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Retricted access

Research article

First published 2015-1

Bayesian Design of Proof-of-Concept Trials

Roland Fisch, Ieuan Jones, Julie Jones [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2021-2

Efficient two-stage sequential arrays of proof of concept studies for pharmaceutical portfolios

Linchen He, Linqiu Du, Zoran Antonijevic [...]

Statistical Methods in Medical Research

Free access

Review article

First published 2019-9

Establishing Proof of Concept for Clinical Processes in Lifestyle Medicine

Garry Egger, John Stevens, Christopher Ganora

American Journal of Lifestyle Medicine

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Other

First published 2010-7

Design Archetypes for Phase 2 Clinical Trials in Central Nervous System Disorders

Craig H. Mallinckrodt, Michael J. Detke, William R. Prucka [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-5

Early Clinical Development Planning via Biomarkers,Clinical Endpoints,and Simulation

Bret Musser, James Bolognese, Ghassan N. Fayad [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-12

A proof-of-concept-to-confirmatory multiple adaptation design in the development of an anti-viral treatment

Xiaoyin F Fan, Paul Gallo, Guoqin Su [...]

Statistical Methods in Medical Research

Open access

Review article

First published 2025-2

Virtual Control Groups in Non-clinical Toxicity Studies: Impacts on Toxicologic Clinical Pathology Data Interpretation

Adeyemi O. Adedeji, Adi Wasserkrug Naor

Toxicologic Pathology

Open access

Other

First published 2015-3

Big Data: Prospects and Challenges

Janakiraman Moorthy, Rangin Lahiri, Neelanjan Biswas [...]

Vikalpa: The Journal for Decision Makers

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Other

First published 2007-05

Pharmacological models in healthy volunteers: their use in the clinical development of psychotropic drugs

Christian Gilles, Remy Luthringer

Journal of Psychopharmacology

Open access

Review article

First published 2025

How LLMs can advance safety case intake—points to consider and insights from a proof of concept

Hans-Joerg Roemming, Manfred Hauben, Wei Wannhoff [...]

Therapeutic Advances in Drug Safety

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