382 国 立 医 薬 品 食 品 衛 生 研 究 所 報 告 第138号（2020）

国立医薬品食品衛生研究所報告第１３8号キーワード索引（アルファベット順）

AAAV 145acceptable daily exposure （ADE） 243acrylamide 223actinorhodin 154adalimumab 132adductomics 229adhesion test 210adjuvant 146ADME 228ADRA （amino acid derivative reactivity assay） 206adverse effect 214adverse outcome pathway 242adverse outcome pathway （AOP） 238Aeromonas salmonicida 161aggregation 131agricultural chemical 150, 222alkali-heat DNA extraction 165alkaloid 142alkene 170alkylating agent 171Allergen Detection methods 222allergen-specific IgG4 174allergic contact dermatitis 152alternative method 16Alzheimer’s disease 170Ames test 201, 203, 233, 234amino acid derivative reactivity assay （ADRA） 208amino acids 180AmpC beta-lactamase 163Amphipathicity 169Amyloid beta 170analgesic effect 140analytical method 211, 222aneugen 230, 231, 232aneurysm 150, 178animal 164Anodic oxidation 171antagonist 169Antagonists 174Anti-allergic property 155antibacterial activity 161antibiotic resistance 163anti-cancer drug 238

anti-drug antibody  132Antimicrobial peptides 169, 171antimicrobial resistance （AMR） 161AOP 230, 238Aortic diseases 178AquAdvantage 172aromatic hydroxylation 154Artificial hydroponic and hydroponic-filed hybrid cultivation 155ascidian 129ASEM 194assay 139Atlantic salmon 172atmospheric pressure chemical ionization 153atomic force microscopy 128, 211ATR 125, 211azide 201azobenzene  169

Bbeagle dogs 190beer 164benchmark dose 202, 205benchmark response 205Berberine 155BIAcore 200bioanalysis 212bioequivalence 135, 210biosynthesis gene cluster 166bleomycin 176BMD 205bone 194bostrycin 158bronchoalveolar lavage fluid 176

CCa2+ microdomains 194calcium signaling 195calibration 128, 170Campylobacter coli 161cancer 147, 238cancer therapeutics 238carcinogenesis 198, 231, 235

383国 立 医 薬 品 食 品 衛 生 研 究 所 報 告

carcinogenicity 197cardiac safety 192cardiomyocyte 192cas no. 110-56-5 185Catechin 170category approach 204CD23 181cell cycle 147Cell penetrating foldmers 170cell proliferation 196cellular alignment 191cellular senescence 148cereulide 163C-glycoside 138changes in plasma concentration 135changes in plasma concentrations 137chemical substances control law 185chlorpromazine 153chromium and cobalt 152circular dichroism 128, 170citreoviridin 166citrinin 202clean analysis 137clinical development 5c-Met 138cocrystal 126co-culture 191Codex 225cold flow 122collagen vitrigel membrane 194combined effect 196complement-dependent cytotoxicity 129computational fluid dynamics 150computational toxicology protocols 236condensed tannin 138confocal Raman microscope 124confocal Raman microscopy 125contractility 192cooked rice 163Copper accumulation 157Coptis japonica 155CRISPR 149criteria 233Critical flicker-fusion 183cryopreservation 191cryoprotectant agent-free 191CSB 200

cyanobacteria 162CYP induction 193

Ddasatinib 188data integration 179data portal 165ddPCR 145deer meat 161dendritic spine 142denosumab 177dental pulp 238Design 171designated substance 214detection method 172deubiquitylation 147Deuteration 170diacetoxyscirpenol 165dietary supplement 142differentiation 193dimethyl sulfoxide 208dimethylarsinic acid 198Dioxin 223Direct Analysis in Real Time-mass spectrometer

（DART-MS） 159disintegration test 141dissolution 210dissolution test 141distribution analysis 210DMH 199DNA adduct 197DNA polymerase 201DNA strip 161DNMT 202DOHaD 226dossier 33doxorubicin release 122drebrin 142drinking water 150, 222droplet dispersion-type 124Drp1 190D-value 185

