کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5863135 | 1133806 | 2011 | 16 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors
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کلمات کلیدی
PBBKSCCsPPRNIHGSTsMOSPPPSQPSGLPECVAMJECFAECHANOAELUGTsCOLIPAPBTKOECD TGFP7SCCPFP6FDASCCNFPDirectorate GeneralJMPREFSAITSNRCADMETTCPBPKDNELIMICYPs - CYPADI - NAMEThreshold of toxicological concern - آستانه نگرانی سمیinnovative medicines initiative - ابتکارات داروهای ابتکاریEuropean Union - اتحادیه اروپاEuropean Food Safety Authority - اداره ایمنی اروپاUS Food and Drug Administration - اداره غذا و داروی ایالات متحدهIntegrated testing strategies - استراتژی تست یکپارچهind - اندرOsiris - اوزیریسQSAR - بزرگسال Toxicokinetics - تاکسیکوسینتیک، تاکسیکوکینتیکSafety testing - تست ایمنیGood Laboratory Practice - تمرین خوب آزمایشگاهیRegistration, Evaluation, Authorisation and Restriction of Chemicals - ثبت، ارزیابی، مجوز و محدودیت مواد شیمیاییabsorption, distribution, metabolism, and excretion - جذب، توزیع، متابولیسم و دفعMargin of safety - حاشیه ایمنیInvestigational New Drug - داروهای جدید تحقیقاتیIn vitro - درونکشتگاهیAcceptable daily intake - دریافت روزانه قابل قبولQuantitative Structure Activity Relationship - رابطه فعالیت ساختاری کمیREACH - رسیدنWorld Health Organization - سازمان بهداشت جهانیDerived No Effect Level - سطح متوالی بدون اثرSulfotransferases - سولفات ترانسفرازcytochrome P450s - سیتوکروم P450sNational Research Council - شورای تحقیقات ملیphysiologically-based pharmacokinetic - فیزیولوژیک مبتنی بر فارماکوکینتیکNIH, National Institutes of Health - مؤسسه ملی سلامتJoint FAO/WHO Expert Committee on Food Additives - مجمع متخصص FAO / WHO در مورد مواد افزودنی مواد غذاییPlant protection products - محصولات گیاهان داروییEuropean Centre for the Validation of Alternative Methods - مرکز اروپا برای اعتبار سنجی روش های جایگزینICH - منNo observed adverse effect level - هیچ عوارض جانبی مشاهده نشدهqualified presumption of safety - پیش شرط ایمنی ایمنیScientific Committee on Consumer Safety - کمیته علمی ایمنی مصرف کنندهInternational Conference on Harmonisation - کنفرانس بین المللی هماهنگیWHO - کهSULTs - گلهاglutathione S-transferases - گلوتاتیون S-transferases
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Toxicology in Vitro - Volume 25, Issue 3, April 2011, Pages 589-604
Journal: Toxicology in Vitro - Volume 25, Issue 3, April 2011, Pages 589-604
نویسندگان
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, W. Diembeck,