6 points, SCA Band 2, 0.125 EFTSL
Undergraduate - Unit
Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.
Faculty
Pharmacy and Pharmaceutical Sciences
Chief examiner(s)
Coordinator(s)
Unit guides
Synopsis
This unit will take students through the process of developing a drug candidate into a registered pharmaceutical product. This encompasses: pre-clinical development, including drug formulation based on the pharmacokinetic, pharmacodynamic and toxicological profile of a drug candidate; clinical trial regulation and design; intellectual property and marketing considerations. Students will be introduced to the regulatory and commercial requirements as well as the scientific concepts underpinning the drug development processes.
Outcomes
After completing this unit students will be able to:
- Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product.
- Design and conduct pre-formulation tests to inform formulation decisions.
- Evaluate formulation options for a drug candidate with regard to medical, technical and commercialisation considerations.
- Propose pre-clinical tests for a drug candidate to provide evidence for its safety.
- Differentiate between the phases of a clinical trial.
- Discuss the commercial lifecycle of a pharmaceutical product, the importance of intellectual property and marketing considerations.
Assessment
End-of-semester examination (50%) and in-semester assessment (50%)
Workload requirements
- Twenty-four 1-hour lectures
- Six 4-hour laboratories
- Six 2-hour workshops
See also Unit timetable information