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Wolf J.C.,Experimental Pathology Laboratories Inc. | Blazer V.S.,U.S. Geological Survey | Camus A.C.,University of Georgia | Engelhardt J.A.,Experimental Pathology Laboratories Inc. | And 13 more authors.
Toxicologic Pathology | Year: 2015

Differentiating salient histopathologic changes from normal anatomic features or tissue artifacts can be decidedly challenging, especially for the novice fish pathologist. As a consequence, findings of questionable accuracy may be reported inadvertently, and the potential negative impacts of publishing inaccurate histopathologic interpretations are not always fully appreciated. The objectives of this article are to illustrate a number of specific morphologic findings in commonly examined fish tissues (e.g., gills, liver, kidney, and gonads) that are frequently either misdiagnosed or underdiagnosed, and to address related issues involving the interpretation of histopathologic data. To enhance the utility of this article as a guide, photomicrographs of normal and abnormal specimens are presented. General recommendations for generating and publishing results from histopathology studies are additionally provided. It is hoped that the furnished information will be a useful resource for manuscript generation, by helping authors, reviewers, and readers to critically assess fish histopathologic data. Copyright © 2014 by The Author(s).


PubMed | AnaPath GmbH, University of Connecticut, Mississippi State University, Experimental Pathology Laboratories Inc. and 11 more.
Type: Journal Article | Journal: Toxicologic pathology | Year: 2015

Differentiating salient histopathologic changes from normal anatomic features or tissue artifacts can be decidedly challenging, especially for the novice fish pathologist. As a consequence, findings of questionable accuracy may be reported inadvertently, and the potential negative impacts of publishing inaccurate histopathologic interpretations are not always fully appreciated. The objectives of this article are to illustrate a number of specific morphologic findings in commonly examined fish tissues (e.g., gills, liver, kidney, and gonads) that are frequently either misdiagnosed or underdiagnosed, and to address related issues involving the interpretation of histopathologic data. To enhance the utility of this article as a guide, photomicrographs of normal and abnormal specimens are presented. General recommendations for generating and publishing results from histopathology studies are additionally provided. It is hoped that the furnished information will be a useful resource for manuscript generation, by helping authors, reviewers, and readers to critically assess fish histopathologic data.


PubMed | Huntingdon Life science, Takeda Pharmaceutical, Bayer AG, AnaPath GmbH and 5 more.
Type: Journal Article | Journal: Journal of toxicologic pathology | Year: 2016

The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) is a joint initiative of the Societies of Toxicologic Pathology from Japan (JSTP), Europe (ESTP), Great Britain (BSTP) and North America (STP) to develop an internationally-accepted nomenclature for proliferative and non-proliferative lesions in laboratory animals. The primary purpose of this publication is to provide a standardized nomenclature for characterizing lesions observed in the cardiovascular (CV) system of rats and mice commonly used in drug or chemical safety assessment. The standardized nomenclature presented in this document is also available electronically for society members on the internet (http://goreni.org). Accurate and precise morphologic descriptions of changes in the CV system are important for understanding the mechanisms and pathogenesis of those changes, differentiation of natural and induced injuries and their ultimate functional consequence. Challenges in nomenclature are associated with lesions or pathologic processes that may present as a temporal or pathogenic spectrum or when natural and induced injuries share indistinguishable features. Specific nomenclature recommendations are offered to provide a consistent approach.


PubMed | Monash University, AnaPath GmbH, Pre Clinical Research Services Inc, Experimental Pathology Laboratories and 2 more.
Type: Journal Article | Journal: International journal of toxicology | Year: 2015

Stem cells have great potential in basic research and are being slowly integrated into toxicological research. This symposium provided an overview of the state of the field, stem cell models, described allogenic stem cell treatments and issues of immunogenicity associated with protein therapeutics, and tehn concentrated on stem cell uses in regenerative medicine focusing on lung and testing strategies on engineered tissues from a pathologists perspective.


PubMed | Vivotecnia Research S.L., AnaPath GmbH, EPL Inc., Olympus Schweiz AG and 2 more.
Type: Journal Article | Journal: International journal of toxicology | Year: 2014

Sperm analysis is one of the end points in reproductive toxicology studies. Different methods for quantitative sperm analysis have been described. For qualitative morphological sperm analysis, either such techniques or smears of sperm and histological sperm staging are in use. Any of these methods provides morphological results on a light microscopy level. Laser scanning microscopy is a technique using a focused laser for scanning an object. The Olympus 3D Laser Scanning Microscope LEXT OLS4000 with optional possibilities of differential interference contrast provides a microscopic method for visualizing microasperities, which are far beyond the resolving power of a typical light or laser microscope. This technique was applied to sperm of mice, rats, rabbits, and cynomolgus monkeys at magnifications up to 17 090. The obtained images are comparable to those of a scanning electron microscope under relatively low-power magnifications. Measurements on sperm parameters were taken by an integrated image analysis software tool. Abnormalities were easily detectable.


Pace V.,AnaPath GmbH | Wieczorek G.,Novartis | Pace M.,University of Florence | Weber K.,AnaPath GmbH | Perentes E.,Novartis
Toxicologic Pathology | Year: 2010

A primary angiosarcoma was found in the tongue of a six-week-old female Wistar rat, sacrificed for humane reasons during the course of a four-week toxicology study. At necropsy, a nodule protruding from the dorsal part of the tongue was found. The nodule displayed microscopically, irregularly shaped vascular spaces separated by collagenous stroma. The spindle-shaped endothelial cells showed pleomorphism, hyperchromatism, and low mitotic activity; large nuclei with one or more nucleoli were present. Multiple metastases were found in the lungs, and the morphology of the cells resembled that of the primary tumor. Immunohistochemically, the primary tumor and the lung metastases were positive for von Willebrand factor and vimentin. The diagnosis of tongue angiosarcoma metastasizing to the lungs was made on the basis of microscopic and immunohistochemical findings. Copyright © 2010 by The Author(s).


