Principles and Practice of Pharmaceutical

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

Lionel D Edwards. MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr. Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug and devices in 10 therapeutic areas. Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a founder member of the American Academy of Pharmaceutical Physicians.

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).

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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Principles and Practice of Pharmaceutical Medicine, 2nd Edition

Summary

Author Biography

Table of Contents

Supplemental Materials