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Research article

First published 2019-1

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

Lewis J. Fermaglich, Ru Chen, Carol Y. Kim [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2025-8

Toxicologic Pathology Forum*: Opinion on Qualitative Severity Descriptors to Express Magnitude of Changes in Clinical Pathology Endpoints in Nonclinical Toxicity Studies

N. K. Tripathi, L. Ramaiah, T. Arndt [...]

Toxicologic Pathology

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Research article

First published 2017-5

Describing the Endpoint

Yeshi Mikyas

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-4

Designing Global Development Programs

Jeffrey Chodakewitz

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-5

A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study

Ming Zhou, Larry Z. Shen

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2011-4

International Cartilage Repair Society (ICRS) Recommended Guidelines for Histological Endpoints for Cartilage Repair Studies in Animal Models and Clinical Trials

Caroline Hoemann, Rita Kandel, Sally Roberts [...]

CARTILAGE

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Research article

First published 2011-5

Magnetic resonance imaging as surrogate for clinical endpoints in multiple sclerosis: data on novel oral drugs

MP Sormani, L Bonzano, L Roccatagliata [...]

Multiple Sclerosis Journal

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Research article

First published 2015-11

“Bring Your Own Device” (BYOD)

Chad Gwaltney, Stephen Joel Coons, Paul O’Donohoe [...]

Therapeutic Innovation & Regulatory Science

Open access

Review article

First published 2020

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description

Matthias Waliszewski, Mark Rosenberg, Harald Rittger [...]

Therapeutic Advances in Cardiovascular Disease

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Research article

First published 2015-12

Impact of weighted composite compared to traditional composite endpoints for the design of randomized controlled trials

Jeffrey A Bakal, Cynthia M Westerhout, Paul W Armstrong

Statistical Methods in Medical Research

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