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📙 Principles and Practice of Pharmaceutical Medicine, Second Edition by — pdf free


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.

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. Fox
Chapter 2 Pharmaceutical Medicine as a Medical Specialty (pages 7–23): Michael D. Young and Peter D. Stonier
Chapter 3 Clinical Research Education and Training for Biopharmaceutical Staff (pages 25–39): Peter Marks
Chapter 4 Drug Discovery: Design and Serendipity (pages 43–50): Ronald R. Cobb and Leslie J. Molony
Chapter 5 Pharmaceutics (pages 51–61): Anthony W. Fox
Chapter 6 Nonclinical Toxicology (pages 63–73): Frederick Reno
Chapter 7 Informed Consent (pages 75–78): Anthony W. Fox
Chapter 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 Gabrielsson
Chapter 9 Phase II and Phase III Clinical Studies (pages 101–117): Anthony W. Fox
Chapter 10 Phase IV Drug Development: Post?Marketing Studies (pages 119–125): Lisa R. Johnson?Pratt
Chapter 11 Site Management (pages 127–138): Barry Miskin
Chapter 12 Good Clinical Practices (pages 139–158): Wendy Bohaychuk and Graham Ball
Chapter 13 Quality Assurance, Quality Control and Audit (pages 159–178): Rita Hattemer?Apostel
Chapter 14 The Unique Role of Over?the?Counter Medicine (pages 179–189): Paul Starkey
Chapter 15 Drug Research in Older Patients (pages 193–201): Lionel D. Edwards
Chapter 16 Drug Development Research in Women (pages 203–221): Dr. Lionel D. Edwards
Chapter 17 Clinical Research in Children (pages 223–229): Lionel D. Edwards
Chapter 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. Yasurhara
Chapter 19 Hepatic and Renal Failure (pages 249–254): Anthony W. Fox
Chapter 20 Drug Interactions (pages 255–263): Anthony W. Fox and Anne?Ruth van Troostenburg de Bruyn
Chapter 21 Orphan Drugs (pages 265–276): Bert Spilker
Chapter 22 Biotechnology Products and Development (pages 279–290): David A. Shapiro and Anthony W. Fox
Chapter 23 Pharmacoeconomics: Economic and Humanistic Outcomes (pages 291–301): Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer
Chapter 24 Pharmacoepidemiology and the Pharmaceutical Physician (pages 303–312): Hugh H. Tilson
Chapter 25 Statistical Principles and Application in Biopharmaceutical Research (pages 313–343): Dan Anbar
Chapter 26 Data Management (pages 345–354): T. Y. Lee and Michael Minor
Chapter 27 Patient Compliance: Pharmionics, a New Discipline (pages 355–373): Jean?Michel Metry
Chapter 28 Monitoring Drug Concentrations in Clinical Practice (pages 377–380): Anthony W. Fox
Chapter 29 Generics (pages 381–385): J. D. Gabriel Lopez and J. D. Thomas Hoxie
Chapter 30 Complementary Medicines (pages 387–392): Anthony W. Fox
Chapter 31 United States Regulations (pages 395–406): William Kennedy
Chapter 32 Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals (pages 407–414): Anthony W. Fox
Chapter 33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 (pages 415–441): John P. Griffin
Chapter 34 Medicines Regulation in the European Union (pages 443–486): Anne?Ruth van Troostenburg de Bruyn and Giuliana Tabusso
Chapter 35 Japanese Regulations (pages 487–507): Etienne Labbe
Chapter 36 Drug Registration and Pricing in the Middle East (pages 509–515): Edda Freidank?Mueschenbornfs
Chapter 37 Medical Affairs (pages 519–527): Gregory P. Geba
Chapter 38 Drug Labeling (pages 529–533): Anthony W. Fox
Chapter 39 Drug Surveillance (pages 535–543): Howard J. Dreskin and Win M. Castle
Chapter 40 Data Mining (pages 545–555): Mirza I. Rahman and Omar H. Dabbous
Chapter 41 Risk Management in Product Approval and Marketing (pages 557–563): Anthony W. Fox
Chapter 42 Publishing Clinical Studies (pages 565–573): Anthony W. Fox
Chapter 43 Organizing and Planning Local, Regional, National and International Meetings and Conferences (pages 575–578): Zofia Dziewanowska and Linda Packard
Chapter 44 Drug Withdrawals from the Market – Causes and Consequences (pages 579–584): Ronald D. Mann
Chapter 45 Introduction to Bioethics for Pharmaceutical Professionals (pages 587–594): Andrew J. Fletcher
Chapter 46 Pharmaceutical Medicine and the Law (pages 595–603): Sarah Croft and Timothy Pratt
Chapter 47 Pharmaceutical Product Liability (pages 605–617): Han W. Choi and Howard B. Yeon
Chapter 48 Patents (pages 619–630): Gabriel Lopez
Chapter 49 Fraud and Misconduct in Clinical Research (pages 631–641): Jane Barrett
Chapter 50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico?commercial Environment (pages 645–651): R. Drucker and R. Graham Hughes
Chapter 51 Advertising and Marketing (pages 654–664): Jonathan Belsey
Chapter 52 Middle East, India, China and the Far East: Pharmaceutical Medicine in the East (pages 665–687): Gamal Hammad
Chapter 53 Financial Aspects of Clinical Trials (pages 689–700): R.G. Hughes and N. Turner
Chapter 54 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (pages 701–723): John R. Vogel
Chapter 55 The Impact of Managed Care on the US Pharmaceutical Industry (pages 725–744): Robert J. Chaponis, Christine Hanson?Divers and Marilyn J. Wells

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