PHARMACEUTICAL INNOVATION AND DRUG DEVELOPMENT

Catalog description

This course will introduce 4th year undergraduates and 1st or 2nd year graduate students to the principles and methodologies used in pharmaceutical drug development through lectures, scientific readings, case study analyses and class discussions. The course covers the range of drug development activities from target product profile, pharmacokinetics, pre-clinical and clinical safety, as well as the objectives of each phase of the drug development process encountered in the pharma, biotech and agriculture sectors as applied to New Chemical Entities (NCEs) and Novel Biologic Agents (NBAs). Regulatory requirements and marketing considerations will also be discussed with regard to clinical outcomes in Phases III and IV as well as post launch surveillance for toxicity. This course provides an introduction to the necessary training, knowledge, logic and steps for successful approval of a drug, including the ethical, conflict of interest and intellectual property issues involved in the process.