DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/757dc9/principles_and_pra) has announced the addition of John Wiley and Sons Ltd's new book "Principles and Practice of Pharmaceutical Medicine, 3rd Edition" to their offering.
The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmaco vigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.
Key Topics Covered:
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
58 The Impact of Managed Care on the US Pharmaceutical Industry
For more information visit http://www.researchandmarkets.com/research/757dc9/principles_and_pra.