04. Drug Development

Sheila A Doggrell

Discipline of Medical Sciences, Faculty of Science and Technology, Queensland University of Technology, Gardens Point, GPO Box 2434, QLD 4001, Australia

Phone +61 7 38705741 Fax +61 7 31381534 Email sheila.doggrell@qut.edu.au

Reviewer required

Key words: drug development, preclinical drug discovery, pharmacological profiling, safety and toxicity, clinical trials, ethics in clinical trials, clinical trial design, Phases in clinical trials, Therapeutics Goods Administration, Pharmaceutical Benefits Scheme

Contents

4. Drug development

4.1 Preclinical drug discovery

4.2 Pharmacological profiling

4.3 Safety and toxicity

4.4 Clinical trials – introduction

4.5 Ethics in clinical trials

4.6 Clinical trials design

4.7 Phases in clinical trials

4.8 Therapeutics Goods Administration

4.9 Pharmaceutical Benefits Scheme

Drug development

From some of the sensational reporting about medicines, you might expect medicine development to be haphazard with little regard for the safety of animals or humans. This is not in fact the case. Drug development is precisely regulated and has regard for animals and humans. A general understanding of the processes of drug development should dispel many myths about drug development.

Why are drugs developed? Drugs are developed so that we can turn fatal or non-fatal diseases into a routine therapeutic exercise (Figure 4.1).

Figure 4.1 The reason for drug development (Copyright QUT, Sheila Doggrell)

For instance, before the development of anti-hypertensive drugs, hypertension was a fatal disease with people dying in a year or two of developing high blood pressure. Now, millions of people with hypertension are successfully managed long term with anti-hypertensive drugs.

Drug development is divided into preclinical and clinical drug development.