Global New Drug Development

The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "e;This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely."e; Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)

The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market.This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious."This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely."Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)

Series Foreword ixPreface xiAcknowledgement xiiiAbbreviations xvIntroduction xxi1 Drug Life Cycle 11.1 Introduction 11.2 Drivers of the search for a new drug 21.3 Structure of a drug life cycle 51.4 Costs and risks of drug research and development 61.5 Risk of drug R&D 71.6 Value for patient and society 91.7 The end of a drug's life 91.8 Management 10References 102 Drug Discovery and Design 132.1 Introduction 132.2 Approaches in drug discovery 142.3 The drug discovery process 17References 213 Drug Development: General Aspects 233.1 Introduction 233.2 The objective of drug development 233.3 Drug development organisations and teams 243.4 Drug development streams 273.5 Phases in drug development 363.6 Regulatory environment 443.7 Quality management 583.8 Project risk management 753.9 Ethical considerations 79References 884 Methods and Techniques Used in Drug Development 914.1 Introduction 914.2 Chemical and pharmaceutical development 914.3 Non-clinical development 1064.4 Clinical development 139References 1665 The Early Development of a New Drug 1695.1 Introduction 1695.2 Preclinical phase 1705.3 Clinical phase 200References 2516 The Late Development of a New Drug 2536.1 Introduction 2536.2 Pre-approval development 2546.3 Marketing authorisation 3166.4 Post-approval development 328References 3477 Special Drug Developments 3517.1 Introduction 3517.2 Development of orphan drugs 3517.3 Paediatric drug development 3547.4 Geriatric drug development 3567.5 Development of fixed-dose drug combinations 3587.6 Other special drug developments 360References 3608 Drug Commercialisation 3618.1 Introduction 3618.2 Market access 3638.3 Pharmaceutical marketing 3708.4 Independent drug information 3828.5 Rational use of medicines 383References 384Epilogue 387Index 391