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Research article

First published 2014-11

Nonclinical Safety of the Sodium-Glucose Cotransporter 2 Inhibitor Empagliflozin

Matthew S. Bogdanffy, Robert F. Stachlewitz, Susan van Tongeren [...]

International Journal of Toxicology

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Research article

First published 2021-7

Scientific and Regulatory Policy Committee Best Practices * : Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies

Justin D. Vidal, Karyn Colman, Manoj Bhaskaran [...]

Toxicologic Pathology

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Research article

First published 2011-8

Nonclinical Safety Assessment of a Synthetic Peptide Thrombopoietin Agonist

Elaine Knight, Gary Eichenbaum, Verna Hillsamer [...]

International Journal of Toxicology

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Research article

First published 2016-5

Nonclinical Safety Profile of Etelcalcetide,a Novel Peptide Calcimimetic for the Treatment of Secondary Hyperparathyroidism

Mark R. Fielden, Charles Dean, Kurt Black [...]

International Journal of Toxicology

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Research article

First published 2021-10

Nonclinical Safety Profile of Sotorasib,a KRAS G12C -Specific Covalent Inhibitor for the Treatment of KRAS p.G12C -Mutated Cancer

Katsu Ishida, Jonathan A. Werner, Rhian Davies [...]

International Journal of Toxicology

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Research article

First published 2020-5

Nonclinical Safety Assessment of Zanubrutinib: A Novel Irreversible BTK Inhibitor

Cuining Zhang, Baohong Tian

International Journal of Toxicology

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Research article

First published 2026-4

An Industry Perspective on Key Considerations for the ICH S13 Guidance: Nonclinical Safety Evaluations of Oligonucleotide-Based Therapeutics

Jennifer D Sisler, Patrik Andersson, Alan Brown [...]

International Journal of Toxicology

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Review article

First published 2021-7

A Review of Specific Biomarkers of Chronic Renal Injury and Their Potential Application in Nonclinical Safety Assessment Studies

Leslie A. Obert, Susan A. Elmore, Daniela Ennulat [...]

Toxicologic Pathology

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Research article

First published 2023-1

Toxicologic Pathology Forum Opinion: Interpretation of Gliosis in the Brain and Spinal Cord Observed During Nonclinical Safety Studies

Brad Bolon

Toxicologic Pathology

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Review article

First published 2022-3

Practical Considerations in Determining Adversity and the No-Observed-Adverse-Effect-Level (NOAEL) in Nonclinical Safety Studies: Challenges,Perspectives and Case Studies

Vijay P. Kale, Ilona Bebenek, Hanan Ghantous [...]

International Journal of Toxicology

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