Guidance on the use of the benchmark dose ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
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Title :
Guidance on the use of the benchmark dose approach in risk assessment
Author(s) :
More, S. J. [Auteur]
Bampidis, V. [Auteur]
Benford, D. [Auteur]
Bragard, C. [Auteur]
Halldorsson, T. I. [Auteur]
Hernandez-Jerez, A. F. [Auteur]
Bennekou, S. H. [Auteur]
Koutsoumanis, K. [Auteur]
Lambre, C. [Auteur]
Machera, K. [Auteur]
Mennes, W. [Auteur]
Mullins, E. [Auteur]
Nielsen, S. S. [Auteur]
Schrenk, D. [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Younes, M. [Auteur]
Aerts, M. [Auteur]
Edler, L. [Auteur]
Sand, S. [Auteur]
Wright, M. [Auteur]
Binaglia, M. [Auteur]
Bottex, B. [Auteur]
Abrahantes, J. C. [Auteur]
Schlatter, J. [Auteur]
Bampidis, V. [Auteur]
Benford, D. [Auteur]
Bragard, C. [Auteur]
Halldorsson, T. I. [Auteur]
Hernandez-Jerez, A. F. [Auteur]
Bennekou, S. H. [Auteur]
Koutsoumanis, K. [Auteur]
Lambre, C. [Auteur]
Machera, K. [Auteur]
Mennes, W. [Auteur]
Mullins, E. [Auteur]
Nielsen, S. S. [Auteur]
Schrenk, D. [Auteur]
Turck, Dominique [Auteur]

Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Younes, M. [Auteur]
Aerts, M. [Auteur]
Edler, L. [Auteur]
Sand, S. [Auteur]
Wright, M. [Auteur]
Binaglia, M. [Auteur]
Bottex, B. [Auteur]
Abrahantes, J. C. [Auteur]
Schlatter, J. [Auteur]
Journal title :
EFSA Journal
Abbreviated title :
EFSA J.
Volume number :
20
Pages :
-
Publication date :
2022-10-31
ISSN :
1831-4732
English keyword(s) :
BMD
BMDL
benchmark response
NOAEL
dose-response modelling
BMD software
Bayesian model averaging
BMDL
benchmark response
NOAEL
dose-response modelling
BMD software
Bayesian model averaging
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). ...
Show more >The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step-by-step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.Show less >
Show more >The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step-by-step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Submission date :
2024-01-12T00:11:28Z
2024-03-28T12:44:40Z
2024-03-28T12:44:40Z
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