1841 Subject Index a Abacavir 59, 82 Acute lymphoid leukemia, see ALL ABCA1 58 Acute myelogenous leukemia (AML) 502 ABCB1 54, 58 – radioimmunotherapy of 505 Abciximab 21, 462, 1086, 1117, 1153 – antibody treatment for 1121 – half-life in plasma 1167 Ad5FGF-4 (Adenovirus 5 fibroblast growth Abscisic acid, responsive element 980 factor-4) Absorption enhancer 1464 – analytical assay 161 – efficacy 1465 – analytical techniques for 164 N-Acetylglucosamine (GlcNAc) 679, 764, 849, – clinical study 175 938 – dose-response 174 N-Acetylglycosaminyl transferase 924 – genome structure 157 N-Acetylmannosamine 1047 – production 158 N-Acetylmuramic acid 938 – toxicology study 174 N-Acetylneuramic acid 811, 1047 Ad5FGF-4 (Adenovirus 5 fibroblast growth N-Acetylneuraminic acid 772 factor-4) vector Acetylphosphate 1075 – isolation of 156 Acetylcysteine – production 156 – in drug delivery 1375 Ad5LacZ 172 Acinar formation assay 643 Adagen 475, 1399, 1401, 1411 Acinetobacter calcoaceticus 706 Adalimumab 22, 455, 1086, 1118, 1150, 1156, Acquired immuno deficiency syndrome, see AIDS 1163 Acromegaly 15 Adeno-associated viral vector (AAV) 317 Actilyse 461 Adenosine deaminase (ADA) 429 Actimmune 17, 467 – deficiency 1401 Actinorhodin 1807 Adenovirus plasmid 156 – structure 1814 Adenovirus serotype 5 (Ad5) 155 Activacin 461 Adjuvants 1423 Activase 11, 461, 726 – for human vaccination 1425 Activase-rtPA 746 – mode of action 1424 Activated clotting time 1012 – ADMET (absorption, distribution, metabolism, Activated partial thromboblastine time (aPTT) excretion and toxicity) 1604, 1773 198 – assessment 1604, 1628 Activated protein C 457 – basic principles 1786 Activator protein-1 236 – models 1786 Actrapid 13, 470 – prediction system 1785 Acute lymphoblastic leukemia, see ALL – prediction tools 1796 Acute lymphocytic leukemia, see ALL – profiling 1785 Modern Biopharmaceuticals. Edited by J. Knäblein Copyright © 2005 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim ISBN: 3-527-31184-X 1842 Subject Index – properties 1775 Alpha-glucosidase 861 – value of prediction 1798 Alpha-iduronidase 862 Adenosine triphosphate (ATP) AlphaNine SD 459 – regeneration system 1074 Alphaparin 457 ADR (adverse drug reactions) 76 Alpha-synuclein 329 Adult respiratory distress syndrome 1009 Altemol 467 Advaferon 467 Alteplase 11, 461 Advate 421, 459 Alternating tangential filtration 1087 Adverse drug reaction 51 Alzheimer disease (AD) 77, 1781 Aequorea victoria 1628 – targeting 1286 AERx-dornase alfa 475 – pathways and targets for 625 Affinity chromatography – epidemiology 326 – characterization of antibodies by 797 Amantadin 330 Aflatoxin B1 AMAXA system 632 – CYP3A4 activated 1586 Ambirix 19 AFP 482 Ames false negatives 1625 Agalsidase alpha 475 Ames false positives 1625 Agalsidase beta 475 Ames II 1527, 1633 Agarose 1380 Ames test 1632 AGENT (angiogenetic GENe therapy) trial 175 Amevive 454–455, 1119 – safety 177 Amiloride 1525 AGENT 2 trial 176 Amino acid depletion – safety 177 – with glutaDON 537 Age-related macular degeneration 1280 Aminoacyl-tRNA synthetase 1068 Agrobacterium tumefaciens 903, 950 Amino-3,8-dimethylimidazoquinoxaline 1634 AIDS (acquired immuno deficiency syndrome) Amino-hydroxybenzoic