Drug Discovery and Clinical Research SK Gupta, Sushma Srivastava
INDEX
Page numbers followed by b refer to box, f refer to figure, fc refer to flowchart, and t refer to table.
A
A and B reactions, characteristics of type 326t
Accidental injury, compensation for 468
Accountability and transparency, principles of 441, 461
Acellular pertussis adsorbed 44
Acne 46
Adalimumab 46, 49
Adjuvant therapy 48
Administrative documents 408
Adventitious infections 17
Adverse drug reaction 321, 349, 451, 499
classification of 325
frequency classification of 328, 328t
reporting 232, 470, 519, 363t
comparison of 363
terminology 336
Adverse event 172, 451, 499
reporting system 258, 341
serious 77, 88, 172, 382
Advertising 238
Adynovate 44
Agent bases simulation models 301
Agranulocytosis 334
Airway epithelial cells 39
small 40
Alcohol 325
Allergen extracts 42
Allergen patch tests 42
Allergenics 42
Allergic reactions 8
American Medical Writers Association 313
American Society for Testing and Materials 439
Amoxicillin 252
Amyloidosis 46
Ancillary care 384
Animal experimentation 387
Animal mimicking diabetes 6
Animal model 19
Animal pharmacology 17
and toxicology studies 21, 60
studies 14
Animal testing facility 19f
Animal toxicity studies 15
Anthrasil 44
Anthrax immune globulin intravenous 44
Antibiotic 252
Antibody 6
Antidepressant 334
Antigen skin test 42
Antihemophilic factor 42, 44
Anti-inhibitor coagulant complex 42
Antiphospholipid syndrome 46
Antithrombin 42
Antivirus software 312
Apoptosis 37
Applicable regulatory requirement(s) 500
Application for permission 84
to Import New Drug 78
Application, submission of 463
Aseptic environment 48
Asia-Pacific Economic Cooperation 134
Association of Clinical Research Professionals 198
Association of Southeast Asian Nations 134
Astemizole 334
Asthma quality-of-life 297
Astrocytes 39
Audiovisual recording 104
Audit 470, 500, 522
certificate 500, 538
of trial 451
report 500
trail 250, 500
Auditing procedures 522
Auditors, selection and qualification of 522
Australasian Medical Writers Association 313
Autoimmune diseases 27
Autoimmune hemolytic anemia 46
Autonomy
respect for 145
Rights and Dignity, Principle of Respect for 440
Avastin 49
Average cost-effectiveness ratio 295
Avonex 49
AYUSH, formulation under 434b
B
Background information 524
Balance incomplete block design 266, 267t
Banner advertising 192
B-cells 221
BCG live 42
Belmont report 73
Beneficence 145
principle of 440
Benefit risk assessment 381, 403
Benzodiazepines 4
withdrawal 325
Bevacizumab 49
Bexsero 44
Bias assessment tool, cochrane risk of 282
Bioanalytical logistics 213
Bioavailability 208, 428
study 92
Bioequivalence 208
center, workflow at 219
study 92
elements of 209
Biologic 41
development of 45
discovery of 45
license application 42, 72
Biological materials, biobanking and datasets 447
Biological products facing shortage 49t
Biological, recently approved 44t
Biomarker 32
based-strategy 45
Biosecurity 438
practices 17
Biostatistician, role of 478
Biotechnology, department of 229, 232
Biotherapeutic monographs, Indian pharmacopoeia status of 234t
Bipolar disorder 10
Birth defect 255
Bisexual 382
and transgender community 420
Black triangle scheme 349
Blind
double 269
single 269
triple 269
Blinded trials, decoding procedures for 534
Blinding 71, 269, 452, 500
techniques 270f
Blood 42
and blood products 42
bank devices 42
components 42
donor screening tests 42
factors 350
Bone 42
cements 242
demineralized 42
Bonus material 194
Brainstem death 159
Brazilian Health Surveillance Agency 223
Breast cancer 45
C
Calcium ions 37
Canadian Science Writers’ Association 313
Carcinogenic effects, long-term 12
Carcinogenicity
studies 484
test 17f
Cardiac side effect 334
Cardiac stents 242
Cartilage 42
Case record form 70
design 248
development 71
login and inventory 249
Case safety reports, individual 233, 337
Case study report, individual 321
Catheters 242
Causal relationship 321
Causality assessment 357
Causality classification 325
Cell
co-culture technology, integrated discrete multiple 38
culture 19
mechanisms, basic 33
types 36
Cell-based treatments 42
Cell-cell talk 44
Cell-matrix talk 44
Cellular and gene therapy products 42
Cellular metabolite content 37
Cellular toxicity 37
Center for Biologics Evaluation and Research 42, 48, 133, 339
Center for Devices and Radiological Health 339
Center for Drug Evaluation and Research 22, 23, 60, 72, 133
Center for Food Safety and Applied Nutrition 339
Center for Tobacco Products 339
Center for Veterinary Medicine 339
Central Drug Authority 242
Central Drugs Standard Control Organization 117, 222, 377, 448
guidelines 31
Central hub 197
Central Licensing Approval Authority 242
Centuries ago medicines 26
Certified copy 505
Cetuximab 49
Challenges and future strategies 34
Chickenpox 428
Chinese Food and Drug Administration 222
Chi-square test 273
Chlordiazepoxide 4
Chlorpromazine 4
Clinical Data Interchange Standards Consortium 247, 260
Clinical data management 71
process 246fc, 258fc
recent advances in 258
system 249
Clinical drug 425
Clinical effectiveness and economic resources 279t
Clinical operations 70
Clinical practice
good 70, 73, 131, 136, 197, 451, 454, 499, 501
guidelines, good 451
Clinical protocols and investigator information 60, 21
Clinical research
associate 197, 198, 246
bioethics in 143
coordinator 186, 197, 198
organization 29, 71, 305, 453
Clinical trial 80
application, data requirement for 231
death
during 80, 99, 113
related to 104
design 67
injury related to 104
phases of 261t
processes 245fc
randomized 171
registry–India, registration with 390
related deaths, case of 101
related injury or death, compensation for 101
Cloning 42
Closing discrepancy
per clinical team 255
per internal correction 255
Clostridium difficile toxins A and B 43
Coagadex 44
Coagulation factor IX 44
Coagulation factor X (human) 44
Cochran Q test 286
Coding checks 253
Coeliac disease 46
Cognitively impaired 421
Cohort event monitoring 337
Cohort study 331, 332
Collaborative research 391
Colorless tetrazolium salt 37
Common technical document 136
Community advisory board/ group 385
Community engagement 385
Community Outreach and Health Associations 190
Community Outreach Programs 190
Community trials 432, 444
Comparator product 453
Compensation 104
quantum of 104
Compliance
principles of 461
with protocol 474, 509
Computer knowledge 311
Computerized systems, validation of 505
Conducting decision tree analysis, steps in 300
Confidentiality 453, 501
statement 526
Confirmatory safety and efficacy study 231
Conflict of interest 384
issues 387
Congenital anomaly 255
Consent
process, procedures after 413
types of 445, 445b
waiver of 413, 445
Consumer health writing 306
Contamination 47
Contraceptives, clinical trial of 436, 480
Contract 453, 468, 501
Contract Research Organization 71, 74, 167, 197, 454, 501, 515
Controlled trials, randomized 277
Convenience and responsiveness 193
Coordinating Committee 501
Coordinating investigator 453, 501
Corneas 42
Cost 292
and time in drug discovery 4t
benefit analysis 296
direct
medical 292
nonmedical 293
effectiveness analysis 294
minimization analysis 294
utility analysis 295
Cost-benefit analysis 296
Cost-effectiveness analysis 295, 296
Cost-minimization analysis 296
Cost-of-illness evaluation 294
Cost-utility analysis 296
Council for International Organizations of Medical Sciences 131, 146, 377
Counterfeit healthcare products 350
Crohn's disease 45
Crossover design 265f
two period 69fc
Crotalidae immune 44
Cryoglobulinemic vasculitis 46
Cytotoxicity screening of drugs, in vitro assays for 36
D
Darbepoetin alfa 49
Data
and safety monitoring 171, 172
and scales of measurement, types of 270f
capture and collection 247
clarification forms 256
collection process 283
consistency checks 251
elements for reporting 99
entry 250
extraction 280
inconsistencies, types of 251fc
on preclinical testing 483
on purity of recombinant product 483
preclinical supporting 457
privacy 248
quality assurance 71
review and validation 250
Safety Monitoring Board 172, 174
standards 260
storage and archival 258
validation of 457
Data checks
continuity of 253
duplicate 254
external 254
Data handling
and management 459
and record keeping 525
Data management 246, 283
plan 246
practice, good 71
Data Monitoring Committee 171, 172, 174
independent 501
Database closure 257
Database development and validation 71
Database research and monitoring 332
Decision making process 463
Decision tree models 300
Declaration of Helsinki 73, 131, 136, 138, 145
Defence Research Development Organisation 480
Demonstration projects 444
Depression 10, 334
Dermal toxicity 16
Dermatomyositis 46
Developing World Bioethics 168
Diagnostic accuracy studies, quality assessment of 281
Diagnostic agents, trials of 434
Diazepam 4
Dichotomous 273
Diet/drug interactions 32
Diphtheria 44
vaccines 428
Disability/incapacity, significant 255
Discovery and development of biologics, challenges in 47
Discrepancy management 255, 256fc
Discrete event simulation models 301
Discrete value group discrepancy 252
Discussion group 135
Disease 32
phenotype of 5
progression
with treatment 28
without treatment 28
Disposal 238
DNA
technology, recombinant 163
vaccines 428
Document history 496
Documentation 453, 476, 501
pretrial 198, 200
quality of 356
Dose
multiple ascending 30, 65
single ascending 30, 65
Dose-response relationship 15
Double dummy technique 269
Draft rules 122
Drawbacks of in vitro cytotoxicity 38
Dropsy 4
Drug 6
absorption 29
activity, early measurement of 89
and other interventions, clinical trials of 424
banned to postmarketing surveillance 333
classification of 434b
discovery of 4
eluting stents 242
