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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5461_Библиотеки_им_академика_М_И_Перельмана
.pdf
Spodoptera frugiperda, 271
Spumavirus, 266
Stable isotope-labeled standards (SILs), 159e161
Standard carcinogenicity bioassays, 82
Standard operating procedures (SOPs), 425
Stargardt’s macular dystrophy (SMD), 439
Starting dose, selection of, 34e35
Stem Cell Research Oversight (SCRO) committee,
410e412
Stem cells, 317
markers, 403
Stem cell therapies (SCT), 314e315
cell fate, 325
challenges associated with, 321e328
immune rejection, 325e328
inappropriate stem cell migration, 325
tumorigenicity, 321e324
Streptococcus pyogenes, 206e207
Stroke, 406
Study design components, 320e321
Study duration, 427e428
Subcutaneous (SC) administration, 6, 133
Subgenomic RNA (sgRNA), 49
Substitutional insertions, 299e300
Summary basis of approval (SBA), 299
Support vector machine (SVM), 243
Surface plasmon resonance (SPR), 158
Surrogate endpoints, 289
Swine, 234e235
Syngeneic models, 333e334
Systemic absorption, 133e134
Systemic corticosteroids, 381
T
Talimogene laherparepvec (TVEC), 14
Tanimoto coefficient, 243
Targeted cytotoxic drugs, 354
Target liability assessment, 97e100
Target-mediated distribution, 143
Target-mediated drug disposition (TMDD), 139e140
Target-mediated processes, 139e140
monoclonal antibodies (mAbs), 139e140, 139f
therapeutic proteins and peptides, 140, 141f
T-cell culture assays, 338
T-cell-dependent antibody response (TDAR), 28e29,
111e112, 381e382
T cell-dependent bispecific antibody (TDB)
biotherapeutics, 35e43
T cell receptor (TCR), 316, 328, 337
cross-reactivity, 336e337
T-cell receptor alpha constant (TRAC), 335
T-cell response, 247
T cells, 329e330
T cells transduced with antigen-specific T cell
receptors (TCR-T therapy), 207e209
Tebentafusp, 35e36
Teclistamab, 42
Teratomas, 434
Test system, justification of, 432
Testing of human pluripotent stem cell (PSCs)
-derived products, 420
TGN1412 case study, 113e116
T helper type 2 (TH2), 318
T-helper cell type 1 (Th1), 109
Therapeutic index (TI), 286, 426
Therapeutic monoclonal antibodies, 12, 20
Therapeutic proteins and peptides, 136e140
Therapeutic vaccination, 180
Therapeutic vaccines, 13, 205e209, 245
Threshold for residual stem cells, 416e417
Thrombocytopenia, 120e121
Thrombotic thrombocytopenia syndrome (TTS), 216
Thrombotic thrombocytopenic purpura (TTP), 24e25
Tissue-binding study, 359e363
nonclinical studies for oncology biologic
therapeutics, 361t
pharmacokinetics (PK), immunogenicity, and
pharmacodynamics (PD), 360e363
Tissue cross-reactivity (TCR) assay, 31e32, 64e65,
116e117, 359e360, 387
Tissue distribution, 142e143
Tissue lysates, 145
Tissue specific stem cells, 314e315
Toll-like receptor (TLR) -dependent pathways, 296
Toxicity assessments, 280e281, 431e435
general toxicity, 431e433
Toxicity studies, 230, 376, 432
Toxicology
development package, 367e368
general principles of, 352e355
program design in wake of coronavirus disease 2019
(COVID-19) pandemic, 9e11
studies, 298
testing
nonclinical species for, 7e8
paradigm for ipilimumab, 381
ToxinPred, 243
Traditional chemotherapy, 350
Traditional monoclonal antibodies, 12
Traditional pharmacokinetic evaluations, 234
Traditional PK-PD models, 286
Traditional preclinical models, 333e334
Transcription-activator-like effector nucleases
(TALENs), 337 e338, 408e409
models for genotoxicity including, 338e339
Transcription RNA (tRNA), 266
Index466
Transferrin receptor (Tfr), 47e48
Transforming growth factor beta (TGF-b), 133e134
Transgene immune responses, 297e298
Transgene product modifications, 318e319
Transgenic immunodeficient pig strains, 424e425
Transgenic mouse models, 245
Trastuzumab, 6, 133e134, 374e377
induced complement-dependent cytotoxicity (CDC),
374e375
ipilimumab, 377e383
Traumatic brain injury (TBI), 406
Trioma antibodies (Triomab), 23e24
Tri-specific killer engager antibodies (TriKEs), 25,
104e106
Tuberculosis (TB), 112
Tumor-associated antigen (TAA), 333e334
Tumor formation in vivo, assaying potential for,
434e435
Tumorigenesis, 9
Tumorigenicity, 321e324, 322te323t
assessment, 434e435
pluripotency and potential for, 415
Tumor-infiltrating lymphocyte (TIL) therapy,
207e209, 316
Tumor lysis syndrome (TLS), 107, 112
induced by monoclonal antibodies (mAbs), 112e116
Tumor necrosis factor (TNF), 327
Tumor necrosis factor alpha (TNF-a), 318
Two-dimensional cell culturing techniques, 333e334
U
UK Stem Cell Bank, 410
United States Food and Drug Administration (US
FDA), 21, 88e89, 151, 184, 231e232, 316
Modernization Act, 58e59
Nonclinical COVID-19 Pandemic Guidance, 357e358
trial, 438e439
of vaccine, 185e193
Upstream process, 270e271
Urogenital malformations, 382
US Biomedical Advanced Research and Development
