Formation of a Global Contract Research Organization Council for Bioanalysis

Name: Work Video:
Duration: 3 min 30 s
Noel Premkumar; Stephen Lowes; James de Jersey; Fabio Garofolo; Isabelle Dumont; Robert Massé; Betty Stamatiou; Maria Cruz Caturla; Ray Steffen; Michele Malone; Elliot Offman; Timothy Samuels; Phillip Oldfield; Lorella Di Donato; Douglas M. Fast; Daniel G. Tang; Marc Moussallie; John Doughty; Mario L. Rocci; Mike Buonarati; Dominique Gouty; Darioush Dadgar; John Stamatopoulos; Alan P. Breau; Bernard Ntsikoussalabongui; Mohammed Bouhajib; Bob Nicholson; Richard Tacey; Peter Ketelaar; Chad Briscoe; Shane Karnik; Jaap Wieling; Jon Kirk Smith; Michael Reid; Richard LeLacheur; John Chapdelaine; Saadya Fatmi; Farhad Sayyarpour; Xinping Fang; Jeremy W. Cook; David R. Browne
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[351], 'Workshop': [352, 512, 1617], 'on': [353, 386, 594, 639, 772, 870, 948, 1026, 1285, 1405, 1578, 1585, 1608, 1618, 1875, 1925, 1958, 2060, 2303, 2454, 3320, 3326, 3582, 3712, 3790, 3909, 4009, 4198, 4208, 4439, 4473, 4702, 4725], 'Regulated': [354], 'hosted': [356], 'in': [357, 440, 472, 484, 513, 592, 661, 682, 747, 776, 997, 1031, 1087, 1125, 1169, 1182, 1257, 1336, 1349, 1442, 1557, 1590, 1606, 1620, 1661, 1701, 1712, 1739, 1787, 1878, 2649, 2984, 3158, 3694, 3912, 4011, 4476, 4700, 4705, 4740, 4777, 4788, 4815], 'Montreal': [358, 593, 1607, 1621], '(April': [359], '2010),': [360], 'unanimous': [362], 'consensus': [363, 1025], 'reached': [365], 'global': [368, 418, 534, 644, 759, 779, 943, 979, 1092, 1537, 1807, 1882], 'identify': [372], 'non-prescriptive,': [373], 'science-based': [374], 'language': [375, 392], 'that': [376, 464, 721, 795, 953, 1079, 1172, 1207, 1356, 1533], 'could': [377], 'form': [378], 'basis': [380], 'proposed': [383, 939], 'guidance': [384, 391, 684, 829], 'document': [385, 463, 1072], 'bioanalysis': [387, 442, 506, 579, 1032, 1880, 3693], '[6].': [388], 'Ideally,': [389], 'such': [390, 417, 750, 777, 1669], 'would': [393, 402, 764, 784], 'describe': [394], 'rationale': [396], 'behind': [397], 'each': [398, 1148, 1274, 1347], 'requirement': [400], 'be': [403, 466, 567, 928, 941, 1074, 1120, 1132, 1154, 1167, 1302, 1312, 1328, 1345, 1377, 1555], 'presented': [404, 467, 1075], 'consideration': [406], 'industry': [410, 3700], 'worldwide.A': [411], 'recent': [412, 1876, 4585], 'concrete': [413], 'action': [414, 1410], 'taken': [415], 'towards': [416, 1763, 1784, 1917], 'creation': [425, 582, 1266], 'Consortium': [430], '(GBC).': [431], 'Drawing': [432], 'from': [433, 502, 602, 689, 818, 849, 1083, 1392, 1460, 1888, 2183, 2652, 4481], 'representatives': [434, 601, 1145, 1152], 'scientific': [436, 610, 958, 993, 1071, 1354], 'associations': [437, 1040], 'with': [438, 486, 675, 740, 1037, 1058, 1220, 1351, 1592, 1636, 1692, 1697, 1705, 1936, 4768, 4773, 4781], 'involvement': [439, 1335, 1691, 4767], 'regulated': [441, 578, 781, 999, 1879, 3159, 3695], 'across': [443], 'globe,': [445], 'objective': [447], 'GBC': [450, 481, 1078], 'is': [451, 482, 854, 918, 938, 969, 1213, 1259, 1536, 1541, 1601, 1630, 1673], 'merge': [453], 'existing': [454], 'or': [455, 1143, 1247, 1386, 1644, 1659, 1689, 1695, 1702, 1709, 1722, 1727, 1730, 1732, 4765, 4771, 4778, 4785, 4798, 4803, 4806, 4808], 'emerging': [456, 748, 1387], 'create': [460], 'unified': [462, 636], 'can': [465, 1654], 'authorities': [471, 981], 'various': [473, 662, 1461], 'countries': [474, 1462], 'regions.': [476], 'The': [477, 680, 963, 1001, 1161, 1215, 1595, 1625, 1779, 1889, 4370, 4697], 'development': [478, 2651], 'currently': [483], 'process,': [485, 1445], 'intention': [488], 'present': [490, 607, 971, 1432], 'plans': [491, 1411], 'updates': [493, 4731], 'at': [494, 1066, 1433, 4377, 4446], 'upcoming': [495, 1569], 'seek': [500], 'input': [501, 1021, 1082, 1469, 1677], 'scientists': [504], 'conducting': [505, 577, 998], '[7].At': [507], 'CVG': [510, 1050, 1366, 1616], 'Montreal,': [514], 'Organizations': [519], '(CROs)': [520], 'highlighted': [521], 'importance': [523, 2456], 'having': [525, 1505], 'strong': [527], 'cohesive': [529, 975], 'contribution': [531], 'process.': [536], 'Having': [537], 'CROs,': [538], 'academic': [539], 'laboratories': [540, 820, 904], 'pharmaceutical': [542, 667], 'industries': [543], 'appropriately': [544], 'represented': [545], 'viewed': [547], 'as': [548, 751, 1122, 1262, 1264, 1291, 1379, 1453, 1458, 1670], 'critical': [549, 2490, 2994, 3792], 'identifying': [551], 'optimum': [552], 'language.': [553], 'Consequently,': [554], 'proposal': [556], 'build': [558], '(GCC)': [563], 'arose,': [564], 'designed': [565], 'distinct': [569], 'group': [570, 945, 1668], 'consisting': [571], 'exclusively': [572], 'members': [576, 1188, 1197, 1281, 1426, 1504, 1510, 1573], 'business.To': [580], 'initiate': [581], 'GCC,': [585, 1116], 'special': [587, 1371], 'closed': [588, 622, 807, 1342, 1373, 1437, 1599, 1628, 3155], 'forum': [589, 623, 1014, 1343, 1438, 1600, 1629], 'held': [591, 1346], '14': [595], 'September': [596, 2443, 2479, 4553, 4568], '2010,': [597], 'where': [598], '41': [599], 'executive': [600], '32': [603], 'CROs': [605, 650, 720, 732, 774, 796, 995, 1118, 1224, 1357], 'were': [606, 799], 'discuss': [609], 'issues': [612, 960, 1388, 1877], 'institution': [615, 1580], 'GCC.': [618, 1309], 'This': [619, 853, 917, 1310, 1715, 4791], 'first': [620, 805], 'unique': [626], 'occasion': [627], 'discuss,': [629], 'review': [630], 'share': [632], 'perspectives': [633], 'upon': [634], 'approach': [638, 1587], 'how': [640, 773, 2284], 'support': [642], 'guidances.Harmonization': [648], 'issuesBioanalytical': [649], 'work': [651, 1283], 'under': [652], 'strict': [653], 'standards,': [655], 'since': [657], 'they': [658, 671], 'operate': [659, 1225], 'globally': [660, 1920], 'countries,': [663], 'similar': [664], 'biotechnology': [669], 'clients,': [670, 1195], 'have': [672, 