Molecules to Medicine III.

Catalog description

Semester course; 2 lecture hours. 2 credits. Prerequisite: PSCI 330 . Concurrent prerequisite: CHEM 403 . Corequisite: PSCZ 425 . Enrollment is restricted to students in the B.S. in Pharmaceutical Sciences program or by permission of the instructor. Part three of a three-course series designed to build on principles from prior courses to develop a deeper understanding of the multidisciplinary process of drug development, this course will explore moving from the pre-clinical space to first-in-human studies, including clinical trial phases and their purpose, dosing regimen, pharmacokinetic profiling, therapeutic safety and efficacy, and the drug regulatory approval process, including guidance and regulations such as ICH, and the development of Chemistry Manufacturing and Controls to support filing of Abbreviated and New Drug Applications. Concepts in pharmacovigilance and surveillance and the use of artificial intelligence in drug manufacturing will be also be introduced in this course.