Index

    • Alzheimer's disease  94, 195, 201
    • American Association of Pharmaceutical Scientists (AAPS)  51
    • American Gastroenterology Association  249
    • Aminoglycoside  259, 268
    • Aminosalicylate  373, 374
      • aminosalicylate‐based therapy  266
    • 5‐Aminosalicylic acid (5‐ASA)  98
    • 5‐Aminosalilycolates  25
    • Amyloid‐β peptide (Aβ)  195
    • Amyloid plaque  195
    • Amyloid precursor protein (APP)  195
    • Ankle joint lymphatic flow rate  54
    • Ankylosing spondylitis (AS)  4, 94, 258, 268
    • Annualized bleeding rate  200
    • Anthrax inhalation  287
    • Anti‐adhesion molecule  216, 220
    • Antibiotic  98, 210, 215, 259
    • Antibody  69, 255
    • Antibody‐binding fragment (Fab)  187
    • Antibody biodistribution coefficient (ABC)  44
    • Antibody bivalent binding cross‐link  76
    • Antibody‐dependent cellular cytotoxicity (ADCC)  67, 74, 190‐192, 196
    • Antibody‐dependent cellular phagocytosis (ADCP)  74, 190
    • Antibody‐drug conjugate  166, 255, 392
    • Antibody Fab‐antigen interaction  73
    • Antibody Fc‐Fcγ receptor interaction  73
    • Antibody fragment  44, 149, 255
    • Antibody‐fusion protein  255
    • Anti‐cancer mAb  268
    • Anti‐CD28 antagonist domain antibody (BMS‐931699)  7, 75, 76, 78
    • Anti‐CD28 mAb  196
    • Anti‐CD28 superagonist  6, 67, 70
    • Anti‐CD3 bispecific therapeutic  83
    • Anti‐CD3/CEA  83, 85
    • Anti‐CD3 mAb  223
    • Anti‐CD3/PSMA  83
    • Anti‐CD40 agonistic antibody  67, 73
    • Anti‐CD40L antibody (hu5c8 IgG1 [BG9588])  78, 79
    • Anti‐CTLA4 mAb  6, 7, 67
    • Anti‐CXCL13 neutralizing mAb  53
    • Anti‐cytotoxic T‐lymphocyte‐associated protein 4 (CTLA‐4) 65
      • CTLA‐4  6, 7
      • CTLA‐4 Fc fusion protein (Oriencia®)  4, 65
      • CTLA4‐Ig  6, 7
    • Anti‐drug antibody (ADA)  98, 116, 118, 191, 193, 197, 217, 244, 245, 248, 255, 257, 266, 267, 269, 277, 325, 366
    • Anti‐FIXa/FX bispecific IgG antibody  193
    • Antigen‐binding fragment  219
    • Antigen burden  257
    • Antigenic self‐peptide  4
    • Antigenic specificity  12
    • Antigenic target  13
    • Antigen presenting cell (APC)  6, 66, 78, 192
    • Antigen recognizing site (epitope)  187, 190
    • Antigen‐specific  12
      • approach  14
      • immune response  8
      • immune therapy  6
      • immuno‐modulatory approach  5
      • immunotherapy  9
      • priming  82
      • response  10
      • strategy for disease interception  6
      • strategy for disease prevention  6
      • T cell  12, 14
      • T cell repertoire  13
    • Anti‐guselkumab antibody  350
    • Anti‐hCD28 dAb  76
    • Anti‐human IL‐23/IL‐12 mAb  55
    • Anti‐IgE antibody  52
    • Anti‐IL‐6R antibody  221, 224
    • Anti‐IL‐6R/IL‐2 antibody  216
    • Anti‐inflammatory  2
    • Anti‐inflammatory drug  129, 215
    • Anti‐integrin mAb  98
    • Anti‐integrin molecule  220
    • Anti‐interleukin (IL)‐6 mAb  49, 53
    • Anti‐interleukin (IL)‐12/IL‐23  49
    • Anti‐interleukin (IL)‐12/IL‐23 p40 mAb  338
    • Anti‐interleukin (IL)‐17A mAb  338
    • Anti‐interleukin (IL)‐17 mAb  45, 49
    • Anti‐interleukin (IL)‐23 mAb  49
    • Anti‐mCD28‐001  76
    • Antimetabolite  25, 28, 244
    • Antimicrobial peptide  210
    • Anti‐mouse CD3 x anti‐human EpCAM  192, 193
    • Anti‐mouse interleukin (IL)‐6 mAb  46
    • Anti‐mouse interleukin (IL)‐23 mAb  54
    • Anti‐natalizumab antibody  421
    • Anti‐outer membrane porin C  214
    • Anti‐P‐cadherin human IgG1 Fc‐containing DART  83
    • Anti‐programmed cell death protein 1 (PD1) mAb (Keytruda®) 65
    • Anti‐programmed cell death protein 1 (PD1) mAb (Opdivo®) 65
    • Anti‐Saccharomyces cerevisiae antibody (ASCA)  214
    • Anti‐TfR/BACE1 (transferrin receptor and β‐secretse 1)  195
    • Anti‐TfR/BACE1  194
    • Antitumor immune response  7
    • Antitumor T cell response  13
    • Anti‐vedolizumab antibody  363, 368, 373‐375
    • APIPPRA trial  6
    • Appendectomy  210
    • Arginine  10
    • Ascites  45, 198, 199
    • Asthma  287
    • At‐risk patient population  3
    • Attack‐decay characteristics  100, 104, 112
    • Atypical hemolytic urenic syndrome  286
    • Atypical perinuclear antineutrophil cytoplasmic antibody (pANCA)  213, 214
    • Autoantibody  214, 396
    • Auto‐antigenic peptide  10
    • Autoimmune diabetes  4
    • Autoimmune disease  1‐8, 13‐15, 53, 66, 79, 268, 431
    • Autoimmune inflammatory disorder  401
    • Autoimmune polyendocrinopathy‐candidiasis‐ectodermal dystrophy (APECED) 10
    • Autoimmune polyendocrinopathy syndrome Type 1 (APS‐1) 10
    • Autoimmune regulator (AIRE) gene  10
    • Autoimmune response  11, 12
    • Autoimmunity  7, 13, 220
    • Autophagy  210
    • Auto‐reactive B cell  11, 393
    • Auto‐reactive T cell  7, 8, 10, 11
    • Axon loss  402
    • Azathioprine  98, 217, 224, 323, 373, 374
    • b
    • B7  6
    • BACE1  195
    • Backward elimination procedure  351
    • Bacterial pore‐forming protein  11
    • Bar‐coding strategy  14
    • Baron score  29
    • Baseline C‐reactive protein (CRP)  383
    • Baseline fecal calprotectin (FCP)  30, 382, 383
    • Baseline IGA score  351
    • Baseline McDonald criteria  410
    • Baseline PASI score  351, 352, 353
    • Baseline relapse rate  410
    • Basiliximab  223, 224, 286, 292, 293
    • Basophil  74
    • Bayes estimation  261, 263, 265
    • Bayesian adaptive design  87, 259, 268‐271, 273, 274
    • Bayesian adaptive dosing strategy  269, 275, 278
    • Bayesian approach  260, 330
    • Bayesian dosing system  260
    • Bayesian PK algorithm  325
    • B cell  8, 10, 11
      • lineage‐specific marker  8
    • B‐cell activating factor  389
    • B‐cell chronic lymphocytic leukemia (B‐CLL)  257
    • B‐cell death  389
    • B‐cell differentiation  389
    • B‐cell survival  389
    • Belimumab (Benlysta7®)  389, 391‐393, 395‐398
    • Beta2‐microglobulin  28, 403
    • Bevacizumab (Avastin®)  285, 293
    • Biacore binding assay  78
    • BiLu  193
    • Bi‐nanobody  188
    • Binding affinity  50, 69, 70
    • Binding rate constant of drug and receptor  289
    • Bioanalytical method  45, 51
    • Biologics License Application (BLA)  321
    • Biologics Price Competition Act  230
    • Biologics tissue distribution  43, 44, 46, 49
    • Biologic‐target complex  50, 51
    • Biologic‐target interaction  54
    • Biologic tissue distribution  54
    • Biomarker of response  329
    • Biosimilar  229, 230
    • Biosimilarity  230
    • Bispecific antibody (BsAb)  50, 166, 187, 189, 190, 192, 194, 195, 196, 197, 200, 201
      • scaffold  188
      • valency  189
    • Bispecific construct  201
    • Bispecific diabody  197
    • Bispecific immunomodulatory biotherapeutic molecule  83
    • Bispecific T‐cell engager (BiTE)  187‐190, 194, 201
    • Bivalent anti‐CD28 agonist mAb  7
    • Bleeding  26
    • Blin‐1  190
    • Blinatumomab  189‐191, 194, 200, 201
    • Blood–brain barrier (BBB)  194, 195, 402, 403
    • Blood‐cerebrospinal fluid barrier (BCSFB)  194
    • Blood flow  299, 300, 304
    • B‐lymphocyte stimulator (BLyS)  389
    • BMS‐931699  75, 76, 78, 85, 86
    • BMS‐986003  79, 81
    • BMS‐986004  78‐81, 85, 86
    • Body mass index (BMI)  215, 391, 404
    • Body size  266, 290, 295, 365, 390, 391
      • body size‐based dosing  291, 295
    • Body surface area (BSA)  68, 226, 257, 291, 295, 365
    • Body weight  55, 68, 69, 199, 227, 245, 288, 368
      • body weight‐based dosing  298, 322, 358, 359, 365
      • body weight proportional dosing  392
    • Bone  45
    • Bone marrow  10, 317
    • Bootstrap  404, 416
    • “Bottom up” approach  179
    • Box and whisker plot  104, 376
    • Brain  45, 194‐196, 201
      • Atrophy  402
    • Breakthrough therapy designation  200
    • Breast cancer (tumor)  83, 198
    • Budesonide  98
    • Burosumab  286
    • c
    • C1q complex  213
    • Cachexia‐driven hypercatabolism  395
    • CALM trial  35
    • Calprotectin  29, 35
    • Canakinumab  286
    • Cancer immunotherapy  6, 7, 13, 82
    • Cancer treatment  66, 74