EE3 ligase 147

384 国 立 医 薬 品 食 品 衛 生 研 究 所 報 告 第138号（2020）

E3 modulator 220East Asian 176effect of moisture content 124EGFR 149elastic modulus 150electrical stimulation 191electro-mechanical relationship 189Electrosynthesis 171ELISA 222EMT phenotype 238endocannabinoids 143enterotoxigenic Escherichia coli 166Entoloma rhodopolium 175environmental mutagen 200, 235Ephedra Herb 140ephedrine 140ephedrine alkaloids-free Ephedra Herb extract 214ephedrine alkaloids-free Ephedra Herb extract

（EFE） 138epigenetic gene regulation 235epigenetic mutagen 202epithelial-mesenchymal transition 238equivalence 137ER stress 145error-reduced sequencing 229ESBL-producing E. coli 163Escherichia albertii 167Escherichia coli 163Estrogen receptor 169ethofumesate 152ethylene glycol methyl ether 204evaluation method 122excitotoxicity 193EXiLE method 180existing chemical substance 33expert alerts 236extended-spectrum beta-lactamase 163extracellular vesicle 179extra-gut sensitization 174eye irritation 207

Ffar-infrared spectroscopy 211Fcγ Receptor 211FFPE RNA-Seq 149fibrosis 176

fingertip 180fish 163flavin-dependent monooxygenases 154flavoring agent 196fluorescence fingerprint 122Foldamer 171food 172food additive 198food additives 156food allergen 173Food allergens 222food chemical 28food safety 156Food Safety Information 28foods with functional claims 141Formosan squirrels 157Fourier-transformed infrared spectrometer 211fragment molecular orbital 225Function 171fungal allergens 165fungal pigment 158fungi 139Fusarium toxin 164FXR 174

Ggamma-ray spectrometry 172gapmer antisense oligonucleotide 146gas chromatography–tandem mass spectrometry 153GC-MS 154GC-MS/MS 152gene molecular network pathway 238gene therapy 5, 145general anesthesia 180genetic toxicology 229genetically modified 172genome editing 5genotoxicity 230, 231, 232genotoxicity in vivo 231genotoxicity tests 235genotyping 167germ cells 232GII.P17-GII.17 162glutamate transporter 193glycerophospholipids 134glycoengineering  129

385国 立 医 薬 品 食 品 衛 生 研 究 所 報 告

glycosylation analysis 132, 133Glycyrrhiza uralensis 155Glycyrrhizae Radix 141Glycyrrhizin 141good cell culture practice 229gpt delta mouse 196gpt delta transgenic rat 199, 202G-quadruplex 171Gram-positive and Gram-negative microbes 171

HHACCP 224Hachimijiogan 135halocynthia roretzi 129Halogen mediator 171halothane-anesthetized dogs 188Hampi 134hardness 150h-CLAT 206health based exposure limit （HBEL） 243Heart 182heat treatment 128Heimia salicifolia 142Helicity 169Helix 171Hemolysis 169HepaRG 193hepatitis C virus 130hepatitis E virus 164hepatotoxicity 204hexyl acetate 198hierarchical Bayesian model 156higher structure 171highly-reducing polyketide synthase 139High-resolution gas chromatography coupled with high-resolution mass spectrometry 223high-resolution mass spectrometry 223high-shear wet granulation 127high-throughput analysis 142hippocampal neurogenesis 165histone methylation 147histone modificaion 173HPLC 141HPLC/PDA 158human cardiomyocyte 190human induced pluripotent stem cell 144

human induced p lur ipotent s tem ce l l -der ived cardiomyocytes 188human iPS cell 193, 194human iPS cell-derived cardiomyocytes 189human iPS cells 192human pluripotent stem cell 144hyaluronan 193hybrid tableting pressure–time profiles 124hydrolysis 152hydrolyzed wheat protein 174hydrophobic tag 168Hydroponic cultivation 155hypocalcaemia 177

