Historical Control Background Incidence of Spontaneous Neoplastic Lesions of Sprague-Dawley Rats in 104-Week Toxicity Studies
Toxicol Pathol. 2024 Jan 28:1926233231224466. doi: 10.1177/01926233231224466. Online ahead of print.ABSTRACTData collected from approximately 1800 male and 1800 female Sprague-Dawley (SD) rats used in 104-week carcinogenicity studies were archived in a historical control database at Labcorp Early Development, Inc, and the neoplastic microscopic observation data from these rats were retrospectively evaluated. Historical control data can provide useful information on the range and incidence of spontaneously occurring background neoplasms in the species and strain of the test animal used in different types of toxicity studies...
Source: Toxicologic Pathology - January 28, 2024 Category: Pathology Authors: Amit Kumar Marie Bockenstedt Victoria Laast Alok Sharma Source Type: research
Risk Assessment for Hepatobiliary Toxicity Liabilities in Drug Development
Toxicol Pathol. 2024 Jan 20:1926233231223751. doi: 10.1177/01926233231223751. Online ahead of print.ABSTRACTRisk assessment of hepatobiliary toxicities represents one of the greatest challenges and, more often than not, one of the most rewarding activities in which toxicologic pathologists can partake, and often times lead. This is in part because each liver toxicity picture is a bit different, informed by a broad range and diversity of relevant data, and also in part because the heavily relied upon animal models are imperfect regarding predictivity of hepatic effects in humans. Following identification and characterizatio...
Source: Toxicologic Pathology - January 20, 2024 Category: Pathology Authors: Richard T Miller Source Type: research
Early-Onset Asymptomatic Polypoid Cystitis in Two Adolescent Male Beagle Dogs
Toxicol Pathol. 2024 Jan 9:1926233231224462. doi: 10.1177/01926233231224462. Online ahead of print.ABSTRACTThis brief communication describes a rare spontaneous background lesion in the lower urinary tract of two male laboratory beagles. Proliferative lesions comprising a constellation of histological features consistent with polypoid cystitis were observed in the bladder of two adolescent dogs from a routine preclinical toxicology study. Both animals were clinically asymptomatic and had only minor alterations in urinalysis parameters. While chronic polypoid cystitis is well-recognized in adult pet dogs, this is the first ...
Source: Toxicologic Pathology - January 9, 2024 Category: Pathology Authors: Giulia Tosi Jennifer Rachael Barnes Source Type: research
Early-Onset Asymptomatic Polypoid Cystitis in Two Adolescent Male Beagle Dogs
Toxicol Pathol. 2024 Jan 9:1926233231224462. doi: 10.1177/01926233231224462. Online ahead of print.ABSTRACTThis brief communication describes a rare spontaneous background lesion in the lower urinary tract of two male laboratory beagles. Proliferative lesions comprising a constellation of histological features consistent with polypoid cystitis were observed in the bladder of two adolescent dogs from a routine preclinical toxicology study. Both animals were clinically asymptomatic and had only minor alterations in urinalysis parameters. While chronic polypoid cystitis is well-recognized in adult pet dogs, this is the first ...
Source: Toxicologic Pathology - January 9, 2024 Category: Pathology Authors: Giulia Tosi Jennifer Rachael Barnes Source Type: research
Toxicologic Pathology Forum: Opinion on Interpretive Challenges for Procedure-Related Effects Associated With Direct Central Nervous System Delivery of Oligonucleotides to Rodents, Dogs, and Nonhuman Primates
Toxicol Pathol. 2024 Jan 5:1926233231218953. doi: 10.1177/01926233231218953. Online ahead of print.ABSTRACTDirect delivery of therapeutics to the central nervous system (CNS) greatly expands opportunities to treat neurological diseases but is technically challenging. This opinion outlines principal technical aspects of direct CNS delivery via intracerebroventricular (ICV) or intrathecal (IT) injection to common nonclinical test species (rodents, dogs, and nonhuman primates) and describes procedure-related clinical and histopathological effects that confound interpretation of test article-related effects. Direct dosing is b...
Source: Toxicologic Pathology - January 5, 2024 Category: Pathology Authors: Lisa D Berman-Booty Stephanie K Klein Curt Mazur Joseph Schroeder Sven Korte Florian T Ludwig Annette Romeike Brad Bolon Jessica L Grieves Source Type: research
Toxicologic Pathology Forum: Opinion on Interpretive Challenges for Procedure-Related Effects Associated With Direct Central Nervous System Delivery of Oligonucleotides to Rodents, Dogs, and Nonhuman Primates
Toxicol Pathol. 2024 Jan 5:1926233231218953. doi: 10.1177/01926233231218953. Online ahead of print.ABSTRACTDirect delivery of therapeutics to the central nervous system (CNS) greatly expands opportunities to treat neurological diseases but is technically challenging. This opinion outlines principal technical aspects of direct CNS delivery via intracerebroventricular (ICV) or intrathecal (IT) injection to common nonclinical test species (rodents, dogs, and nonhuman primates) and describes procedure-related clinical and histopathological effects that confound interpretation of test article-related effects. Direct dosing is b...
Source: Toxicologic Pathology - January 5, 2024 Category: Pathology Authors: Lisa D Berman-Booty Stephanie K Klein Curt Mazur Joseph Schroeder Sven Korte Florian T Ludwig Annette Romeike Brad Bolon Jessica L Grieves Source Type: research
Toxicologic Pathology Forum: Opinion on Interpretive Challenges for Procedure-Related Effects Associated With Direct Central Nervous System Delivery of Oligonucleotides to Rodents, Dogs, and Nonhuman Primates
Toxicol Pathol. 2024 Jan 5:1926233231218953. doi: 10.1177/01926233231218953. Online ahead of print.ABSTRACTDirect delivery of therapeutics to the central nervous system (CNS) greatly expands opportunities to treat neurological diseases but is technically challenging. This opinion outlines principal technical aspects of direct CNS delivery via intracerebroventricular (ICV) or intrathecal (IT) injection to common nonclinical test species (rodents, dogs, and nonhuman primates) and describes procedure-related clinical and histopathological effects that confound interpretation of test article-related effects. Direct dosing is b...
Source: Toxicologic Pathology - January 5, 2024 Category: Pathology Authors: Lisa D Berman-Booty Stephanie K Klein Curt Mazur Joseph Schroeder Sven Korte Florian T Ludwig Annette Romeike Brad Bolon Jessica L Grieves Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing
This article reviews ganglion anatomy, cytology, and pathology (emphasizing sensory ganglia) among common nonclinical species used in assessing product safety for such test articles (TAs). Principal histopathologic findings associated with sensory ganglion injury include neuron degeneration, necrosis, and/or loss; increased satellite glial cell and/or Schwann cell numbers; and leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. Ganglion findin...
Source: Toxicologic Pathology - December 4, 2023 Category: Pathology Authors: Bindu M Bennet Ingrid D Pardo Basel T Assaf Elizabeth Buza Sarah D Cramer LaTasha K Crawford Jeffery A Engelhardt Elizabeth J Galbreath Branka Grubor James P Morrison Tanasa S Osborne Alok K Sharma Brad Bolon Source Type: research
