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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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Research article

First published 2014-7

Regulatory Forum Commentary *

Daniel Morton, Frank D. Sistare, Prashant R. Nambiar [...]

Toxicologic Pathology

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Other

First published 2005-10

ICH E14: A New Regulatory Guidance on the Clinical Evaluation of QT/QTc Internal Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs *

Philip T. Sager, Thierry Nebout, Borje Darpo

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-7

The Active Pharmaceutical Ingredients Starting Material (APISM) and Other Materials in API Manufacture: Scientifically-Based Principles for the Common Technical Dossier

Helga Möller, Chris Oldenhof

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-12

Regulatory Forum*

W. Michael Peden

Toxicologic Pathology

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Other

First published 1999-7

An Algorithmic Approach to Incorporating the ICH E2A Guidelines into Safety Department ADR Reporting in the United States

Stephen L. Klincewicz, Nancy A. Woolpert, Mark K. Blake [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2020-12

Safety of Anticoagulation in Patients With an Intracranial Hemorrhage at a Comprehensive Stroke Center

Sarah F. Boyko, Olivia Morgan, Kruti Shah [...]

Journal of Stroke Medicine

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Research article

First published 2012-2

Development of Immunotoxicity Testing Strategies for Immunomodulatory Drugs

Thomas T. Kawabata, Ellen W. Evans

Toxicologic Pathology

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Research article

First published 2013-2

Improving Carcinogenicity Assessment

Daniel Morton, Todd Bourcier, Carl L. Alden

Toxicologic Pathology

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Research article

First published 2015-9

Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework

Ann Meeker-O’Connell, Maria Magdalena Borda, Janis A. Little [...]

Therapeutic Innovation & Regulatory Science

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