scholarly journals When Are Adverse Outcome Pathways and Associated Assays “Fit for Purpose” for Regulatory Decision‐Making and Management of Chemicals?

2019 ◽  
Vol 15 (4) ◽  
pp. 633-647 ◽  
Author(s):  
Katie Coady ◽  
Patience Browne ◽  
Michelle Embry ◽  
Thomas Hill ◽  
Eeva Leinala ◽  
...  
Keyword(s):  
Decision Making ◽  
Adverse Outcome ◽  
Regulatory Decision ◽  
Fit For Purpose ◽  
Adverse Outcome Pathways ◽  
Management Of Chemicals

scholarly journals Adverse outcome pathways – development and potential regulatory application

2021 ◽  
Vol 9 (3) ◽  
pp. 2-13
Author(s):  
Thania Rios Rossi Lima ◽  
◽  
Nathália Pereira de Souza ◽  
Lílian Cristina Pereira ◽  
João Lauro Viana de Camargo ◽  
...  
Keyword(s):  
Decision Making ◽  
Scientific Community ◽  
Adverse Outcome ◽  
Adverse Outcomes ◽  
Empirical Science ◽  
Chemical Safety ◽  
Mechanisms Of Toxicity ◽  
Testing Procedures ◽  
Regulatory Decision ◽  
Adverse Outcome Pathways

Introduction: Over the last two decades, chemical safety assessment and regulatory toxicology have progressed from empirical science based on direct observation of apical adverse outcomes in whole organisms to a predictive practice that infers outcomes and risks on the basis of accumulated understanding of toxicological mechanisms and modes of action. Objective: To provide general concepts on how Adverse Outcome Pathways (AOPs) are developed and examples related to skin sensitization, endocrine, disruption, and mitochondrial dysfunction. Method: Narrative review based on data of the scientific literature relevant to the theme addressed and on the experience of the authors. Results: An AOP framework provides a systematic approach to organize knowledge about mechanisms of toxicity that may inform analytical domains in regulatory decision-making. AOPs are open structures that may indicate not only data gaps in the understanding of a toxicity process, but also testing procedures that will generate the necessary knowledge to fill those gaps. Every AOP should be continuously refined through the collaborative efforts of the scientific community. Depending on the amount and detail of information that is successively inserted, AOP may progress from the stage of a putative AOP to the stages of qualitative and quantitative AOPs, which are more fit-for-purpose to support regulatory decision-making. Conclusions: Continuous collaboration between AOP developers within the scientific community and the regulatory corps toward the development of this mechanistic structure will support the advancement of toxicological sciences, regardless of its immediate application for regulatory purposes.

Adverse Outcome Pathways--Organizing Toxicological Information to Improve Decision Making

2015 ◽  
Vol 356 (1) ◽  
pp. 170-181 ◽  
Author(s):  
S. W. Edwards ◽  
Y.-M. Tan ◽  
D. L. Villeneuve ◽  
M. E. Meek ◽  
C. A. McQueen
Keyword(s):  
Decision Making ◽  
Adverse Outcome ◽  
Adverse Outcome Pathways

The Adverse Outcome Pathway Concept: A Basis for Developing Regulatory Decision-making Tools

2016 ◽  
Vol 44 (5) ◽  
pp. 417-429 ◽  
Author(s):  
Nathalie Delrue ◽  
Magdalini Sachana ◽  
Yuki Sakuratani ◽  
Anne Gourmelon ◽  
Eeva Leinala ◽  
...  
Keyword(s):  
Decision Making ◽  
Adverse Outcome ◽  
Adverse Outcome Pathway ◽  
Regulatory Decision

scholarly journals sAOP: linking chemical stressors to adverse outcomes pathway networks

2019 ◽  
Author(s):  
Alejandro Aguayo-Orozco ◽  
Karine Audouze ◽  
Troels Siggaard ◽  
Robert Barouki ◽  
Søren Brunak ◽  
...  
Keyword(s):  
Decision Making ◽  
Human Health ◽  
Adverse Outcome ◽  
Adverse Outcomes ◽  
Supplementary Information ◽  
Adverse Outcome Pathway ◽  
Supplementary Data ◽  
Biological Organization ◽  
Regulatory Decision ◽  
Pathway Networks

