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Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully pe...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4096541/ https://www.ncbi.nlm.nih.gov/pubmed/24980283 http://dx.doi.org/10.1186/1471-2288-14-84 |