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Use of controlled human infection models (CHIMs) to support vaccine development: US regulatory considerations

Roshan Ramanathan1, Scott Stibitz1, Douglas Pratt1

  • 1Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.

Vaccine
|June 26, 2019
PubMed

Keywords:
Clinical developmentControlled human infection modelsRegulationVaccineVaccine licensure

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