Principles and Practice of Pharmaceutical Medicine 2/e 2007
定價
$ 2,450
售價
$ 2,328
數量:
Principles and Practice of Pharmaceutical Medicine 2/e 2007-需求單
內容簡介
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 Regulations
• Ethics of Pharmaceutical Medicine
• Licensing and Due Diligence
• Pharmacogenomics
Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available.
作者簡介
Lionel D Edwards. 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 & 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.
Anthony W Fox. 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 guardant 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.
Peter D Stonier. 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.
Andrew J. Fletcher. MB, BChir, (Cantab), MS (Columbia), FFPM, DipPharmMedRCP, was formerly the Senior Assistant Editor of The Merck Manual, and is Adjunct Professor of Pharmaceutical Health Care at Temple University School of Pharmacy. He teaches pharmaceutical medicine, bioethics, and medical and scientific writing at Temple University’s School of Pharmacy. He is a founder member and former trustee of the Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharmaceutical Physicians).
目次
SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE.
CHAPTER 1. The Practice and Practitioners of Pharmaceutical Medicine / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 2. Pharmaceutical Medicine as a Medical Specialty / Michael D. Young, Peter D. Stonier BA, BSc, PhD, MBChB, MRCPsych, FRCP, FRCPE, FFPM
CHAPTER 3. Clinical Research Education and Training for Biopharmaceutical Staff / Peter Marks
SECTION II: DRUG DISCOVERY AND DEVELOPMENT.
Part Introduction
CHAPTER 4. Drug Discovery: Design and Serendipity / Ronald R. Cobb, Leslie J. Molony
CHAPTER 5. Pharmaceutics / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 6. Nonclinical Toxicology / Frederick Reno
CHAPTER 7. Informed Consent / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 8. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure / Stephen H. Curry, Dennis McCarthy, Helen H. DeCory, Matthew Marler, Johan Gabrielsson
CHAPTER 9. Phase II and Phase III Clinical Studies / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 10. Phase IV Drug Development: Post-Marketing Studies / Lisa R. Johnson-Pratt
CHAPTER 11. Site Management / Barry Miskin
CHAPTER 12. Good Clinical Practices / Wendy Bohaychuk, Graham Ball
CHAPTER 13. Quality Assurance, Quality Control and Audit / Rita Hattemer-Apostel
CHAPTER 14. The Unique Role of Over-the-Counter Medicine / Paul Starkey
SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES.
Part Introduction
CHAPTER 15. Drug Research in Older Patients / Lionel D. Edwards MB, BS, LRCP, MRCS, DipRCOG, FFPM
CHAPTER 16. Drug Development Research in Women / Dr. Lionel D. Edwards MB, BS, LRCP, MRCS, DipRCOG, FFPM
CHAPTER 17. Clinical Research in Children / Lionel D. Edwards MB, BS, LRCP, MRCS, DipRCOG, FFPM
CHAPTER 18. Racial and Ethnic Issues in Drug Registration / Lionel D. Edwards MB, BS, LRCP, MRCS, DipRCOG, FFPM, J. M. Husson, E. Labbé, C. Naito, M. Papaluca Amati, S. Walker, R. Williams, H. Yasurhara
CHAPTER 19. Hepatic and Renal Failure / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 20. Drug Interactions / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol, Anne-Ruth van Troostenburg de Bruyn
CHAPTER 21. Orphan Drugs / Bert Spilker
SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT.
Part Introduction
CHAPTER 22. Biotechnology Products and Development / David A. Shapiro, Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 23. Pharmacoeconomics: Economic and Humanistic Outcomes / Raymond J. Townsend, Jane T. Osterhaus, J. Gregory Boyer
CHAPTER 24. Pharmacoepidemiology and the Pharmaceutical Physician / Hugh H. Tilson
CHAPTER 25. Statistical Principles and Application in Biopharmaceutical Research / Dan Anbar
CHAPTER 26. Data Management / T. Y. Lee, Michael Minor
CHAPTER 27. Patient Compliance: Pharmionics, a New Discipline / Jean-Michel Métry
CHAPTER 28. Monitoring Drug Concentrations in Clinical Practice / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 29. Generics / J. D. Gabriel Lopez, J. D. Thomas Hoxie
CHAPTER 30. Complementary Medicines / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
SECTION V: DRUG REGULATION.
Part Introduction
CHAPTER 31. United States Regulations / William Kennedy
CHAPTER 32. Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 33. The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 / John P. Griffin
CHAPTER 34. Medicines Regulation in the European Union / Anne-Ruth van Troostenburg de Bruyn, Giuliana Tabusso
CHAPTER 35. Japanese Regulations / Etienne Labbé
CHAPTER 36. Drug Registration and Pricing in the Middle East / Edda Freidank-Mueschenbornfs
SECTION: VI: MEDICAL SERVICES.
Part Introduction
CHAPTER 37. Medical Affairs / Gregory P. Geba
CHAPTER 38. Drug Labeling / Anthony W. Fox
CHAPTER 39. Drug Surveillance / Howard J. Dreskin, Win M. Castle
CHAPTER 40. Data Mining / Mirza I. Rahman, Omar H. Dabbous
CHAPTER 41. Risk Management in Product Approval and Marketing / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 42. Publishing Clinical Studies / Anthony W. Fox BSc, MBBS, FFPM, FRCP, MD, DipPharmMedRCP, CBiol, FIBiol
CHAPTER 43. Organizing and Planning Local, Regional, National and International Meetings and Conferences / Zofia Dziewanowska, Linda Packard
CHAPTER 44. Drug Withdrawals from the Market – Causes and Consequences / Ronald D. Mann
SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE.
Part Introduction
CHAPTER 45. Introduction to Bioethics for Pharmaceutical Professionals / Andrew J. Fletcher MB, BChir, MS, DipPharmMedRCP, FFPM
CHAPTER 46. Pharmaceutical Medicine and the Law / Sarah Croft, Timothy Pratt
CHAPTER 47. Pharmaceutical Product Liability / Han W. Choi, Howard B. Yeon
CHAPTER 48. Patents / Gabriel Lopez
CHAPTER 49. Fraud and Misconduct in Clinical Research / Jane Barrett
SECTION VIII: BUSINESS ASPECTS.
Part Introduction
CHAPTER 50. The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment / R. Drucker, R. Graham Hughes
CHAPTER 51. Advertising and Marketing / Jonathan Belsey
CHAPTER 52. Middle East, India, China and the Far East: Pharmaceutical Medicine in the East / Gamal Hammad
CHAPTER 53. Financial Aspects of Clinical Trials / R.G. Hughes, N. Turner
CHAPTER 54. Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors / John R. Vogel
CHAPTER 55. The Impact of Managed Care on the US Pharmaceutical Industry / Robert J. Chaponis, Christine Hanson-Divers, Marilyn J. Wells
Appendix: Useful Internet links
Index
ISBN-13碼 :
9780470093139
出版日期 :
2007
版次 :
2
書系代碼 :
37129
作者 :
Lionel D. Edwards.Andrew J. Fletcher.Anthony W. Fox.Peter D. Stonier
開數 :
18開
頁數 :
780
裝訂 :
精裝
定價 :
NT$2,450.00
