Document Detail

Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors.
MedLine Citation:
PMID:  21167275     Owner:  NLM     Status:  Publisher    
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.
K Schroeder; K D Bremm; N Alépée; J G M Bessems; B Blaauboer; S N Boehn; C Burek; S Coecke; L Gombau; N J Hewitt; J Heylings; J Huwyler; M Jaeger; M Jagelavicius; N Jarrett; H Ketelslegers; I Kocina; J Koester; J Kreysa; R Note; A Poth; M Radtke; V Rogiers; J Scheel; T Schulz; H Steinkellner; M Toeroek; M Whelan; P Winkler; W Diembeck
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2010-12-15
Journal Detail:
Title:  Toxicology in vitro : an international journal published in association with BIBRA     Volume:  -     ISSN:  1879-3177     ISO Abbreviation:  -     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2011-1-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8712158     Medline TA:  Toxicol In Vitro     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2010 Elsevier Ltd. All rights reserved.
Henkel AG & Co. KGaA, Henkelstr. 67, 40589, Düsseldorf, Germany; BioMed - zet Life Science GmbH, zet Life Science Laboratorium, Industriezeile 36/VII, A-4020 Linz, Austria.
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