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European Medicines Evaluation Agency (EMEA), 422 |
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tasks of, 423-425 |
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European Union (EU), 380 |
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clinical pathology studies in, 379-420 |
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marketing authorization procedures in, 422-441 |
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centralized procedures, 425-431 |
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decentralized procedures, 431-436 |
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national procedures, 436-437 |
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Evolution, 5 |
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Excipients, 118-128 |
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adhesive, 118 |
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in direct compression, 122-123 |
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drug, 119 |
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in drug development, 118-128 |
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general characteristics, 119-121 |
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liquid, 119 |
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performance characteristics, 121-128 |
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in wet granulation, 122-123 |
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Expert systems, 222-224 |
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data-based, 222-224 |
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FDA, 16-19, 22, 30, 32, 33, 67 |
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regulators, 16 |
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Formularies, 65 |
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Fraction Released Immediately (FRI), 147 |
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Future shock, 3 |
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Gene |
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manipulation, 8, 10 |
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modification, 10 |
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therapy, 10 |
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General Agreement on Tariffs and Trade (GATT), 61 |
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Generic drugs, 65-66 |
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Good Clinical Practice (GCP), 386 |
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Good Laboratory Practice (GLP), 386 |
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Government research, 14, 15 |
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Health care reform, 59-60 |
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Hill equation, 146 |
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Ic agents, 7 |
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Imaging, 247-250 |
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International Conference of |
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Harmonization (ICH), 354, 380 |
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In vitro |
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metabolism, 225-226 |
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scaling, 230-232 |
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In vitro-in vivo correlations, 154-167 |
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basics of, 155-156 |
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classification of, 155 |
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parameters in, 156-161 |
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Iontophoresis, 178, 192 |
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Japan |
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clinical needs in, 367-372 |
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Ministry of Health and Welfare (MHW), 369 |
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preclinical needs in, 362-367 |
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quality needs in, 361-362 |
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regulatory process in, 354-361 |
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Japanese Pharmaceutical Affairs Law (PAL), 354 |
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Lactose diluents, 124 |
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Lamivudine, 307 |
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Liability (see Product liability) |
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Lipid therapy |
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dosage establishment in, 24 |
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Litogens, 46, 47 |
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Lorcainide, 7 |
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Lyakuhin Kikou, 355 |
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Makoid-Banakar Function, 139-154 |
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practical experiences with, 146-154 |
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utility in product development, 145-146 |
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Managed care, 64-65 |
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Mannitol, 122 |
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Market-Oriented, Sector-Selective (MOSS) talks, 354 |
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Metabolic isoforms, 226-229 |
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Microcrystalline cellulose, 122 |
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Microdialysis, 247 |
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