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'Katashima‡,': [23], 'Masaaki': [24, 65, 3702], 'Kakehi,': [25, 3703], 'Hiroyuki': [26, 74, 3710, 3716, 3718], 'Kakuo,': [27, 3717], 'Takayoshi': [28, 83], 'Suzuki,': [29], 'Masanari': [30, 93], 'Mabuchi,': [31], 'Ryosuke': [32, 102, 3724], 'Nakamura,': [33, 35, 3707, 3725], 'Takahiro': [34, 112, 3706], 'Noriko': [36, 122], 'Katori,': [37], 'Seiji': [38, 132, 3698], 'Tanaka': [39, 133, 2988, 4103], '&': [40, 141, 2900, 3728, 3889, 3932, 4015], 'Yoshiro': [41, 142, 3729, 3878], 'SaitoYoshiaki': [42], 'Ohtsu‡': [43], 'Astellas': [44, 60, 2942, 4057], 'Pharma': [45, 61, 97], 'Inc.,': [46, 62], 'Tsukuba,': [47, 80], 'Ibaraki,': [48, 81], 'Japan,': [49, 57, 64, 73, 82, 92, 101, 111, 121, 131, 2821, 3301], 'Matsumaru‡': [51], 'Otsuka': [52, 2950, 4065], 'Pharmaceutical': [53, 68, 77, 135, 363, 422, 569, 2889, 4004], 'Co.,': [54, 78, 136], 'Ltd,': [55, 79, 118, 137], 'Osaka,': [56], 'Katashima‡': [59], 'Tokyo,': [63, 529, 3300], 'Kakehi': [66, 2953, 3274, 4068], 'Takeda': [67, 2958, 4073], 'Company': [69], 'Limited,': [70], 'Fujisawa,': [71], 'Kanagawa,': [72, 91, 100, 110, 130, 139, 155], 'Kakuo': [75, 2961, 4076], 'Taiho': [76, 2966, 4081], 'Suzuki': [84], 'National': [85, 104, 124, 149, 3057, 4172], 'Institute': [86, 105, 125, 150, 3058, 4173], 'of': [87, 106, 126, 151, 189, 198, 225, 242, 254, 258, 267, 280, 304, 362, 421, 445, 514, 567, 586, 601, 607, 649, 678, 689, 711, 721, 736, 750, 806, 813, 832, 852, 855, 863, 884, 889, 907, 922, 930, 959, 963, 970, 995, 1012, 1033, 1060, 1075, 1099, 1124, 1154, 1178, 1222, 1234, 1255, 1267, 1306, 1344, 1357, 1363, 1395, 1408, 1423, 1441, 1528, 1532, 1603, 1622, 1627, 1649, 1669, 1701, 1726, 1736, 1852, 1864, 1873, 1905, 1910, 1920, 1943, 1945, 1978, 1985, 2000, 2020, 2036, 2048, 2052, 2094, 2117, 2131, 2182, 2209, 2231, 2264, 2323, 2360, 2548, 2711, 2719, 2723, 2828, 2844, 2865, 2913, 2922, 2941, 2949, 2957, 2965, 2973, 2982, 2992, 3039, 3056, 3059, 3064, 3069, 3071, 3079, 3082, 3092, 3160, 3191, 3229, 3256, 3260, 3286, 3394, 3400, 3423, 3460, 3480, 3516, 3549, 3570, 3615, 3637, 3664, 3670, 3900, 4028, 4037, 4056, 4064, 4072, 4080, 4088, 4097, 4107, 4154, 4171, 4174, 4179, 4184], 'Health': [88, 107, 127, 152, 3060, 3481, 4175], 'Sciences,': [89, 108, 128, 153], 'Kawasaki,': [90, 109, 129, 138, 154], 'Mabuchi': [94, 2969, 4084], 'Mitsubishi': [95, 2974, 4089], 'Tanabe': [96, 2975, 4090], 'Corporation,': [98], 'Yokohama,': [99], 'Nakamura': [103, 113, 2978, 4093], 'Shin': [114, 2983, 4098], 'Nippon': [115, 2984, 4099], 'Biomedical': [116, 2985, 4100], 'Laboratories,': [117], 'Kainan,': [119], 'Wakayama,': [120], 'Katori': [123, 3360], 'Aska': [134, 2993, 4108], 'Japan': [140, 399, 496, 510, 524, 530, 568, 1721, 2694, 2888, 2927, 3118, 4003, 4042], 'Saito*Author': [143], 'correspondence:': [145], 'E-mail': [146], 'Address:': [147], '[email protected]': [148], 'JapanPublished': [156], 'Online:26': [157], 'Nov': [158], '2018https://doi.org/10.4155/bio-2018-0257AboutSectionsView': [159], 'ArticleSupplemental': [160], 'MaterialPDF/EPUB': [161], 'ToolsAdd': [162], 'favoritesDownload': [164], 'CitationsTrack': [165], 'CitationsPermissionsReprints': [166], 'ShareShare': [167], 'onFacebookTwitterLinkedInReddit': [168], 'View': [169], 'articleKeywords:': [170], 'validationbiomarkerclinical': [172, 3981], 'trialsJapanstandard': [173, 3982], 'operating': [174, 796, 3983], 'procedureThe': [175], 'industry': [177, 2031], 'has': [178, 350, 437, 1292, 1772], 'been': [179, 245, 275, 351, 438, 1293, 1773, 3075], 'working': [180, 276, 481], 'on': [181, 277, 284, 373, 409, 536, 718, 799, 840, 1206, 1507, 1677, 1693, 1782, 1981, 2089, 2126, 2137, 2626, 2635, 2684, 2789, 2856, 2916, 3095, 3251, 3283, 3344, 3366, 3451, 3760, 3775, 3949, 4031], 'improving': [182], 'drug': [183, 202, 235, 271, 702, 1755, 2706, 2868, 3097, 3163, 3261, 3427, 3523, 3644, 3675, 3691], 'development': [184, 236, 416, 906, 1620, 1756, 2576, 2707, 3214, 3293, 3692], 'since': [185], 