Idiopathic Aneurysms of the Ascending Aorta in the Mouse and Rat
Toxicol Pathol. 2021 Dec 2:1926233211056872. doi: 10.1177/01926233211056872. Online ahead of print.ABSTRACTAneurysms of the ascending aorta, unrelated to xenobiotic administration, are described in 5 rats and 2 mice in nonclinical safety studies conducted at Charles River Laboratories (CRL) sites over the past 10 years. The most prominent microscopic finding was focal dilation with disruption of the wall of the ascending aorta with chronic adventitial inflammation or fibroplasia. The pathogenesis of this finding is unknown. There were no associated macroscopic findings, clinical abnormalities, or vascular lesions elsewhere...
Source: Toxicologic Pathology - December 2, 2021 Category: Pathology Authors: Daniel Petkov Daniel J Patrick Petrina Rogerson David Rehagen Gayle Hennig Alys Bradley Paul Howroyd Melissa Czajkowski Joshua Decker Ahamat Aboulmali Bethany Balmer Source Type: research

Idiopathic Aneurysms of the Ascending Aorta in the Mouse and Rat
Toxicol Pathol. 2021 Dec 2:1926233211056872. doi: 10.1177/01926233211056872. Online ahead of print.ABSTRACTAneurysms of the ascending aorta, unrelated to xenobiotic administration, are described in 5 rats and 2 mice in nonclinical safety studies conducted at Charles River Laboratories (CRL) sites over the past 10 years. The most prominent microscopic finding was focal dilation with disruption of the wall of the ascending aorta with chronic adventitial inflammation or fibroplasia. The pathogenesis of this finding is unknown. There were no associated macroscopic findings, clinical abnormalities, or vascular lesions elsewhere...
Source: Toxicologic Pathology - December 2, 2021 Category: Pathology Authors: Daniel Petkov Daniel J Patrick Petrina Rogerson David Rehagen Gayle Hennig Alys Bradley Paul Howroyd Melissa Czajkowski Joshua Decker Ahamat Aboulmali Bethany Balmer Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Carcinogenicity Evaluation of Baclofen in TgrasH2 Mice
In conclusion, baclofen was considered as noncarcinogenic in CB6F1-TgrasH2 mice, which is consistent with results previously obtained in a 2-year rat study.PMID:34814786 | DOI:10.1177/01926233211054767 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 24, 2021 Category: Pathology Authors: Guillaume Chevalier Nicolas Aubert Catherine Thirion-Delalande Bernard Palate Pramila Singh Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Granulocytosis, a Paraneoplastic Syndrome Associated With Non-Glandular Squamous Cell Carcinomas (NGSCC) in the Tg.rasH2 Studies
Toxicol Pathol. 2021 Nov 7:1926233211055717. doi: 10.1177/01926233211055717. Online ahead of print.ABSTRACTNon-glandular squamous cell carcinoma (NGSCC) is an extremely rare tumor in Tg.raH2 mice. There have been 5 NGSCC in 1615 control male mice (0.31%) and 2 NGSCC in 1560 control female mice (0.13%) on 26-week carcinogenicity studies, with a range of 0 to 1 of per group per sex in each study without statistical significance in 52 male and 51 female studies conducted in Tg.rasH2 mice. Every case of NGSCC was accompanied by profound granulocytosis.PMID:34747286 | DOI:10.1177/01926233211055717 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - November 8, 2021 Category: Pathology Authors: Madhav Paranjpe Peter Mann Melissa Denton Source Type: research

