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Article ; Online: Response to Cohen et al. (2016) regarding response to Druwe and Burgoon.

Druwe, Ingrid L / Burgoon, Lyle D

2016 Volume 90, Issue 12, Page(s) 3131–3132

Language	English
Publishing date	2016
Publishing country	Germany
Document type	Editorial ; Comment
ZDB-ID	124992-7
ISSN	1432-0738 ; 0340-5761
ISSN (online)	1432-0738
ISSN	0340-5761
DOI	10.1007/s00204-016-1858-9
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Article ; Online: Revisiting Cohen et al. 2015, Cohen et al. 2014 and Waalkes et al. 2014: a bayesian re-analysis of tumor incidences.

Druwe, Ingrid L / Burgoon, Lyle

Archives of toxicology

2016 Volume 90, Issue 8, Page(s) 2047–2048

MeSH term(s)	Bayes Theorem ; Humans ; Incidence ; Neoplasms
Language	English
Publishing date	2016
Publishing country	Germany
Document type	Editorial ; Comment
ZDB-ID	124992-7
ISSN	1432-0738 ; 0340-5761
ISSN (online)	1432-0738
ISSN	0340-5761
DOI	10.1007/s00204-016-1749-0
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Article ; Online: Erratum: "Systematic Evidence Map for over One Hundred and Fifty Per- and Polyfluoroalkyl Substances (PFAS)".

Carlson, Laura M / Angrish, Michelle / Shirke, Avanti V / Radke, Elizabeth G / Schulz, Brittany / Kraft, Andrew / Judson, Richard / Patlewicz, Grace / Blain, Robyn / Lin, Cynthia / Vetter, Nicole / Lemeris, Courtney / Hartman, Pamela / Hubbard, Heidi / Arzuaga, Xabier / Davis, Allen / Dishaw, Laura V / Druwe, Ingrid L / Hollinger, Hillary /

Jones, Ryan / Kaiser, J Phillip / Lizarraga, Lucina / Noyes, Pamela D / Taylor, Michele / Shapiro, Andrew J / Williams, Antony J / Thayer, Kristina A

Environmental health perspectives

2024 Volume 132, Issue 1, Page(s) 19001

Language	English
Publishing date	2024-01-10
Publishing country	United States
Document type	Journal Article ; Published Erratum
ZDB-ID	195189-0
ISSN	1552-9924 ; 0091-6765 ; 1078-0475
ISSN (online)	1552-9924
ISSN	0091-6765 ; 1078-0475
DOI	10.1289/EHP14191
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Article ; Online: Health Effects of Naphthalene Exposure: A Systematic Evidence Map and Analysis of Potential Considerations for Dose-Response Evaluation.

Yost, Erin E / Galizia, Audrey / Kapraun, Dustin F / Persad, Amanda S / Vulimiri, Suryanarayana V / Angrish, Michelle / Lee, Janice S / Druwe, Ingrid L

Environmental health perspectives

2021 Volume 129, Issue 7, Page(s) 76002

Abstract: Background: Naphthalene is a polycyclic aromatic hydrocarbon that has been associated with health effects, including cancer. As the state of the science on naphthalene toxicity continues to evolve, updated toxicity reference value(s) may be required to ... ...

