BPS2042 - Drug development - 2019

6 points, SCA Band 2, 0.125 EFTSL

Undergraduate - Unit

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.


Pharmacy and Pharmaceutical Sciences

Chief examiner(s)

Dr Ben Boyd


Dr Ben Boyd

Unit guides



  • Second semester 2019 (On-campus)


BPS1032 Physical chemistry II: Solutions, surfaces and solids

BPS1042 Pharmaceutical Science in context


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.


After completing this unit students will be able to:

  1. Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product.
  2. Design and conduct 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.


End-of-semester examination (50%) and in-semester assessment (50%)

Workload requirements

  • Twenty-four 1-hour lectures
  • Six 4-hour laboratories
  • Six 2-hour workshops

See also Unit timetable information

Additional information on this unit is available from the faculty at: