Glossary of Terms

Exploratory IND

Exploratory IND study is intended to describe a clinical trial that  

  • is conducted early in phase 1,  
  • involves very limited human exposure, and  
  • has no therapeutic or diagnostic intent (e.g., screening studies, micro dose studies).

Such exploratory IND studies are conducted prior to the traditional dose escalation, safety, and tolerance studies that ordinarily initiate a clinical drug development program.  

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