'decades.': [186], 'Currently,': [187], 'lack': [188], 'efficacy': [190], 'and': [191, 212, 240, 256, 322, 343, 358, 365, 378, 418, 424, 457, 501, 533, 560, 581, 596, 618, 666, 682, 724, 748, 753, 766, 810, 825, 847, 937, 975, 987, 993, 1007, 1064, 1126, 1247, 1287, 1322, 1335, 1342, 1361, 1378, 1415, 1421, 1447, 1477, 1496, 1515, 1571, 1591, 1667, 1672, 1686, 1796, 1798, 1844, 1889, 1928, 1950, 1972, 2002, 2071, 2153, 2158, 2300, 2315, 2331, 2354, 2392, 2398, 2433, 2449, 2461, 2482, 2493, 2502, 2507, 2528, 2540, 2656, 2667, 2708, 2754, 2769, 2835, 2860, 2887, 2918, 2920, 2932, 2936, 3043, 3051, 3067, 3125, 3215, 3254, 3387, 3462, 3482, 3514, 3542, 3582, 3753, 3771, 3778, 4002, 4033, 4035, 4047, 4051, 4158, 4166, 4182], 'safety': [192, 213, 944, 1840, 1865, 1890, 1900], 'concerns': [193], 'are': [194, 330, 583, 1110, 1210, 1835, 2286, 2714, 2939, 3049, 4054, 4164], 'the': [195, 205, 223, 265, 278, 316, 379, 410, 443, 472, 476, 479, 485, 495, 515, 522, 564, 599, 622, 634, 654, 691, 696, 713, 719, 728, 731, 738, 764, 781, 800, 807, 814, 823, 833, 853, 856, 864, 879, 895, 904, 916, 919, 931, 956, 964, 976, 996, 1013, 1057, 1065, 1076, 1084, 1097, 1112, 1131, 1140, 1143, 1155, 1158, 1179, 1182, 1186, 1196, 1207, 1223, 1239, 1256, 1276, 1312, 1330, 1345, 1358, 1364, 1393, 1400, 1442, 1472, 1505, 1519, 1529, 1579, 1583, 1600, 1625, 1637, 1646, 1650, 1661, 1683, 1702, 1706, 1723, 1737, 1788, 1812, 1832, 1884, 1911, 1917, 1941, 1946, 1963, 1982, 1992, 1998, 2015, 2025, 2030, 2034, 2043, 2046, 2127, 2177, 2180, 2200, 2205, 2232, 2239, 2253, 2258, 2269, 2278, 2294, 2338, 2343, 2352, 2358, 2361, 2375, 2381, 2418, 2422, 2471, 2515, 2522, 2525, 2529, 2546, 2573, 2581, 2589, 2597, 2620, 2662, 2712, 2744, 2759, 2782, 2804, 2829, 2842, 2863, 2885, 2926, 3019, 3026, 3037, 3053, 3391, 3398, 3458, 3494, 3668, 3953, 4000, 4041, 4134, 4141, 4152, 4168], 'major': [196], 'causes': [197], 'attrition': [199], 'during': [200, 233, 413, 727, 2134, 2699], 'late': [201, 414], 'development.': [203, 3098, 3262, 3524, 3645, 3676], 'Under': [204], 'current': [206, 473, 1724], 'situation,': [207], 'biomarkers': [208, 243, 285, 1109, 1834, 1866, 1875, 1888, 1893, 2001, 2866, 3257, 3290, 3401, 3641, 3672, 3688], 'including': [209], 'pharmacodynamics': [210], '(PD)': [211], 'play': [214], 'an': [215, 549, 1069, 1088, 1202, 1296, 1902, 2115, 2223, 2947, 2955, 2963, 2971, 2980, 2990, 4062, 4070, 4078, 4086, 4095, 4105], 'important': [216, 1297, 2794], 'role.': [217], 'Hayashi': [218, 3085, 3414], 'et': [219, 1957, 2439, 2459, 2463, 2475, 2491, 2495, 2641, 2645, 2649, 2653, 2658, 3116, 3184, 3210, 3245, 3276, 3341, 3446, 3509], 'al.': [220, 1958, 2440, 2460, 2464, 2476, 2492, 2496, 2642, 2646, 2650, 2654, 2659, 3117, 3185, 3211, 3246, 3277, 3342, 3447, 3510], 'proved': [221], 'that': [222, 870, 903, 1189, 1371, 1536, 1599, 1656, 1746, 1817, 1823, 1861, 1872, 1935, 2110, 2171, 2282, 2293, 2366, 2409, 2535, 2556, 2696, 2813, 2850], 'use': [224, 241, 315, 958, 1407, 1531, 1771, 1904, 1984, 2208, 2263, 3425], 'biomarker': [227, 313, 341, 347, 392, 411, 446, 480, 558, 602, 679, 698, 722, 743, 774, 783, 802, 923, 960, 1090, 1459, 1694, 1727, 1743, 1748, 1770, 1783, 1906, 1964, 1986, 2021, 2049, 2132, 2138, 2284, 2606, 2636, 2668, 2686, 2697, 2720, 2771, 2790, 2857, 3093, 3219, 3230, 3345, 3367, 3424, 3499, 3520, 3607, 3905], 'resulted': [228], 'higher': [230], 'success': [231], 'rates': [232], 'anticancer': [234, 3616], '[1].': [237], 'The': [238, 450, 946, 999, 1630, 1793, 1877, 2512, 2775, 2995, 3186, 3278, 4110], 'discovery': [239], 'have': [244, 274, 875, 1740, 1750, 1820, 1828, 2674, 2702, 2796, 2997, 3074, 4112], 'facilitated': [246], 'by': [247, 461, 494, 557, 593, 598, 1051, 2009, 2119, 2166, 2247, 2639, 2909, 3349, 4024], 'recent': [248, 2536, 3452], 'advancements': [249], 'omics': [251], 'technology,': [252], 'establishment': [253, 3253], 'databases': [255], 'understanding': [257], 'pathophysiology': [259], '–': [260, 3320, 3457, 3474, 3758], 'among': [261, 2514], 