The Experts below are selected from a list of 864 Experts worldwide ranked by ideXlab platform
Brad Bolon - One of the best experts on this subject based on the ideXlab platform.
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regulatory perspectives on juvenile animal Toxicologic Pathology
Toxicologic Pathology, 2021Co-Authors: Deepa B. Rao, Alan M Hoberman, Paul Brown, Aurore Varela, Brad BolonAbstract:The Society of Toxicologic Pathology's Annual Virtual Symposium (2021) included a session on "Regulatory Perspectives on Juvenile Animal Toxicologic Pathology." The following narrative summarizes the key concepts from the four talks included in this symposium session chaired by Drs Deepa Rao and Alan Hoberman. These encompass an overview of various global regulations impacting the conduct of juvenile animal studies in pharmaceutical drug development and chemical toxicity assessments in a talk by Dr Alan Hoberman. Given the numerous regulatory guidances and legal statutes that have covered the conduct of juvenile animal studies and the recent harmonization of these guidances for pharmaceuticals, Dr Paul Brown provided an update on the harmonization of these guidances for pharmaceuticals, in the recently finalized version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use S11 guidance document, "Nonclinical Safety Testing in Support of Development of Pediatric Medicines." The first two talks on regulations were followed by two talks focused on an evaluation of the postnatal development of two major organ systems relevant in juvenile animals. Dr Aurore Varela covered study design and endpoints impacting the skeletal system (bone), while Dr Brad Bolon presented a talk on the study design and conduct of neuroPathology evaluations for the developing nervous system.
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the society of Toxicologic Pathology advances and adventures in the first 50 years
Toxicologic Pathology, 2021Co-Authors: Mark J Hoenerhoff, Stacey Fossey, Charlotte M Keenan, Agathe Bedard, Typhaine Lejeune, William D Kerns, Daniel Patrick, Erin M Quist, Brad BolonAbstract:The Society of Toxicologic Pathology (STP, https://www.toxpath.org/) was founded in North America in 1971 as a nonprofit scientific and educational association to promote the professional practice ...
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Supplemental Material, sj-docx-3-tpx-10.1177_01926233211037934 - The Society of Toxicologic Pathology: Advances and Adventures in the First 50 Years
2021Co-Authors: Mark Hoenerhoff, Stacey Fossey, Agathe Bedard, Typhaine Lejeune, Daniel Patrick, Charlotte Keenan, William Kerns, Erin Quist, Brad BolonAbstract:Supplemental Material, sj-docx-3-tpx-10.1177_01926233211037934 for The Society of Toxicologic Pathology: Advances and Adventures in the First 50 Years by Mark Hoenerhoff, Stacey Fossey, Charlotte Keenan, Agathe Bédard, Typhaine Lejeune, William Kerns, Daniel Patrick, Erin Quist and Brad Bolon in Toxicologic Pathology
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the exposome in Toxicologic Pathology
Toxicologic Pathology, 2020Co-Authors: Brad Bolon, Wanda M HaschekAbstract:The "exposome" is an individual's lifetime spectrum of chemical exposures beginning at conception. An exposome includes general external influences such as pollution and weather; external individual-specific factors (diet, infections, self-selected chemical intake); and internal individual-specific constituents (metabolic byproducts, microbiome derivatives, inflammatory mediators, stress hormones, etc). The exposome paradigm is inherent in animal toxicity testing because laboratory studies are designed so that subjects share a common exposure history encompassing not only exposure(s)/treatment(s) but also other chemical sources (eg, air, bedding, food, water). Toxicologic pathologists should remember that some differences in responsiveness to a test article may reflect subtle differences in individual exposomes of seemingly equivalent test animals. Translation of toxicity data obtained in tests of genetically inbred animals maintained under controlled environmental conditions to produce quasi-identical exposomes at best offers only approximate guidance regarding potential responses in genetically heterogeneous human populations who live in many environmental settings and thus have divergent, complex exposomes.