event monitoring 330
hunting, science of 41
indication, limited 321
information association 198
likeness 28
molecule, small 6
pharmacodynamics 12
rapid alert system for 232
regulation 357
response 32
safety monitoring of 319
supplies 263
therapy, current 5
withdrawals, recent 334t
Drug and biological material collection 213
administration of 213
Drug and Cosmetics Amendment Bill 242
Drug candidate
rate of 36
stages of selection of 9f
Drug Controller General of India 76, 167, 229, 333, 242
Drug development 3, 56, 58
bioequivalence in 207
cost of 36
during 40
phases of 425b
preclinical 12
process 36, 57, 171
Drug discovery 57f
and development 1
of biologics 41
phases of 56f
portfolio 11
process 3, 4, 20f
steps in 4
Drug safety 36
predict 36
Drugs and Cosmetics Act 77, 228
Drugs and Cosmetics Rules 78, 84f
Drugs and Pharmaceutical Research Programme 34
Duplicate reports, identification of 357
Duties and Responsibilities, Allocation of 468
E
East African community 134
Economic models 299
Education 357
Educational medical writing 306
Efficacy
assessment of 458, 525
guidelines 136, 137
Egyptian Drug Authority 223
Electronic consent 412
Electronic data
capture 176, 179, 247
processing 477
systems, validation of 477
Electronic standards for transfer of regulatory information, development of 136
Embryo 162
cloning 163
Employ decision analysis 302
Ensuring privacy and confidentiality, principle of 379
Environmental protection, principle of 380
Enzyme 6
Equivalence trial 70
Erbitux 49
Erythema nodosum 46
Erythropoietin
concentrated solution 234
injection 234
Escape treatment 453
Essential documents 453, 501, 530
Essentially similar products 208
Etanercept 46, 49
Ethical and safety considerations 460
Ethical challenges in India 167
Ethical considerations 458
in collaborative research 391
policy statement on 377
Ethical implications 429
Ethical inquiry 162
Ethical issues
concerning organ
donors 157
recipients 155
of epidemiological and public health research study designs 441
related to reviewing protocol 403t
Ethical principles 460
Ethical review procedures 394
Ethics 525
Ethics Committee 103, 175, 453, 461, 469
accreditation of 109
communication with 474
composition of 96
functional 200
registration of 82, 97, 105, 106, 118
researchers and institutions, responsibilities of 392
responsibilities of 88
roles and responsibilities 73
trial protocol by 98
EU technical file for medical devices, components of 242t
European Federation of Pharmaceutical Industries and Associations 132, 133
European Medical Writers Association 313
European Medicines Agency 133, 134, 222, 226, 349
European Union Regulation and Guidelines 226
Expert working group 135
Extended Program of Immunization 354
Extrapyramidal side effect 334
F
Facility 217
audit 70
Factorial design 68, 267, 267f
Fascia 42
Fatal adverse drug reactions 319
Federal Commission for Protection against Sanitary Risks 223
Federal Food, Drug and Cosmetics Act 228
Federal Regulations, code of 72, 175
Female fertility 16
Female reproduction and developmental toxicity 16
Fibrin sealant 44
Filgrastim concentrated solution 234
Filgrastim injection 234
Final report 453
by investigator 513
Financial aspects of trial 532
Financing 517
and insurance 525
First-in-human milestone, microdosing vs conventional pathway to 65t
Fisher's exact probability test for small numbers 273
Flu vaccine 428
Fluad 44
Flupentixol 334
Food and Drug Administration 60, 61, 131, 133, 237
Amendments Act 340
Foot 254
Foreign direct investment 76
Foreign sponsor, role of 471
Forest plot 282, 285f
Foxglove 4
Full committee meeting 404
Fungi, infection by 5
G
Gas chromatography 214
Gastric 254
Gatifloxacin 334
Gay 382, 420
Gene 6
therapy
discussion group 135
ethics of 164
Gene-based treatments 42
General ethical issues 381
General principles 139
statement of 379
General public 189
General responsibilities 198, 199
General safety test 483
General statutory orders 77
Generic instruments 297
Genetic
disorders 5, 27
engineering approval committee 479
factors affect 32
manipulation, committee on 229
material, harmful effects on 16
Genotoxicity 16
studies 484
Geriatric 90
Giant cell arteritis 46
Global cooperation 134
Global harmonization task force 236
Global increase in clinical trials 181f
Global scenario examples 194
Glomerulonephritis 46
Good medical writing, fundamentals of 304
Graeco-latin square design 266, 266t
Graft disease 46
Granting waiver of consent, conditions for 413b
Grave's disease 46
Group sequential design 68
Guidelines, nomenclature and regulatory authorities of different countries 222t
Gulf Central Committee 134
H
Handling of product(s) 458
Harmonization, process of 135
Health
conditions, serious 148
products and food branch 134, 223
related quality of life 297
sciences authority 222
technology assessment 274, 279
Health and Science Communications Association 313
