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Principles and Practice of Pharmaceutical Medicine

780 Pages · 2007 · 7.46 MB · English

  • Principles and Practice of Pharmaceutical Medicine

    Principles and Practice


    of Pharmaceutical Medicine


    Second Edition Principles and Practice


    of Pharmaceutical Medicine


    Second Edition


    Edited by


    Lionel D. Edwards


    NovartisandPharmaProPlusInc.NewJersey,USA


    Andrew J. Fletcher


    TempleUniversitySchoolofPharmacy,Philadelphia,USA


    Anthony W. Fox


    EBDGroupInc.,California,USAandMunich,Germany


    andSkaggsSPPS,UniversityofCalifornia,SanDiego


    Peter D. Stonier


    ConsultantinPharmaceuticalMedicine,Richmond,Surrey,UK Copyright(cid:1)2007 JohnWiley&SonsLtd,TheAtrium,SouthernGate,Chichester,


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    LibraryofCongressCataloging-in-PublicationData


    Principlesandpracticeofpharmaceuticalmedicine/editedbyLionelD.Edwards...[etal.].–2nded.


    p.;cm.


    Includesbibliographicalreferencesandindex.


    ISBN978-0-470-09313-9(cloth:alk.paper)


    1.Drugdevelopment.2.Drugs–Research.3.Pharmacology.I.Edwards,LionelD.


    [DNLM:1. DrugEvaluation.2. DrugIndustry–organization&administration. QV736P95672007]