Spontaneous Primary Pleural Mesothelioma in Fischer 344 (F344) and Other Rat Strains: A Retrospective Review
The objectives of this retrospective study were to develop historical incidence data and better characterize the light-microscopic morphology of these naturally occurring neoplasms in a large cohort of rats of several strains. A retrospective review was performed of National Toxicology Program (NTP) studies in rats conducted between 1980 and 2019 and comprising a total of 104,029 rats (51,326 males, 52,703 females), predominantly (90%) of the F344 strain. Of the 94,062 F344 rats surveyed, there were 30 cases of primary pleural mesotheliomas (22 males, 8 females). Of the 2998 Wistar Han rats surveyed, primary pleural mesoth...
Source: Toxicologic Pathology - November 3, 2021 Category: Pathology Authors: Debra A Tokarz Margarita M Gruebbel Gabrielle A Willson Jerry F Hardisty Gail Pearse Mark F Cesta Source Type: research

Spontaneous Primary Pleural Mesothelioma in Fischer 344 (F344) and Other Rat Strains: A Retrospective Review
The objectives of this retrospective study were to develop historical incidence data and better characterize the light-microscopic morphology of these naturally occurring neoplasms in a large cohort of rats of several strains. A retrospective review was performed of National Toxicology Program (NTP) studies in rats conducted between 1980 and 2019 and comprising a total of 104,029 rats (51,326 males, 52,703 females), predominantly (90%) of the F344 strain. Of the 94,062 F344 rats surveyed, there were 30 cases of primary pleural mesotheliomas (22 males, 8 females). Of the 2998 Wistar Han rats surveyed, primary pleural mesoth...
Source: Toxicologic Pathology - November 3, 2021 Category: Pathology Authors: Debra A Tokarz Margarita M Gruebbel Gabrielle A Willson Jerry F Hardisty Gail Pearse Mark F Cesta Source Type: research

Spontaneous Primary Pleural Mesothelioma in Fischer 344 (F344) and Other Rat Strains: A Retrospective Review
The objectives of this retrospective study were to develop historical incidence data and better characterize the light-microscopic morphology of these naturally occurring neoplasms in a large cohort of rats of several strains. A retrospective review was performed of National Toxicology Program (NTP) studies in rats conducted between 1980 and 2019 and comprising a total of 104,029 rats (51,326 males, 52,703 females), predominantly (90%) of the F344 strain. Of the 94,062 F344 rats surveyed, there were 30 cases of primary pleural mesotheliomas (22 males, 8 females). Of the 2998 Wistar Han rats surveyed, primary pleural mesoth...
Source: Toxicologic Pathology - November 3, 2021 Category: Pathology Authors: Debra A Tokarz Margarita M Gruebbel Gabrielle A Willson Jerry F Hardisty Gail Pearse Mark F Cesta Source Type: research

Spontaneous Primary Pleural Mesothelioma in Fischer 344 (F344) and Other Rat Strains: A Retrospective Review
The objectives of this retrospective study were to develop historical incidence data and better characterize the light-microscopic morphology of these naturally occurring neoplasms in a large cohort of rats of several strains. A retrospective review was performed of National Toxicology Program (NTP) studies in rats conducted between 1980 and 2019 and comprising a total of 104,029 rats (51,326 males, 52,703 females), predominantly (90%) of the F344 strain. Of the 94,062 F344 rats surveyed, there were 30 cases of primary pleural mesotheliomas (22 males, 8 females). Of the 2998 Wistar Han rats surveyed, primary pleural mesoth...
Source: Toxicologic Pathology - November 3, 2021 Category: Pathology Authors: Debra A Tokarz Margarita M Gruebbel Gabrielle A Willson Jerry F Hardisty Gail Pearse Mark F Cesta Source Type: research