acid 1823 14 (2-Amino)isobutyric acid 413 – gene therapy 549 Aminolevulinic acids 1617 – vaccine 1164 (3-Aminomethyl)benzenesulfonylglycine 407– Airway hyper responsiveness 234 408 Akanthamoeba castellanii 685 Amino-3-methyl-imidazoquinoline 1634 Aktraphane 13 Aminopeptidase 1379 Alamar blue dye metabolism 168 2-O-Aminopropyl oligoribonucleotide 261 Albuterol 59 Amiodarone Aldurazyme 24, 475 – clearance of 1594 Alefacept 455 – CYP2C9 inhibitor 1590 Alemtuzumab 22, 455, 479, 1086, 1156 Amitriptyline Alfaferone 467 – CYP3A4 activated 1586 Alfatronol 17, 468, 480 Ammonium tartrate 922 Alferon LDO 467 Amoxibeta T1000 1352 Alferon N 467 Amoxicillin 1352 Alglucerase 475 Amphotericin B 1370 Alkaline phosphatase 712 Ampicillin 610 – secreted 731 – resistant plasmids 1024 ALL (acute lymphoid leukemia) 76, 202 Amyloid precursor protein (APP) 1782 – murine model 203 – processing scheme of 1783 Alosetron 52 Amyloidosis 1286 Alpha-1 464 Anact C 454, 457 Alpha-1 antitrypsin 463 ANAFP (a novel antifungal peptide) 483 – from transgenic system 858 Anakinra 17, 464, 1118 Alpha-defensin 383 Analytical assay validation Alphaferon 467–468, 480 – regulations 1650 Alpha-fetoprotein 862 Analytical methods Subject Index 1843 – in quality control 1557 – epitope/paratope interaction 1108 – in vivo 1572 – fully human 1111, 1113, 1157 – specifications for drug substances – half-lives of therapeutic 1166 and products 1561 – humanized 1153 – validation 1567 – immunogenic 1150 Analytical protein A chromatography (APAC) – in disease targeting 1273 – characterization of antibodies by 797 – isotope conjugates 1174 Angelmann syndrome (AS) 219 – libraries 1157 Anger position network 1221 – linking of phenotype and genotype in selection Angioblasts systems 1161 – for angiogenesis 319 – marker for autoimmune disease 1189 Angiogenesis 1235 – murine 1156 – markers of 1281 – naked 1169 – non-tumor 1280 – on the market 1151 – related disease 1278 – pharmacological characteristics of 1114 Angioedema, hereditary 859 – protective function of 1166 Angiogenetic switch 1279 – polyclonal 1109 Angiogenic GENe therapy, see AGENT – radiotracer 1258 Angiomax 461 – screening technologies 1160 Angiostatin 381 – single chain 1115 Angiotensin-converting enzyme (ACE) 78, 317 – single domain 1115 Angiox 461 – synthetic 1176 Animal models Antibody-antigen interaction 1190 – selection 1658 Antibody-dependent cellular cytotoxicity 733, Animal rule 1662 1274 Animal, transgenic 29 Antibody-directed enzyme prodrug therapy – biopharmaceuticals from 833, 995 (ADEPT) 1277 Anion-exchange HPLC 164 Antibody fragments 1113 Anistreolase 461 – manufacture in microbial systems 1088 Annexin 5 detection assay 644 – pharmacokinetics of 1116 Annexin A1 1281 Antibody library technology 1163 Annexin V 1262 Antibody response 1199, 1500 – for SPECT studies 1263 Antibody technology 1147 ANP, see atrial natriuretic peptide Antibody, therapeutic Antegren 1122 – productivity advantages 1726 Anthracycline 139 Anticoagulants 454 Anthrax 1489 Antide structure 1408 – toxine 1166 Antiepileptic drugs 58 Antibiotic resistance gene 299 Antigen-nanoparticle conjugate 1310 Antibody 454 Antigen-presenting cell 191, 360 – against infectious