Evolving concepts in Phase I and II Drug Development for Crohn's Disease.
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 ineffe...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Oxford University Press
2016
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| _version_ | 1826292029297000448 |
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| author | Jairath, V Levesque, B Vande Casteele, N Khanna, R Mosli, M Hindryckx, P Travis, S Duijvenstein, M Rimola, J Panes, J D'Haens, G Sandborn, W Feagan, B |
| author_facet | Jairath, V Levesque, B Vande Casteele, N Khanna, R Mosli, M Hindryckx, P Travis, S Duijvenstein, M Rimola, J Panes, J D'Haens, G Sandborn, W Feagan, B |
| author_sort | Jairath, V |
| collection | OXFORD |
| description | 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. |
| first_indexed | 2024-03-07T03:08:24Z |
| format | Journal article |
| id | oxford-uuid:b35b185a-1ec2-421f-85f7-ab1e0f8314eb |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T03:08:24Z |
| publishDate | 2016 |
| publisher | Oxford University Press |
| record_format | dspace |
| spelling | oxford-uuid:b35b185a-1ec2-421f-85f7-ab1e0f8314eb2022-03-27T04:18:25ZEvolving concepts in Phase I and II Drug Development for Crohn's Disease.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b35b185a-1ec2-421f-85f7-ab1e0f8314ebEnglishSymplectic Elements at OxfordOxford University Press2016Jairath, VLevesque, BVande Casteele, NKhanna, RMosli, MHindryckx, PTravis, SDuijvenstein, MRimola, JPanes, JD'Haens, GSandborn, WFeagan, BThe 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. |
| spellingShingle | Jairath, V Levesque, B Vande Casteele, N Khanna, R Mosli, M Hindryckx, P Travis, S Duijvenstein, M Rimola, J Panes, J D'Haens, G Sandborn, W Feagan, B Evolving concepts in Phase I and II Drug Development for Crohn's Disease. |
| title | Evolving concepts in Phase I and II Drug Development for Crohn's Disease. |
| title_full | Evolving concepts in Phase I and II Drug Development for Crohn's Disease. |
| title_fullStr | Evolving concepts in Phase I and II Drug Development for Crohn's Disease. |
| title_full_unstemmed | Evolving concepts in Phase I and II Drug Development for Crohn's Disease. |
| title_short | Evolving concepts in Phase I and II Drug Development for Crohn's Disease. |
| title_sort | evolving concepts in phase i and ii drug development for crohn s disease |
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