    • Cardiovascular disease  3
    • Catabolism  149, 188, 189
      • pathway  395
    • Categorical endpoint  126, 128, 134, 135
    • Categorical variable  134, 350
    • Catumaxomab  190, 192, 193, 198, 199
    • CD100 K‐PD model  112
    • CD16A (FcγRIIIa) expressing cell  67
    • CD19  191
      • CD19‐expressing cell line  190
      • CD19+ lymphoma cell  194
      • CD19+ target cell  191
      • receptor  194, 200
    • CD20  191
    • CD25  223, 414
    • CD28  6, 73, 76, 78, 85, 86
      • CD28‐B7 (CD80/86)  76
      • CD28‐CD80/86 axis  7
      • receptor  76, 196
      • superagonist  70
    • CD2‐LFA3 interaction  8
    • CD3  6, 73, 191, 192
      • bispecific antibody  86
      • CD3‐expressing Jurkat cell  190
      • expression  84
      • receptor  83, 85, 190, 194, 200
    • CD40 ligand (CD40L)  78, 85
      • antibody‐mediated platelet activation  79
      • CD40‐CD40L pathway  78
      • CHO CD40L assay  81
      • receptor occupancy (RO)  80, 82
      • trimer assay  81
    • CD4+ effector memory T (TEM) cell  70, 196
    • CD52  73, 257
    • CD54  221
    • CD56bright NK cell  414, 415, 417, 425
    • CD62P  79
    • CD80/86  6
    • CD8+ T cell  82
      • lineage  10
      • proliferation  83
      • TCR  13
    • CDAI (Crohns Disease Activity Index)  96, 98‐102, 105, 107‐109, 111, 116, 222, 226, 318, 320, 363, 373
      • K‐PD model  104
      • response  104, 110
      • score  375
      • 70‐point drop from baseline in CDAI (CR‐70)  96, 99, 229
      • 100‐point drop from baseline in CDAI (CR‐100)  96, 98, 99, 101, 103, 113, 116
    • CD diagnosis type  373
    • CDP571  105, 106
    • CDP870  99, 105‐107, 112
    • CD+ T cell  10, 12, 73, 80, 82, 223, 415
      • lineage  10
    • Celiac disease  29
    • Cell activation  73
    • Cell adhesion molecule  221, 246
    • Cell and tissue injury  65
    • Cell‐based potency  75
    • Cell depletion  8
    • Cell‐extrinsic inhibitory mechanism  6
    • Cell‐mediated cytotoxic reaction  216
    • Cell‐mediated inflammation  221
    • Cell surface interferon receptor  403
    • Cell surface marker  73
    • Cell surface receptor  129, 149, 338
    • Cell surface target  44, 45, 66, 73
    • Cell trafficking  221
    • Central immune tolerance  1
    • Central nervous system (CNS)  401‐403
    • Cerebrospinal fluid  29
    • Certolizumab pegol (Cimzia®, CZP)  66, 99, 105‐107, 112, 116, 118, 211, 212, 217, 219, 224, 225, 226, 243, 244, 245, 266, 268
    • CHARM trial  217, 218
    • Checkpoint inhibitor  6‐8
    • Chemokine  53, 66, 210
      • production  73
    • Childrens Registry for the Advancement of Therapeutics  328
    • Chimpanzee  194, 201
    • Chronic inflammation  3, 33, 117, 209, 317
      • cell infiltrate  33
    • Chronic lymphocytic leukemia (CLL)  191
    • Chronic spontaneous/idiopathic urticaria  287
    • Chronic viral infection  67
    • Citrullinated peptides  10
    • Citrullinated protein antigen (ACPA)  4, 10, 11
    • Citrullination  11
    • Citrulline  10, 11
    • CLASSIC I trial  217, 218, 320
    • CLASSIC II trial  218, 320
    • CLASSIC trials  228
    • Clearance mechanism  149, 255
    • Clinical atherosclerotic cardiovascular disease (CVD)  287
    • Clinically isolated syndrome (CIS)  401
    • Clinical remission  30, 32, 34, 217, 219, 221‐224, 246, 247, 323, 324. 372, 379, 381
    • Clinical response  218‐220, 222, 223, 277, 323, 347, 350–352, 355, 356, 358, 381, 382, 384
    • Clinical trial simulation  328‐330
    • Clonal hierarchy  12
    • CNTO 3723  49, 54
    • CNTO 345  49‐51, 53, 54
      • CNTO345/IL‐6 complex  54
    • Code of Federal Regulations (CFR)  322
    • Colectomy  25, 27, 28, 32, 243, 267
    • Collagen‐induced arthritis (CIA) animal disease model  49
    • Collagen‐induced arthritis (CIA) mouse  46, 53
    • Collagen‐induced arthritis (CIA) rat  45
    • Colon cancer  29, 198
    • Colonic biopsy  31, 34
    • Colonic bowel disease  34
    • Colonoscopy  31
    • Colon proximal  316
    • Colorectal cancer  32, 209
    • Combinatorial library yeast display system  13
    • Combinatorial peptide library  13
    • Communication‐driven DSS  259
    • Comorbid condition  257, 258
    • Comorbidity  228, 266, 348, 356
    • Complement activation  74, 192
    • Complement cascade  27, 213
    • Complement‐dependent cytotoxicity (CDC)  67, 74, 190, 191, 196, 301
      • CDC‐mediated cytotoxicity  74
    • Computational biology  9
    • Computerized decision support system (DSS)  259
    • Concomitant immunosuppressive agent  266
    • Concomitant medication  227
    • Confirmatory population PK analysis  130, 135, 348
    • Continent reservoir  25
    • Continuous endpoint  128, 134, 144, 145
    • Continuous vascular endothelial structure  47
    • Continuous vascular endothelium  44
    • Correlational quantitative analysis  344, 347
    • Corticosteroid  25, 28, 98, 266, 322, 323
      • corticosteroid‐dependent  32
    • Costimulation blockade  6
    • Costimulatory regulator  8, 85
    • Covariate analysis  227, 244, 351, 356
    • Covariate model  260, 351, 390, 391, 398
    • CP‐870893  67, 73
    • C‐reactive protein (CRP)  26‐28, 30, 34, 35, 52, 98‐101, 115, 116, 213, 226, 245‐247, 267, 351, 363, 365
    • Crohn's disease (CD)  8, 25, 27, 34, 35, 94, 96, 98, 129, 145, 209, 212‐221, 224‐229, 243‐245, 247, 286, 287, 316, 321, 323, 363, 364, 365, 371, 376, 378‐381, 395
    • Crohn's disease endoscopic index of severity (CDEIS)  35
    • CrossMab  4, 187, 188
    • Cross‐product safety registry  331
    • Cross‐reactivity  191, 192, 201
    • Cryopyrin‐associated periodic syndrome  286
    • Crypt abscesses  33
    • Crypt architectural irregularity  33
    • Crypt branching  33
    • Crypt destruction  33
    • Crypt erosion  33
    • Crypt ulcer  33
    • C‐telopeptide  100
    • Cuffitis  25
    • CXCL13  53
    • CXCR5  53
    • Cyclosporine  338
    • CYP‐450‐mediated metabolism  300
    • Cystic fibrosis  29
    • CyTOF  8, 12, 14
    • Cytokine  66, 210, 222, 389
      • neutralizing biologic  49
      • production  73
    • Cytokine release  67, 71, 73, 74
    • Cytokine release assay (CRA)  74, 81
    • Cytokine release risk  74
    • Cytokine release syndrome (CRS)  67, 73, 84
    • Cytokine storm  65, 70, 71, 73
    • Cytopenia  67, 74
    • Cytoplasma  213
    • Cytotoxicity EC20  85
    • d
    • Daclizumab  257, 258, 285, 286, 292, 293, 414‐418
    • Daclizumab beta (Zinbryta®)  401, 414‐418, 425
    • DART  188
    • DART‐Fc  188
    • DAS28 (28‐joint disease activity score using CRP)  125, 126, 133‐136, 138‐141
    • Dashboard  256, 259, 260, 268
    • Dashboard‐based PK prediction  325
    • Dashboard‐guided dosing  267
    • Dashboard system  259, 260, 277, 325
    • Data‐driven DSS  259
    • Daudi  190
    • Degradation of biologic  45
    • Degree of systemic inflammation  266
    • Demyelination  401, 402
    • Dendritic cell  66, 190, 211, 414
    • Denosumab  286
    • de novo protein synthesis  188
    • Dermal interstitial fluid  46, 49
    • Destructive arthritis  4
    • Developmental pharmacology  300, 308
    • Dexamethasone  395
    • Diabetes comorbidity  266, 356
    • Diabody  187
    • Diarrhea  25, 67
    • Diet  9, 210
    • Digestive Disease Week (DDW)  99
    • Dinutuximab  286
    • Direct pathway‐related biomarker  402
    • Disease duration  351, 353
    • Disease induction  1, 12
    • Disease interception  1‐8, 11, 13, 14
    • Disease interception approach  9
    • Disease‐modifying anti‐rheumatic drug (DMARD)  119, 129
    • Disease pathophysiology  43, 330
    • Disease phenotype  317, 329
    • Disease predisposition  12
    • Disease progression  12, 35, 119, 243, 330
    • Disease severity  28, 34, 119, 125, 227, 243, 258, 267
    • Disease state  257, 288
    • Disease status  44, 257
    • Disease trigger  11
    • Disease type  120, 200, 244, 266
    • Dissociation constant of IgG to FcRn  305
    • Dissociation constant of palivizumab to FcRn  305
    • Dissociation rate of the IgG‐FcRn  305
    • DNL‐Fab3  188
    • Dock‐and‐Lock  187
    • Document‐driven DSS  259
