F

FDA see Food and Drug

Administration fed-batch process 59 ff. Federal Institute for Risk Assessment

(BfR) 208 fibroblasts 18, 190 fibrosarcoma QT6-C5 194 Flp 186 Flp/RT 184 fluorophores 141

- fixation procedures 141

- fluorescent semiconductor nanocrystals 141

- long-wavelength dyes 141

- multicolor assays 141

- photostability 141

- resistance 141

- solubility 141

follicular dendritic cell networks 167 Food and Drug Administration (FDA)

96, 271 fowlpox 155 frt sites 187 ff.

functional screens 128 ff g gap junctions 145 gas exchange 105 gaseous contaminants 113 genetic stability 239 genomic locus 186 ff. genomics 209 genotoxicity 107 genotypic diversity 278 germ layers 215 f.

- ectoderm 215

- endoderm 215

- mesoderm 215 germinal centers 69, 167

GFP see green fluorescence protein giga seal formation 92 glomerular epithelial cells 184 GMP see good manufacturing practice good cell culture practice 233 good manufacturing practice (GMP) 264

good quality tissues for testing 236 G-protein coupled receptors (GPCRs) 88, 142 f.

- internalization assays 142

- pharmacological characterization 142

- receptor-tagged dye 143

- signaling pathways 143

- translocation 142 G-protein receptors 137 granzyme B 164

green fluoresence protein (GFP) 141

growth rate 238 growth receptor pathways 137 growth-arrested cells 133 guidelines for validation 243 ff.

HAART see highly active anti-

retroviral therapy HBV see hepatitis B virus hCMV promoter 186 HCS see high-content screening HCV see hepatitis C virus heart 91

- muscle 17

- valves 20 heart tissue 17, 88

- acellularized 10

- electrical activities 17

- hypertrophy 17

- mechanical function 17 HEK293 182

HeLa cell line 155, 240 HeLa cells 193

hematopoietic stem cells 68, 180, 275 hepatic drug discovery 15 hepatic spheroids 15 hepatitis B virus (HBV) 191 hepatitis B virus vaccine 153 hepatitis C virus (HCV) 191

hepatocytes 11 ff., 113, 178, 184, 255 hepatoma BC2 179 HepG2 179 HepG2-hepatoma 115 heterologous antigens 157 high-content screening (HCS) 79, 142

- CPCRs 142

- mechanism-oriented 142

- multiplexed assay 144

- primary human cells 144

- target oriented 142 high-resolution images 139 high-throughput screening (HTS)

- amount of cells 132 f -assay interference 135

- automation systems 133

- cAMP 138

- cell storage 133

- ELISA-based assays 134 f.

- fluorescence imaging 138

- fluorescent probes 140 ff.

- instrumentation 139

- intracellular Ca2+ 138

- ion channels 138

- reader characteristics 140 -second messenger assays 138

- target-unrelated effects 135 highly active anti-retroviral therapy

(HAART) 190 Hinxton Statement 233 histone acetylase 182 HIV-vaccines 166 ff. HIV-1 see human immunodeficiency virus type 1 HIV-1 vaccines 166 HK-2 184 H5N1 replication 27 hollow-fiber bioreactors 15, 38, 273 homeostatic conditions 237, 273 homologous recombination 186 ff. host cells 189 housekeeping genes 186

HPV E6 182 HTLV-I virus 189 HTS see high throughput screening HUH-7 cells 196 human cell lines 232 human cell supply 278 human cells, hazards 242 human embryonal stem cells 207, 217

- enzyme activities 217

- ethical concerns 221

- surface antigens 217

- undifferentiated 217 human environment 273 human genome project 209 human histotypic cultures 273 human immunodeficiency 189,

- abacavir 193

- enfuvirtide 193

- zidovudine 193

human immunodeficiency virus type 1 (HIV-1) 154 ff., 158 -acute viremia phase 158

- Ad5 viral vector 159

- clinical trials 165 ff.

- CTL response 159

- efficacy 161

- glycoprotein gp120 158

- potency 161

- recombinant poxvirus vaccines 159

- seronegatives 158

- therapeutic vaccine 159

- viral clearance 159 human in-vitro models 37 human papillomavirus 181 human placental model 57 human stem cell sources 279 human stem cells 273 human telomerase 180

human tissues 233 ff.