IICCVAM 205ICH guidelines 130ICH M10 guideline 212ICP 161identification test 134, 136, 139IgE 181IKr inhibitor 188imaging 127, 210immunogenicity 131, 212Immunological disorders 178immunotoxic assay 208impairment of learning and memory 143in silico model 204in vitro assay 233in vitro assay data 204in vivo comet assay 231in vivo gene mutation 203in vivo micronucleus test 231incorrect origin 142indentation test 150indinavir sulfate ethanol 123indoor air 151induced pluripotent stem cells 189infliximab 132inkjet cell printing 191INN 216, 217, 218inotropic state 192integrated approaches to testing and assessment 242inter-laboratory comparison 179interlaboratory study 133international guidelines 144

386 国 立 医 薬 品 食 品 衛 生 研 究 所 報 告 第138号（2020）

international workshop 233, 235intestinal organoids 189ion chromatography-mass spectrometry 177iPS cell-derived endoderm cells 194iPS cell-derived intestinal epithelial cell 193iPS cells 189IQ 202IUCLID 33IWGT 233, 234

JJaCVAM 16, 241japanese new biopharmaceuticals 130Japanese pharmacopoeia 132JECDB 33J–Tpeakc 190

Kkuma bamboo grass extracts 161kurarinone 147Kyushu region of Japan 164

Llaboratory proficiency 234lactic acid fermentation 123law enforcement 214LC/MS 132LC/MS/MS 150LC-MS 140LC-MS/MS 153, 163, 167left–right asymmetry  129Ligustrum fruit 136lipid mixture 128lipidomics 179lipids 150, 180lipopolysaccharide 206lipoprotein 179liposomal drug 122liposome stiffness 128liver 227liver disease 227livestock products 153loop-mediated isothermal amplification 161low-frequency band 211

low-frequency Raman spectroscopy 126, 127lucidin-3-O-primeveroside 197luciferase assay 208lung cancer 149

Mmammalian cells 233material differentiation 159mechanistic target of rapamycin （mTOR） 182mechanistic workflow 203medical devices 221medical information database 177metabolomics 140, 179metallothionein 157Methylmercury 175mice 195microcystin 162Microcystis 162microflora change 164microminipigs 190micronucleus 199microphysiological systems 239microphysiological systems （MPS） 228mitochondria 190modified mycotoxin 164molecular network 238molecular surveillance 162monoclonal antibody 130, 131, 132morphology 122mortality 180motion vector 189MRL 225mTOR 148mucAB 200multi element analysis 161multiregional clinical trial 176mushrooms 175mycoplasma testing 168

Nnanobody 131nanostructure  146nanotechnology-based medicine 211NBOMes induced rhabdomyolysis 143near infrared 124, 126, 127

387国 立 医 薬 品 食 品 衛 生 研 究 所 報 告

near-infrared imaging 210near-infrared spectroscopy 210new psychoactive substance 214NGS 149N-heterocyclic carbene 170Ni 156NISTmAb  133Nitric oxide 145NMR 140N-nitrosodimethylamine 141, 154non-animal 240nonblind tip reconstruction method 128nontargeted metabolomics 177Norovirus 162, 210Nrf2-knockout 199Nucleic acid 171nucleic acid amplification test （NAT） 168nucleotide excision repair 201nuzhenide 136

OO-antigen gene cluster 167occludin 130ochratoxin A 202OECD 16, 193, 238, 241, 242OECD guidelines 235OECD TG471 234off-target 146ointment 124, 125oligosaccharide profiling 132oncogene 148Operant behavior 183Organ i sa t i on f o r Economic Co - opera t i on and Development （OECD） 238organoids 239organ-on-a-chip 227organ-on-chip 239organs-on-a-chip 228Oxidative migration 171oxidative stress 165, 199