Abstract Motivation Adverse outcome pathway (AOP) is a toxicological concept proposed to provide a mechanistic representation of biological perturbation over different layers of biological organization. Although AOPs are by definition chemical-agnostic, many chemical stressors can putatively interfere with one or several AOPs and such information would be relevant for regulatory decision-making. Results With the recent development of AOPs networks aiming to facilitate the identification of interactions among AOPs, we developed a stressor-AOP network (sAOP). Using the ‘cytotoxitiy burst’ (CTB) approach, we mapped bioactive compounds from the ToxCast data to a list of AOPs reported in AOP-Wiki database. With this analysis, a variety of relevant connections between chemicals and AOP components can be identified suggesting multiple effects not observed in the simplified ‘one-biological perturbation to one-adverse outcome’ model. The results may assist in the prioritization of chemicals to assess risk-based evaluations in the context of human health. Availability and implementation sAOP is available at http://saop.cpr.ku.dk Supplementary information Supplementary data are available at Bioinformatics online.

Adverse outcome pathways: A conceptual framework to support ecotoxicology research and risk assessment

2011 ◽  
pp. n/a-n/a ◽  
Author(s):  
Gerald T. Ankley ◽  
Richard S. Bennett ◽  
Russell J. Erickson ◽  
Dale J. Hoff ◽  
Michael W. Hornung ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Conceptual Framework ◽  
Adverse Outcome ◽  
Adverse Outcome Pathways

Voluntary food fortification policy in Australia: did ‘formal’ stakeholder consultation influence the outcome?

2021 ◽  
Author(s):  
Bronwyn Ashton ◽  
Cassandra Star ◽  
Mark Lawrence ◽  
John Coveney
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Policy Process ◽  
Policy Development ◽  
Food Fortification ◽  
Policy Debate ◽  
Stakeholder Consultation ◽  
Regulatory Decision ◽  
Food Regulation ◽  
Ministerial Council

Summary This research aimed to understand how the policy was represented as a ‘problem’ in food regulatory decision-making in Australia, and the implications for public health nutrition engagement with policy development processes. Bacchi’s ‘what’s the problem represented to be?’ discourse analysis method was applied to a case study of voluntary food fortification policy (VFP) developed by the then Australia and New Zealand Food Regulation Ministerial Council (ANZFRMC) between 2002 and 2012. As a consultative process is a legislated aspect of food regulatory policy development in Australia, written stakeholder submissions contributed most of the key documents ascertained as relevant to the case. Four major categories of stakeholder were identified in the data; citizen, public health, government and industry. Predictably, citizen, government and public health stakeholders primarily represented voluntary food fortification (VF) as a problem of public health, while industry stakeholders represented it as a problem of commercial benefit. This reflected expected differences regarding decision-making control and power over regulatory activity. However, at both the outset and conclusion of the policy process, the ANZFRMC represented the problem of VF as commercial benefit, suggesting that in this case, a period of ‘formal’ stakeholder consultation did not alter the outcome. This research indicates that in VFP, the policy debate was fought and won at the initial framing of the problem in the earliest stages of the policy process. Consequently, if public health nutritionists leave their participation in the process until formal consultation stages, the opportunity to influence policy may already be lost.

Real‐world evidence to support regulatory decision making: New or expanded medical product indications

2021 ◽  
Author(s):  
Jessica M. Franklin ◽  
Kai‐Li Liaw ◽  
Solomon Iyasu ◽  
Cathy Critchlow ◽  
Nancy Dreyer
Keyword(s):  
Decision Making ◽  
Real World ◽  
Medical Product ◽  
Regulatory Decision ◽  
Real World Evidence

Use of External Controls in Regulatory Decision-Making

2017 ◽  
Vol 101 (5) ◽  
pp. 595-596 ◽  
Author(s):  
JP Jarow
Keyword(s):  
Decision Making ◽  
Regulatory Decision
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