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List of works by Harvey J Clewell

A case study on quantitative in vitro to in vivo extrapolation for environmental esters: Methyl-, propyl- and butylparaben.

scientific article published on 31 March 2015

A consistent approach for the application of pharmacokinetic modeling in cancer and noncancer risk assessment

scientific article

A hybrid CFD-PBPK model for naphthalene in rat and human with IVIVE for nasal tissue metabolism and cross-species dosimetry

scientific article published on 25 March 2014

A kinetic analysis of DNA-deoxy guanine adducts in the nasal epithelium produced by inhaled formaldehyde in rats - assessing contributions to adduct production from both endogenous and exogenous sources of formaldehyde

scientific article published on 31 July 2020

A method to integrate benchmark dose estimates with genomic data to assess the functional effects of chemical exposure

scientific article

A model of functional thyroid disease status over the lifetime

scientific article published on 18 July 2019

A pharmacokinetic model of the intracellular dosimetry of inhaled nickel.

scientific article published in March 2007

A preliminary regional PBPK model of lung metabolism for improving species dependent descriptions of 1,3-butadiene and its metabolites

scientific article

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing - t4 report*.

scientific article published on January 2012

A semiphysiologically based pharmacokinetic modeling approach to predict the dose-exposure relationship of an antiparasitic prodrug/active metabolite pair.

scientific article published on 27 September 2011

A tissue dose-based comparative exposure assessment of manganese using physiologically based pharmacokinetic modeling-The importance of homeostatic control for an essential metal

scientific article

Addressing Early Life Sensitivity Using Physiologically Based Pharmacokinetic Modeling and In Vitro to In Vivo Extrapolation.

scientific article published on 31 January 2016

An analysis of N-acetylcysteine treatment for acetaminophen overdose using a systems model of drug-induced liver injury.

scientific article

An evaluation of the USEPA Proposed Approaches for applying a biologically based dose-response model in a risk assessment for perchlorate in drinking water

scientific article published on 29 January 2019

Analysis of Transcriptomic Dose-Response Data for Toxicology and Risk Assessment

article

Analysis of genomic dose-response information on arsenic to inform key events in a mode of action for carcinogenicity

scientific article published on January 2010

Analysis of manganese tracer kinetics and target tissue dosimetry in monkeys and humans with multi-route physiologically based pharmacokinetic models

scientific article published on 27 December 2010

Application of a combined aggregate exposure pathway and adverse outcome pathway (AEP-AOP) approach to inform a cumulative risk assessment: A case study with phthalates

scientific article published on 08 April 2020

Application of a multi-route physiologically based pharmacokinetic model for manganese to evaluate dose-dependent neurological effects in monkeys

scientific article published on 21 June 2012

Application of a physiologically based pharmacokinetic model for isopropanol in the derivation of a reference dose and reference concentration

scientific article published in August 2002

Application of pharmacokinetic data to the risk assessment of inhaled manganese

scientific article

Application of physiological computational fluid dynamics models to predict interspecies nasal dosimetry of inhaled acrolein

scientific article published in February 2008

Application of the adverse outcome pathway (AOP) approach to inform mode of action (MOA): A case study with inorganic arsenic

scientific article published on 19 September 2018

Application of transcriptional benchmark dose values in quantitative cancer and noncancer risk assessment

scientific article published on 22 November 2010

Applying mode-of-action and pharmacokinetic considerations in contemporary cancer risk assessments: an example with trichloroethylene

scientific article

Assessing bioactivity-exposure profiles of fruit and vegetable extracts in the BioMAP profiling system

scientific article published on 12 September 2018

Assessing the relevance of in vitro measures of phthalate inhibition of steroidogenesis for in vivo response

scientific article published on 20 August 2009

Associations of Perfluoroalkyl Substances (PFAS) with Lower Birth Weight: An Evaluation of Potential Confounding by Glomerular Filtration Rate Using a Physiologically Based Pharmacokinetic Model (PBPK)

scientific article

Bayesian analysis of a rat formaldehyde DNA-protein cross-link model

scientific article

Bayesian calibration of a physiologically based pharmacokinetic/pharmacodynamic model of carbaryl cholinesterase inhibition

scientific article published in January 2008

Bayesian estimation of pharmacokinetic and pharmacodynamic parameters in a mode-of-action-based cancer risk assessment for chloroform

scientific article

Bayesian population analysis of a harmonized physiologically based pharmacokinetic model of trichloroethylene and its metabolites

scientific article published on 4 August 2006

Can case study approaches speed implementation of the NRC report: “Toxicity Testing in the 21st Century: A Vision and a Strategy?” ⬇️

scientific article published on January 1, 2011

Can the observed association between serum perfluoroalkyl substances and delayed menarche be explained on the basis of puberty-related changes in physiology and pharmacokinetics?