PP/Qtype Ca2+ channels 194Palladium 170pancreatic cancer 148

PBPK modeling 242p-cresidine 149Penicillium citreonigrum 166peptides 195perioperative length of stay 180permitted daily exposure （PDE） 243pesticide 153, 223pesticide residue 156Peucedanum ledebourielloides root 136pH 141pharmaceutical analysis 211pharmaceutical inspection 210pharmacopeia 211photopharmacology 169phthalic acid esters 151Pig-a gene mutation assay 203pKM101 200polar metabolite 177Pollen-associated food allergy syndrome 180polyamide 159polyethylene terephthalate （PET） 161Polygala tenuifolia 138polygalaxanthone 138polyketide 139polymerase chain reaction （PCR） 173Polζ 196population difference 176positive/negative threshold 173poultice formulation 126poultry meat 162predictive 240Predictive markers 178pre-mRNA 146pressure ulcer 124prick-prick test 180Proanthocyanidin 170probe 127Procyanidin 170product lifecycle 210propensity 144prostate 198PROTAC 168, 219, 220proteasome 147protein-knockdown 168Psoriasis 173purity test 137

388 国 立 医 薬 品 食 品 衛 生 研 究 所 報 告 第138号（2020）

QQiSS 226

（Q）SAR 236QSAR 203quantitative NMR 224quantitative real time-PCR 189Quercetin 145

Rradioactivity 172Raman spectroscopy 125, 126, 128, 211rapid determination method 153Reactive oxygen species 170read-across 205, 242real-time PCR 165, 166, 175Red snow crab 175Redox 182reference gene 189reference material 224regenerative medicine 238regulation 5regulatory 240regulatory acceptance 16regulatory purpose 205regulatory science 1, 221relative molar sensitivity 158Reproductive toxicology 226response factor 224retinoic acid 189Retinoid 183RhoH 173ribonucleotide 201rice 164risk communication 156risk-benefit balance 221rupture 150

Ssafety 156, 214saffron 137SALL3 144Saposhnikoviae radix 136selected reaction monitoring 132selective media 166

sequence context 196sewage 164Shiga toxin-producing Escherichia coli 165Shoseiryuto 137single crude drug extract 139single-cell scChIC-seq 173single-domain antibody 131sinicuichi 142siRNA delivery 170size measurement 211skin permeability 126skin sensitization 206, 208SNIPER 168, 219, 220solvate 123solvent effect 225Sophora flavescens 147specificity 172Spermatogenesis 183spherical carbon granule 122Sr resin 153ST-1562 161standard cell lines 149stem 216, 217, 218stem cell 238Stenotrophomonas maltophilia 162sterigmatocystin 167strontium-90 153Structure 171structure-activity relationship 169subchronic toxicity 196, 198sulfotransferase 197surveillance 167synthetic cannabinoids 143

TT cell 181tableting compression 124targeted protein degradation 147TAZ 148TEER 207terahertz spectroscopy 123, 211test guideline 203testicular toxicity 204textile 152textile dye 158TG 241

389国 立 医 薬 品 食 品 衛 生 研 究 所 報 告

TH17 cell 173therapeutic monoclonal antibody 129threshold 199THz-ATR 123THz-QCL 210Tinuvin-P® 152tobacco 156Toll-like receptor 7/8 146topical and transdermal patches 210torsade de pointes 188Total diet study 223Total mercury 175Toxicology 183transdermal patches 122Transgeneration 226translation 148translesion DNA synthesis 201translesion synthesis 196transmission 125, 126transparency enhancement in the drug review process 130TTC 242tumorigenicity 144

Uunivariate analysis 125urinary bladder 197usability 128, 170U-SENSTM 241

Vvalidation 16, 151, 168validation study 206, 207, 208valsartan 141, 154vanillin propylene glycol acetal 196veterinary drug 223VHH 131viral vector 5Visual contrast 183Vitex agnus-castus 142

Wwater content 124wear 150

wrist band 152

XXPC 200X-ray 194X-ray micro-computed tomography 122

Yyeast FLO1 promoter 202

Zzebrafish 143zilpaterol 153

1H-NMR metabolome 1361H-qNMR 1582,4,6-tri-tert-butylphenol 2232-acetylaminofluorene 1492-aminoisobutyric acid 1705-HT2A and 5-HT2C receptors 143

Ames試験 237BBBチップ 229Codex残留農薬部会 225Codex文書 225IgGサブクラス 211in vitro培養系 228JECFA規格 157mRNA医薬 218α,α-disubstituted amino acids 169α-exo-Methylene ketones 171β2-agonist 153β-blockade 188γ-H2AX 197

