BIOT 5500: Concepts in Regulatory Science
Lecture - 3 credits
- Introduces the science that supports regulatory affairs in the biopharmaceutical industry.
- Focuses on the methods and instruments used to characterize the processes and products of biotechnology including the production, separation, purification, characterization, and formulation of biologics; the pharmacokinetics of proteins; chemical and biological equivalencies of biogenerics; stability testing; high throughput assays; cell system expression; variants; method validation; and quality control.
Introduces the science that supports regulatory affairs in the biopharmaceutical industry. Show more.