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Elke Anklam, Martin Iain Bahl, Robert Ball, Richard D. Beger, Jonathan E. Cohen, Suzanne Fitzpatrick, Philippe Girard, Blanka Halamoda‐Kenzaoui, Denise Hinton, Akihiko Hirose and 38 more
technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.
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Anklam, E., Bahl, M. I., Ball, R., Beger, R. D., Cohen, J. E., Fitzpatrick, S., Girard, P., Halamoda‐Kenzaoui, B., Hinton, D., Hirose, A., Hoeveler, A., Honma, M., Hugas, M., Ishida, S., Kass, G. E., Kojima, H., Krefting, I., Liachenko, S. M., Liu, Y., … Slikker, W. (2021). Emerging technologies and their impact on regulatory science. Experimental Biology and Medicine, 247(1), 1–75. https://doi.org/10.1177/15353702211052280
Anklam, Elke, et al. "Emerging technologies and their impact on regulatory science." Experimental Biology and Medicine, vol. 247, no. 1, 2021, pp. 1–75, https://doi.org/10.1177/15353702211052280.
Anklam, Elke, Martin Iain Bahl, Robert Ball, Richard D. Beger, Jonathan E. Cohen, Suzanne Fitzpatrick, Philippe Girard, et al. "Emerging technologies and their impact on regulatory science." Experimental Biology and Medicine 247, no. 1 (2021): 1–75. https://doi.org/10.1177/15353702211052280.
Anklam E., Bahl M. I., Ball R. [и др.] Emerging technologies and their impact on regulatory science // Experimental Biology and Medicine. — 2021. — Vol. 247, № 1. — P. 1–75. — URL: https://doi.org/10.1177/15353702211052280
@article{anklam2021emerging,
title = {{Emerging technologies and their impact on regulatory science}},
author = {Elke Anklam and Martin Iain Bahl and Robert Ball and Richard D. Beger and Jonathan E. Cohen and Suzanne Fitzpatrick and Philippe Girard and Blanka Halamoda‐Kenzaoui and Denise Hinton and Akihiko Hirose and Arnd Hoeveler and Masamitsu Honma and Marta Hugas and Seichi Ishida and George E.N. Kass and Hajime Kojima and Ira Krefting and Serguei M. Liachenko and Yan Liu and Shane C. Masters and Uwe Marx and Timothy McCarthy and Tim R. Mercer and Anil K. Patri and Carmen Peláez and Munir Pirmohamed and Stefan J. Platz and Alexandre J. S. Ribeiro and Joseph V. Rodricks and Ivan Rusyn and Reza M. Salek and Reinhilde Schoonjans and Primal Silva and Clive Niels Svendsen and Susan Sumner and Kyung Eun Sung and Danilo A. Tagle and Tong Li and Weida Tong and Janny van den Eijnden–van Raaij and Neil Vary and Tao Wang and John C. Waterton and May Dongmei Wang and Hairuo Wen and David Scott Wishart and Yinyin Yuan and William Slikker},
journal = {Experimental Biology and Medicine},
year = {2021},
volume = {247},
number = {1},
pages = {1--75},
doi = {10.1177/15353702211052280},
url = {https://doi.org/10.1177/15353702211052280}
}TY - JOUR AU - Anklam, Elke AU - Bahl, Martin Iain AU - Ball, Robert AU - Beger, Richard D. AU - Cohen, Jonathan E. AU - Fitzpatrick, Suzanne AU - Girard, Philippe AU - Halamoda‐Kenzaoui, Blanka AU - Hinton, Denise AU - Hirose, Akihiko AU - Hoeveler, Arnd AU - Honma, Masamitsu AU - Hugas, Marta AU - Ishida, Seichi AU - Kass, George E.N. AU - Kojima, Hajime AU - Krefting, Ira AU - Liachenko, Serguei M. AU - Liu, Yan AU - Masters, Shane C. AU - Marx, Uwe AU - McCarthy, Timothy AU - Mercer, Tim R. AU - Patri, Anil K. AU - Peláez, Carmen AU - Pirmohamed, Munir AU - Platz, Stefan J. AU - Ribeiro, Alexandre J. S. AU - Rodricks, Joseph V. AU - Rusyn, Ivan AU - Salek, Reza M. AU - Schoonjans, Reinhilde AU - Silva, Primal AU - Svendsen, Clive Niels AU - Sumner, Susan AU - Sung, Kyung Eun AU - Tagle, Danilo A. AU - Li, Tong AU - Tong, Weida AU - Raaij, Janny van den Eijnden–van AU - Vary, Neil AU - Wang, Tao AU - Waterton, John C. AU - Wang, May Dongmei AU - Wen, Hairuo AU - Wishart, David Scott AU - Yuan, Yinyin AU - Slikker, William TI - Emerging technologies and their impact on regulatory science JO - Experimental Biology and Medicine VL - 247 IS - 1 SP - 1 EP - 75 PY - 2021 DA - 2021/11/16 DO - 10.1177/15353702211052280 UR - https://doi.org/10.1177/15353702211052280 ER -
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