'others': [262, 977, 1020], '[2–4].': [263], 'In': [264, 397, 828, 1329, 1613, 1854, 1922, 1954, 2091, 2276], 'field': [266], 'quantitative': [268, 282, 302, 697, 2509, 3284], 'bioanalysis': [269, 356, 2806, 3255], 'development,': [272], 'scientists': [273, 307], 'delivery': [279], 'reliable': [281], 'data': [283, 303, 699, 1409, 1987, 3128], 'with': [286, 730, 912, 1482, 1660, 2342, 2380, 2588, 3005, 3010, 4120, 4125], 'limited': [287, 2570, 2787], 'resources': [288, 1996], 'timely': [291], 'manner.': [292], 'However,': [293, 2262], 'there': [294, 329, 436], 'appears': [295, 2191], 'be': [297, 1526, 1868, 2060, 2067, 2144, 2245, 2349, 2372, 2415, 2519, 2730, 2736, 2748], 'room': [298], 'improvement.To': [300], 'deliver': [301], 'high': [305], 'quality,': [306], 'conduct': [308, 505], 'validation.': [310, 2140], 'While': [311, 1433, 2014, 2810], 'some': [312, 331, 1301, 1390, 1657, 2098, 2188], 'assays': [314, 321, 342, 447, 680, 723, 924, 932, 948, 965, 986, 989, 1001, 1015, 1035, 1044, 1082, 1184, 1360, 1443, 1473, 1506, 1638, 1728, 1749, 1912, 1925, 1947, 2022, 2050, 2058, 2065, 2073, 2133, 2236, 2274, 2285, 2330, 2388, 2394, 2403, 2429, 2435, 2472, 2510, 2666, 2687, 2698, 2713, 2721, 2728, 2734, 2740, 2831, 3395], 'same': [317, 1066, 1085, 1113, 1144, 1240, 1277, 2201, 2254], 'methodologies': [318, 2149, 2753], '(e.g.,': [319, 1318], 'ligand-binding': [320, 1014, 1027, 1043, 1224, 1359, 2064, 2072, 2273, 2287, 2329, 2387, 2402, 2428, 2830], 'chromatographic': [323, 988, 1034, 1081, 1257, 1365, 2057, 2235, 2393, 2434], 'assays)': [324, 2157], 'as': [325, 663, 669, 844, 1056, 1068, 1087, 1105, 1116, 1147, 1162, 1242, 1279, 1295, 1769, 1968, 2055, 2081, 2176, 2204, 2257, 2630, 2632, 2726, 3289, 3689, 3902], 'pharmacokinetics': [326], '(PK)': [327], 'assays,': [328, 997, 1028, 1156, 1225, 1258, 1346, 2669], 'differences': [332, 821, 1882, 2356, 2513, 2523, 2663], 'points': [334, 2082, 2541, 2675, 2797, 3694], 'consider': [336, 2084, 2543, 2677, 2799], 'between': [340, 763, 822, 1589, 1886, 2524, 2664], 'PK': [344, 1678, 1715, 2627, 2665, 2766], 'assays.': [345, 1180, 1460, 1651, 2189, 2334, 2791], 'Therefore,': [346], 'hot': [353], 'topic': [354], 'conferences': [357], 'communities.': [359], 'American': [360, 419, 459, 2302, 2834], 'Association': [361, 420, 571, 2891, 4006], 'Sciences': [364, 423, 2915, 3061, 4030, 4176], 'Clinical': [366], 'Ligand': [367], 'Assay': [368], 'Society': [369], 'organized': [370], 'workshop': [372], 'this': [374, 1136, 1190, 1450, 1761, 1785, 1805, 1855, 2851, 2897, 3040, 3047, 4012, 4155, 4162], 'subject': [375, 3020, 4135], '2003,': [377], 'meeting': [380, 431], 'outcome': [381], 'was': [382, 453, 492, 555, 628, 641, 761, 910, 925, 1150, 1174, 1192, 1350, 1435, 1452, 1466, 1608, 1632, 1786, 2079, 2425, 2815, 2823, 2905, 3034, 3233, 4020, 4149], 'published': [383], '2006': [385], '[5].': [386, 1988, 2226], 'European': [387, 456, 1664, 2299, 2590, 2836, 3247], 'Bioanalysis': [388, 400, 466, 525, 540, 2591, 3248, 3263, 3351, 3371, 3464, 3525, 3552, 3677], 'Forum': [389, 401, 526, 2592, 3249], 'formed': [390], 'its': [391], 'team': [393], '2010': [395], '[6].': [396], '2015,': [398], 'Biomarker': [402], 'Task': [403], 'Force': [404], 'prepared': [405, 556, 2246], 'concept': [407, 3228, 3281], 'paper': [408, 2594, 3048, 3282, 3450, 4163], 'analysis': [412, 726, 749, 755, 1091, 2165, 3285], '[7],': [417], 'US': [425, 1662, 2776, 3478, 3485], 'FDA': [426, 2010, 2777, 3746, 3762], 'held': [427], 'Crystal': [428, 3317], 'City': [429, 3318], 'IV': [430], '[8].However,': [432], 'our': [434], 'knowledge,': [435], 'only': [439, 451, 625, 706, 938, 1352, 1609, 2270, 2504, 2786], 'one': [440, 626, 778, 908, 2230], 'assessing': [442, 1838], 'status': [444], 'industry.': [449], 'conducted': [454, 742, 772, 1539, 1741, 1914, 2824], 'within': [455], 'North': [458, 2301, 2833], 'CROs': [460, 582, 2303, 2837], 'Global': [462], 'CRO': [463], 'Council': [464], '(GCC)': [467], '2012': [469, 2305], '[9].To': [470], 'investigate': [471, 1392], 'situation': [474, 1725, 3365], 'companies,': [478, 659], 'group': [482], '(WG)': [483], 'bioanalytical': [486, 3321, 3346, 3575], 'study': [489, 1117, 1148, 1243, 1280, 2206, 2259, 3576], 'group,': [490], 'which': [491, 2803], 'subsidized': [493], 'Agency': [497, 1666, 2928, 4043], 'Medical': [499, 2930, 4045], 'Research': [500, 2912, 2931, 4027, 4046], 'Development,': [502], 'decided': [503], '[10].': [511], 'A': [512, 1367, 1652, 1699], 'part': [513, 1700, 2908, 4023], 'results': [517, 1205, 1585, 2296, 2341], 'were': [518, 591, 610, 892, 933, 942, 966, 978, 1022, 1036, 1045, 1083, 1338, 1387, 1500, 1549, 1616, 1641, 1894, 1913, 1931, 2308, 2367, 2384, 2410, 2611, 3411], 'already': [519], 'presented': [520, 3045, 4160], 'at': [521, 972, 1101, 1697, 2184], 'ninth': [523], 'symposium': [527], '2018': [532, 2012, 3761, 3962, 3966, 3971, 3978], 'twelfth': [534], 'Workshop': [535, 3315], 'Recent': [537, 3742], 'Issues': [538, 3743], 'PA,': [542], 'USA': [543, 3489], '2018.Survey': [545], 'methodsA': [546], 'Excel': [550], 'format': [551], 'Japanese': [553, 664, 765, 808, 824, 834, 865, 1547, 1590, 1738, 1791, 1815, 2805, 3131, 3187], 'language': [554], 'WG': [559, 603], 'distributed': [561], 'all': [563, 690, 712, 737, 830, 1636, 2470, 2879, 3994], 'member': [565], 'Manufacturers': [570, 2890, 4005], '(JPMA;': [572], '71': [573], 'companies)': [574], 'July': [576], '2017.': [577], 'Generic': [578], 'not': [584, 837, 900, 1129, 1193, 1200, 1689, 1787, 1810, 1819, 2559, 2579, 2601, 2770, 2816, 3052, 4167], 'members': [585], 'JPMA.': [587], 'All': [588], 'responses': [590], 'collected': [592, 629, 2297], 'September': [594, 3731, 3961], '2017': [595], 'blinded': [597], 'secretariat': [600], 'before': [604], 'analysis.The': [605], 'types': [606, 2054, 2130, 2725], 'questions': [609, 617, 717], 'company-based': [611, 623], 'questions,': [612, 624], 'new': [613, 701], 'medical': [614], 'entity': [615, 3009, 4124], '(NME)-based': [616], 'assay-based': [619], 'questions.': [620], 'For': [621, 633, 955, 1181, 1218, 1251, 1518, 1578, 2101], 'response': [627], 'from': [630, 1403, 1605, 1848, 2222, 2298, 2925, 3129, 4040], 'each': [631, 639], 'company.': [632], 'other': [635, 786, 947, 1000, 1183, 1520, 1580, 1923, 2148, 2240, 2752, 2999, 3028, 4114, 4143], 'two': [636, 2362], 'groups,': [638], 'company': [640, 1425], 'encouraged': [642], 'provide': [644, 838, 1201], 'multiple': [645, 789, 913], 'responses.Survey': [646], 'resultsCompany-based': [647], 'questionsTotal': [648, 888], '37': [650], 'responded': [652], 'survey.': [655, 897, 2531], 'Of': [656, 769], 'these': [657], 'respondent': [658, 692, 714, 739], '26': [660, 3969], 'identified': [661, 668], 'themselves': [662], '11': [667], 'non-Japanese': [670, 767, 815, 826, 857, 1428, 1537, 1592, 1606, 1778], 'companies.First,': [671], 'we': [672, 791, 1398, 1808, 2336, 2347, 2811], 'asked': [673, 792, 1617, 2309, 2612], 'them': [674, 885], 'about': [675, 793, 2351, 2613, 2685], 'their': [676, 794], 'experiences': [677], 'after': [683, 2781], '2012.': [684], 'Approximately': [685], 'third': [687, 883, 1909], '(32.4%)': [688], 'had': [694, 741, 777, 788, 817, 1780], 'submitted': [695], 'application': [703, 3190, 3611], '(NDA),': [704], 'whereas': [705, 785, 850, 881, 1019, 1157, 2457, 2489], 'small': [708, 2332], 'percentage': [709], '(5.4%)': [710], 'received': [716], 'validity': [720], 'sample': [725, 1376, 2571], 'interaction': [729], 'regulatory': [732, 1918, 2026, 2624, 2679, 2716, 2801, 3388, 3496], 'agency.': [733], 'Most': [734], '(62.2%)': [735], '(except': [744], 'laboratory': [746], 'tests': [747], 'DNA,': [751], 'RNA': [752], 'metal)': [754], 'trials.': [758, 1731], 'This': [759, 1989, 2077, 2190, 2227, 2584, 3492], 'result': [760, 1402], 'similar': [762, 1587], 'companies.': [768, 827, 1593, 1792], 'those': [770, 951, 1483, 1511, 1713, 3030, 4145], 'who': [771, 1704], 'analysis,': [775, 784, 1744, 1784], '34.8%': [776], 'NME': [779, 909, 971, 1623], 'NMEs.Then,': [790], 'standard': [795, 1497, 1572], 'procedures': [797], '(SOPs)': [798], 'analysis.': [803], 'Some': [804], '(19.2%)': [805], 'most': [811, 1093, 1777, 2283, 2826], '(63.6%)': [812], 'SOPs,': [818], 'indicating': [819], 'clear': [820], 'addition,': [829, 1614, 2092, 2277], 'SOPs': [831, 854, 868, 876, 1781, 1821, 1829], 'did': [836, 859, 886, 1199, 1688, 1818, 2578, 2600], 'guidance': [839, 2011, 2016, 2778], '(such': [843, 1161, 1967], 'test': [845], 'items': [846, 1209, 1535, 2365, 2408], 'acceptance': [848, 1684, 1709, 2762, 3409], 'criteria),': [849], 'majority': [851, 928, 1031, 1073, 1439, 1647, 2047, 2718], 'so.': [860], 'Interestingly,': [861, 1487], 'two-thirds': [862], 'without': [867, 2220], 'considered': [869, 1309, 1822], 'it': [871, 1824, 1936, 2028, 2103, 2142, 2557, 2670, 2746], 'is': [872, 899, 1092, 1127, 1308, 1327, 1825, 1937, 2007, 2104, 2122, 2174, 2197, 2212, 2229, 2267, 2533, 2558, 2585, 2671, 2793, 2946, 2954, 2962, 2970, 2979, 2989, 3493, 4061, 4069, 4077, 4085, 4094, 4104], 'necessary': [873, 1826, 2145, 2749], 'somewhere': [877, 1830], 'future,': [880, 1768, 2745], 'not.NME-based': [887], '52': [890], 'NMEs': [891], 'included': [893, 950, 1003, 1166, 2312], 'present': [896, 917, 1141, 1331, 1718, 1878, 2168, 2279, 2344, 2376, 2419, 2526, 2574, 2598, 2691, 2783], 'It': [898, 2121, 2532, 2792], 'rare': [901], '(26.9%)': [902], 'associated': [911], 'biomarkers.Assay-based': [914], 'questionsIn': [915], 'survey,': [918, 1142, 1332, 2575, 2784], 'total': [920, 1601], 'number': [921, 1602, 1762], '82.': [926], 'Vast': [927, 1072], '(82.9%)': [929], 'PD': [935, 1874, 1887, 1892], 'biomarkers,': [936], 'few': [940, 1354, 1858], '(3.7%)': [941], 'biomarkers.': [945, 3167, 3325], '(13.4%)': [949], 'patient': [953], 'stratification.': [954], 'intended': [957, 1406, 1530, 1903, 1983], 'data,': [961, 1907], '32.9%': [962], 'claiming': [968], 'characteristics': [969, 1885], 'NDA': [973, 1416, 1448, 1478, 1516], 'submission': [974, 1479], 'exploration': [980, 1485, 1927, 1949, 1999], '(29.3%)': [981], 'or': [982, 1198, 1315, 1384, 2678, 2800, 3002, 3008, 3015, 3022, 3062, 4117, 4123, 4130, 4137, 4177], 'sponsor': [983, 1413, 1445, 1475, 1508, 1929, 1951, 2003], 'decision-making': [984, 1414, 1446, 1476, 1509, 1930, 1952], '(35.4%).Ligand-binding': [985], 'accounted': [990], '62.2': [992], '20.7%': [994], 'respectively.': [998], '(17.1%)': [1002], 'flow': [1004, 2151], 'cytometry,': [1005], 'immunohistochemistry': [1006], 'enzymatic': [1008], 'methods.': [1009], 'Majority': [1010], '(74.5%)': [1011], 'used': [1016, 1041, 1079, 1134, 1151, 1175, 1339, 1708, 1836, 2175, 3396, 3642], 'commercial': [1017, 1168, 2075, 2095, 2112, 2742, 3517, 3665], 'kits,': [1018, 1169], '(25.5%)': [1021], 'developed': [1023, 1037, 2061, 2068, 2160, 2731, 2737, 2756], 'de': [1024, 1038, 2062, 2069, 2732, 2738], 'novo.': [1025], 'Unlike': [1026], 'vast': [1030, 1438], '(82.4%)': [1032], 'novo.Reference': [1039], 'standards': [1040, 1078], 'mostly': [1046], 'recombinant': [1047, 1320, 1336], 'proteins': [1048], '(64.9%),': [1049], 'followed': [1050], 'surrogate': [1053, 1159, 1272, 1313, 1316, 1333, 1464, 2172, 2210, 2265, 3543], 'analyte': [1054, 1070, 1317, 2116, 2195, 2225, 3544], 'such': [1055, 1104], 'signature': [1058], 'peptide': [1059], 'protein': [1061, 1170, 1321, 1337, 3573], 'analytes': [1062, 2251], '(13.5%)': [1063], 'chemical': [1067, 1086], '(5.4%).': [1071], '(88.2%)': [1074], 'reference': [1077], 'analyte.Quantitative': [1089], 'likely': [1094], 'involve': [1096], 'preparation': [1098, 2181], 'samples': [1100, 1118, 1149, 2183, 2219, 2243], 'known': [1102, 2185, 2353], 'concentrations,': [1103], 'calibration': [1106, 1229, 1262, 2218, 2242], 'samples.': [1107], 'As': [1108], 'endogenous,': [1111], 'biological': [1114, 1145, 2202, 2255, 3403], 'matrix': [1115, 1133, 1146, 1160, 1241, 1245, 1278, 1282, 1285, 1314, 1334, 1489, 2173, 2178, 2203, 2211, 2256, 2266, 3541], 'often': [1119, 2819], 'contains': [1120], 'variable': [1122], 'concentration': [1123, 2186, 2196], 'analyte,': [1125], 'therefore,': [1128, 1845], 'always': [1130, 2560], 'best': [1132, 3459], 'purpose.': [1137], 'According': [1138], '39.0%': [1153], 'water,': [1163], 'buffer,': [1164], 'solution': [1165, 1498, 1573], 'solution,': [1171], 'stripped': [1172], 'matrix)': [1173], '37.8%': [1177], '(23.2%),': [1185], 'respondents': [1187, 1226, 1259, 1615, 1658, 1703, 2760], 'indicated': [1188], 'question': [1191, 1369], 'applicable': [1194], 'answer.The': [1203], 'shown': [1211], 'Supplementary': [1213, 1418, 1430], 'Figure': [1214, 1419, 1431], '1': [1215], '(per': [1216], 'methodology).': [1217], 'more': [1219, 1252, 1468, 1502, 1540, 1869, 1897, 2368], 'than': [1220, 1253, 1510, 1546, 1712, 1733, 1871, 1899, 2421, 3029, 4144], 'half': [1221, 1254, 1734], 'examined': [1227, 1260, 1351, 1388, 1436, 1467, 2373, 2416], 'selectivity,': [1228, 1261], 'curve,': [1230, 1263], 'LLOQ,': [1231, 1264], 'upper': [1232, 1265], 'limit': [1233, 1266], 'quantification,': [1235, 1268], 'accuracy,': [1236, 1269, 2316], "'precision": [1237, 1270, 1274, 1462], "samples',": [1244, 1281], 'stability': [1246, 1286, 1377, 1499, 1574], 'dilution': [1248, 1288, 1562, 2399, 2480, 2500], 'linearity/dilution': [1249, 1289], 'integrity.': [1250, 1290], "matrix',": [1273], 'effect,': [1283, 1374, 1490], 'carryover,': [1284, 1491], 'Parallelism': [1291], 'deemed': [1294], 'item': [1299, 1451], 'white': [1302, 1691, 2593, 2603, 2633, 2773], 'papers': [1303, 1692, 2604, 2634], '[8,9,11].': [1304], 'Evaluation': [1305], 'parallelism': [1307, 1349, 1495, 1567, 2426, 2483, 2503, 2549, 2564, 2814, 2822, 2845], 'critical': [1310], 'if': [1311, 1618, 2193], 'stable': [1324, 2249], 'isotope-labeled': [1325, 2250], 'analyte)': [1326], 'used.': [1328], '37.8': [1341], '34.1%': [1343], 'respectively;': [1347], 'however,': [1348, 1807], 'cases': [1355], '(16.7%': [1356], '0.0%': [1362], 'assays).': [1366], 'free-text': [1368, 1653], 'revealed': [1370, 1655, 1722, 1880, 2170, 2281, 2695], 'recovery,': [1372], 'hook': [1373], 'processed': [1375], 'cross': [1379], '(between': [1381], 'different': [1382, 1385, 1404], 'methods': [1383, 2359, 3639], 'laboratories)': [1386], 'cases.To': [1391], 'determinant': [1394], 'items,': [1397, 1521, 1582, 2290], 'analyzed': [1399, 1895], 'angles;': [1405], '(i.e.,': [1410, 2237], 'exploratory': [1411, 1458, 1513, 1969, 2040, 2446], 'purpose,': [1412], 'submission;': [1417], '2)': [1420], 'origin': [1422], '(Japanese': [1426], 'vs': [1427, 1552, 1556, 1560, 1565, 1569, 1576, 2390, 2396, 2405, 2431, 2437], 'company;': [1429], '3).': [1432], 'accuracy': [1434, 1554], '(81.3–93.8%)': [1440], 'submission,': [1449], 'validated': [1453, 2328], 'less': [1454, 2411], 'frequently': [1455, 1469, 1503, 1541, 1898, 2369, 2412], '(60.9%)': [1456], 'Similarly,': [1461], "matrix'": [1465], '(50.0–56.3%)': [1470], 'comparison': [1481, 2379], '(30.4%).': [1486], 'specificity,': [1488], 'minimum': [1492], 'required': [1493], 'dilution,': [1494, 2324], 'investigated': [1501], 'purpose': [1514], 'submission.': [1517], 'executing': [1522], 'appeared': [1524], 'independent': [1527], 'data.': [1533], 'Validation': [1534, 2364, 2407, 3569, 3636], '(at': [1542], 'least': [1543], '20%': [1544], 'differences)': [1545], 'specificity': [1550], '(75.0': [1551], '26.5%),': [1553], '(100': [1555, 2395], '73.5%),': [1557], 'carryover': [1558], '(50.0': [1559, 1575], '24.5%),': [1561], 'linearity/integrity': [1563], '(83.3': [1564, 2404], '63.3%),': [1566], '(33.3': [1568], '10.2%)': [1570], '16.3%).': [1577], 'showed': [1586], 'frequencies': [1588], 'We': [1594, 1759, 2551, 2839, 2848], 'should': [1595, 1867, 2348, 2552, 2840], 'keep': [1596, 2553], 'mind': [1598, 2555], 'answers': [1604], 'six': [1610], 'eight.': [1612], 'stage': [1621, 2577], 'affected': [1624], 'selection': [1626], 'items.': [1629, 2583], 'answer': [1631], "'no'": [1633], 'almost': [1635], '(97.7%).Acceptance': [1639], 'criteria': [1640, 