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Sci Transl Med. 2016 Jan 6;8(320):320ps1. doi: 10.1126/scitranslmed.aac9888.

Data gaps limit the translational potential of preclinical research.

Author information

1
Translational Neuroscience Center, Kirby Neurobiology Center, Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. robin.kleiman@childrens.harvard.edu michael.ehlers@pfizer.com.
2
Neuroscience & Pain Research Unit, BioTherapeutics, Worldwide Research and Development, Pfizer Inc., Cambridge, MA 02139, USA. robin.kleiman@childrens.harvard.edu michael.ehlers@pfizer.com.

Abstract

The absence of mouse pharmacokinetic reference data hinders translation. An analysis of recent literature highlights a systematic lack of discussion regarding rationale for the selection of dosing paradigms in preclinical studies, and in particular for neuroscience studies in which the lack of brain penetration can limit target-organ exposure. We propose solutions to improve study design.

PMID:
26738793
DOI:
10.1126/scitranslmed.aac9888
[Indexed for MEDLINE]

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