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The Use of Clinical Utility Assessments in Early Clinical Development
A quickly realizable benefit of model-based drug development is in reducing uncertainty in risk/benefit, comprising individually of safety and effectiveness, two key attributes of a product evaluated for regulatory approval, marketing, and use. In this review, we investigate gaps and opportunities i...
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| Main Authors: | , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer US
2009
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2664875/ https://ncbi.nlm.nih.gov/pubmed/19145490 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-008-9074-z |
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