    • Domain antibody (dAb)  76
    • Dose calculator  258
    • Dose‐exposure‐safety analysis  324
    • Dose individualization  258
    • Dose intensification  28
    • Dose‐limiting toxicity  296
    • Dose‐response analysis  343
    • Downstream pharmacodynamics  59
    • Drug–drug interaction  374
    • Drug‐related thromboembolism  78
    • Drug‐specific parameter  54
    • Drug‐specific property  55
    • Drug‐target association  157
    • Drug‐target binding  151, 166, 167
    • Drug‐target complex  149, 151, 152, 155, 157, 159‐162, 164, 167, 168, 174, 175, 177, 178, 180
    • Drug‐target interaction  149, 154
    • Dual‐affinity retargeting  83
    • Dual‐affinity retargeting molecule (DART)  187
    • Dual‐variable‐domain immunoglobulin  187
    • Du Bois formula  296
    • Duobody  187
    • DVD‐Ig  188
    • Dyspnea  222
    • e
    • Early rheumatoid arthritis (RA)  4, 6
    • Eculizumab  285, 286
    • Edema  402
    • Effector cell  190, 193, 196, 198
    • Effector cytokine  338
    • Effector phenotype  12
    • Effector T cell  7, 10, 82
    • Elimination rate constant (Ke)  100
    • Emax model  341, 351
    • Emicizumab (ACE910)  189, 191, 193, 194, 199, 285, 287
    • EMT6 tumor model  83
    • Endocytosis  149, 188
    • Endocytosis rate  300
    • End‐of‐Phase 2 meeting (EoP2) 321
    • Endogenous degradation rate of receptor  289
    • Endogenous IgG  189, 196, 301, 303, 305, 307, 392, 393
    • Endogenous synthesis rate of receptor  289
    • Endoscopically active disease  29, 30
    • Endoscopic assessment  26, 320
    • Endoscopic finding  29
    • Endoscopic healing  267
    • Endoscopic outcome  31, 35, 324
    • Endoscopic remission  31
    • Endoscopic subscore  30, 32, 368, 369
    • Endoscopy  26, 29, 31, 33
    • Endosomal space  46
    • Endothelial  47, 73
    • Endothelial adhesion molecule  220
    • Endothelial cell  188, 195, 212, 219, 299, 419
    • Endothelial clearance  305
    • Endothelial integrity  368
    • Endothelial space  300
    • Endothelial uptake rate of native IgG  305
    • Endothelial volume  304
    • Enlarged T2 lesion  412
    • Entero‐cutaneous fistulae  229
    • Environmental factor  4
    • Environmental perturbation  14
    • Environmental risk factor  11
    • Environmental trigger  2, 3
    • Enzyme‐linked immunosorbent assay (ELISA)  152
    • Epidermal growth factor  222, 295
    • Epigenetic marker  33
    • Episodic treatment  216
    • Epithelial cell adhesion molecule (EpCAM)  192, 198
    • Epithelial cell cancer  198
    • Epitope specificity  12
    • Erythrocyte sedimentation rate (ESR)  26, 27, 34
    • Erythrocyte size  26
    • E‐selectin  220
    • Established rheumatoid arthritis (RA)  7
    • Etanercept (Enbrel®)  45, 49, 67, 266, 338
    • Etrolizumab  34
    • EUCALYPTUS trial  34
    • European Crohn's and Colitis Organization (ECCO)  99, 220
    • European Medicine Agency (EMA)  286, 414
    • Evidence‐based rating system  301, 302
    • Evolocumab  287
    • Exaggerated pharmacology  66, 67, 85
    • Expanded disability status scale (EDSS) score  410
    • Exposome  98
    • Exposure‐based dosing strategy  247
    • Exposure‐driven toxicity  392
    • Exposure‐efficacy (ER) relationship  43, 49, 53, 59, 316, 317, 323, 324, 329, 348, 378
    • Exposure‐response (ER) model  141, 142, 403, 404
    • Exposure‐response (ER) modeling (analysis)  74, 125, 130, 135, 138, 322, 339, 342, 351, 358, 365, 389, 404
    • Exposure threshold  249
    • External control  316, 327
    • Extracellular domain  296
    • Extracellular space  66
    • Extrapolation of efficacy  315, 316, 322, 323
    • Extravascular distribution space  47
    • f
    • Factor VIII (FVIII)  191, 193, 199, 200
    • Fat‐free mass  391, 392
    • Fc‐fragment fusion  201
    • Fc fusion protein  44, 46, 65, 66, 69, 395
    • Fc‐fusion protein  44, 46, 47, 69, 395
    • Fcγ‐mediated catabolism  290
    • Fcγ‐mediated endocytosis  291
    • Fcγ‐mediated phagocytosis  291
    • FcγR  83
    • FcγR‐bearing cell  74
    • Fcγ receptor (FcγR)  73, 192, 196
    • FcγRIIa binding capability  79
    • FcγRIIa receptor  78
    • FcγRIII (CD16A) receptor  73
    • Fc isotype  74
    • Fc‐mediated complement activation  74
    • Fc‐mediated cross‐linking  67
    • Fc‐mediated direct activation  74
    • Fc receptor (FcRn)  83, 188, 189, 290, 368, 389, 393
      • binding affinity  299, 300, 303
      • binding site  189
      • concentration  306, 307
      • expression  290, 395
      • FcRn‐mediated catabolism  290
      • FcRn‐mediated endocytosis  44, 46
      • FcRn‐mediated mechanism  394
      • FcRn‐mediated recycling  394, 395
      • FcRn‐mediated transcytosis  44, 46
      • FcRn‐mediated transfer  396
      • FcRn‐/‐ mouse  396
      • knockout mouse  49
      • mRNA  395
      • receptor  290, 368, 389, 392, 393
      • receptor binding  190
      • salvage pathway  189
      • total concentration  305
    • Fc region  73, 190, 200
    • Fecal biomarker  29, 31
    • Fecal calprotectin (FCP)  29, 34, 35, 213, 365, 373, 375, 381
    • Fecal immunochemical testing (FIT)  31
    • Fecal lactoferrin  31
    • Fenestrated vascular endothelial structure  47
    • Fenestrated vascular endothelium  44
    • Fibrinogen  26‐28
    • Fibroblast  73
    • Ficks Laws of perfusion and diffusion  47
    • FIH dose selection  192
    • FIH safe starting dose  67, 68, 70, 71, 72
    • FIH starting dose  65, 70, 86
    • FIH starting dose projection (selection)  66, 77, 86, 87
    • Filgrastim  222
    • Fingolimod  8
    • First‐generation mPBPK model  47, 48
    • First‐in‐human study  94, 342
    • Fixed dosing approach (strategy)  292, 295, 365, 390, 391, 392, 398
    • Flat‐dose strategy  256, 365
    • Fluid recirculation coefficient  302, 304
    • Flu vaccine  11
    • Follow‐on biologics (FOBs)  230
    • Fontolizumab  223
    • Food and Drug Administration Safety and Innovation Act (FDASIA)  321
    • Fragment crystallizable (Fc)  363
      • Fc‐mediated elimination  366
    • Free CXCL13 concentration  53
    • Free interleukin (IL)‐23 suppression  55, 57
    • Free interleukin (IL)‐6  50, 51, 52, 54
    • Free soluble target  50
    • Free target concentration  152‐154, 162‐166
    • Free target suppression (inhibition)  50, 51, 52
    • Full PBPK model  46, 47, 49, 299
    • Full TMDD model  158, 160, 167, 168, 173, 174, 177, 179, 180, 186
    • Fusion with human serum albumin  201
    • FVIII inhibitor  200
    • FXIa‐trigger TG assay  191
    • g
    • Gadolinium‐enhanced (Gd+)  408
      • Gd+ lesion count  404, 405, 407, 409, 410
      • Gd+ lesion count mixture negative binomial model  409
    • GAIN trial  217
    • Gamma‐secretase  195
    • Gastric cancer (carcinoma)  198, 199, 257
    • Gastroenterologist  32
    • Gastrointestinal tract  7, 25, 209, 289, 364, 368, 419
    • Gd‐enhancing lesion  402
    • Geboes score (GS)  33
    • GEMINI 1 trial 11, 217, 247, 364, 366, 369, 371, 372, 374, 375, 376, 378, 380‐382
    • GEMINI 2 trial 12, 217, 247, 364, 366, 371, 372, 376, 378, 379, 380, 383
    • GEMINI 3 trial 221, 364, 371, 376, 378
    • Genetic marker  33
    • Genetic susceptibility  4, 5
    • Genome  98
    • Genome sequencing coupled with computational approach  14
    • Geriatric  228
    • Germinal center involvement  53
    • Giant cell tumor  286
    • Gliosis  402
    • Glomerular barrier  395, 396
    • Glomerular basement membrane  396
    • Glomerular filtration  189, 190, 290
    • Glomerular filtration rate (eGFR)  396
    • Glomerular lesion  396
    • Glomerulonephritis  398
    • Glucocorticoid  317, 395
    • Golimumab (Simponi®)  212, 217, 219, 220, 243, 266, 268, 327
    • GO‐NO GO decision‐making  94
    • Goodness of fit (GOF) plot  104, 180
    • Granta tumor  194
    • Granulocyte  31, 74, 213
    • Granulocyte‐colony stimulating factor (G‐CSF)  222
    • Granulocyte‐macrophage colony‐stimulating factor (GM‐CSF)  222
    • Gray matter atrophy  402
    • Growth factor  216, 222, 224, 295
    • Growth failure  317
    • Growth hormone  222
    • Gum tissue  11