scientific article published on 29 May 2015

Challenges in the application of quantitative approaches in risk assessment: a case study with di-(2-ethylhexyl)phthalate ⬇️

scientific article published on August 1, 2011

Challenges in working towards an internal threshold of toxicological concern (iTTC) for use in the safety assessment of cosmetics: Discussions from the Cosmetics Europe iTTC Working Group workshop

scientific article published on 15 January 2019

Combining transcriptomics and PBPK modeling indicates a primary role of hypoxia and altered circadian signaling in dichloromethane carcinogenicity in mouse lung and liver

scientific article

Comment on M.V. Evans and J.C. Caldwell: evaluation of two different metabolic hypotheses for dichloromethane toxicity using physiologically based pharmacokinetic modeling of in vivo gas uptake data exposure in female B6C3F1 mice, Toxicol. Appl. Pha

scientific article published on 22 July 2010

Comparing respiratory-tract and hepatic exposure-dose relationships for metabolized inhaled vapors: a pharmacokinetic analysis

scientific article

Comparison and evaluation of pharmacokinetics of PFOA and PFOS in the adult rat using a physiologically based pharmacokinetic model

scientific article published on 4 May 2011

Comparison of tissue dosimetry in the mouse following chronic exposure to arsenic compounds

scientific article published on March 2005

Consensus report on the future of animal-free systemic toxicity testing

scientific article

Considerations for refining the risk assessment process for formaldehyde: Results from an interdisciplinary workshop

scientific article published on 03 May 2019

Cross-species transcriptomic analysis of mouse and rat lung exposed to chloroprene

scientific article

Derivation of an Inhalation Reference Concentration Based upon Olfactory Neuronal Loss in Male Rats following Subchronic Acetaldehyde Inhalation

scientific article published on 01 February 2008

Derivation of inhalation toxicity reference values for propylene oxide using mode of action analysis: example of a threshold carcinogen

scientific article published on January 2009

Deriving an explicit hepatic clearance equation accounting for plasma protein binding and hepatocellular uptake

scientific article published on 17 October 2012

Determination of Human Hepatic CYP2C8 and CYP1A2 Age-Dependent Expression to Support Human Health Risk Assessment for Early Ages

scientific article published on 22 February 2017

Determination of an occupational exposure guideline for manganese using the benchmark method

scientific article

Developing context appropriate toxicity testing approaches using new alternative methods (NAMs)

scientific article published on 01 January 2019

Development and specification of physiologically based pharmacokinetic models for use in risk assessment

scientific article

Development of 3D dynamic flow model of human liver and its application to prediction of metabolic clearance of 7-ethoxycoumarin

scientific article published on 4 March 2014

Development of PBPK models for PFOA and PFOS for human pregnancy and lactation life stages

scientific article

Development of a physiologically based pharmacokinetic model for volatile fractions of gasoline using chemical lumping analysis

scientific article published in November 2004

Development of a physiologically based pharmacokinetic model of diisononyl phthalate (DiNP) in pregnant rat and human

scientific article published on 06 August 2020

Development of a screening approach to interpret human biomonitoring data on volatile organic compounds: reverse dosimetry on biomonitoring data for trichloroethylene

scientific article

Development of an integrated multi-species and multi-dose route PBPK model for volatile methyl siloxanes - D4 and D5.

scientific article published on 23 December 2015

Development of multi-route physiologically-based pharmacokinetic models for ethanol in the adult, pregnant, and neonatal rat ⬇️

scientific article published on September 1, 2012

Differential lymphatic versus portal vein uptake of the synthetic pyrethroids deltamethrin and cis-permethrin in rats

scientific article published on 14 August 2020

Dose-response for assessing the cancer risk of inorganic arsenic in drinking water: the scientific basis for use of a threshold approach

scientific article published on 01 January 2019

Effects of endogenous formaldehyde in nasal tissues on inhaled formaldehyde dosimetry predictions in the rat, monkey, and human nasal passages

scientific article published on 2 January 2014

Evaluating opportunities for advancing the use of alternative methods in risk assessment through the development of fit-for-purpose in vitro assays.

