Principles and practice of pharmaceutical medicine

Content: Cover --
Contents --
Preface to the First Edition --
Preface to the Second Edition --
About the Editors --
Contributors --
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 --
Introduction --
4 Drug Discovery: Design and Serendipity --
5 Pharmaceutics --
6 Nonclinical Toxicology --
7 Informed Consent --
8 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure --
9 Phase II and Phase III Clinical Studies --
10 Phase IV Drug Development: Post-Marketing Studies --
11 Site Management --
12 Good Clinical Practices --
13 Quality Assurance, Quality Control and Audit --
14 The Unique Role of Over-the-Counter Medicine --
SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES --
Introduction --
15 Drug Research in Older Patients --
16 Drug Development Research in Women --
17 Clinical Research in Children --
18 Racial and Ethnic Issues in Drug Registration --
19 Hepatic and Renal Failure --
20 Drug Interactions --
21 Orphan Drugs --
SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT --
Introduction --
22 Biotechnology Products and Development --
23 Pharmacoeconomics: Economic and Humanistic Outcomes --
24 Pharmacoepidemiology and the Pharmaceutical Physician --
25 Statistical Principles and Application in Biopharmaceutical Research --
26 Data Management --
27 Patient Compliance: Pharmionics, a New Discipline --
28 Monitoring Drug Concentrations in Clinical Practice --
29 Generics --
30 Complementary Medicines --
SECTION V: DRUG REGULATION --
Introduction --
31 United States Regulations --
32 Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals --
33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 --
34 Medicines Regulation in the European Union --
35 Japanese Regulations --
36 Drug Registration and Pricing in the Middle East --
SECTION VI: MEDICAL SERVICES --
Introduction --
37 Medical Affairs --
38 Drug Labeling --
39 Drug Surveillance --
40 Data Mining --
41 Risk Management in Product Approval and Marketing --
42 Publishing Clinical Studies --
43 Organizing and Planning Local, Regional, National and International Meetings and Conferences --
44 Drug Withdrawals from the Market --
Causes and Consequences --
SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE --
Introduction --
45 Introduction to Bioethics for Pharmaceutical Professionals --
46 Pharmaceutical Medicine and the Law --
47 Pharmaceutical Product Liability --
48 Patents --
49 Fraud and Misconduct in Clinical Research --
SECTION VIII: BUSINESS ASPECTS --
Introduction --
50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico.