Drug Development

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)

Corequisite(s)

Nil

Teaching method

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)
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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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* 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.