MPS5104 · Drug formulation, clinical trials and registration

Overview

This unit will take you through the process of developing a drug candidate into a registered pharmaceutical product and beyond. Once a lead candidate has been identified, the drug development pathway encompasses drug formulation; clinical trial regulation and design; intellectual property and marketing considerations. You will be introduced to the regulatory and commercial requirements of drug registration and analyse real-life drug development cases. Upon completing this unit, you will have gained an appreciation of the interdependent components of the drug development and registration process.

Offerings

Assessment

The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

The Handbook lists no prerequisite, corequisite or prohibition for this unit.

Learning outcomes

1. Compare and contrast properties and characteristics of selected essential pharmaceutical forms
2. Suggest and evaluate formulation approaches for drugs based on their physicochemical properties, physiological factors and medical considerations
3. Rationally choose and defend a pharmaceutical form to create a medicine
4. Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product
5. Differentiate between the phases of a clinical trial, and use exemplars to describe outcomes that indicate success or failure through each phase
6. Define the factors that underpin commercial success of a medicine, including the importance of intellectual property and marketing considerations, and surveillance of consumer outcomes
7. Use effective teamwork and collaborative skills to write effective formulation, clinical trials and medicine registration reports that follow conventions in the discipline

Workload

• Twelve 2-hour online modules • Nine 2-hour workshops • Three 1.5-hour in-class assessments • 60 hours of team-based collaborative work • 37 hours independent study

Student experience, not official rules. Nothing here changes what the Handbook says.