765, 905, 954, 1199, 1685, 4761], 'deal': [674], 'different': [676, 728, 850], 'regulations': [677, 1853, 1886], 'guidances.': [679], 'differences': [681, 1516], 'documents': [685], '(or': [686], 'lack': [687], 'of)': [688], 'major': [690, 914, 1353], '(e.g.,': [693, 1041, 1363], 'FDA': [695, 3319, 3324, 4107], 'EMA': [698], 'ANVISA': [701], 'Brazil,': [703], 'TGA': [704], 'Australia,': [706], 'SFDA': [707], 'China': [709, 2814], 'MHLW': [711], 'Japan)': [713], 'are': [714, 736, 797, 833, 1189, 1431], 'becoming': [715], 'serious': [717], 'hurdle': [718], 'conduct': [722], 'studies': [723, 735], 'destined': [724], 'submission': [726], 'health': [729, 980], 'agencies.': [730, 916, 1594], 'Many': [731], 'performing': [733], 'bioequivalence': [734], 'struggling': [737], 'comply': [739], 'both': [741], 'national': [742], 'guidelines,': [745], 'especially': [746], 'economies': [749], 'Asia-Pacific,': [752], 'Latin': [753], 'America': [754], 'Eastern': [756], 'Europe.': [757], 'Therefore,': [758, 1227], 'strong,': [767], 'profound': [768], 'positive': [770, 3794], 'impact': [771, 2461], 'function': [775], 'environment,': [782], 'help': [785, 989], 'achieve': [787, 1091], 'consistent': [789], 'quality': [791, 831], 'standard.Several': [792], 'specific': [793, 992, 1107, 1279], 'challenges': [794, 994], 'facing': [798], 'raised': [800], 'discussed': [802, 1711, 4787], 'during': [803, 1412], 'forum.': [808], 'For': [809], 'instance,': [810], 'multiple': [811], 'questions': [812], 'regarding': [813], 'cross-validation': [814], 'transferred': [816], 'methods': [817], 'sponsor': [819], 'associated': [822], 'stability': [823, 2501, 3585], 'assessments': [824], 'still': [825], 'consensus.': [827], 'Adequate': [828], 'standards': [832, 895, 2182], 'lacking': [834], 'some': [836, 1418], 'matrix-related': [837], 'issues,': [838], 'including': [839], 'assessment': [841], 'hemolysis': [843], 'use': [846], 'matrices': [848], 'ethnic': [851], 'groups.': [852, 1339], 'also': [855, 1376], 'case': [857], 'many': [859, 1454], 'other': [860, 1038, 1126], 'general': [861], 'validation': [862, 1961, 2063, 3691, 3716], 'requirements': [863], 'concerning': [864], 'sample': [865, 872, 3584, 4582], 're-injection': [866], 'versus': [867], 're-assay,': [868], 'investigations': [869], 'incurred': [871, 3469, 3583, 4581], 'reproducibility': [873], '(ISR)': [874], 'failures;': [875], 're-assay': [876], 'pharmacokinetic': [878], 'reasons;': [879], 'assays': [880], 'using': [881, 1315, 1521], 'dried': [882], 'blood': [883, 3170], 'spot': [884], 'analysis;': [885], 'method': [887, 1927, 2276, 2494, 2820, 3161, 3165, 3690, 3715], 'parameters': [888], 'biomarkers/ligand-binding': [890], 'assays.': [891], 'In': [892, 1277], 'addition,': [893, 1278], 'suitable': [894], 'outlining': [896], 'an': [897, 929, 1088, 3699], 'appropriate': [898, 1390, 1483], 'Quality': [899], 'Management': [900], 'System': [901], 'not': [906, 925, 1135, 1218, 1539], 