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decision-making x Biological Sciences x Toxicology (Non-medical) x clear all

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Challenges Associated With Applying Physiologically Based Pharmacokinetic Modeling for Public Health Decision-Making

Yu-Mei Tan, Rachel R Worley, Jeremy A Leonard and Jeffrey W Fisher.

in Toxicological Sciences

April 2018; p ublished online January 2018 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 6496 words.

Abstract

The development and application of physiologically based pharmacokinetic (PBPK) models in chemical toxicology have grown steadily since their...

Risk Characterization: A Bridge to Informed Decision Making

Edward V. Ohanian, John A. Moore, John R. Fowle, Gilbert S. Omenn, Steven C. Lewis, George M. Gray and D. Warner North.

in Toxicological Sciences

October 1997; p ublished online October 1997 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 0 words.

Regulatory decisions should be made in the most expert and informed way since they are precipitated by real and perceived threats to human health, under the glare of public scrutiny. In...

Corrigendum to “Challenges Associated With Applying Physiologically Based Pharmacokinetic Modeling for Public Health Decision-Making”

Yu-Mei Tan, Rachel Worley, Jeremy A Leonard and Jeffrey Fisher.

in Toxicological Sciences

April 2018; p ublished online March 2018 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 143 words.

Probabilistic Exposure Analysis for Chemical Risk Characterization

Kenneth T. Bogen, Alison C. Cullen, H. Christopher Frey and Paul S. Price.

in Toxicological Sciences

May 2009; p ublished online February 2009 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 12666 words.

This paper summarizes the state of the science of probabilistic exposure assessment (PEA) as applied to chemical risk characterization. Current probabilistic risk analysis methods applied...

The Impact of Novel Assessment Methodologies in Toxicology on Green Chemistry and Chemical Alternatives

Ivan Rusyn and Nigel Greene.

in Toxicological Sciences

February 2018; p ublished online September 2017 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 6714 words.

Abstract

The field of experimental toxicology is rapidly advancing by incorporating novel techniques and methods that provide a much more granular view into...

Enhancing the Credibility of Decisions Based on Scientific Conclusions: Transparency Is Imperative

Jay Schreider, Craig Barrow, Norman Birchfield, Kerry Dearfield, Dennis Devlin, Sara Henry, Melissa Kramer, Seema Schappelle, Keith Solomon, Douglas L. Weed and Michelle R. Embry.

in Toxicological Sciences

July 2010; p ublished online April 2010 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 1893 words.

Transparency and documentation of the decision process are at the core of a credible risk assessment and, in addition, are essential in the presentation of a weight of evidence (WoE)–based...

Toxicogenomics in Risk Assessment: Applications and Needs

Darrell R. Boverhof and Timothy R. Zacharewski.

in Toxicological Sciences

February 2006; p ublished online October 2005 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 6402 words.

Since its inception, there have been high expectations for the science of toxicogenomics to decrease the uncertainties associated with the risk assessment process by providing valuable...

Identification and Characterization of Adverse Effects in 21st Century Toxicology

Douglas A. Keller, Daland R. Juberg, Natasha Catlin, William H. Farland, Frederick G. Hess, Douglas C. Wolf and Nancy G. Doerrer.

in Toxicological Sciences

April 2012; p ublished online January 2012 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 5147 words.

The practice of toxicology is changing rapidly, as demonstrated by the response to the 2007 NRC report on “Toxicity Testing in the 21st Century.” New assays are being developed to replace...

Intensity of the Internal Standard Response as the Basis for Reporting a Test Specimen as Negative or Inconclusive

Ray H. Liu, Chih-Hung Wu, Yi-Jun Chen, Chiung-Dan Chang, Jason G. Linville and Dennis V. Canfield.

in Journal of Analytical Toxicology

November 2007; p ublished online November 2007 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 0 words.

Under normal circumstances, a test specimen is reported as “negative” when the response of the analyte is absent. However, if the intensity of the internal standard (IS) is low, indicating...

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Interlaboratory Evaluation of Genomic Signatures for Predicting Carcinogenicity in the Rat

Mark R. Fielden, Alex Nie, Michael McMillian, Chandi S. Elangbam, Bruce A. Trela, Yi Yang, Robert T. Dunn, Yvonne Dragan, Ronny Fransson-Stehen, Matthew Bogdanffy, Stephen P. Adams, William R. Foster, Shen-Jue Chen, Phil Rossi, Peter Kasper, David Jacobson-Kram, Kay S. Tatsuoka, Patrick J. Wier, Jeremy Gollub, Donald N. Halbert, Alan Roter, Jamie K. Young, Joseph F. Sina, Jennifer Marlowe, Hans-Joerg Martus, Jiri Aubrecht, Andrew J. Olaharski, Nigel Roome, Paul Nioi, Ingrid Pardo, Ron Snyder, Richard Perry, Peter Lord, William Mattes and Bruce D. Car.

in Toxicological Sciences

May 2008; p ublished online February 2008 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 5074 words.

The Critical Path Institute recently established the Predictive Safety Testing Consortium, a collaboration between several companies and the U.S. Food and Drug Administration, aimed at...

