Publication Information

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1822, 1884, 2768, 2845, 2893, 2918], 'outline': [124], 'opportunities': [127], 'select': [129, 1182, 2807], 'patient.': [136], 'The': [137, 235, 272, 304, 448, 510, 872, 925, 980, 999, 1050, 1399, 1732, 1845, 1888, 2023, 2154, 2211, 2789, 2947, 3094], 'goal': [138, 822], 'this': [140, 3086, 3099], 'article': [141], 'is': [142, 165, 573, 732, 1676, 1762, 1962, 2131, 2227, 2263, 2320, 2594, 2673], 'provide': [144, 947, 1270, 2061, 2603, 2777], 'balanced': [146], 'perspective': [147, 3100], 'on': [148, 167, 258, 283, 482, 631, 714, 746, 768, 916, 1005, 1210, 1770, 1841, 1970, 2002, 2197, 2302, 2455, 2477, 2625, 2988, 3085], 'role': [150], 'pharmacology': [153, 195, 2801, 2832], 'novel': [158, 879], 'oncology': [159, 697, 1915, 1979, 2810], 'drug': [160, 280, 639, 667, 830, 1153, 1209, 1219, 1522, 1559, 1597, 1608, 1666, 1697, 1946, 2036, 2073, 2104, 2135, 2315, 2344, 2358, 2368, 2393, 2415, 2434, 2525, 2574, 2592, 2626, 2672, 2750, 3078], 'products.': [161], 'Traditional': [162], 'based': [166, 257, 282, 630, 713, 745, 767, 1840, 2599], 'assessment': [169], 'tolerability': [171, 1395, 1694, 1819], 'first-in-human': [174], '(FIH)': [175], 'trial;': [176], 'however,': [177, 1584], 'several': [178, 632, 695, 1133, 1795, 2717, 2847, 2895], 'additional': [179, 241, 339, 2656], 'be': [182, 238, 610, 676, 744, 755, 992, 1035, 1054, 1079, 1129, 1407, 1437, 1461, 1487, 1587, 1605, 1626, 1657, 1699, 1745, 1780, 1824, 1860, 1986, 2090, 2183, 2237, 2346, 2378, 2437, 2446, 2566, 2668, 2704, 2770], 'considered': [183, 1080, 2091], 'when': [184, 763, 2094, 2166], 'evaluating': [185, 338, 1491, 1662, 2855], 'further': [189, 354, 796, 1383, 1928], 'development,': [191, 1122, 1452, 1811], 'including': [192, 325, 536, 699, 1135, 1470, 1917, 2720], 'nonclinical': [194, 259, 892, 926, 1012, 1492, 2864], 'data': [196, 208, 242, 260, 267, 390, 669, 895, 927, 949, 1088, 1225, 1303, 1357, 1493, 1501, 1669, 1751, 1852, 1895, 2555, 2605, 2779], 'preliminary': [199], 'pharmacokinetic': [201, 2600], '(PK),': [202], 'safety,': [203, 263, 485, 1508, 1528, 1772], 'activity': [205, 761, 1047, 1169, 1273, 1347, 1510, 1530, 1817, 2460], 'data.': [206, 749], 'These': [207, 334, 385, 577, 727, 850, 1277, 1926, 2143, 2284, 2737, 2825, 2898], 'serve': [210, 2996], 'basis': [213], 'models': [219, 236, 453, 858, 876, 1013, 1033, 1051, 1077, 1119, 1127, 1300, 1369, 1404, 1458, 1849, 2588, 2601, 2962], 'dose-response': [221], 'exposure-response': [223], '(ER)': [224], 'analyses': [225, 404, 562, 578, 608, 656, 716, 2466], 'support': [227, 1057, 1227, 1829, 1879, 1929, 2027, 2781, 2885, 2901, 3062], 'evaluated': [230, 250, 756, 2379], 'registration': [233, 499, 742, 1083, 1417, 1441, 1630, 2178, 2308, 2497, 2581, 2774, 2921], 'trials.': [234, 384, 398, 1084, 2430, 2508], 'refined': [239], 'become': [243], 'available.': [244], 'For': [245, 1162, 1764, 2006, 2128, 2509, 2628, 2715], 'example,': [246, 654, 1163, 1566, 1617, 1765, 2007, 2129, 2510, 2629, 2716], '2': [247, 294, 1072, 2514, 2520, 2532, 2823], 'doses': [248, 295, 394, 712, 867, 1039, 1061, 1073, 1425, 1812, 2165, 2907, 2929, 2977], 'were': [249, 2632, 2647], 'sonidegib': [256, 