Spontaneous Primary Pleural Mesothelioma in Fischer 344 (F344) and Other Rat Strains: A Retrospective Review
The objectives of this retrospective study were to develop historical incidence data and better characterize the light-microscopic morphology of these naturally occurring neoplasms in a large cohort of rats of several strains. A retrospective review was performed of National Toxicology Program (NTP) studies in rats conducted between 1980 and 2019 and comprising a total of 104,029 rats (51,326 males, 52,703 females), predominantly (90%) of the F344 strain. Of the 94,062 F344 rats surveyed, there were 30 cases of primary pleural mesotheliomas (22 males, 8 females). Of the 2998 Wistar Han rats surveyed, primary pleural mesoth...
Source: Toxicologic Pathology - November 3, 2021 Category: Pathology Authors: Debra A Tokarz Margarita M Gruebbel Gabrielle A Willson Jerry F Hardisty Gail Pearse Mark F Cesta Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies
Toxicol Pathol. 2021 Oct 26:1926233211049156. doi: 10.1177/01926233211049156. Online ahead of print.ABSTRACTSamples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data...
Source: Toxicologic Pathology - October 27, 2021 Category: Pathology Authors: Carole E Harbison Adam D Aulbach Bindu M Bennet Molly H Boyle Mary E Carsillo Torrie A Crabbs Natalie D Keirstead Krista M D La Perle Arun R Pandiri Ahmed M Shoieb William D Siska Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies
Toxicol Pathol. 2021 Oct 26:1926233211049156. doi: 10.1177/01926233211049156. Online ahead of print.ABSTRACTSamples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data...
Source: Toxicologic Pathology - October 27, 2021 Category: Pathology Authors: Carole E Harbison Adam D Aulbach Bindu M Bennet Molly H Boyle Mary E Carsillo Torrie A Crabbs Natalie D Keirstead Krista M D La Perle Arun R Pandiri Ahmed M Shoieb William D Siska Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies
Toxicol Pathol. 2021 Oct 26:1926233211049156. doi: 10.1177/01926233211049156. Online ahead of print.ABSTRACTSamples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data...
Source: Toxicologic Pathology - October 27, 2021 Category: Pathology Authors: Carole E Harbison Adam D Aulbach Bindu M Bennet Molly H Boyle Mary E Carsillo Torrie A Crabbs Natalie D Keirstead Krista M D La Perle Arun R Pandiri Ahmed M Shoieb William D Siska Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies
Toxicol Pathol. 2021 Oct 26:1926233211049156. doi: 10.1177/01926233211049156. Online ahead of print.ABSTRACTSamples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data...
Source: Toxicologic Pathology - October 27, 2021 Category: Pathology Authors: Carole E Harbison Adam D Aulbach Bindu M Bennet Molly H Boyle Mary E Carsillo Torrie A Crabbs Natalie D Keirstead Krista M D La Perle Arun R Pandiri Ahmed M Shoieb William D Siska Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies
Toxicol Pathol. 2021 Oct 26:1926233211049156. doi: 10.1177/01926233211049156. Online ahead of print.ABSTRACTSamples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data...
Source: Toxicologic Pathology - October 27, 2021 Category: Pathology Authors: Carole E Harbison Adam D Aulbach Bindu M Bennet Molly H Boyle Mary E Carsillo Torrie A Crabbs Natalie D Keirstead Krista M D La Perle Arun R Pandiri Ahmed M Shoieb William D Siska Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies
Toxicol Pathol. 2021 Oct 26:1926233211049156. doi: 10.1177/01926233211049156. Online ahead of print.ABSTRACTSamples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data...
Source: Toxicologic Pathology - October 27, 2021 Category: Pathology Authors: Carole E Harbison Adam D Aulbach Bindu M Bennet Molly H Boyle Mary E Carsillo Torrie A Crabbs Natalie D Keirstead Krista M D La Perle Arun R Pandiri Ahmed M Shoieb William D Siska Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Fixation, Trimming, and Sectioning of Nonrodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies
Toxicol Pathol. 2021 Oct 25:1926233211047562. doi: 10.1177/01926233211047562. Online ahead of print.ABSTRACTA Working Group of the Society of Toxicologic Pathology's Scientific and Regulatory Policy Committee conducted a technical and scientific review of current practices relating to the fixation, trimming, and sectioning of the nonrodent eye to identify key points and species-specific anatomical landmarks to consider when preparing and evaluating eyes of rabbits, dogs, minipigs, and nonhuman primates from ocular and general toxicity studies. The topics addressed in this Points to Consider article include determination of...
Source: Toxicologic Pathology - October 25, 2021 Category: Pathology Authors: Helen S Booler Typhaine Lejeune Steven Sorden Margarita M Gruebbel Kenneth A Schafer Brian Short Cindy Farman Meg Ferrell Ramos Bindu Bennet Krishna Yekkala Elke-Astrid Atzpodien Oliver C Turner Jaqueline Brassard George Foley Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Fixation, Trimming, and Sectioning of Nonrodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies
Toxicol Pathol. 2021 Oct 25:1926233211047562. doi: 10.1177/01926233211047562. Online ahead of print.ABSTRACTA Working Group of the Society of Toxicologic Pathology's Scientific and Regulatory Policy Committee conducted a technical and scientific review of current practices relating to the fixation, trimming, and sectioning of the nonrodent eye to identify key points and species-specific anatomical landmarks to consider when preparing and evaluating eyes of rabbits, dogs, minipigs, and nonhuman primates from ocular and general toxicity studies. The topics addressed in this Points to Consider article include determination of...
Source: Toxicologic Pathology - October 25, 2021 Category: Pathology Authors: Helen S Booler Typhaine Lejeune Steven Sorden Margarita M Gruebbel Kenneth A Schafer Brian Short Cindy Farman Meg Ferrell Ramos Bindu Bennet Krishna Yekkala Elke-Astrid Atzpodien Oliver C Turner Jaqueline Brassard George Foley Source Type: research

