University of Greenwich
United States
Vyteris, Inc.
Roberts, Michael S.
Australia, Brisbane
The University of Queensland
Romonchuk, W.
United States, Golden
Colorado School of Mines
Roper, C. S.
United Kingdom, Tranent
Inveresk Research
Schenk, D.
Germany
Novosis ag
Simonsen, L.
Denmark, Ballerup
Leo Pharma as
Simpson, A.
United Kingdom, Tranent
Inveresk Research
Traversa, B. D.
Portugal, Lisbon
Lab. de Estudos Farmacêuticos
Trottet, L.
United Kingdom, Brentford
Glaxosmithkline Plc.
Watkinson, A.
United Kingdom, Galashiels
Strakan Pharmaceuticals
Wilkinson, S. C.
United Kingdom, Newcastle
School of Medical Education
Williams, Faith M.
United Kingdom, Newcastle
School of Medical Education
Yamamoto, Akira
Japan, Kyoto
Kyoto Pharmaceutical University
Hadcraft, J.
United Kingdom, London
University of Greenwich
Statistics
Citations: 42
Authors: 42
Affiliations: 22
Identifiers
Doi:
10.1002/jps.20229
ISSN:
00223549