This course is designed to provide an understanding of how pharmaceutical companies discover, develop, and bring drugs and biopharmaceuticals to market. This course will focus on the development of traditional and biological drugs. The course will follow the process of drug development, taking the drug substance through the process of becoming a drug product, and then into clinical development and commercialization. The key steps by which the drugs are formulated, characterized, manufactured, and advanced through the regulatory pathway toward marketing authorization will be examined and analyzed.
After completing this course, students should have
(1) A fundamental knowledge of the drug development process that takes a potential active drug substance through the various stages of development to the final GMP manufactured product, and the decisions that need to be made through the process.
(2) A fundamental understanding of the differences between traditional drugs and biological drugs and how these differences affect the regulatory approval strategies when taking the drug through the development stages.
(3) Comprehension of the methodologies used in preclinical development, formulation, clinical characterization, and manufacturing of drugs.
(4) A broad overview of improved outcome products for therapies utilizing drug delivery systems.