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Research article

First published 2011-12

Importance of protocols for simulation studies in clinical drug development

Mike K Smith, Andrea Marshall

Statistical Methods in Medical Research

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Research article

First published 1991-1

Screening for Illicit Drug Use in Drug Development Studies

Beverly M. DeVries, George S. Hughes, Linda S. Huyser

Therapeutic Innovation & Regulatory Science

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Other

First published 2013-12

Why Animal Studies are Still Being Used in Drug Development

Marlous Kooijman

Alternatives to Laboratory Animals

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Other

First published 1998-1

Orphan Drug Development — International Program and Study Design Issues

Marlene E. Haffner

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2021-1

The Utility of Novel Urinary Biomarkers in Mice for Drug Development Studies

Adeyemi O. Adedeji, Yi-Zhong Gu, Tony Pourmohamad [...]

International Journal of Toxicology

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Research article

First published 1995-03

The Role of Drug Metabolism in Drug Discovery: A Case Study in the Selection of an Oxytocin Receptor Antagonist for Development

Shuet-Ling L. Chiu, A. Thompson, Stella H. Vincent [...]

Toxicologic Pathology

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Research article

First published 2018-1

Neonatal Safety Information Reported to the FDA During Drug Development Studies

Debbie Avant, Gerri Baer, Jason Moore [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2012-6

Timing of Carcinogenicity Studies and Predictability of Genotoxicity for Tumorigenicity in Anti-HIV Drug Development

Kuei-Meng Wu, Mark W. Powley, Hanan Ghantous

International Journal of Toxicology

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Research article

First published 2007-9

Implementation of a Biomarker into Drug Development: Example of Identifying the Right Imaging “Tool” for an Oncology Study

Barry T. Peterson, Timothy J. McCarthy, Philip Murphy

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-4

Vehicle Systems and Excipients Used in Minipig Drug Development Studies

Margaret L. Weaver, Anette Blak Grossi, Jorgen Schützsack [...]

Toxicologic Pathology

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