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18 results on '"Strikwold, Marije"'

6. Selecting the dose metric in reverse dosimetry based QIVIVE: Reply to ‘Comment on ‘Use of an in vitro–in silico testing strategy to predict inter-species and inter-ethnic human differences in liver toxicity of the pyrrolizidine alkaloids lasiocarpine and riddelliine’ by Ning et al., Arch Toxicol doi: https://doi.org/10.1007/s00204-019-02397-7’, Arch Toxicol doi: https://doi.org/10.1007/s00204-019-02421-w

Author

Rietjens, Ivonne M. C. M., Ning, Jia, Chen, Lu, Wesseling, Sebastiaan, Strikwold, Marije, and Louisse, Jochem

Published
2019
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8. New approach methodologies (NAMs) for human-relevant biokinetics predictions

Author

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, 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, and Applied Stem Cell Technologies

Subjects
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
Abstract

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.

Published
2020
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10. Inter-individual variation in chlorpyrifos toxicokinetics characterized by physiologically based kinetic (PBK) and Monte Carlo simulation comparing human liver microsome and Supersome™ cytochromes P450 (CYP)-specific kinetic data as model input

Author

Zhao, Shensheng, Wesseling, Sebastiaan, Rietjens, Ivonne. M. C. M., and Strikwold, Marije

Subjects
CHLORPYRIFOS, MONTE Carlo method, CYTOCHROMES, ACETYLCHOLINESTERASE, ERYTHROCYTES, CONFIDENCE intervals, DATA modeling
Abstract

The present study compares two approaches to evaluate the effects of inter-individual differences in the biotransformation of chlorpyrifos (CPF) on the sensitivity towards in vivo red blood cell (RBC) acetylcholinesterase (AChE) inhibition and to calculate a chemical-specific adjustment factor (CSAF) to account for inter-individual differences in kinetics (HKAF). These approaches included use of a Supersome™ cytochromes P450 (CYP)-based and a human liver microsome (HLM)-based physiologically based kinetic (PBK) model, both combined with Monte Carlo simulations. The results revealed that bioactivation of CPF exhibits biphasic kinetics caused by distinct differences in the Km of CYPs involved, which was elucidated by Supersome™ CYP rather than by HLM. Use of Supersome™ CYP-derived kinetic data was influenced by the accuracy of the intersystem extrapolation factors (ISEFs) required to scale CYP isoform activity of Supersome™ to HLMs. The predicted dose–response curves for average, 99th percentile and 1st percentile sensitive individuals were found to be similar in the two approaches when biphasic kinetics was included in the HLM-based approach, resulting in similar benchmark dose lower confidence limits for 10% inhibition (BMDL10) and HKAF values. The variation in metabolism-related kinetic parameters resulted in HKAF values at the 99th percentile that were slightly higher than the default uncertainty factor of 3.16. While HKAF values up to 6.9 were obtained when including also the variability in other influential PBK model parameters. It is concluded that the Supersome™ CYP-based approach appeared most adequate for identifying inter-individual variation in biotransformation of CPF and its resulting RBC AChE inhibition. [ABSTRACT FROM AUTHOR]

Published
2022
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11. New approach methodologies (NAMs) for human-relevant biokinetics predictions: Meeting the paradigm shift in toxicology towards an animal-free chemical risk assessment

Author

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, 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, and Heringa, Minne B

Abstract

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 as a critical step. To this end, a need for an expert group on biokinetics within the Organisation of Economic Cooperation and Development (OECD) was formulated to supervise this process. 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 field of stem-cells, organoids and organ-on-a-chip provide promising tools to meet these research needs in the future.

Published
2020

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

Author

IRAS OH Toxicology, dIRAS RA-1, Afd Pharmacology, Interne geneeskunde GD, dCSCA RMSC-1, Leerstoel Honk, CS_STEM, 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, IRAS OH Toxicology, dIRAS RA-1, Afd Pharmacology, Interne geneeskunde GD, dCSCA RMSC-1, Leerstoel Honk, CS_STEM, 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, and Heringa, Minne B

Published
2020

13. Replacing animal experiments in developmental toxicity testing of phenols by combining in vitro assays with physiologically based kinetic (PBK) modelling

Author

Strikwold, Marije, Wageningen University, Ivonne Rietjens, Ruud Woutersen, and Ans Punt

Subjects
fenolen, phenols, testen, Toxicology, dosage, weefsels, dierproeven, tissues, cellen, Toxicologie, VLAG, animal testing alternatives, toxiciteit, animal health, toxicity, toxicologie, in vitro, diergezondheid, dosering, embryonic stem cells, animal experiments, testing, cells, embryonale stamcellen, alternatieven voor dierproeven, toxicology
Published
2016

17. Selecting the dose metric in reverse dosimetry based QIVIVE: Reply to 'Comment on 'Use of an in vitro–in silico testing strategy to predict inter-species and inter-ethnic human differences in liver toxicity of the pyrrolizidine alkaloids lasiocarpine and riddelliine' by Ning et al., Arch Toxicol doi: https://doi.org/10.1007/s00204-019-02397-7', Arch Toxicol doi: https://doi.org/10.1007/s0020 4-019-02421-w

Author

Rietjens, Ivonne M. C. M., Ning, Jia, Chen, Lu, Wesseling, Sebastiaan, Louisse, Jochem, and Strikwold, Marije

Subjects
SILICON testing, HEPATOTOXICOLOGY, PYRROLIZIDINES
Published
2019
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