    • Guselkumab (Tremfya®)  49, 55‐57, 338‐353, 356‐358, 360
    • Gut mucosal immune response  13
    • h
    • Heart  45, 49, 220, 285
    • HED (Human equivalent dose)  68, 69, 70, 78, 197
    • Hematological disorder  394
    • Hemophagocytic lymphohistiocytosis  317
    • Hemophilia A  189, 193, 199, 287
    • Hepatosplenic T cell lymphoma  229
    • Her2‐neu  257
    • HER‐2 positive metastatic breast cancer  295
    • Heterozygous familial hypercholesterolemia (HeFH)  287
    • Heuristic algorithm  167
    • Hierarchy of TMDD model approximation  163, 164
    • Highest nonseverely toxic dose (HNSTD)  68, 69, 83, 85
    • High molecular weight (HMW) PEG  66
    • High‐throughput next‐generation sequencing  9
    • Histocompatibility complex (MHC)  4, 6, 10, 14
    • Histologic inflammation  30, 33
    • Histologic remission  30, 31, 33
    • Histopathologic colonic inflammation  32
    • Histopathology  32
    • Historical control  327, 329, 330
    • HIV infection  201
    • HLA (Human leukocyte antigen)  4
    • HLA allele  12
    • HLA‐Cw06 molecule  13
    • HLA‐DQ6  11
    • HLA‐DQ molecule  11
    • HLA‐DR molecule  4, 10
    • HLA molecule  12, 13
    • Hospitalization  32, 259, 268, 325
    • Host hypocreatin receptor  11
    • Host immune cell  11
    • Host microbiome  13
    • Host microbiome signature  14
    • Hu5c8  79, 80, 82
    • Hu5C8 IgG1  78, 81
    • Human epidermal growth factor receptor 2 protein (HER2) 295
    • Human genetic mutation  7
    • Human growth factor  222
    • Human HLA‐DR2‐restricted TCR  13
    • Human immunoglobulin G1 (IgG1)  45, 129
    • Human pharmacologically active dose (hPAD)  197
    • Human recombinant tumor necrosis factor‐a (rhTNF‐a)  52
    • Human TfR knock‐in mouse model  195
    • Hydraulic conductivity  302, 304
    • Hydrocortisone  33
    • Hyperglycemia  4
    • Hyperglycemia comorbidity  266
    • Hypersensitivity  65
    • Hypersensitivity reaction  67, 197
    • Hypertension  394
    • Hypodermis  289, 290
    • Hypogammaglobulinemia  394
    • i
    • ICH S9 Guideline  67, 197
    • IDEC‐131  78
    • Identifiability of model parameter  150, 166, 168, 179
    • Idiopathic membranous nephropathy (IMN)  397
    • Idiopathic pulmonary fibrosis  201
    • Idiopathic thrombocytopenic purpura (ITP)  78, 80, 82
    • IFNγ (Interferon γ)  73, 223, 395
    • IGA analysis  73, 223, 353, 355‐359, 395
    • IGA categorical modeling  352
    • IgE‐mediated asthma  287
    • IGF1  296
    • IgF1 receptor  296
    • IgG catabolism  300, 306, 395
    • IgG homeostasis  299
    • IgG‐like BsAb  187‐190
    • IgG multiple myeloma  394
    • IgG recycling  389
    • IgG‐scFv  188
    • IgG synthesis rate  303, 305
    • IgG urinary excretion  396
    • IL10RA/B XIAP  317
    • IL‐12R/23R  211
    • IL‐23 baseline  55
    • IL‐23 binding affinity  55
    • IL‐23 dynamics related parameter  55
    • IL23R  210
    • IL‐23‐specific intracellular signaling  338
    • IL‐2A receptor  223
    • IL‐2 receptor signaling  414
    • IL‐2 signaling modulation  415
    • Ileal pouch‐anal anastomosis (IPAA)  25
    • Ileocolonic Crohn's disease phenotype  317
    • Imaging biomarker  402
    • Immune activating antibody  74
    • Immune‐activating protein therapeutic  66
    • Immune activating therapeutic  73
    • Immune activation  76, 395
    • Immune activation receptor  66
    • Immune agonist agent  85
    • Immune cell  5, 10, 11, 66, 73, 196, 197, 212, 215, 220
    • Immune cell activation  3
    • Immune cell infiltration  402
    • Immune checkpoint inhibitor  65, 67, 82
    • Immune complex  197, 396
    • Immune disorder  27
    • Immune dysregulation  2, 3, 8, 266
    • Immune inhibitory receptor  67
    • Immune‐mediated inflammatory diseases  1, 86, 145, 266
    • Immune‐related adverse event (irAE)  67, 68
    • Immune‐related toxicity  84
    • Immune repertoire  8, 9, 14
    • Immune repertoire diversity  14
    • Immune repertoire specificity  14
    • Immune response  12, 14, 53, 63, 130, 152
    • Immune suppression  6, 8, 67
    • Immune surveillance  8
    • Immune system  67, 70, 117, 190‐193, 337
    • Immune system disorder  394
    • Immune system‐specific effector mechanism  190
    • Immune target cell  67
    • Immune target pathway  67
    • Immune thrombocytopenic purpura (ITP)  78
    • Immune trafficking  8
    • Immunogenicity  69, 98, 99, 101, 103, 112, 116, 117, 191, 197, 201, 220, 246, 317, 322, 403
      • K‐PD model  112
    • Immunogenic potential  197
    • Immunomodulator monotherapy  317
    • Immunomodulatory protein therapeutic (IMPT)  65, 66, 67, 68, 69, 71, 72, 73, 74, 75, 85, 87
    • Immunomodulatory therapy  320
    • Immuno‐oncology therapy  6, 395
    • Immunopathogenesis  337, 402
    • Immunoregulatory CD56bright natural killer (NK) cell  414
    • Immunostimulator  216, 222
    • Immunosuppressant  98, 119, 215, 216
    • Immunosuppressive regulatory T (Treg) cell  70
    • Improve Care Now  328
    • Indirect response (IDR) model  125, 126, 136, 164, 165, 226, 342, 343, 355
    • Indirect stimulatory Smax function  417
    • Individualized adaptive dosing  259
    • Individualized dosing  251, 260, 268
    • Individualized therapy  256
    • Infection  11, 14, 27, 65, 210, 220, 221, 247
    • Infectious colitis  29
    • Infectious immunity  9
    • Infectious trigger  5
    • Infertility  25
    • Inflamed ankle joint  49
    • Inflamed parenchymal tissue  420
    • Inflamed tissue‐resident T cell  12
    • Inflammation  26, 65, 402
    • Inflammatory and autoimmune disease  65
    • Inflammatory autoimmune disease  269
    • Inflammatory bowel diseases (IBD)  1, 26, 29, 34, 94, 97‐99, 116, 117, 120, 145, 209, 210, 213‐217, 222, 224, 227‐229, 231, 243, 244, 246‐249, 251, 266, 268, 269, 271, 277, 278, 315, 316, 317, 323, 324, 325, 326, 327, 328, 331, 363, 368
    • Inflammatory bowel diseases (IBD) diagnosis type  373
    • Inflammatory burden  29, 267, 325
    • Inflammatory cascade  28
    • Inflammatory cell infiltrate  33
    • Inflammatory cytokine  49, 212, 337
    • Inflammatory immune response  5, 212
    • Inflammatory marker  27, 28
    • Inflammatory mediator  1, 216, 221
    • Inflammatory pathway  215
    • Inflammatory‐related pathway  395
    • Inflammatory response  11, 74, 218
    • Inflammatory site  66
    • Inflammatory status  27, 28, 226
    • Inflammatory transcription factor  212
    • Infliximab (Remicade®)  27, 28, 30, 32, 48, 49, 67, 99, 104‐113, 115, 211, 216, 217, 218, 219, 223, 225, 226, 228, 229, 243, 244, 246, 247‐250, 257, 258, 266, 267, 268, 269, 271‐273, 275, 277, 278, 285, 287, 292, 294, 317, 320, 323, 324, 325, 338, 374
    • Infusion reaction  220
    • Infusion‐related reaction (IRR)  84
    • Injection reaction  220
    • Injection site reaction  222
    • Innate immune cell  78, 338
    • Innate immune response  27, 213
    • in silico drug discovery  328
    • Insulin  5, 11
    • Integrated mechanistic PK/PD modeling approach  84
    • Integrated pharmacology‐based method  66
    • Integrin  34
    • Integrin antagonist  243, 246
    • Integrin VCAM1  211
    • Intent‐to‐treat (ITT)  363, 378
    • Intercellular adhesion molecule 1 (ICAM‐1) 220, 221
    • Intercellular adhesion molecule 2 (ICAM‐2) 220
      • anti‐ICAM‐1  221
    • Interferon beta  419
    • Interferon beta‐1a  403, 420
    • Interferon‐stimulated gene  403
    • Interleukin (IL)  1
    • Interleukin (IL) antagonist  243
    • International Classification of Disease (ICD)  328
    • International Federation of Psoriasis Associations (IFPA)  337
    • Interstitial fluid pressure  45
    • Interstitial space  45, 46, 47, 188, 290, 300, 303, 305
    • Intestinal inflammation  27, 29, 222, 229, 243
    • Intestinal protein loss  267
    • Intracellular Ca2+  11
    • Intracellular uptake  188, 189
    • Intraepithelial leukocyte retention  34
    • Investigative new drug (IND) application  73, 74
    • Investigators Global Assessment (IGA)  341, 342, 347, 348‐351, 355‐359
    • in vitro cytokine release assay (CRA)  71
