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Principles and Practice of Pharmaceutical Medicine
Second edition
edited by Lionel D. Edwards

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, Principles and Practice of Pharmaceutical Medicine is the most up-to-date international guide on the subject.


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

Drug Discovery and Development

  1. Drug Discovery: Design and Serendipity
  2. Pharmaceutics
  3. Non-clinical Toxicology
  4. Informed Consent
  5. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure
  6. Phase II and Phase III Clinical Studies
  7. Phase IV Drug Development: Post-marketing Studies
  8. Site Management
  9. Good Clinical Practices
  10. Quality Assurance, Quality Control, and Audit
  11. The Unique Role of Over-the-counter Medicine

Special Populations and Required Spcial Studies

  1. Drug Research in Older Patients
  2. Drug Development Research in Women
  3. Clinical Research in Children
  4. Racial and Ethnic Issues in Drug Registration
  5. Hepatic and Renal Failure
  6. Drug Interactions
  7. Orphan Drugs

Applied Aspects of Drug Development

  1. Biotechnology Products and Development
  2. Pharmacoeconomics: Economic and Humanistic Outcomes
  3. Pharmacoepidemiology and the Pharmaceutical Physician
  4. Statistical Principles and Application in Biopharmaceutical Research
  5. Data Management
  6. Patient Compliance: Pharmionics, A New Discipline
  7. Monitoring Drug Concentrations in Clinical Practice
  8. Generics
  9. Complementary Medicines

Drug Regulation

  1. United States Regulations
  2. Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals
  3. The Development of Human Medicines Control in Europe From Classical Times to the Year 2000
  4. Medicines Regulation in the European Union
  5. Japanese Regulations
  6. Drug Registration and Pricing in the Middle East

Medical Services

  1. Medical Affairs
  2. Drug Labeling
  3. Drug Surveillance
  4. Data Mining
  5. Risk Management in Product Approval and Marketing
  6. Publishing Clinical Studies
  7. Organizing and Planning Local, Regional, National, and International Meetings and Conferences
  8. Drug Withdrawals from the Market - Causes and Consequences

Legal and Ethical Aspects of Pharmaceutical Medicine

  1. Introduction to Bioethics for Pharmaceutical Professionals
  2. Pharmaceutical Medicine and the Law
  3. Pharmaceutical Product Liability
  4. Patents
  5. Fraud and Misconduct in Clinical Research

Business Aspects

  1. The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment
  2. Advertising and Marketing
  3. Pharmaceutical Medicine in the East
  4. Financial Aspects of Clinical Trials
  5. Outsourcing Clinical Drug Development Activities to Contract Research. Organizations (CROs): Critical Success Factors
  6. The Impact of Managed Care on the Pharmaceutical Industry


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Principles and Practice of Pharmaceutical Medicine
Second edition
edited by Lionel D. Edwards

2007 761 pages $249.00 + shipping
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