scientific article

Evaluating pharmacokinetic and pharmacodynamic interactions with computational models in supporting cumulative risk assessment ⬇️

scientific article

Evaluating placental transfer and tissue concentrations of manganese in the pregnant rat and fetuses after inhalation exposures with a PBPK model

scientific article published on 2 September 2009

Evaluation and prediction of pharmacokinetics of PFOA and PFOS in the monkey and human using a PBPK model

scientific article published in February 2011

Evaluation of Age-Related Pyrethroid Pharmacokinetic Differences in Rats: Physiologically-Based Pharmacokinetic Model Development Using In Vitro Data and In Vitro to In Vivo Extrapolation

scientific article published on 01 June 2019

Evaluation of a predictive in vitro Leydig cell assay for anti-androgenicity of phthalate esters in the rat.

scientific article published on 8 April 2013

Evaluation of gene expression changes in human primary lung epithelial cells following 24-hr exposures to inorganic arsenic and its methylated metabolites and to arsenic trioxide

scientific article

Evaluation of gene expression changes in human primary uroepithelial cells following 24-hr exposures to inorganic arsenic and its methylated metabolites

scientific article

Evaluation of oral and intravenous route pharmacokinetics, plasma protein binding, and uterine tissue dose metrics of bisphenol A: a physiologically based pharmacokinetic approach

scientific article published on 2 March 2005

Evaluation of physiologically based pharmacokinetic models in risk assessment: an example with perchloroethylene

scientific article

Evaluation of placental and lactational pharmacokinetics of PFOA and PFOS in the pregnant, lactating, fetal and neonatal rat using a physiologically based pharmacokinetic model

scientific article published on 18 August 2011

Evaluation of simple in vitro to in vivo extrapolation approaches for environmental compounds.

scientific article published on 8 November 2013

Evaluation of the potential impact of age- and gender-specific lung morphology and ventilation rate on the dosimetry of vapors

scientific article published in September 2003

Evaluation of the potential impact of age- and gender-specific pharmacokinetic differences on tissue dosimetry

scientific article published on 31 March 2004

Evaluation of the potential impact of pharmacokinetic differences on tissue dosimetry in offspring during pregnancy and lactation

scientific article published in August 2003

Evidence of a "clear and consistent threshold" for bladder and liver cancer in the large ED01 carcinogenicity study

scientific article published on 2 May 2003

Excretion of Di-2-ethylhexyl phthalate (DEHP) metabolites in urine is related to body mass index because of higher energy intake in the overweight and obese

scientific article published on 31 January 2018

Exposure assessment and risk characterization for perfluorooctanoate in selected consumer articles

scientific article published in June 2005

Extended Analysis and Evidence Integration of Chloroprene as a Human Carcinogen

scientific article published on 16 September 2019

Fluid Dynamic Modeling to Support the Development of Flow-Based Hepatocyte Culture Systems for Metabolism Studies

scientific article

Formaldehyde: integrating dosimetry, cytotoxicity, and genomics to understand dose-dependent transitions for an endogenous compound

scientific article published on 30 September 2010

Gas Uptake Inhalation Techniques and the Rates of Metabolism of Chloromethanes, Chloroethanes, and Chloroethylenes in the Rat

Genome-wide analysis of DNA methylation and gene expression changes in the mouse lung following subchronic arsenate exposure

scientific article published on 28 July 2010

Genomic signatures and dose-dependent transitions in nasal epithelial responses to inhaled formaldehyde in the rat.

scientific article published on 21 May 2008

High-throughput in-silico prediction of ionization equilibria for pharmacokinetic modeling

scientific article

Hormesis and adaptive cellular control systems

scientific article published on 19 March 2008

How can biologically-based modeling of arsenic kinetics and dynamics inform the risk assessment process? - A workshop review.

scientific article published on 15 July 2008

In vitro intestinal and hepatic metabolism of Di(2-ethylhexyl) phthalate (DEHP) in human and rat.

scientific article published on 29 March 2013

In vitro metabolism of di(2-ethylhexyl) phthalate (DEHP) by various tissues and cytochrome P450s of human and rat.

scientific article published on 13 December 2011

In vitro to in vivo extrapolation and species response comparisons for drug-induced liver injury (DILI) using DILIsym™: a mechanistic, mathematical model of DILI.

scientific article

Incorporating High-Throughput Exposure Predictions With Dosimetry-Adjusted In Vitro Bioactivity to Inform Chemical Toxicity Testing

scientific article

Incorporating human dosimetry and exposure into high-throughput in vitro toxicity screening.

scientific article published on 16 July 2010

Incorporating new technologies into toxicity testing and risk assessment: moving from 21st century vision to a data-driven framework.