    • in vitro cytokine (IL‐6) release EC20  85
    • in vitro cytokine release risk  73
    • in vitro target‐binding affinity  75
    • in vitro toxicology‐based approach  71
    • Ipilimumab  67
    • Iron‐binding glycoprotein  31
    • Irreversible binding approximation  162
    • Islet beta cell  11
    • Islet beta‐cell antigen  3, 4
    • Islet‐resident T cell repertoire  13
    • Isoelectric point (pI)  189
    • Ixekizumab  49, 338
    • j
    • JAK‐STAT pathway  395
    • Joint DAS28‐ACR exposure‐response (ER) model  137
    • Joint destruction  11
    • Joint exposure‐response modeling  134, 145
    • Joint lavage  46
    • Joint model  137, 140‐145
    • Joint model for DAS28  141, 144
    • Joint residual modeling approach  131
    • Joint synovial fluid  46, 51, 53
    • Joint synovial fluid tissue compartment  54
    • Joint synovium vasculature leakiness  49
    • Juvenile idiopathic arthritis  7
    • k
    • Keratinocyte growth factor  222
    • Kidney  44, 45, 49, 290, 299
    • KiH IgG common LC  188
    • Kinase inhibitor  1
    • Kinetic‐pharmacodynamic (K‐PD) model  97, 99, 100
    • KLH‐induced antigen response  80
    • KLH‐induced IgG production  79
    • KLH‐induced IgG response  80, 82
    • Knobs‐into‐Holes technology  187, 195
    • Knowledge‐driven DSS  259
    • l
    • Label dosing  248, 269‐271, 273, 274, 326
    • Lactoferrin  29, 34
    • Lamina propria  33
    • Lamina propria neutrophil  33
    • Landmark analysis  350, 355
      • exposure‐response (ER) model  352, 358
      • exposure‐response (ER) modeling  347, 351
      • model  342, 353
      • modeling  348, 356
    • Large pore  290, 304
    • Latent tuberculosis  224
    • Latent variable  125, 126, 127, 128, 136, 137, 140, 144, 145
      • indirect response (IDR) model  126, 355
    • Leaky compartment  47
    • Lean body weight (LBW)  257
    • Lesional skin site  54
    • Leucocyte  220, 221
    • Leukocyte tissue infiltration  53
    • Leukotriene  31
    • Lifestyle modification  5, 9, 14
    • Ligand‐Binding Assay Bioanalytical Focus Group  51
    • Likelihood concept  261
    • Limit of quantification (LOQ)  51
    • Lineage‐specific depletion strategy  8
    • Linear body‐sized dosing approach  295, 296
    • Linear clearance  149, 257, 367, 368, 373, 375, 390, 421
    • Linear elimination pathway  154
    • Linear model  180, 183
    • Linear pharmacokinetics  69, 200, 257, 343
    • Linear regression approach  260
    • Liver  44, 45
    • Liver disease  394
    • LOE  302, 303
    • Logistic propensity‐score‐based case‐matching model  381
    • Logistic regression  127, 137, 350
    • Logistic regression analysis  351, 378, 381
    • Log‐Poisson model  408
    • Longitudinal exposure‐response modeling  342, 347, 355
    • Longitudinal model  342
    • Longitudinal modeling analysis  341, 355, 356
    • Loss of response (LOR)  247, 266, 277
    • Loss of surface epithelium integrity  33
    • Luminal diarrhea  25
    • Lung  45
    • Lung cancer  198
    • Lupus  80, 396
    • Lupus nephritis  78, 397
    • Lymphatic system  289
    • Lymph drainage  44, 46, 47, 54
    • Lymph flow rate  49
    • Lymphocyte  8, 9, 14, 28
    • Lymphocyte count  99
    • Lymphocyte extravasation  8
    • Lymphocyte function‐associated antigen 3 (LFA3‐Ig) 8
    • Lymphocyte Peyers patch adhesion molecule 1 (LPAM‐1) 221
    • Lymphocyte trafficking  8
    • Lymphoid organ  10, 66
    • Lymphoid tissue inducer cell  414
    • Lymphoproliferative disease  317
    • Lymph volume  304
    • Lysosomal average time of ingested protein  305
    • Lysosomal degradation  189, 190, 195
    • Lysozyme  29
    • m
    • MABEL  66, 71‐75, 77, 79, 80‐87, 197
    • MABEL‐based approach  71, 76, 79
    • MABEL‐based FIH starting dose  76
    • MABEL determination  66, 78
    • MABEL dose projection  85
    • mAb‐ligand complex  226
    • mAb X  134‐137
    • Machine‐learning methodology  4
    • Macrophage  27, 29, 66, 74, 190, 211, 213, 214, 215, 402
    • Macroscopic intestinal inflammation  229
    • MAdCAM‐1  34, 212, 220, 221, 363, 364, 419
    • Magnetic resonance imaging (MRI)  402
    • Maintenance of remission  218, 224, 317, 319
    • Maintenance of response  319
    • Maintenance therapy  216, 218, 219, 221
    • Major histocompatibility complex (MHC)  4, 6, 10, 299
    • Malignancy  27, 220
    • Malignant ascites  198
    • Manganese  29
    • Marginal negative binomial model  404
    • Marginal Poisson model  404
    • Marginal zero‐inflated Poisson (ZIP) model  404
    • Mass cytometry (CyTOF) coupled with single‐cell approach  8, 12, 14
    • Mast cell  74
    • Master protocol  331
    • Matrix metalloproteinase 9 (MMP‐9) 29
    • Maximum recommended starting dose (MRSD)  68, 197
    • Maximum target‐mediated elimination rate  161
    • Mayo Clinic Score (MCS)  32, 99
    • Mayo endoscopic sub score  30, 369
    • MCMC method  182
    • Mean absorption time  415
    • Mechanism‐based FIH safety starting dose  68
    • Mechanism‐based method  66
    • Mechanism‐based PK/PD  225
    • Mechanism of action (MOA)  43, 67, 74, 83, 190, 194, 221, 246, 247, 249, 329, 342, 403
    • Mechanistic framework  227, 329
    • Mechanistic mPBPK modeling  59
    • Mechanistic PK/PD‐modeling‐based  85
    • Mechanistic PK/TE/PD model  50
    • Membrane‐bound IL‐6  221
    • Membrane‐bound target  44, 46, 50, 155, 156, 165, 180
    • Membrane‐bound TNFa  216
    • Membrane‐expressed target  154, 162
    • Memory B cell  246
    • Memory T cell  246
    • Mepolizumab  287
    • Mesalamine  30, 32, 230, 266
    • Mesalamine enemas  32
    • Meta‐analysis  27, 29‐31, 34, 93, 97, 99, 117, 220, 392
    • Metabolic disease  9
    • Metabolomic marker  33
    • Metastatic breast cancer  257, 295
    • Methotrexate (MTX)  25, 98, 134, 135, 244, 266, 317, 323, 338, 373, 374
    • Methoxy poly(ethyleneglycol) (PEG) polymer  403
    • Michaelis–Menten approximation  160‐162, 168, 178, 181
    • Michaelis–Menten elimination  160, 163, 165, 179, 421, 423
    • Michaelis–Menten equation  160, 161, 167, 168, 178
    • Michaelis–Menten PK model  69
    • Microbe  11, 29, 220
    • Microbial population  14
    • Microbial trigger  13
    • Microbiome  1, 13, 14, 98
    • Microbiota‐related influence  5
    • Microglia  402
    • Microscopic inflammation  31, 32
    • Minimal anticipated biological effect level (MABEL)  66, 70
    • Minimal intended pharmacological effect  82
    • Minimal pharmacological active dose (MPAD)  83
    • Minimal physiologically based pharmacokinetic (mPBPK) model  46‐49, 52, 54, 55, 59, 299, 300‐303, 305, 307
      • with TMDD  54
    • Minimum efficacy  343
    • Mixed effect negative binomial model  404
    • Mixed lymphocyte reaction (MLR) assay  76
    • Mixture negative binomial model  404, 405, 407
    • MLN0002  105‐107
    • MoA‐related PD response  83
    • Model‐based approach  260, 360, 419
    • Model‐based dosing  248, 249
    • Model‐based exposure‐response (ER) analysis  346
    • Model‐based meta‐analysis (MBMA)  93‐97, 99, 116, 117, 119, 120
    • Model‐based simulation  339, 342, 355, 356, 358
    • Model‐driven DSS  259
    • Modified citrullinated self‐protein  4
    • Modified Riley Score (MRS)  33
    • Molecular mimicry  11, 13
    • Molecular size  44, 190, 194,
    • Molecular structure  44
    • Monoclonal antibody (mAb)  7, 34, 44, 46, 66, 70, 99, 154, 156, 215, 216, 255, 257, 285, 288, 289, 363
    • Monocyte  29, 213‐215
    • Monovalent anti‐CD28 antagonist  7
    • Morbidity  396
    • Mortality  396
    • Mouse psoriasis‐like (PsL) disease model  49
    • Mouse surrogate  76, 83, 86
    • Mouse tumor model  83, 86, 198
    • MOXR0916  82, 83, 85
    • MRI biomarker  402
    • MRI lesion  403, 410
    • MRSD  68‐71, 76, 78, 81, 85, 197
    • Mucosal addressin cell adhesion molecule‐1 (MAdCAM‐1)  34, 212, 220, 221, 363, 364, 419
    • Mucosal appearance  32
    • Mucosal healing  32, 33, 216, 229, 249, 318‐320, 325, 368
    • Mucosal vascular cell adhesion molecule‐1 (VCAM‐1)  212, 220, 364, 419
    • Mucous depletion  33
