Principles and practice of pharmaceutical medicine:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Chichester [u.a.]
Wiley
2007
|
| Ausgabe: | 2. ed. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVIII, 761 S. Ill., graph. Darst. |
| ISBN: | 9780470093139 |
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Datensatz im Suchindex
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|---|---|
| adam_text | PRINDPLES AND PRACTICE OF PHARMACEUTICAL MEDICINE SECOND EDITION EDITED
BY LIONEL D. EDWARDS NOVARLIS AND PHARMA PRO PLUS INC. NEW JERSEY, USA
ANDREW J. FLETCHER TETNPLE UNIVERSITY SCHOOL OFPHARMACY, PHILADELPHIA,
USA ANTHONY W. FOX EBD GROUP INC., CALIFORNIA, USA AND MIMICH, GENNANY
AND SKAGGS SPPS, UNIVERSITY OF CALIFORNIA, SAU DIEGO PETER D. STONIER
CONSULTANT IN PHARMACEUTICAL MEDICINE, RUHMOND, SURREX, UK 1 8 O 7
FIWILEY 2 OO7 JOHN WILEY & SONS, LTD CONTENTS PREFACE TO THE FIRST
EDITION IX PREFACE TO THE SECOND EDITION I AEBOUT THE EDITORS XIII
CONTRIBUTORS XV SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE 1 1 THE
PRACTICE AND PRACTITIONERS OF PHARMACEUTICAL MEDICINE ? 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 INTRODUKTION 41 4 DRUG DISCOVERY: DESIGN AND SERENDIPITY
43 RONALD R. COBB AND LESLIE J, MOLONY 5 PHARMACEUTICS ^ ANTHONY W. FOX
6 NONDINICAL TOXICOLOGY ^ FREDERICK RENO 1 INFORMED CONSENT 7 ^ ANTHONY
W. FOX 8 PHASE I: THE FIRST OPPORTUNITY FOR EXTRAPOLATION FROM ANIMAL
DATA TO HUMAN EXPOSURE M STEPHEN H. CURRY, DENNIS MCCARTHY, HELEN H.
DECORY. MATTHEW MARTER AND JOHAN GABRIELSSON 9 PHASE II AND PHASE III
CLINICAL STUDIES T( ANTHONY W. FOX 10 PHASE IV DRUG DEVELOPMENT:
POST-MARKETING STUDIES 119 LISA R. JOHNSON-PRATT VI CONTENTS 11 SITE
MANAGEMENT ^7 BARRY MISKIN 12 GOOD CLINICAL PRACTICES 13 9 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. TOWMEND, 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 METRY 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 REGULATION 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 ^35
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 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 VNI: 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 LUST. 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 74Q
|
| adam_txt |
PRINDPLES AND PRACTICE OF PHARMACEUTICAL MEDICINE SECOND EDITION EDITED
BY LIONEL D. EDWARDS NOVARLIS AND PHARMA PRO PLUS INC. NEW JERSEY, USA
ANDREW J. FLETCHER TETNPLE UNIVERSITY SCHOOL OFPHARMACY, PHILADELPHIA,
USA ANTHONY W. FOX EBD GROUP INC., CALIFORNIA, USA AND MIMICH, GENNANY
AND SKAGGS SPPS, UNIVERSITY OF CALIFORNIA, SAU DIEGO PETER D. STONIER
CONSULTANT IN PHARMACEUTICAL MEDICINE, RUHMOND, SURREX, UK 1 8 O 7
FIWILEY 2 OO7 JOHN WILEY & SONS, LTD CONTENTS PREFACE TO THE FIRST
EDITION IX PREFACE TO THE SECOND EDITION \I AEBOUT THE EDITORS XIII
CONTRIBUTORS XV SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE 1 1 THE
PRACTICE AND PRACTITIONERS OF PHARMACEUTICAL MEDICINE ? 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 INTRODUKTION 41 4 DRUG DISCOVERY: DESIGN AND SERENDIPITY
43 RONALD R. COBB AND LESLIE J, MOLONY 5 PHARMACEUTICS ^' ANTHONY W. FOX
6 NONDINICAL TOXICOLOGY ^ FREDERICK RENO 1 INFORMED CONSENT 7 ^ ANTHONY
W. FOX 8 PHASE I: THE FIRST OPPORTUNITY FOR EXTRAPOLATION FROM ANIMAL
DATA TO HUMAN EXPOSURE M STEPHEN H. CURRY, DENNIS MCCARTHY, HELEN H.
