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Research article

First published 2025-3

First-in-human feasibility study of the aXess graft (aXess-FIH): 6-Month results

Matteo Tozzi, Jan De Letter, Dainis Krievins [...]

The Journal of Vascular Access

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Research article

First published 2017-5

Safety in FIH Trials

Howard E. Greenberg, Mattheus (Thijs) van Iersel, Mary L. Westrick [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-5

Structured Risk Assessment for First-in-Human Studies

Mattheus (Thijs) van Iersel, Howard E. Greenberg, Mary L. Westrick

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2014-1

The Study Pathologist’s Role in GLP Studies

Mark Seaton

Toxicologic Pathology

Free access

Research article

First published 2023-1

Toxicologic Pathology Forum: Opinion on Approaches for Reporting Toxic and Adverse Dose Levels in Nonclinical Toxicology Studies Supporting the Development of Anticancer Pharmaceuticals

Renee R. Hukkanen, Tomoyuki Moriyama, Daniel J. Patrick [...]

Toxicologic Pathology

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Research article

First published 2025

Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up

Matteo Tozzi, Jan De Letter, Dainis Krievins [...]

The Journal of Vascular Access

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Research article

First published 2016-9

Nonclinical Safety Considerations for the Development of Pediatric-First Drugs

G. Schmitt, J. Ridings, L. De Schaepdrijver [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019

Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018

Jan Willem van der Laan, Charles T. Benson, Walter Janssens [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2024-12

An Evaluation of First-in-Human Studies for RNA Oligonucleotides

Sydney Stern, Ronald L. Wange, Hobart Rogers

Nucleic Acid Therapeutics

Open access

Research article

First published 2022-03

Human safety study of a selective neuronal adenylate cyclase 1 inhibitor NB001 which relieves the neuropathic pain and blocks ACC in adult mice

Weicong Wang, Qi-Yu Chen, Pengpeng Zhao [...]

Molecular Pain

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