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Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program

Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long‐term POC studies (≥48 weeks) add cost and time to the “Go/No Go” decision process. However, it is po...

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Detalhes bibliográficos
Publicado no:Clin Pharmacol Ther
Main Authors: Williams, RN, Filozof, C, Goldstein, BJ, Cusi, K
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5367378/
https://ncbi.nlm.nih.gov/pubmed/28032901
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.560
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