CLRA 510 - Introduction to Drug Development

Introduction to the pharmaceutical industry and the process of drug development. Drug development phases 1-4 are discussed. Regulatory requirements of the Food and Drug Administration are reviewed along with the content of the investigational new drug application (IND), the new drug application (NDA) and the marketing authorization application (international). The roles of investigator, coordinator, sponsor and monitor are discussed. Exposure to the skills necessary to function as a successful study monitor is given.

Credit 3 hrs May not be repeated for additional credit
Grade Mode Normal (A-F) Course Rotation Fall

Prerequisites -
Other Restrictions -
Restriction by Major -
Restriction by Degree Type -

Updates: Course Rotation added 9/2014

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