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May 02, 2024
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2020-2021 Catalog Volume XXX Ver 2 [ARCHIVED CATALOG]
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PSC 6014 Introduction to Biologics and Biosimilars
Lecture: 3 Lab: 0 Practica: 0 Total Credits: 3
This course is designed to introduce the student to the scientific principles that guide the development and manufacture of biological therapeutics (biologics) and their corresponding biosimilar analogs. Furthermore, the student will be exposed to (1) the regulatory requirements that must be met before a biologic is approved, (2) the regulatory requirements before a biosimilar is approved, (3) the differences between a biologic and a biosimilar as well as, (4) the issues associated with the use of biologics and biosimilars in a clinical setting. In addition, concepts regarding the substitution of a corresponding biosimilar for the Innovator’s biologic, the interchangeability of the biosimilar, and the ethical use of biosimilars will be presented.
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