Principles and practice of pharmaceutical medicine / 2nd ed.
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作 者：edited by Lionel D. Edwards ... [et al.].
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ISBN：9780470093139
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简介
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.
目录
Table of contents Front Matter (pages i–xviii)
The Practice and Practitioners of Pharmaceutical Medicine (pages 1–5)Anthony W. Fox
Pharmaceutical Medicine as a Medical Specialty (pages 7–23)Michael D. Young and Peter D. Stonier
Clinical Research Education and Training for Biopharmaceutical Staff (pages 25–39)Peter Marks
Drug Discovery: Design and Serendipity (pages 43–50)Ronald R. Cobb and Leslie J. Molony
Pharmaceutics (pages 51–61)Anthony W. Fox
Nonclinical Toxicology (pages 63–73)Frederick Reno
Informed Consent (pages 75–78)Anthony W. Fox
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 Gabrielsson
Phase II and Phase III Clinical Studies (pages 101–117)Anthony W. Fox
Phase IV Drug Development: Post-Marketing Studies (pages 119–125)Lisa R. Johnson-Pratt
Site Management (pages 127–138)Barry Miskin
Good Clinical Practices (pages 139–158)Wendy Bohaychuk and Graham Ball
Quality Assurance, Quality Control and Audit (pages 159–178)Rita Hattemer-Apostel
The Unique Role of Over-the-Counter Medicine (pages 179–189)Paul Starkey
Drug Research in Older Patients (pages 193–201)Lionel D. Edwards
Drug Development Research in Women (pages 203–221)Dr. Lionel D. Edwards
Clinical Research in Children (pages 223–229)Lionel D. Edwards
Racial and Ethnic Issues in Drug Registration (pages 231–247)Lionel D. Edwards, J. M. Husson, E. Labbé, C. Naito, M. Papaluca Amati, S. Walker, R. Williams and H. Yasurhara
Hepatic and Renal Failure (pages 249–254)Anthony W. Fox
Drug Interactions (pages 255–263)Anthony W. Fox and Anne-Ruth van Troostenburg de Bruyn
Orphan Drugs †(pages 265–276)Bert Spilker
Biotechnology Products and Development (pages 279–290)David A. Shapiro and Anthony W. Fox
Pharmacoeconomics: Economic and Humanistic Outcomes (pages 291–301)Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer
Pharmacoepidemiology and the Pharmaceutical Physician (pages 303–312)Hugh H. Tilson
Statistical Principles and Application in Biopharmaceutical Research (pages 313–343)Dan Anbar
Data Management (pages 345–354)T. Y. Lee and Michael Minor
Patient Compliance: Pharmionics, a New Discipline (pages 355–373)Jean-Michel Métry
Monitoring Drug Concentrations in Clinical Practice (pages 377–380)Anthony W. Fox
Generics (pages 381–385)J. D. Gabriel Lopez and J. D. Thomas Hoxie
Complementary Medicines (pages 387–392)Anthony W. Fox
United States Regulations †(pages 395–406)William Kennedy
Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals (pages 407–414)Anthony W. Fox
The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 †(pages 415–441)John P. Griffin
Medicines Regulation in the European Union (pages 443–486)Anne-Ruth van Troostenburg de Bruyn and Giuliana Tabusso
Japanese Regulations †(pages 487–507)Etienne Labbé
Drug Registration and Pricing in the Middle East (pages 509–515)Edda Freidank-Mueschenbornfs
Medical Affairs (pages 519–527)Gregory P. Geba
Drug Labeling (pages 529–533)Anthony W. Fox
Drug Surveillance (pages 535–543)Howard J. Dreskin and Win M. Castle
Data Mining (pages 545–555)Mirza I. Rahman and Omar H. Dabbous
Risk Management in Product Approval and Marketing (pages 557–563)Anthony W. Fox
Publishing Clinical Studies (pages 565–573)Anthony W. Fox
Organizing and Planning Local, Regional, National and International Meetings and Conferences (pages 575–578)Zofia Dziewanowska and Linda Packard
Drug Withdrawals from the Market – Causes and Consequences (pages 579–584)Ronald D. Mann
Introduction to Bioethics for Pharmaceutical Professionals (pages 587–594)Andrew J. Fletcher
Pharmaceutical Medicine and the Law (pages 595–603)Sarah Croft and Timothy Pratt
Pharmaceutical Product Liability (pages 605–617)Han W. Choi and Howard B. Yeon
Patents (pages 619–630)Gabriel Lopez
Fraud and Misconduct in Clinical Research (pages 631–641)Jane Barrett
The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment (pages 645–651)R. Drucker and R. Graham Hughes
Advertising and Marketing (pages 654–664)Jonathan Belsey
Middle East, India, China and the Far East: Pharmaceutical Medicine in the East (pages 665–687)Gamal Hammad
Financial Aspects of Clinical Trials (pages 689–700)R.G. Hughes and N. Turner
Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (pages 701–723)John R. Vogel
