Drug Development

Course aim

To provide a comprehensive understanding of the major phases of drug development and to develop skills in the design and evaluation of such a program for a new drug.

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 1005	Pharmaceutical Industry
PHAR 2010	Drug Discovery

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

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

Assessment

Examination, Group assignment, Test

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.