Authority (BARDA), 201
US Centers for Disease Control and Prevention
(CDC), 193
US Defense Advanced Research Projects Agency
(DARPA), 201
V
Vaccine Adjuvant Compendium (VAC), 198
Vaccine Adverse Event Reporting System (VAERS),
216
Vaccine Impact Modeling Consortium, 193
Vaccine Monitoring Platform (VMP), 216e217
Vaccine platform technology master files (vPTMF),
195e196
Vaccines, 210e211, 228, 233, 240, 249
with adjuvants, 245
antigens, 189
arms of immune system, 180e184, 182te183t
regulation of vaccines, 184e185
United States Food and Drug Administration (US
FDA), 185e193, 186te188t, 190te191t
assays, 246e247
cell-mediated immune response assays, 247
de-risking strategies for, 240e241, 244e245
development, 8
differences in nonclinical safety assessment of
vaccines and biopharmaceutical drugs, 248e249
formulations, 243
functional assays, 248
general de-risking strategies for, 242e244
impacts on human health, 193
ligand-binding assays, 247
pharmacokinetics (PK) and pharmacodynamics (PD)
assessments, 246
platforms accelerate development and approval of
new vaccines, 195e196
adjuvant platforms feasible, 196e199, 197t, 199t
regulation, 184e185
science and business of vaccinology, 193e199
serious infectious diseases, 201e205
antimicrobial resistant bacteria, 201e202, 204t
parasitic diseases, 204e205
studies, 234
therapeutic vaccines, 205e209
complexity from product quality perspective,
209e210, 210t
development using animal rule, 211e213, 212t
nonclinical testing, 210e211
platforms, 205e209, 208te209t
toxicology
programs, 248e249
studies, 241, 248e
249
World Health Organization’s (WHO) threats
to global health, 193e199, 202t
hesitancy and importance of vaccinology
education, 213e217
Vaccinology, 213e214
science and business of, 193e199
vaccine platforms accelerate development and
approval of new vaccines, 195e196, 196t
VAMP4, 299
Variable heavy (VH) chain, 24e25
Variable light (VL) chain, 24e25
Vascular endothelial growth factor (VEGF), 120,
133e134, 366e367
Index 467
VCTX-210, 369, 440
Vectors, 258
and applications, 258e268
development, 270
envelope immune responses, 297
modification, 297
Vesicular stomatitis virus (VSV), 230
ViaCyte, 440
Viral-based gene therapy (GT) products, 281
Viral genomes, 262e263
Viral transduction methods, 428
Viral vector gene therapies (GT)
chemistry manufacturing and controls (CMC),
270e273
lessons learned from clinical trials to guide future
development, 290e300
capsid/vector envelope immune responses, 297
cardiotoxicity, 294e295
hepatotoxicity, 291e293
immunogenicity, 295e299
insertional mutagenesis, 299e300
linking immunity and nonclinical findings, 297
neurotoxicity, 293e294
transgene immune responses, 297e298
on use of immunosuppressants in nonclinical
studies, 298e299
nonclinical development, 273e283
considerations for immunogenicity in toxicology
studies, 281
considerations for study designs, safety endpoints
and safety pharmacology, 280e281
delivery method, justification of, 279
developmental and reproductive toxicity (DART),
281e282
dose, justification of, 279
general toxicity, 278e279
genotoxicity, 282e283
justification for route and administration method,
274
nonclinical safety evaluation, 278e283
pharmacodynamics (PD) and pharmacokinetics
(PK), 276e278
pharmacologic efficacy assessments, 275e276
principles of, 273e275
selection of animal model, 274e275
selection of test article for nonclinical studies,
273e274
study design, dose selection and justi
fication of
endpoints, 275e276
test system, 279e280
translating nonclinical data to regulatory success,
283e290
clinical trial design, 287e289
considerations for dose extrapolation,
286e287
control subjects, placebo groups, and use of
real-world data (RWD), 288e289
ethical considerations and weighing risk/benefit,
289e290
expansion cohort trial designs, 287
innovative trial designs and clinical trials for rare
diseases, 288
master clinical protocols, 287e288
regulatory landscape, 283e286, 284t
use of surrogate endpoints, 289
vectors and applications, 258e268
delivering gene therapy (GT) products,
258e268
Viral vectored vaccines, 229t
Viral vectors, 262e263, 262f, 281, 292e293, 299
characterization, and testing, 270e273
Virus-like particles (VLPs), 185e189
W
Weight of evidence (WOE), 434
Wisconsin International Stem Cell (WISC) Bank, 410
Women of child-bearing potential (WoCBP), 74, 233,
249
Working cell banks (WCB), 413
World Health Organization (WHO), 59, 184
threats to global health, 193e199
World Health Organization Listed Authorities
(WLAs), 185
X
Xenograft models in NSG mice, 333e334
Xenotransplantation mouse models, 108e109
X-linked myotubular myopathy (XL-MTM), 291
Y
Y chromosomes, 428e429
Z
Zinc-finger nucleases (ZFNs), 408e409, 433
Index468
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