scientific article

Incorporating population variability and susceptible subpopulations into dosimetry for high-throughput toxicity testing

scientific article published on 21 August 2014

Incorporation of in vitro metabolism data and physiologically based pharmacokinetic modeling in a risk assessment for chloroprene

scientific article published on 01 November 2019

Integrating pathway-based transcriptomic data into quantitative chemical risk assessment: a five chemical case study

scientific article

Integration of dosimetry, exposure, and high-throughput screening data in chemical toxicity assessment

scientific article

Interspecies dose extrapolation for inhaled dimethyl sulfate: a PBPK model-based analysis using nasal cavity N7-methylguanine adducts

scientific article published in August 2004

Is the relationship between prenatal exposure to PCB-153 and decreased birth weight attributable to pharmacokinetics?

scientific article published on 09 August 2013

Kinetic modeling of β-chloroprene metabolism: Probabilistic in vitro–in vivo extrapolation of metabolism in the lung, liver and kidneys of mice, rats and humans ⬇️

scientific article published on April 19, 2012

Kinetics of metabolism of deltamethrin and cis- and trans-permethrin in vitro. Studies using rat and human liver microsomes, isolated rat hepatocytes and rat liver cytosol

scientific article published on 06 August 2020

Lactational transfer of manganese in rats: predicting manganese tissue concentration in the dam and pups from inhalation exposure with a pharmacokinetic model

scientific article published on 2 September 2009

Letter to the editor re: Cheng, YH., Chou, WC., Yang, YF. et al. Environ Sci Pollut Res (2017). https://doi.org/10.1007/s11356-017-0875-4

scientific article published on 06 October 2018

Manganese tissue dosimetry in rats and monkeys: accounting for dietary and inhaled Mn with physiologically based pharmacokinetic modeling

scientific article published on 19 December 2008

Measurement of tumor-associated mutations in the nasal mucosa of rats exposed to varying doses of formaldehyde.

scientific article published on 27 March 2010

Molecular signaling network motifs provide a mechanistic basis for cellular threshold responses

scientific article

Multi-dose-route, multi-species pharmacokinetic models for manganese and their use in risk assessment

scientific article published in January 2010

On the incorporation of chemical-specific information in risk assessment

scientific article published on 08 June 2008

PBPK Model for Atrazine and Its Chlorotriazine Metabolites in Rat and Human

scientific article published on 21 January 2016

PBPK-Based Probabilistic Risk Assessment for Total Chlorotriazines in Drinking Water

scientific article published on 21 January 2016

PLETHEM – An interactive open-source platform for bridging the source-to-outcome continuum

scientific article published in 2017

Perchlorate and radioiodide kinetics across life stages in the human: using PBPK models to predict dosimetry and thyroid inhibition and sensitive subpopulations based on developmental stage

scientific article published in March 2007

Pharmacokinetic Modeling of Manganese in the Rat IV: Assessing Factors that Contribute to Brain Accumulation During Inhalation Exposure

article

Pharmacokinetic Modeling of Manganese. I. Dose Dependencies of Uptake and Elimination

article

Pharmacokinetic Modeling of Manganese. II. Hepatic Processing After Ingestion and Inhalation

article

Pharmacokinetic Modeling of Manganese. III. Physiological Approaches Accounting for Background and Tracer Kinetics

article

Pharmacokinetic bias analysis of the epidemiological associations between serum polybrominated diphenyl ether (BDE-47) and timing of menarche

scientific article published on 15 July 2016

Pharmacokinetic modeling of saturable, renal resorption of perfluoroalkylacids in monkeys--probing the determinants of long plasma half-lives

scientific article published on 12 August 2006

Physiologically Based Pharmacokinetic/Toxicokinetic Modeling ⬇️

scientific article published on January 1, 2012

Physiologically based pharmacokinetic (PBPK) modeling of interstrain variability in trichloroethylene metabolism in the mouse

scientific article

Physiologically based pharmacokinetic model use in risk assessment--Why being published is not enough.

scientific article published in November 2011

Physiologically based pharmacokinetic modeling of arsenic in the mouse

scientific article

Physiologically based pharmacokinetic modeling of fetal and neonatal manganese exposure in humans: describing manganese homeostasis during development.

scientific article published on 27 May 2011

Physiologically based pharmacokinetic modeling of styrene and styrene oxide respiratory-tract dosimetry in rodents and humans

scientific article

Physiologically-based pharmacokinetic modeling suggests similar bioavailability of Mn from diet and drinking water

scientific article published on 20 September 2018

Predicting lung dosimetry of inhaled particleborne benzo[a]pyrene using physiologically based pharmacokinetic modeling

scientific article

Prenatal PCB-153 Exposure and Decreased Birth Weight: Verner et al. Respond

scientific article published on April 2014

Quantitative bias analysis for epidemiological associations of perfluoroalkyl substance serum concentrations and early onset of menopause

scientific article published on 5 December 2016

Quantitative bias analysis of a reported association between perfluoroalkyl substances (PFAS) and endometriosis: The influence of oral contraceptive use.

