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Models |
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neutral networks, 245-246 |
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physiological systems, 241-244 |
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receptor based, 241 |
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Monoclonal antibodies (MoAbs), 188 |
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Neural networks, 245-246 |
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New Drug Application (NDA), 33-35, 83 |
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Nicotine Transdermal Systems, 184 |
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Nonclinical development, 272-273 |
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Novel drug delivery systems, 9, 170-192 |
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buccal, 179-181 |
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future, 186-192 |
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nasal, 181 |
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oral, 173-176 |
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parenteral, 182-183 |
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pulmonary, 181 |
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pulsatile, 191 |
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recent innovations, 183-186 |
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regulated, 190 |
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routes of administration, 172-183 |
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targeted, 186-190 |
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transdermal, 176-179 |
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Nuclear magnetic resonance (NMR), 111, 208 |
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Operational excellence, 41 |
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Oral osmotic pumps (OROS), 175 |
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Orphan Drug Act, 62-63 |
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Patent and Trademark Office (PTO), 61 |
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Pharmaceutical industry changes in, 39-44 |
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Pharmacodynamics, 23 |
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Pharmacognosy, 5 |
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Pharmacy benefit management companies (PBMs), 64 |
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Programmed electrical stimulation (PES), 23 |
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Pharmacokinetically guided dose escalations (PGDE), 288 |
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Pharmacokinetic/pharmacodynamic relationship, 23 |
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Pharmacokinetics, 23, 262-264 |
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studies, 266-277 |
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Physiological systems modeling, 241-244 |
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mathematical, 242 |
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Portfolio |
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analysis, 101-114 |
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criteria for, 103-104 |
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interpretation of, 112-114 |
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complications, 101-103 |
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considerations, 101-103 |
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development, 106-107 |
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discovery, 104-106 |
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quantitative assessment of, 107-109 |
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research and development, 101-114 |
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review, 109-112 |
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Positron emission tomography (PET), 248 |
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Powdered cellulose, 122 |
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Preclinical studies, 220-252 |
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Pregelatinized starch, 123 |
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Prescription Drug User Fee Act of 1992, 59 |
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Price controls, 66 |
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Procardia XL, 185-186 |
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Product insert, 35 |
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Product leadership, 41 |
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Product liability, 46-55 |
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basis in drug development, 47-49 |
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and drug development, 52-53 |
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and the manufacturer, 49-52 |
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reform, 53-55 |
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Pulsatile delivery, 191 |
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Quantitative Structure Pharmacokinetic Relationship (QSPR), 222-223 |
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Quinidine, 4 |
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Quinine, 4 |
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r-TPA, 9 |
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Ranitidine, 300, 304 |
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Receptor-based models, 241 |
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