Principles and Practice of Pharmaceutical Medicine, Third Edition

The new edition of Principles and Practice of Pharmaceutical Medicine 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.Content: Chapter 1 The Practice and Practitioners of Pharmaceutical Medicine (pages 1–5): Anthony W. FoxChapter 2 Pharmaceutical Medicine as a Medical Specialty (pages 6–21): Michael D. Young and Peter D. StonierChapter 3 Clinical Research Education and Training for Biopharmaceutical Staff (pages 22–35): Peter Marks and Sheila GwizdakChapter 5 Translational Medicine, Pharmaceutical Physicians, Patients, and Payers (pages 47–57): Robert Sands and Douglas RoyChapter 6 Pharmaceutics (pages 58–67): Anthony W. FoxChapter 7 Nonclinical Toxicology (pages 68–78): Frederick RenoChapter 8 Informed Consent (pages 79–83): Anthony W. FoxChapter 9 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure (pages 84–106): Stephen H. Curry, Helen H. Decory and Johan GabrielssonChapter 10 Phase II and Phase III Clinical Studies (pages 107–123): Anthony W. FoxChapter 11 Phase IV Drug Development: Post?Marketing Studies (pages 124–130): Lisa R. Johnson?PrattChapter 12 Site Management (pages 131–141): Barry MiskinChapter 13 Good Clinical Practices (pages 142–162): Lionel D. EdwardsChapter 14 Quality Assurance, Quality Control and Audit (pages 163–181): Rita Hattemer?ApostelChapter 15 The Unique Role of Over?the?Counter Medicine (pages 182–193): Paul W. StarkeyChapter 4 Drug Discovery: Design and Development (pages 39–46): Ronald R. Cobb and Leslie J. MolonyChapter 16 Drug Research in Older Patients (pages 197–206): Lionel D. EdwardsChapter 17 Drug Development Research in Women (pages 207–225): Lionel D. EdwardsChapter 18 Clinical Research in Children (pages 226–232): Lionel D. EdwardsChapter 19 Racial and Ethnic Issues in Drug Regulation (pages 233–249): Lionel D. Edwards, J?M. Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R. L. Williams and H. YasurharaChapter 20 Special Populations: Hepatic and Renal Failure (pages 250–254): Anthony W. FoxChapter 21 Drug Interactions (pages 255–263): Anthony W. Fox and Anne?Ruth van TroostenburgChapter 22 Orphan Drugs (pages 264–274): Bert SpilkerChapter 23 QT Interval Prolongation and Drug Development (pages 275–286): Bruce H. Morimoto and Anthony W. FoxChapter 24 Biotechnology Products and Their Development (pages 289–300): David A. Shapiro and Anthony W. FoxChapter 25 Health Economics (pages 301–314): Daniel C. Malone, Edward P. Armstrong and Mirza I. RahmanChapter 26 Pharmacoeconomics: Economic and Humanistic Outcomes (pages 315–325): Raymond J. Townsend, Jane T. Osterhaus and J. Gregory BoyerChapter 27 Pharmacoepidemiology and the Pharmaceutical Physician (pages 326–335): Hugh H. TilsonChapter 28 Statistical Principles and Application in Biopharmaceutical Research (pages 336–367): Dan AnbarChapter 29 Data Management (pages 368–378): T. Y. Lee, Michael Minor and Lionel D. EdwardsChapter 30 Patient Compliance: Pharmionics, A New Discipline (pages 379–387): Dr. Jean?Michel MetryChapter 31 Monitoring Drug Concentrations in Clinical Practice (pages 388–392): Anthony W. FoxChapter 32 Generics (pages 393–398): Gabriel Lopez and Thomas HoxieChapter 33 Complementary Medicines (pages 399–405): Anthony W. FoxChapter 34 United States Regulations (pages 409–421): William Kennedy and Lionel D. EdwardsChapter 35 Special US Regulatory Procedures: Emergency and “Compassionate” INDs and Accelerated Product Approvals (pages 422–429): Anthony W. FoxChapter 36 The Development of Human Medicines Control in Europe from Classical Times to the 21st Century (pages 430–455): John P. GriffinChapter 37 Medicines Regulation in the European Union (pages 456–508): Anne?Ruth van Troostenburg and Giuliana TabussoChapter 38 Japanese Regulations (pages 509–527): Etienne LabbeChapter 39 Drug Registration and Pricing in the Middle East (pages 528–534): Edda Freidank?Mueschenborn and Anja KonigChapter 40 China's Regulated Pharmaceutical Market (pages 535–550): Yan Yan Li StarkeyChapter 41 India's New Era in Pharmaceuticals (pages 551–567): Darshan KulkarniChapter 42 Medical Affairs (pages 571–581): Gregory P. GebaChapter 43 Drug Labeling (pages 582–586): Anthony W. FoxChapter 44 Data Mining (pages 587–600): Mirza I. Rahman and Robbert P. van ManenChapter 45 Risk Management in Product Approval and Marketing (pages 601–607): Anthony W. FoxChapter 46 Publishing Clinical Studies (pages 608–615): Anthony W. FoxChapter 47 Organizing and Planning Local, Regional, National, and International Meetings and Conferences (pages 616–619): Zofia Dziewanowska and Linda PackardChapter 48 When Things Go Wrong: Drug Withdrawals from the Market (pages 620–624): Ronald D. MannChapter 49 International Trials: Successful Planning and Conduct (pages 625–633): Katie P. J. WoodChapter 50 Introduction to Bioethics for Pharmaceutical Professionals (pages 637–644): Andrew J. FletcherChapter 51 Pharmaceutical Medicine and the Law (pages 645–654): Sarah CroftChapter 52 Fraud and Misconduct in Clinical Research (pages 655–665): Jane BarrettChapter 53 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico?Commercial Environment (pages 669–675): R. Drucker and R. Graham HughesChapter 54 Advertising and Marketing (pages 676–687): Jonathan BelseyChapter 55 Pharmaceutical Product Liability (pages 688–702): Han W. Choi and Jae Hong LeeChapter 56 Patents (pages 703–715): Gabriel LopezChapter 57 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (pages 716–738): John R. VogelChapter 58 The Impact of Managed Care on the US Pharmaceutical Industry (pages 739–761): Robert J. Chaponis, Christine Hanson?Divers and Marilyn J. Wells