UnitLevel 5Postgraduate

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 periodCampusMode
First semesterMalaysiaOn campus
First semesterParkvilleOn campus

Assessment

  • Online quizzesQuiz / Test
    40%
  • Formulation ReportPresentation
    20%
  • Clinical Trials ReportWritten
    20%
  • Medicine Registration ReportWritten
    20%

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. 1

    Compare and contrast properties and characteristics of selected essential pharmaceutical forms

  2. 2

    Suggest and evaluate formulation approaches for drugs based on their physicochemical properties, physiological factors and medical considerations

  3. 3

    Rationally choose and defend a pharmaceutical form to create a medicine

  4. 4

    Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product

  5. 5

    Differentiate between the phases of a clinical trial, and use exemplars to describe outcomes that indicate success or failure through each phase

  6. 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. 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.

More details

Credit points
6
Level
5
Study level
Postgraduate
Faculty
Faculty of Pharmacy and Pharmaceutical Sciences
Type
Coursework
EFTSL
0.125
Student contribution
SCA Band 2
Study abroad
Not available
Handbook years
202220232024202520262027