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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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Detalles Bibliográficos
Autor principal: Patat, Alain A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Les Laboratoires Servier 2000
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181605/
https://www.ncbi.nlm.nih.gov/pubmed/22033693

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