Basics of drug safety:
Gespeichert in:
| Beteiligte Personen: | , , |
|---|---|
| Format: | Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
München [u.a.]
Zuckschwerdt
1999
|
| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008427993&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | XIII, 197 S. graph. Darst. |
| ISBN: | 388603660X |
Internformat
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| 100 | 1 | |a Pfeiffer, Martin |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Basics of drug safety |c M. Pfeiffer ; R. Rychlik ; K. Sprenger |
| 246 | 1 | 3 | |a Drug Safety |
| 264 | 1 | |a München [u.a.] |b Zuckschwerdt |c 1999 | |
| 300 | |a XIII, 197 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Adverse Drug Reaction Reporting Systems | |
| 650 | 4 | |a Clinical Trials as Topic | |
| 650 | 4 | |a Drug Labeling | |
| 650 | 4 | |a Drug Therapy | |
| 650 | 4 | |a Drugs |x Safety measures | |
| 650 | 4 | |a Legislation, Drug | |
| 650 | 4 | |a Product Surveillance, Postmarketing | |
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| 700 | 1 | |a Rychlik, Reinhard |e Verfasser |0 (DE-588)121115658 |4 aut | |
| 700 | 1 | |a Sprenger, Kuno |e Verfasser |4 aut | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008427993&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
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Datensatz im Suchindex
| _version_ | 1819330787547283456 |
|---|---|
| adam_text | VII
Contents
Preface v
Contents vn
1 Introduction 1
1.1 Why Drug Safety? 1
1.2 What are the Targets of Drug Safety? 2
2 Historical Aspects 5
2.1 Introduction 5
2.2 Ancient Regulations 5
2.3 Modern Times 7
3 Definitions n
3.1 Introduction 11
3.2 Drug Use Therapeutic or Non Therapeutic ? 12
3.3 Definitions 14
3.3.1 Drugs 14
3.3.2 Adverse Reactions to Drugs 14
3.3.2.1 Adverse Event (AE) 15
3.3.2.2 Adverse Drug Reaction (ADR) 16
3.3.2.3 Side Effect (SE) 18
3.3.3 Characteristics of AEs/ADRs 18,
3.3.3.1 Expected and Unexpected Adverse Drug Reactions 18
3.3.3.1.1 Unexpected AEs/ADRs 19
3.3.3.1.2 Expected AEs/ADRs 19
3.3.3.2 Serious and Non Serious 20
3.3.3.2.1 Serious Adverse Event or Adverse Drug Reaction 20
3.3.3.2.2 Non Serious Adverse Drug Reactions 21
Contents VI11
3.3.3.3 Serious and Unexpected Adverse Drug Reaction 21
3.3.3.4 Adverse Drug Reaction Types 21
3.3.4 Safety Information 22
3.3.4.1 International Prescribing Information
(Core Data Sheet) 22
3.3.4.2 Reportable Case Histories 22
3.3.5 Clinical Trials 23
4 Drug Safety Information from the
Investigational Phases 25
4.1 Introduction 25
42 Pre ClinicalTests 27
4.2.1 Drug Discovery 27
4.2.2 Pharmacological Tests 27
4.2.3 Toxicological Tests 27
4.2.3.1 Basic Toxicity Tests 28
4.2.3.1.1 Acute Toxicity 28
4.2.3.1.2 Subacute Toxicity 28
4.2.3.1.3 Chronic Toxicity 29
4.2.3.2 Special Toxicity Tests 29
4.2.3.2.1 Mutagenicity Tests 29
4.2.3.2.2 Carcinogenic Studies 30
4.2.3.2.3 Teratogenicity Studies 30
4.2.3.2.4 Tests on the Immune System 31
4.2.4 Conclusion 31
43 Clinical Studies .[ 32
4.3.1 Clinical Study Phase I 33
4.3.1.1 Single Dose Studies 33
4.3.1.2 Multiple Dose Studies 34
4.3.1.3 Information from Phase I Studies 34
4.3.2 Clinical Studies Phase II and Phase III .... ..,. . . . 35
4.3.2.1 Detection of ADRs in Phase II and III 36
4.3.2.2 The Role of Investigators 36
4.3.2.3 Role of Pharmaceutical Manufacturers 38
4.3.3 Conclusion 3g
44 Marketing Options / New Indications .................... 40
Contents IX
5 Labeling 41
5.1 Introduction 41
5.2 Problems and Questions 43
5.2.1 Problems 43
5.2.2 Questions 44
5.2.3 The CIOMS Working Group III 45
5.3 Guidelines for Preparing Good Clinical Safety Information .. 46
5.3.1 General Guidelines 46
5.3.1.1 The Life Cycle of a Drug and its Core Information 46
5.3.1.2 The First CSI 48
5.3.1.3 Updating the CSI 48
5.3.1.4 Different Presentations and Uses of Medicinal Products 49
