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  1. Article ; Online: Toxicologic Pathology Forum Opinion: Rational Approaches to Expanded Neurohistopathology Evaluation for Nonclinical General Toxicity Studies and Juvenile Animal Studies.

    Bolon, Brad

    Toxicologic pathology

    2024  Volume 51, Issue 6, Page(s) 363–374

    Abstract: Existing nervous system sampling and processing "best practices" for nonclinical general toxicity studies (GTS) were designed to assess test articles with unknown, no known, or well-known neurotoxic potential. Similar practices are applicable to juvenile ...

    Abstract Existing nervous system sampling and processing "best practices" for nonclinical general toxicity studies (GTS) were designed to assess test articles with unknown, no known, or well-known neurotoxic potential. Similar practices are applicable to juvenile animal studies (JAS). In GTS and JAS, the recommended baseline sampling for all species includes brain (7 sections), spinal cord (cervical and lumbar divisions [cross and longitudinal sections for each]), and 1 nerve (sciatic or tibial [cross and longitudinal sections]) in hematoxylin and eosin-stained sections. Extra sampling and processing (ie, an "expanded neurohistopathology evaluation" [ENHP]) are used for agents with anticipated neuroactivity (toxic ± therapeutic) of incompletely characterized location and degree. Expanded sampling incorporates additional brain (usually 8-15 sections total), spinal cord (thoracic ± sacral divisions), ganglia (somatic ± autonomic, often 2-8 total), and/or nerves (2-6 total) depending on the species and study objectives. Expanded processing typically adds special neurohistological procedures (usually 1-4 for selected samples) to characterize glial reactions, myelin integrity, and/or neuroaxonal damage. In my view, GTS and JAS designs should sample neural tissues at necropsy as if ENHP will be needed eventually, and when warranted ENHP may incorporate expanded sampling and/or expanded processing depending on the study objective(s).
    MeSH term(s) Animals ; Brain ; Neurotoxicity Syndromes ; Research Design ; Myelin Sheath ; Spinal Cord
    Language English
    Publishing date 2024-01-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/01926233231225239
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Toxicologic Pathology Forum Opinion: Interpretation of Gliosis in the Brain and Spinal Cord Observed During Nonclinical Safety Studies.

    Bolon, Brad

    Toxicologic pathology

    2023  Volume 51, Issue 1-2, Page(s) 68–76

    Abstract: Gliosis, defined as a nonneoplastic reaction (hypertrophy and/or proliferation) of astrocytes and/or microglial cells, is a frequent finding in the central nervous system (CNS [brain and/or spinal cord]) in nonclinical safety studies. Gliosis in rodents ... ...

    Abstract Gliosis, defined as a nonneoplastic reaction (hypertrophy and/or proliferation) of astrocytes and/or microglial cells, is a frequent finding in the central nervous system (CNS [brain and/or spinal cord]) in nonclinical safety studies. Gliosis in rodents and nonrodents occurs at low incidence as a spontaneous finding and is induced by various test articles (e.g., biomolecules, cell and gene therapies, small molecules) delivered centrally (i.e., by injection or infusion into cerebrospinal fluid or neural tissue) or systemically. Several CNS gliosis patterns occur in nonclinical species. First, gliosis may accompany degeneration and/or necrosis of cells (mainly neurons) or neural parenchyma (neuron processes and myelin). Second, gliosis often follows inflammation (i.e., leukocyte accumulation causing parenchymal damage) or neoplasm formation. Third, gliosis may appear as variably sized, randomly scattered foci of reactive glial cells in the absence of visible parenchymal damage or inflammation. In interpreting test article-related CNS gliosis, adversity is indicated by parenchymal injury (e.g., degeneration, necrosis, or inflammation) and not the mere existence of a glial reaction. In the absence of clear structural damage to the parenchyma, gliosis as a standalone CNS finding should be interpreted as a nonadverse reaction to regional alterations in microenvironmental conditions rather than as evidence of a glial reaction associated with neurotoxicity.
    MeSH term(s) Humans ; Gliosis/drug therapy ; Gliosis/etiology ; Gliosis/pathology ; Spinal Cord/pathology ; Astrocytes/metabolism ; Astrocytes/pathology ; Brain/metabolism ; Inflammation/pathology ; Necrosis/complications ; Necrosis/pathology ; Glial Fibrillary Acidic Protein/metabolism
    Chemical Substances Glial Fibrillary Acidic Protein
    Language English
    Publishing date 2023-04-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/01926233231164557
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Musings on Education for Toxicologic Pathology Proficiency in a Post-pandemic, Remotely Working World.

