Principles and Practice of Pharmaceutical Medicine

Contributors.
 
Preface to the First Edition.
 
Preface to the Second Edition.
 
Preface to the Third Edition.
 
About the Editors.
 
Section I Overview of Pharmaceutical Medicine.
 
1 The Practice and Practitioners of Pharmaceutical Medicine (Anthony W. Fox).
 
2 Pharmaceutical Medicine as a Medical Specialty (Michael D. Young & Peter D. Stonier).
 
3 Clinical Research Education and Training for Biopharmaceutical Staff (Peter Marks & Sheila Gwizdak).
 
Section II Drug Discovery and Development.
 
4 Drug Discovery: Design and Development (Ronald R. Cobb & Leslie J. Molony).
 
5 Translational Medicine, Pharmaceutical Physicians, Patients, and Payers (Robert Sands & Douglas Roy).
 
6 Pharmaceutics (Anthony W. Fox).
 
7 Nonclinical Toxicology (Frederick Reno).
 
8 Informed Consent (Anthony W. Fox).
 
9 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure (Stephen H. Curry, Helen H. DeCory, & Johan Gabrielsson).
 
10 Phase II and Phase III Clinical Studies (Anthony W. Fox).
 
11 Phase IV Drug Development: Post-marketing Studies (Lisa R. Johnson-Pratt).
 
12 Site Management (Barry Miskin).
 
13 Good Clinical Practices (Lionel D. Edwards).
 
14 Quality Assurance, Quality Control and Audit (Rita Hattemer-Apostel).
 
15 The Unique Role of Over-the-Counter Medicine (Paul Starkey).
 
Section III Special Populations and Required Special Studies.
 
16 Drug Research in Older Patients (Lionel D. Edwards).
 
17 Drug Development Research in Women (Lionel D. Edwards).
 
18 Clinical Research in Children (Lionel D. Edwards).
 
19 Racial and Ethnic Issues in Drug Regulation (Lionel D. Edwards, J-M. Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R.L., Williams, & H. Yasurhara).
 
20 Special Populations: Hepatic and Renal Failure

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

"Written at a high level, this comprehensive compilation of the many aspects of pharmaceutical medicine should be a must read for those involved in or contemplating a career in this specialty area." (Doody's, 7 October 2011) "This third edition offers a comprehensive reference on the subject of pharmaceutical medicine, a relatively new and very diverse field." (Booknews, 1 April 2011) "The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine." (Financial Technology, 1 March 2011)

"Written at a high level, this comprehensive compilation of the many aspects of pharmaceutical medicine should be a must read for those involved in or contemplating a career in this specialty area." (Doody's, 7 October 2011)
 
"This third edition offers a comprehensive reference on the subject of pharmaceutical medicine, a relatively new and very diverse field." (Booknews, 1 April 2011)
 
"The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine." (Financial Technology, 1 March 2011)