ALS 333: Pharmaceutical Development
Course Number: ALS 333
Course Name: Pharmaceutical Development
Year: First-year
Semester: Fall
No. Units: .5
Faculty/Instructor(s): Larry Grill
Description
This course follows course ALS 330 and together these course are designed to provide an understanding of how pharmaceutical and biotechnology companies discover, develop, and bring drugs to market. This course will focus on the development of drugs. The course will follow the process of pharmaceutical 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.
This book is not required, but is very good for providing overview & background. It costs $72 on Amazon.com, and is a book that might easily be shared among a few students to provide a useful supplemental text.
Topics Covered
- Regulatory Applications: IND
- Active Pharmaceutical Ingredients (API), GRAS excipients, Pharmacopeia
- Small Molecule Formulation and Product Characterization
- GMP, Contract Manufacturing
- GCP, Clinical Trials
- Regulatory Applications: NDA, ANDA
- Case Study: Rise and Fall of the COX-2 Inhibitors
- Post-marketing Phase, Drug Advertising
- Drug delivery systems (oral, pulmonary, injectable, needle-less injectors, device based)
Learning Objectives
After completing this course, students should have
(1) A fundamental knowledge of the drug discovery and development process, including scientific challenges and management issues that arise during the key phases of pharmaceutical discovery; product development and regulatory approval processes;
(2) Comprehension of the methodologies used in the discovery, preclinical development, formulation, clinical characterization, and manufacturing of drugs;
(3) An understanding of the regulatory pathways used to register drugs in the United States;
(4) A broad overview of improved outcome products for therapies utilizing drug delivery systems.
Required Texts