Parkville Second semester 2008 (Day)
Pharmacokinetics of intravenous and oral administrations. One compartment pharmacokinetics. Two compartment pharmacokinetics. Hepatic clearance. Renal clearance. Non-compartmental methods. Biopharmaceutics. Structure and properties of membranes. Mechanisms of drug transfer across membranes. Effect of ionisation. pH partition hypothesis. Pre-systemic clearance. Bioavailability. Bioequivalence. Dosage form performance tests. In Vitro, In-vivo correlations.
Students will develop an understanding of:
Principles outlined in the syllabus in relation to oral drug delivery, biopharmaceutics and pharmacokinetics of intravenous and oral drug administrations;
Theoretical and practical issues of assessment of drug bioavailability and bioequivalence, the design of bioavailability and bioequivalence studies both in terms of regulatory requirements and also in terms of their ability to critically evaluate literature-based information sources.
Various factors affecting bioavailability including dose form issues, regional absorption, metabolic events and how these issues can be addressed during bioavailability/bioequivalence testing.
2.5 hour examination (100%)
34 hours of lectures, 5 three-hour workshops and 1 one-hour tutorial.
Successful completion of this unit will require participants to allocate an average of 6 hours per week for 12 weeks (a total of 78 hours per study period).