Artificial Intelligence in Toxicological Pathology: Quantitative Evaluation of Compound-Induced Follicular Cell Hypertrophy in Rat Thyroid Gland Using Deep Learning Models
Toxicol Pathol. 2021 Oct 20:1926233211052010. doi: 10.1177/01926233211052010. Online ahead of print.ABSTRACTDigital pathology has recently been more broadly deployed, fueling artificial intelligence (AI) application development and more systematic use of image analysis. Here, two different AI models were developed to evaluate follicular cell hypertrophy in hematoxylin and eosin-stained whole-slide-images of rat thyroid gland, using commercial AI-based-software. In the first, mean cytoplasmic area measuring approach (MCA approach), mean cytoplasmic area was calculated via several sequential deep learning (DL)-based algorith...
Source: Toxicologic Pathology - October 21, 2021 Category: Pathology Authors: Valeria Bertani Olivier Blanck Davy Guignard Frederic Schorsch Hannah Pischon Source Type: research

Artificial Intelligence in Toxicological Pathology: Quantitative Evaluation of Compound-Induced Follicular Cell Hypertrophy in Rat Thyroid Gland Using Deep Learning Models
Toxicol Pathol. 2021 Oct 20:1926233211052010. doi: 10.1177/01926233211052010. Online ahead of print.ABSTRACTDigital pathology has recently been more broadly deployed, fueling artificial intelligence (AI) application development and more systematic use of image analysis. Here, two different AI models were developed to evaluate follicular cell hypertrophy in hematoxylin and eosin-stained whole-slide-images of rat thyroid gland, using commercial AI-based-software. In the first, mean cytoplasmic area measuring approach (MCA approach), mean cytoplasmic area was calculated via several sequential deep learning (DL)-based algorith...
Source: Toxicologic Pathology - October 21, 2021 Category: Pathology Authors: Valeria Bertani Olivier Blanck Davy Guignard Frederic Schorsch Hannah Pischon Source Type: research

