SmartSellTM - The New Way to Sell Online

We won't be beaten by anyone. Guaranteed

Global New Drug Development
By

Rating

Product Description
Product Details

Table of Contents

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

About the Author

Jan A. Rosier, Professor, Faculty of Pharmaceutical Sciences, University of Leuven/Cranfield, School of Management. Mark Martens, Belgium; Toxicologist. Josse Thomas, Belgium; Guest Profrssor Leuven and Universite de Liege, Belgium).

Ask a Question About this Product More...
Write your question below:
Look for similar items by category
Home » Books » Science » Medical » Pharmacy
How Fishpond Works
Fishpond works with suppliers all over the world to bring you a huge selection of products, really great prices, and delivery included on over 25 million products that we sell. We do our best every day to make Fishpond an awesome place for customers to shop and get what they want — all at the best prices online.
Webmasters, Bloggers & Website Owners
You can earn a 5% commission by selling Global New Drug Development: An Introduction (Postgraduate Pharmacy Series) on your website. It's easy to get started - we will give you example code. After you're set-up, your website can earn you money while you work, play or even sleep! You should start right now!
Authors / Publishers
Are you the Author or Publisher of a book? Or the manufacturer of one of the millions of products that we sell. You can improve sales and grow your revenue by submitting additional information on this title. The better the information we have about a product, the more we will sell!
Item ships from and is sold by Fishpond Retail Limited.
Back to top