The Impact of Managed Care on the US Pharmaceutical Industry (pages 725–744)Robert J. Chaponis, Christine Hanson-Divers and Marilyn J. Wells
The Practice and Practitioners of Pharmaceutical Medicine (pages 1–5)Anthony W. Fox
Pharmaceutical Medicine as a Medical Specialty (pages 7–23)Michael D. Young and Peter D. Stonier
Clinical Research Education and Training for Biopharmaceutical Staff (pages 25–39)Peter Marks
Drug Discovery: Design and Serendipity (pages 43–50)Ronald R. Cobb and Leslie J. Molony
Pharmaceutics (pages 51–61)Anthony W. Fox
Nonclinical Toxicology (pages 63–73)Frederick Reno
Informed Consent (pages 75–78)Anthony W. Fox
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 Gabrielsson
Phase II and Phase III Clinical Studies (pages 101–117)Anthony W. Fox
Phase IV Drug Development: Post-Marketing Studies (pages 119–125)Lisa R. Johnson-Pratt
Site Management (pages 127–138)Barry Miskin
Good Clinical Practices (pages 139–158)Wendy Bohaychuk and Graham Ball
Quality Assurance, Quality Control and Audit (pages 159–178)Rita Hattemer-Apostel
The Unique Role of Over-the-Counter Medicine (pages 179–189)Paul Starkey
Drug Research in Older Patients (pages 193–201)Lionel D. Edwards
Drug Development Research in Women (pages 203–221)Dr. Lionel D. Edwards
Clinical Research in Children (pages 223–229)Lionel D. Edwards
Racial and Ethnic Issues in Drug Registration (pages 231–247)Lionel D. Edwards, J. M. Husson, E. Labbé, C. Naito, M. Papaluca Amati, S. Walker, R. Williams and H. Yasurhara
Hepatic and Renal Failure (pages 249–254)Anthony W. Fox
Drug Interactions (pages 255–263)Anthony W. Fox and Anne-Ruth van Troostenburg de Bruyn
Orphan Drugs †(pages 265–276)Bert Spilker
Biotechnology Products and Development (pages 279–290)David A. Shapiro and Anthony W. Fox
Pharmacoeconomics: Economic and Humanistic Outcomes (pages 291–301)Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer
Pharmacoepidemiology and the Pharmaceutical Physician (pages 303–312)Hugh H. Tilson
Statistical Principles and Application in Biopharmaceutical Research (pages 313–343)Dan Anbar
Data Management (pages 345–354)T. Y. Lee and Michael Minor
Patient Compliance: Pharmionics, a New Discipline (pages 355–373)Jean-Michel Métry
Monitoring Drug Concentrations in Clinical Practice (pages 377–380)Anthony W. Fox
Generics (pages 381–385)J. D. Gabriel Lopez and J. D. Thomas Hoxie
Complementary Medicines (pages 387–392)Anthony W. Fox
United States Regulations †(pages 395–406)William Kennedy
Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals (pages 407–414)Anthony W. Fox
The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 †(pages 415–441)John P. Griffin
Medicines Regulation in the European Union (pages 443–486)Anne-Ruth van Troostenburg de Bruyn and Giuliana Tabusso
Japanese Regulations †(pages 487–507)Etienne Labbé
Drug Registration and Pricing in the Middle East (pages 509–515)Edda Freidank-Mueschenbornfs
Medical Affairs (pages 519–527)Gregory P. Geba
Drug Labeling (pages 529–533)Anthony W. Fox
Drug Surveillance (pages 535–543)Howard J. Dreskin and Win M. Castle
Data Mining (pages 545–555)Mirza I. Rahman and Omar H. Dabbous
Risk Management in Product Approval and Marketing (pages 557–563)Anthony W. Fox
Publishing Clinical Studies (pages 565–573)Anthony W. Fox
Organizing and Planning Local, Regional, National and International Meetings and Conferences (pages 575–578)Zofia Dziewanowska and Linda Packard
Drug Withdrawals from the Market – Causes and Consequences (pages 579–584)Ronald D. Mann
Introduction to Bioethics for Pharmaceutical Professionals (pages 587–594)Andrew J. Fletcher
Pharmaceutical Medicine and the Law (pages 595–603)Sarah Croft and Timothy Pratt
Pharmaceutical Product Liability (pages 605–617)Han W. Choi and Howard B. Yeon
Patents (pages 619–630)Gabriel Lopez
Fraud and Misconduct in Clinical Research (pages 631–641)Jane Barrett
The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment (pages 645–651)R. Drucker and R. Graham Hughes
Advertising and Marketing (pages 654–664)Jonathan Belsey
Middle East, India, China and the Far East: Pharmaceutical Medicine in the East (pages 665–687)Gamal Hammad
Financial Aspects of Clinical Trials (pages 689–700)R.G. Hughes and N. Turner
Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (pages 701–723)John R. Vogel
The Impact of Managed Care on the US Pharmaceutical Industry (pages 725–744)Robert J. Chaponis, Christine Hanson-Divers and Marilyn J. Wells
Principles and practice of pharmaceutical medicine / 2nd ed.
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