|IPPH 521 - Drug Development
Information current as of 10:32 PM on February 11, 2016.
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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