|IPPH 521 - Drug Development
Information current as of 8:45 AM on October 27, 2016.
The materials for this course are only accessible to current students and instructors. In order to access course materials you will be required to provide a valid username and password.
Credit Hours: 3
Prerequisites: PHAD 501
Semesters: Summer, Fall, Spring
A review of drug discovery and drug development, with emphasis on the regulatory aspects of these activities. Animal preclinical research and human clinical research are discussed in detail. In addition, the process for the assembly of an IND and NDA is discussed along with the Phases (I,II,III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents.
Instructors: Stephen Robert Byrn, Kari L. Clase
Supporting Staff: Mary Ellen Hurt