Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C

BACKGROUND: US Food and Drug Administration (FDA) set a rigorous standard for defining patient responders in irritable bowel syndrome-C (IBS-C; i.e., FDA's Responder Endpoint) for regulatory approval. However, this endpoint's utility for health-care practitioners to assess clinical respons...

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Detalhes bibliográficos
Publicado no:Neurogastroenterol Motil
Main Authors: Lacy, B E, Lembo, A J, MacDougall, J E, Shiff, S J, Kurtz, C B, Currie, M G, Johnston, J M
Formato: Artigo
Idioma:Inglês
Publicado em: BlackWell Publishing Ltd 2014
Assuntos:
Original Articles
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4282394/
https://ncbi.nlm.nih.gov/pubmed/24382134
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/nmo.12264
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