This unit of study provides a broad overview of the processes involved in translating a new pharmaceutical product from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical industry. This unit will give students the skills to understand how medicines are researched, developed and regulated. The regulatory requirements for chemistry, manufacturing and controls, pre-clinical testing including toxicity studies, and clinical testing will be discussed. Finally, the unit will examine the legal and regulatory requirements for registration of these types of products.
Unit details and rules
Academic unit | Pharmacy |
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Credit points | 6 |
Prerequisites
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None |
Corequisites
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None |
Prohibitions
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PCOL5101 |
Assumed knowledge
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None |
Available to study abroad and exchange students | Yes |
Teaching staff
Coordinator | Orin Chisholm, orin.chisholm@sydney.edu.au |
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Guest lecturer(s) | Noelia Nebot, noelia.nebot@sydney.edu.au |
Slade Matthews, slade.matthews@sydney.edu.au | |
Lecturer(s) | Philip Kwok, philip.kwok@sydney.edu.au |
Tutor(s) | Belinda Butcher, belinda.butcher@sydney.edu.au |