2024-2025 Academic Catalog 
    
    Jul 12, 2025  
2024-2025 Academic Catalog [ARCHIVED 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