Monash University Handbook 2011 Undergraduate - Unit

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

Synopsis

This unit will provide students with a detailed understanding of the specific biopharmaceutical and formulation considerations for non-oral drug delivery routes, including transdermal, pulmonary, nasal, buccal, rectal, vaginal, ocular, intramuscular and subcutaneous.

The unit will also address advanced oral drug delivery technologies and targeted drug delivery systems.

The unit will provide students with an opportunity to apply their knowledge of pharmaceutics and further develop skills in evaluating scientific literature and preparing professional written reports.

The unit will explain the drug development process for novel therapeutic agents and generic drugs. These processes will be illustrated through the presentation of several case studies. Case studies will also be presented to highlight the importance of good manufacturing practices and quality assurance in the pharmaceutical industry.

Objectives

1. The biopharmaceutical barriers to effective drug delivery various routes of drug delivery
2. The formulation approaches that can be employed to overcome the biopharmaceutical barriers to effective drug delivery via various routes of drug delivery
3. The advantages and disadvantages of various routes of delivery
4. Situations when one route of delivery is preferred over another route of drug delivery
5. The need for a quality system in the manufacturing of pharmaceuticals and
6. The process for drug registration for a generic formulation compared to a novel therapeutic drug
7. Phase I, II and III clinical trials

Assessment

group assignments: 25%; on-line quizzes: 10%; final exam (3 hour): 65%

Chief examiner(s)

Dr Michelle McIntosh

Contact hours

72 hours of formal study per semester (36 hours of lectures, 2 x 3 hour tutorials, self-directed learning).

Prerequisites

PAC3241 and PAC3252

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

http://www.monash.edu.au/muso/support/