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Considerations in the Assessment of Clinical Benefit with a Focus on Pain: a Regulatory Perspective
In the USA, the regulatory standard for demonstration of efficacy of a drug is evidence of clinical benefit from adequate and well-controlled clinical trials. Understanding the natural history of disease and how treatment is expected to alter its course, and gathering input from relevant stakeholder...
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| Publicado no: | Neurotherapeutics |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2020
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7609809/ https://ncbi.nlm.nih.gov/pubmed/32779129 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s13311-020-00906-6 |
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