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Designing and interpreting the results of first-time-to-man studies
First human administration of a new chemical entity (NCE) constitutes a critical step in drug development. The primary objective of such a study is the assessment of the shortterm safety and tolerability of single and multiple doses of the NCE in healthy volunteers. Secondary objectives are to obtai...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Les Laboratoires Servier
2000
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181605/ https://www.ncbi.nlm.nih.gov/pubmed/22033693 |