- approval 233

- availability 233

- hazards 242

- informed consent 233

- recommendations 234 hyaluronic hydrogels 36

ICCVAM see Interagency Coordinating Center for the Validation of Alternative Methods ICH see International Conference on

Harmonisation ICS see intracellular cytokine staining IFN-y ELISPOT 160 ff. immobile cell phase 57 immortal cell lines 184 immortalization 179 ff., 183 f., 233

- conditional 183 immune cell therapies 65 immune cells 178 immune functions 65 ff., 168 immune organs 65

- primary 65

- secondary 65 immune response 68

- cellular 68

- humoral 68 immunity 153

- pre-existing 157 immunization 167 immunoassays 153, 158 immunogenicity 54 ff., 156

- testing 275 immunological synapses 68 immunotoxicity 54 ff. impedance 88, 90

- frequency-dependent 90

- recording platform 88

- spectroscopy 85 ff. inflammatory cell systems 146 influenza virus 155 inhalation 109

inhalation toxicity 107

- acute 107

- repeated dose 107

- subchronic 107 inhibitors of transactivation 193 in-silico membrane permeation assay

insulin 264 integration locus 188 intelligent biomatrices 3 ff intelligent biomimetic scaffolds 3 ff.

Interagency Coordinating Center for the Vlidation of Alternative Methods (ICCVAM) 251 International Conference on

Harmonisation (ICH) 214 intracellular Ca + 138 intracellular cytokine staining (ICS) 160, 162 ff. intracellular fluorophore labeling 142

- biarsenical fluorophores 142

- O -alkylguanine-DNA alkyl-transferase 142

intracellular trafficking 143 intranasal administration 167 in-vitro assay 191 in-vitro culture 272 ff.

- history 272

in-vitro drug screens 195 in-vitro exposure 111 in-vitro exposure system 115 in-vitro gas exposure 113 in-vitro inhalation studies 115 in-vitro method 263

- biological drugs 263

in-vitro models 108, 178, 210, 221, 259

- for organ toxicity 108

- hematotoxic 108

- hESC-based 217

- nephrotoxic 108

- neurotoxic 108

in-vitro phototoxicizy test 252 in-vitro testing 15, 154 ff.

- relevance 154

- validity 154 in-vitro tests 259 in-vitro tissue models 15 in-vitro toxicity 258 in-vitro toxicology 107 ff.

- cytotoxicity testing 107

- irritancy testing 107

- mutagenicity 107

- organ toxicity 107

- reproductive toxicity 107 in-vivo environments 273 in-vivo situation 238 in-vivo tests 213

ion channels 91, 138, 219

- channelopathies 91

- central nervous system 91

- heart 91

- hereditary diseases 92

ionotropic receptors 218 J

JaCVAM see Japanese Centre for

Evaluation of Alternative Methods Japanese Centre for Evaluation of Alternative Methods (JaCVAM) 244, 252

Japanese encephalitis virus 155 Jurkat cell lines 192

k keratinocytes 180 kidney 184, 274 kinases 143

- autophosphorylation 143 kinetic measurements 139

l lacZ 194

- reporter genes 192 lead optimization 127, 143 legal guidelines 218 leukemia inhibitory factor (LIF)

LIF see leukemia inhibitory factor lipid bilayers 91, 194

lipid film 91

lipid rafts 90

Lipobay 215

lipophilicity 29

live cell imaging 145

live cell measurements 139

LiveCount assay 164

liver 11 ff.

- amimal models 15

- failure 15

- metabolism 11, 15

- scaffolds 12 ff.

- slices 178 -tissue engineering 11 local microenvironment 68 LTR-reporter system 190 luciferase expression cassette 194 lung 21 ff., 274

- acellularized 10

- distal airways 21

- extracellular matrix 22

- Matrigel 22

- pharmacological models 27

- proximal airways 21

- tissue engineering 21 ff. lymph node 274 lymphatic cells 65 lymphatic fluid 66 lymphocyte segregation 69 lymphocytes 66 lymphoid organs 167 lymphoid tissue 65 lyophilization 9

m mass transfer 56 ff.

