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Br J Clin Pharmacol. 2018 Jul;84(7):1457-1466. doi: 10.1111/bcp.13529. Epub 2018 May 15.

Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects.

Author information

1
Central Commission for Human Research (CCMO), Den Haag, The Netherlands.
2
Centre for Human Drug Research, Leiden, The Netherlands.

KEYWORDS:

Phase I; clinical trials; drug development, animal models; statistics and study design, methodology; toxicity; toxicology

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