Comprehensive Realism's Weight-of-Evidence Based Distributional Dose-Response Characterization

1996 ◽  
Vol 2 (1) ◽  
pp. 175-193 ◽  
Author(s):  
Robert L. Sielken ◽  
Ciriaco Valdez-Flores
Keyword(s):  
Dose Response ◽  
Weight Of Evidence ◽  
Evidence Based

Report of an independent peer review of an acrylonitrile risk assessment

2005 ◽  
Vol 24 (10) ◽  
pp. 487-527 ◽  
Author(s):  
L T Haber ◽  
J Patterson
Keyword(s):  
Risk Assessment ◽  
Peer Review ◽  
Dose Response ◽  
Environmental Protection Agency ◽  
Mode Of Action ◽  
Response Assessment ◽  
Weight Of Evidence ◽  
Protection Agency ◽  
Review Panel ◽  
Independent Review

A peer review panel made up of experts in toxicology, epidemiology, cancer mode of action (MOA), cancer mechanisms, carcinogenicity, genotoxicity, dose–response, US Environmental Protection Agency (EPA) cancer and noncancer methods, pharmacokinetic modeling and acrylonitrile, met on 22–23 September 2003 in Cincinnati, OH. The purpose of the meeting was to provide an independent review of a risk assessment of acrylonitrile that had been prepared by the Acrylonitrile Group (AN Group). Toxicology Excellence for Risk Assessment (TERA) organized the peer review and selected the panel. The panel discussed the toxicity and epidemiology literature of acrylonitrile and MOA information, and reached conclusions regarding its MOA, weight of evidence (WOE) for carcinogenicity, preferred approach for dose-response assessment and risk values. This paper summarizes the discussion and conclusions of the panel regarding the acrylonitrile assessment. Subsequent to the peer review, the authors of the acrylonitrile assessment revised their report and the panel reviewed the revised report. A manuscript of the revised assessment is being published in Regulatory Toxicology and Pharmacology.

Evidence-based causation in toxicology

2015 ◽  
Vol 34 (12) ◽  
pp. 1245-1252 ◽  
Author(s):  
RC James ◽  
JK Britt ◽  
NC Halmes ◽  
PS Guzelian
Keyword(s):  
Decision Making ◽  
Evidence Based Medicine ◽  
Weight Of Evidence ◽  
Evidence Based ◽  
Definition Of ◽  
Evidence Based Guidelines ◽  
Available Information ◽  
Based Medicine ◽  
Lay Public ◽  
Reproducible Manner

We introduced Evidence-based Toxicology (EBT) in 2005 to address the disparities that exist between the various Weight-of-Evidence (WOE) methods typically applied in the regulatory hazard decision-making arena and urged toxicologists to adopt the evidence-based guidelines long-utilized in medicine (i.e., Evidence-Based Medicine or EBM). This review of the activities leading to the adoption of evidence-based methods and EBT during the last decade demonstrates how fundamental concepts that form EBT, such as the use of systematic reviews to capture and consider all available information, are improving toxicological evaluations performed by various groups and agencies. We reiterate how the EBT framework, a process that provides a method for performing human chemical causation analyses in an objective, transparent and reproducible manner, differs significantly from past and current regulatory WOE approaches. We also discuss why the uncertainties associated with regulatory WOE schemes lead to a definition of the term “risk” that contains unquantifiable uncertainties not present in this term as it is used in epidemiology and medicine. We believe this distinctly different meaning of “risk” should be clearly conveyed to those not familiar with this difference (e.g., the lay public), when theoretical/nomologic risks associated with chemical-induced toxicities are presented outside of regulatory and related scientific parlance.