    • Multicentric Castlemans disease (MCD)  50
    • Multimerization  201
    • Multiple clinical endpoints  125, 145
    • Multiple melanoma  120
    • Multiple sclerosis (MS)  4, 8, 228, 257, 401, 402
    • Multiscale system level  224
    • Muromonab (anti‐CD3)  73, 285
    • Muscle  44, 45, 299
    • Musculoskeletal pain  222
    • Myelin basic protein (MBP)  13
    • Myxovirus resistance protein A (MxA)  403
    • n
    • Naïve T cell activation  6
    • Naïve T cell proliferation  6
    • NALM‐6 tumor  194
    • Nancy index  33
    • Narcolepsy  11
    • Natalizumab  8, 99, 105‐107, 112, 116, 211, 221, 224, 228, 243, 401, 419‐424, 426‐430
    • National Biotechnology Conference (NBC)  82
    • NAVIGATE trial  338, 339
    • Negative binomial distribution  407
    • Negative binomial model  404, 405, 407, 408
    • Neonate  285
    • Neonate Fc receptor (FcRn)  299, 363, 368, 389, 393
      • recycle  189
    • Neopterin  31, 403
    • Nephrotoxicity  259, 268
    • Neurodegenerative diseases  9
    • Neurologic impairment  410
    • Neutralizing antibody (Nab)  415
    • Neutrophil  28, 29, 31, 33, 74, 211, 213
    • New Drug Application (NDA)  321, 359
    • NFκB pathway  395
    • Nivolumab  365
    • NK cell  66, 73, 74, 192, 414, 417
      • expansion  418
      • NK cell‐mediated cytokine release  73
      • signaling  415
    • NOAEL  68, 69, 70, 71, 78, 81, 82, 83, 85
    • NOD2  210
    • Nomogram  258, 260
    • Nonfucosylation  74
    • Non‐Hodgkins lymphoma  200
    • Non‐IgG‐like BsAb  187, 189
    • Noninvasive biomarker  26, 35
    • Nonlinear clearance  257, 367, 373
    • Nonlinear Michaelis‐Menten elimination  423
    • NONlinear Mixed Effect Modeling (NONMEM, Nonmen)  96, 97, 102, 104, 120, 126, 129, 130‐132, 134‐136, 139, 150, 151, 160, 161, 168, 173‐176, 178, 181, 182, 244, 259, 368, 404, 416, 426, 427
      • $DES block  175‐178
      • $ERROR block  176‐178
      • $INPUT block  176
      • $OMEGA block  176
      • $PK block  175‐178
      • $SIGMA block  176
      • $SIZE option  182
      • $THETA block  176
    • Nonlinear pharmacokinetics  69, 257
    • Nonmechanism‐based toxicity  66
    • Non‐obese diabetic (NOD) mouse  194
    • Nonparametric bootstrap  368, 370, 406, 409, 411, 426, 427
    • Nonspecific (linear) clearance  189, 290, 390
    • Nonspecific proteolytic degradation  188
    • Nonsteroidal anti‐inflammatory drugs (NSAIDs)  129, 210
    • Nontumor bearing mouse  49
    • No‐observed‐adverse‐effect‐level (NOAEL)  68
    • Nuclear factor kappa B (NF‐κB)  212
    • o
    • Obesity  27, 215, 266, 391
    • Objective function value (OFV)  130, 179, 351, 390, 394
    • OBSERVE trial  415, 417
    • Occult blood  29
    • Occult disease activity  30
    • Off‐label medication  228
    • Off‐target effect  225
    • Off‐target toxicity  66, 285
    • 2,5‐Oligoadenylate synthetase (2,5‐OAS)  403
    • Omalizumab  52, 287, 294
    • On‐target biological (pharmacological) effect  83
    • On‐target toxicity  66, 71, 83, 85
    • Opportunistic bacterial infection  67
    • Opportunistic fungal infection  67
    • Opportunistic infection  220
    • Opportunistic parasitic infection  67
    • Ordered categorical variable  134, 350
    • Organ‐specific autoimmune disease  4
    • Orosomucoid  28
    • Orthoclone (OKT3)  255, 285
    • Ortho‐Fab IgG  188
    • Osmotic reflection coefficient  302, 304
    • Osteopenia  317
    • Outer membrane porin C (OmpC)  213
    • Ovarian cancer (carcinoma)  198
    • OX40  82, 83, 85
    • Ozaralizumab  201
    • p
    • PAC‐1  79
    • PAD  11
    • PAD‐4  10
    • Palivizumab  285, 287, 292, 300, 301, 303, 305, 307
    • Pancreatic carcinoma  198
    • Pancreatic islet beta cell  4
    • Paracellular convection  44, 46
    • Parallel computing  181, 182
    • Parallel linear and Michaelis‐Menten elimination  163, 165, 179, 183
    • Paravascular convection  47
    • Paroxysmal nocturnal hemoglobinuria  286
    • Partial Mayo Score  99, 373, 375, 381, 384
    • Passive size‐ and charge‐selective sieve  395
    • Pathogenesis of plaque psoriasis (PsO)  49, 337
    • Pathogenesis of rheumatoid arthritis (RA)  49
    • Pathogenic autoimmune response  13
    • Pathogenic repertoire  9
    • Pathophysiology of inflammatory bowel disease (IBD)  210, 316
    • Patient Protection and Affordable Act  230
    • Patient reported outcomes (PROs)  26
    • Pattern recognition receptor (PRR)  212
    • PBPK  46, 47, 49
    • P‐cadherin  83‐85
    • P‐cadherin LP‐DART  197
    • PD‐1  8, 12
    • PD‐1/PD‐L molecule  7
    • PD‐1/PD‐L pathway  6
    • Pediatric Crohns disease  316, 318, 320
    • Pediatric Crohns disease activity index (PCDAI)  318, 320, 324
    • Pediatric dose selection  288
    • Pediatric dosing strategy  291
    • Pediatric extrapolation  330
    • Pediatric IBD  317, 322, 327, 328, 331
    • Pediatric indication  286, 288, 289, 331
    • Pediatric investigation plan (PIP)  288
    • Pediatric population  221, 285, 288‐291, 295, 307, 315, 316, 322, 323, 331, 365, 374, 376
    • Pediatric product development  315, 322, 331
    • Pediatric Regulation  288
    • Pediatric Research Equity Act (PREA)  321
    • Pediatrics  228, 244, 315, 392
    • Pediatric ulcerative colitis  318
    • Peginterferon beta‐1a  401, 403, 404, 406, 408, 412, 413
    • PEGylated protein  69
    • PEGylation  201
    • Peptide‐MHC multimer  14
    • Peptidyl arginine deiminases (PADs) enzyme  10
    • Perforin‐granzyme  191
    • Periodontal disease  4, 11
    • Peripheral blood leukocyte count  28
    • Peripheral blood mononuclear cell (PBMC)  73, 191, 193, 194
      • PBMC solid‐phase CRA  74
    • Peripheral tolerance  1, 7
    • Permeability surface area  290, 304
    • Personalized induction dosing  250
    • Personalized medicine  258
    • Pertuzumab (Perjeta®)  295
    • PF‐06671008  83‐85
    • Pharmacodynamic marker  329
    • Pharmacodynamic model  416
    • Pharmacodynamic surrogate  28
    • Pharmacokinetic‐pharmacodynamic‐disease relationship  289
    • Pharmacokinetics‐based dosing strategy  255, 256
    • Pharmacologic half‐life  407
    • Pharmacology‐based MABEL approach  73
    • Pharmacometric analysis  389, 397, 398
    • Pharmacostatistical model  93
    • Pharmacotherapy  288, 289, 338
    • pH‐dependent endocytic salvage pathway  299
    • Phenotypic alteration  2, 4, 5
    • Phenotypic analysis  7
    • Phenotypic marker  12
    • Phosphocholine‐containing antigen  213
    • Photodamage  338
    • Physical global rating  32
    • Physicians Global Assessment (PGA)  339‐341, 343, 344, 346
    • Physiologically based pharmacokinetic (PBPK) model  43, 69, 299
    • Physiologically based pharmacokinetics (PBPK)/pharmacodynamics (PD)  43
    • Physiological/pharmacological relevance  351
    • Pinocytosis  188
    • PK dashboard  326
    • PK‐driven approach  84
    • PK‐exposure relationship  376
    • PK/PD‐driven approach  84, 197
    • PK/PD/efficacy relationship  75
    • PK/PD model  225, 226, 260, 414, 415
    • PK/PD modeling  75
    • PK/PD modeling‐based approach  76, 87
    • Placebo effect modeling  131
    • Placebo response  102, 133, 137
    • Plaque psoriasis  46, 129, 337, 338, 340, 342, 360
    • Plasma cell  11, 12, 402
    • Plasma‐to‐tissue fluid exchange rate  44
    • Platelet  28, 78
    • Platelet activation  78‐80, 82
    • Platelet activation assay  79
    • Pleural effusion  45
    • Point‐of‐care assay  248, 250
    • Poisson‐gamma model  408
    • Poisson model  404, 408
    • Polyarticular juvenile idiopathic arthritis  286, 287
    • Polycolonal T cell activation  70
    • Polyethlene glycol moiety  219
    • Polyethylene glycol (PEG)ylated protein  66
    • Polymorphonuclear cell  33
    • Polymorphonuclear neutrophil (PMN)‐elastase  31
    • Population‐based cohort  328
    • Population‐based exposure‐response (ER) modeling  126
    • Population‐based pharmacokinetic modeling  126
    • Population mechanism‐based exposure‐response (ER) model  342
    • Population model  260, 261, 274, 275
