Principles and Practice of Pharmaceutical Medicine

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.

Contributors. 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 Biopharmaceutical Staff (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 Animal Data 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 (Rita Hattemer-Apostel).

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

Section III Special Populations and Required Special Studies.

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 van Troostenburg).

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. Gregory Boyer).

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

28 Statistical Principles and Application in Biopharmaceutical Research (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 D Edwards).

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

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

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

38 Japanese Regulations (Etienne Labbe).

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

40 China's Regulated Pharmaceutical Market (Yan Yan Li Starkey).

41 India's New Era in Pharmaceuticals (Darshan Kulkarni).

Section VI Medical Services.

42 Medical Affairs (Gregory P. Geba).

43 Drug Labeling (Anthony W. Fox).

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

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

46 Publishing Clinical Studies (Anthony W. Fox).

47 Organizing and Planning Local, Regional, National, and International 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 Pharmaceutical Medicine.

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 (Jane Barrett).

Section VIII Business Aspects.

53 The Multinational Corporations: Cultural Challenges, the Legal/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 & Jae Hong Lee).

56 Patents (Gabriel Lopez).

57 Outsourcing Clinical Drug Development Activities to Contract Research 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.

Index.