2204, 2262, 2267, 2639], 'activity,': [264, 1028], 'pharmacodynamic': [266], 'from': [268, 451, 1304, 1402, 1512, 1575, 2506, 2522, 2863], 'FIH': [270, 383, 1000, 1514, 1976, 2009, 2385], 'trial.': [271, 1515, 1977, 2309, 2386, 2922], 'ER': [273, 305, 561, 655, 941, 981, 1007, 1016, 1886, 2465, 2967, 3028, 3074], 'relationships—in': [274], 'concert': [275], 'exposure': [281, 668, 1243, 1523, 1727, 2244, 2416, 2860, 2992], 'modifications—demonstrated': [285], 'similar': [286, 988, 2243, 2941], 'efficacy': [287, 311, 487, 525, 596, 986, 1594, 1774, 2482, 3031], 'different': [289, 3041], 'safety': [290, 309, 351, 523, 594, 759, 920, 984, 1349, 1592, 2054, 2162, 2480, 3033], 'profiles': [291], 'supported': [297, 642, 1074, 2173, 2648], 'approval': [299, 832], 'lower': [302, 673], 'dose.': [303, 691], 'relationships': [306, 982, 1008, 1017, 1342, 2968, 3029], 'both': [308, 593, 2889], 'also': [313, 706, 991, 1460, 2377, 2468, 2703, 2951], 'provided': [314, 2553], 'supportive': [315, 2604], 'evidence': [316], 'recommended': [319, 2259], 'dosing': [320, 2611, 2614, 2886, 3006], 'regimen': [321, 3007], 'many': [323, 1198], 'drugs,': [324, 698, 1916, 2719], 'idelalisib': [326, 1109], 'dasatinib,': [328, 2722], 'outlined': [330, 430], 'Table': [332, 725, 1924], '1.': [333, 726, 1925], 'demonstrate': [336, 729, 1167, 2827], 'facilitated': [341], 'active': [346], 'manageable': [350], 'profile': [352], 'evaluation.': [355], 'As': [356, 652, 1564, 1615], 'alternative': [358, 690, 711, 842, 1424, 1539, 2608, 2735], 'traditional': [361, 2584], 'rule-based': [362], 'maximum': [363, 1252], 'tolerated': [364], 'paradigm,': [366], 'model-based': [367, 386, 400, 558, 1880], 'approaches': [368, 387, 401, 559, 3024], '(eg,': [369, 899, 1174, 1200, 1245, 1316, 1728, 1798], 'continual': [370], 'reassessment': [371], 'method': [372], 'or': [373, 548, 617, 625, 649, 964, 971, 1060, 1251, 1254, 1348, 1545, 1555, 1561, 1621, 1652, 1673, 1756, 1893, 1994, 2107, 2413, 2491, 2586, 2613, 2616, 2734, 2981, 2991, 3112], 'escalation': [374], 'overdose': [376], 'control)': [377], 'incorporated': [380], 'into': [381, 1659], 'some': [382, 1164, 1703, 1914, 2953], 'incorporate': [388], 'identify': [392, 411, 456, 588, 782, 805, 1038, 1284, 1336, 1464, 1533, 1549, 2065, 2233, 2485, 2557, 2976], 'potential': [393, 854, 1114, 1390, 1733, 2138, 2340, 2364, 2391, 2472, 2571, 2661, 2696, 2748, 2954], 'future': [396, 2428, 3017], 'Although': [399], 'only': [406, 1319, 1859], 'currently': [407, 2228], 'being': [408], 'used': [409, 928, 993, 1036, 1055, 1408, 1462], '(or': [414], 'range': [416, 1022], 'doses)': [418], 'well-described': [421], '(as': [424], 'established': [425], 'by': [426, 464, 489, 612, 643, 1075, 1104, 1132, 1170, 1490, 1862, 2348, 2439, 2606, 2617, 2649, 2813, 3067], 'eligibility': [428, 1685, 2325], 'criteria': [429, 2326], 'trial': [434, 500, 648, 684, 743, 1001, 1418, 1661, 2010, 2226, 2582, 2775], 'protocol),': [435], 'these': [436, 452, 571, 607, 875, 997, 1032, 1076, 1118, 1126, 1363, 1403, 1848, 2222, 2361, 2504, 2507, 2653, 2713, 2851, 2931], 'methods': [437, 572], 'integral': [440], 'step': [441], 'application': [444, 640, 661, 721, 2637, 2911], 'medicine.': [447], 'information': [449, 2063, 