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Toxicologic Pathology of the peripheral nervous system pns overview challenges and current practices
Toxicologic Pathology, 2018Co-Authors: Ingrid D. Pardo, Alok K. Sharma, Deepa B. Rao, Mark T Butt, Bernard S Jortner, William M Valentine, Joseph C Arezzo, Brad BolonAbstract:Peripheral nervous system (PNS) toxicity is a frequent adverse effect encountered in patients treated with certain therapeutics (e.g., antiretroviral drugs, cancer chemotherapeutics), in occupational workers exposed to industrial chemicals (e.g., solvents), or during accidental exposures to household chemicals and/or environmental agents (e.g., pesticides). However, the literature and expertise needed for the effective design, conduct, analysis, and reporting of safety studies to identify and define PNS toxicity are hard to find. This half-day course familiarized participants with basic PNS biology; causes and mechanisms of PNS Pathology; classic methods and current best practice recommendations for PNS sampling, preparation, and evaluation; and examples of commonly observed lesions and artifacts. Three concluding case presentations synthesized information from the prior technical lectures by presenting real-world examples of lesions caused by drugs and chemicals to demonstrate how PNS toxicity may be addressed in evaluating product safety during nonclinical studies. Topics emphasized comparative and correlative data among animal species used in toxicity studies and clinical evaluation in humans in order to facilitate the translation of animal data into human risk assessment with respect to PNS Toxicologic Pathology.
Mark J Hoenerhoff - One of the best experts on this subject based on the ideXlab platform.
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the society of Toxicologic Pathology advances and adventures in the first 50 years
Toxicologic Pathology, 2021Co-Authors: Mark J Hoenerhoff, Stacey Fossey, Charlotte M Keenan, Agathe Bedard, Typhaine Lejeune, William D Kerns, Daniel Patrick, Erin M Quist, Brad BolonAbstract:The Society of Toxicologic Pathology (STP, https://www.toxpath.org/) was founded in North America in 1971 as a nonprofit scientific and educational association to promote the professional practice ...
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overview of the epigenetic end points in Toxicologic Pathology and relevance to human health session of the 2014 society of Toxicologic Pathology annual symposium
Toxicologic Pathology, 2015Co-Authors: Mark J Hoenerhoff, James HartkeAbstract:The theme of the Society of Toxicologic Pathology 2014 Annual Symposium was "Translational Pathology: Relevance of Toxicologic Pathology to Human Health." The 5th session focused on epigenetic end points in biology, toxicity, and carcinogenicity, and how those end points are relevant to human exposures. This overview highlights the various presentations in this session, discussing integration of epigenetics end points in Toxicologic Pathology studies, investigating the role of epigenetics in product safety assessment, epigenetic changes in cancers, methodologies to detect them, and potential therapies, chromatin remodeling in development and disease, and epigenomics and the microbiome. The purpose of this overview is to discuss the application of epigenetics to Toxicologic Pathology and its utility in preclinical or mechanistic based safety, efficacy, and carcinogenicity studies.
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a brief overview of the 33rd annual stp symposium on the translational Pathology relevance of Toxicologic Pathology to human health
Toxicologic Pathology, 2015Co-Authors: Mark J Hoenerhoff, Lee Silverman, Sabine FranckeAbstract:The 33rd Society of Toxicologic Pathology’s Annual Symposium focused on translational science and the relevance of Toxicologic Pathology to human health. Toxicologic pathologists work in diverse settings studying changes elicited by pharmacological, chemical, and environmental agents and factors that modify these responses. Regardless of the work setting, society members are dedicated to the integration of Toxicologic Pathology into hazard identification, risk assessment, and risk communication regarding human and animal exposure to potentially toxic substances. Toxicologic pathologists routinely face not only questions regarding pathological changes related to compound exposure but also questions concerning what translational relevance those lesions and exposures have to a human population or organ system. This symposium provided a basis for the membership to understand the variety of roles the Toxicologic pathologist plays in translational science, where our gaps in translational science are, and how we...
Wolfgang Kaufmann - One of the best experts on this subject based on the ideXlab platform.
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adversity considerations for thyroid follicular cell hypertrophy and hyperplasia in nonclinical toxicity studies results from the 6th estp international expert workshop
Toxicologic Pathology, 2020Co-Authors: Maike Huisinga, Sabine Francke, Takanori Harada, Lise Bertrand, Ronnie Chamanza, Isabelle Damiani, Jeff Engelhardt, Alexius Freyberger, Johannes Harleman, Wolfgang KaufmannAbstract:The European Society of Toxicologic Pathology organized an expert workshop in May 2018 to address adversity considerations related to thyroid follicular cell hypertrophy and/or hyperplasia (FCHH), ...
