Stephens Detection and Evaluation 6e

Ed. by Talbot, John; Aronson, Jeffrey

• Gebundenes Buch

Produktbeschreibung

Written with practitioners in mind, this new edition of Stephen's Detection of Adverse Drug Reactions: Principleand Practice continues to be one of the corner stonesof the pharmaceutical medicine list. The classic text covers theissues and problems involved in the detection of adverse drugreactions (ADRs) throughout the life cycle of a medicine fromanimal studies through to clinical trials, its introduction to themarket, followed by wide clinical use, and eventual decline in useor withdrawal. The sixth edition is completely revised and updatedincluding five new chapters on pharmacogenomics, ADRs with herbalmedicines, safety of medical devices, safety issues with oncologydrugs, and economic aspects of ADRs. All tables and web informationneeded in order to practice are included to make this sixth editiona complete primer for the new practitioner and a reference for themore experienced.

Produktdetails

• Verlag: Wiley & Sons
• Artikelnr. des Verlages: 14598634000
• 6. Aufl.
• Seitenzahl: 750
• Erscheinungstermin: 19. Dezember 2011
• Englisch
• Abmessung: 250mm x 175mm x 44mm
• Gewicht: 1224g
• ISBN-13: 9780470986349
• ISBN-10: 0470986344
• Artikelnr.: 33840986

Autorenporträt

John Talbot, Senior Lecturer, University of Hertfordshire, UK. Formerly Director, Global Drug Safety, AstraZeneca R&D Charnwood, Loughborough, Leicestershire, UK Jeffrey Aronson, Reader in Clinical Pharmacology, University of Oxford, Oxford, UK and President Emeritus of the British Pharmacological Society

