The Textbook of Pharmaceutical Medicine

Contributors
 
The editors
 
Acknowledgements
 
List of abbreviations
 
Preface
 
Part I Research and development
 
1 Discovery of new medicines
Yves J. Ribeill
 
2 Pharmaceutical development
Michael Gamlen and Paul Cummings
 
3 Preclinical safety testing
Lutz Müller and Elisabeth Husar
 
4 Exploratory development
John Posner
 
5 Clinical pharmacokinetics
Paul Rolan and Valéria Molnár
 
6 Biological therapeutics
Peter Lloyd and Jennifer Sims
 
7 Objectives and design of clinical trials
John Posner and Steve Warrington
 
8 Conduct of clinical trials: Good Clinical Practice
Kate L.R. Darwin
 
9 Medical statistics
Andrew P. Grieve
 
10 Development of medicines: full development
Peter D. Stonier
 
11 Pharmacovigilance
Stephen F. Hobbiger, Bina Patel and Elizabeth Swain
 
12 Vaccines
John Beadle
 
13 Drugs for cancer
James Spicer and Johann De Bono
 
14 Ethics of human experimentation
Jane Barrett
 
15 Drug development in paediatrics and neonatology
Nazakat M. Merchant and Denis V. Azzopardi
 
16 Due diligence and the role of the pharmaceutical physician
Geoffrey R. Barker
 
Part II Regulation
 
17 A history of drug regulation in the UK
John P. Griffin
 
18 The Clinical Trials Directive
Fergus Sweeney and Agnès Saint Raymond
 
19 Human medicinal products in the European Union: Regulations, Directives and structures
Agnès Saint Raymond and Anthony J. Humphreys
 
20 Human medicinal products in the European Union: Procedures
Agnès Saint Raymond and Anthony J. Humphreys
 
21 European regulation of medical devices
Shuna Mason
 
22 Paediatric regulation
Heike Rabe and Agnès Saint-Raymond
 
23 Technical requirements for registration of pharmaceuticals for human use: The ICH process
Dean W.G. Harron
 
24 The regulation of drug products by the US Food

"This book is expected to be useful for pharmaceutical physicians and for anyone interested in learning about the various issues in drug discovery and development. In addition to many other topics, the regulatory aspects of drug development in the U.S., Europe, and Japan are well covered ... Nevertheless, this is an admirable effort and the book deserves a place on the bookshelves of pharmaceutical physicians. " ( Doody's , 30 August 2013)

"This comprehensive volume covers the processes by which medicines are developed, tested and approved. The chapters are written by leading academics, medical directors and legal experts in the field of harmaceutical medicine and provide authorative and in-depth information for both physicians working in and those who are currently training in the pharmaceutical industry." (British Journal of Clinical Pharmacology, 22 April 2014)
 
"This book is expected to be useful for pharmaceutical physicians and for anyone interested in learning about the various issues in drug discovery and development. In addition to many other topics, the regulatory aspects of drug development in the U.S., Europe, and Japan are well covered . . . Nevertheless, this is an admirable effort and the book deserves a place on the bookshelves of pharmaceutical physicians. " (Doody's, 30 August 2013)