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fundamentals of translational neuroscience in Toxicologic Pathology optimizing the value of animal data for human risk assessment
Toxicologic Pathology, 2015Co-Authors: James P. Morrison, Alok K. Sharma, Ingrid D. Pardo, Robert H. Garman, Wolfgang Kaufmann, Brad BolonAbstract:A half-day Society of Toxicologic Pathology continuing education course on “Fundamentals of Translational Neuroscience in Toxicologic Pathology” presented some current major issues faced when extra...
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fundamentals of translational neuroscience in Toxicologic Pathology optimizing the value of animal data for human risk assessment
Toxicologic Pathology, 2015Co-Authors: James P. Morrison, Alok K. Sharma, Ingrid D. Pardo, Robert H. Garman, Wolfgang Kaufmann, Deepa Rao, Brad BolonAbstract:A half-day Society of Toxicologic Pathology continuing education course on "Fundamentals of Translational Neuroscience in Toxicologic Pathology" presented some current major issues faced when extrapolating animal data regarding potential neurological consequences to assess potential human outcomes. Two talks reviewed functional-structural correlates in rodent and nonrodent mammalian brains needed to predict behavioral consequences of morphologic changes in discrete neural cell populations. The third lecture described practical steps for ensuring that specimens from rodent developmental neurotoxicity tests will be processed correctly to produce highly homologous sections. The fourth talk detailed demographic factors (e.g., species, strain, sex, and age); physiological traits (body composition, brain circulation, pharmacokinetic/pharmacodynamic patterns, etc.); and husbandry influences (e.g., group housing) known to alter the effects of neuroactive agents. The last presentation discussed the appearance, unknown functional effects, and potential relevance to humans of polyethylene glycol (PEG)-associated vacuoles within the choroid plexus epithelium of animals. Speakers provided real-world examples of challenges with data extrapolation among species or with study design considerations that may impact the interpretability of results. Translational neuroscience will be bolstered in the future as less invasive and/or more quantitative techniques are devised for linking overt functional deficits to subtle anatomic and chemical lesions.
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stp 2014 continuing education course 3 fundamentals of translational neuroscience in Toxicologic Pathology optimizing the value of animal data for human risk assessment
Toxicologic Pathology, 2014Co-Authors: James P. Morrison, Wolfgang Kaufmann, Lok A K Sharma, I Ngrid, Dayssy Alexandra Diaz Pardo, Obert R H Garman, Brad BolonAbstract:A half-day Society of Toxicologic Pathology continuing education course on ‘‘Fundamentals of Translational Neuroscience in ToxicologicPathology’’ presented some current major issues faced when extrapolating animal data regarding potential neurological consequences to assesspotential human outcomes. Two talks reviewed functional–structural correlates in rodent and nonrodent mammalian brains needed to predict beha-vioral consequences of morphologic changes in discrete neural cell populations. The third lecture described practical steps for ensuring that speci-mens from rodent developmental neurotoxicity tests will be processed correctly to produce highly homologous sections. The fourth talk detaileddemographic factors (e.g., species, strain, sex, and age); physiological traits (body composition, brain circulation, pharmacokinetic/pharmacody-namic patterns, etc.); and husbandry influences (e.g., group housing) known to alter the effects of neuroactive agents. The last presentation discussedthe appearance, unknown functional effects, and potential relevance to humans of polyethylene glycol (PEG)–associated vacuoles within the choroidplexus epithelium of animals. Speakers provided real-world examples of challenges with data extrapolation among species or with study design con-siderations that may impact the interpretability of results. Translational neuroscience will be bolstered in the future as less invasive and/or morequantitative techniques are devised for linking overt functional deficits to subtle anatomic and chemical lesions.Keywords: nervous system; neuroanatomy; neuroPathology; neurotoxicity; neuroscience; translational medicine; PEGylation.
Robert C Sills - One of the best experts on this subject based on the ideXlab platform.
