University of Technology, Sydney

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96014 Molecule to Market

6cp; 1 x 2hpw (lecture), 2 x 2hpw (workshop)
Requisite(s): 96009 Professional Services 3 AND 96010 Integrated Therapeutics 2 AND 96011 Primary Health Care
These requisites may not apply to students in certain courses.
There are course requisites for this subject. See access conditions.

Description

This subject covers the drug development process from laboratory to patient – a high risk, high cost but high reward process. One in 10,000 screened compounds makes it to market. The subject outlines the stages of the pharmaceutical research and development of a drug. The process begins with drug discovery that can take five years in assessing 10,000 compounds. Of these 10,000 compounds, 250 are subject to pre-clinical studies that can take upwards of two years. Of these 250 compounds, only five make it to clinical trials, which can take six years. This includes phase 1 to phase 3 efficacy and safety clinical studies. Of these five compounds, it is likely only one will have the necessary chemistry, pre-clinical and clinical data for a regulatory dossier to be compiled and submitted to the Therapeutic Goods Administration (TGA) in Australia. The TGA is responsible for evaluating the efficacy, safety and quality of new drugs. Access to subsidised medicines for patients involves product registration via the TGA and pricing reimbursement via the Pharmaceutical Benefits Advisory Committee (PBAC). This subject also outlines what is involved in successfully registering a medicine and listing it with the Pharmaceutical Benefits Scheme (PBS).

Typical availability

Spring session, City campus


Detailed subject description.

Access conditions

Note: The requisite information presented in this subject description covers only academic requisites. Full details of all enforced rules, covering both academic and admission requisites, are available at access conditions and My Student Admin.