Course Description
Introduces students to the basic scientific concepts and policies that guide drug discovery and development. The course starts with the roles and responsibilities of various scientists critical to this process, including dosage forms, complementary therapies, biologics, vaccines, how drug targets are prioritized, and how they are manufactured.
Additional Requirements for Graduate Students:
Graduate students will be assigned a contemporary topic beyond the typical content of the course. They will have to
independently research this topic and prepare an informative lecture on this topic for the class.
Athena Title
Intro to Pharm Industry
Non-Traditional Format
This course will be taught 95% or more online.
Semester Course Offered
Offered summer semester every year.
Grading System
A - F (Traditional)
Course Objectives
• Understand the path of the therapeutic discovery/development along with the regulatory and patient care development steps necessary to bring a therapeutic to the bedside. • Define the roles of various scientists involved with drug discovery and development. • Describe the different types of dosage forms and routes of administration that are currently used. • Understand the preclinical evaluation of a new chemical entity and how decisions are made as to which compounds will move to human testing. • Understand the clinical trials process and decision-making that takes place in clinical trials. • Compare the approval process for generic drugs versus biosimilars.
Topical Outline
• Introduction to the Pharmaceutical Industry: Big Pharma, Biotech Companies, and Academia • Medicinal Chemists, Pharmacologists, Toxicologists, Pharmaceutical Scientists, Pharmacokineticists, and Statisticians: What do they do in drug discovery/development? • Complementary Medicine, standard dosage forms, biologics, and vaccines • Preclinical Testing: In vitro screening, toxicology studies, animal disease models, pharmacokinetic studies • Clinical Trials: What is accomplished in each phase? • Generics versus Biosimilars • Personalized medicine: How does it impact healthcare? • Role of the FDA in the drug approval process
Syllabus
Public CV