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ntp niehs global contributions to Toxicologic Pathology
Toxicologic Pathology, 2017Co-Authors: Robert C Sills, Mark F. Cesta, Amy E Brix, Sheba R Churchill, Michelle C Cora, Darlene Dixon, Michael J Dykstra, Gordon P Flake, Ron Herbert, Ramesh C KoviAbstract:National Toxicology Program (NTP) pathologists are engaged in important initiatives that have significant global impact. These initiatives build on its leadership in Pathology peer review and publications in the areas of Toxicologic Pathology, clinical Pathology, and laboratory animal medicine. Over the past decade, NTP/National Institute of Environmental Health Sciences research initiatives have focused on cancer and noncancer hazard identification, with the goal of understanding cellular and molecular mechanisms of disease. New initiatives of significant global impact include the web-based nonneoplastic lesion atlas and an NTP partnership with international scientists to investigate molecular mechanisms at the whole genome level, which will be used to inform potential mechanisms of environmental exposures in human cancers. Also, we are dedicated to contributing to Pathology and toxicology organizations through service on executive committees and editorial boards, participating in international projects and symposiums, and providing training for future leaders in Toxicologic Pathology. Herein, we provide highlights of our global contributions.
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introduction and commentary Toxicologic neuroPathology and a whole lot more the 2010 joint stp ifstp international symposium on Toxicologic Pathology
Toxicologic Pathology, 2011Co-Authors: Brad Bolon, Kathleen A Funk, Robert C SillsAbstract:A regrettable tendency throughout recorded human history is that neurotoxicants have initially been discovered during human epidemics of neurotoxicity. Well-known agents illustrating this trend include ethanol, n-hexane, lead, mercury, polychlorinated biphenyls (PCBs), and tri-ortho cresyl phosphate (TOCP) (Costa et al. 2004; Inoue et al. 1988). During the late 20th and early 21st centuries, neural dysfunction has remained a key occupational hazard for adults (Connelly and Malkin 2007; Gobba 2003) and a devastating congenital event in children (Bearer 2001). Both of these age groups may be exposed to neurotoxicants via endogenous production of toxic metabolites during the course of certain diseases (ammonia, unconjugated bilirubin) or, more commonly, by contact with exogenous materials in the external habitat (e.g., agrochemicals, metals, pesticides, solvents) or deliberately introduced into the body (i.e., biopharmaceuticals, drugs, natural toxins [animals, microbes, plants]). The potential scale of toxicant-induced neuroPathology is enormous. Each year, about 85,000 chemicals are manufactured and another 2,000 to 3,000 new compounds are registered in the United States alone (Goldman 1998). At least 2,500 (3%) of these entities are thought to be neurotoxic to some extent (Claudio 1992), though many—including up to two-thirds of chemicals made annually in amounts exceeding one million pounds—have not received a detailed analysis to assess their neurotoxic potential (Environmental Defense Fund 1997). Thus, a main aim of neuroToxicologic research today is to prospectively identify the neurotoxic capacity of novel compounds rather than to discover it retrospectively after neurotoxicity epidemics appear in humans. Many Toxicologic pathologists are outstanding contributors to this public health effort. The collective interest by the Toxicologic Pathology community has resulted in the selection of ‘‘Toxicologic NeuroPathology’’ as the focus of the Society of Toxicologic Pathology’s annual scientific symposium about every decade during the past 30 years, with the subsequent production of dedicated issues of Toxicologic Pathology that collate the then current, state-of-the-art concepts and practices in this field. (Prior STP symposium issues devoted to Toxicologic neuroPathology may be accessed in Toxicologic Pathology [1990] 18, 81–224 and Toxicologic Pathology [2000] 28, 1–214.) The rapid growth of the discipline in the past decade again led to the choice of Toxicologic neuroPathology for the STP’s 29th annual scientific symposium, which was jointly sponsored by the International Federation of Societies of Toxicologic Pathologists (IFSTP) and held in Chicago, Illinois, USA, June 20–24, 2010. As noted during the previous STP symposium on Toxicologic neuroPathology, the three factors driving growth in this field are (1) our greatly increased understanding of neural structure and function; (2) an intense effort to find new therapies for treating neurodegenerative, neurooncologic, and neurovascular diseases; and (3) a greater demand by global regulatory agencies for specific neurotoxicity testing in the registration packages for new products (Fix 2000). These same factors retain their importance at the present time.
Takanori Harada - One of the best experts on this subject based on the ideXlab platform.
