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Structured Risk Assessment for First-in-Human Studies

Mattheus Thijs van Iersel1, Howard E Greenberg2, Mary L Westrick3

  • 11 Early Development Services, PRA Health Sciences, Groningen, the Netherlands.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed

Keywords:
first-in-humanphase 1risk assessmentrisk mitigationsafety

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