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| IPPH 52100 - Drug Development |
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Credit Hours: 3.00. 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. Typically offered Summer Fall Spring.
3.000 Credit hours Levels: Graduate, Professional, Undergraduate Schedule Types: Distance Learning, Lecture Offered By: College of Pharmacy Department: Industrial and Physical Pharm Course Attributes: Upper Division May be offered at any of the following campuses: West Lafayette Continuing Ed West Lafayette Restrictions: Must be enrolled in one of the following Colleges: Graduate School College of Pharmacy Doctor of Pharmacy May not be enrolled as the following Classifications: Junior: 75 - 89 hours Professional First Year Freshman: 15 - 29 hours Sophomore: 30 - 44 hours Sophomore: 45 - 59 hours Junior: 60 - 74 hours Freshman: 0 - 14 hours |
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