disease 1175 Antihemolytic factor VIII, see fVIII – anti-neutrophil cytoplasmic 1195 Antihemophilia agents 454 – anti nuclear 1190 Antinuclear autoantibodies, mononuclear 1371 – binding haptens, peptides or proteins 1154 Antiperinuclear factor 1192 – binding site 1163 Antisense RNA – bispecific 1174 – for gene silencing 633 – categories 1150 – plasmid-borne 671 – chimeric 7, 1109, 1153 Antisense technology 31 – class determination 1107 Antithrombic agents 460 – combining site 1190 Antithrombin (AT) 29, 995 – complexes of 1155 – anti-inflammatory activity 1009 – different fragments and formats 1274 – hereditary deficiency 997, 1014 – epitope 1190 – human 1001 1844 Subject Index – recombinant production of 998 Ascorbate peroxidase 977 – serpin 996 – ROS scavenger 979 – vector construction 999 Asialoglycoprotein 716, 1512 Antithrombin III 458, 996 Asialoorosomucoid 1512 – human 855 Asparaginase, PEGylated 543 Antithrombin transgene 999 Aspergillus giganteus 482 Anti-thymocyteglobulin 456 Aspergillus terrus 1804 Antitrypsin 463–464, 858 Astemizole 52 Anti-tumor agent 474 Atenativ 458, 1006 Antiviral agents Atherosclerosis 313 – RNA-based 570 – targeting 1281 Antril 464, 1117 Atomoxetine 57, 61, 64 AP 486 – label recommendation 56 AP-1 233 Atorvastatin 58 Apcitide 1283 Atrial natriuretic peptide (ANP) 290 APEX 84 Atrioventricular block 298 Apidaecins 486 Atriplex gmelini 974 Apidra 13, 469 ATryn 29, 855, 995 Aplysia kurodai 482 – clinical studies 1011 Apolipoprotein E (APOE) Auerbach plexus 327 – locus 78 Auger electron emitter 500 – satin system 78 – targeted radiotherapy with antibodies 524 Apoptosis 644 Auger electron radiotherapy – delaying 819 – antitumor effects 519 – imaging 1238, 1262, 1284 – gene-targeted 525 Aprepitant 1538 – In-DTPA-D-Phe-octreotide 519 AproliZean 903 Auristatin derivatives – Apronexin NP 854 – cytotoxic 1172 Aprotinin 904, 1470, 1472 Autoantibody – from transgenic system 854 – antinuclear, mononuclear 1371 – variants 1027 – pathogenic 1188 Aptamers 635 – responses 1187 Arabidobsis thaliana 869, 921, 950, 973 Autoantibody-autoantigen complexes Aralast 463 – characterization of 1199 Aralia elata 482 Autographa californica Aranesp 8, 472 – nuclear polyhedrosis virus 1046 Arcitumomab 21 Autoimmune disease 1187 Ardeparin sodium 458 Autoimmune encephalomyelitis (EAE) 1200 Area under the curve (AUC) 438 Autologous stem cell 500 Argatroban 413 Auxotrophic marker 766 Argonaute protein family 222 Available chemical directory (ACD) 1790 Argoproteins 245 Avakine 456 Arixtra 457 Avastin 143, 454–455, 479, 1121, 1169 ARMS 84 Average internal stability profile 250 Aroclor 1254, 1626 Avidin from transgenic systems 852 ARPE-19 168 Aviptadil 1742 Array-on technology 88 – dosage 1748 Arterial re-stenosis 313 – effects 1748 Arthrobacter globiformis 977 – in PAH 1743 Arthrobacter panescens 977 – increase in CRE binding 1746 Artificial neural network 1789 – pharmacology 1744 – for CNS activity prediction 1794 – release 1748 – topology of three-layer 1790 – secretion enhancement 1748 Subject Index 1845 Avonex 17, 467, 1404 Beromun 23, 463, 479 5-Azacytidine 320 Beta-cyclodextrin 407 5-Aza-2-deoxycytidine 294 Betaferon 4, 17, 467 Beta-glucocerebrosidase