The role of proof of concept (POC) studies in drug development using the EVP-6124 POC Study as an example
Preskorn, Sheldon H.
Preskorn, Sheldon H.
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2014-01
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Article
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Drug development,Proof of concept
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Preskorn, Sheldon H. MD. The Role of Proof of Concept (POC) Studies in Drug Development Using the EVP-6124 POC Study as an Example. Journal of Psychiatric Practice 20(1):p 59-60, January 2014. | DOI: 10.1097/01.pra.0000442938.61575.c2
Abstract
The goal of early proof of concept studies, typically involving a small number of subjects and more latitude in statistical requirements, is to provide evidence that a drug is likely to be successful in later stages of drug development. Although often not published, such studies allow drug developers to make "Go/No Go" decisions about proceeding with larger, more expensive studies. (Journal of Psychiatric Practice 2014;20:59-60) Copyright © 2014 Lippincott Williams & Wilkins Inc.
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Wolters Kluwer Health
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Journal of Psychiatric Practice
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15274160