1685, 1707, 1710, 3410], 'defined': [1642], 'advance': [1644], '(76.8%)': [1648], 'consulted': [1659], 'FDA,': [1663, 3486], 'Medicines': [1665], 'Ministry': [1668, 3063, 4178], 'Health,': [1670, 3065, 4180], 'Labour': [1671, 3066, 4181], 'Welfare': [1673, 3068, 4183], '(of': [1674], 'Japan)': [1675], 'guidelines': [1676, 2625, 2768], 'defining': [1682], 'they': [1687, 2311, 2327, 2610, 2615, 2681, 2764], 'mention': [1690, 2602], 'all.': [1698], 'set': [1705], 'lenient': [1711], 'validation.DiscussionThe': [1717], 'More': [1732], '(57.7%)': [1735], 'suggesting': [1745, 1934], 'also': [1751, 2688], 'become': [1752, 2703], 'common': [1753, 2214, 2704], 'Japan.': [1758, 3370], 'expect': [1760], 'will': [1763, 2143, 2747, 2853], 'increase': [1764], 'further': [1765], 'near': [1767], 'increasing': [1774], 'globally': [1775], '[12].While': [1776], 'case': [1789], "companies'": [1794], 'size': [1795], 'policy,': [1797], 'prioritized': [1799], 'therapeutic': [1800], 'areas': [1801], 'may': [1802], 'partially': [1803], 'explain': [1804], 'difference;': [1806], 'could': [1809], 'determine': [1811], 'reasons.': [1813], 'Many': [1814], 'future.Safety': [1833], "patients'": [1839], 'trials,': [1843], 'draw': [1846], 'attention': [1847], 'broad': [1850], 'range': [1851], 'stakeholders.': [1853], 'context,': [1856], 'articles': [1859, 2517], 'state': [1860], 'extensive': [1870], '[6,13].': [1876], 'additional': [1881], 'biomarkers;': [1891], 'much': [1896], 'biomarkers.For': [1901], 'support': [1916, 2024, 3259, 3580], 'review': [1919], 'NMEs.': [1921], 'words,': [1924], 'majority,': [1933], 'prudent': [1938], 'discuss': [1940, 2147, 2751, 2841], 'level': [1942], 'carefully.': [1953], '2006,': [1955], 'Lee': [1956, 2474, 2640, 3204], 'proposed': [1959], 'fit-for-purpose': [1960], 'approach': [1961, 1990, 2006], 'advanced': [1973, 2453], 'validation),': [1975], 'wherein': [1976], 'rigor': [1977], 'depends': [1980], 'assists': [1991], 'conserving': [1995], 'decision-making.': [2004], 'Fit-for-purpose': [2005, 3212, 3408, 3606], 'supported': [2008, 2906, 4021], '[14].': [2013], 'requires': [2017], 'full': [2018], 'decision-making,': [2027], 'allows': [2029], 'decide': [2033], 'extent': [2035], 'assays.According': [2041], 'results,': [2045, 2346], 'consisted': [2051], 'three': [2053, 2129, 2516, 2724], 'follows:': [2056], 'novo,': [2063], 'novo': [2070], 'using': [2074, 2741, 3165], 'kits.': [2076], 'finding': [2078], 'important,': [2080], 'depend': [2088], 'methodology.': [2090], 'usage': [2093, 2864, 3094], 'kits': [2096, 3518, 3666], 'need': [2097], 'consideration': [2099], '[15].': [2100], 'example,': [2102], 'good': [2106, 2672], 'practice': [2107], 'confirm': [2109], 'kit': [2113], 'measures': [2114], 'interest': [2118, 3013, 4128], 'experimentation.': [2120], 'recommended': [2123], 'focus': [2125], 'above-mentioned': [2128], 'initial': [2135], 'discussion': [2136, 2855], 'Henceforth,': [2141], '(including': [2150, 2162], 'cytometry': [2152], 'polymerase': [2154], 'chain': [2155], 'reaction': [2156], 'newly': [2159, 2755], 'technologies': [2161], 'large': [2163], 'molecule': [2164, 2333], 'LC–MS).The': [2167], 'reasonable;': [2192], 'endogenous': [2194, 2224, 3550], 'detectable': [2198], 'samples,': [2207], 'strategy': [2215, 2228], 'prepare': [2217], 'interference': [2221], 'options': [2233], 'option,': [2241], 'can': [2244, 2682, 2808], 'spiking': [2248], 'into': [2252], 'samples)': [2260], '[16].': [2261], 'essentially': [2268], 'option': [2271], '[17].': [2275], 'assays.For': [2288], 'GCC': [2291, 2339, 2382, 2423, 2530, 2621], 'reported': [2292, 2370, 2413], '[9].': [2306, 2838], 'Respondents': [2307], 'whether': [2310], 'calibration,': [2313], 'precision': [2314], 'selectivity/specificity,': [2317], 'parallelism,': [2318], 'storage': [2319], 'stability,': [2320], 'sensitivity,': [2321], 'linearity': [2322, 2400, 2481, 2501], 'recovery': [2325], 'when': [2326, 2609], 'When': [2335, 2758], 'compare': [2337], 'careful': [2350], 