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| TLI 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 Fall Spring Summer.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Lecture, Recitation Offered By: College of Technology Department: Technology Ldrshp & Innovatn Course Attributes: Upper Division May be offered at any of the following campuses: West Lafayette Continuing Ed West Lafayette Learning Outcomes: 1. Comprehend strategies used for biotechnology innovation: regulatory and quality documents and materials in the areas of drug development and discovery. 2. Ability to meld theory and practice. 3. Examine issues rationally, logically, and coherently; and acquire, evaluate, and synthesize information and knowledge relevant to an identified problem; and make sound decisions in both familiar and unfamiliar contexts. 4. Read, write, speak, listen, and use data, media and computers to send and respond effectively to communication for varied audiences and purposes. 5. Demonstrate sensitivity to and facility with personal values and ethical principles in professional and social contexts. 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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