{"product_id":"principles-and-practice-of-pharmaceutical-medicine-isbn-9781405194723","title":"Principles and Practice of Pharmaceutical Medicine","description":"The new edition of \u003ci\u003ePrinciples and Practice of Pharmaceutical Medicine\u003c\/i\u003e is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.  Contributors.  \u003cp\u003ePreface to the First Edition.\u003c\/p\u003e \u003cp\u003ePreface to the Second Edition.\u003c\/p\u003e \u003cp\u003ePreface to the Third Edition.\u003c\/p\u003e \u003cp\u003eAbout the Editors.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection I Overview of Pharmaceutical Medicine.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 The Practice and Practitioners of Pharmaceutical Medicine (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2 Pharmaceutical Medicine as a Medical Specialty (\u003ci\u003eMichael D. Young \u0026amp; Peter D. Stonier\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3 Clinical Research Education and Training for Biopharmaceutical Staff (\u003ci\u003ePeter Marks \u0026amp; Sheila Gwizdak\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection II Drug Discovery and Development.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4 Drug Discovery: Design and Development (\u003ci\u003eRonald R. Cobb \u0026amp; Leslie J. Molony\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5 Translational Medicine, Pharmaceutical Physicians, Patients, and Payers (\u003ci\u003eRobert Sands \u0026amp; Douglas Roy\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e6 Pharmaceutics (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7 Nonclinical Toxicology (\u003ci\u003eFrederick Reno\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8 Informed Consent (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure (\u003ci\u003eStephen H. Curry, Helen H. DeCory, \u0026amp; Johan Gabrielsson\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e10 Phase II and Phase III Clinical Studies (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e11 Phase IV Drug Development: Post-marketing Studies (\u003ci\u003eLisa R. Johnson-Pratt\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e12 Site Management (\u003ci\u003eBarry Miskin\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e13 Good Clinical Practices (\u003ci\u003eLionel D. Edwards\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e14 Quality Assurance, Quality Control and Audit (\u003ci\u003eRita Hattemer-Apostel\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e15 The Unique Role of Over-the-Counter Medicine (\u003ci\u003ePaul Starkey\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection III Special Populations and Required Special Studies.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16 Drug Research in Older Patients (\u003ci\u003eLionel D. Edwards\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e17 Drug Development Research in Women (\u003ci\u003eLionel D. Edwards\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e18 Clinical Research in Children (\u003ci\u003eLionel D. Edwards\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e19 Racial and Ethnic Issues in Drug Regulation (\u003ci\u003eLionel D. Edwards, J-M. Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R.L., Williams, \u0026amp; H. Yasurhara\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e20 Special Populations: Hepatic and Renal Failure (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e21 Drug Interactions (\u003ci\u003eAnthony W. Fox \u0026amp; Anne-Ruth van Troostenburg\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e22 Orphan Drugs (\u003ci\u003eBert Spilker\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e23 QT Interval Prolongation and Drug Development (\u003ci\u003eBruce H. Morimoto \u0026amp; Anthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection IV Applied Aspects.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24 Biotechnology Products and Their Development (\u003ci\u003eDavid A. Shapiro \u0026amp; Anthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e25 Health Economics (\u003ci\u003eDaniel C. Malone, Edward P. Armstrong, \u0026amp; Mirza I. Rahman\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e26 Pharmacoeconomics: Economic and Humanistic Outcomes (\u003ci\u003eRaymond J. Townsend, Jane T. Osterhaus, \u0026amp; J. Gregory Boyer\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e27 Pharmacoepidemiology and the Pharmaceutical Physician (\u003ci\u003eHugh H. Tilson\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e28 Statistical Principles and Application in Biopharmaceutical Research (\u003ci\u003eDan Anbar\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e29 Data Management (\u003ci\u003eT.Y. Lee, Michael Minor, \u0026amp; Lionel D. Edwards\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e30 Patient Compliance: Pharmionics, A New Discipline (\u003ci\u003eDr. Jean-Michel Metry\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e31 Monitoring Drug Concentrations in Clinical Practice (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e32 Generics (\u003ci\u003eGabriel Lopez \u0026amp; Thomas Hoxie\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e33 Complementary Medicines (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection V Drug Regulation.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e34 United States Regulations (\u003ci\u003eWilliam Kennedy \u0026amp; Lionel D Edwards\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e35 Special US Regulatory Procedures: Emergency and \"Compassionate\" INDs and Accelerated Product Approvals (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e36 The Development of Human Medicines Control in Europe from Classical Times to the 21st Century (\u003ci\u003eJohn P. Griffin\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e37 Medicines Regulation in the European Union (\u003ci\u003eA-R. van Troostenburg \u0026amp; G. Tabusso\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e38 Japanese Regulations (\u003ci\u003eEtienne Labbe\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e39 Drug Registration and Pricing in the Middle East (\u003ci\u003eEdda Freidank-Mueschenborn \u0026amp; Anja Konig\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e40 China's Regulated Pharmaceutical Market (\u003ci\u003eYan Yan Li Starkey\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e41 India's New Era in Pharmaceuticals (\u003ci\u003eDarshan Kulkarni\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection VI Medical Services.