MPS5104 Drug formulation, clinical trials and registration
Faculty of Pharmacy and Pharmaceutical Sciences
MPS5104 Drug formulation, clinical trials and registration is a level 5, 6-credit-point, postgraduate unit from the Faculty of Pharmacy and Pharmaceutical Sciences, offered in 2027 in Semester 1 at Malaysia and Parkville. It has no prerequisites.
- Credit points
- 6
- Offered in 2027
- Semester 1
- Malaysia, Parkville
- Assessment
- No exam
- 4 tasks
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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 in 2027
| Teaching period | Campus | Mode |
|---|---|---|
| First semester | Malaysia | On campus |
| First semester | Parkville | On campus |
Assessment
- Online quizzesQuiz / Test40%
- Formulation ReportPresentation20%
- Clinical Trials ReportWritten20%
- Medicine Registration ReportWritten20%
Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.
Learning outcomes
When you finish this unit, you should be able to:
- 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 and teaching
- Assessments4.5 hours
- Workshops18 hours
- Teaching approachPeer assisted learning
- Teaching approachCase-based teaching
- Teaching approachEnquiry-based learning
- Teaching approachSimulation or virtual practice
- Teaching approachActive learning
- 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
Learning resources
Technology resources
This unit requires access to a laptop that meets minimum specifications. Free specialist software is available via MoVE.
Contacts
- Unit Coordinators
- Associate Professor Celine Liew
- Dr Narges Mahdavian
- Chief Examiners
- Yassmin Samak
Common questions
What are the prerequisites for MPS5104?
MPS5104 has no prerequisites.
When is MPS5104 offered?
In 2027, MPS5104 runs in Semester 1 at Malaysia and Parkville.
Does MPS5104 have an exam?
No. MPS5104 has 4 assessment tasks and no exam.