New approach methodologies (NAMs) for human-relevant biokinetics predictions Meeting the paradigm shift in toxicology towards an animal-free chemical risk assessment

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Ans Punt
Hans Bouwmeester
Bas J. Blaauboer
Sandra Coecke
Betty Hakkert
Delilah F. G. Hendriks
Paul Jennings
Nynke I. Kramer
Sibylle Neuhoff
Rosalinde Masereeuw
Alicia Paini
Ad A. C. M. Peijnenburg
Martijn Rooseboom
Michael L. Shuler
Ian Sorrell
Bart Spee
Marije Strikwold
Andries D. van der Meer
Meike van der Zande
Mathieu Vinken
Huan Yang
Peter M. J. Bos
Minne B. Heringa


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.

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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. and 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 - Alternatives to animal experimentation, 37(4), pp. 607–622. doi: 10.14573/altex.2003242.

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