CLNR 415 - New Product Development

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This course is designed to focus on the processes of bringing a new drug molecule into clinical practice. The course will encompass aspects of discovery, finding suitable molecular targets, clinical development, to the commercial launch of a new drug product. The course considers the dynamics of regulatory affairs, advances in technology, and scientific methodologies and their respective impact on new product development to meet unmet medical needs. This course draws upon the prior curriculum and provides further practical and contemporary application. The knowledge and skills obtained within the course will prepare students for the variety of roles in the clinical research industry and how the roles contribute to the availability of new products. Every Fall Prerequisite(s): CLNR 340 and CLNR 364