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 2021 in Semester 2 at Parkville. It needs BPS1042 and BPS1032.
- Credit points
- 6
- Offered in 2021
- Semester 2
- Parkville
- Assessment
- Exam 50%
- and 2 other tasks
This is the 2021 handbook entry. See the 2027 entry.
Reviews
No reviews yetNo reviews yet. Be the first to review BPS2042.
Requisites
Before BPS2042
Prerequisites
Pass these before you enrol.
After BPS2042
No unit lists BPS2042 as a prerequisite in the 2021 handbook.
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.
Offerings in 2021
| Teaching period | Campus | Mode |
|---|---|---|
| Second semester | Parkville | On campus |
Assessment
- Online quizzesOtherThreshold hurdle15%
- Group PresentationPresentationThreshold hurdle35%
- ExamThreshold hurdle50%
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
- Workshops24 hours
- Lectures24 hours
- Applied sessions12 hours
- Teaching approachCase-based teaching
- Teaching approachActive learning
- Twelve 1-hour online preparation modules (Discovery)
- Twenty-four 1-hour interactive lectures (online modules)
- Twelve 1-hour applied sessions (Q&A)
- Twelve 2-hour workshops
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
- Professor Michelle McIntosh
- Chief Examiners
- Professor Michelle McIntosh