Target Validation Before First-in-Human: What Preclinical Packages Systematically Omit

Authors

  • Janis Grinbergs Centre for Preclinical Modelling, Sela Centre for Experimental Therapeutics, Bauska, Latvia Author
  • Josefine Damsgaard Department of Clinical Pharmacology, Himmerland Institute of Translational Medicine, Hobro, Denmark Author
  • Kolbeinn Snaebjornsdottir Centre for Regulatory Science, Arnessysla Institute of Translational Medicine, Hveragerdi, Iceland Author

DOI:

https://doi.org/10.5281/zenodo.22648817

Keywords:

Target Validation Before First-in-Human, Translational medicine, Evidence synthesis;, Clinical implementation;, Health services research

Abstract

Target Validation Before First-in-Human is an area of active development in translational medicine, with evidence that has
accumulated unevenly across its component questions. We review the current evidence base for target validation before
first-in-human, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice
has converged and where it continues to vary, and set out the practical considerations relevant to a service considering its
adoption. We conclude that selective, context-specific use is best supported by the evidence currently available, rather than
uniform adoption or avoidance.

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Jankowiak G, Grabowski J, et al. "Target Validation Before First-in-Human: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.17219/acem/208596

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Published

2022-01-11

Issue

Vol. 1 No. 1 (2022): Vol 1 Issue 1 2022

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Articles

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How to Cite

Target Validation Before First-in-Human: What Preclinical Packages Systematically Omit. (2022). Translational Medicine & Therapeutics Journal, 1(1), 1-9. https://doi.org/10.5281/zenodo.22648817