Clinical Trials for Drug Development

Course aim

To provide an understanding of the scientific and regulatory aspects of each phase of the drug development pathway, and the role they play in bringing new drugs to the market.

Course content

Overview of the drug development process; drug screening; in vitro pharmacology models; preclinical pharmacology and toxicology studies; pharmacokinetic/pharmacodynamic evaluation; allometric scaling; first-in-human clinical trials; study design; clinical trial conduct; ethical considerations in drug development; regulatory frameworks governing drug development studies.

Textbook(s)

Nil

Prerequisite(s)

Nil

Corequisite(s)

Nil

Teaching method

Component	Duration
INTERNAL, CITY EAST
Workshop	3 hours x 13 weeks
Online	- x 13 weeks
Seminar	4 hours x 2 weeks

Note: These components may or may not be scheduled in every study period. Please refer to the timetable for further details.

Assessment

Technical documentation, Test/Quiz

Fees

EFTSL*: 0.125
Commonwealth Supported program (Band 2)
To determine the fee for this course as part of a Commonwealth Supported program, go to:
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Fee-paying program for domestic and international students
International students and students undertaking this course as part of a postgraduate fee paying program must refer to the relevant program home page to determine the cost for undertaking this course.

Non-award enrolment
Non-award tuition fees are set by the university. To determine the cost of this course, go to:
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Not all courses are available on all of the above bases, and students must check to ensure that they are permitted to enrol in a particular course.

* Equivalent Full Time Study Load. Please note: all EFTSL values are published and calculated at ten decimal places. Values are displayed to three decimal places for ease of interpretation.