Adverse Outcome Pathway Development II: Best Practices

Daniel L. Villeneuve, Doug Crump, Natàlia Garcia-Reyero, Markus Hecker, Thomas H. Hutchinson, Carlie A. LaLone, Brigitte Landesmann, Teresa Lettieri, Sharon Munn, Malgorzata Nepelska, Mary Ann Ottinger, Lucia Vergauwen and Maurice Whelan.

in Toxicological Sciences

December 2014; p ublished online November 2014 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 8208 words.

Organization of existing and emerging toxicological knowledge into adverse outcome pathway (AOP) descriptions can facilitate greater application of mechanistic data, including those derived...

Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach

Stanley E Lazic, Nicholas Edmunds and Christopher E Pollard.

in Toxicological Sciences

March 2018; p ublished online November 2017 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 6199 words.

Abstract

Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict...

Adverse Outcome Pathways for Regulatory Applications: Examination of Four Case Studies With Different Degrees of Completeness and Scientific Confidence

Edward J. Perkins, Philipp Antczak, Lyle Burgoon, Francesco Falciani, Natàlia Garcia-Reyero, Steve Gutsell, Geoff Hodges, Aude Kienzler, Dries Knapen, Mary McBride and Catherine Willett.

in Toxicological Sciences

November 2015; p ublished online October 2015 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 8332 words.

Adverse outcome pathways (AOPs) offer a pathway-based toxicological framework to support hazard assessment and regulatory decision-making. However, little has been discussed about the...

The Value of DNA Methylation Analysis in Basic, Initial Toxicity Assessments

Rebecca E. Watson, James M. McKim, Gary L. Cockerell and Jay I. Goodman.

in Toxicological Sciences

May 2004; p ublished online May 2004 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 7090 words.

DNA methylation is an epigenetic mechanism regulating patterns of gene expression. Our goal was to see if the assessment of DNA methylation might be a useful tool, when used in conjunction...

Human Carcinogenic Risk Evaluation, Part III: Assessing Cancer Hazard and Risk in Human Drug Development

Abigail Jacobs and David Jacobson-Kram.

in Toxicological Sciences

October 2004; p ublished online May 2004 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 2091 words.

Assessing cancer risk for human pharmaceuticals is important because drugs are taken at pharmacologically active doses and often on a chronic basis. Epidemiologic studies on patient...

Don’t Judge A Neuron Only by Its Cover: Neuronal Function in In Vitro Developmental Neurotoxicity Testing

Martje W. G. D. M. de Groot, Remco H. S. Westerink and Milou M. L. Dingemans.

in Toxicological Sciences

March 2013; p ublished online September 2012 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 4950 words.

Classical cases of developmental neurotoxicity (DNT) in humans and advances in risk assessment methods did not prevent the emergence of new chemicals with (suspected) DNT potential....

Chemical Carcinogenesis

Samuel M. Cohen and Lora L. Arnold.

in Toxicological Sciences

March 2011; p ublished online December 2010 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 13855 words.

Understanding the relationship of chemicals to carcinogenesis has progressed significantly since the initial observations of Hill and Pott in the 1700’s. Distinguishing between DNA-reactive...

Editor’s Highlight: Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS): A Web-Based Tool for Addressing the Challenges of Cross-Species Extrapolation of Chemical Toxicity

Carlie A. LaLone, Daniel L. Villeneuve, David Lyons, Henry W. Helgen, Serina L. Robinson, Joseph A. Swintek, Travis W. Saari and Gerald T. Ankley.

in Toxicological Sciences

October 2016; p ublished online June 2016 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 11940 words.

Conservation of a molecular target across species can be used as a line-of-evidence to predict the likelihood of chemical susceptibility. The web-based Sequence Alignment to Predict Across...

The Influence of Human Interindividual Variability on the Low-Dose Region of Dose-Response Curve Induced by 2,3,7,8-Tetrachlorodibenzo-p-Dioxin in Primary B Cells

Peter Dornbos, Robert B. Crawford, Norbert E. Kaminski, Sarah L. Hession and John J. LaPres.

in Toxicological Sciences

October 2016; p ublished online July 2016 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 5761 words.

The influence of interindividual variability is not typically assessed in traditional toxicological studies. Given that chemical exposures occur in heterogeneous populations, this knowledge...

Adverse Outcome Pathway (AOP) Development I: Strategies and Principles

Daniel L. Villeneuve, Doug Crump, Natàlia Garcia-Reyero, Markus Hecker, Thomas H. Hutchinson, Carlie A. LaLone, Brigitte Landesmann, Teresa Lettieri, Sharon Munn, Malgorzata Nepelska, Mary Ann Ottinger, Lucia Vergauwen and Maurice Whelan.

in Toxicological Sciences

December 2014; p ublished online November 2014 .

Journal Article. Subjects: Medical Toxicology; Toxicology (Non-medical). 6776 words.

An adverse outcome pathway (AOP) is a conceptual framework that organizes existing knowledge concerning biologically plausible, and empirically supported, links between molecular-level...