Stem Cell-Food and Drug Administration (FDA) part 2

Stem cell 4

 

Preclinical animal testing

Important design elements for preclinical animal studies

  • Selection of relevant disease/injury models
  • Testing of product intended for clinical administration
  • Using route and method of delivery comparable to clinical plan
  • Optimal timing of intervention relative to disease/injury onset
  • Duration necessary to assess durable biological activity
  • Need for immunocompetence modification of animal model
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