New approach methodologies (NAMs) for human-relevant biokinetics predictions
| العنوان: | New approach methodologies (NAMs) for human-relevant biokinetics predictions |
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| المؤلفون: | Punt, Ans, Bouwmeester, Hans, Blaauboer, Bas J, Coecke, Sandra, Hakkert, Betty, Hendriks, Delilah F G, Jennings, Paul, Kramer, Nynke I, Neuhoff, Sibylle, Masereeuw, Rosalinde, Paini, Alicia, Peijnenburg, Ad A C M, Rooseboom, Martijn, Shuler, Michael L, Sorrell, Ian, Spee, Bart, Strikwold, Marije, Van der Meer, Andries D, Van der Zande, Meike, Vinken, Mathieu, Yang, Huan, Bos, Peter M J, Heringa, Minne B |
| المساهمون: | Molecular and Computational Toxicology, AIMMS, Liver Connexin and Pannexin Research Group, Pharmaceutical and Pharmacological Sciences, Connexin Signalling Research Group, Experimental in vitro toxicology and dermato-cosmetology, Applied Stem Cell Technologies |
| المصدر: | ALTEX : Alternatives to Animal Experimentation, 37(4), 607-622 Altex 37 (2020) 4 ALTEX, 37(4), 607-622. Spektrum, Akad. Verl., Springer Science + Business Altex, 37(4), 607-622 ALTEX, 37(4), 607-622. Elsevier Punt, A, Bouwmeester, H, Blaauboer, B J, Coecke, S, Hakkert, B, Hendriks, D F G, Jennings, P, Kramer, N I, Neuhoff, S, Masereeuw, R, Paini, A, Peijnenburg, A A C M, Rooseboom, M, Shuler, M L, Sorrell, I, Spee, B, Strikwold, M, Van der Meer, A D, Van der Zande, M, Vinken, M, Yang, H, Bos, P M J & Heringa, M B 2020, ' New approach methodologies (NAMs) for human-relevant biokinetics predictions : Meeting the paradigm shift in toxicology towards an animal-free chemical risk assessment ', ALTEX, vol. 37, no. 4, pp. 607-622 . https://doi.org/10.14573/altex.2003242 |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | in vitro, Animal Testing Alternatives, Toxicology, Risk Assessment, biokinetics, Hazardous Substances, SDG 17 - Partnerships for the Goals, BU Toxicologie, Novel Foods & Agroketens, in silico, next-generation risk evaluations, PB(P)K, Animals, Humans, BU Toxicology, Novel Foods & Agrochains, Toxicologie, VLAG, QIVIVE |
| الوصف: | For almost fifteen years, the availability and regulatory acceptance of new approach methodologies (NAMs) to assess the absorption, distribution, metabolism and excretion (ADME/biokinetics) in chemical risk evaluations are a bottleneck. To enhance the field, a team of 24 experts from science, industry, and regulatory bodies, including new generation toxicologists, met at the Lorentz Centre in Leiden, The Netherlands. A range of possibilities for the use of NAMs for biokinetics in risk evaluations were formulated (for example to define species differences and human variation or to perform quantitative in vitro-in vivo extrapolations). To increase the regulatory use and acceptance of NAMs for biokinetics for these ADME considerations within risk evaluations, the development of test guidelines (protocols) and of overarching guidance documents is considered a critical step. To this end, a need for an expert group on biokinetics within the Organisation of Economic Cooperation and Development (OECD) to supervise this process was formulated. The workshop discussions revealed that method development is still required, particularly to adequately capture transporter mediated processes as well as to obtain cell models that reflect the physiology and kinetic characteristics of relevant organs. Developments in the fields of stem cells, organoids and organ-on-a-chip models provide promising tools to meet these research needs in the future. |
| وصف الملف: | application/pdf; application/octet-stream |
| اللغة: | English |
| تدمد: | 1868-596X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::69b35f8cbe1e63b3a7566638341cdfaa https://doi.org/10.14573/altex.2003242 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.pmid.dedup....69b35f8cbe1e63b3a7566638341cdfaa |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1868596X |
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