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|a 9780470093146 (electronic bk.)
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|a Principles and practice of pharmaceutical medicine /
|c edited by Lionel D. Edwards ... [et al.].
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|a 2nd ed.
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|a Chichester, West Sussex ;
|a Hoboken, NJ :
|b John Wiley & Sons,
|c c2007.
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|a 1 online resource.
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|a Includes bibliographical references and index.
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|a Cover -- Contents -- Preface to the First Edition -- Preface to the Second Edition -- About the Editors -- Contributors -- SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE -- 1 The Practice and Practitioners of Pharmaceutical Medicine -- 2 Pharmaceutical Medicine as a Medical Specialty -- 3 Clinical Research Education and Training for Biopharmaceutical Staff -- SECTION II: DRUG DISCOVERY AND DEVELOPMENT -- Introduction -- 4 Drug Discovery: Design and Serendipity -- 5 Pharmaceutics -- 6 Nonclinical Toxicology -- 7 Informed Consent -- 8 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure -- 9 Phase II and Phase III Clinical Studies -- 10 Phase IV Drug Development: Post-Marketing Studies -- 11 Site Management -- 12 Good Clinical Practices -- 13 Quality Assurance, Quality Control and Audit -- 14 The Unique Role of Over-the-Counter Medicine -- SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES -- Introduction -- 15 Drug Research in Older Patients -- 16 Drug Development Research in Women -- 17 Clinical Research in Children -- 18 Racial and Ethnic Issues in Drug Registration -- 19 Hepatic and Renal Failure -- 20 Drug Interactions -- 21 Orphan Drugs -- SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT -- Introduction -- 22 Biotechnology Products and Development -- 23 Pharmacoeconomics: Economic and Humanistic Outcomes -- 24 Pharmacoepidemiology and the Pharmaceutical Physician -- 25 Statistical Principles and Application in Biopharmaceutical Research -- 26 Data Management -- 27 Patient Compliance: Pharmionics, a New Discipline -- 28 Monitoring Drug Concentrations in Clinical Practice -- 29 Generics -- 30 Complementary Medicines -- SECTION V: DRUG REGULATION -- Introduction -- 31 United States Regulations -- 32 Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals -- 33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 -- 34 Medicines Regulation in the European Union -- 35 Japanese Regulations -- 36 Drug Registration and Pricing in the Middle East -- SECTION VI: MEDICAL SERVICES -- Introduction -- 37 Medical Affairs -- 38 Drug Labeling -- 39 Drug Surveillance -- 40 Data Mining -- 41 Risk Management in Product Approval and Marketing -- 42 Publishing Clinical Studies -- 43 Organizing and Planning Local, Regional, National and International Meetings and Conferences -- 44 Drug Withdrawals from the Market -- Causes and Consequences -- SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE -- Introduction -- 45 Introduction to Bioethics for Pharmaceutical Professionals -- 46 Pharmaceutical Medicine and the Law -- 47 Pharmaceutical Product Liability -- 48 Patents -- 49 Fraud and Misconduct in Clinical Research -- SECTION VIII: BUSINESS ASPECTS -- Introduction -- 50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico.
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|a Description based on print version record.
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|a Drug development.
|0 http://id.loc.gov/authorities/subjects/sh97007921
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|a Drugs
|x Research.
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|a Pharmacology.
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|a Drug Evaluation.
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|a Pharmacology.
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|a Edwards, Lionel D.
|0 http://id.loc.gov/authorities/names/n2007181249
|1 http://viaf.org/viaf/166059581
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|i Print version:
|t Principles and practice of pharmaceutical medicine.
|b 2nd ed.
|d Chichester, West Sussex ; Hoboken, NJ : John Wiley & Sons, c2007
|z 9780470093139
|z 0470093137
|w (DLC) 2007011029
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|a RM301.25 .P75 2007
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