PAC4261 - Drug delivery and development - 2017

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.

This aim of this unit is to expand the student's knowledge of biopharmaceutics, pharmacokinetics and formulation considerations for a range of non-oral drug delivery routes, advanced oral drug delivery technologies and targeted drug delivery systems.

The unit will also provide students with an overview of the drug development process from pre-clinical stages through to product registration. Additionally, this unit aims to develop students' generic skills in evaluation of scientific literature, critical thinking, problem-solving, report writing, leadership and working in teams.

In this unit students will develop an appreciation of:

1. The role of the Therapeutic Goods Administration and its responsibilities in ensuring the safe, efficacy, and quality of medicines available in Australia;
2. The process of clinical drug development ;
3. The importance of Good Manufacturing Practices in the pharmaceutical industry.

   In this unit, students will develop an understanding of:

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

    In this unit students will develop skills in:

11. Analysis of pharmaceutical formulations and identification of key excipients;
12. Locating and evaluating scientific literature on pharmaceutical drug formulations;
13. Working effectively in teams;
14. Time management and meeting deadlines;
15. Writing scientific reports that reflect an understanding of the pharmaceutical and biopharmaceutical rationale behind a specific pharmaceutical formulation;
16. Preparing high quality, well formatted and presented written documents.

    Upon completion of this unit students will be able to:

    • Describe the biopharmaceutical barriers to effective drug delivery various routes of drug delivery
    • Discuss the formulation approaches that can be employed to overcome the biopharmaceutical barriers to effective drug delivery via various routes of drug delivery
    • Analyse pharmaceutical formulations and identify key excipients and describe the potential functions of the excipients in the formulation
    • Compare and contrast the advantages and disadvantages of various routes of delivery
    • Identify situations when one route of delivery is preferential to another route of delivery for a drug
    • Discuss the need for a quality system in the manufacturing of pharmaceuticals and the role of Good Manufacturing Practices
    • Explain why the process for drug registration for a generic formulation can be different to a novel therapeutic drug
    • Summarise the purpose of Phase I, II and III clinical trials
    • Describe the role of the TGA and its responsibilities in ensuring the safe, efficacy, and quality of medicines available in Australia
    • Explain the process of clinical drug development
    • Propose a rationale behind a specific pharmaceutical formulation
    • Prepare a high quality, well formatted and presented written document.

Final exam (2.5 hour):60%; within semester assessment 30%, which consists of individual and group assignment work, online quizzes 10%.

Contact hours for on-campus students:

• Twenty 1-hour lectures
• Two 3-hour workshops
• Twenty hours of individual and group project
• Twenty four hours of self-study topics

See also Unit timetable information

Dr Suzanne Caliph

PAC3241

PAC3252

http://www.monash.edu/pharm/current/