Course overview
The aim of this course is to provide an understanding of the scientific and regulatory aspects of each phase of the drug development pathway, and the role they play in bringing new drugs to the market. Overview of the drug development process; drug screening; in vitro pharmacology models; preclinical pharmacology and toxicology studies; pharmacokinetic/pharmacodynamic evaluation; allometric scaling; first-in-human clinical trials; study design; clinical trial conduct; ethical considerations in drug development; regulatory frameworks governing drug development studies.
Course learning outcomes
- Describe the pathway from molecule identification to drug approval.
- Demonstrate an understanding of the design and analysis of preclinical studies to support drug development.
- Evaluate and interpret preclinical study data to support progression to clinical trials.
- Describe the concepts underpinning clinical trial design and conduct.
- Demonstrate an ability to work within the ethical, regulatory and governance requirements for the conduct of clinical trials.