3097], 'garnered': [450, 1401], 'help': [455, 804, 995, 1532, 2469, 2484], 'postapproval': [463, 1835], 'helping': [465], 'describe': [467, 2965, 3026], 'effects': [469, 1805, 1999, 2620], '(such': [474, 1494, 1502, 1541, 1552], 'age,': [476, 1743, 2082, 3046], 'weight,': [477, 1471, 3047], 'race,': [478, 1740, 3048], 'organ': [480, 546, 1472, 1546, 1569, 1613, 1623, 1654, 1690, 1706, 1718, 3052], 'function)': [481, 1547], 'biomarkers,': [484, 1031, 1145, 1939, 2858], 'supporting': [490], 'prospective': [492, 511, 1421, 2903, 2925], 'general': [503, 2891], 'well-defined': [507, 517], 'specific': [508, 518, 1428, 2848, 2896, 2932, 2979], 'populations': [519, 1307, 1534, 1551, 2933, 2980], 'ongoing': [521, 2229], 'trials': [526, 534, 537, 693, 762, 839, 1577, 1631, 1867, 1882, 1898, 2041, 2157, 2179, 2404, 2578, 2631, 2868], 'could': [527, 803, 1002, 1482, 1486, 1625, 1656, 1744, 1779, 1828, 2376, 2445, 2986, 3019], 'reduce': [528, 1582], 'need': [530, 794, 836, 1931, 2330, 2501], 'conduct': [532], 'dedicated': [533], 'postmarket,': [535], 'designed': [538, 2016], 'determine': [540, 1786, 2470, 2707], 'patients': [544, 827, 1567, 1611, 1618, 1649, 1688, 1704, 1715, 2505, 2939, 3039], 'impairment': [547, 1570, 1624, 1655, 1675, 1691, 1707], 'coadministered': [549, 2762], 'interacting': [551], 'drug.': [552, 2049, 2464], 'Despite': [553, 1112, 1362], 'clear': [555], 'utility': [556, 605, 1124, 1353], 'aide': [564], 'selection,': [567], 'use': [569], 'still': [574], 'very': [575], 'limited.': [576], 'typically': [579, 846, 1572, 1643], 'occur': [580], 'too': [581], 'late': [582, 1995, 2207], 'effectively': [587], 'before': [597, 814, 2305, 2380, 2494, 2579, 2634, 2908, 3088], 'submission': [598, 815, 3089], 'marketing': [601, 660, 720, 818, 2636, 2910, 3092], 'application.': [602, 3093], 'may': [609, 675, 754, 791, 1128, 1166, 1350, 1444, 1531, 1536, 1708, 2089, 2551, 2565, 2934, 2971], 'limited': [611, 1136, 1141, 1146, 1224, 1302, 1993], 'low': [614], 'response': [616, 1560], 'adverse': [618, 1562, 1711, 2282, 2534], 'event': [619], 'rate,': [620, 3050], 'single': [622, 918, 1184], 'level': [624], 'lack': [627, 1159], 'comparator': [629], 'recent': [633, 1796], 'which': [636, 844, 1443, 1827, 3037], 'initial': [638, 1749, 2402], 'was': [641, 685, 2168, 2205], 'small': [646, 1305], 'open-label': [647], 'expansion': [650, 2014], 'cohort.': [651], 'included': [657, 717], 'cabozantinib': [663], 'conjunction': [665], 'suggested': [670], 'effective': [678], 'improved': [680], 'tolerability.': [681, 2142], 'A': [682, 1430, 2224, 2660], 'postmarket': [683, 838, 1455, 2225], 'required': [686, 1268], 'explore': [688, 710, 1341], 'Postmarket': [692], 'trastuzumab,': [700], 'ado-trastuzumab': [701], 'emantasine,': [702], 'vandetanib,': [704], 'requested': [708], 'discussed': [723], 'it': [731, 1179, 1281, 1585, 2564], 'imperative': [733], 'selected': [737, 1062, 1212, 2285], 'all': [747, 890, 1086, 1865], 'available': [748, 891, 1087, 1356, 1668, 2862], 'More': [750], 'than': [751, 2685], '1': [752, 905], 'feasible.': [764], 'Dose': [765], 'multiple': [769, 1172, 2906, 2928], 'factors,': [770, 1134, 1527], 'illustrated': [772], 'described': [776, 1009, 1922, 2949], 'above,': [777], 