BTEC 610 - Advanced Topics in Drug Discovery and Delivery

(3 semester hours)
Prerequisites: Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor
Description: This course introduces the student to the planning and preparatory phase skills required to develop potential new drugs and biologics efficiently. The student gains a thorough appreciation of FDA regulations and guidelines. It is known that in the drug discovery sector, it is important to plan before the proceeding to the development phase. With emphasis on the process, the course focuses on the final analysis and report before developing the protocols. Other important aspects of drug development covered in the course are preclinical investigations; new drug application (NDA) or biologic license application (BLA) format and content; clinical development plans; product and assay development; the Investigational New Drug (IND) process; and trial design, implementation, and management. Lastly, the course provides an overview of trending concepts such as controlled and targeted drug delivery.