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| ABE 51100 - Drug Development |
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Credit Hours: 3.00. (TLI 52100) 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.
0.000 OR 3.000 Credit hours Syllabus Available Levels: Undergraduate, Graduate, Professional Schedule Types: Distance Learning, Lecture Offered By: College of Agriculture Department: Ag & Biological Eng Program Course Attributes: Dept Credit, 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. |
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