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Textbook of Pharmaceutical Medicine
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Main description:

The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine.


This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine.


Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine.


The text breaks down into three core sections:


Part I: Research and Development
Part II: Regulation
Part III: Healthcare marketplace

View Table of Contents in detail


Contents:

Contributors vii


The editors x


Acknowledgements xiii


List of abbreviations xiv


Preface xix


Part I Research and development 1


1 Discovery of new medicines 3
Yves J. Ribeill


2 Pharmaceutical development 32
Michael Gamlen and Paul Cummings


3 Preclinical safety testing 42
Lutz Müller and Elisabeth Husar


4 Exploratory development 82
John Posner


5 Clinical pharmacokinetics 113
Paul Rolan and Valéria Molnár


6 Biological therapeutics 132
Peter Lloyd and Jennifer Sims


7 Objectives and design of clinical trials 143
John Posner and Steve Warrington


8 Conduct of clinical trials: Good Clinical Practice 155
Kate L.R. Darwin


9 Medical statistics 189
Andrew P. Grieve


10 Development of medicines: full development 219
Peter D. Stonier


11 Pharmacovigilance 235
Stephen F. Hobbiger Bina Patel and Elizabeth Swain


12 Vaccines 254
John Beadle


13 Drugs for cancer 270
James Spicer and Johann De Bono


14 Ethics of human experimentation 286
Jane Barrett


15 Drug development in paediatrics and neonatology 295
Nazakat M. Merchant and Denis V. Azzopardi


16 Due diligence and the role of the pharmaceutical physician 306
Geoffrey R. Barker


Part II Regulation 317


17 A history of drug regulation in the UK 319
John P. Griffin


18 The Clinical Trials Directive 347
Fergus Sweeney and Agnès Saint Raymond


19 Human medicinal products in the European Union: Regulations Directives and structures 360
Agnès Saint Raymond and Anthony J. Humphreys


20 Human medicinal products in the European Union: Procedures 379
Agnès Saint Raymond and Anthony J. Humphreys


21 European regulation of medical devices 418
Shuna Mason


22 Paediatric regulation 435
Heike Rabe and Agnès Saint–Raymond


23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447
Dean W.G. Harron


24 The regulation of drug products by the US Food and Drug Administration 461
Peter Barton Hutt


25 The US FDA in the drug development evaluation and approval process 501
Richard N. Spivey Judith K. Jones William Wardell and William W. Vodra


26 Future prospects of the pharmaceutical industry and its regulation in the USA 518
Richard N. Spivey William W. Vodra Judith K. Jones and William Wardell


27 Regulatory and clinical trial systems in Japan 537
Mamiko Satake and Natsuko Hosoda


28 The regulation of therapeutic products in Australia 554
Elizabeth de Somer Deborah Monk and Janice Hirshorn


Part III Health care marketplace 587


29 An Introduction to life cycle management of medicines 589
David Gillen


30 Availability of medicines online and counterfeit medicines 597
Ruth Diazaraque and David Gillen


31 The supply of unlicensed medicines for individual patient use 610
Ian Dodds–Smith and Ewan Townsend


32 Legal and ethical issues relating to medicinal products 632
Nick Beckett Sarah Hanson and Shuna Mason


33 Medical marketing 653
David B. Galloway and Bensita M.V. Thottakam


34 Information and promotion 670
Charles De Wet


35 Economics of health care 692
Carole A. Bradley and Jane R. Griffin


36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons 707
John P. Griffi n and Geoffrey R. Barker


37 Pharmaceutical medicine in the emerging markets 728
Nadarajah Sreeharan Jennie A. Sykes and Richard B. Nieman


38 Biosimilars 744
Raymond A. Huml and John Posner


Appendix 1 Declaration of Helsinki 751


Appendix 2 Agreements and Guidelines for Implementation of Clinical Trials 755


Appendix 3 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 771


Appendix 4 PharmaTrain Syllabus 2010 783


Index 788