    Bolon, Brad

    Toxicologic pathology

    2023  Volume 51, Issue 4, Page(s) 225–227

    MeSH term(s) Pandemics ; International Cooperation ; Societies, Scientific ; Pathology/education ; Toxicology/education
    Language English
    Publishing date 2023-08-14
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/01926233231190403
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Book: Fundamental neuropathology for pathologists and toxicologists

    Bolon, Brad / Butt, Mark T.

    principles and techniques

    2011  

    Author's details ed. by Brad Bolon ; Mark T. Butt
    Language English
    Size XX, 590 S., [16] Bl. : zahlr. Ill., graph. Darst.
    Publisher Wiley
    Publishing place Hoboken, NJ
    Publishing country United States
    Document type Book
    HBZ-ID HT016983088
    ISBN 978-0-470-22733-6 ; 0-470-22733-8
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    2011 A 3885 order for loan Magazin

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  5. Article ; Conference proceedings: Symposium Use of Genetically Engineered Mice in Drug Discovery and Development: Wielding Occam's Razor to Prune the Product Portfolio

    Bolon, Brad

    from the ACT 2000 annual conference

    2002  

    Title variant Use of genetically engineered mice in drug discovery and development: wielding occam's razor to prune the product portfolio
    Institution Symposium Use of Genetically Engineered Mice in Drug Discovery and Development: Wielding Occam's Razor to Prune the Product Portfolio
    American College of Toxicology
    Author's details Brad Bolon
    Language English
    Publishing country United States
    Document type Article ; Conference proceedings
    Note In: International journal of toxicology. - ISSN 1091-5818. - 21 (2002),1, S. 55 - 79
    HBZ-ID HT013391328
    Database Catalogue ZB MED Medicine, Health

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    Zs A 1870 -21- not available for loan Zeitschriften-Lesesaal

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  6. Article ; Online: Toxicologic Pathology Forum Opinion: Apoptosis/Single Cell Necrosis as a Possible Procedural Effect in Primate Brain Following Ice-Cold Saline Perfusion.

    Bolon, Brad / Gary, Joy M

    Toxicologic pathology

    2024  , Page(s) 1926233241247044

    Abstract: Nonclinical studies of test articles (TAs) in nonhuman primates are often designed to assess both biodistribution and toxicity. For this purpose, studies commonly use intravenous perfusion of ice-cold (2°C-8°C) saline to facilitate measurements of TA- ... ...

    Abstract Nonclinical studies of test articles (TAs) in nonhuman primates are often designed to assess both biodistribution and toxicity. For this purpose, studies commonly use intravenous perfusion of ice-cold (2°C-8°C) saline to facilitate measurements of TA-associated nucleic acids and proteins, after which tissues undergo later fixation by immersion for histological processing and microscopic evaluation. Intriguingly, minimal apoptosis/single cell necrosis (A/SCN) of randomly distributed neural cells is evident in the cerebral cortex and less often the hippocampus in animals from all groups, including vehicle-treated controls. Affected cells exhibit end-stage features such as cytoplasmic hypereosinophilia, nuclear condensation or fragmentation, and shape distortions, so their lineage(s) generally cannot be defined; classical apoptotic bodies are exceedingly rare. In addition, A/SCN is not accompanied by glial reactions, leukocyte infiltration/inflammation, or other parenchymal changes. The severity is minimal in controls but may be slightly exacerbated (to mild) by TA that accumulate in neural cells. One plausible hypothesis explaining this A/SCN exacerbation is that cold shock (perhaps complicated by concurrent tissue acidity and hypoxia) drives still-viable but TA-stressed cells to launch a self-directed death program. Taken together, these observations indicate that A/SCN in brain processed by cold saline perfusion with delayed immersion fixation represents a procedural artifact and not a TA-related lesion.
    Language English
    Publishing date 2024-04-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/01926233241247044
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  7. Book ; Online ; E-Book: Fundamentals of toxicologic pathology

    Wallig, Matthew A. / Haschek, Wanda M. / Rousseaux, Colin G. / Bolon, Brad

    2018  

    Author's details edited by Matthew A. Wallig, Wanda M. Haschek, Colin G. Rousseaux, Brad Bolon
    Keywords Poisoning / pathology
    Language English
    Size 1 Online-Ressource (xv, 885 Seiten)
    Edition Third edition
    Publisher Academic Press
    Publishing place London
    Publishing country Great Britain
    Document type Book ; Online ; E-Book
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    HBZ-ID HT019506172
    ISBN 978-0-12-809842-4 ; 9780128098417 ; 0-12-809842-2 ; 0128098414
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  8. Article ; Online: Selected Resources for Pathology Evaluation of Nonhuman Primates in Nonclinical Safety Assessment.

    Bolon, Brad / Everitt, Jeffrey I

    Toxicologic pathology

    2022  Volume 50, Issue 5, Page(s) 725–732

    Abstract: Humans and nonhuman primates (NHPs) share numerous anatomical and physiological characteristics, thereby explaining the importance of NHPs as essential animal models for translational medicine and nonclinical toxicity testing. Researchers, toxicologic ... ...

