2025-2026 Academic Catalog 
    
    Aug 14, 2025  
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2025-2026 Academic Catalog

BIOT 1400 - Drug Development Process and Regulations

This course will provide the milestones of the scientific and regulatory aspects in drug development. It will emphasize the quality controls and processes, including Good Documentation Practices (GDP), that are needed in this highly regulated endeavor, for small molecules, bio-therapeutics, and new technology such as gene therapy.  Furthermore, the use of sensors, omics information, and other new approaches in drug development will be discussed.  

Prerequisites: BIOT 1000 - Introduction to Biotechnology  

Anticipated Terms Offered: fall
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