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Record W3212971182 · doi:10.1177/15353702211052280

Emerging technologies and their impact on regulatory science

2021· review· en· W3212971182 on OpenAlex
Elke Anklam, Martin Iain Bahl, Robert Ball, Richard D. Beger, Jonathan E. Cohen, Suzanne Fitzpatrick, Philippe Girard, Blanka Halamoda‐Kenzaoui, Denise Hinton, Akihiko Hirose, Arnd Hoeveler, Masamitsu Honma, Marta Hugas, Seichi Ishida, George E.N. Kass, Hajime Kojima, Ira Krefting, Serguei Liachenko, Yan Liu, Shane C. Masters, Uwe Marx, Timothy J. McCarthy, Tim R. Mercer, Anil K. Patri, Carmen Peláez, Munir Pirmohamed, Stefan Platz, Joseph V. Rodricks, Ivan Rusyn, Reza M. Salek, Reinhilde Schoonjans, Primal Silva, Clive N. Svendsen, Susan Sumner, Kyung E. Sung, Danilo A. Tagle, Tong Li, Weida Tong, Janny van den Eijnden–van Raaij, Neil Vary, Tao Wang, John C. Waterton, May D. Wang, Hairuo Wen, David S. Wishart, Yinyin Yuan, William Slikker

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenueExperimental Biology and Medicine · 2021
Typereview
Languageen
FieldEngineering
Topic3D Printing in Biomedical Research
Canadian institutionsUniversity of AlbertaCanadian Food Inspection Agency
FundersNational Center for Advancing Translational SciencesNational Institute of Neurological Disorders and StrokeNational Institute of Diabetes and Digestive and Kidney DiseasesCancer Research UKNational Cancer InstituteNational Institute of Environmental Health SciencesNational Institute for Health and Care ResearchWorld Health Organization
KeywordsEmerging technologiesRisk analysis (engineering)Regulatory scienceQuality (philosophy)Computer scienceField (mathematics)BusinessManagement scienceMedicineEngineeringArtificial intelligence

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.994
Threshold uncertainty score0.937

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.003
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.040
GPT teacher head0.422
Teacher spread0.382 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it