Health Associations 191
Health Canada 134
Health Canada's Biologics and Genetic Therapies Directorate 223
Health Ministry's Screening Committee 393
Heart
attack and stroke 334
risk of 334
valves 42, 242
Hematology
record 252
test 252
Hepatitis
B vaccine 42, 234
C 46
chronic 46
chronic 46
Hepatocytes 36, 39
Herbal products, categories of 481
Herbal remedies and medicinal plants, clinical trials of 481
Herceptin 49
Heterooligomers 7
Hierarchical system 422
HIV trials 29
HIV/AIDS, interventions in 432
Homologous enzymes 7
Hormones 4
Hospitalization, prolongation of existing 255
Host disease 46
HPV vaccine 42
Human
aortic endothelial cells 39
cells 36
clinical trials, phases of 61
cloning 162
ethics of 162
dignity 162
disease, pathophysiology of 27
effects in 486, 528
embryonic stem cell 160
embryos, unjust killing of 160
genetics testing and research 447
genome 10
publication 10
medicines, commission on 349
organs, transplantation of 159
pain and suffering 165
participants, protection of 387
pharmacology 64, 88
research 146
specific xenobiotic toxicity 38
subject 146
protection guidelines 73t
translation to 27, 28
Human/clinical pharmacology
immunogenic potency 484
trials 452
Humanistic evaluation methods 297
Humanized antibody 49
Humira 49
Hydradenitis suppurativa 46
Hyperglycemia in elderly 334
Hyperostosis 46
Hypertension 325
Hypothesis, testing of 270
I
Ileum preparation 13
Imlygic 44
Immune diseases 27
Immune-mediated inflammatory diseases 46, 46t
Immunodiagnostic reagents, recombinant 484
Immunogenicity 47, 484
Immunoglobulin products 350
Immunotoxicity 484
Implantable medical devices directive, active 241
Implied causality 321
In situ hybridization 32
In vitro diagnostic medical devices 241
In vitro model 6
systems 36
In vitro screening methods, preclinical 36
In vitro specific cell 38
In vivo clinical research 33
In vivo models 6
In vivo preclinical imaging 33
In vivo testing 6
In vivo toxicity 39
Independent discrete multiple organ co-culture technology, principle of 39f
Independent Ethics Committee 502
Indian Conformity Assessment Certificate 242
Indian Council of Medical Research 103, 145, 152, 377
Indian Medical Devices Regulatory Authority 480
Indian Medical Writers Association 313
Individual's worthiness, criteria of 156
Industry trends, background and 180
Infection by bacteria 5
Inflammatory demyelinating polyneuropathy, chronic 46
Infliximab 46, 49
Influenza
A vaccine 42
A virus 337
vaccine 44
Information technology 218
Informed consent 87, 95, 104, 140, 146, 148, 445, 454, 502
document 382, 407, 410b
form 198, 201, 210, 382, 532
form enrollment 202
form recruitment 202
form, screening 202
in nontherapeutic study 466
of subject 464
of trial subjects 510
process 382, 404, 410, 464
Inhalational toxicity 16
Inherent limitations 48
Injury 104
Inpatient hospitalization 255
In-silico technology 9f
Institutional Animal Ethical Committee 19, 230
Institutional arrangements, principle of 379, 461
Institutional Biosafety Committee 230
Institutional Ethics Committee 73
Institutional Review Board 61, 138, 148, 189, 198, 200
Instruments, types of 297
Insulin glargine injection 234
Insurance statement 532
Interactive voice
recognition system 200
response system 247
Interchangeable products 227
Internal prosthetic replacements 242
International collaborations, types of 393b
International Conference on Harmonization 131, 132, 173, 197, 377
International Council for Harmonization 73, 132
coordinators 134
guidelines 136
process of harmonization 135f
secretariat 134
working groups 135
International drug monitoring 319
International Ethical Guidelines 146
International Federation of Catholic Medical Associations 168
International Science Writers Association 313
Internet 192
Intracellular pathways 44
Intraocular lenses 242
Investigational pharmaceutical product 457
Investigational product 454, 474, 502, 509
accountability 537
Investigator 454, 502, 508
and institution selection 468
brochure 454, 484, 502, 526, 529, 532
meeting 198, 202
qualifications and agreements 508
responsibilities 74, 87, 103, 477
selection 517
Investigator's brochure
contents of 484, 527
table of contents of 530
Irritable bowel syndrome 334
Irritation, local 8
Ixinity 44
J
Japan Pharmaceutical Manufacturers Association 133
Josef Mengele's twin study 323, 323f
Justice, distributive 382
Juvenile idiopathic arthritis 46
K
Karch and Lasagna scale 326
Kawasaki disease 46
Kidney 39
Kruskal-Wallis test 273
L
Laboratory practice
good 18, 213, 431
requirements, good 19f
Lactate dehydrogenase 36, 37
assay, principle of 37, 37f
Lactic acidosis 334
Langendorff's heart preparation 13
Language 188, 477
Last patient last visit 257
Latin square design 266t
Lay person(s) 397
Lead identification 3, 6, 57
Lead optimization 8, 58
delivery 8
formulation 8
Least infringement, principle of 440