    Abstract Humans and nonhuman primates (NHPs) share numerous anatomical and physiological characteristics, thereby explaining the importance of NHPs as essential animal models for translational medicine and nonclinical toxicity testing. Researchers, toxicologic pathologists, toxicologists, and regulatory reviewers must be familiar with normal and abnormal NHP biological traits when designing, performing, and interpreting data sets from NHP studies. The current compilation presents a list of essential books, journal articles, and websites that provide context to safety assessment and research scientists working with NHP models. The resources used most frequently by the authors have been briefly annotated to permit readers to rapidly ascertain their applicability to particular research endeavors. The references are aimed primarily for toxicologic pathologists working with cynomolgus and rhesus macaques and common marmosets in efficacy and safety assessment studies.
    MeSH term(s) Animals ; Humans ; Macaca fascicularis ; Macaca mulatta ; Models, Animal ; Primates ; Toxicity Tests
    Language English
    Publishing date 2022-04-28
    Publishing country United States
    Document type Journal Article
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/01926233221091763
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  9. Article ; Online: Mini-Review: Toxic Tendinopathy.

    Bolon, Brad

    Toxicologic pathology

    2017  Volume 45, Issue 7, Page(s) 834–837

    Abstract: Toxic tendinopathy is a rare but reproducible complication in humans, given agents of four drug classes: aromatase inhibitors, fluoroquinolone antibiotics, glucocorticoids (long-term regimens), and statins. Toxic tendinopathy in humans has been linked ... ...

    Abstract Toxic tendinopathy is a rare but reproducible complication in humans, given agents of four drug classes: aromatase inhibitors, fluoroquinolone antibiotics, glucocorticoids (long-term regimens), and statins. Toxic tendinopathy in humans has been linked less consistently to treatment with anabolic steroids, antiretroviral agents (mainly protease inhibitors), metalloproteinase inhibitors (MMPI), and isotretinoin. Classic drug-induced tendinopathies appear as "tendinosis" (i.e., progressive tendon degeneration without inflammation), although cases associated with aromatase inhibitors exhibit mainly tenosynovitis. Any tendon may be affected, but fluoroquinolones, glucocorticoids, and statins most frequently affect large load-bearing tendons in the lower limb, especially the calcaneal ("Achilles") tendon-which ruptures in approximately 30 to 40% of cases. The time to symptom onset ranges from days (fluoroquinolones) to weeks, months, or even years. The pathogenesis is incompletely understood, but proposed mechanisms include apoptosis of tenoblasts and tenocytes, deficient tenocyte function (leading to abnormal extracellular matrix maintenance and repair as well as disrupted intercellular signaling), and structural disintegration (via a combination of increased expression of lytic enzymes, lessened cholesterol content in cell membranes, and neoangiogenesis within highly ordered tendon tissue). Nonclinical safety assessment of therapeutic candidates in these drug classes should incorporate tendon routinely as a protocol-specified tissue for pathology evaluation.
    MeSH term(s) Achilles Tendon/drug effects ; Animals ; Aromatase Inhibitors/adverse effects ; Disease Models, Animal ; Drug-Related Side Effects and Adverse Reactions/diagnosis ; Fluoroquinolones/adverse effects ; Glucocorticoids/adverse effects ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Tendinopathy/chemically induced ; Tendinopathy/diagnosis
    Chemical Substances Aromatase Inhibitors ; Fluoroquinolones ; Glucocorticoids ; Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Language English
    Publishing date 2017
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/0192623317711614
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Regulatory Forum Opinion Piece*: Effective Sectioning of Spinal Cord during Regulatory-type Nonclinical Toxicity Studies.

    Bolon, Brad

    Toxicologic pathology

    2017  Volume 45, Issue 5, Page(s) 580–583

    Abstract: Regulatory guidelines for nonclinical neurotoxicity testing require spinal cord evaluation but do not specify a trimming scheme. The Society of Toxicologic Pathology (STP) "best practices" for nervous system sampling during nonclinical general toxicity ... ...

    Abstract Regulatory guidelines for nonclinical neurotoxicity testing require spinal cord evaluation but do not specify a trimming scheme. The Society of Toxicologic Pathology (STP) "best practices" for nervous system sampling during nonclinical general toxicity studies recommend that spinal cord be assessed in both longitudinal/oblique and transverse sections. This article defines possible longitudinal/oblique orientations, describes their benefits and challenges, and provides an expert recommendation regarding suitable trimming planes. Longitudinal parasagittal (LP) sections follow a vertical plane just lateral to the midline, revealing sensory and motor tracts but little gray matter. Longitudinal horizontal sections transect only sensory or motor tracts and variable quantities of gray matter. Oblique vertical (OV) sections angle across the spinal cord from side to side. Oblique transverse (OT) sections slant through from top (dorsal [posterior]) to bottom (ventral [anterior]). Compared to longitudinal planes, oblique orientations demonstrate considerably more gray matter and white matter. Current STP "best practices" explicitly recommend the LP and OV options; the OT orientation also will yield suitable sections while permitting assessment of anatomic symmetry. Selection among the LP, OT, and OV planes should be at the discretion of the study pathologist. The bilaterally symmetrical OT sections likely will be analyzed most easily by nonneuropathologists.
    Language English
    Publishing date 2017-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 841009-4
    ISSN 1533-1601 ; 0192-6233
    ISSN (online) 1533-1601
    ISSN 0192-6233
    DOI 10.1177/0192623317720120
    Database MEDical Literature Analysis and Retrieval System OnLINE

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