About the Book: 

'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 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 clinicals 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’ 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.

Contents:

Section I Overview of Pharmaceutical Medicine.

1. The Practice and Practitioners of Pharmaceutical Medicine

2. Pharmaceutical Medicine as a Medical Specialty

3. Clinical Research Education and Training for Biopharmaceutical Staff

Section II Drug Discovery and Development

4. Drug Discovery: Design and Development

5. Translational Medicine, Pharmaceutical Physicians, Patients, and Payers

6. Pharmaceutics

7. Nonclinical Toxicology

8. Informed Consent

9. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure

10. Phase II and Phase III Clinical Studies

11. Phase IV Drug Development: Post-marketing Studies

12. Site Management

13. Good Clinical Practices

14. Quality Assurance, Quality Control and Audit

15. The Unique Role of Over-the-Counter Medicine

Section III Special Populations and Required Special Studies

16. Drug Research in Older Patients

17. Drug Development Research in Women

18. Clinical Research in Children

19. Racial and Ethnic Issues in Drug Regulation

20. Special Populations: Hepatic and Renal Failure

21. Drug Interactions

22. Orphan Drugs

23. QT Interval Prolongation and Drug Development

Section IV Applied Aspects

24. Biotechnology Products and Their Development

25. Health Economics

26. Pharmacoeconomics: Economic and Humanistic Outcomes

27. Pharmacoepidemiology and the Pharmaceutical Physician

28. Statistical Principles and Application in Biopharmaceutical Research

29. Data Management

30. Patient Compliance: Pharmionics, A New Discipline

31. Monitoring Drug Concentrations in Clinical Practice

32. Generics

33. Complementary Medicines

Section V Drug Regulation

34. United States Regulations

35. Special US Regulatory Procedures: Emergency and "Compassionate" INDs and Accelerated Product Approvals

36. The Development of Human Medicines Control in Europe from Classical Times to the 21st Century

37. Medicines Regulation in the European Union

38. Japanese Regulations

39. Drug Registration and Pricing in the Middle East

40. China's Regulated Pharmaceutical Market

41. India's New Era in Pharmaceuticals

Section VI Medical Services

42. Medical Affairs

43. Drug Labeling

44. Data Mining

45. Risk Management in Product Approval and Marketing

46. Publishing Clinical Studies

47. Organizing and Planning Local, Regional, National, and International Meetings and Conferences

48. When Things Go Wrong: Drug Withdrawals from the Market

49. International Trials: Successful Planning and Conduct

Section VII Legal and Ethical Aspects of Pharmaceutical Medicine

50. Introduction to Bioethics for Pharmaceutical Professionals

51. Pharmaceutical Medicine and the Law

52. Fraud and Misconduct in Clinical Research

Section VIII Business Aspects

53. The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment

54. Advertising and Marketing

55. Pharmaceutical Product Liability

56. Patents

57. Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors

About the Authors:

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.