Abstract	Background: Naphthalene is a polycyclic aromatic hydrocarbon that has been associated with health effects, including cancer. As the state of the science on naphthalene toxicity continues to evolve, updated toxicity reference value(s) may be required to support human health risk assessment. Objectives: We present a systematic evidence map of studies that could be used to derive toxicity reference value(s) for naphthalene. Methods: Human and animal health effect studies and physiologically based pharmacokinetic (PBPK) models were identified from a literature search based on populations, exposures, comparators, and outcomes (PECO) criteria. Human and animal studies meeting PECO criteria were refined to a smaller subset considered most informative for deriving chronic reference value(s), which are preferred for assessing risk to the general public. This subset was evaluated for risk of bias and sensitivity, and the suitability of each study for dose-response analysis was qualitatively assessed. Lowest observed adverse effect levels (LOAELs) were extracted and summarized. Other potentially relevant studies (e.g., mechanistic and toxicokinetic studies) were tracked as supplemental information but not evaluated further. Existing reference values for naphthalene are also summarized. Results: We identified 26 epidemiology studies and 16 animal studies that were considered most informative for further analysis. Eleven PBPK models were identified. The available epidemiology studies generally had significant risk of bias and/or sensitivity concerns and were mostly found to have low suitability for dose-response analysis due to the nature of the exposure measurements. The animal studies had fewer risk of bias and sensitivity concerns and were mostly found to be suitable for dose-response analysis. Conclusion: Although both epidemiological and animal studies of naphthalene provide weight of evidence for hazard identification, the available animal studies appear more suitable for reference value derivation. PBPK models and mechanistic and toxicokinetic data can be applied to extrapolate these animal data to humans, considering mode of action and interspecies metabolic differences. https://doi.org/10.1289/EHP7381.
MeSH term(s)	Animals ; Epidemiologic Studies ; Naphthalenes/toxicity ; Reference Values ; Risk Assessment
Chemical Substances	Naphthalenes
Language	English
Publishing date	2021-07-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	195189-0
ISSN	1552-9924 ; 0091-6765 ; 1078-0475
ISSN (online)	1552-9924
ISSN	0091-6765 ; 1078-0475
DOI	10.1289/EHP7381
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Article: Assessing author willingness to enter study information into structured data templates as part of the manuscript submission process: A pilot study.

Wilkins, A Amina / Whaley, Paul / Persad, Amanda S / Druwe, Ingrid L / Lee, Janice S / Taylor, Michele M / Shapiro, Andrew J / Blanton Southard, Natalie / Lemeris, Courtney / Thayer, Kristina A

Heliyon

2022 Volume 8, Issue 3, Page(s) e09095

Abstract: Background: Environmental health and other researchers can benefit from automated or semi-automated summaries of data within published studies as summarizing study methods and results is time and resource intensive. Automated summaries can be designed ... ...

Abstract	Background: Environmental health and other researchers can benefit from automated or semi-automated summaries of data within published studies as summarizing study methods and results is time and resource intensive. Automated summaries can be designed to identify and extract details of interest pertaining to the study design, population, testing agent/intervention, or outcome (etc.). Much of the data reported across existing publications lack unified structure, standardization and machine-readable formats or may be presented in complex tables which serve as barriers that impede the development of automated data extraction methodologies.As full automation of data extraction seems unlikely soon, encouraging investigators to submit structured summaries of methods and results in standardized formats with meta-data tagging of content may be of value during the publication process. This would produce machine-readable content to facilitate automated data extraction, establish sharable data repositories, help make research data FAIR, and could improve reporting quality. Objectives: A pilot study was conducted to assess the feasibility of asking participants to summarize study methods and results using a structured, web-based data extraction model as a potential workflow that could be implemented during the manuscript submission process. Methods: Eight participants entered study details and data into the Health Assessment Workplace Collaborative (HAWC). Participants were surveyed after the extraction exercise to ascertain 1) whether this extraction exercise will impact their conducting and reporting of future research, 2) the ease of data extraction, including which fields were easiest and relatively more problematic to extract and 3) the amount of time taken to perform data extractions and other related tasks. Investigators then presented participants the potential benefits of providing structured data in the format they were extracting. After this, participants were surveyed about 1) their willingness to provide structured data during the publication process and 2) whether they felt the potential application of structured data entry approaches and their implementation during the journal submission process should continue to be further explored. Conclusions: Routine provision of structured data that summarizes key information from research studies could reduce the amount of effort required for reusing that data in the future, such as in systematic reviews or agency scientific assessments. Our pilot study suggests that directly asking authors to provide that data, via structured templates, may be a viable approach to achieving this: participants were willing to do so, and the overall process was not prohibitively arduous. We also found some support for the hypothesis that use of study templates may have halo benefits in improving the conduct and completeness of reporting of future research. While limitations in the generalizability of our findings mean that the conditions of success of templates cannot be assumed, further research into how such templates might be designed and implemented does seem to have enough chance of success that it ought to be undertaken.
Language	English
Publishing date	2022-03-11
Publishing country	England
Document type	Journal Article
ZDB-ID	2835763-2
ISSN	2405-8440
ISSN	2405-8440
DOI	10.1016/j.heliyon.2022.e09095
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Article ; Online: Use of study-specific MOE-like estimates to prioritize health effects from chemical exposure for analysis in human health assessments.