- resistance 63

Master Cell Bank 129, 241 matrigel 5, 9, 20, 22 matrix deposition 59 mean deviation 135 measles virus 155 mechanical strength 19 membrane potential 138

membrane transistors 90 ff. MEMS see microelectrochemical systems mesenchymal stem cells 180 mesoderm germ layers 215 metabotropic receptors 218 microelectrode arrays 62 microelectrodes 94 ff. microelectromechanical systems

(MEMS) 16 microfluidic channel system 92 ff. micro-organoids 275 ff., 278

- assembly of 278

- genotypic diversity 278

- predisposition 278 microporous hollow fibres 67 microsystems technology 80, 81 ff. microvascular endothelium 29 miniaturization 134 miniaturized cultur systems 178 mitochondrial membrane potential

- chloromethyl-X-rosmaine 146 MMEAs multi-electrode assays mobile cell phase 67

modified vaccnia virus Ankara (MVA) 155

molecular changes 210 molecular models 262 monensin 162 monolayer culture 57 multicellular spheroid model 62 multi-electrode assays (MMEAs) 81 multiparametric chips 82 multiparametric sensor chip 96 ff. multicolor assays 141 murine embryonic stem cells 206 mutagenicity 107 mutation rates 190 MVA see modified vaccinia virus

Ankara MVA-vectores vaccines 165 myc 182

Mycoplasma 238 ff.

- testing 239

myelotoxicity 244 myocardial infarction 17 myocardium 17 ff.

n nanotechnology 245 natural biomaterials 4 ff.

- elastin 4 ff. neo gene 187 neural tissues 88 neuronal cells 18

neuronal monolayer networks 95 ff. neuronal stem cells 180 neurons 28 ff., 179, 217 neuroprotective conditions 219 neuroprotective substance 219 neurospheres 88 neurotoxic effects 217 neurotoxicity 218 neurotoxins 95

neurovascular physiological entity 28

neutralizing antibodies 153, 158 ff. nitrogen dioxide 115 nonenzymatic solutions 132 Ntera2 179 nuclear receptors 137

OECD see Organisation of Economic

Cooperation and Development OECD-guidelines 258

- harmonization 259

- testing of chemicals 259 oncogenes 180

organ slice culture 62 Organisation of Economic Cooperation and Development (OECD) 244 organoids 65, 275, 278

- genotypic diversity 278

- in-vitro assembly of 278 organotypic cell cultures 208

organotypic culture conditions 238 osteocytes 184 oxygen supply 56 ff., 63 oxygenation 67 ozone 112

P(LLA-CL) see poly(L-lactide-co-e-

caprolactone) P16 INK4a 181 P53-pathway 181 PACE see phosphospecific antibody cell-based ELISA pancreas 274 PANi see polyaniline parainfluenza virus 155 parasite plasmodium 190 parasites 189

patch-clamp technique 92 ff., 139 PCL see poly(e-caprolactone) percutaneous absorption 244 perfusion 59, 66

- bioreactors 68 pericytes 28 ff., 36 permeability 28

- coefficient 34 peroxisome proliferator-activated receptor 178 persistent infection 190 PET see polyethylene terephthalate filters

PGA see polyglycolic acid pharmaceutical testing 92 pharmacokinetic properties 15 pharmacokinetics 221 pharmacological models 27, 37 pharmacologically active compounds 146

pharmacopoeia 252

- standards 232 phenotypic screening 139 phosphorylation 143, 145

phosphospecific antibody cell-based ELISA (PACE) screens 136

phototoxicity 244 phototoxicity test 260 ff.

- Annex V of Directive 67/548 EEC 261

pituitary gland 274 PLA see polylacic acid plasmid DNA vaccines 165 plasticity 33

PLGA see poly(lactidic-co-glycolic acid) pluripotent stem cells 273 polio vaccine 155 poly(e-caprolactone (PCL) 4 ff. poly(lactidic-co-glycolic acid) (PLGA) 4 ff., 13

poly(L-lactide-co-e-caprolactone)

(P(LLA-CL)) 4 ff., 13 polyaniline (PANi) 5 polyethylene terephthalate filters

(PET) 34 polyglycolic acid (PGA) 4 ff., 13 polymerase II complex 182 polypyrrole (Ppy) 5 POT1 180 potency 156 -batch consistency 156 poxvirus-based HIV vaccines 166 poxviruses 155 ff.

- avian 155

Ppy see polypyrrole prediction model 259 predisposition 278 pregnancy 217 preventive vaccines 167 primary cells 178 ff.

- limitations 178

- suitability 178 prime-boost regimes 165 process flows 56

- circulation 56

- convection 56

- perfusion 56

- transfusion 56 procyanidolic oligomers 36 proliferation 215, 238

promoter 186 ff. protein biomarkers 210 protein modifications 209

- post-transcriptional 209

- post-translational 209 protein phosphatase 181 protein-coupled receptors (CPCRs)

proteomic display techniques 217 proteomics 210 ff.

- technologies 208 provirus 190 proximal airways 21 pulmonary cells 26 pulmonary tissue models 21 ff. pulmonary toxicology 27 pyrogen testing 244

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