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adversity considerations for thyroid follicular cell hypertrophy and hyperplasia in nonclinical toxicity studies results from the 6th estp international expert workshop
Toxicologic Pathology, 2020Co-Authors: Maike Huisinga, Sabine Francke, Takanori Harada, Lise Bertrand, Ronnie Chamanza, Isabelle Damiani, Jeff Engelhardt, Alexius Freyberger, Johannes Harleman, Wolfgang KaufmannAbstract:The European Society of Toxicologic Pathology organized an expert workshop in May 2018 to address adversity considerations related to thyroid follicular cell hypertrophy and/or hyperplasia (FCHH), ...
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Supplemental Material, TS4_TPX_10.1177_0192623318765392 - Pathological and Clinical Pathological Changes Induced by Four-week, Repeated-dose, Oral Administration of the Wood Preservative Chromated Copper Arsenate in Wistar Rats
2018Co-Authors: Naofumi Takahashi, Toshinori Yoshida, Sayuri Kojima, Satoru Yamaguchi, Ryoichi Ohtsuka, Makio Takeda, Tadashi Kosaka, Takanori HaradaAbstract:Supplemental Material, TS4_TPX_10.1177_0192623318765392 for Pathological and Clinical Pathological Changes Induced by Four-week, Repeated-dose, Oral Administration of the Wood Preservative Chromated Copper Arsenate in Wistar Rats by Naofumi Takahashi, Toshinori Yoshida, Sayuri Kojima, Satoru Yamaguchi, Ryoichi Ohtsuka, Makio Takeda, Tadashi Kosaka, and Takanori Harada in Toxicologic Pathology
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Supplemental Material, DS1_TPX_10.1177_0192623318765392 - Pathological and Clinical Pathological Changes Induced by Four-week, Repeated-dose, Oral Administration of the Wood Preservative Chromated Copper Arsenate in Wistar Rats
2018Co-Authors: Naofumi Takahashi, Toshinori Yoshida, Sayuri Kojima, Satoru Yamaguchi, Ryoichi Ohtsuka, Makio Takeda, Tadashi Kosaka, Takanori HaradaAbstract:Supplemental Material, DS1_TPX_10.1177_0192623318765392 for Pathological and Clinical Pathological Changes Induced by Four-week, Repeated-dose, Oral Administration of the Wood Preservative Chromated Copper Arsenate in Wistar Rats by Naofumi Takahashi, Toshinori Yoshida, Sayuri Kojima, Satoru Yamaguchi, Ryoichi Ohtsuka, Makio Takeda, Tadashi Kosaka, and Takanori Harada in Toxicologic Pathology
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a review of nomenclature and diagnostic criteria for proliferative lesions in the liver of rats by a working group of the japanese society of Toxicologic Pathology
Journal of Toxicologic Pathology, 2003Co-Authors: Isao Narama, Katsumi Imaida, Hijiri Iwata, Dai Nakae, Akiyoshi Nishikawa, Takanori HaradaAbstract:The final version of the international harmonized nomenclature for proliferative lesions in rats was issued on June 21, 2000. The recommended nomenclature for proliferative lesions in the liver includes focus of cellular alteration, regenerative hepatocellular hyperplasia, cholangiofibrosis, cholangiofibroma, oval cell hyperplasia, hepatocellular adenoma, hepatocellular carcinoma, bile duct hyperplasia, cholangioma, cholangiocarcinoma, hepatocholangiocellular adenoma, and hepatocholangiocellular carcinoma. Foci of cellular alteration are further classified into the following phenotypes: amphophilic, diffusely basophilic, tigroid basophilic, clear cell, eosinophilic, and mixed (basophilic/eosinophilic). Hepatocellular carcinomas are divided into 3 types based on their growth patterns: acinar, solid, and trabecular. In consideration of this international harmonized nomenclature, the current classification, terminology, and diagnostic criteria for prolifrative lesions in the liver of rats recommended by the Japanese Society of Toxicologic Pathology (JSTP) were reviewed by a Working Group of the JSTP. The hepatic proliferative lesions reviewed by the present Working Group included lesions of hepatocellular, cholangiocellular, mixed hepatocholangiocellular, sinusoidal, and hemangioendothelial origins. Any comments and questions on these lesions were discussed among pathologists in the Working Group and the results of discussions were presented at the 1st seminar on the continuing education program of the JSTP in November 2000.