Artificial Intelligence in Toxicological Pathology: Quantitative Evaluation of Compound-Induced Follicular Cell Hypertrophy in Rat Thyroid Gland Using Deep Learning Models
Toxicol Pathol. 2021 Oct 20:1926233211052010. doi: 10.1177/01926233211052010. Online ahead of print.ABSTRACTDigital pathology has recently been more broadly deployed, fueling artificial intelligence (AI) application development and more systematic use of image analysis. Here, two different AI models were developed to evaluate follicular cell hypertrophy in hematoxylin and eosin-stained whole-slide-images of rat thyroid gland, using commercial AI-based-software. In the first, mean cytoplasmic area measuring approach (MCA approach), mean cytoplasmic area was calculated via several sequential deep learning (DL)-based algorith...
Source: Toxicologic Pathology - October 21, 2021 Category: Pathology Authors: Valeria Bertani Olivier Blanck Davy Guignard Frederic Schorsch Hannah Pischon Source Type: research

Artificial Intelligence in Toxicological Pathology: Quantitative Evaluation of Compound-Induced Follicular Cell Hypertrophy in Rat Thyroid Gland Using Deep Learning Models
Toxicol Pathol. 2021 Oct 20:1926233211052010. doi: 10.1177/01926233211052010. Online ahead of print.ABSTRACTDigital pathology has recently been more broadly deployed, fueling artificial intelligence (AI) application development and more systematic use of image analysis. Here, two different AI models were developed to evaluate follicular cell hypertrophy in hematoxylin and eosin-stained whole-slide-images of rat thyroid gland, using commercial AI-based-software. In the first, mean cytoplasmic area measuring approach (MCA approach), mean cytoplasmic area was calculated via several sequential deep learning (DL)-based algorith...
Source: Toxicologic Pathology - October 21, 2021 Category: Pathology Authors: Valeria Bertani Olivier Blanck Davy Guignard Frederic Schorsch Hannah Pischon Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus Vectors
This article describes our current understanding of fundamental biological principles and possible procedures (emphasizing those related to toxicology and toxicologic pathology) needed to support research and development of in vivo GTx products. This article is not intended to provide comprehensive guidance on all GTx modalities but instead provides an overview relevant to in vivo GTx generally by utilizing recombinant adeno-associated virus-based GTx-the most common in vivo GTx platform-to exemplify the main points to be considered in nonclinical research and development of GTx products.PMID:34657529 | DOI:10.1177/0192623...
Source: Toxicologic Pathology - October 18, 2021 Category: Pathology Authors: Julie A Hutt Basel T Assaf Brad Bolon Joy Cavagnaro Elizabeth Galbreath Branka Grubor Lisa M Kattenhorn Annette Romeike Laurence O Whiteley Source Type: research

Kidney Injury Monitoring in Tobramycin-Treated Rhesus Monkeys: Supplementing Urinary Kidney Biomarkers With Kidney Biopsy Gene Expression Profiling
Toxicol Pathol. 2021 Oct 17:1926233211049171. doi: 10.1177/01926233211049171. Online ahead of print.ABSTRACTKidney biopsies are used sparingly to diagnose kidney injury in the clinic. Here we have conducted a small exploratory study to directly compare the low-grade kidney injury monitoring performance of serum safety biomarkers, novel urine safety biomarkers, microscopic histopathology and targeted gene expression alterations in kidney biopsy specimens in rhesus monkeys treated with tobramycin. Targeted gene expression increases were observed in the kidney biopsy samples and whole kidney sections for kidney injury molecul...
Source: Toxicologic Pathology - October 18, 2021 Category: Pathology Authors: Yi-Zhong Gu Larry Handt Katerina Vlasakova Vasudevan Bakthavatchalu Roger Smith Guillermo E Fernandez Stephanie L Born Warren E Glaab Frank D Sistare Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus Vectors
This article describes our current understanding of fundamental biological principles and possible procedures (emphasizing those related to toxicology and toxicologic pathology) needed to support research and development of in vivo GTx products. This article is not intended to provide comprehensive guidance on all GTx modalities but instead provides an overview relevant to in vivo GTx generally by utilizing recombinant adeno-associated virus-based GTx-the most common in vivo GTx platform-to exemplify the main points to be considered in nonclinical research and development of GTx products.PMID:34657529 | DOI:10.1177/0192623...
Source: Toxicologic Pathology - October 18, 2021 Category: Pathology Authors: Julie A Hutt Basel T Assaf Brad Bolon Joy Cavagnaro Elizabeth Galbreath Branka Grubor Lisa M Kattenhorn Annette Romeike Laurence O Whiteley Source Type: research

