Edwards L. (ed.) Principles and Practice of Pharmaceutical Medicine

JohnWiley & Sons Ltd, 2007. - 780 p. ISBN: 0470093137 2nd editionPharmaceutical medicine is now a recognized medical specialty in many countries, and the second edition of Principles and practice of Pharmaceutical Medicine responds to this by offering a one-stop text across this rapidly expanding and increasingly diverse discipline. It retains its original aim, to provide an up-to-date international guide to all areas of drug development and the medical aspects of marketing and support of medicines. In addition, readers of the new edition will find a greater breadth of topics, including:
European regulations
Bioethics in pharmaceutical medicine
pharmaceutical medicine and the law
Licensing and due diligence
Pharmacogenomics
Drug withdrawals from the market - causes and consequences
This book will appeal to all those working in pharmaceutical medicine, including pharmaceutical physicians, regulatory physicians, clinical researchers, research nurses and marketing executives. It provides essential information for those studying for exams through internationally-harmonized courses for Diplomas in pharmaceutical medicine or related professional qualifications and for specialists fulfilling requirements for continuing medical education.Preface to the First Edition.
Preface to the Second Edition.
About the Editors.Overview of Pharmaceutical Medicine.
The Practice and Practitioners of Pharmaceutical Medicine
Pharmaceutical Medicine as a Medical Specialty
Clinical Research Education and Training for Biopharmaceutical Staff
Drug Discovery and Development.Drug Discovery: Design and Serendipity
Pharmaceutics
Non-clinical Toxicology
Informed Consent
Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure
Phase II and Phase III Clinical Studies
Phase IV Drug Development: Post-Marketing Studies
Site Management
Good Clinical Practices
Quality Assurance, Quality Control, and Audit
The Unique Role of Over-the-counter Medicine
Special Populations and Required Special Studies.Drug Research in Older Patients
Drug Development Research in Women
Clinical Research in Children
Racial and Ethnic Issues in Drug Registration
Hepatic and Renal Failure
Drug Interactions
Orphan Drugs
Applied Aspects of Drug Development.Biotechnology Products and Development
Pharmacoeconomics: Economic and Humanistic Outcomes
Pharmacoepidemiology and the Pharmaceutical Physician
Statistical Principles and Application in Biopharmaceutical Research
Data Management
Patient Compliance: Pharmionics, A New Discipline
Monitoring Drug Concentrations in Clinical Practice
Generics
Complementary Medicines
Drug Regulation.United States Regulations
Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals
The Development of Human Medicines Control in Europe From Classical Times to the Year 2000
Medicines Regulation in the European Union
Japanese Regulations
Drug Registration and Pricing in the Middle East
Medical Services.Medical Affairs
Drug Labeling
Drug Surveillance
Data Mining
Risk Management in Product Approval and Marketing
Publishing Clinical Studies
Organizing and Planning Local, Regional, National, and International Meetings and Conferences
Drug Withdrawals from the Market - Causes and Consequences
Legal and Ethical Aspects of Pharmaceutical Medicine.Introduction to Bioethics for Pharmaceutical Professionals
Pharmaceutical Medicine and the Law
Pharmaceutical Product Liability
Patents
Fraud and Misconduct in Clinical Research
Business Aspects.The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment
Advertising and Marketing
Pharmaceutical Medicine in the East
Financial Aspects of Clinical Trials
Outsourcing Clinical Drug Development Activities to Contract Research. Organizations (CROs): Critical Success Factors
The Impact of Managed Care on the Pharmaceutical Industry
Appendix Useful Internet Links.