Legal affairs 9
Legal expert/s 397
Legislation in India 159
Lesbian 382, 420
Life-threatening 321
illness 255
Ligaments 42
Ligand-receptor interactions 44
Liquid chromatography, high performance 214
Listen and care 193
Live and attenuated vaccines 428
Local Ethics Committee 148, 189
Log rank test 273
Luciferase assay, principle of 37f
Lung toxicity 40
Lysosomal functions 37
M
MabThera 49
Magic bullet 320
Male fertility studies 16
Mammary cancer cell 39
Mann-Whitney test 273
Manufacturing information 21, 60
Manufacturing practice, good 136, 138, 431, 480
Manufacturing process 230
Manufacturing, packaging, labeling, and coding investigational product(s) 518
Market authorization application, data requirement for 232
Marketing authorization approval 131
Markov model 300, 301
structure, simple 301f
Masking 452, 500
Mass media 190
Master randomization list 534
Matched pairs 264, 265f
Material transfer agreements 391
Matthews media group 182
Mature market enrollment 183f
Maximum benefit, criteria of 156
Measles 428
Medical and science writers, organizations for 312, 313
Medical application 32
Medical care
factors affecting 176f
of study subjects 473
of trial subjects 508
Medical community outreach 189
Medical device 236, 239, 349, 480
agency 341
classification of 238, 240t, 431t
clinical trials with 480
directive 241
lifespan of 237, 237f
regulations and research 236
regulatory authorities across globe 241t
reporting 243
research, ethics in 165
safety 242
Medical expertise 515
Medical management decisions and effect 175
Medical monitor
in clinical trials
responsibilities of 172
role of 172
responsibilities of 173fc
Medical review 22, 61
Medical scientist(s), basic 396
Medical termination of pregnancy 152, 436, 467
Medical worthiness and social worthiness 156
Medical writer, career opportunities for 309, 309f
Medical writing
essentials of 304
types of 306
Medication error prevention and analysis, division of 339, 340
Medicinal chemists 9
Medicinal Products for Human, committee for 133, 226
Medicine
and statistics 262fc
defective 349
evidence-based 275
report center, defective 349
side effect reporting form 360f, 361f
Medicines Control Agency 341
Medicines Control Council 223
Medicomarketing writing 307
MedWatch adverse drug event reporting forms 341
Melitracen 334
Member Secretary, alternate 396
Membrane integrity 36
Meningococcal group B vaccine 44
Mental illness 421
Mentally disabled 148
Meprobamate 4
Meta-analysis 282, 332
Metabolism-dependent toxicity 39
Metabolize 6
Metamizole combinations 334
Microdosing 61
advantages of 62
limitations of 64
Microorganisms, infections caused by 27
Microsimulation models 301
Microvascular endothelial cells 40
Ministry of Health and Family Welfare 110, 116, 118, 122, 123, 126, 127, 128, 130, 222, 350
Ministry of Health, Labour and Welfare 133, 134
Ministry of Healthcare of Russian Federation 222
Ministry of Public Health 223
Mitochondrial function 37
Mobile smartphones and digital devices 192
Molecular target drugs 32
Molecular weight 7
Molecularbiology 9
Molecules 6
small 48
Monitor, selection and qualifications of 519
Monitor's responsibilities 520
Monitoring 198, 203, 470, 503, 519
and auditing of records 474
extent and nature of 520
in clinical trials 171
plan 505, 522
procedures 521
report 503, 521
final trial close-out 538
visit reports 536
Monoclonal antibodies 48
Mounting international pressure 207
Mouth 254
Moving towards telehealth technology 177
Multicausal diseases 27
Multicenter studies 471
Multicenter trial 69, 503, 523
Multicentric research 406
Multicentric reticulohistiocytosis 46
Multicentric study 455
Multicentric trials 429
Multidisciplinary guidelines 136, 137
Multifactorial diseases 5, 27
Mumps 428
Myasthenia gravis 46
Myelodysplastic syndrome 46
N
Naranjo algorithm
questionnaire 327t
scoring for 326
Naranjo probability scale 326
National Accreditation Board for Hospitals and Healthcare Providers 409
National Accreditation Board for Testing and Calibration Laboratories 439
National Administration of Drugs, Foods and Medical Devices 223
National AIDS Control Organization guidelines 433
National bioethics organizations 168
National cancer institute 174
National Coordination Center 233, 350
working composition of 350
National Education Technology Writers Association 313
National Guidelines for Stem Cell Research 431
National Institute for Clinical Excellence 12
National Institute of Care and Health Excellence Critical Appraisal Guidance 282
National Institute of Care and Health Excellence Tool 282
National Institute of Health 60, 173, 175
Policy 131
National Institute of Hygiene Rafael Rangel 223
National Research Act 131
Nazi doctors’ trial 323
NCC-PVPI, responsibilities of 353
Nervous system 39
Neurology trials 175
Neurotransmitters 4
New drug 82, 357
application 31, 42, 72, 261, 306
