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Bone Neoplasms in F344 Rats Given Teriparatide [rhPTH(1-34)] Are Dependent on Duration of Treatment and Dose

Toxicologic pathology, 2004-07, Vol.32 (4), p.426-438

2004

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Immunogenicity and Immune Complex Disease in Preclinical Safety Studies

Toxicologic pathology, 2018-12, Vol.46 (8), p.1013-1019

Vahle, John L.

2018

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ICH S1 prospective evaluation study and weight of evidence assessments: commentary from industry representatives

Frontiers in toxicology, 2024-05, Vol.6, p.1377990

2024

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Skeletal Changes in Rats Given Daily Subcutaneous Injections of Recombinant Human Parathyroid Hormone (1-34) for 2 Years and Relevance to Human Safety

Toxicologic pathology, 2002-05, Vol.30 (3), p.312-321

2002

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Inspiration and Exasperation: The Challenges of Inhaled Biologics

Toxicologic pathology, 2021-02, Vol.49 (2), p.232-234

2021

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Role of Anatomic Pathology in Skeletal Evaluations: Applying INHAND Diagnostic Criteria

Toxicologic pathology, 2017-10, Vol.45 (7), p.845-850

Vahle, John L.

2017

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The Dog as a Second Species for Toxicology Testing Provides Value to Drug Development

International journal of toxicology, 2022-12, Vol.41 (6), p.431-441

2022

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Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies

Toxicologic pathology, 2024-02, Vol.52 (2-3), p.138-148

2024

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Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective

Regulatory toxicology and pharmacology, 2018-07, Vol.96, p.18-29

2018

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Chronic Toxicology Studies of Basal Insulin Peglispro in Rats and Dogs: A Novel, PEGylated Insulin Lispro Analog with a Prolonged Duration of Action

Toxicologic pathology, 2017-04, Vol.45 (3), p.402-415

2017

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Pancreatic Effects of a Bruton’s Tyrosine Kinase Small-molecule Inhibitor in Rats Are Strain-dependent

Toxicologic pathology, 2018-06, Vol.46 (4), p.460-472

2018

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Chronic Toxicity and Carcinogenicity Studies of the Long-Acting GLP-1 Receptor Agonist Dulaglutide in Rodents

Endocrinology (Philadelphia), 2015-07, Vol.156 (7), p.2417-2428

2015

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Lack of Bone Neoplasms and Persistence of Bone Efficacy in Cynomolgus Macaques After Long‐Term Treatment With Teriparatide [rhPTH(1‐34)]

Journal of bone and mineral research, 2008-12, Vol.23 (12), p.2033-2039

2008

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Proceedings of the 2009 National Toxicology Program Satellite Symposium

Toxicologic pathology, 2010-01, Vol.38 (1), p.9-36

2010

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An Investigative Study of Pancreatic Exocrine Biomarkers, Histology, and Histomorphometry in Male Zucker Diabetic Fatty (ZDF) Rats Given Dulaglutide by Subcutaneous Injection Twice Weekly for 13 Weeks

Toxicologic pathology, 2015-12, Vol.43 (8), p.1093-1102

2015

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Effects of Dulaglutide on Thyroid C Cells and Serum Calcitonin in Male Monkeys

Endocrinology (Philadelphia), 2015-07, Vol.156 (7), p.2409-2416

2015

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Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR®/ABASAGLAR®) approved in the European Union

Regulatory toxicology and pharmacology, 2017-08, Vol.88, p.56-65

2017

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Carcinogenicity Assessments: The Debate Continues

Toxicologic pathology, 2010-04, Vol.38 (3), p.486-486

Vahle, John L.

2010

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Best Practices for Clinical Pathology Testing in Carcinogenicity Studies

Toxicologic pathology, 2011-02, Vol.39 (2), p.429-434

2011

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Effects of the GLP-1 Receptor Agonist Dulaglutide on the Structure of the Exocrine Pancreas of Cynomolgus Monkeys

Toxicologic pathology, 2015-10, Vol.43 (7), p.1004-1014

2015

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Invited Review: Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations

Toxicologic pathology, 2010-06, Vol.38 (4), p.522-553

2010

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Rat-Specific Decreases in Platelet Count Caused by a Humanized Monoclonal Antibody Against Sclerostin

Toxicological sciences, 2012-02, Vol.125 (2), p.586-594

2012

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Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations

Toxicologic Pathology, 2010-06, Vol.38 (4), p.522-553

2010

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Introduction to Paper by Long et al. on Digital Pathology Validation

Toxicologic Pathology, 2013-01, Vol.41 (1), p.114-114

Vahle, John L.

2013

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International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Non-proliferative and Proliferative Lesions of the Non-human Primate (M. fascicularis)

Journal of Toxicologic Pathology, 2021, Vol.34(3_Suppl), pp.1S-182S

2021

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Bone Neoplasms in F344 Rats Given Teriparatide [rhPTH(1-34)] Are Dependent on Duration of Treatment and Dose

Immunogenicity and Immune Complex Disease in Preclinical Safety Studies

ICH S1 prospective evaluation study and weight of evidence assessments: commentary from industry representatives

Skeletal Changes in Rats Given Daily Subcutaneous Injections of Recombinant Human Parathyroid Hormone (1-34) for 2 Years and Relevance to Human Safety

Inspiration and Exasperation: The Challenges of Inhaled Biologics

Role of Anatomic Pathology in Skeletal Evaluations: Applying INHAND Diagnostic Criteria

The Dog as a Second Species for Toxicology Testing Provides Value to Drug Development

Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies

Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective

Chronic Toxicology Studies of Basal Insulin Peglispro in Rats and Dogs: A Novel, PEGylated Insulin Lispro Analog with a Prolonged Duration of Action

Pancreatic Effects of a Bruton’s Tyrosine Kinase Small-molecule Inhibitor in Rats Are Strain-dependent

Chronic Toxicity and Carcinogenicity Studies of the Long-Acting GLP-1 Receptor Agonist Dulaglutide in Rodents

Lack of Bone Neoplasms and Persistence of Bone Efficacy in Cynomolgus Macaques After Long‐Term Treatment With Teriparatide [rhPTH(1‐34)]

Proceedings of the 2009 National Toxicology Program Satellite Symposium

An Investigative Study of Pancreatic Exocrine Biomarkers, Histology, and Histomorphometry in Male Zucker Diabetic Fatty (ZDF) Rats Given Dulaglutide by Subcutaneous Injection Twice Weekly for 13 Weeks

Effects of Dulaglutide on Thyroid C Cells and Serum Calcitonin in Male Monkeys

Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR®/ABASAGLAR®) approved in the European Union

Carcinogenicity Assessments: The Debate Continues

Best Practices for Clinical Pathology Testing in Carcinogenicity Studies

Effects of the GLP-1 Receptor Agonist Dulaglutide on the Structure of the Exocrine Pancreas of Cynomolgus Monkeys

Invited Review: Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations

Rat-Specific Decreases in Platelet Count Caused by a Humanized Monoclonal Antibody Against Sclerostin

Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations

Introduction to Paper by Long et al. on Digital Pathology Validation

International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Non-proliferative and Proliferative Lesions of the Non-human Primate (M. fascicularis)

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