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The Textbook of Pharmaceutical Medicine-[5th ed]-[pdf]-[John P. Griffin, John O'Grady]

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    书籍信息:
    标题: The Textbook of Pharmaceutical Medicine
    语言: English
    格式: pdf
    大小: 5.1M
    页数: 873
    年份: 2006
    作者: John P. Griffin, John O'Grady
    版次: 5th ed
    出版社: Blackwell

    简介

    New edition of succesful standard reference book for the pharmaceutical industry and pharmaceutical physicians!   The Textbook of Pharmaceutical Medicine  is the coursebook for the Diploma in Pharmaceutical Medicine, and is used as a standard reference throughout the pharmaceutical industry. The new edition includes greater coverage of good clinical practice, a completely revised statistics chapter, and more on safety. Covers the course information for the Diploma in Pharmaceutical Medicine  
    • Fully updated, with new authors  
    • Greater coverage of good clinical practice and safety  
    • New chapters on regulation of medical devices in Europe and regulation of therapeutic products in Australia



    目录
    Cover......Page 1
    The Textbook of Pharmaceutical Medicine, Fifth Edition......Page 2
    Copyright......Page 3
    Contents......Page 4
    Contributors......Page 6
    Preface......Page 8
    Acknowledgements......Page 9
    The Editors......Page 10
    Part I Research and Development......Page 12
    1 Discovery of New Medicines......Page 13
    2 Pharmaceutical Development......Page 97
    3 Preclinical Safety Testing......Page 121
    4 Exploratory Development......Page 154
    5 Clinical Pharmacokinetics......Page 186
    6 Purpose and Design of Clinical Trials......Page 208
    7 Conduct of Clinical Trials: Good Clinical Practice......Page 249
    8 Medical Statistics......Page 285
    9 Development of Medicines: Full Development......Page 320
    Part II: Medical Department Issues......Page 339
    10 The Medical Department......Page 340
    11 Medical Marketing......Page 349
    12 Information and Promotion......Page 364
    13 The Supply of Unlicensed Medicines for Particular Patient Use......Page 389
    14 Legal and Ethical Issues Relating to Medicinal Products......Page 399
    15 The Safety of Medical Products......Page 419
    Part III: Regulatory Aspects......Page 463
    16 History of Drug Regulation in the United Kingdom......Page 464
    17 Regulation of Human Medicinal Products in the European Union......Page 496
    18 European Regulation of Medical Devices......Page 542
    19 Technical Requirements for Registration of Pharmaceuticals for Human Use: the ICH Process......Page 559
    20 The Regulation of Drug Products by the United States Food and Drug Administration......Page 572
    21 The US FDA in the Drug Development, Evaluation and Approval Process......Page 609
    22 Past Evolution and Future Prospects of the Pharma Industry and its Regulation in the USA......Page 621
    23 Regulatory and Clinical Trial Systems in Japan......Page 644
    24 The Regulation of Therapeutic Products in Australia......Page 659
    Part IV: Pharmacoeconomic and Other Issues......Page 692
    25 Economics of Healthcare......Page 693
    26 Controls on NHS Medicines Prescribing and Expenditure in the UK (A Historical Perspective) with some International Comparisons......Page 708
    Appendix 1 Declaration of Helsinki......Page 726
    Appendix 2 Code of Practice for the Pharmaceutical Industry......Page 732
    Appendix 3 Guidelines and Documentation for Implementation of Clinical Trials......Page 792
    Appendix 4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001......Page 831
    Index......Page 848

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