Global New Drug Development – An Introduction

<p>Series Foreword ix<br /> <br /> Preface xi<br /> <br /> Acknowledgement xiii<br /> <br /> Abbreviations xv<br /> <br /> Introduction xxi<br /> <br /> 1 Drug Life Cycle 1<br /> <br /> 1.1 Introduction 1<br /> <br /> 1.2 Drivers of the search for a new drug 2<br /> <br /> 1.3 Structure of a drug life cycle 5<br /> <br /> 1.4 Costs and risks of drug research and development 6<br /> <br /> 1.5 Risk of drug R&amp;D 7<br /> <br /> 1.6 Value for patient and society 9<br /> <br /> 1.7 The end of a drug s life 9<br /> <br /> 1.8 Management 10<br /> <br /> References 10<br /> <br /> 2 Drug Discovery and Design 13<br /> <br /> 2.1 Introduction 13<br /> <br /> 2.2 Approaches in drug discovery 14<br /> <br /> 2.3 The drug discovery process 17<br /> <br /> References 21<br /> <br /> 3 Drug Development: General Aspects 23<br /> <br /> 3.1 Introduction 23<br /> <br /> 3.2 The objective of drug development 23<br /> <br /> 3.3 Drug development organisations and teams 24<br /> <br /> 3.4 Drug development streams 27<br /> <br /> 3.5 Phases in drug development 36<br /> <br /> 3.6 Regulatory environment 44<br /> <br /> 3.7 Quality management 58<br /> <br /> 3.8 Project risk management 75<br /> <br /> 3.9 Ethical considerations 79<br /> <br /> References 88<br /> <br /> 4 Methods and Techniques Used in Drug Development 91<br /> <br /> 4.1 Introduction 91<br /> <br /> 4.2 Chemical and pharmaceutical development 91<br /> <br /> 4.3 Non–clinical development 106<br /> <br /> 4.4 Clinical development 139<br /> <br /> References 166<br /> <br /> 5 The Early Development of a New Drug 169<br /> <br /> 5.1 Introduction 169<br /> <br /> 5.2 Preclinical phase 170<br /> <br /> 5.3 Clinical phase 200<br /> <br /> References 251<br /> <br /> 6 The Late Development of a New Drug 253<br /> <br /> 6.1 Introduction 253<br /> <br /> 6.2 Pre–approval development 254<br /> <br /> 6.3 Marketing authorisation 316<br /> <br /> 6.4 Post–approval development 328<br /> <br /> References 347<br /> <br /> 7 Special Drug Developments 351<br /> <br /> 7.1 Introduction 351<br /> <br /> 7.2 Development of orphan drugs 351<br /> <br /> 7.3 Paediatric drug development 354<br /> <br /> 7.4 Geriatric drug development 356<br /> <br /> 7.5 Development of fixed–dose drug combinations 358<br /> <br /> 7.6 Other special drug developments 360<br /> <br /> References 360<br /> <br /> 8 Drug Commercialisation 361<br /> <br /> 8.1 Introduction 361<br /> <br /> 8.2 Market access 363<br /> <br /> 8.3 Pharmaceutical marketing 370<br /> <br /> 8.4 Independent drug information 382<br /> <br /> 8.5 Rational use of medicines 383<br /> <br /> References 384<br /> <br /> Epilogue 387<br /> <br /> Index 391</p>