Drug Development 1

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

Assessing drug safety, Investigational New Drug (IND) application, and the design and evaluation of ‘first time in man’ studies; clinical imaging for drug development; formulating medicines for clinical development; Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP); 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; incorporating preclinical knowledge; 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; the costs of drug development.

Textbook(s)

Raymond G. Hill and Duncan B. Richards 2020, 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

Corequisite(s)

Nil

Teaching method

Component	Duration
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

Presentation, Report, Skills demonstration, 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.