    RM301.25.P752007


    615’.19–dc22 2007011029


    BritishLibraryCataloguinginPublicationData


    AcataloguerecordforthisbookisavailablefromtheBritishLibrary


    ISBN978-0-470-09313-9


    Typesetin10.5/12.5ptTimesbyThomsonDigital,India


    PrintedandboundinGreatBritainbyAntonyRoweLtd.,Chippenham,Wilts


    Thisbookisprintedonacid-freepaperresponsiblymanufacturedfromsustainableforestry


    inwhichatleasttwotreesareplantedforeachoneusedforpaperproduction. Contents


    Preface to the First Edition ix


    Preface to the Second Edition xi


    About the Editors xiii


    Contributors xv


    SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE 1


    1 The Practice and Practitioners of Pharmaceutical Medicine 3


    Anthony W. Fox


    2 Pharmaceutical Medicine as a Medical Specialty 7


    Michael D. Young and Peter D. Stonier


    3 Clinical Research Education and Training for Biopharmaceutical Staff 25


    Peter Marks


    SECTION II: DRUG DISCOVERY AND DEVELOPMENT 41


    Introduction 41


    4 Drug Discovery: Design and Serendipity 43


    Ronald R. Cobb and Leslie J. Molony


    5 Pharmaceutics 51


    Anthony W. Fox


    6 Nonclinical Toxicology 63


    Frederick Reno


    7 Informed Consent 75


    Anthony W. Fox


    8 Phase I: The First Opportunity for Extrapolation from Animal


    Data to Human Exposure 79


    Stephen H. Curry, Dennis McCarthy, Helen H. DeCory, Matthew Marler


    and Johan Gabrielsson


    9 Phase II and Phase III Clinical Studies 101


    Anthony W. Fox


    10 Phase IV Drug Development: Post-Marketing Studies 119


    Lisa R. Johnson-Pratt vi CONTENTS


    11 Site Management 127


    Barry Miskin


    12 Good Clinical Practices 139


    Wendy Bohaychuk and Graham Ball


    13 Quality Assurance, Quality Control and Audit 159


    Rita Hattemer-Apostel


    14 The Unique Role of Over-the-Counter Medicine 179


    Paul Starkey


    SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES 191


    Introduction 191


    15 Drug Research in Older Patients 193


    Lionel D. Edwards


    16 Drug Development Research in Women 203


    Lionel D. Edwards


    17 Clinical Research in Children 223


    Lionel D. Edwards


    18 Racial and Ethnic Issues in Drug Registration 231


    Lionel D. Edwards, J.M. Husson, E. Labbe´, C. Naito, M. Papaluca Amati,


    S. Walker, R. Williams and H. Yasurhara


    19 Hepatic and Renal Failure 249


    Anthony W. Fox


    20 Drug Interactions 255


    Anthony W. Fox and Anne-Ruth van Troostenburg de Bruyn


    21 Orphan Drugs 265


    Bert Spilker


    SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT 277


    Introduction 277


    22 Biotechnology Products and Development 279


    David A. Shapiro and Anthony W. Fox


    23 Pharmacoeconomics: Economic and Humanistic Outcomes 291


    Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer


    24 Pharmacoepidemiology and the Pharmaceutical Physician 303


    Hugh H. Tilson


    25 Statistical Principles and Application in Biopharmaceutical Research 313


    Dan Anbar


    26 Data Management 345


    T.Y. Lee and Michael Minor CONTENTS vii


    27 Patient Compliance: Pharmionics, a New Discipline 355


    Jean-Michel Me´try


    28 Monitoring Drug Concentrations in Clinical Practice 375


    Anthony W. Fox


    29 Generics 381


    J.D. Gabriel Lopez and J.D. Thomas Hoxie


    30 Complementary Medicines 387


    Anthony W. Fox


    SECTION V: DRUG REGULATION 393


    Introduction 393


    31 United States Regulations 395


    William Kennedy


    32 Special US Regulatory Procedures: Emergency and Compassionate INDs


    and Accelerated Product Approvals 407


    Anthony W. Fox


    33 The Development of Human Medicines Control in Europe from Classical


    Times to the Year 2000 415


    John P. Griffin


    34 Medicines Regulation in the European Union 443


    Anne-Ruth van Troostenburg de Bruyn and Giuliana Tabusso


    35 Japanese Regulations 487


    Etienne Labbe´


    36 Drug Registration and Pricing in the Middle East 509


    Edda Freidank-Mueschenbornfs


    SECTION VI: MEDICAL SERVICES 517


    Introduction 517


    37 Medical Affairs 519


    Gregory P. Geba


    38 Drug Labeling 529


    Anthony W. Fox


    39 Drug Surveillance 535


    Howard J. Dreskin and Win M. Castle


    40 Data Mining 545


    Mirza I. Rahman and Omar H. Dabbous


    41 Risk Management in Product Approval and Marketing 557


    Anthony W. Fox viii CONTENTS


    42 Publishing Clinical Studies 565


    Anthony W. Fox


    43 Organizing and Planning Local, Regional, National and International Meetings


    and Conferences 575


    Zofia Dziewanowska and Linda Packard


    44 Drug Withdrawals from the Market – Causes and Consequences 579


    Ronald D. Mann


    SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE 585


    Introduction 585


    45 Introduction to Bioethics for Pharmaceutical Professionals 587


    Andrew J. Fletcher


    46 Pharmaceutical Medicine and the Law 595


    Sarah Croft and Timothy Pratt


    47 Pharmaceutical Product Liability 605


    Han W. Choi and Howard B. Yeon


    48 Patents 619


    Gabriel Lopez


    49 Fraud and Misconduct in Clinical Research 631


    Jane Barrett


    SECTION VIII: BUSINESS ASPECTS 643


    Introduction 643


    50 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory


    Framework and the Medico-commercial Environment 645


    R. Drucker and R. Graham Hughes


    51 Advertising and Marketing 653


    Jonathan Belsey


    52 Middle East, India, China and the Far East: Pharmaceutical Medicine in the East 665


    Gamal Hammad


    53 Financial Aspects of Clinical Trials 689


    R.G. Hughes and N. Turner


    54 Outsourcing Clinical Drug Development Activities to Contract Research


    Organizations (CROs): Critical Success Factors 701


    John R. Vogel


    55 The Impact of Managed Care on the US Pharmaceutical Industry 725


    Robert J. Chaponis, Christine Hanson-Divers, and Marilyn J. Wells


    Appendix: Useful Internet Links 745


    Index 749 Preface to the First Edition


    Pharmaceutical medicine is a relatively new, but rapidly growing, academic discipline. As these trends


    continueintothe21stcentury,pharmaceuticalphysiciansareincreasinglyregardingconsultancyworkand


    contractresearchorganization(CRO)affiliationasgoodcareeropportunities,andnowrecognizetheneed


    forcontinuingeducationandtraininginthisbroadspectrumdiscipline.


    Aseditors,wewouldliketothankourcontributorsfortheirexpertise,theirdedication,andtheirvision.


    We would like to thank and acknowledge the work and counsel of our colleague Robert Bell, MD,


    MRPharmS,who helpedusgreatly duringtheearly partof this project.Wewould alsoliketo thank and


    acknowledgetheenormoushelp,encouragement,andpatienceoftheteamatJohnWiley&Sons,Inc.,UK,


    withwhomwehaveworkedcloselyoverthesepastfewyears,amongwhomwehaveparticularlystressed(!)


    MichaelDavis,DeborahReece,HannahBradley,LewisDerrick,andHilaryRowe.


    Lastly,wewouldliketothankourfamilies,andfriends,whohavewithstoodthefrequenttelephonecalls,


    e-mails,andmeetings,oftenlateintothenight.Indeed,toallwhomadethisprojectpossible,bothauthors


    andnon-authors,wethankyou.Wearecertainthatthisspecialty,andourpatients,eventhoughwemayhelp


    themvicariously,willbenefitbecauseofyourcontributions.


    Andrew Fletcher


    Lionel Edwards


    Tony Fox


    Peter Stonier


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