Hobbie, Kevin / Shao, Kan / Henning, Cara / Mendez, William / Lee, Janice S / Cote, Ila / Druwe, Ingrid L / Davis, J Allen / Gift, Jeffrey S

Environment international

2020 Volume 144, Page(s) 105986

Abstract: There are unique challenges in estimating dose-response with chemicals that are associated with multiple health outcomes and numerous studies. Some studies are more suitable than others for quantitative dose-response analyses. For such chemicals, an ... ...

Abstract	There are unique challenges in estimating dose-response with chemicals that are associated with multiple health outcomes and numerous studies. Some studies are more suitable than others for quantitative dose-response analyses. For such chemicals, an efficient method of screening studies and endpoints to identify suitable studies and potentially important health effects for dose-response modeling is valuable. Using inorganic arsenic as a test case, we developed a tiered approach that involves estimating study-specific margin of exposure (MOE)-like unitless ratios for two hypothetical scenarios. These study-specific unitless ratios are derived by dividing the exposure estimated to result in a 20% increase in relative risk over the background exposure (RRE
MeSH term(s)	Arsenic/toxicity ; Arsenicals ; Cohort Studies ; Cross-Sectional Studies ; Environmental Exposure/adverse effects ; Epidemiologic Studies ; Humans ; Risk Assessment ; United States
Chemical Substances	Arsenicals ; Arsenic (N712M78A8G)
Language	English
Publishing date	2020-08-30
Publishing country	Netherlands
Document type	Journal Article ; Systematic Review
ZDB-ID	554791-x
ISSN	1873-6750 ; 0160-4120
ISSN (online)	1873-6750
ISSN	0160-4120
DOI	10.1016/j.envint.2020.105986
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Article ; Online: A Physiologically Based Pharmacokinetic Model for Naphthalene With Inhalation and Skin Routes of Exposure.

Kapraun, Dustin F / Schlosser, Paul M / Nylander-French, Leena A / Kim, David / Yost, Erin E / Druwe, Ingrid L

Toxicological sciences : an official journal of the Society of Toxicology

2020 Volume 177, Issue 2, Page(s) 377–391

Abstract: Naphthalene, a volatile organic compound present in moth repellants and petroleum-based fuels, has been shown to induce toxicity in mice and rats during chronic inhalation exposures. Although simpler default methods exist for extrapolating toxicity ... ...

Abstract	Naphthalene, a volatile organic compound present in moth repellants and petroleum-based fuels, has been shown to induce toxicity in mice and rats during chronic inhalation exposures. Although simpler default methods exist for extrapolating toxicity points of departure from animals to humans, using a physiologically based pharmacokinetic (PBPK) model to perform such extrapolations is generally preferred. Confidence in PBPK models increases when they have been validated using both animal and human in vivo pharmacokinetic (PK) data. A published inhalation PBPK model for naphthalene was previously shown to predict rodent PK data well, so we sought to evaluate this model using human PK data. The most reliable human data available come from a controlled skin exposure study, but the inhalation PBPK model does not include a skin exposure route; therefore, we extended the model by incorporating compartments representing the stratum corneum and the viable epidermis and parameters that determine absorption and rate of transport through the skin. The human data revealed measurable blood concentrations of naphthalene present in the subjects prior to skin exposure, so we also introduced a continuous dose-rate parameter to account for these baseline blood concentration levels. We calibrated the three new parameters in the modified PBPK model using data from the controlled skin exposure study but did not modify values for any other parameters. Model predictions then fell within a factor of 2 of most (96%) of the human PK observations, demonstrating that this model can accurately predict internal doses of naphthalene and is thus a viable tool for use in human health risk assessment.
MeSH term(s)	Administration, Inhalation ; Animals ; Inhalation Exposure ; Mice ; Models, Biological ; Naphthalenes/toxicity ; Rats ; Skin
Chemical Substances	Naphthalenes
Language	English
Publishing date	2020-07-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfaa117
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Article ; Online: Model averaging methods for the evaluation of dose-response model uncertainty when assessing the suitability of studies for estimating risk.

