New approach methodologies (NAMs) for human-relevant biokinetics predictions
| Autor: | Michael L. Shuler, Delilah F. G. Hendriks, Betty C. Hakkert, Alicia Paini, Peter M.J. Bos, Bart Spee, Marije Strikwold, Ian Sorrell, Paul Jennings, Ans Punt, Huan Yang, Hans Bouwmeester, Bas J. Blaauboer, Minne B. Heringa, Meike van der Zande, Rosalinde Masereeuw, Martijn Rooseboom, Ad A. C. M. Peijnenburg, Mathieu Vinken, Andries D. van der Meer, Sandra Coecke, Nynke I. Kramer, Sibylle Neuhoff |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Pharmacology Process (engineering) Computer science Guidance documents General Medicine Research needs Expert group Method development Economic cooperation 03 medical and health sciences Medical Laboratory Technology 030104 developmental biology 0302 clinical medicine Risk analysis (engineering) 030220 oncology & carcinogenesis Paradigm shift Chemical risk |
| Zdroj: | ALTEX. |
| ISSN: | 1868-596X |
| DOI: | 10.14573/altex.2003242 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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