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The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: "This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries." -BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Preface to the First Edition
Preface to the Second Edition
About the Editors
Contributors
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
Introduction
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
Introduction
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
Introduction
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
Introduction
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
Introduction
Medical Affairs
Drug Labeling
Drug Surveillance
Data Mining
Risk Management in Product Approval and Marketing
Publishing Clinical Studies
Organizing and Planning Lo
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Principles and Practice of Pharmaceutical Medicine, 2nd Edition

0470093145

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