scientific article published on 6 April 2017

Quantitative bias analysis of the association between subclinical thyroid disease and two perfluoroalkyl substances in a single study

scientific article published on 09 December 2019

Quantitative estimates of risk for noncancer endpoints

scientific article published on 01 April 2005

Quantitative in vitro to in vivo extrapolation (QIVIVE): An essential element for in vitro-based risk assessment

scientific article published on 11 February 2015

Quantitative in vitro to in vivo extrapolation of cell-based toxicity assay results

scientific article published on 06 June 2012

Quantitative interpretation of human biomonitoring data

scientific article

Refinement of the oral exposure description in the cyclic siloxane PBPK model for rats and humans: Implications for exposure assessment

scientific article published on 10 April 2017

Relative impact of incorporating pharmacokinetics on predicting in vivo hazard and mode of action from high-throughput in vitro toxicity assays

scientific article

Research toward the development of a biologically based dose response assessment for inorganic arsenic carcinogenicity: a progress report

scientific article published on 30 March 2007

Response to Comments by Caldwell et al. on Article “Applying Mode-of-Action and Pharmacokinetic Considerations in Contemporary Cancer Risk Assessments: An Example with Trichloroethylene”

Response to letter to editor “letter to the editors regarding “the Conundrum of the PFOA human half-life, an international collaboration.”

scientific article published in 2022

Reverse dosimetry: interpreting trihalomethanes biomonitoring data using physiologically based pharmacokinetic modeling

scientific article

Review and evaluation of the potential impact of age- and gender-specific pharmacokinetic differences on tissue dosimetry

scientific article

Revised assessment of cancer risk to dichloromethane II. Application of probabilistic methods to cancer risk determinations

scientific article published on 24 January 2006

Revised assessment of cancer risk to dichloromethane: part I Bayesian PBPK and dose-response modeling in mice

scientific article published on 25 January 2006

Temporal concordance between apical and transcriptional points of departure for chemical risk assessment.

scientific article published on 17 April 2013

The Contribution of Peroxisome Proliferator-Activated Receptor Alpha to the Relationship Between Toxicokinetics and Toxicodynamics of Trichloroethylene.

scientific article

The Conundrum of the PFOA human half-life, an international collaboration

scientific article published in 2022

The impact of recent advances in research on arsenic cancer risk assessment.

scientific article published on 15 February 2014

The use of Markov chain Monte Carlo uncertainty analysis to support a Public Health Goal for perchloroethylene

article

The use of biomarkers of toxicity for integrating in vitro hazard estimates into risk assessment for humans.

scientific article published in January 2012

The use of non-tumor data in cancer risk assessment: reflections on butadiene, vinyl chloride, and benzene

scientific article

Time dependencies in perfluorooctylacids disposition in rat and monkeys: a kinetic analysis

scientific article published on 27 December 2007

Update on a Pharmacokinetic-Centric Alternative Tier II Program for MMT-Part II: Physiologically Based Pharmacokinetic Modeling and Manganese Risk Assessment

scientific article

Updating physiologically based pharmacokinetic models for manganese by incorporating rapid association/dissociation processes in tissues

scientific article published on 09 April 2019

Use of Markov Chain Monte Carlo analysis with a physiologically-based pharmacokinetic model of methylmercury to estimate exposures in US women of childbearing age

scientific article published on 01 August 2007

Use of a physiologically based pharmacokinetic model to identify exposures consistent with human biomonitoring data for chloroform

scientific article

Use of in vitro data in developing a physiologically based pharmacokinetic model: Carbaryl as a case study.

scientific article

Using a physiologically based pharmacokinetic model to link urinary biomarker concentrations to dietary exposure of perchlorate ⬇️

scientific article published on April 20, 2012

Using exposure prediction tools to link exposure and dosimetry for risk-based decisions: A case study with phthalates

scientific article published on 24 June 2017

Xenobiotic Metabolism in Alginate-Encapsulated Primary Human Hepatocytes Over Long Timeframes

p53 codon 271 CGT to CAT mutant fraction does not increase in nasal respiratory and olfactory epithelia of rats exposed to inhaled naphthalene.

scientific article published on 13 February 2011

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