Principles and Practice of Pharmaceutical Medicine 3e

Edited by Lionel D. Edwards, Anthony W. Fox and Peter D. Stonier



Praise for Previous Editions:


"The authors provide a one-stop international guide to the various aspects of drug ...

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Principles and Practice of Pharmaceutical Medicine

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Principles and Practice of Pharmaceutical Medicine 3e

Edited by Lionel D. Edwards, Anthony W. Fox and Peter D. Stonier



Praise for Previous Editions:


"The authors provide a one-stop international guide to the various aspects of drug development."  from a review in The Pharmaceutical Journal

"…this text should serve as a useful instructional tool in the classroom for those entering this medical specialty and as a field guide to those already working in the industry." – from a review in Journal of the American Medical Association

"...This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries." – from a review in British Association of Pharmaceutical Physicians Newsletter



Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of the increasingly diverse and international field of pharmaceutical medicine.


This third edition includes new chapters and coverage on approaches to drug discovery and development, international clinical trials, the regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs, and international regulatory updates including emerging Asian markets. It also covers special population studies, medical services, business aspects and the legal and ethical aspects of pharmaceutical medicine.


Principles and Practice of Pharmaceutical Medicine is an up-to-date reference for anyone working in pharmaceutical medicine, including pharmaceutical physicians, regulatory physicians, clinical researchers and research nurses. It provides essential information for those studying for Diplomas in Pharmaceutical Medicine, related professional qualifications and for specialists fulfilling requirements for continuing medical education.

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Editorial Reviews

From the Publisher
"Written at a high level, this comprehensive compilation of the many aspects of pharmaceutical medicine should be a must read for those involved in or contemplating a career in this specialty area." (Doody's, 7 October 2011)

"This third edition offers a comprehensive reference on the subject of pharmaceutical medicine, a relatively new and very diverse field." (Booknews, 1 April 2011)

"The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine." (Financial Technology, 1 March 2011)

Doody's Review Service
Reviewer: Nicole Sifontis, PharmD (Temple University School of Pharmacy)
Description: This is a comprehensive review of the specialty area of pharmaceutical medicine, which encompasses drug discovery, research, and development, as well as global regulatory aspects of practice.
Purpose: The purpose is to expand on the global aspects of pharmaceutical medicine and to provide a comprehensive resource to the various healthcare providers who are involved in the practice of pharmaceutical medicine.
Audience: Practitioners in the pharmaceutical industry and academicians involved in drug studies are the intended audience.
Features: The book provides a historical and current review of drug discovery and development, informed consent procedures, complementary/alternative medicine, regulations in the cosmetic industry, and research involving special populations such as minors, children, and pregnant women. Particularly well covered are statistical principles and business aspects, areas that are often overlooked in other books with similar objectives.
Assessment: Written at a high level, this comprehensive compilation of the many aspects of pharmaceutical medicine should be a must read for those involved in or contemplating a career in this specialty area.
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Product Details

  • ISBN-13: 9781444348125
  • Publisher: Wiley
  • Publication date: 7/12/2011
  • Sold by: Barnes & Noble
  • Format: eBook
  • Edition number: 3
  • Pages: 800
  • File size: 11 MB
  • Note: This product may take a few minutes to download.

Meet the Author

Lionel D Edwards MB, BS, LRCP, MRCS, DipRCOG, FFPM, isSenior Director of Medical Affairs for Novartis USA, and Presidentof Pharma Pro Plus Inc., a drug development consulting company. Dr.Edwards has been involved in all aspects of clinical trials forover 33 years on many different research drug and devices in 10therapeutic areas. Dr. Edwards is a Fellow of the Faculty ofPharmaceutical Medicine and an Adjunct Professor at TempleUniversity Graduate School of Pharmacology. He has taught for thePharmaceutical Education & Research Institute for over 12 yearsand was on the teaching faculty of the National Association ofPhysicians. He is a founder member of the American Academy ofPharmaceutical Physicians.

Anthony W Fox BSc, MBBS, FFPM, FRCP, MD(Lond),DipPharmMedRCP, CBiol, FIBiol, FRSA is President of EBD Group, aconsultancy with offices in San Diego and Munich. Tony is aliveryman guardant of the Worshipful Society of Apothecariesof London. He is an Adjunct (i.e., honorary) Associate ClinicalProfessor in the Skaggs School of Pharmacy and PharmaceuticalSciences, at the University of California, San Diego. Hispublications span several areas of pharmaceutical medicine, e.g.regulation, pharmacology, clinical trials, pharmacovigilance,analgesics, migraine, genotoxicology, and metabolism, and he isnamed as inventor on several patents. He is on the editorial boardsof several journals, and serves in a more senior capacity for twoof them.

Peter D Stonier BA, BSc, PhD, MBChB, MRCPsych, FRCP,FRCPE, FFPM has 29 years experience in pharmaceutical medicine.Peter is Director of Education and Training of the Faculty ofPharmaceutical Medicine, Royal Colleges of Physicians of the UK. Heis Medical Director of Amdipharm Plc, and of Medical ResourceProvider Axess Ltd, and Visiting Professor in pharmaceuticalmedicine at the University of Surrey, which under his directionintroduced the first MSc degree in Pharmaceutical Medicine in 1993,which is now part of the Postgraduate Medical School of theUniversity. His publications include edited works in humanpsychopharmacology, pharmaceutical medicine, clinical research,medical marketing, and careers in the pharmaceutical industry. Heis a member of the Association of Pharmaceutical Physicians andInvestigators (APPI). Professor Stonier has been elected a Fellowof the Royal Society for the encouragement of Arts, Manufacturesand Commerce.

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Table of Contents


Preface to the First Edition.

