Journal article
Evolving concepts in Phase I and II Drug Development for Crohn's Disease.
- Abstract:
- The highest attrition rates during drug development programs occur at the proof of concept stage. Given the large number of molecules under development for Crohn's disease, a need exists to improve the efficiency of early drug development by fast-tracking promising agents and terminating ineffective ones. Multiple opportunities are available to achieve these goals, including the use of more responsive outcome measures, and the incorporation of sophisticated pharmacokinetic modeling and/or highly specific pharmacodynamic markers into exposure-based dosing regimens and novel trial designs. In this article we review these strategies and propose an integrated paradigm of early drug development in Crohn's disease.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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Access Document
- Files:
-
-
(Preview, Accepted manuscript, pdf, 867.4KB, Terms of use)
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- Publisher copy:
- 10.1093/ecco-jcc/jjw137
Authors
- Publisher:
- Oxford University Press
- Journal:
- Journal of Crohn's and Colitis More from this journal
- Volume:
- 11
- Issue:
- 2
- Pages:
- 246-255
- Publication date:
- 2016-08-03
- Acceptance date:
- 2016-08-01
- DOI:
- EISSN:
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1876-4479
- ISSN:
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1873-9946
- Language:
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English
- Keywords:
- Pubs id:
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pubs:637254
- UUID:
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uuid:b35b185a-1ec2-421f-85f7-ab1e0f8314eb
- Local pid:
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pubs:637254
- Source identifiers:
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637254
- Deposit date:
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2016-08-18
- ARK identifier:
Terms of use
- Copyright holder:
- European Crohn’s and Colitis Organisation
- Copyright date:
- 2016
- Notes:
- Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. This is the accepted manuscript version of the article. The final version is available online from OUP at: [10.1093/ecco-jcc/jjw137]
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