Inhaltsangabe

Foreword xi Preface to the Sixth Edition xiii List of Contributors xv
Acknowledgements xvii 1 Adverse Drug Reactions: History, Terminology,
Classification, Causality, Frequency, Preventability 1 Jeffrey K. Aronson
1.1 Introduction 1 1.2 Defining pharmacovigilance 1 1.3 The modern history
of pharmacovigilance 3 1.4 Terminology and definitions in pharmacovigilance
6 1.5 Medication errors 25 1.6 Pharmacological classification of adverse
drug reactions 32 1.7 Drug interactions 53 1.8 Reporting suspected adverse
drug reactions 59 1.9 Causality assessment 64 1.10 Frequencies of adverse
drug reactions 69 1.11 Risk perception and adverse drug reactions 77 1.12
Class effects of drugs 78 1.13 Unlicensed indications, off-label uses, and
orphan drugs 80 1.14 Preventing adverse drug reactions 84 1.15 Publishing
accounts of adverse drug reactions 95 References 101 2 Pharmacogenetics of
Adverse Drug Reactions 121 Sudeep P. Pushpakom and Munir Pirmohamed 2.1
Introduction 121 2.2 Historical review 121 2.3 Sources of genetic
variability 122 2.4 Role of pharmacogenetic factors in drug
pharmacokinetics 123 2.5 Role of pharmacogenetic factors in drug
pharmacodynamics 133 2.6 The role of pharmacogenetics in pharmaceutical
companies 139 2.7 The impact of pharmacogenetics on regulatory agencies 141
2.8 The impact of pharmacogenetics on clinical practice 143 2.9 Conclusions
145 References 145 3 Toxicology and Adverse Drug Reactions 157 D. J. Snodin
and A. Suitters 3.1 Introduction 157 3.2 Toxicity testing 157 3.3 Drug
discovery and development 168 3.4 Data interpretation and risk assessment
174 3.5 Adverse drug reactions detected after marketing authorization 186
3.6 Examples of toxicological investigation of ADRs 199 3.7 Conclusions 200
Acknowledgements 201 References 201 4 Clinical Trials--Collecting Safety
Data and Establishing the Adverse Drug Reactions Profile 215 John Talbot,
Marianne Keisu, and Lars St°ahle 4.1 Introduction 215 4.2 Adverse events
216 4.3 Clinical studies and safety 236 4.4 The emerging safety profile 267
4.5 Presentation of safety data 271 4.6 Conclusions 280 References 281 5
Clinical Laboratory Safety Data 291 Alan Craig 5.1 Introduction 291 5.2
Factors that influence the interpretation of clinical laboratory data 294
5.3 Sample collection procedure 300 5.4 Analytical variation 301 5.5
Reference ranges 304 5.6 Intra-individual biological variation 307 5.7
Detecting adverse events during drug development 309 5.8 Test selection 333
5.9 Exclusion criteria and "panic levels" 335 5.10 Harmonization of data
from different laboratories 337 5.11 Data analysis and presentation 339
5.12 Conclusions 344 5.13 Appendix 345 References 346 6 Statistics:
Analysis and Presentation of Safety Data 349 Stephen J. W. Evans and
Dorothea Nitsch 6.1 Introduction and background 349 6.2 Problems with
efficacy trials for detecting adverse drug reactions 352 6.3 Analysis and
presentation of data from trials 355 6.4 Statistical measures of the
occurrence of adverse events 356 6.5 Combining data from several
trials--meta-analysis 364 6.6 Use of statistical methods for signal
detection from spontaneous reports 365 6.7 Analysis and presentation of
data from observational studies 373 6.8 Summary and conclusions 384
Acknowledgements 385 References 386 7 Proactive Pharmacovigilance and Risk
Management 389 June Raine, Lesley Wise, John Talbot, and Jeffrey K. Aronson
7.1 Introduction 389 7.2 Risk management--definition and general principles
390 7.3 Defining the knowledge base--the safety specification 391 7.4
Extending the knowledge of safety and characterizing risk--the
pharmacovigilance plan 394 7.5 Minimizing risks 395 7.6 Special challenges
for risk management 397 7.7 Experience with risk evaluation and mitigation
strategies (REMS) in the USA 398 7.8 A possible method for risk management
when a new adverse reaction is discovered after marketing 399 7.9 Future
challenges for risk management 405 7.10 Conclusions 406 References 407 8
Regulatory Aspects of Pharmacovigilance 411 Kristina Leila Strutt and Barry
David Charles Arnold 8.1 Introduction 411 8.2 The standardization and
harmonization of safety data collection and reporting: CIOMS and ICH 412
8.3 The European Union 447 8.4 The UK 481 8.5 France 483 8.6 Germany 485
8.7 USA 487 8.8 Japan 500 Acknowledgements 505 References 506 Useful web
sites 509 9 Legal Aspects of Pharmacovigilance in the European Union 511
Christine H. Bendall 9.1 Introduction 511 9.2 Application of EU legislation
in Member States 511 9.3 Interpretation of EU law 514 9.4 Relationship
between law and guidelines 515 9.5 Issues in interpreting EU
pharmacovigilance legislation 517 9.6 Legal responsibility for
pharmacovigilance activities 519 9.7 Failures to meet pharmacovigilance
requirements 522 9.8 Enforcement and sanctions 524 9.9 European powers and
procedures in the event of a product safety issue 528 9.10 Civil liability
534 9.11 Personal data privacy 537 9.12 Safety in research products 538
References 541 10 Dictionaries and Coding in Pharmacovigilance 545 E. G.
Brown and J. E. Harrison 10.1 Introduction 545 10.2 Scope of this chapter
546 10.3 What is a dictionary? 546 10.4 Drug dictionaries 547 10.5 Disease
classifications 554 10.6 Medical Dictionary for Regulatory Activities,
MedDRA R557 10.7 Common Terminology Criteria for Adverse Events (CTCAE) 567
10.8 Definition of adverse reaction terms 567 10.9 Dictionaries used in
electronic health records 568 10.10 Use of dictionaries in standard product
information 570 10.11 Conclusions 571 Acknowledgements 571 References 571
11 Adverse Drug Reactions: Societal Considerations 573 Nicky Britten 11.1
Introduction 573 11.2 Adverse drug reactions at the population level 574
11.3 The social production of ADRs 576 11.4 Trust 579 11.5 Information
about ADRs 581 11.6 Conclusions 583 References 583 12 Safety of
Biotherapeutics 585 Andrew Erdman, James Nickas, and Benton Brown 12.1
Introduction 585 12.2 Properties of proteins 586 12.3 Classification of
biotherapeutics 587 12.4 Monitoring for adverse events due to
biotherapeutics 589 12.5 Conclusions 598 References 598 13 Vaccine Safety
Surveillance 603 E. Miller and J. Stowe 13.1 Introduction 603 13.2 What is
special about vaccine safety compared with other drugs? 604 13.3
Pathogenesis of vaccine reactions 605 13.4 Criteria for establishing
causality after vaccine-related adverse events 608 13.5 Pre-licensing
evaluation of vaccine safety 610 13.6 Objectives of an ideal post-licensing
vaccine safety surveillance system 611 13.7 Conclusions 620 References 620
14 Assessing the Safety of Drugs Used in Oncology 625 Anne Kehely 14.1
Introduction 625 14.2 Factors to consider when assessing the safety of
drugs used in oncology 627 14.3 Sources of adverse effect data 632 14.4
Nature of the data 634 14.5 Assessment of adverse effects data in oncology
635 14.6 Conclusions 641 References 642 15 Adverse Drug Reactions and
Pharmacovigilance of Herbal Medicines 645 Joanne Barnes 15.1 Introduction
645 15.2 Herbal medicines: definitions and descriptions 646 15.3
Characteristics of herbal medicines 647 15.4 Regulation of herbal medicines
and pharmacovigilance requirements 648 15.5 Access to and use of herbal
medicines 655 15.6 Adverse reactions associated with herbal medicines 656
15.7 Methods for pharmacovigilance of herbal medicines 666 15.8 Responding
to safety concerns associated with herbal medicines 673 15.9 The future for
pharmacovigilance of herbal medicines 674 15.10 Conclusions 675 References
676 Appendix 1 Web Sites Relevant to Pharmacovigilance--An Analysis of
Contents 685 Charlotte I. S. Barker, John Talbot, and Jeffrey K. Aronson
A1.1 Introduction 685 A1.2 Ten national pharmacovigilance web sites 685
A1.3 Twelve institutional web sites 689 Acknowledgements 697 References 697
Appendix 2 Guidelines and a Checklist for Reporting Suspected Adverse Drug
Reactions Anecdotally in Journals 699 Jeffrey K. Aronson A2.1 Introduction
699 A2.2 Notes on the checklist 700 A2.3 Conclusions 706 Note 706
References 706 Index 709