5.3.1.5 Excipients and Other Substances 49
5.3.1.6 National Differences in Data Sheets 50
5.3.2 What Has to be Included? 50
5.3.2.1 Introduction 50
5.3.2.2 What Not to Include 50
5.3.2.3 Legal Considerations: Duty to Warn and Advisability Not to Warn . 52
5.3.2.4 The CSI and General Medical Knowledge 52
5.3.2.5 Lack of Efficacy 53
5.3.3 When is Information to be Included? 53
5.3.3.1 Introduction 53
5.3.3.2 The Concept of Threshold 54
5.3.3.3 Threshold Criteria and Their Order of Importance 54
5.3.3.4 The Importance of Well Documented Cases 55
5.3.3.5 Threshold and Clinical Utility 56
5.3.3.6 Considerations of Seriousness of an Adverse Drug Reaction .. 56
5.3.3.7 Role of Indication for Treatment and Extent of Use 56
5.3.3.8 When to Add Hypersensitivity Reactions 57
5.3.3.9 When to Delete or Downgrade Safety Information 58
5.3.4 How to Include Safety Information? Good Safety
Information Principles 58
5.3.4.1 General Formatting Principles 58
5.3.4.2 Class Labeling 59
5.3.4.3 Format of Initial Core Safety Information (CSI) 59
5.3.4.4 Frequency of Adverse Drug Reactions 61
5.3.4.5 Good Safety Information: Ten General Principles 61
5.3.5 Where is Drug Safety Information to be Included? 64
Contents X
5.3.5.1 Introduction 64
5.3.5.2 Posology (Dosing) and Method of Administration 65
5.3.5.3 Contraindications 65
5.3.5.4 Special Warnings and Special Precautions for Use 65
5.3.5.5 Interaction With Other Medications and Other Forms
of Interaction 66
5.3.5.6 Pregnancy and Lactation 67
5.3.5.6.1 Use During Pregnancy 67
5.3.5.6.2 Use During Lactation 69
5.3.5.7 Effects on Ability to Drive Vehicles and
Operate Machinery 70
5.3.5.8 Undesirable Effects (Adverse Reactions) 71
5.3.5.9 Overdose 71
5.3.5.10 Pharmacological Properties 71
5.3.5.11 Pre Clinical Safety Data 72
5.4 European Summary of Product Characteristics (SPC) 72
5.5 FDA Requirements for Labeling 79
6 Post Marketing Surveillance (PMS) 83
6.1 Introduction 83
6.2 Clinical Trials 84
6.3 Spontaneous Reporting 85
6.3.1 Reduction of ADRs by Physicians 86
6.3.1.1 Benefits Versus Risks of Drug Therapy 86
6.3.1.2 Individualization of Drug Therapy 87
6.3.1.3 Monitoring of Efficacy and ADRs 88
6.3.2 Influencing of Reporting Rates 88
6.3.3 Conclusion 89
6.4 Epidemiological Studies 90
6.4.1 Cohort Studies 90
6.4.1.1 Prospective Cohort Trials 91
6.4.1.1.1 Use of Cohort Studies 91
6.4.1.1.2 Advantages of Prospective Cohort Trials 91
6.4.1.1.3 Disadvantages of Prospective Cohort Trials 92
6.4.1.2 Retrospective Cohort Trials 92
6.4.2 Case control Studies 92
6.4.2.1 Advantages of Case Control Studies 93
Contents XI
6.4.2.2 Disadvantages of Case Control Studies 93
6.4.3 Procedures, Methods and Problems in the Realization of
Pharmacoepidemiological Studies 94
6.4.3.1 Cooperation with the Reporting Physicians 95
6.4.3.2 Handling of Adverse Events 96
6.4.3.3 Appropriate Fields of Therapies and Diseases 96
6.4.4 Monitored Release 98
6.4.5 Cross sectional Studies/Evaluation of Medical Standard Data . 100
6.4.6 Observational Studies in a Single Study Location 101
7 Causality Assessment 103
7.1 Introduction 103
7.2 Methods of Causality Assessment 103
7.2.1 Global / Clinical Judgement 104
7.2.2 Algorithm: Verbal Judgement 106
7.2.2.1 FDAAIgorithm 107
7.2.2.2 The Karch and Lasagna Method 108
7.2.3 Algorithm with Numerical Scoring 108
7.2.3.1 Naranjo Algorithm 108
7.2.3.2 The Kramer etal. Method 110
7.2.3.3 The Begaud et al. Method 111
7.2.4 Probabilistic 114
7.2.4.1 Bayesian Approach 114
7.2.5 Uses of the Methods 117
7.3 Conclusion 119
8 Argumentation and Public Affairs:
Legal Aspects 121
8.1 Introduction 121
8.2 The Problem of Public Affairs 121
8.2.1 Legal Requirements 122
8.2.2 The Tasks of the Pharmaceutical Company 123
8.2.2.1 The Importance of a New ADR for the Pharmaceutical Company . 123
8.2.2.2 Whatto Discuss 124
8.2.2.3 ...and With Whom? 124
8.2.3 Possible Consequences 124
Contents XII
