To obtain approval from the Food and Drug Administration (FDA) or an equivalent agency outside the United States to market and sell a new drug or biologic product for use in humans, a series of clinical studies must be performed. These clinical studies exist in four phases. Each phase has specific and differing requirements for patient types, goals, inclusion/exclusion criteria, design features, and expected outcomes. Combined, they build the patient care database for safety and efficacy that hopefully will lead to product approval.


Gauche Disease Drug Development Process Heterogeneous Patient Population Central Institutional Review Board Adverse Event Database 
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© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Lewis J. Smith
    • 1
  1. 1.College of MedicineNorthwestern UniversityIL

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