'yet': [907], 'been': [908], 'issued': [909], 'most': [911, 1482, 1542, 1547], 'small': [920], 'sampling': [921], 'topics': [923], 'considered': [926, 1121], 'exhaustive': [930], 'list.Formation': [931], 'CouncilThe': [936], 'GCC': [937, 968, 1007, 1165, 1187, 1216, 1232, 1275, 1280, 1290, 1326, 1341, 1372, 1400, 1413, 1425, 1436, 1455, 1475, 1503, 1509, 1535, 1572, 1583, 1598, 1627, 1672, 2185, 2487, 2654, 2795, 2978, 3154, 3467, 3788], 'independent': [944, 1294], 'specifically': [946], 'focused': [947], 'guidelines': [952], 'particular': [955, 1384, 1435], 'relevance': [956], 'impacting': [961], 'CROs.': [962], 'extended': [964], 'vision': [965], 'formal': [973, 1251], 'body': [977, 1112], 'around': [985], 'world': [987, 1789], 'address': [990], 'encounter': [996], 'bioanalysis.': [1000, 1791], 'goals': [1002], 'objectives': [1004], 'include': [1008], 'following:': [1010], '▪': [1011, 1450], 'Offer': [1012], 'gather': [1020], 'reach': [1023, 1480], 'concerns': [1027], 'about': [1028], 'developments': [1030], 'CRO-specific': [1034], 'challenges;▪': [1035], 'Communicate': [1036], 'Scientists': [1047], '[AAPS],': [1048], 'Forum': [1055, 1758], '[EBF])': [1056], 'via': [1061], 'official': [1062, 1331], 'publications': [1063], 'presentations': [1065, 1333], 'meetings;▪': [1068], 'Generate': [1069], 'will': [1080, 1119, 1131, 1146, 1166, 1173, 1198, 1282, 1301, 1311, 1327, 1344, 1358, 1401, 1439, 1552, 1574], 'provide': [1081, 1655, 1676], 'perspective': [1086], 'effort': [1089], 'guidances;▪': [1096], 'Support': [1097], 'interests': [1099, 1682, 4758], 'sponsors': [1102], 'identification': [1105], 'solutions': [1108], 'concerns.When': [1113], 'building': [1114, 1561, 1665], 'members,': [1124], 'words,': [1127], 'itself': [1130], 'member,': [1134], 'individual': [1137], 'person': [1138], 'representing': [1139], 'CRO.': [1141], 'One': [1142], 'two': [1144], 'represent': [1147], 'CRO,': [1149], 'these': [1151], 'must': [1153, 1217, 1233], 'part': [1155, 1441], "CRO's": [1158], 'senior': [1159], 'management.': [1160], 'structure': [1162, 1206], 'established': [1168], 'way': [1171, 1761], 'promote': [1174], 'collaboration,': [1175], 'facilitate': [1176], 'effective': [1177, 1299, 1519], 'communication': [1178, 1300], 'maintain': [1180], 'efficiency': [1181], 'reaching': [1183, 1518], 'science-driven': [1184], 'consensus.Since': [1185], 'competitors': [1190], 'often': [1191], 'sharing': [1192], 'same': [1194], 'all': [1196, 1474, 1502], 'equal': [1200, 1506], 'representation.': [1201], 'Hence,': [1202], 'flat': [1204], 'organizational': [1205], 'preserves': [1208], 'equality': [1209], 'minimizes': [1211], 'hierarchy': [1212], 'advocated.': [1214], 'interfere': [1219], 'competitive': [1222], 'environment': [1223], 'in.': [1226], 'operation': [1229], 'officially': [1234], 'discourage': [1235], 'any': [1236, 1243, 1693, 4769], 'potential': [1237], 'anti-competitive': [1238], 'behavior': [1239], 'totally': [1241], 