About the Book
Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook.
* The authors are all experts in their field and include an assessment of the current status of their specialities
* This book provides an insight into how things may develop in the future
* It is designed to be a guide for those who are actually practicing pharmaceutical medicine
Table of Contents:
About the Editors.
List of Contributors.
Preface.
Section 1: Overview of Pharmaceutical Medicine.
1. Pharmaceutical Medicine as a Medical Speciality (Michael D. Young).
2. What Pharmaceutical Medicine Is and Who Does It (W. Wardell, Susan Toland, and Anthony W. Fox).
3. Competency-based Training System for Clinical Research Staff (Jay D. Miller).
Section II: Drug Discovery and Development.
Introduction (Lionel D. Edwards and Anthony W. Fox).
4. Drug Discovery: Design and Serendipity (Leslie J. Molony).
5. Pharmaceutics (Anthony W. Fox).
6. Non-clinical Toxicology (Frederick Reno).
7. Informed Consent (Anthony W. Fox).
8. Good Clinical Practices (Wendy Bohaychuk and Graham Ball).
9. Quality Assurance, Quality Control and Audit (Donna Cullen).
10. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Experience (Stephen Curry, Dennis McCarthy, Heleen H. DeCory, Matthew Marler, and Johan Gabrielsson).
11. Phase II and Phase III Clinical Studies (Anthony W. Fox).
12. Phase IV Drug Development: Post-marketing Studies (Lisa R. Johnson-Pratt).
13. Over-the-counter Medicines (Paul Starkey).
Section III: Special Populations.
Introduction (Lionel D. Edwards).
14. Drug Research in Older Patients (Lionel D. Edwards).
15. Drug Development Research in Women (Lionel D. Edwards).
16. Clincial Research in Children (Lionel D. Edwards).
Section IV: Applied Aspects of Drug Development.
Introduction (Anthony W. Fox).
17. Biotechnology Products and Their Development (David Shapiro and Anthony W. Fox).
18. Orphan Drugs (Bert Spilker).
19. Pharmacoeconomics: Economic and Humanistic Outcomes (Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer).
20. Pharmacoepidemiology and the pharmaceutical Physician (Hugh Tilson).
21. Statistical Principles and Their Application in Biopharmaceutical Research (Dan Anbar).
22. Data Management (T.Y. Lee and Michael Minor).
23. Patient Compliance (Jean-Michel Métry).
24. Complementary Medicine (Anthony W. Fox).
Section V: Drug Registration.
Introduction (Anthony W. Fox).
25. United States Regulations (William Kennedy).
26. Emergency and Compassionate-use INDs and Accelerated NDA and ANDA approvals -
Procedures, Benefits and Pitfalls (Anthony W. Fox).
27. Japanese Regulations (Etienne Labbe).
28. The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 (John Griffin).
29. Ethnic Issues in Drug Registration (Lionel D. Edwards, J.M. Husson, A. Kumagai, E. Labbé, C. Naito, M. Papaluca, S. Walker, R. Williams, M. Weintraub, and H. Yasurhara).
Section VI: Medical Services.
Introduction (Anthony W. Fox).
30. An Introduction to Medical Affiars (Gill Price).
31. Drug Labelling (Anthony W. Fox).
32. Organizing and Planning Local, Regional, National and International Meetings and Conferences (Zofia E. Dziewanovska, Linda Packard, and Lionel D. Edwards).
33. Drug Surveillance (Howard J. Dreskin and Win M. Castle).
34. Disease Management -
What Does It Mean? (Roy Lilley).
35. Publishing Clinical Studies (Anthony W. Fox).
Section VII: Legal and Ethical Aspects.
Introduction (Sara Croft and Tim Pratt).
36. Pharmaceutical Product Liability (Han W. Choi and Howard B. Yeon).
37. Patents (Gabriel Lopez).
38. Fraud and Misconduct in Clinical Research (Frank Wells).
Section VIII: Business Aspects.
The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment (R. Drucker and R. Graham Hughes).
40. Outsourcing Clinical Drug Development Activities to Contract Research Organisation CROs): Critical Success Factors (John R. Vogel).
41. Third World (Gamal Hammad).
42. Financial Aspects of Clinical Trials (R. Graham Hughes and N. Turner).
43. The Impact of Managed Care on the US Pharmaceutical Industry (Robert Chaponis, Christine Hanson-Divers and Marilyn J. Wells).
Appendix: Useful Internet Links.
Index.
About the Author :
Andrew J. Fletcher, MB, BChir, (Cantab), MS (Columbia), FFPM, DipPharmMedRCP, was formerly the Senior Assistant Editor of The Merck Manual, and is Adjunct Professor of Pharmaceutical Health Care at Temple University School of Pharmacy. He teaches pharmaceutical medicine, bioethics, and medical and scientific writing at Temple University's School of Pharmacy. He is a founder member and former trustee of the Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharmaceutical Physicians).
Lionel D Edwards, MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr. Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug and devices in 10 therapeutic areas. Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a founder member of the American Academy of Pharmaceutical Physicians.
Anthony W Fox, BSc, MBBS, FFPM, FRCP, MD(Lond), DipPharmMedRCP, CBiol, FIBiol, FRSA is President of EBD Group, a consultancy with offices in San Diego and Munich. Tony is a liveryman guardant of the Worshipful Society of Apothecaries of London. He is an Adjunct (i.e., honorary) Associate Clinical Professor in the Skaggs School of Pharmacy and Pharmaceutical Sciences, at the University of California, San Diego. His publications span several areas of pharmaceutical medicine, e.g. regulation, pharmacology, clinical trials, pharmacovigilance, analgesics, migraine, genotoxicology, and metabolism, and he is named as inventor on several patents. He is on the editorial boards of several journals, and serves in a more senior capacity for two of 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 of Pharmaceutical Medicine, Royal Colleges of Physicians of the UK. He is Medical Director of Amdipharm Plc, and of Medical Resource Provider Axess Ltd, and Visiting Professor in pharmaceutical medicine at the University of Surrey, which under his direction introduced the first MSc degree in Pharmaceutical Medicine in 1993, which is now part of the Postgraduate Medical School of the University. His publications include edited works in human psychopharmacology, pharmaceutical medicine, clinical research, medical marketing, and careers in the pharmaceutical industry. He is a member of the Association of Pharmaceutical Physicians and Investigators (APPI). Professor Stonier has been elected a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce.
Review :
"...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". (British Association of Pharmaceutical Physicians Newsletter) "...a good introduction to the development of new products and their worldwide marketing." (Pharmaceutical Research, Vol. 20, No. 9, September 2003)
