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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...
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| Publicado no: | JNCI Cancer Spectr |
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| Main Authors: | , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Oxford University Press
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7050006/ https://ncbi.nlm.nih.gov/pubmed/32337484 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1093/jncics/pkz058 |
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