Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications

BACKGROUND. Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy’s clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. MATERIALS AND METHODS. We explored the rela...

पूर्ण विवरण

में बचाया:
ग्रंथसूची विवरण
में प्रकाशित:Oncologist
मुख्य लेखकों: Liberti, Lawrence, Stolk, Pieter, McAuslane, James Neil, Schellens, Jan, Breckenridge, Alasdair M., Leufkens, Hubert
स्वरूप: Artigo
भाषा:Inglês
प्रकाशित: AlphaMed Press 2015
विषय:
Regulatory Issues: EMA
ऑनलाइन पहुंच:https://ncbi.nlm.nih.gov/pmc/articles/PMC4571776/
https://ncbi.nlm.nih.gov/pubmed/25948678
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2014-0297
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