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Retricted access

Review article

First published 2026

Understanding and addressing placebo response in clinical trials: a comprehensive guide

Krishna S. Upadhye, Paritosh Tayade

Journal of Investigative Medicine

Retricted access

Research article

First published 2015-11

Regulatory Definitions and Good Pharmacovigilance Practices in Social Media

Paulami Naik, Thomas Umrath, John van Stekelenborg [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2011-12

Biorepository Regulatory Considerations: A Detailed Topic Follow-Up to the Blueprint for the Development of a Community-Based Hospital Biorepository

Dixie N. Mayol-Heath, Pamela Woo, Kyle Galbraith

Biopreservation and Biobanking

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

Retricted access

Research article

First published 2012-9

Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members

Josephine Mary Glover, Richard Kay

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2020-8

Regulatory-grade clinical trial design using real-world data

Mark S Levenson

Clinical Trials

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Research article

First published 2025-6

An Industry Perspective on the Use of Novel Excipients in Lipid Nanoparticles—Nonclinical Considerations

Lorrene A. Buckley, Jessica E. Sutherland, Prachi Borude [...]

International Journal of Toxicology

Retricted access

Research article

First published 2004-1

Humane Regulatory Testing: The United Kingdom Experience

Jon D. Richmond

Alternatives to Laboratory Animals

Retricted access

Research article

First published 2019-3

Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials

Cynthia McNamara, Nina Engelhardt, William Potter [...]

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2022-09

FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

Daniel Eisenman, Scott Swindle

Applied Biosafety

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