Preface to the Second Edition.

Preface to the Third Edition.

About the Editors.

Section I Overview of Pharmaceutical Medicine.

1 The Practice and Practitioners of Pharmaceutical Medicine(Anthony W. Fox).

2 Pharmaceutical Medicine as a Medical Specialty (Michael D.Young & Peter D. Stonier).

3 Clinical Research Education and Training for BiopharmaceuticalStaff (Peter Marks & Sheila Gwizdak).

Section II Drug Discovery and Development.

4 Drug Discovery: Design and Development (Ronald R. Cobb& Leslie J. Molony).

5 Translational Medicine, Pharmaceutical Physicians, Patients,and Payers (Robert Sands & Douglas Roy).

6 Pharmaceutics (Anthony W. Fox).

7 Nonclinical Toxicology (Frederick Reno).

8 Informed Consent (Anthony W. Fox).

9 Phase I: The First Opportunity for Extrapolation from AnimalData to Human Exposure (Stephen H. Curry, Helen H. DeCory, &Johan Gabrielsson).

10 Phase II and Phase III Clinical Studies (Anthony W.Fox).

11 Phase IV Drug Development: Post-marketing Studies (Lisa R.Johnson-Pratt).

12 Site Management (Barry Miskin).

13 Good Clinical Practices (Lionel D. Edwards).

14 Quality Assurance, Quality Control and Audit (RitaHattemer-Apostel).

15 The Unique Role of Over-the-Counter Medicine (PaulStarkey).

Section III Special Populations and Required SpecialStudies.

16 Drug Research in Older Patients (Lionel D.Edwards).

17 Drug Development Research in Women (Lionel D.Edwards).

18 Clinical Research in Children (Lionel D. Edwards).

19 Racial and Ethnic Issues in Drug Regulation (Lionel D.Edwards, J-M. Husson, E. Labbe, C. Naito, M. Papaluca Amati, S.Walker, R.L., Williams, & H. Yasurhara).

20 Special Populations: Hepatic and Renal Failure (Anthony W.Fox).

21 Drug Interactions (Anthony W. Fox & Anne-Ruth vanTroostenburg).

22 Orphan Drugs (Bert Spilker).

23 QT Interval Prolongation and Drug Development (Bruce H.Morimoto & Anthony W. Fox).

Section IV Applied Aspects.

24 Biotechnology Products and Their Development (David A.Shapiro & Anthony W. Fox).

25 Health Economics (Daniel C. Malone, Edward P. Armstrong,& Mirza I. Rahman).

26 Pharmacoeconomics: Economic and Humanistic Outcomes(Raymond J. Townsend, Jane T. Osterhaus, & J. GregoryBoyer).

27 Pharmacoepidemiology and the Pharmaceutical Physician(Hugh H. Tilson).

28 Statistical Principles and Application in BiopharmaceuticalResearch (Dan Anbar).

29 Data Management (T.Y. Lee, Michael Minor, & Lionel D.Edwards).

30 Patient Compliance: Pharmionics, A New Discipline (Dr.Jean-Michel Metry).

31 Monitoring Drug Concentrations in Clinical Practice(Anthony W. Fox).

32 Generics (Gabriel Lopez & Thomas Hoxie).

33 Complementary Medicines (Anthony W. Fox).

Section V Drug Regulation.

34 United States Regulations (William Kennedy & Lionel DEdwards).

35 Special US Regulatory Procedures: Emergency and"Compassionate" INDs and Accelerated Product Approvals (AnthonyW. Fox).

36 The Development of Human Medicines Control in Europe fromClassical Times to the 21st Century (John P. Griffin).

37 Medicines Regulation in the European Union (A-R. vanTroostenburg & G. Tabusso).

38 Japanese Regulations (Etienne Labbe).

39 Drug Registration and Pricing in the Middle East (EddaFreidank-Mueschenborn & Anja Konig).

40 China's Regulated Pharmaceutical Market (Yan Yan LiStarkey).

41 India's New Era in Pharmaceuticals (DarshanKulkarni).

Section VI Medical Services.

42 Medical Affairs (Gregory P. Geba).

43 Drug Labeling (Anthony W. Fox).

44 Data Mining (Mirza I. Rahman & Robbert P. vanManen).

45 Risk Management in Product Approval and Marketing (AnthonyW. Fox).

46 Publishing Clinical Studies (Anthony W. Fox).

47 Organizing and Planning Local, Regional, National, andInternational Meetings and Conferences (Zofia Dziewanowska &Linda Packard).

48 When Things Go Wrong: Drug Withdrawals from the Market(Ronald D. Mann).

49 International Trials: Successful Planning and Conduct(Katie P.J. Wood).

Section VII Legal and Ethical Aspects of PharmaceuticalMedicine.

50 Introduction to Bioethics for Pharmaceutical Professionals(Andrew J. Fletcher).

51 Pharmaceutical Medicine and the Law (Sarah Croft).

52 Fraud and Misconduct in Clinical Research (JaneBarrett).

Section VIII Business Aspects.

53 The Multinational Corporations: Cultural Challenges, theLegal/Regulatory Framework and the Medico-commercial Environment(R. Drucker & R. Graham Hughes).

54 Advertising and Marketing (Jonathan Belsey).

55 Pharmaceutical Product Liability (Han W. Choi & JaeHong Lee).

56 Patents (Gabriel Lopez).

57 Outsourcing Clinical Drug Development Activities to ContractResearch Organizations (CROs): Critical Success Factors (John R.Vogel).

58 The Impact of Managed Care on the US Pharmaceutical Industry(Robert J. Chaponis, Christine Hanson-Divers, & Marilyn J.Wells).

Appendix: Useful Web Links.


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