A carregar...
Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan, Non‐oncology Drugs in the European Union and United States from 2012−2016
For regulatory approval of a new medicine, the gold standard for demonstration of efficacy has traditionally been a minimum of two positive, adequate, and well‐controlled clinical trials. Nevertheless, drugs to treat cancer and rare diseases are usually approved based on a single and often uncontrol...
Na minha lista:
| Publicado no: | Clin Transl Sci |
|---|---|
| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2019
|
| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6662549/ https://ncbi.nlm.nih.gov/pubmed/30681284 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12617 |
| Tags: |
Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!
|