Faculty of Pharmacy and Pharmaceutical Sciences

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Monash University Handbook 2010 Undergraduate - Unit

3 points, SCA Band 0 (NATIONAL PRIORITY), 0.0625 EFTSL

FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville Second semester 2010 (Day)
Coordinator(s)Dr Michelle McIntosh


The overall aim of this unit is to provide students with a knowledge and appreciation of the steps taken to develop a drug from design or discovery to a pharmaceutical product and to present an overview of the pharmaceutical industry and its peak organisations and associations.

This will involve the study of:

  • Target Identification
  • Identification or discovery of new drug candidates
  • Biopharmaceutical Assessment
  • Toxicological Assessment
  • Process Development and Manufacturing
  • Clinical Testing
  • Drug Regulation and Registration, Overiew of the Pharmaceutical Industry, and Promotion of Pharmaceuticals in Australia


At the end of this unit students will be able to:

  1. Describe what is meant by drug target selection and validation.
  2. Explain broadly the different approaches by which drugs are identified or discovered and the advantages/disadvantages of each approach.
  3. Discuss the relationship between basic physicochemical properties and pharmacokinetic processes and how this information is used in drug discovery.
  4. Describe the stages of toxicological assessment .
  5. Discuss the need for a quality system in the manufacturing of pharmaceuticals and the role of Good Manufacturing Practices.
  6. Describe briefly the process of clinical development.
  7. Briefly describe the role fo the TGA and its responsibilities in ensuring the safe, efficacy, and quality of medicines available in Australia.
  8. Discuss the manner in which new drug products are priced in Australia and the main bodies which are associated with this task.


Final exam (3 hour): 80%; 2 mid-semester exams: 10% each.

Chief examiner(s)

Dr Michelle McIntosh

Contact hours

27 hours of lectures, 12 hours of online self-assessment tasks.


all 3rd year Bachelor of Pharmacy units

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