Cargando…
Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes
A typical biosimilar study in oncology uses the overall response evaluated at a specific time point as the primary endpoint, which is generally acceptable regulatorily, to assess clinical equivalence between a biosimilar and its reference product. The standard primary endpoint for evaluating an anti...
| Autores principales: | , , , , , , |
|---|---|
| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Oxford University Press
2019
|
| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050006/ https://www.ncbi.nlm.nih.gov/pubmed/32337484 http://dx.doi.org/10.1093/jncics/pkz058 |