'appears': [778, 1089, 1374, 2435], 'more': [779, 1710, 2778], 'likely': [780, 1043, 1186, 1603, 1815, 2150, 2595], 'decrease': [792, 2414], 'exploration': [798, 1517], 'postmarket.': [799], 'An': [800, 1516, 2387, 2542, 2691, 2755], 'early': [801, 859, 1120, 1290, 1370, 1489, 1782, 1809, 1906, 2155, 2395, 2543, 2692, 2752, 2756, 2802], 'application,': [819], 'improving': [824], 'taking': [828], 'following': [831, 1214, 1326], 'reducing': [834], 'investigate': [841], 'doses,': [843], 'difficult': [847, 1180, 1282], 'conduct.': [849], 'highlight': [852, 2114, 2287, 2739, 2792, 2952], 'benefits': [855, 1115], 'developing': [857, 1117], 'evaluate': [864, 1590, 1966, 2338, 2449, 2569], 'pontential': [866], 'later': [869, 1064, 2039], 'development.': [871, 1361, 1947, 2210, 2754], 'represents': [877], 'approach': [880], 'requires': [885, 1850], 'examination': [888], 'at': [896, 900, 1070, 2681], 'each': [897], 'milestone': [898], 'end': [902, 908], 'phase': [904, 910], '2);': [911], 'traditionally,': [912], 'focused': [915], 'variable—the': [919], 'profile,': [921, 2055], 'stated': [923], 'earlier.': [924], 'build': [930, 1004], 'model': [932, 1360], 'include': [934, 950, 1301, 1687, 1868, 1891, 2012, 3038], 'vitro': [937, 2336], 'vivo': [940], 'relationship.': [942], 'Examples': [943], 'studies': [945, 2337, 2654, 2865], 'such': [948, 1235, 1738, 2080, 2695, 2874, 3044], '(1)': [951], 'interaction': [952, 2575, 2593, 2663], 'kinases': [955], 'biochemical': [957, 965], 'kinase': [958], 'assays;': [959], '(2)': [960], 'inhibition': [961, 973, 1267, 3011], 'biological': [963], 'function': [966], 'tumor': [968, 975, 1139], 'cell': [969], 'lines;': [970], '(3)': [972], 'growth': [976], 'animal': [978], 'models.': [979, 998], 'compounds': [989], 'develop': [996, 2961], 'ideally': [1003], 'establish': [1015], 'across': [1018], 'humans.': [1024, 2597], 'By': [1025], 'leveraging': [1026], 'tolerability,': [1029, 2458], 'reasonably': [1042], 'balance': [1045, 1816], 'safety.': [1049], 'then': [1053, 1435], 'trials;': [1066], 'incorporation': [1068], 'least': [1071], 'should': [1078], 'Leveraging': [1085], 'risk,': [1101], 'exemplified': [1103], '(Table': [1110], '1).': [1111], 'negatively': [1130], 'affected': [1131], 'access': [1137], 'tissues,': [1140], 'availability': [1142], 'reliable': [1144], 'understanding': [1147, 1387, 1934, 2051, 2116, 2291, 2388, 2693, 2743, 2757, 3071], 'between': [1151, 1343, 1521], 'its': [1155], 'target,': [1156, 1234], 'biomarkers.': [1161], 'drugs': [1165, 1980, 2113, 2409, 2763, 2811], 'inhibiting': [1171], 'targets': [1173], 'regorafenib,': [1175], 'sorafenib,': [1176], 'sunitinib),': [1177], 'making': [1178], 'marker': [1185], 'predict': [1188], 'benefit.': [1190], 'Additionally,': [1191, 1648, 2431, 2563, 2850, 3016], 'serial': [1192], 'biopsies': [1193], 'not': [1195, 1642, 3108], 'feasible': [1196], 'tumors': [1199], 'solid': [1201], 'tumors)': [1202], 'assess': [1204, 1289, 1902], 'effect': [1206, 1734, 1767, 1967, 2020, 2118, 2194, 2299, 2451, 2547, 3081], 'target': [1213, 1344], 'administration': [1215, 2037, 2100], 'new': [1218, 1664, 2103, 2343, 2357, 2367, 2463], 'product.': [1220], 'there': [1222, 1961], 'best': [1229, 1242], 'means': [1230, 