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1-5 of 5 results for ICH S6(R1)

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Open access

Review article

First published 2022-5

Exploring the Definition of “Similar Toxicities”: Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species

Helen Prior, David O Clarke, David Jones [...]

International Journal of Toxicology

Free access

Research article

First published 2022-6

Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics

Christina L. Burnett, Wilma F. Bergfeld, Donald V. Belsito [...]

International Journal of Toxicology

Open access

Review article

First published 2024-10

Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs Considerations

Helen Prior, Paul Baldrick, David O. Clarke [...]

International Journal of Toxicology

Free access

Review article

First published 2018-10

A Brief Introduction to Antibody–Drug Conjugates for Toxicologic Pathologists

Lars Mecklenburg

Toxicologic Pathology

Free access

Meeting report

First published 2021-3

Development and Regulatory Challenges for Peptide Therapeutics

Doris Zane, Paul L. Feldman, Tomi Sawyer [...]

International Journal of Toxicology