Principles and Practice of Pharmaceutical Medicine, Second Edition

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 RegulationsEthics of Pharmaceutical MedicineLicensing and Due DiligencePharmacogenomicsEncompassing 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 Content: Chapter 1 The Practice and Practitioners of Pharmaceutical Medicine (pages 1–5): Anthony W. FoxChapter 2 Pharmaceutical Medicine as a Medical Specialty (pages 7–23): Michael D. Young and Peter D. StonierChapter 3 Clinical Research Education and Training for Biopharmaceutical Staff (pages 25–39): Peter MarksChapter 4 Drug Discovery: Design and Serendipity (pages 43–50): Ronald R. Cobb and Leslie J. MolonyChapter 5 Pharmaceutics (pages 51–61): Anthony W. FoxChapter 6 Nonclinical Toxicology (pages 63–73): Frederick RenoChapter 7 Informed Consent (pages 75–78): Anthony W. FoxChapter 8 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure (pages 79–100): Stephen H. Curry, Dennis McCarthy, Helen H. DeCory, Matthew Marler and Johan GabrielssonChapter 9 Phase II and Phase III Clinical Studies (pages 101–117): Anthony W. FoxChapter 10 Phase IV Drug Development: Post?Marketing Studies (pages 119–125): Lisa R. Johnson?PrattChapter 11 Site Management (pages 127–138): Barry MiskinChapter 12 Good Clinical Practices (pages 139–158): Wendy Bohaychuk and Graham BallChapter 13 Quality Assurance, Quality Control and Audit (pages 159–178): Rita Hattemer?ApostelChapter 14 The Unique Role of Over?the?Counter Medicine (pages 179–189): Paul StarkeyChapter 15 Drug Research in Older Patients (pages 193–201): Lionel D. EdwardsChapter 16 Drug Development Research in Women (pages 203–221): Dr. Lionel D. EdwardsChapter 17 Clinical Research in Children (pages 223–229): Lionel D. EdwardsChapter 18 Racial and Ethnic Issues in Drug Registration (pages 231–247): Lionel D. Edwards, J. M. Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R. Williams and H. YasurharaChapter 19 Hepatic and Renal Failure (pages 249–254): Anthony W. FoxChapter 20 Drug Interactions (pages 255–263): Anthony W. Fox and Anne?Ruth van Troostenburg de BruynChapter 21 Orphan Drugs (pages 265–276): Bert SpilkerChapter 22 Biotechnology Products and Development (pages 279–290): David A. Shapiro and Anthony W. FoxChapter 23 Pharmacoeconomics: Economic and Humanistic Outcomes (pages 291–301): Raymond J. Townsend, Jane T. Osterhaus and J. Gregory BoyerChapter 24 Pharmacoepidemiology and the Pharmaceutical Physician (pages 303–312): Hugh H. TilsonChapter 25 Statistical Principles and Application in Biopharmaceutical Research (pages 313–343): Dan AnbarChapter 26 Data Management (pages 345–354): T. Y. Lee and Michael MinorChapter 27 Patient Compliance: Pharmionics, a New Discipline (pages 355–373): Jean?Michel MetryChapter 28 Monitoring Drug Concentrations in Clinical Practice (pages 377–380): Anthony W. FoxChapter 29 Generics (pages 381–385): J. D. Gabriel Lopez and J. D. Thomas HoxieChapter 30 Complementary Medicines (pages 387–392): Anthony W. FoxChapter 31 United States Regulations (pages 395–406): William KennedyChapter 32 Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals (pages 407–414): Anthony W. FoxChapter 33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 (pages 415–441): John P. GriffinChapter 34 Medicines Regulation in the European Union (pages 443–486): Anne?Ruth van Troostenburg de Bruyn and Giuliana TabussoChapter 35 Japanese Regulations (pages 487–507): Etienne LabbeChapter 36 Drug Registration and Pricing in the Middle East (pages 509–515): Edda Freidank?MueschenbornfsChapter 37 Medical Affairs (pages 519–527): Gregory P. GebaChapter 38 Drug Labeling (pages 529–533): Anthony W. FoxChapter 39 Drug Surveillance (pages 535–543): Howard J. Dreskin and Win M. CastleChapter 40 Data Mining (pages 545–555): Mirza I. Rahman and Omar H. DabbousChapter 41 Risk Management in Product Approval and Marketing (pages 557–563): Anthony W. FoxChapter 42 Publishing Clinical Studies (pages 565–573): Anthony W. FoxChapter 43 Organizing and Planning Local, Regional, National and International Meetings and Conferences (pages 575–578): Zofia Dziewanowska and Linda PackardChapter 44 Drug Withdrawals from the Market – Causes and Consequences (pages 579–584): Ronald D. MannChapter 45 Introduction to Bioethics for Pharmaceutical Professionals (pages 587–594): Andrew J. FletcherChapter 46 Pharmaceutical Medicine and the Law (pages 595–603): Sarah Croft and Timothy PrattChapter 47 Pharmaceutical Product Liability (pages 605–617): Han W. Choi and Howard B. YeonChapter 48 Patents (pages 619–630): Gabriel LopezChapter 49 Fraud and Misconduct in Clinical Research (pages 631–641): Jane BarrettChapter 50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico?commercial Environment (pages 645–651): R. Drucker and R. Graham HughesChapter 51 Advertising and Marketing (pages 654–664): Jonathan BelseyChapter 52 Middle East, India, China and the Far East: Pharmaceutical Medicine in the East (pages 665–687): Gamal HammadChapter 53 Financial Aspects of Clinical Trials (pages 689–700): R.G. Hughes and N. TurnerChapter 54 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (pages 701–723): John R. VogelChapter 55 The Impact of Managed Care on the US Pharmaceutical Industry (pages 725–744): Robert J. Chaponis, Christine Hanson?Divers and Marilyn J. Wells