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Biotechnology Innovation and Regulatory Science
Fall 2024 - Drug Development
COURSE DESCRIPTION
Description:
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.
Registration in this course is subject to the Purdue University Online Non-Credit Policies.
SECTION DETAILS
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Course Section
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Course:
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1146 182-00
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Term:
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25FY
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Section Number:
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1
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Schedule Number:
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28576
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Instructor(s):
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Mary Speer, Lauren Terruso
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Enrollment Options:
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