ALS 333: Pharmaceutical Development
Course Number: ALS 333
Course Name: Pharmaceutical Development
No. Units: 1.5
Faculty/Instructor(s): Larry Grill
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.
The course will provide the terminology, timelines and practical examples for successfully understanding the challenges in progressing an idea for a drug from the earliest discovery stages through to product approval and launch. Case studies from industry will be presented detailing companies and products that utilize state-of-the-art discovery technologies and advanced drug delivery systems. This is a science course that freely intersperses business and regulatory issues into the lectures and assignments.
Textbooks are not required, but the following are useful in the course:
DRUGS from Discovery to Approval. 2nd edition. 2009. Rick Ng. Published by John Wiley & Sons, Ltd.
Aulton's Pharmaceuticals, The Design and Manufacture of Medicines. 3rdedition. 2007, Michael E. Aulton, Published by Churchill Livingston - Elsevier.
- Descriptions of Biological Drugs and Traditional Drugs
- Active Pharmaceutical Ingredients (API), GRAS excipients, Pharmacopeia
- Drug Formulation and Product Characterization
- GMP, Contract Manufacturing
- Regulatory Applications: NDA, ANDA, BLA, and CTE
- Post-marketing Phase, Drug Advertising
- Drug delivery systems (oral, pulmonary, injectable, needle-less injectors, device based)
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.