    • Population pharmacokinetic analysis (modeling)  130, 135, 150, 226, 274, 300, 322, 389, 390, 396, 398
    • Population pharmacokinetic model  244, 245, 248, 250, 260, 296, 358, 365, 373, 374‐376, 414
    • Population pharmacokinetics  368, 372
    • Population PK parameters and data (PPP&D)  130
    • Population PK/PD model  248, 260
    • Population PK/PD modeling  150
    • Post‐marketing commitment (PMC)  229
    • Post‐marketing requirement (PMR)  360
    • Posttranslational modification  10, 230
    • Pouchitis  25
    • PRECiSE 1 trial 217, 219
    • PRECiSE 2 trial 217, 219
    • PRECiSE trial  228
    • Prediabetic stage  5
    • Predisease stage  5
    • Prediction‐corrected visual predictive check  427
    • Prediction interval (PI)  104, 263, 265
    • PREDPP subroutine  181
    • Pregnancy  27, 220
    • Prescription Drug User Fee Act (PDUFA)  229
    • Primary progressive multiple sclerosis (PPMS)  401
    • Prior TNFα antagonist use  382, 383
    • Prior TNF antagonist therapy  365, 373, 381
    • Prior TNF antagonist therapy status  365
    • PRO307205  83
    • Proactive dose optimization  325
    • Proactive therapeutic drug monitoring  247
    • Proctoscope  32
    • Prognosis of IBD  212
    • Programmed cell death  216
    • Progressive multifocal leukoencephalopathy (PML)  8, 99, 221, 224, 228
    • Proinflammatory cytokine  27, 213, 214, 222, 338
    • Proinflammatory mediator  215
    • Prolonged pharmacological effect  67
    • Proof of concept (POC)  321, 329, 330, 342
    • Propensity score‐based case‐matching algorithm  381
    • Prophylaxis of acute kidney rejection  286
    • Prophylaxis of acute organ rejection  286
    • Proportional adaptive dosing  269, 270, 273
    • Proportional dosing  249
    • Propranolol  326
    • Prostaglandin  31
    • Prostate cancer  198
    • Prostate specific membrane antigen (PSMA)  83
    • Protein  47
    • Protein aggregation  230
    • Protein losing enteropathy  267, 368
    • Protein therapeutic  65‐69, 71, 73‐75, 194, 222,
    • Protein therapeutic‐induced systemic cytokine release  73
    • Proteinuria  389, 390, 395‐397
    • Proteinuria‐dependent dosing regimen  390
    • Proteolysis  368, 403
    • Proteomic marker  33
    • Psoralen plus ultraviolet A light therapy  338
    • Psoriasis  1, 8, 13, 46, 49, 56, 94, 126, 145, 266, 268, 337‐340, 343, 347, 358
    • Psoriasis Area and Severity Index (PASI)  56, 125, 126, 128, 130‐341, 350, 351
    • Psoriatic arthritis (PsA)  94, 125, 128‐130, 134, 145
    • Psoriatic immune pathway  337
    • PSUMMIT II trial  133
    • PSUMMIT I trial  129, 130
    • Purine antimetabolite  244
    • PURSUIT‐M trial  217
    • PURSUIT‐SC trial  217
    • q
    • Quadroma  187
    • Quality of life  25, 32, 98, 222, 223
    • Quantitative clinical pharmacology (QCP)  403, 431
    • Quantitative pharmacology  291, 358
    • Quantitative response‐similarity evaluation  330
    • Quantitative systems pharmacology (QSP, SP)  224, 225, 227, 328‐330
    • Quartiles analysis  378
    • Quasi‐equilibrium (QE) approximation  161, 166‐168
    • Quasi‐equilibrium (QE) condition  159
    • Quasi‐equilibrium (QE) dissociation constant  160
    • Quasi‐steady‐state (QSS) approximation  157‐159, 160, 162, 164‐168, 176, 179‐181
    • Quasi‐steady‐state (QSS) assumption  163
    • Quasi‐steady‐state (QSS) condition  159
    • Quasi‐steady‐state‐irreversible binding (QSS‐IB) approximation  163
    • Quasi‐steady‐state (QSS) model  177, 185
    • Quiescent disease  30, 31
    • r
    • Raji tumor model  194
    • Rapid binding approximation  157, 176
    • Rare disease  329
    • Rational human efficacious dose projection  59
    • Raxibacumab  285, 287
    • REACH trial  317, 318
    • Reactive dose adjustment  268
    • Real‐world evidence  316, 327, 328
    • Real‐world post‐marketing data  331
    • Receptor occupancy (RO)  71, 76, 78, 82‐85, 99, 178, 247
    • Recombinant immunostimulator  216
    • Recombinant mouse interleukin (IL)‐23 (rmIL‐23)  54
    • Rectal bleeding  32
    • Recycling pathway  395
    • Reference listed drug (RLD)  230
    • Refractory solid tumor  82
    • Regulatory T cell (Treg)  4, 7, 10, 12, 13, 82, 415
    • Regulatory T cell‐like phenotype  12
    • Regulatory T cell lymphocyte  223
    • Relapse count  403, 408
    • Relapsed/refractory B‐precursor acute lymphoblatic leukemia  200
    • Relapsing multiple sclerosis (RMS)  401, 403
    • Relapsing‐remitting course  98
    • Relapsing‐remitting disease  402
    • Relapsing‐remitting multiple sclerosis (RRMS)  401
    • Renal disease  396
    • Renal failure  27
    • Renal filtration  149, 396
    • Renal leakage  394
    • Repertoire of B cells  5
    • Repertoire of effector T cell  4
    • Repertoire of regulatory T cell  4
    • Repertoire of T cell  5
    • Restorative protocolectomy  25
    • Restricted clonality  12
    • Reticuloendothelial system  188
    • Rheumatoid arthritis (RA)  1, 4, 8, 10, 11, 12, 45, 49, 52, 67, 117, 119, 120, 125, 134‐137, 145, 201, 266, 268, 295
      • seronegative RA  4, 10, 12
    • Riley score (RS)  33
    • Risk Evaluation and Mitigation Strategy (REMS)  229
    • Risk of relapse  30
    • Rituximab (Rituxan®)  67, 73, 223, 285, 295
    • Robarts histopathologic index (RHI)  33
    • RSV infection  287
    • s
    • S100A12  31
    • Safety factor  68, 69
    • Salvage pathway  189
    • Sample size re‐estimation  326
    • Sargramostim  222
    • scFv2‐Fc  188
    • scFv‐HAS‐scFv  188
    • Seamless Phase 2/3 design  326
    • Secondary progressive multiple sclerosis (SPMS)  401
    • Second‐generation mPBPK model  47‐49, 54
    • Secukinumab  46, 49, 338
    • Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)  26, 35
    • SELECTION trial  417, 421
    • SELECT trial  414, 417, 421
    • Self‐peptide  11
    • Self‐reactive T cell  6, 7
    • Self‐reactivity  1, 5, 7
    • Self‐tolerant state  1
    • Sentinel cohort approach  86
    • Sero‐conversion  5
    • Serum biomarker  26, 29
    • Serum hematologic marker  28
    • Severe combined immunodeficiency (SCID) mouse  193, 194
    • Severely toxic dose (STD 10)  68
    • Shared epitope  10, 11
    • Sieving effect of paracellular pores  44
    • Sigmoidal Emax direct effect model  422
    • Sigmoidal maximum response (Emax) model  415, 418
    • Silenced Fc‐mediated effect  74
    • Siltuximab  50, 52
    • Simple allometry method  69
    • Simulation‐based meta‐analysis  392
    • Simulation study  161, 165, 295, 329
    • Single‐cell technological platform  9
    • Single‐chain fragment variable (scFv)  187
    • Single‐chain variable fragment‐based platform  197
    • Single‐domain antibody (sdAb)  187
    • Site of action  43, 48, 49, 50, 52‐54, 59
    • Sjogrens syndrome  398
    • Skin interstitial concentration  45
    • Skin lesion site  55, 56
    • Skin malignancy  338
    • Small bowel disease  34
    • Small pore  302, 304
    • Smoking  4, 11
    • Software‐guided dosing  259
    • Solid organ transplant rejection  6
    • Solid‐phase assay  74
    • Solid‐phase resonance (SPR) assay  75
    • Soluble antigen  66
    • Soluble free target concentration  153
    • Soluble IL‐6R  221
    • Soluble inflammatory cytokine  50
    • Soluble P‐cadherin  84
    • Soluble proinflammatory cytokine  49, 52
    • Soluble receptor  257
    • Soluble target  50, 51, 149, 153‐156, 165
    • Soluble TNFa  212, 216, 219
    • Solution‐based assay  73
    • Specific target binding  44
    • Sphingosine‐1 phosphate receptor‐agonist  8
    • Spleen  44, 45, 53
    • Splenic flexure  316
    • Standard of care (SOC)  94, 216, 278, 325, 326
    • Statins  3
    • “Step up” approach  98, 266
    • Stepwise adaptive dosing  269, 270, 272, 273
    • Stepwise dosing  248
    • Stepwise forward selection  351
    • Stochastic model  260, 261, 404
    • Stool frequency  26, 27, 32
    • Stratification biomarker  329
    • Stricturing phenotype  317
    • Subcutaneous tissue  289
    • Submucosa  27
    • Subtherapeutic drug concentration  267, 324
    • Suction blister technique  45
    • Superagonistic activity  71