for approval to manufacture 78
investigational 21, 59, 62f, 66
clinical development of 55
develop 58
development
process 59f
stakeholders in 9
steps in 5f
discovery 261
investigational 8, 10, 29, 59, 60, 72, 77, 79
regulations 21
stages of development of 58
success rate of developing 58
New technology 180, 438
Newspaper advertisements 190
Nicotine 40
Nominal scale 269
Non critical devices 480
Nonclinical study 455, 485, 503, 527
Nonexploitation, principle of 379, 460
Non-governmental organization 384
Non-human cells, transplantation of 42
Non-humanized antibody 49
Noninferiority 70
Non-maleficence, principle of 440
Nonrepresentative patient selection 320
Nontherapeutic study 455
Notification/Submission to Regulatory Authority 517
Null hypothesis 270
Nuremberg code 73
Nursing women 91, 467
O
Ocular
tests, rabbits kept ready for 16f
tissues 42
toxicity 16
Office of surveillance and epidemiology, divisions of 339fc
Oncology 29
clinical trial in 437
trials 175
Opiate abstainer, restlessness in 325
Opioid analgesics 334
Optical character recognition 248
Optical mark recognition 248
Organ 42
from alternative sources 159
from cadaveric source 157
from living donors 158
function 33
sharing, united network of 155
specific toxicity 40
toxicity, multiple 39
transplant 159
ethics in 155
Original medical record 503
Orthopedic implants 242
Osteitis 46
P
Packaging and labeling 238
Pain relief 334
Palivizumab 49
Pan-American network for drug regulatory harmonization 134
PaniFlow 336
Paracetamol 254, 255
Patent and commercial issues 48
Patient awareness packets 189
Patient compliance 48
Patient recruitment
and retention, principles of 179
conferences 181
landscape 195
Patient-facing strategies 189
Pediatrics 90
Pegfilgrastim 234
Pemphigus 46
Performance management 193
Pergolide 334
Perinatal study 16
Periodic benefit-risk evaluation report 332
Periodic safety update report 104, 322, 332
Persistent disability/incapacity 255
Personal digital assistants 259
Pharmaceutical
alternatives 207
equivalents 207
industry 10
manufacturers association 134
products, supply, storage and handling of 469
Pharmaceutical Research and Manufacturers of America 133, 134
Pharmaceuticals and Medical Devices Agency 133, 134
Pharmacodynamic
and safety studies 226
and toxicology studies 231
properties 8
complicated 47
studies 231
Pharmacoeconomic
analysis 292t
types of 293, 296t
applications of 297
evaluation 301
method 298
principles of 291
problem 301
studies, conducting literature of 298
techniques 291
Pharmacokinetic 12, 18, 20, 89
and product metabolism
in animals 485
in humans 486
parameters 214
pharmacodynamic modeling and simulation 33
properties 8
properties, complicated 47
studies 226, 231
Pharmacological classification 325
Pharmacology review 22
Pharmacovigilance 319
division of 339
in different countries 339
in India 350
in United Kingdom 341
in United States of America 339
methods of 329
objectives of 325
office of 339
plan 232
Program of India 350, 353fc
softwares for 365, 365t
system 233, 362t
comparison of 362
Phenformin 334
Phosphotidylserine, translocation of 37
Photo-allergy 16
Physician Referral Programs 189
Physicochemical properties 8
Physiotherapy 255
Phytopharmaceutical drugs 429
Pilot studies 240
Pioglitazone 334
Pivotal studies 240
Placebo 141
Plasma concentration 29
time curve, non-transformed 215f
Policy 387
for handling misconduct 390
Poliovirus vaccine, inactivated 44
Polyarteritis nodosa 46
Polymyalgia rheumatic 46
Polymyositis 46
Population level, translation to 27, 31
Positron emission tomography 64
Postmarket data requirement 232
Postmarketing studies 232, 240
Postmarketing surveillance 91, 104, 332
methods of 332
studies 240
Postmarketing trials 67, 90
Postresearch access and benefit sharing 385
Power of test 271, 271f
Practice and research, ethics in 143
Precaution and risk minimization, principles of 460
Preclinical studies
data requirement for 230
types of 13
Preclinical work, purpose of 17
Pregnancy and clinical trials 436
Pregnant women 91, 152, 467
and foetuses 437b
Pre-market approval 241
Premature termination 471, 513, 523
President's council on bioethics 162
Pre-trial monitoring report 534
PRISMA guidelines 283t
Privacy and confidentiality 140, 382
principles of 460
Private information 146
Product characterization 230
Professional competence, principle of 379, 461
Professional gains 312
Progress reports 476, 513
Propidium iodide exclusion assay 37
Proposal-related documents 408
Propoxyphene 334
Prospective research participants, essential information for 410
Protein 6
complexes 7
Protocol 455, 457, 503
amendment 455, 503
develop 278
relevant components of 457
Protozoa, infection by 5
Provisions, post-trial 142
Proximal tubule epithelial cells 39
Pseudomonas aeruginosa infections 43
Public domain, principles of 461
Public health
concern 3