DECORY. MATTHEW MARTER AND JOHAN GABRIELSSON 9 PHASE II AND PHASE III
CLINICAL STUDIES T( " ANTHONY W. FOX 10 PHASE IV DRUG DEVELOPMENT:
POST-MARKETING STUDIES 119 LISA R. JOHNSON-PRATT VI CONTENTS 11 SITE
MANAGEMENT ^7 BARRY MISKIN 12 GOOD CLINICAL PRACTICES 13 9 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. TOWMEND, 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 METRY 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 REGULATION 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 ^35
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 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 VNI: 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 LUST. 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 74Q |
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| id | DE-604.BV022523880 |
| illustrated | Illustrated |
| index_date | 2024-07-02T18:04:11Z |
| indexdate | 2024-07-09T20:59:28Z |
| institution | BVB |
| isbn | 9780470093139 |
| language | English |
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| publisher | Wiley |
| record_format | marc |
| spelling | Principles and practice of pharmaceutical medicine ed. by Lionel D. Edwards ... Pharmaceutical medicine 2. ed. Chichester [u.a.] Wiley 2007 XVIII, 761 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Farmaceutische industrie gtt Geneesmiddelen gtt Médicaments - Développement Médicaments - Recherche Pharmacologie Drug Evaluation Drug Industry organization & administration Drug development Drugs Research Pharmacology Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf Pharmakologie (DE-588)4045687-0 gnd rswk-swf Pharmakologie (DE-588)4045687-0 s DE-604 Arzneimittelentwicklung (DE-588)4143176-5 s 1\p DE-604 Edwards, Lionel D. Sonstige oth GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015730582&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Principles and practice of pharmaceutical medicine Farmaceutische industrie gtt Geneesmiddelen gtt Médicaments - Développement Médicaments - Recherche Pharmacologie Drug Evaluation Drug Industry organization & administration Drug development Drugs Research Pharmacology Arzneimittelentwicklung (DE-588)4143176-5 gnd Pharmakologie (DE-588)4045687-0 gnd |
| subject_GND | (DE-588)4143176-5 (DE-588)4045687-0 |
| title | Principles and practice of pharmaceutical medicine |
| title_alt | Pharmaceutical medicine |
| title_auth | Principles and practice of pharmaceutical medicine |
| title_exact_search | Principles and practice of pharmaceutical medicine |
| title_exact_search_txtP | Principles and practice of pharmaceutical medicine |
| title_full | Principles and practice of pharmaceutical medicine ed. by Lionel D. Edwards ... |
| title_fullStr | Principles and practice of pharmaceutical medicine ed. by Lionel D. Edwards ... |
| title_full_unstemmed | Principles and practice of pharmaceutical medicine ed. by Lionel D. Edwards ... |
| title_short | Principles and practice of pharmaceutical medicine |
| title_sort | principles and practice of pharmaceutical medicine |
| topic | Farmaceutische industrie gtt Geneesmiddelen gtt Médicaments - Développement Médicaments - Recherche Pharmacologie Drug Evaluation Drug Industry organization & administration Drug development Drugs Research Pharmacology Arzneimittelentwicklung (DE-588)4143176-5 gnd Pharmakologie (DE-588)4045687-0 gnd |
| topic_facet | Farmaceutische industrie Geneesmiddelen Médicaments - Développement Médicaments - Recherche Pharmacologie Drug Evaluation Drug Industry organization & administration Drug development Drugs Research Pharmacology Arzneimittelentwicklung Pharmakologie |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015730582&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT edwardslioneld principlesandpracticeofpharmaceuticalmedicine AT edwardslioneld pharmaceuticalmedicine |