    • Surface area (BSA)‐based dosing  256, 257, 291, 292
    • Surgical intervention  210
    • Surrogate biomarker  212, 213, 226
    • Surrogate endpoint  3
    • Synergistic combinatorial effect  216
    • Synovial fluid  49
    • Synovial T cell  8
    • Synovium  12, 54
    • Systematic reviews and meta‐analyses (PRISMA)  95
    • Systemic autoimmune disease  389
    • Systemic exposure‐based approach  69
    • Systemic inflammation  52, 266
    • Systemic inflammatory disease  27
    • Systemic juvenile idiopathic arthritis  286, 287
    • Systemic lupus erythematosus (SLE)  389, 390, 393, 395‐397
    • Systemic T cell activation  7
    • System‐level response  329
    • System‐specific parameter  54, 299
    • t
    • TAB08  196
    • TandAb  188
    • Tandem diabody (TandAb) system  187
    • Tandem scFv  197
    • Target antigen level  199, 291
    • Target baseline concentration  51
    • Target binding  43, 44, 45, 50, 52, 54, 67, 189
    • Target‐binding affinity  50
    • Target‐binding process  50
    • Target cell  73, 74, 190
    • Target degradation  44
    • Target degradation rate  152, 164
    • Target dynamics  43, 50, 54
    • Targeted receptor  289
    • Target engagement  43, 50, 52, 59, 75, 79, 86, 420
    • Target exposure  269, 274
    • Target expression  45, 69, 71, 75
    • Target expression level  67
    • Target expression profile  43
    • Target interaction  44, 197
    • Target internalization  44
    • Target mechanism  73
    • Target‐mediated clearance  69, 149
    • Target‐mediated drug disposition (TMDD)  48, 52‐54, 69, 149‐152, 154, 157, 163, 165, 174, 182, 189, 226, 290, 291, 366
    • Target‐mediated drug disposition (TMDD) model  50, 150, 161, 164‐167, 173, 174, 177‐181, 290, 291
    • Target‐mediated drug disposition (TMDD) system  159, 162, 163, 166, 168, 226
    • Target‐mediated elimination  373
    • Target‐mediated elimination pathway  149, 154
    • Target‐mediated pharmacokinetics  257
    • Target modulation  49
    • Target occupancy  50, 174
    • Target pharmacology  71
    • Target production rate  152
    • Target systemic exposure  274
    • Target window for dose adjustment  272
    • TAXIT trial  246, 247, 249, 268
    • T cell  4, 5, 10, 13, 14, 27, 66, 73, 211, 215, 216
    • T‐cell activation  6‐8, 70, 82, 83, 194, 338, 403, 414
    • T‐cell co‐stimulation  79
    • T‐cell co‐stimulation inhibitor  76
    • T cell co‐stimulatory receptor CD28  70
    • T cell‐dependent immune response  6
    • T cell‐dependent keyhole limpet hemocyanin antigen response (anti‐KLH TDAR)  76
    • T‐cell‐dependent keyhole limpet hemocyanin (KLH)‐induced IgG response  76
    • T cell depletion  8
    • T cell development  10
    • T cell dysfunction  7
    • T cell epitope  11
    • T cell lymphocyte  223
    • T‐cell‐mediated immune response  222
    • T cell proliferation  82
    • T‐cell proliferation  84, 223
    • T cell receptor (TCR)  6, 9, 12, 70
    • T cell receptor (TCR) specificity  13
    • T cell recruiting BsAb  196
    • T cell repertoire  10‐13
    • TCR recognition  6, 11
    • TCR repertoire  12
    • TCR sequence  12
    • T‐dependent mouse immunization (TD1) model  53
    • TDM‐based dose adjustment algorithm  266
    • Teduglutide  222
    • TfR affinity  195
    • TfR binding  195
    • TGN1412  66, 67, 70, 71, 73, 75, 86, 196, 201
    • TGN1412‐like cytokine release  74
    • T helper 17 (Th 17) 403
    • The National Institute for Health and Care Excellence (NICE)  34
    • Therapeutic drug monitoring (TDM)  226, 246, 247, 249, 251, 256, 259, 260, 266, 268, 277, 324, 325
    • Therapeutic drug monitoring‐guided dosing  248
    • Therapeutic index  259, 392
    • Therapeutic monoclonal antibody  155, 249
    • Therapeutic protein  73, 94, 98, 149, 152, 162, 167, 174, 197, 201, 315, 317, 322, 331, 338, 403, 431
    • Therapeutic target  6, 26, 43, 52, 78, 223, 268
    • Thiopurine  25, 317, 324
    • Thrombin generation (TG) assay  191
    • Thromboembolism  78
    • Thymic selection  10
    • Thymus  4, 10
    • Tiered fixed dosing  291
    • Tight compartment  47
    • Tissue biomarker  34
    • Tissue centrifugation  45
    • Tissue compartment  46
    • Tissue distribution  46, 48, 49, 54, 55
    • Tissue distribution kinetics of biologics  44
    • Tissue distribution of biologics  45
    • Tissue injury  67, 74
    • Tissue interstitial fluid  45
    • Tissue interstitial space  45, 47
    • Tissue marker  33
    • Tissue‐resident repertoire  12
    • Tissue site of action  43, 45, 48, 50, 52‐54, 59
    • Tissue vascular endothelium  44
    • T2 lesion count  411
    • T2 lesion count mixture negative binomial model  411
    • T2 lesion count model  407
    • T lymphocyte trafficking  364
    • Tocilizumab  221, 222, 287
    • Tolerance  1, 3, 6, 7, 14, 192
    • Tolerogenic application  12
    • Toll‐like receptor  212
    • Total clearance  366, 367
    • Total CXCL13 concentration  53
    • Total interleukin(IL)‐6 concentration  50, 51
    • Total Mayo score  318
    • Total target concentration  152‐154, 160‐162, 164‐168, 176‐179
    • Total tissue concentration  45
    • Toxicology‐based approach  66, 70, 71
    • Transcriptional regulation  14
    • Transcytosis  196
    • Transcytotic receptor  44, 46, 195, 196
    • Transgenic knock‐in mouse model  201
    • Translational pharmacology  82
    • Transmembrane TNFa  212, 219
    • Transmigration  221, 419
    • Transmural inflammation  27
    • Transplant rejection  6, 66, 78, 79
    • Transporter‐mediated transcytosis  195
    • Trastuzumab (Herceptin®)  257, 285
    • Treat‐to‐target approach  26, 35, 243, 268, 326
    • Treg  83
    • Treg activation  13
    • Treg cell  67, 70
    • Treg‐dependent circuit  7
    • Treg down‐regulation model  423
    • Treg reduction  83, 418
    • Treg reduction model  416
    • Trifunctional antibody (trAb)  192, 198
    • Tri‐molecular complex  83
    • Tri‐molecular synapse assembly  197
    • Tri‐molecule (tumor‐T‐cell‐drug)  84
    • Triomab  188
    • Tri‐specific antibody  50
    • Tuberculosis  224, 228
    • Tubular reabsorption of IgG  396
    • Tumor‐bearing mouse  49
    • Tumor cell  191, 192
    • Tumor cell cytotoxicity  67
    • Tumor cell killing  74, 83, 84
    • Tumor cell lysis  191
    • Tumor immunity  9
    • Tumor lysis syndrome  65, 74
    • Tumor necrosis factor (TNF)  1, 27, 48, 52, 98, 395
      • anti‐TNF biologic  211, 317
      • anti‐TNF mAb  268, 324
      • anti‐TNF therapeutic protein  338
      • anti‐TNF therapy  98, 267
      • TNF experienced  134
      • TNF inhibitor  219
      • TNF receptor  45
      • TNF/TNF‐R superfamily  6, 78
    • Tumor necrosis factor alpha (TNFα)  48, 49, 51, 52, 73, 78, 98, 213, 215, 216, 219, 226, 293, 338, 395
      • anti‐TNFα  220, 265
      • anti‐TNFα agent  129, 221, 230
      • anti‐TNFα biologic agent  223, 224
      • anti‐TNFα Fab  66
      • anti‐TNFα mAb  49, 65
      • anti‐TNFα treatment  213
      • TNFα antagonist  217
      • TNFα blocker  323
      • TNFα inhibitor  216
    • Tumor necrosis factor (TNF) antagonist  243, 246, 247, 364, 365, 368, 373, 381
      • TNF antagonist therapy‐naïve  375
    • T1‐weighted Gadolinium (Gd)‐enhancing image  402
    • T1‐weighted image  402
    • T2‐weighted image  402
    • T2‐weighted lesion  402
    • Two‐pore minimal PBPK model  300
    • Two‐target TMDD approximation  165
    • Two‐target TMDD model  165
    • Type 1 diabetes (T1D) 4, 8, 11, 13
    • Type I error rate  326
    • Type I indirect response model  342
    • Type I interferon family  403
    • Tyr30Glu mutation  190
    • w
    • Wagner equation  161, 162, 168
    • Wald CI  105, 106
    • Warfarin  249, 259, 277
    • Weight‐based dosing  256, 291, 292, 295, 320, 398
    • Weight normalized FcRn concentration  306
    • Weight proportional dosing  391, 392
    • WELCOME trial  219
    • White cell lineage  28
    • Whole blood receptor occupancy (RO)  75
    • Whole‐body PBPK model  48
    • z
    • Zero‐inflated‐Poisson model  404, 408
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