interventions 432
research 440, 446b
ethics, principles of 440
proposal 441b
stakeholders in 446
studies, epidemiological and 441
Publication policy 460, 525
Publishing tools 312
Pustulosis 46
Pyoderma gangrenosum 46
Q
Quadracel 44
Qualifications and skills needed 309
Quality adjusted life years 295
Quality assessment/appraisal 281
Quality assurance 455, 477, 503
and quality control 257, 515
systems 469
Quality comparability study 230
Quality control 455, 503
and quality assurance 459, 525
Quality guidelines 136, 137
Quality index 257
Quality management 514
Quality review panel 354
Quality-based considerations 230
Query writing 256
R
Radio advertising 190
Radiofrequency identifications 166
Randomization 71, 212, 455, 503
and blinding 478
procedures 510
techniques 267
Raplixa 44
Ratio analysis 217
Rats, reproductive studies done on 16f
Raw data 456
Reaction, serious 357
Rebif 49
Reciprocity, principle of 441
Record access 519
Record and report 476, 512
Record keeping 464
and archiving 408
and data handling 476
Record, maintenance of 98
Recruitment, strategies for 191
Rectal tolerance test 16
Rectus abdominus muscle preparation 13
Refractory asthma 46
Regional harmonization initiatives 134
Regional training centers 350
Registration of Ethics Committee, requirements and guidelines for 119
Regulation and Guidelines in India 228
Regulations for conducting clinical trials in India 76
Regulations for development and clinical trials of biosimilars 220
Regulations in India for clinical trials 77
Regulatory affairs, office of 339
Regulatory and postmarketing experiences 486
Regulatory approvals 73
Regulatory authority 455, 503, 533, 535
Regulatory medical writing 306
Relapsing polychondritis 46
Relational database management system 336
Relevant communications 536
Religion 188
Remicade 49
Remote data
capture 248
entry 248
Renal proximal tubule cells 39
Replicated crossover design 211
Reporting forms, types of 355
Reporting, advice about 359
Reproductive and developmental toxicity 484
Research 146
administration 9
among tribal population 421
and therapy, creating embryos for 162
basic 27
during humanitarian emergencies and disasters 447
ethics 144
committees 140
involving human subjects 145
involving vulnerable subjects, ethics of 147
misconduct 390
on children, conditions for 419b
on human subjects 377
participants privacy and confidentiality, protection of 404
pharmacy and drug accountability 198, 202
protocol, preparation of 278
publications, types of 307
related to healthcare in developing countries, ethics of 168
responsible conduct of 386
values of 386
Researchers, responsibility of 411
Research-related harm, compensation for 383
Responsibility, allocation of 517
Risk communication 514
Risk reporting 514
Rituxan 49
Rituximab 46, 49
Rofecoxib 334
Roman technique, old 55
Rubella 428
S
Safeguarding confidentiality 466
Safeguards, additional 416
Safety
and efficacy 225, 486
and immunogenicity data 232
and medical monitoring 171
practices, good 175, 176t
and tolerability, initial 29
assessment of 459, 525
biologics 50
evaluation 9
guidelines 136, 137
implications 47
information 470, 519
limited 48
management teams, establishing formal multidisciplinary 177
pharmacology endpoints 15
reporting 513
Sapho syndrome 46
Sarcoidosis 46
Saudi Food and Drug Authority 222
Scalp vein sets 242
Schizophrenia 10
Scientific medical writing 305
Scientific writing 306
Sclera 42
Sclerosis, multiple 46
Scurvy 56
Search strategy theory 279f
Selecting suitable test, guidelines for 273t
Sentinel sites 330
Sepsis 45
Seriousness classification 325, 327
Severity classification 325, 327
Sex workers 420
Sexual minority 420
group 420
Sham surgery, conditions for 432b
Sibutramine 334
Signal detection procedures 333
Signal generation and strengthening 357
Signal Review Panel 354
Signal strengthening 333
Signature sheet 537
Simple randomization 267, 268f
Simulation models 301
Single cell
in vitro systems 38
system 38
type cultures 38
Single cell-culture system, conventional 38
Site initiation visit 70, 198, 201
Site management organization 197
Site staff, training of 198, 201
Skin 16, 42
Social and behavioral sciences research for health 447
Social justice, principle of 441
Social networks 192
Social responsibility, principle of 379
Social values 403
Social worthiness 156
Societal perspective 292
Society for clinical research associates 198
Society of biomedical technology 480
Solidarity, principle of 441
Somatic cell nuclear transfer 163
Somatropin 234
concentrated solution 234
for injection 234
Sophisticated husbandry 17
Spare embryos, fate of 161
Special populations, studies in 90
Sperm 42
Sponsor 174, 456, 468, 504, 514
and monitor, responsibilities of 477
investigator 504
name 529
notification 23
pre-study site visit 70
responsibilities of 74, 86, 103
to pay, obligation of 468
