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 2020 in Semester 2 at Parkville. It needs BPS1032 and BPS1042 and unlocks 4 units, leading on to 7 units in all.
- Credit points
- 6
- Offered in 2020
- Semester 2
- Parkville
- Assessment
- Exam 50%
- and 7 other tasks
This is the 2020 handbook entry. See the 2027 entry.
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Requisites
Before BPS2042
Prerequisites
Pass these before you enrol.
After BPS2042
4 units list BPS2042 as a prerequisite or corequisite.
Overview
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.
Offerings in 2020
| Teaching period | Campus | Mode |
|---|---|---|
| Second semester | Parkville | On campus |
Assessment
- Assessment 1: Mini-test 1 (weeks 1-4)5%
- Assessment 2: Mini-test 2 (weeks 5-8)5%
- Assessment 3: Group module submission5%
- Assessment 4: Mini-test 3 (weeks 9-12)5%
- Assessment 5: Quality Module5%
- Assessment 6: Clinical trial5%
- Assessment 7: Lab reports20%
- Assessment 8: Exam50%
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.
Workload and teaching
- Workshops18 hours
- Laboratories18 hours
- Lectures24 hours
- Teaching approachCase-based teaching
- Teaching approachActive learning
- Twenty-four 1-hour lectures
- Six 3-hour laboratories
- Six 3-hour workshops
Workshops will use primarily group work to work through case studies in different aspects of the drug development process
Laboratories will be primarily case-based teaching in 2020 with potential for limited hands on laboratory work
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
- Chief Examiners
- Dr Benjamin Boyd
- Unit Coordinators
- Dr Benjamin Boyd
Common questions
What can I take after BPS2042?
BPS2042 is a prerequisite or corequisite for 4 units, including BPS3112, BPS3212, BPS3311 and BPS3322. Those lead on to 7 units in all.
When is BPS2042 offered?
In 2020, BPS2042 runs in Semester 2 at Parkville.
Does BPS2042 have an exam?
Yes. The exam is worth 50% of the final mark, alongside 7 other tasks.