Principles and Practice of Pharmaceutical Medicine (eBook)

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. 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).

Principles and Practice of Pharmaceutical Medicine 3
Contents 7
Preface to the First Edition 11
Preface to the Second Edition 13
About the Editors 15
Contributors 17
SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE 21
1 The Practice and Practitioners of Pharmaceutical Medicine 23
2 Pharmaceutical Medicine as a Medical Specialty 27
3 Clinical Research Education and Training for Biopharmaceutical Staff 45
SECTION II: DRUG DISCOVERY AND DEVELOPMENT 61
Introduction 61
4 Drug Discovery: Design and Serendipity 63
5 Pharmaceutics 71
6 Nonclinical Toxicology 83
7 Informed Consent 95
8 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure 99
9 Phase II and Phase III Clinical Studies 121
10 Phase IV Drug Development: Post-Marketing Studies 139
11 Site Management 147
12 Good Clinical Practices 159
13 Quality Assurance, Quality Control and Audit 179
14 The Unique Role of Over-the-Counter Medicine 199
SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES 211
Introduction 211
15 Drug Research in Older Patients 213
16 Drug Development Research in Women 223
17 Clinical Research in Children 243
18 Racial and Ethnic Issues in Drug Registration 251
19 Hepatic and Renal Failure 269
20 Drug Interactions 275
21 Orphan Drugs 285
SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT 297
Introduction 297
22 Biotechnology Products and Development 299
23 Pharmacoeconomics: Economic and Humanistic Outcomes 311
24 Pharmacoepidemiology and the Pharmaceutical Physician 323
25 Statistical Principles and Application in Biopharmaceutical Research 333
26 Data Management 365
27 Patient Compliance: Pharmionics, a New Discipline 375
28 Monitoring Drug Concentrations in Clinical Practice 395
29 Generics 401
30 Complementary Medicines 407
SECTION V: DRUG REGULATION 413
Introduction 413
31 United States Regulations 415
32 Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals 427
33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 435
34 Medicines Regulation in the European Union 463
35 Japanese Regulations 507
36 Drug Registration and Pricing in the Middle East 529
SECTION VI: MEDICAL SERVICES 537
Introduction 537
37 Medical Affairs 539
38 Drug Labeling 549
39 Drug Surveillance 555
40 Data Mining 565
41 Risk Management in Product Approval and Marketing 577
42 Publishing Clinical Studies 585
43 Organizing and Planning Local, Regional, National and International Meetings and Conferences 595
44 Drug Withdrawals from the Market - Causes and Consequences 599
SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE 605
Introduction 605
45 Introduction to Bioethics for Pharmaceutical Professionals 607
46 Pharmaceutical Medicine and the Law 615
47 Pharmaceutical Product Liability 625
48 Patents 639
49 Fraud and Misconduct in Clinical Research 651
SECTION VIII: BUSINESS ASPECTS 663
Introduction 663
50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment 665
51 Advertising and Marketing 673
52 Middle East, India, China and the Far East: Pharmaceutical Medicine in the East 685
53 Financial Aspects of Clinical Trials 709
54 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors 721
55 The Impact of Managed Care on the US Pharmaceutical Industry 745
Appendix: Useful Internet Links 765
Index 769

"The authors provide a one-stop international guide to the various
aspects of drug development." (The Pharmaceutical Journal,
2008)

"...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." (Journal
of the American Medical Association, June 25, 2008)

"...a truly fine book on the development of
pharmaceuticals...useful book for those who want a behind the
scenes look..." (Doody's Health Services)