Report from the EPAA workshop : in vitro ADME in safety testing used by EPAA industry sectors

Schroeder, K. and Bremm, K. D. and Alepee, N. and Bessems, J. G. and Blaauboer, B. and Boehn, S. N. and Burek, C. and Coecke, S. and Gombau, L. and Hewitt, N. J. and Heylings, J. and Huwyler, J. and Jaeger, M. and Jagelavicius, M. and Jarrett, N. and Ketelslegers, H. and Kocina, I. and Koester, J. and Kreysa, J. and Note, R. and Poth, A. and Radtke, M. and Rogiers, V. and Scheel, J. and Schulz, T. and Steinkellner, H. and Toeroek, M. and Whelan, M. and Winkler, P. and Diembeck, W.. (2011) Report from the EPAA workshop : in vitro ADME in safety testing used by EPAA industry sectors. Toxicology in vitro, Vol. 25, H. 3. pp. 589-604.

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Official URL: http://edoc.unibas.ch/dok/A5841718

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There are now numerous in vitro and in silico ADME alternatives to in vivo assays but how do different industries incorporate them into their decision tree approaches for risk assessment, bearing in mind that the chemicals tested are intended for widely varying purposes? The extent of the use of animal tests is mainly driven by regulations or by the lack of a suitable in vitro model. Therefore, what considerations are needed for alternative models and how can they be improved so that they can be used as part of the risk assessment process? To address these issues, the European Partnership for Alternative Approaches to Animal Testing (EPAA) working group on prioritisation, promotion and implementation of the 3Rs research held a workshop in November, 2008 in Duesseldorf, Germany. Participants included different industry sectors such as pharmaceuticals, cosmetics, industrial- and agro-chemicals. This report describes the outcome of the discussions and recommendations (a) to reduce the number of animals used for determining the ADME properties of chemicals and (b) for considerations and actions regarding in vitro and in silico assays. These included: standardisation and promotion of in vitro assays so that they may become accepted by regulators; increased availability of industry in vivo kinetic data for a central database to increase the power of in silico predictions; expansion of the applicability domains of in vitro and in silico tools (which are not necessarily more applicable or even exclusive to one particular sector) and continued collaborations between regulators, academia and industry. A recommended immediate course of action was to establish an expert panel of users, developers and regulators to define the testing scope of models for different chemical classes. It was agreed by all participants that improvement and harmonization of alternative approaches is needed for all sectors and this will most effectively be achieved by stakeholders from different sectors sharing data.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler)
UniBasel Contributors:Huwyler, Jörg
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:08 Jun 2012 06:56
Deposited On:08 Jun 2012 06:51

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