'avoid': [1242], 'operational,': [1244], 'strategic,': [1245], 'pricing': [1246], 'confidential': [1248], 'issues.': [1249], 'A': [1250, 1340], 'articulation': [1252], "GCC's": [1255], 'mission': [1256], 'by-laws': [1258], 'being': [1260], 'considered,': [1261], 'well': [1263], 'admonition': [1268], 'statements': [1269], 'meeting': [1271], 'minutes': [1272], 'meeting.': [1276], 'together': [1284, 1577], 'incorporation': [1287], 'nonprofit': [1293], 'organization.As': [1296], 'previously': [1297], 'outlined,': [1298], 'crucial': [1303], 'success': [1306], 'accomplished': [1313], 'internally': [1314], 'face-to-face': [1316], 'dialog,': [1317], 'electronic': [1318, 3176, 3476], 'conversations': [1319], 'surveys.': [1321], 'External': [1322], 'visibility': [1323], 'supported': [1329], 'cross-organization': [1337], 'discussion': [1338], 'parallel': [1350], 'conference': [1355, 1641, 1649], 'usually': [1359], 'plan': [1360], 'attend': [1362], 'AAPS,': [1365], 'EBF': [1368, 1648], 'conferences).': [1369], 'Other': [1370], 'forums': [1374], 'may': [1375], 'organized': [1378], 'needed;': [1380], 'example,': [1382], 'following': [1383, 1448, 1613], 'events': [1385], 'needing': [1389], 'response': [1391], 'perspective.': [1395], 'To': [1396], 'ensure': [1397], 'efficiency,': [1398], 'focus': [1404, 3789], 'clear': [1406], 'goals,': [1407], 'outcomes': [1408], 'meetings.': [1414], 'Figure': [1415], '1': [1416], 'summarizes': [1417], 'dynamics': [1421], 'surrounding': [1422], 'GCC.Only': [1424], '(i.e.,': [1427], 'representatives)': [1429], 'who': [1430, 1653], 'take': [1440, 1604], 'decision-making': [1444], 'utilizing': [1446], 'guidelines:': [1449], 'Inclusive:': [1451], 'involving': [1452], 'member': [1456], 'companies': [1457], 'possible,': [1459], 'regions;▪': [1464], 'Participatory:': [1465], 'actively': [1466], 'soliciting': [1467], 'participation': [1472], 'members;▪': [1476], 'Cooperative:': [1477], 'working': [1478, 1576, 1916], 'decision': [1484], 'group,': [1487], 'rather': [1488], 'than': [1489], 'pursuing': [1490], 'majority': [1492], 'opinion': [1493], 'potentially': [1494], 'detriment': [1497], 'minority;▪': [1500], 'Egalitarian:': [1501], 'input;▪': [1507], 'Solution-oriented:': [1508], 'aiming': [1511], 'common': [1513], 'agreement': [1514], 'over': [1515], 'decisions': [1520], 'mutually': [1522], 'beneficial': [1523], 'solutions;▪': [1524], 'Dissent': [1525], 'early:': [1526], 'maximizing': [1527], 'chances': [1528], 'accommodating': [1530], 'views.The': [1531], 'fact': [1532], 'local': [1540], 'certainly': [1543], 'one': [1544], 'its': [1546], 'essential': [1548], 'features,': [1549], 'kept': [1556], 'mind': [1558], 'throughout': [1559], 'growing': [1563], 'GCC.Future': [1566], 'considerationsIn': [1567], 'months,': [1570], 'continue': [1575], 'adopt': [1589], 'communicating': [1591], 'next': [1596], 'annual': [1597], 'planned': [1602], 'place': [1605], '15': [1609], 'April': [1610, 1623, 2268, 2787, 