Mendez, William / Shao, Kan / Lee, Janice S / Cote, Ila / Druwe, Ingrid L / Davis, Allen / Gift, Jeffrey S

Environment international

2020 Volume 143, Page(s) 105857

Abstract: This paper describes the use of multiple models and model averaging for considering dose-response uncertainties when extrapolating low-dose risk from studies of populations with high levels of exposure. The model averaging approach we applied builds upon ...

Abstract	This paper describes the use of multiple models and model averaging for considering dose-response uncertainties when extrapolating low-dose risk from studies of populations with high levels of exposure. The model averaging approach we applied builds upon innovative methods developed by the U.S. Food and Drug Administration (FDA), principally through the relaxing of model constraints. The relaxing of model constraints allowed us to evaluate model uncertainty using a broader set of model forms and, within the context of model averaging, did not result in the extreme supralinearity that is the primary concern associated with the application of individual unconstrained models. A study of the relationship between inorganic arsenic exposure to a Taiwanese population and potential carcinogenic effects is used to illustrate the approach. We adjusted the reported number of cases from two published prospective cohort studies of bladder and lung cancer in a Taiwanese population to account for potential covariates and less-than-lifetime exposure (for estimating effects on lifetime cancer incidence), used bootstrap methods to estimate the uncertainty surrounding the µg/kg-day inorganic arsenic dose from drinking water and dietary intakes, and fit multiple models weighted by Bayesian Information Criterion to the adjusted incidence and dose data to generate dose-specific mean, 2.5th and 97.5th percentile risk estimates. Widely divergent results from adequate model fits for a broad set of constrained and unconstrained models applied individually and in a model averaging framework suggest that substantial model uncertainty exists in risk extrapolation from estimated doses in the Taiwanese studies to lower doses more relevant to countries like the U.S. that have proportionally lower arsenic intake levels.
MeSH term(s)	Arsenic/analysis ; Arsenic/toxicity ; Bayes Theorem ; Environmental Exposure ; Humans ; Prospective Studies ; Risk Assessment ; Uncertainty
Chemical Substances	Arsenic (N712M78A8G)
Language	English
Publishing date	2020-06-29
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	554791-x
ISSN	1873-6750 ; 0160-4120
ISSN (online)	1873-6750
ISSN	0160-4120
DOI	10.1016/j.envint.2020.105857
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Article ; Online: Using In Vitro High-Throughput Screening Data for Predicting Benzo[k]Fluoranthene Human Health Hazards.

Burgoon, Lyle D / Druwe, Ingrid L / Painter, Kyle / Yost, Erin E

Risk analysis : an official publication of the Society for Risk Analysis

2016 Volume 37, Issue 2, Page(s) 280–290

Abstract: Today there are more than 80,000 chemicals in commerce and the environment. The potential human health risks are unknown for the vast majority of these chemicals as they lack human health risk assessments, toxicity reference values, and risk screening ... ...