'unknown': [2355], 'surveys.': [2363], 'LLOQ': [2385, 2444, 2451, 2468], '(90.6': [2389], '56–60%)': [2391], '60–75%)': [2397], '44–60%).': [2406], '(16.7': [2430], '60–67%)': [2432], '(0': [2436], '25–30%).Lee': [2438], 'suggested': [2441, 2465, 2477, 2497], 'estimate': [2443], 'establish': [2450], '[5],': [2456, 2488, 2643], 'Cummings': [2458, 2490, 2652, 3596], 'Chau': [2462, 2494, 2657, 3628], 'include': [2467, 2479, 2499, 2563], '[18,19].': [2473, 2511], 'both': [2485], 'definitive': [2506, 3547], 'relative': [2508], 'might': [2518], 'linked': [2520], 'noteworthy': [2534], 'discussions': [2537], 'workshops': [2539], 'document': [2544, 3497], 'emphasize': [2545], 'importance': [2547], '[8,11].': [2550], 'possible': [2561], 'due': [2568], 'availability.In': [2572], 'affect': [2580], 'line': [2587], '[6].Respondents': [2595], 'validations': [2608], 'documents': [2614, 2680], 'consult': [2616, 2765], 'with.': [2617], 'Those': [2618], 'mentioned': [2623], 'validation,': [2629, 2859], 'well': [2631], 'Nowatzke': [2644, 3655], '[20],': [2647], 'Valentin': [2648, 3559], '[17],': [2651], '[18]': [2655], '[19].': [2660], 'Considering': [2661], 'rely': [2683], 'Japan.ConclusionThe': [2690], 'trials': [2701, 3614], 'approximately': [2709], '30%': [2710], 'decision-making.The': [2717], 'consist': [2722], 'follows:Chromatographic': [2727], 'novo;Ligand-binding': [2733, 2739], 'kits.In': [2743], 'technologies.': [2757], 'designate': [2761], 'criteria,': [2763], 'papers.': [2774], '2018,': [2779], 'issued': [2780], 'provided': [2785], 'recommendations': [2788], 'documents,': [2802], 'community': [2807], 'embrace.': [2809], 'found': [2812], 'tested': [2817], 'very': [2818], '(60–67%)': [2827], 'necessity': [2843], 'future.': [2847], 'hope': [2849], 'facilitate': [2854], 'therefore': [2861], 'promote': [2862], 'development.Supplementary': [2869], 'dataSee': [2870, 3985], 'online': [2871, 3968, 3986], 'at:': [2872, 3296, 3987], 'https://www.future-science.com/doi/suppl/10.4155/bio-2018-0257AcknowledgementsThe': [2873, 3988], 'authors': [2874, 2996, 3989, 4111], 'would': [2875, 3990], 'like': [2876, 3991], 'thank': [2878, 3993], 'participants': [2881, 3996], 'filling': [2883, 3998], 'out': [2884, 3999], 'kind': [2893, 4008], 'cooperation': [2894, 4009], 'perform': [2896, 4011], 'survey.Financial': [2899, 4014], 'competing': [2901, 4016], 'interests': [2902, 4017], 'disclosureThis': [2903, 4018], 'grants': [2910, 4025], 'Regulatory': [2914, 3754, 3772, 4029], 'Drugs': [2917, 4032], 'Others,': [2919, 4034], 'Development': [2921, 4036], 'New': [2923, 4038], 'Drugs,': [2924, 4039], 'Development.': [2933, 4048], 'Y': [2934, 4049], 'Ohtsu': [2935, 3362, 4050], 'M': [2937, 2952, 2968, 3275, 3508, 4052, 4067, 4083], 'Katashima': [2938, 4053], 'employees': [2940, 4055], 'Pharma.': [2943, 2976, 4058, 4091], 'T': [2944, 2977, 3183, 4059, 4092], 'Matsumaru': [2945, 4060], 'employee': [2948, 2956, 2964, 2972, 2981, 2991, 4063, 4071, 4079, 4087, 4096, 4106], 'Pharmaceutical.': [2951, 2959, 2967, 2994, 4066, 4074, 4082, 4109], 'H': [2960, 4075], 'Laboratories.': [2986, 4101], 'S': [2987, 4102], 'no': [2998, 4113], 'relevant': [3000, 4115], 'affiliations': [3001, 4116], 'financial': [3003, 3012, 3016, 4118, 4127, 4131], 'involvement': [3004, 4119], 'any': [3006, 4121], 'organization': [3007, 4122], 'in,': [3014, 4129], 'conflict': [3017, 4132], 'with,': [3018, 4133], 'matter': [3021, 4136], 'materials': [3023, 4138], 'discussed': [3024, 4139], 'manuscript': [3027, 4142], 'disclosed.No': [3031, 4146], 'writing': [3032, 4147], 'assistance': [3033, 4148], 'utilized': [3035, 4150], 'production': [3038, 4153], 'manuscript.DisclaimerThe': [3041, 4156], 'opinions': [3042, 4157], 'perspectives': [3044, 4159], 'personal': [3050, 4165], 'official': [3054, 4169], 'statement': [3055, 4170], 'Japan.Papers': [3070], 'special': [3072], 'note': [3073], 'highlighted': [3076], 'as:': [3077], '•': [3078, 3407, 3491], 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