Kidney Injury Monitoring in Tobramycin-Treated Rhesus Monkeys: Supplementing Urinary Kidney Biomarkers With Kidney Biopsy Gene Expression Profiling
Toxicol Pathol. 2021 Oct 17:1926233211049171. doi: 10.1177/01926233211049171. Online ahead of print.ABSTRACTKidney biopsies are used sparingly to diagnose kidney injury in the clinic. Here we have conducted a small exploratory study to directly compare the low-grade kidney injury monitoring performance of serum safety biomarkers, novel urine safety biomarkers, microscopic histopathology and targeted gene expression alterations in kidney biopsy specimens in rhesus monkeys treated with tobramycin. Targeted gene expression increases were observed in the kidney biopsy samples and whole kidney sections for kidney injury molecul...
Source: Toxicologic Pathology - October 18, 2021 Category: Pathology Authors: Yi-Zhong Gu Larry Handt Katerina Vlasakova Vasudevan Bakthavatchalu Roger Smith Guillermo E Fernandez Stephanie L Born Warren E Glaab Frank D Sistare Source Type: research

Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus Vectors
This article describes our current understanding of fundamental biological principles and possible procedures (emphasizing those related to toxicology and toxicologic pathology) needed to support research and development of in vivo GTx products. This article is not intended to provide comprehensive guidance on all GTx modalities but instead provides an overview relevant to in vivo GTx generally by utilizing recombinant adeno-associated virus-based GTx-the most common in vivo GTx platform-to exemplify the main points to be considered in nonclinical research and development of GTx products.PMID:34657529 | DOI:10.1177/0192623...
Source: Toxicologic Pathology - October 18, 2021 Category: Pathology Authors: Julie A Hutt Basel T Assaf Brad Bolon Joy Cavagnaro Elizabeth Galbreath Branka Grubor Lisa M Kattenhorn Annette Romeike Laurence O Whiteley Source Type: research

Kidney Injury Monitoring in Tobramycin-Treated Rhesus Monkeys: Supplementing Urinary Kidney Biomarkers With Kidney Biopsy Gene Expression Profiling
Toxicol Pathol. 2021 Oct 17:1926233211049171. doi: 10.1177/01926233211049171. Online ahead of print.ABSTRACTKidney biopsies are used sparingly to diagnose kidney injury in the clinic. Here we have conducted a small exploratory study to directly compare the low-grade kidney injury monitoring performance of serum safety biomarkers, novel urine safety biomarkers, microscopic histopathology and targeted gene expression alterations in kidney biopsy specimens in rhesus monkeys treated with tobramycin. Targeted gene expression increases were observed in the kidney biopsy samples and whole kidney sections for kidney injury molecul...
Source: Toxicologic Pathology - October 18, 2021 Category: Pathology Authors: Yi-Zhong Gu Larry Handt Katerina Vlasakova Vasudevan Bakthavatchalu Roger Smith Guillermo E Fernandez Stephanie L Born Warren E Glaab Frank D Sistare Source Type: research

Prenatal Evaluations: A Prologue to Postnatal Pathology Interpretations
This article aims to share information on the importance of, and strategies for, mouse embryo, placenta, and metrial gland evaluations. Information on early postnatal development is also provided as well as select examples of developmental information on organ systems needed for postnatal evaluations. A list of additional studies that can aid in the evaluation of prenatal and postnatal phenotypes is also provided.PMID:34652981 | DOI:10.1177/01926233211046540 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - October 15, 2021 Category: Pathology Authors: Susan A Elmore Source Type: research

