Probabilistic assessment method of the non-monotonic dose-responses-Part II: Robustness assessment

Chevillotte, G.; Bernard, A.; Varret, Clémence; Ballet, Pascal; Bodin, Laurent; Roudot, Alain‐Claude

doi:10.1016/j.fct.2017.10.030

Cited by 6 publications

(16 citation statements)

References 17 publications

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“…In a follow‐up study, Chevillotte et al. ( 2017b ) added four statistical criteria to assess the robustness of the assumption of non‐monotonicity and characterise the types of curves obtained. These addressed aspects of distribution and intensity, as well as minimum and maximum confirmation.…”

Section: Introductionmentioning

confidence: 99%

“…The authors developed a software that is available from Chevillotte et al. ( 2017b ) and concluded that their method provides a probabilistic and objective characterisation of the type of dose‐response curve, relevant for the assessment of the likelihood of non‐monotonic responses.…”

Section: Introductionmentioning

confidence: 99%

“…Chevillotte et al. ( 2017a , b ) reviewed the same data using a different but complementary probabilistic approach. Whereas a small percentage of the eligible in vivo dataset suggests the statistical possibility of a NMDR, the biological relevance of the statistical findings as well as the possible impact on EFSA risk assessments was, however, not assessed.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, in case biological relevant non‐monotonic dose responses are identified, the SC is requested to address the possible consequences for the human health risk assessments conducted by EFSA. Specifically, the SC is requested: To assess the biological relevance of the non‐monotonic dose responses identified in vivo in the EFSA external Report (Beausoleil et al., 2016 ) and the follow up probabilistic assessment (Chevillotte et al., 2017a , b ), based on visual/statistics/probabilistic considerations. To further analyse the non‐monotonic dose‐responses assessed as biologically plausible, grouping them if appropriate, and evaluate their potential link with adverse effects, considering if the response induction/increase and response inhibition/decrease should be associated to the same or to different adverse outcomes.…”

Section: Introductionmentioning

confidence: 99%

“…To assess the biological relevance of the non‐monotonic dose responses identified in vivo in the EFSA external Report (Beausoleil et al., 2016 ) and the follow up probabilistic assessment (Chevillotte et al., 2017a , b ), based on visual/statistics/probabilistic considerations.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments

More¹,

Benford²,

Bennekou³

et al. 2021

EFS2

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This Opinion assesses the biological relevance of the non‐monotonic dose responses ( NMDR ) identified in a previous EFSA External Report (Beausoleil et al., 2016) produced under GP / EFSA / SCER /2014/01 and the follow‐up probabilistic assessment (Chevillotte et al., 2017a,b), focusing on the in vivo data sets fulfilling most of the checkpoints of the visual/statistical‐based analysis identified in Beausoleil et al. (2016). The evaluation was completed with cases discussed in EFSA assessments and the update of the scientific literature. Observations of NMDR were confirmed in certain studies and are particularly relevant for receptor‐mediated effects. Based on the results of the evaluation, the Opinion proposes an approach to be applied during the risk assessment process when apparent non‐monotonicity is observed, also providing advice on specific elements to be considered to facilitate the assessment of NMDR in EFSA risk assessments. The proposed approach was applied to two case studies, Bisphenol A and bis(2‐ethylhexyl phthalate ( DEHP ) and these evaluations are reported in dedicated annexes. Considering the potential impact of NMDR s in regulatory risk assessment, the Scientific Committee recommends a concerted international effort on developing internationally agreed guidance and harmonised frameworks for identifying and addressing NMDR s in the risk assessment process.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%