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780 Pages·2007·7.46 MB·English
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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, WestSussexPO198SQ,England Telephone(þ44)1243779777 Email(forordersandcustomerserviceenquiries):[email protected] Visit our Home Page on www.wileyeurope.com or www.wiley.com AllRightsReserved.Nopartofthispublicationmaybereproduced,storedinaretrievalsystemortransmittedinanyformorbyany means,electronic,mechanical,photocopying,recording,scanningorotherwise,exceptunderthetermsoftheCopyright,DesignsandPatents Act1988orunderthetermsofalicenceissuedbytheCopyrightLicensingAgencyLtd,90TottenhamCourtRoad,LondonW1T4LP,UK, withoutthepermissioninwritingofthePublisher.RequeststothePublishershouldbeaddressedtothePermissionsDepartment,JohnWiley &SonsLtd,TheAtrium,SouthernGate,Chichester,WestSussexPO198SQ,England,[email protected],orfaxedto (þ44)1243770620. Designationsusedbycompaniestodistinguishtheirproductsareoftenclaimedastrademarks.Allbrandnamesandproductnamesusedinthis bookaretradenames,servicemarks,trademarksorregisteredtrademarksoftheirrespectiveowners.ThePublisherisnotassociatedwithany productorvendormentionedinthisbook. Thispublicationisdesignedtoprovideaccurateandauthoritativeinformationinregardtothesubjectmattercovered.Itissoldonthe understandingthatthePublisherisnotengagedinrenderingprofessionalservices.Ifprofessionaladviceorotherexpertassistanceisrequired, theservicesofacompetentprofessionalshouldbesought. OtherWileyEditorialOffices JohnWiley&SonsInc.,111RiverStreet,Hoboken,NJ07030,USA Jossey-Bass,989MarketStreet,SanFrancisco,CA94103-1741,USA Wiley-VCHVerlagGmbH,Boschstr.12,D-69469Weinheim,Germany JohnWiley&SonsAustraliaLtd,42McDougallStreet,Milton,Queensland4064,Australia JohnWiley&Sons(Asia)PteLtd,2ClementiLoop#02-01,JinXingDistripark,Singapore129809 JohnWiley&SonsCanadaLtd,6045FreemontBlvd,Mississauga,Ontario,L5R4J3,Cananda Wileyalsopublishesitsbooksinavarietyofelectronicformats.Somecontentthatappearsinprintmaynotbeavailableinelectronicbooks. AnniversaryLogoDesign:RichardJ.Pacifico 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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