Staffing plan, create 193
Stakeholders
duties of 416
obligations/duties of 416, 417t
Standard operating procedures 73, 200, 214, 246, 319, 384, 456, 468, 504
Statistical analysis 22, 61, 216, 263, 478
Statistical classification 325, 329
Statistical issues 281
Statistical significance 270
Statistical techniques 284
Statistics 459, 478, 525
Steering committee 132, 353
Stem cell 42
clinical trials with 431
research
ethics in 160
institutional committee for 401
Steven Johnson syndrome 334
Still's disease, adult onset 46
Stratified randomization 267, 268f
Streptococcal infection 252
Streptokinase bulk solution 234
recombinant 234
Streptokinase for injection, recombinant 234
Streptomycin 252
Students T-test
paired 273
unpaired 273
Study
design 210, 458, 478
feasibility analysis 187
flyers, distribution of 190
management 457
data handling and record keeping 468
perspective 298
population 263
information on 209
procedures 263
product 456
protocol 209
reports 470
results 299
subjects, selection and recruitment of 475
Subject enrolment log 537
Subject identification code 456, 504
list 537
completed 538
Subject recruitment, advertisement for 532
Subject screening log 537
Subjects and investigators, compensation to 517
Suicidal tendency and seizures 334
Sulphanilamide tragedy 322
Surgical interventions 432
Surgical procedures, clinical trials with 480
Surveillance 442
active 330
Switchover design 265, 266t
Synagis 49
Synovitis 46
Synthetic biology 438
Systematic literature reviews 274, 275
Systematic review 275
and meta-analysis 274
demerits of 287
and narrative review 276t
methodology 286f
over narrative reviews, advantages of 275
steps of 275
Systemic lupus erythematosus 46
Systemic toxicity studies 15
repeated-dose 15
T
Takayasu's arteritis 46
Talimogene laherparepvec 44
T-cell 221
Technical skill 311
Tegaserod 334
Telephone contact report 205
Television advertising 190
Tendons 42
Teratogenicity study 16
Terminal deoxynucleotidyl transferase 37
Terminally ill 422
Termination and final report 476
Tetanus
toxoids 44
vaccines 428
Textual data checks 255
Thalidomide tragedy 324, 324f
Therapeutic agent 6
Therapeutic biologic applications 72
Therapeutic confirmatory 31
trials 66, 89
Therapeutic effects 320
Therapeutic equivalents 208
Therapeutic exploratory 30
trials 66, 89
Therapeutic goods administration 224
Tissue 33, 42
and tissue products 42
Title 307
page stating 333
Tools 311
major critical appraisal 282t
web 312
Torsades de Pointes 334
Toxic effects, categorization of 12
Toxicity 20
local 16
studies, acute 15
Toxicokinetic studies 15
Toxicological evaluation 39
Toxicology 486
and pharmacokinetics 484
predictive 33
review 61
testing 17
Toxin cancer drug 17f
Toxoid vaccines 428
Traditional medicines 433
Training 399
Transformed plasma concentration time curve 216f
Transgender 382
Transgenic animal models 13
Translating research 34
Translational biology 33
Translational medicine, development of 32
Translational research 26
phases of 26, 27fc
tools of 32, 32f
Transparency and accountability, principle of 380
Trastuzumab 49
Trial initiation monitoring report 534
Trials, types of 69, 69t
Tuberculin testing 42
Tumor necrosis factor 45
Tunel assay 37
Tuskegee syphilis study 322
U
Ulcers 254
Union Ministry of Health, Government of India 159
Uppsala monitoring centre 322
Urinary bladder cancer 334
US Food and Drug Administration 133, 173, 222
Useful products, shortage of 48
V
Vaccine 42, 155
clinical trials of 479
development 425
for children and adults 42
in trial 155
inactivated 428
research, ethics in 153
trials, phases of 479
types of 428b
Vaginal mucous membrane 16
Vaginal toxicity 16
Valdecoxib 334
Valvulopathy 334
Vascular endothelium 39
Vector vaccines, recombinant 428
VigiAccess 336
result output screen 337f
VigiBase 336
VigiLyze 336
VigiMed 336
VigiMine 336
VigiRank 336
Viruses, infection by 5
Voluntariness
informed consent and community agreement, principles of 460
principle of 379
Volunteer
hospitalization and discharge 212
recruitment and selection 212
von Willebrand factor complex 42
Vulnerability 147, 415
Vulnerability, causes of 148
Vulnerable groups 422
and individuals 140
and protection 148
Vulnerable populations 415, 415b
W
Wegener's granulomatosis 46
Wegener's vasculitis 46
Weight loss pill 334
Wellcome trust's 168
Wilcoxon rank sum test 273
Willowbrook study 324
Witness, impartial 454, 501
Women participants, risks for 418b
Working group 354
World Association of Medical Editors 389
World Federation of Science Journalists 313
World Health Organization 133, 224, 319, 333, 335
Worst-case analysis 297
Writer's role 305
Writing career, initiating 309
Writing research articles, requirements for 307
Written information 532
X
Xenotransplantation 42
Y
Yellow card 329, 349
reporting form 351f
scheme 349
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