アルファ線核医学治療（TAT） 226安衛法 237安全性 215, 239

390 国 立 医 薬 品 食 品 衛 生 研 究 所 報 告 第138号（2020）

安全性評価 217, 218, 228アンチセンス 219異性体存在比 157遺伝子組換え 224, 225遺伝子治療 217, 218, 219遺伝子治療薬 216医薬品 225医薬品開発 228医薬部外品 239ウイルス安全性試験 214オフターゲット効果 219おもちゃ 159ガイドライン 215開発動向 217, 218, 219化学合成医薬品 210科学的不確実性 225化学薬品 217, 218核酸医薬品 218, 219, 220可塑剤 159がん遺伝子パネル検査 221頑健性 228眼刺激性試験 241感染症 213カンピロバクター 224カンピロバクター感染症 224漢方製剤 214間葉系間質細胞／間葉系幹細胞 215規格 216規制 217, 219規制整備 218寄生虫 167急性毒性試験 227許容値 237禁止薬物 227クロロ酢酸類 160血液試料 154血液脳関門 229ゲノム編集 217, 218, 225健康食品 225検査法 224抗悪性腫瘍薬 216国際調和 210公衆衛生 168合成樹脂製器具・容器包装 160抗体医薬品 211抗体薬物複合体 217香料 157

個別化医療 221再構築ヒト角膜様上皮モデル 241再生・細胞治療製品 215再生医療 215最大残留基準値 225細胞加工製品 215, 216細胞形態 215細胞治療薬 216細胞培養 229採卵養鶏場 163作業療法 225殺菌剤 224サルモネラ 163サルモネラ不活化ワクチン 163残存未分化ヒト人工多能性幹細胞 215残留農薬 225残留溶剤 160指針 219次世代シークエンサー 214自然毒 225実測値 157実態調査 160質量分析 225指定成分 224承認申請ガイドライン 214蒸発残留物油脂および脂肪性食品 160食中毒 167, 225食鳥処理 224食品 224, 225食品香料化合物 157食品接触材料 237食品テロ対策 154食品添加物 224食品用器具・容器包装 224初代培養ヒト肝細胞 239真菌叢 168神経細胞 228審査報告書 213, 220診断治療 224スフェロイド 239摂取量推定 175造腫瘍性 215相対モル感度 159多国間協調 225多施設検証 215妥当性確認 175多能性幹細胞 229

391国 立 医 薬 品 食 品 衛 生 研 究 所 報 告

タンパク質医薬品 212タンパク質医薬品注射剤 213タンパク質定量法 212中毒学・毒性学 227定量NMR 157定量的構造活性相関（QSAR） 237データベース解析 213動物実験代替法 239, 241トータルダイエットスタディ 175ドーピング 227毒物および劇物 227トランスジェニックカイコ 213内分泌・代謝系関連疾患薬 216ナショナルコンソーシアム 215日米会議 224日米比較 219日本薬局方 212, 213, 214バイオ医薬品 213ハイコンテンツイメージング 215ヒトiPS細胞 228ヒト化細胞アッセイ 228ヒト型化 229ヒト細胞加工製品 215ヒト人工多能性幹細胞 215避難施設 168ヒハツ 159皮膚感作性 241ピぺリン類 159病原性 224非臨床安全性評価 220非臨床試験 215品質 215, 216品質確保 213品質管理 213品質評価 218, 219, 220品質保証 210不均一性 215不純物 219不溶性微粒子試験法 213プロテアソーム 219分子パスウェイ 238分析法 224ヘッドスペース-GC/MS 160変異原性不純物 237放射性薬剤合成装置 226ポリ塩化ビニル 159ミネラルウォーター 160

有害事象報告 225薬物誘発性肝障害 239有機リン系農薬 154有毒微生物 224ユビキチン 220用量反応関係 227ラミネートフィルム 160リアルワールドエビデンス 215リアルワールドデータ 215リスク管理 225臨床試験 215連続生産 213