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 -
Corequisites - CLRA 520
Other Restrictions -
Restriction by Major -
Restriction by Degree Type - Graduate standing

Updates: Course Rotation added 9/2014

Winter 2025 Course Sections

Summer 2025 Course Sections

Fall 2025 Course Sections