Abstract	Today there are more than 80,000 chemicals in commerce and the environment. The potential human health risks are unknown for the vast majority of these chemicals as they lack human health risk assessments, toxicity reference values, and risk screening values. We aim to use computational toxicology and quantitative high-throughput screening (qHTS) technologies to fill these data gaps, and begin to prioritize these chemicals for additional assessment. In this pilot, we demonstrate how we were able to identify that benzo[k]fluoranthene may induce DNA damage and steatosis using qHTS data and two separate adverse outcome pathways (AOPs). We also demonstrate how bootstrap natural spline-based meta-regression can be used to integrate data across multiple assay replicates to generate a concentration-response curve. We used this analysis to calculate an in vitro point of departure of 0.751 μM and risk-specific in vitro concentrations of 0.29 μM and 0.28 μM for 1:1,000 and 1:10,000 risk, respectively, for DNA damage. Based on the available evidence, and considering that only a single HSD17B4 assay is available, we have low overall confidence in the steatosis hazard identification. This case study suggests that coupling qHTS assays with AOPs and ontologies will facilitate hazard identification. Combining this with quantitative evidence integration methods, such as bootstrap meta-regression, may allow risk assessors to identify points of departure and risk-specific internal/in vitro concentrations. These results are sufficient to prioritize the chemicals; however, in the longer term we will need to estimate external doses for risk screening purposes, such as through margin of exposure methods.
MeSH term(s)	Algorithms ; DNA Damage ; Dose-Response Relationship, Drug ; Fatty Liver/chemically induced ; Fluorenes/toxicity ; High-Throughput Screening Assays/methods ; Humans ; Oxidative Stress ; Proportional Hazards Models ; Risk ; Risk Assessment/methods ; Toxicity Tests
Chemical Substances	Fluorenes ; fluoranthene (360UOL779Z) ; benzo(k)fluoranthene (U0P6LY48VF)
Language	English
Publishing date	2016-04-18
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	778660-8
ISSN	1539-6924 ; 0272-4332
ISSN (online)	1539-6924
ISSN	0272-4332
DOI	10.1111/risa.12613
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Article ; Online: Assessing author willingness to enter study information into structured data templates as part of the manuscript submission process

A. Amina Wilkins / Paul Whaley / Amanda S. Persad / Ingrid L. Druwe / Janice S. Lee / Michele M. Taylor / Andrew J. Shapiro / Natalie Blanton Southard / Courtney Lemeris / Kristina A. Thayer

Heliyon, Vol 8, Iss 3, Pp e09095- (2022)

A pilot study

2022

Abstract	Background: Environmental health and other researchers can benefit from automated or semi-automated summaries of data within published studies as summarizing study methods and results is time and resource intensive. Automated summaries can be designed to identify and extract details of interest pertaining to the study design, population, testing agent/intervention, or outcome (etc.). Much of the data reported across existing publications lack unified structure, standardization and machine-readable formats or may be presented in complex tables which serve as barriers that impede the development of automated data extraction methodologies.As full automation of data extraction seems unlikely soon, encouraging investigators to submit structured summaries of methods and results in standardized formats with meta-data tagging of content may be of value during the publication process. This would produce machine-readable content to facilitate automated data extraction, establish sharable data repositories, help make research data FAIR, and could improve reporting quality. Objectives: A pilot study was conducted to assess the feasibility of asking participants to summarize study methods and results using a structured, web-based data extraction model as a potential workflow that could be implemented during the manuscript submission process. Methods: Eight participants entered study details and data into the Health Assessment Workplace Collaborative (HAWC). Participants were surveyed after the extraction exercise to ascertain 1) whether this extraction exercise will impact their conducting and reporting of future research, 2) the ease of data extraction, including which fields were easiest and relatively more problematic to extract and 3) the amount of time taken to perform data extractions and other related tasks. Investigators then presented participants the potential benefits of providing structured data in the format they were extracting. After this, participants were surveyed about 1) their willingness to provide ...
Keywords	Data extraction ; Automated data extraction ; Manuscript submission ; Structured data ; Data sharing ; Author opinion ; Science (General) ; Q1-390 ; Social sciences (General) ; H1-99
Subject code	306
Language	English
Publishing date	2022-03-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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