The association between blood lipid and breast cancer risk: Evidence based on a dose-response meta-analysis comprising 900,669 participants.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e24331-e24331
Author(s):  
Kang Liu ◽  
Dingli Song ◽  
Shuai Lin ◽  
Meng Wang ◽  
Tian Tian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Risk ◽  
Cancer Risk ◽  
Dose Response ◽  
Meta Analysis ◽  
Blood Lipid ◽  
Evidence Based

Some implications for quantitative risk assessment if hormesis exists

1998 ◽  
Vol 17 (5) ◽  
pp. 259-262 ◽  
Author(s):  
Robert L Sielken ◽  
Donald E Stevenson
Keyword(s):  
Risk Assessment ◽  
Dose Level ◽  
Dose Response ◽  
Epidemiological Data ◽  
Quantitative Risk Assessment ◽  
Upper And Lower Bounds ◽  
Weight Of Evidence ◽  
Adverse Health Effects ◽  
Response Information ◽  
Relevant Dose

The existence of hormesis should impact quantitative risk assessment in at least seven fundamental ways. (1) The dose-reponse models for bioassay and epidemiological data should have greater flexibility to fit the observed shape of the dose-response data and no longer be forced to always be linearly increasing at low doses. (2) Experimental designs should be altered to provide greater opportunity to identify the hormetic component of a dose-response relationship. (3) Rather than a lifetime average daily dose or its analog for shorter time periods, dose scales or metrics should be used that reflect the age or time dependence of the dose level. (4) Low-dose risk characterization should include the likelihood of bene-ficial effects and the likelihood that a dose level has reasonable certainty of no appreciable adverse health effects. (5) Exposure assessments should make greater efforts to characterize the distribution of actual doses from exposure rather than just upper bounds. (6) Uncertainty characterizations should be expanded to include both upper and lower bounds, and there should be an increased explicit use of expert judgement and weight-of-evidence based distributional analyses reflecting more of the available relevant dose-response information and alternative risk characterizations. (7) Risk should be characterized in terms of the net effect of a dose on health rather than a dose's effect on a single factor affecting health - for example, risk would be better expressed in terms of mortality from all causes combined rather than a specific type of fatal disease.

Dose-response issues concerning physical activity and health: an evidence-based symposium

2001 ◽  
Vol 33 (Supplement) ◽  
pp. S351-S358 ◽  
Author(s):  
Y. ANTERO KESANIEMI (Chair) ◽  
ELLIOT DANFORTH ◽  
MICHAEL D. JENSEN ◽  
PETER G. KOPELMAN ◽  
PIERRE LEF??BVRE ◽  
...  
Keyword(s):  
Physical Activity ◽  
Dose Response ◽  
Evidence Based

Identifying potential liver toxicants using in vitro and in silico methods in a weight-of-evidence based approach

2017 ◽  
Vol 280 ◽  
pp. S133 ◽  
Author(s):  
Judith Madden ◽  
Julia Pletz ◽  
Steven Webb ◽  
Steven Enoch ◽  
Mark Cronin
Keyword(s):  
In Silico ◽  
Weight Of Evidence ◽  
Evidence Based ◽  
In Silico Methods

scholarly journals A Theory of Evidence for Evidence-Based Policy

2011 ◽  
Author(s):  
NANCY CARTWRIGHT ◽  
JACOB STEGENGA
Keyword(s):  
Weight Of Evidence ◽  
International Agency ◽  
Evidence Based ◽  
Current Standard ◽  
Policy Makers ◽  
Evidence Based Policy ◽  
Standards Of Evidence ◽  
What Works Clearinghouse ◽  
Theory Of Evidence

Evidence-based policy is all the rage now. But no one knows quite how to do it. Policy questions do not generally fall neatly within any one of our scientific or social science disciplines, where the standards and rules of evidence for the questions studied are fairly clearly delineated. There is by now a variety of guides available on standards of evidence for evidence-based policy. But these focus narrowly on only part of the problem. This chapter lays the foundations for a guide for the use of evidence in predicting policy effectiveness in situ — a more comprehensive guide than current standard offerings such as the Maryland rules in criminology, the weight of evidence scheme of the International Agency for Research on Cancer, or the US ‘What Works Clearinghouse’. The guide itself is meant to be well-grounded but at the same time to give practicable advice, that is, advice that can be used by policy-makers not experts in the natural and social sciences, assuming they are well-intentioned and have a reasonable but limited amount of time and resources available for searching out evidence and deliberating.

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