A
Abdominal pain 144
Absorption 46
Acetylation of isoniazid 48
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
C
Case reports in literature 64
Caveat document 2
Centralized or decentralized reporting 98
Chemically reactive metabolite
Chest pain 144
Chinese materia medica 152
Classification of adverse drug interactions 53
Collaborative perinatal project 88
Common adverse reactions 112
Communication division 130
Compassionate use program 3
Complementary and alternative medicine 152
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
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
E
Environmental risk assessment working party 172
Epidemiology 5
Essential medicines 5
Estrogens 82
Eudravigilance 5
European
manufacturers associates 151
medicines
agency 5
evaluation agency 171
risk management strategy 172
scientific cooperative on phytotherapy 151
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
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
Grapefruit juice induced herb-drug interactions 148
Gray baby syndrome 49
H
Hairs 47
Halothane 82
Headache 144
Hemovigilance 176
Hepatic veno-occlusive disease 152
Heterogeneous patients 198
Homeopathy 6
Human resource 95
Hypersensitivity 45
Hypertension 144
I
Ibufenac and liver damage 83
Idiosyncrasy 45
Indexing and hyperlinking 194
Individual case safety report 6
Informatics in pharmacovigilance 194
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
drug
information center 66
monitoring 93
organizations of medical sciences 66
Ion channels 167
M
Major problem in conducting a case control study 85
Marketing authorization holder 6
Martindale 6
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
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
P
Paper-based method 193
Passive surveillance 29
P-glycoprotein 166
Pharmacodynamic interactions 53
Pharmacoeconomics 7
Pharmacoepidemiology 7
Pharmacogenomics 8
Pharmacology 8
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
Pre-existing medical conditions
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
Rational drug use 9
Regional pharmacovigilance centers 177
Regulations for traditional Chinese medicine 182
Restructuring capabilities 197
Retrospective study 10
Review of adverse drug experiences 187
S
Salvia miltiorrhiza 146
Scanning existing structure 127
Scientific literature 188
Se Massengill company 192
Sentinel sites 32
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
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
T
Therapeutic goods administration 183
Threat sources for crisis in pharmacovigilance 121
Thrombocytopenia 144
Thromboembolism 82
Turbo model 112
Type B adverse reactions 50
U
UMC signalling process 70
Unexpected adverse reaction 11
Unreliability of preclinical safety data 21
Urticaria 144