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Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

Objective To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs’ originally approved indications. Design Systematic review. Setting Publicly accessible data on supplemental indications a...

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Detalhes bibliográficos
Publicado no:BMJ
Main Authors: Wang, Bo, Kesselheim, Aaron S
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group Ltd. 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4580725/
https://ncbi.nlm.nih.gov/pubmed/26400844
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmj.h4679
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