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Research article

First published 2009-1

The Liver Toxicity Biomarker Study: Phase I Design and Preliminary Results

Robert N. Mcburney, Wade M Hines, Linda S. Von Tungeln [...]

Toxicologic Pathology

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Review article

First published 2012-1

Flexible Phase I Study Designs

David Underwood

Therapeutic Innovation & Regulatory Science

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Research article

First published 1989-10

Challenges in the Design of Phase I and Early Phase II Studies

George S. Hughes

Therapeutic Innovation & Regulatory Science

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Research article

First published 1997-7

From Mouse to Man: The Early Clinical Testings

Kimberly T. Perry

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-12

Sequential or combined designs for Phase I/II clinical trials? A simulation study

Caroline Rossoni, Aurélie Bardet, Birgit Geoerger [...]

Clinical Trials

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Research article

First published 2015-1

Incorporating Historical Data in Bayesian Phase I Trial Design

Kentaro Takeda, Satoshi Morita

Therapeutic Innovation & Regulatory Science

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Research article

First published 2024-6

The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies

Cody Chiuzan, Hakim-Moulay Dehbi

Clinical Trials

Open access

Research article

First published 2026-1

Joint time-to-event partial order continual reassessment method and Joint time-to-event Bayesian logistic regression model: Statistical designs for dual agent phase I/II dose finding studies with late-onset toxicity and activity outcomes

Helen Barnett, Oliver Boix, Dimitris Kontos [...]

Statistical Methods in Medical Research

Free access

Research article

First published 2012-2

Pharmacokinetics and Antiviral Activity of Phx1766,a Novel HCV Protease Inhibitor,Using An Accelerated Phase I Study Design

Daphne M Hotho, Joep de Bruijne, A Marie O'Farrell [...]

Antiviral Therapy

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Research article

First published 2008-8

The Neuroprotection with Statin Therapy for Acute Recovery Trial (Neustart): An Adaptive Design Phase I Dose-Escalation Study of High-Dose Lovastatin in Acute Ischemic Stroke

Mitchell S. V. Elkind, Ralph L. Sacco, Robert B. MacArthur [...]

International Journal of Stroke

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