The Textbook of Pharmaceutical Medicine / Edition 7

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $232.23
Usually ships in 1-2 business days
(Save 19%)
Other sellers (Hardcover)
  • All (9) from $232.23   
  • New (8) from $232.23   
  • Used (1) from $240.73   


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

Read More Show Less

Editorial Reviews

From the Publisher

“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)

Doody's Review Service
Reviewer: Scott J Weir, PharmD, PhD (University of Kansas Medical Center)
Description: This is a book for pharmaceutical and medical related sciences programs in the U.K. The first edition was published in 1993.
Purpose: The purpose is to educate its readers on drug discovery and development. The book is broken down into four appropriate sections or parts: research and development, medical, regulatory, and pharmacoeconomics.
Audience: It is written for students, either in medicine or pharmaceutical sciences, pursuing advanced degrees. There are many contributing authors to this text book.
Features: The structure and content of the book is at an appropriate level. I found the U.K. perspectives helpful, but wonder whether U.S. students may be turned off a bit by the European viewpoint.
Assessment: The quality of the book is fine. It is written at a pretty high level, more for students than experts in the field of drug discovery and development.
Read More Show Less

Product Details

  • ISBN-13: 9780470659878
  • Publisher: Wiley
  • Publication date: 6/4/2013
  • Edition number: 7
  • Pages: 854
  • Product dimensions: 16.80 (w) x 9.80 (h) x 1.70 (d)

Meet the Author

John Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM
Director, Asklepieion Consultancy Ltd; Visiting Professor, Unviersity of Surrey Postgraduate Medical School; Former Director, ABPI; Formerly Professional Head of the Medicines Division, DHSS, London

Read More Show Less

Read an Excerpt

Click to read or download

Read More Show Less

Table of Contents


The editors


List of abbreviations


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 and Drug Administration
Peter Barton Hutt

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

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

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

Part III Health care marketplace

29 An Introduction to life cycle management of medicines
David Gillen

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

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

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

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

34 Information and promotion
Charles De Wet

35 Economics of health care
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
John P. Griffin and Geoffrey R. Barker

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

38 Biosimilars
Raymond A. Huml and John Posner

Appendix 1 Declaration of Helsinki

Appendix 2 Agreements and Guidelines for Implementation of Clinical Trials

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

Appendix 4 PharmaTrain Syllabus 2010


Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star


4 Star


3 Star


2 Star


1 Star


Your Rating:

Your Name: Create a Pen Name or

Barnes & Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation


  • - By submitting a review, you grant to Barnes & and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Terms of Use.
  • - Barnes & reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)