Textbook of Pharmacovigilance SK Gupta
INDEX
A
Abdominal pain 144
Absolute risk 1, 2
Absorption 46
Acetylation of isoniazid 48
Active surveillance 1, 31
Adverse
drug
interactions 52
reaction 1, 39, 66, 93, 164, 170
event 1, 39
relationship 198
reporting 149, 151
experience 39
health effect 104
Advisory committee 96
Age and gender specific terms 160
Agência Nacional de Vigilância Sanitária 178
Allium sativum 146
Allopathy 1
Amiodarone induced hepatitis 83
Anatomical therapeutic chemical 79
Angioedema 144
Annual safety report 2
Antagonism 53
Applications of MedDRA 155
Aris global total safety suite 200
Aristolochic acid nephropathy 146
Attributable risk 2
Automated quantitative signal detection 65
B
Bayesian confidence propagation neural network 68, 135
Benefit
risk
analysis 2
assessment 105, 109
score 112
Blood products 23
Body site specific terms 161
Bones 47
C
Case reports in literature 64
Causality
assessment 2
classification 42
Caveat document 2
Central drugs standard control organization 3, 19, 29, 101
Centralized or decentralized reporting 98
Changing
pharmaceutical marketing strategies 22
physician and patient preferences 22
Chemically reactive metabolite
Chest pain 144
Chinese materia medica 152
Classification of adverse drug interactions 53
Clinical trial
authorization 3
duration 76
Cohort studies 29, 87
Collaborative perinatal project 88
Combination
database 3
term 160
Common adverse reactions 112
Communication division 130
Comparative observational studies 28, 33
Compare
allopathy 6
homeopathy 2
Compassionate use program 3
Complementary and alternative medicine 152
Computer based
methods 194
system approach 192
Computer software for case report management 138
Concomitant medications 78
Conduct randomized 153
Confidentiality 3
Conflicting 160
Consumer 3
Continuous drug use 41
Control group 3
Controlled
clinical trial 153
situation of clinical trials 88
Council for international organizations of medical 1, 3, 18, 66, 109
Crisis 119
handling 125
in pharmacovigilance 120
management 121
cycle 122
in pharmacovigilance 119
model 124
response 123
Criteria for term selection 159
Current methods of pharmacovigilance 28
Cytochrome p450 enzyme family 165
D
Data
lock point 4
mining 4
and signal detection 212
safety monitoring board 4
standards and interoperable systems 195
Database research and monitoring 89
Dermatitis 144
Descriptive studies 28
Development safety update report 4
Diarrhea 144
Direct
interaction 53
pharmacodynamic interactions 53
Drug
controller general of India 9, 179
event monitoring 32
interactions 162
monitoring program 18
safety technology vendors 200
utilization
data 4
studies 28, 36
E
Effect of
concomitant medications 198
preexisting disease 198
Environmental risk assessment working party 172
Epidemiology 5
Essential medicines 5
Establishing
strategic crisis planning team 126
tactical crisis management team 129
Estrogens 82
Eudravigilance 5
European
manufacturers associates 151
medicines
agency 5
evaluation agency 171
risk management strategy 172
scientific cooperative on phytotherapy 151
Example of
case control study 85
cross-sectional study 86
meta-analysis 89
Expanded access program 5
Exposure during pregnancy and breastfeeding 161
Extrapyramidal side effects 83
Eye 47
F
Face edema 144
Failure of therapy 42
Fats 47
Fever 144
Food and drug administration 5, 9
Framingham, heart study 87
French agency for safety of health products 177
Frequency classification 45
G
Gathering information 127
Germander hepatotoxicity 147
Gingko biloba induced thrombocytopenia 146
Gingko biloba 146
Global strategy for pharmacovigilance 139
Good
clinical practice 171, 178
laboratory practice 171
manufacturing practice 171
Grapefruit juice induced herb-drug interactions 148
Gray baby syndrome 49
H
Hairs 47
Halothane 82
Headache 144
Health care professional 6
communication 31
Hemovigilance 176
Hepatic veno-occlusive disease 152
Hepatitis 83, 144
Herbal medicines 6, 142
Heterogeneous patients 198
High
dimension of data 198
level
group term 156, 157
term 156, 157
quality safety data 195
Homeopathy 6
Human resource 95
Hypersensitivity 45
Hypertension 144
Hypothesis
generating methods 28
testing methods 28, 29
I
Ibufenac and liver damage 83
Idiosyncrasy 45
Indexing and hyperlinking 194
Individual case safety report 6
Informatics in pharmacovigilance 194
Information
component 70
exchange 135
Initiation of drug monitoring centers 94
Intensive hospital-based drug surveillance system 63
Interactions due to