9 Organization of Drug Safety 127
9.1 Introduction 127
9.2 The Tasks of the Pharmaceutical Company 128
9.2.1 General Tasks 128
9.2.2 Data Processing Systems 129
9.2.2.1 Coding 129
9.2.2.2 Storage and Administration 131
9.2.3 Statistical Evaluation 132
9.2.4 CROs 133
10 Country Regulations 135
10.1 Introduction 135
10.2 Regulations of the EU, Japan, and the USA 136
10.2.1 European Union (EU) 136
10.2.2 Japan 138
10.2.3 USA 138
10.3 The Council for International Organizations of Medical
Sciences 139
10.3.1 CIOMS I: International Reporting of Adverse Drug Reactions . 140
10.3.2 CIOMS II: Periodic Safety Update of Drugs 141
10.3.3 CIOMS III: Core Safety Data Sheets of Drugs 141
10 4 The International Conference on Harmonization 142
10.4.1 Introduction 142
10.4.2 ICH Organization 143
10.4.3 The Steering Committee 143
10.4.4 Expert Working Groups (EWGs) 144
10.4.5 ICH Administration 144
10.4.6 ICH Process 145
10.4.7 Selection of Topics 145
10.4.8 ICH Meetings and Conferences 146
10.4.9 The ICH Harmonization Process 146
m m_,. ..... ..„, .. ^
Contents XIII
11 Reporting of Adverse Drug Reactions... 149
11.1 Introduction 149
11.2 Sources of Adverse Drug Reaction Reports 150
11.2.1 Spontaneous Reporting 151
11.2.2 Clinical Trials 154
11.3 Receiving Drug Safety Information 156
11.3.1 Physician Manufacturer 157
11.3.2 Physician Authorities Manufacturer 160
11.3.3 Reporting Pathways within an Affiliate and between Affiliate
and Headquarters 160
11.4 The Way of Reporting Adverse Drug Reactions
to Authorities 161
11.4.1 Reporting Individual Cases 162
11.4.1.1 Key Data Elements 163
11.4.1.2 The ICH Standards for Expedited Reporting 166
11.4.1.3 Report Forms 170
11.4.2 Periodic Safety Update Summaries 174
11.4.2.1 Scope of Periodic Drug Safety Update Summaries 175
11.4.2.2 Content of Periodic Drug Safety Update Summaries 176
12 Glossary 183
13 References 189
|
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| id | DE-604.BV012420616 |
| illustrated | Illustrated |
| indexdate | 2024-12-20T10:29:59Z |
| institution | BVB |
| isbn | 388603660X |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-008427993 |
| oclc_num | 41559586 |
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| owner | DE-19 DE-BY-UBM DE-12 |
| owner_facet | DE-19 DE-BY-UBM DE-12 |
| physical | XIII, 197 S. graph. Darst. |
| publishDate | 1999 |
| publishDateSearch | 1999 |
| publishDateSort | 1999 |
| publisher | Zuckschwerdt |
| record_format | marc |
| spellingShingle | Pfeiffer, Martin Rychlik, Reinhard Sprenger, Kuno Basics of drug safety Adverse Drug Reaction Reporting Systems Clinical Trials as Topic Drug Labeling Drug Therapy Drugs Safety measures Legislation, Drug Product Surveillance, Postmarketing Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| subject_GND | (DE-588)4143182-0 |
| title | Basics of drug safety |
| title_alt | Drug Safety |
| title_auth | Basics of drug safety |
| title_exact_search | Basics of drug safety |
| title_full | Basics of drug safety M. Pfeiffer ; R. Rychlik ; K. Sprenger |
| title_fullStr | Basics of drug safety M. Pfeiffer ; R. Rychlik ; K. Sprenger |
| title_full_unstemmed | Basics of drug safety M. Pfeiffer ; R. Rychlik ; K. Sprenger |
| title_short | Basics of drug safety |
| title_sort | basics of drug safety |
| topic | Adverse Drug Reaction Reporting Systems Clinical Trials as Topic Drug Labeling Drug Therapy Drugs Safety measures Legislation, Drug Product Surveillance, Postmarketing Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| topic_facet | Adverse Drug Reaction Reporting Systems Clinical Trials as Topic Drug Labeling Drug Therapy Drugs Safety measures Legislation, Drug Product Surveillance, Postmarketing Arzneimittelsicherheit |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008427993&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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