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Area/Catalogue
PHAR 2009

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Course Level
Undergraduate

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Offered Externally
No

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Course ID
101433

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Unit Value
4.5

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University-wide elective course
No

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Timetable/s
First Semester
(Study Period 2)

Course aim

To apply prior knowledge of drug discovery in the critical evaluation of the major phases of the drug development process and be able to discuss strengths and weaknesses of a new drug program.

Course content

Overview of the aims and objectives of Phase 1, 2 and 3 of drug development; factors leading to continuance or discontinuance of drug development at each phase; the design and evaluation of ‘first time in man’ study, incorporating preclinical knowledge; formulating medicines for clinical development; evaluating the pharmacokinetics, clinical effectiveness and safety of new drugs during Phase 1-3; measuring clinical benefit and the use of surrogate markers of drug efficacy and safety; regulation of phase 1-3 studies and ethical requirements; obligations of a sponsor; modifying the formulation of a drug product during late-phase drug development, pharmaceutical issues; the costs of drug development; Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP); filing a New Drug Application (NDA); the evaluation of an NDA by the Food and Drug Administration and the Therapeutics Goods Administration; and case studies in drug development – success stories and failures.

Textbook(s)

H.P. Rang 2012, Drug Discovery and Development: Technology in Transition, Current edition, Churchill Livingstone (Elsevier)

Prerequisite(s)

Common to all relevant programs
Subject Area & Catalogue Number Course Name
PHAR 2010 Drug Discovery
PHAR 1005 Pharmaceutical Industry

Corequisite(s)

Nil

Teaching method

Component Duration
INTERNAL, CITY EAST
Lecture 1 hour x 13 weeks
Tutorial 2 hours x 13 weeks
Workshop 1 hour x 13 weeks
Practical 3 hours x 3 weeks
INTERNAL, CITY WEST
Lecture 1 hour x 13 weeks
Tutorial 2 hours x 13 weeks
Workshop 1 hour x 13 weeks
Practical 3 hours x 3 weeks

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


Assessment

Task Length Weighting Duration
INTERNAL, CITY EAST
Test - 15% 30 minutes
Group assignment Equiv 2000 words per student 50% -
Examination - 35% 2 hours
INTERNAL, CITY WEST
Test - 15% 30 minutes
Group assignment Equiv 2000 words per student 50% -
Examination - 35% 2 hours

Fees

EFTSL*: 0.1250
Commonwealth Supported program (Band 2)
To determine the fee for this course as part of a Commonwealth Supported program, go to:
How to determine your Commonwealth Supported course fee. (Opens new window)

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 Division offering the course. To determine the cost of this course, go to:
How to determine the relevant non award tuition fee. (Opens new window)

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

Course Coordinators

School of Pharmacy and Medical Sciences

Degrees this course is offered in

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