Weber K.,AnaPath GmbH | Hailey J.R.,GlaxoSmithCline | Mann P.C.,Experimental Pathology Laboratories Northwest | Seaton M.,FDA CDER | Funk K.A.,Experimental Pathology Laboratories
Toxicologic Pathology | Year: 2014

This continuing education course presented at the Society of Toxicologic Pathology's 31st Annual Symposium explored and defined the many roles that toxicologic pathologists serve Good Laboratory Practice (GLP)-conducted toxicology and carcinogenicity studies. © 2014 by The Author(s).


Wolf J.C.,Experimental Pathology Laboratories Inc. | Ruehl-Fehlert C.,Bayer AG | Segner H.E.,University of Bern | Weber K.,AnaPath GmbH | Hardisty J.F.,Experimental Pathology Laboratories Inc.
Aquatic Toxicology | Year: 2014

While the pathology peer review/pathology working group (PWG) model has long been used in mammalian toxicologic pathology to ensure the accuracy, consistency, and objectivity of histopathology data, application of this paradigm to ecotoxicological studies has thus far been limited. In the current project, the PWG approach was used to evaluate histopathologic sections of gills, liver, kidney, and/or intestines from three previously published studies of diclofenac in trout, among which there was substantial variation in the reported histopathologic findings. The main objectives of this review process were to investigate and potentially reconcile these interstudy differences, and based on the results, to establish an appropriate no observed effect concentration (NOEC). Following a complete examination of all histologic sections and original diagnoses by a single experienced fish pathologist (pathology peer review), a two-day PWG session was conducted to allow members of a four-person expert panel to determine the extent of treatment-related findings in each of the three trout studies. The PWG was performed according to the United States Environmental Protection Agency (US EPA) Pesticide Regulation (PR) 94-5 (EPA Pesticide Regulation, 1994). In accordance with standard procedures, the PWG review was conducted by the non-voting chairperson in a manner intended to minimize bias, and thus during the evaluation, the four voting panelists were unaware of the treatment group status of individual fish and the original diagnoses associated with the histologic sections. Based on the results of this review, findings related to diclofenac exposure included minimal to slightly increased thickening of the gill filament tips in fish exposed to the highest concentration tested (1000. μg/L), plus a previously undiagnosed finding, decreased hepatic glycogen, which also occurred at the 1000. μg/L dose level. The panel found little evidence to support other reported effects of diclofenac in trout, and thus the overall NOEC was determined to be >320. μg/L. By consensus, the PWG panel was able to identify diagnostic inconsistencies among and within the three prior studies; therefore this exercise demonstrated the value of the pathology peer review/PWG approach for assessing the reliability of histopathology results that may be used by regulatory agencies for risk assessment. © 2013 The Authors.


Weber K.,AnaPath GmbH.
Toxicologic Pathology | Year: 2014

Toxicologic pathology relies on many disciplines of toxicology and basic sciences and often requires other fields and skills such as biostatistics, study design, guidelines, and knowledge of Good Laboratory Practices (GLP) regulations. Pathology is an integrative discipline where specific training and experience are required in order to integrate chemical or biological structures, molecular biology, physiology, and morphology for candidate selection and early development of a test article and to help in the design of appropriate preclinical/toxicology studies. Experience does matter and successful learning is determined by personal behavior; pathologists who not only read slides but research their topics and keep current with the literature are apt to be successful. © 2013 by The Author(s).


PubMed | Experimental Pathology Laboratories Inc., AnaPath GmbH, University of Bern and Bayer AG
Type: | Journal: Aquatic toxicology (Amsterdam, Netherlands) | Year: 2014

While the pathology peer review/pathology working group (PWG) model has long been used in mammalian toxicologic pathology to ensure the accuracy, consistency, and objectivity of histopathology data, application of this paradigm to ecotoxicological studies has thus far been limited. In the current project, the PWG approach was used to evaluate histopathologic sections of gills, liver, kidney, and/or intestines from three previously published studies of diclofenac in trout, among which there was substantial variation in the reported histopathologic findings. The main objectives of this review process were to investigate and potentially reconcile these interstudy differences, and based on the results, to establish an appropriate no observed effect concentration (NOEC). Following a complete examination of all histologic sections and original diagnoses by a single experienced fish pathologist (pathology peer review), a two-day PWG session was conducted to allow members of a four-person expert panel to determine the extent of treatment-related findings in each of the three trout studies. The PWG was performed according to the United States Environmental Protection Agency (US EPA) Pesticide Regulation (PR) 94-5 (EPA Pesticide Regulation, 1994). In accordance with standard procedures, the PWG review was conducted by the non-voting chairperson in a manner intended to minimize bias, and thus during the evaluation, the four voting panelists were unaware of the treatment group status of individual fish and the original diagnoses associated with the histologic sections. Based on the results of this review, findings related to diclofenac exposure included minimal to slightly increased thickening of the gill filament tips in fish exposed to the highest concentration tested (1,000 g/L), plus a previously undiagnosed finding, decreased hepatic glycogen, which also occurred at the 1,000 g/L dose level. The panel found little evidence to support other reported effects of diclofenac in trout, and thus the overall NOEC was determined to be >320 g/L. By consensus, the PWG panel was able to identify diagnostic inconsistencies among and within the three prior studies; therefore this exercise demonstrated the value of the pathology peer review/PWG approach for assessing the reliability of histopathology results that may be used by regulatory agencies for risk assessment.

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