Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?

Human protection policies require favorable risk–benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment often stems from preclinical efficacy studies (PCESs). We undertook a systematic investigation of application materials (investigator brochures...

Descripción completa

Detalles Bibliográficos
Autores principales: Wieschowski, Susanne, Chin, William Wei Lim, Federico, Carole, Sievers, Sören, Kimmelman, Jonathan, Strech, Daniel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Meta-Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5886385/
https://www.ncbi.nlm.nih.gov/pubmed/29621228
http://dx.doi.org/10.1371/journal.pbio.2004879

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5886385/
https://www.ncbi.nlm.nih.gov/pubmed/29621228
http://dx.doi.org/10.1371/journal.pbio.2004879

Ejemplares similares