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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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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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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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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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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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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 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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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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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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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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Teriparatide [PTH(1–34)] Strengthens the Proximal Femur of Ovariectomized Nonhuman Primates Despite Increasing Porosity

Journal of bone and mineral research, 2004-04, Vol.19 (4), p.623-629

2004

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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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International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) progress to date and future plans

Journal of Toxicologic Pathology, 2015, Vol.28(1), pp.51-53

2015

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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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Nonproliferative and Proliferative Lesions of the Rat and Mouse Skeletal Tissues (Bones, Joints, and Teeth)

Journal of Toxicologic Pathology, 2016, Vol.29(3_Suppl), pp.49S-103S

2016

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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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Immunogenicity and Immune Complex Disease in Preclinical Safety Studies

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

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

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

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

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

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

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

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

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

Teriparatide [PTH(1–34)] Strengthens the Proximal Femur of Ovariectomized Nonhuman Primates Despite Increasing Porosity

Best Practices for Clinical Pathology Testing in Carcinogenicity Studies

International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) progress to date and future plans

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

Nonproliferative and Proliferative Lesions of the Rat and Mouse Skeletal Tissues (Bones, Joints, and Teeth)

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

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