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Open access

Research article

First published 2022-11

Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies

Jeffrey S. Moffit, Diann L. Blanset, Jessica L. Lynch [...]

Human Gene Therapy

Free access

Research article

First published 1998-10

Nonclinical Safety Assessment of Intravenous Optison®: A Perfluoropropane (PFP)-Filled Albumin Microspheres Contrast Agent for Ultrasonography

Yigal Greener, Anne L. Killam, Stephen T. Cornell [...]

International Journal of Toxicology

Free access

Research article

First published 2021-7

Opinion on the Use of Animal Models in Nonclinical Safety Assessment: Pros and Cons

Radhakrishna Sura, Julie Hutt, Sherry Morgan

Toxicologic Pathology

Retricted access

Research article

First published 2018-03

Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics

Vladimir Bantseev, Rebecca Erickson, Douglas Leipold [...]

Journal of Ocular Pharmacology and Therapeutics

Free access

Research article

First published 2022-7

Selected Resources for Pathology Evaluation of Nonhuman Primates in Nonclinical Safety Assessment

Brad Bolon, Jeffrey I. Everitt

Toxicologic Pathology

Free access

Research article

First published 2022-5

Distortion Product Otoacoustic Emission Test is Not the Test to Use in Nonclinical Safety Assessment

David V Gauvin, Margaret McComb, Rachel Tapp [...]

International Journal of Toxicology

Retricted access

Other

First published 1994-1

Nonclinical Kinetics and Metabolism Studies in Support of the Safety Assessment of Drugs

Joseph Heykants, Willem Meuldermans

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2010-1

Nonclinical Safety Assessment of the Histone Deacetylase Inhibitor Vorinostat

Janet S. Kerr, Sheila Galloway, Armando Lagrutta [...]

International Journal of Toxicology

Free access

Research article

First published 2013-7

A Nonclinical Safety Assessment of MnTE-2-PyP,a Manganese Porphyrin

Shayne C. Gad, Dexter W. Sullivan, James D. Crapo [...]

International Journal of Toxicology

Free access

Research article

First published 2017-4

Regulatory Forum Opinion Piece * : Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey

Sherry J. Morgan, Jessica Couch, Peggy Guzzie-Peck [...]

Toxicologic Pathology

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