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e42 Medical Affairs (\u003ci\u003eGregory P. Geba\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e43 Drug Labeling (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e44 Data Mining (\u003ci\u003eMirza I. Rahman \u0026amp; Robbert P. van Manen\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e45 Risk Management in Product Approval and Marketing (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e46 Publishing Clinical Studies (\u003ci\u003eAnthony W. Fox\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e47 Organizing and Planning Local, Regional, National, and International Meetings and Conferences (\u003ci\u003eZofia Dziewanowska \u0026amp; Linda Packard\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e48 When Things Go Wrong: Drug Withdrawals from the Market (\u003ci\u003eRonald D. Mann\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e49 International Trials: Successful Planning and Conduct (\u003ci\u003eKatie P.J. Wood\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection VII Legal and Ethical Aspects of Pharmaceutical Medicine.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e50 Introduction to Bioethics for Pharmaceutical Professionals (\u003ci\u003eAndrew J. Fletcher\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e51 Pharmaceutical Medicine and the Law (\u003ci\u003eSarah Croft\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e52 Fraud and Misconduct in Clinical Research (\u003ci\u003eJane Barrett\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection VIII Business Aspects.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e53 The Multinational Corporations: Cultural Challenges, the Legal\/Regulatory Framework and the Medico-commercial Environment (\u003ci\u003eR. Drucker \u0026amp; R. Graham Hughes\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e54 Advertising and Marketing (\u003ci\u003eJonathan Belsey\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e55 Pharmaceutical Product Liability (\u003ci\u003eHan W. Choi \u0026amp; Jae Hong Lee\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e56 Patents (\u003ci\u003eGabriel Lopez\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e57 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (\u003ci\u003eJohn R. Vogel\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e58 The Impact of Managed Care on the US Pharmaceutical Industry (\u003ci\u003eRobert J. Chaponis, Christine Hanson-Divers, \u0026amp; Marilyn J. Wells\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003eAppendix: Useful Web Links.\u003c\/p\u003e \u003cp\u003eIndex.\u003c\/p\u003e \"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)  \u003cp\u003e \"This third edition offers a comprehensive reference on the subject of pharmaceutical medicine, a relatively new and very diverse field.\" (Booknews, 1 April 2011)\u003c\/p\u003e  \u003cp\u003e \"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)\u003c\/p\u003e  \u003cb\u003eLionel D Edwards\u003c\/b\u003e 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 \u0026amp; 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. \u003cbr\u003e \u003cp\u003e\u003cb\u003eAnthony W Fox\u003c\/b\u003e 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 \u003ci\u003eguardant\u003c\/i\u003e 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.\u003cbr\u003e \u003c\/p\u003e \u003cp\u003e\u003cb\u003ePeter D Stonier\u003c\/b\u003e 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.\u003c\/p\u003e  \u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003ePrinciples and Practice of Pharmaceutical Medicine 3e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cbr\u003e \u003cbr\u003e   \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003eEdited by Lionel D. Edwards, Anthony W. Fox and Peter D. Stonier\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003e9781405194723\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small; font-family: Calibri;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003ePraise for Previous Editions:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small; font-family: Calibri;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"font-size: 12pt; font-family: \" times new roman mso-ansi-language: en-us mso-fareast-font-family: mso-bidi-language: th\u003e\"The authors provide a one-stop international guide to the various aspects of drug development.\"\u003cspan style=\"mso-spacerun: yes;\"\u003e \u003c\/span\u003e from a review in \u003ci\u003eThe Pharmaceutical Journal\u003c\/i\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"font-size: 12pt; font-family: \" times new roman mso-ansi-language: en-us mso-fareast-font-family: mso-bidi-language: th\u003e\"…this text should serve as a useful instructional tool in the classroom for those entering this medical specialty and as a field guide to those already working in the industry.\" – from a review in \u003ci\u003eJournal of the American Medical Association\u003c\/i\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003e\u003cspan style=\"mso-ansi-language: EN-US;\"\u003e\"...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.\" – from a review in \u003ci\u003eBritish Association of Pharmaceutical Physicians Newsletter\u003c\/i\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small; font-family: Calibri;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small; font-family: Calibri;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003e\u003ci\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003ePrinciples and Practice of Pharmaceutical Medicine\u003c\/span\u003e\u003c\/i\u003e \u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003eis a comprehensive reference guide to all aspects of the increasingly diverse and international field of pharmaceutical medicine.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small; font-family: Calibri;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003eThis third edition includes new chapters and coverage on approaches to drug discovery and development, international clinical trials, the regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs, and international regulatory updates including emerging Asian markets. It also covers special population studies, medical services, business aspects and the legal and ethical aspects of pharmaceutical medicine.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003e\u003cspan style=\"font-size: small; font-family: Calibri;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Calibri;\"\u003e\u003ci\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003ePrinciples and Practice of Pharmaceutical Medicine\u003c\/span\u003e\u003c\/i\u003e \u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US;\"\u003eis a\u003c\/span\u003e\u003cspan style=\"mso-bidi-font-family: Calibri; mso-ansi-language: EN-US; mso-fareast-font-family: 'Times New Roman'; mso-bidi-language: TH;\"\u003en up-to-date reference for anyone working in pharmaceutical medicine, including pharmaceutical physicians, regulatory physicians, clinical researchers and research nurses. It provides essential information for those studying for Diplomas in Pharmaceutical Medicine, related professional qualifications and for specialists fulfilling requirements for continuing medical education.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":47989849719013,"sku":"NP9781405194723","price":386.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781405194723.jpg?v=1761785667","url":"https:\/\/k12savings.com\/products\/principles-and-practice-of-pharmaceutical-medicine-isbn-9781405194723","provider":"K12savings","version":"1.0","type":"link"}