absorption of drugs 54
distribution of drugs 54
excretion of drugs 56
metabolism of drugs 54
International
birth date 6
classification of diseases 66
conference on harmonization 18, 178
drug
information center 66
monitoring 93
organizations of medical sciences 66
Ion channels 167
J
Jaundice 82
K
Kidneys 47
L
Large size of database 198
Liver 47
Lowest level term 156, 157
Lungs 47
M
Major problem in conducting a case control study 85
Marketing authorization holder 6
Martindale 6
MedDRA 7
and SMQ in signal detection 162
rules 158
structure 156
versioning 162
Medical
devices 23
dictionary for
drug regulatory affairs 156
regulatory activities 55
Medwatch 7
Member countries 7
Methodological research 139
Methods of safety data analysis 193
Methyldopa 83
Metoclopramide 83
Mianserine 83
Multisource product 5
N
N-acetyl P-benzoquinone imine 51
Nalidixic acid 82
National
health surveillance agency 178
patient safety agency 176
pharmacovigilance
centers 7, 101
system 83
Natural history of disease 36
Nausea 144
Neoplasms 161
Neural network 7
New drug application 16
Non-representative patient selection 77
Nonsteroidal anti-inflammatory drugs 25
Nucleic acids 47
O
Objectives of MedDRA 155
Organosulfur compounds induced CYP inhibition 148
P
Paper-based method 193
Passive surveillance 29
Periodic safety update report 4, 7
P-glycoprotein 166
Pharmaceutical interactions 53, 57
Pharmacodynamic interactions 53
Pharmacoeconomics 7
Pharmacoepidemiology 7
Pharmacogenetics 7, 164
Pharmacogenomics 8
Pharmacokinetic interactions 53, 54
Pharmacology 8
Pharmacovigilance 1, 8, 13, 18, 164, 170
centers in India 101
in 18th century 13, 15, 17
in Europe 170
methods 28
of herbal
drugs 142
medicines 148
Phocomelia 8
Phytotherapy 8
Piroxicam 83
Planning for crisis management 126
PMS methodologies 78
Polypharmacy 8
Post-crisis 123
Post-marketing surveillance 8
Post-registration safety study 8
Practical challenges of pharmacogenomics 167
Precrisis
conditions 122
planning 124
Pre-existing medical conditions
Prescription
event monitoring 9, 28, 64
only medicine 9
Prethalidomide 15
Priority areas of pharmacovigilance 23
Process of regulatory pharmacovigilance 172
Prophylaxis 9
Proportional ADR reporting ratio 69
Protriptyline-photosensitivity 82
Providing training and consultancy support 137
Pruritus 144
Pulegone toxicity 147
Purpose of pharmacovigilance 23
R
Rare adverse reactions 112
Rash 144
erythematous 144
Rational drug use 9
Regional pharmacovigilance centers 177
Regulations for traditional Chinese medicine 182
Regulatory
authority 9
status/historical overview 156
Reporting
FDA form 3500A 189
odds ratio 69
Restructuring capabilities 197
Retrospective study 10
Review of adverse drug experiences 187
Role of
national pharmacovigilance centers in sign 64
WHO program for international drug monitor 135
S
Safety database
mining 213
querying 213
Salvia miltiorrhiza 146
Scanning existing structure 127
Scientific literature 188
Se Massengill company 192
Sentinel sites 32
Serious adverse
events 19, 176
reaction 176
Seriousness classification 44
Setting up of pharmacovigilance center 93
Severity classification 43
Signal
absorption 211
detection in pharmacovigilance 60
generation 61
masking 211
strengthening 61
testing, evaluation and explanation 62
Single nucleotide polymorphisms 164
Skin 47
Sources and methods of signal detection 62
Spontaneous reporting system 62, 78
Stakeholders 121
Standardized MedDRA queries 162
State food and drug administration 181
Statistical classification 45
Stimulation of reporting 98
Substandard medicines 23
Suicide 160
Sulphanilamide 170
Suspected
serious adverse reaction 44
unexpected serious adverse reaction 11, 44
System organ class 156, 157
T
Targeted clinical investigations
28, 5
Thalidomide 11
tragedy 192
Therapeutic goods administration 183
Threat sources for crisis in pharmacovigilance 121
Thrombocytopenia 144
Thromboembolism 82
Traditional
and complementary medicines 23
Chinese medicines 152
medicine 11
Turbo model 112
Type B adverse reactions 50
U
UMC signalling process 70
Unexpected adverse reaction 11
Unreliability of preclinical safety data 21
Uppsala monitoring center 1, 11, 93, 213
Urticaria 144
V
Vigibase 12
Vigiflow 12
Vigimed 12
Vigisearch 12
Vioxx saga 25
Volume of data for analysis
Vomiting 144
W
World Health Organization 39, 93
Y
Yellow card scheme 175
Z
Zonal pharmacovigilance centers 102
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Chapter Notes

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