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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...
Autores principales: | Wieschowski, Susanne, Chin, William Wei Lim, Federico, Carole, Sievers, Sören, Kimmelman, Jonathan, Strech, Daniel |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2018
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Materias: | |
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 |
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