UnitLevel 2Undergraduate

BPS2042 Drug development

Faculty of Pharmacy and Pharmaceutical Sciences

BPS2042 Drug development is a level 2, 6-credit-point, undergraduate unit from the Faculty of Pharmacy and Pharmaceutical Sciences, offered in 2027 in Semester 2 at Malaysia and Parkville. It needs BPS1011, BPS1012, BPS1021, BPS1022, BPS1031, BPS1032, BPS1041 and BPS1042 and unlocks 13 units.

Credit points: 6
Offered in 2027: Semester 2; Malaysia, Parkville
Assessment: No exam; 4 tasks

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Requisites

Before BPS2042

Prerequisites

Pass these before you enrol.

All of

After BPS2042

13 units list BPS2042 as a prerequisite or corequisite.

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Overview

This unit will take you 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. You will be introduced to the regulatory and commercial requirements as well as the scientific concepts underpinning the drug development processes. This unit also explores a range of career paths available in the pharmaceutical industry.

Offerings in 2027

Teaching period	Campus	Mode
Second semester	Malaysia	On campus
Second semester	Parkville	On campus

Assessment

Online quizzesQuiz / Test
50%
Careers AssignmentWritten
10%
Ethics AssignmentWritten
20%
Group PresentationPresentation
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
Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product.
2
Explain the basis of pre-formulation tests to inform formulation decisions.
3
Evaluate formulation options for a drug candidate with regard to medical, technical and commercialisation considerations.
4
Propose pre-clinical tests for a drug candidate to provide evidence for its safety.
5
Differentiate between the phases of a clinical trial.
6
Discuss the commercial lifecycle of a pharmaceutical product, the importance of intellectual property and marketing considerations.
7
Identify and describe a range of jobs that exist in the pharmaceutical industry.

Workload and teaching

Workshops26 hours
Applied sessions12 hours
Teaching approachCase-based teaching
Teaching approachActive learning

Twelve 1-hour online preparation modules (Discovery)
Twenty-four 1-hour interactive online modules
Twelve 1-hour applied sessions (Q&A)
Eleven 2-hour workshops
One 4-hour workshop (GMP)

Workshops will use primarily group work to work through case studies in different aspects of the drug development process

Learning resources

Technology resources

For more information on Bring Your Own Device (BYOD) specifications and the technology systems and services available to students, review the Student Technology Essentials Handbook https://www.monash.edu/__data/assets/pdf_file/0010/1041220/student-it-brochure.pdf

Contacts

Unit Coordinators: Dr Nagashekhara Molugulu; Showmika Supti
Chief Examiners: Showmika Supti

Common questions

What are the prerequisites for BPS2042?

You need BPS1011, BPS1012, BPS1021, BPS1022, BPS1031, BPS1032, BPS1041 and BPS1042 before you enrol.

What can I take after BPS2042?

BPS2042 is a prerequisite or corequisite for 13 units, including BPS3011, BPS3012, BPS3021, BPS3022, BPS3031 and BPS3032.

When is BPS2042 offered?

In 2027, BPS2042 runs in Semester 2 at Malaysia and Parkville.

Does BPS2042 have an exam?

No. BPS2042 has 4 assessment tasks and no exam.

More details

Credit points: 6
Level: 2
Study level: Undergraduate
Faculty: Faculty of Pharmacy and Pharmaceutical Sciences

Type: Coursework
EFTSL: 0.125
Student contribution: SCA Band 2
Study abroad: Available
Handbook years: 2020 2021 2022 2023 2024 2025 20262027