1580, 2069], 'inhibit': [1232], 'sustained': [1237, 1271], 'vs': [1238, 1247], 'intermittent': [1239], 'inhibition,': [1240, 1262], 'metric': [1244], 'bound': [1246], 'free': [1248], 'concentrations,': [1249, 1253], 'minimum': [1250], 'area': [1255], 'under': [1256], 'curve)': [1258], 'correlates': [1260], 'degree': [1265], 'minimal': [1275], 'toxicity.': [1276], 'limitations': [1278, 2955], 'make': [1280], 'reasonable': [1286, 1588, 2998], 'biomarker': [1287], 'activity.': [1292, 1398], 'Other': [1293, 2078], 'possible': [1294], 'concerns': [1295], 'study': [1306, 2609, 2892], '(eg': [1308], 'rare': [1309], 'diseases)': [1310], 'arbitrary': [1312], 'data-collection': [1313], 'time': [1314], 'points': [1315], 'dose-limiting': [1317], 'toxicities': [1318], 'identified': [1320, 1488, 2669], 'within': [1321], '3': [1322], '4': [1324], 'weeks': [1325], 'first': [1328], 'despite': [1330, 1720], 'continuous': [1331], 'dosing).': [1332], 'Additional': [1333], 'research': [1334], 'surrogate': [1337], 'markers': [1338], 'engagement': [1345], 'allow': [1351, 1420, 2765], 'greater': [1352, 1933, 2684], 'known': [1364], 'limitations,': [1365], 'influence': [1394, 1483, 2418, 2473, 2760], 'observations': [1400], 'subsequently': [1406, 1436, 2026], 'modify': [1410], 'proposed': [1412], 'broader': [1431, 2767, 2917, 3035], 'will': [1434, 1814], 'enrolled': [1438, 1627, 1658, 2771], 'trial,': [1442], 'encourage': [1445], 'faster': [1446], 'enrollment,': [1447], 'shorter': [1448], 'duration': [1449], 'fewer': [1454], 'studies.': [1456], 'Population': [1457], 'covariates': [1465, 1808], 'affect': [1467, 1679, 2122, 2151], 'interindividual': [1468, 1504, 2058], 'variability,': [1469, 1505], 'function,': [1473, 1719], 'comedications,': [1474, 2086], 'factors.': [1478], 'Potential': [1479], 'metabolism': [1496], 'elimination)': [1498], 'PK,': [1507, 1771, 1870, 1942, 2056, 2457], 'data)': [1511], 'demographic': [1526], 'require': [1537, 2731], 'genetic': [1543], 'responder': [1550], 'prognostic': [1554], 'predictive': [1556], 'reactions).': [1563], 'excluded': [1574], '“noise”;': [1583], 'would': [1586, 2149], 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'variability': [1755, 2059], 'group': [1759], 'outliers': [1761], 'observed.': [1763], 'weight': [1769], 'monoclonal': [1777], 'antibody': [1778], 'feasibility': [1788], 'flat': [1790], 'dosing,': [1791], 'observed': [1793, 2269], 'approvals': [1797], 'nivolumab,': [1799], 'pembrolizumab).': [1800], 'When': [1801], 'we': [1802], 'understand': [1803], 'prospectively': [1825], 'evaluated,': [1826], 'his/her': [1842], 'characteristics.': [1844], 'adequate': [1851, 1869, 1953, 3010], 'inform': [1854, 2044], 'model.': [1856], 'This': [1857], 'achieved': [1861], 'ensuring': [1863], 'biomarker,': [1871], 'pharmacogenomic': [1873, 1894], 'sampling': [1874, 1954], 'analysis': [1876, 1956], 'plans': [1877, 1957], 'dose-finding': [1881], 'analyses.': [1887], 'failure': [1889], 'has': [1909, 2688], 'impeded': [1910], 'ponatinib4': [1918], 'rociletinib,5': [1920], 'among': [1938], 'genomics': [1944], 'Along': [1948], 'inclusion': [1951], 'trials,': [1960, 2498], 'opportunity': [1964], 'food': 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