Prenatal Evaluations: A Prologue to Postnatal Pathology Interpretations
This article aims to share information on the importance of, and strategies for, mouse embryo, placenta, and metrial gland evaluations. Information on early postnatal development is also provided as well as select examples of developmental information on organ systems needed for postnatal evaluations. A list of additional studies that can aid in the evaluation of prenatal and postnatal phenotypes is also provided.PMID:34652981 | DOI:10.1177/01926233211046540 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - October 15, 2021 Category: Pathology Authors: Susan A Elmore Source Type: research

Prenatal Evaluations: A Prologue to Postnatal Pathology Interpretations
This article aims to share information on the importance of, and strategies for, mouse embryo, placenta, and metrial gland evaluations. Information on early postnatal development is also provided as well as select examples of developmental information on organ systems needed for postnatal evaluations. A list of additional studies that can aid in the evaluation of prenatal and postnatal phenotypes is also provided.PMID:34652981 | DOI:10.1177/01926233211046540 (Source: Toxicologic Pathology)
Source: Toxicologic Pathology - October 15, 2021 Category: Pathology Authors: Susan A Elmore Source Type: research

Symmetric Dimethylarginine Is a Sensitive Biomarker of Glomerular Injury in Rats
Toxicol Pathol. 2021 Oct 11:1926233211045341. doi: 10.1177/01926233211045341. Online ahead of print.ABSTRACTGlomerular filtration rate is the gold-standard method for assessment of renal function but is rarely performed in routine toxicity studies. Standard serum biomarkers of renal function are insensitive and become elevated only with significant loss of organ function. Symmetric dimethylarginine (SDMA) is a ubiquitous analyte that is freely filtered by the glomerulus and can be detected in serum. It has shown utility for the detection of renal injury in dogs and cats in clinical veterinary practice, but the potential ut...
Source: Toxicologic Pathology - October 12, 2021 Category: Pathology Authors: Rebecca Kohnken Lauren Himmel Michael Logan Richard Peterson Sabyasachi Biswas Christina Dunn Bruce LeRoy Source Type: research

Proceedings of the 2021 National Toxicology Program Satellite Symposium
This article presents summaries of the speakers' talks along with select images that were presented to the audience for voting and discussion. Various lesions and topics covered during the symposium included differentiation of canine oligodendroglioma, astrocytoma, and undefined glioma with presentation of the National Cancer Institute's updated diagnostic terminology for canine glioma; differentiation of polycystic kidney, dilated tubules and cystic tubules with a discussion of human polycystic kidney disease; a review of various rodent nervous system background lesions in control animals from NTP studies with a focus on ...
Source: Toxicologic Pathology - October 12, 2021 Category: Pathology Authors: Susan A Elmore Shambhunath Choudhary Gregory A Krane Quinci Plumlee Erin M Quist Andrew W Suttie Debra A Tokarz Jerrold M Ward Michelle Cora Source Type: research

Symmetric Dimethylarginine Is a Sensitive Biomarker of Glomerular Injury in Rats
Toxicol Pathol. 2021 Oct 11:1926233211045341. doi: 10.1177/01926233211045341. Online ahead of print.ABSTRACTGlomerular filtration rate is the gold-standard method for assessment of renal function but is rarely performed in routine toxicity studies. Standard serum biomarkers of renal function are insensitive and become elevated only with significant loss of organ function. Symmetric dimethylarginine (SDMA) is a ubiquitous analyte that is freely filtered by the glomerulus and can be detected in serum. It has shown utility for the detection of renal injury in dogs and cats in clinical veterinary practice, but the potential ut...
Source: Toxicologic Pathology - October 12, 2021 Category: Pathology Authors: Rebecca Kohnken Lauren Himmel Michael Logan Richard Peterson Sabyasachi Biswas Christina Dunn Bruce LeRoy Source Type: research