
Principles and Practice of Pharmaceutical Medicine, 2nd Edition
by Editor: Lionel D. Edwards (Novartis and Pharma Pro Plus Inc, New Jersey, USA); Editor: Andrew J. Fletcher (Temple University, Pennsylvania, USA); Editor: Anthony W. Fox (EBD Group Inc, California, USA); Editor: Peter D. Stonier (Hoechst UK Ltd)-
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Summary
Author Biography
Anthony W Fox. BSc, MBBS, FFPM, FRCP, MD(Lond), DipPharmMedRCP, CBiol, FIBiol, FRSA is President of EBD Group, a consultancy with offices in San Diego and Munich. Tony is a liveryman guardant of the Worshipful Society of Apothecaries of London. He is an Adjunct (i.e., honorary) Associate Clinical Professor in the Skaggs School of Pharmacy and Pharmaceutical Sciences, at the University of California, San Diego. His publications span several areas of pharmaceutical medicine, e.g. regulation, pharmacology, clinical trials, pharmacovigilance, analgesics, migraine, genotoxicology, and metabolism, and he is named as inventor on several patents. He is on the editorial boards of several journals, and serves in a more senior capacity for two of them.
Peter D Stonier. BA, BSc, PhD, MBChB, MRCPsych, FRCP, FRCPE, FFPM has 29 years experience in pharmaceutical medicine. Peter is Director of Education and Training of the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians of the UK. He is Medical Director of Amdipharm Plc, and of Medical Resource Provider Axess Ltd, and Visiting Professor in pharmaceutical medicine at the University of Surrey, which under his direction introduced the first MSc degree in Pharmaceutical Medicine in 1993, which is now part of the Postgraduate Medical School of the University. His publications include edited works in human psychopharmacology, pharmaceutical medicine, clinical research, medical marketing, and careers in the pharmaceutical industry. He is a member of the Association of Pharmaceutical Physicians and Investigators (APPI). Professor Stonier has been elected a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce.
Andrew J. Fletcher. MB, BChir, (Cantab), MS (Columbia), FFPM, DipPharmMedRCP, was formerly the Senior Assistant Editor of The Merck Manual, and is Adjunct Professor of Pharmaceutical Health Care at Temple University School of Pharmacy. He teaches pharmaceutical medicine, bioethics, and medical and scientific writing at Temple University’s School of Pharmacy. He is a founder member and former trustee of the Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharmaceutical Physicians).
Table of Contents
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 Local, Regional, National, and International Meetings and Conferences | |
Table of Contents provided by Publisher. All Rights Reserved. |
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