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Assessment of benefits and risks in development of targeted therapies for cancer — The view of regulatory authorities
Drug licensing and approval decisions involve the balancing of benefits against the risks (harms) in the presence of uncertainty. Typically, the benefits are estimated from primary efficacy endpoints from confirmatory (phase III) clinical trials although exceptions where promising early data from si...
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| Publicado no: | Mol Oncol |
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| Principais autores: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2014
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5528738/ https://ncbi.nlm.nih.gov/pubmed/25481691 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.molonc.2014.10.003 |
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