2969, 4190], '2011,': [1611], 'immediately': [1612], '5th': [1615], '(11–14': [1622], '2011).': [1624], 'subsequent': [1626], 'tentatively': [1631], 'scheduled': [1632], 'occur': [1634], 'concurrently': [1635], 'October': [1638, 1950, 3899, 4001, 4737], '2011': [1639, 1647, 4430, 4464, 4554, 4569, 4689, 4712], 'AAPS': [1640], '(Washington,': [1642], 'USA)': [1643], 'December': [1646, 2288, 3459, 4429, 4463], '(Barcelona,': [1650], 'Spain).': [1651], 'Anyone': [1652], 'relevant': [1656, 1687, 4763], 'insight,': [1657], 'wisdom': [1658], 'knowledge': [1660], 'relation': [1662], 'invited': [1674], 'feedback.Financial': [1679], 'competing': [1681, 4757], 'disclosureThe': [1683, 4759], 'authors': [1684, 4760], 'no': [1686, 4762], 'affiliations': [1688, 4764], 'financial': [1690, 1699, 1703, 4766, 4775, 4779], 'organization': [1694, 2452, 4770], 'entity': [1696, 4772], 'interest': [1700, 4776], 'conflict': [1704, 4780], 'subject': [1707, 4783], 'matter': [1708, 4784], 'materials': [1710, 4786], 'manuscript.': [1714, 4790], 'includes': [1716, 4792], 'employment,': [1717, 4793], 'consultancies,': [1718, 4794], 'honoraria,': [1719, 4795], 'stock': [1720, 4796], 'ownership': [1721, 4797], 'options,': [1723, 4799], 'expert': [1724, 4800], 'testimony,': [1725, 4801], 'grants': [1726, 4802], 'patents': [1728, 4804], 'received': [1729, 4805], 'pending,': [1731, 4807], 'royalties.': [1733, 4809], 'No': [1734, 4810], 'writing': [1735, 4811], 'assistance': [1736, 4812], 'utilized': [1738, 4814], 'production': [1741, 4817], 'manuscript.Bibliography1': [1744], 'Lausecker': [1745, 1843], 'B,': [1746, 1844], 'van': [1747, 1840, 1867, 1902, 2843, 3124, 3286, 3415, 4498], 'Amsterdam': [1748, 1841, 1868, 1903], 'P,': [1749, 1798, 1842, 1848, 1904], 'Brudny-Kloeppel': [1750, 1849], 'M,': [1751, 1827, 1906], 'Luedtke': [1752, 1845], 'S,': [1753, 1800, 1825, 1846], 'Timmerman': [1754, 1797, 1847], 'P.': [1755], 'forward': [1762], 'harmonized': [1764, 1852, 1923], 'regulations.': [1765], 'Bioanalysis1(5),873–875': [1766], '(2009).Link,': [1767], 'CAS,': [1768, 1794, 1821, 1837, 1860, 1931], 'Google': [1769, 1795, 1822, 1838, 1861, 1932], 'Scholar2': [1770], 'Abbott': [1771], 'R.': [1772], 'Forum,': [1775], '2nd': [1776], 'Open': [1777], 'Symposium:': [1778], 'broadening': [1780], 'scope': [1781], 'validation:': [1783, 2277], 'best': [1785], 'practices': [1786], 'Bioanalysis2(4),703–708': [1792], '(2010).Link,': [1793, 1820, 1836, 1930], 'Scholar3': [1796], 'Lowes': [1799], 'Fast': [1801], 'DM,': [1802], 'Garofolo': [1803, 1828, 1865], 'F.': [1804, 1829], 'Request': [1805], 'Guidance': [1811, 3325], 'Method': [1814, 2309, 3328, 4210], 'Sample': [1817], 'Analysis.': [1818], 'Bioanalysis2(4),683': [1819], 'Scholar4': [1823], 'Bansal': [1824, 1907], 'Arnold': [1826, 1905], 'International': [1830, 4379, 4449], 'guidance.': [1834], 'Bioanalysis2(4),685–687': [1835], 'Scholar5': [1839], 'M.': [1850], 'Towards': [1851], 'bioanalysis:': [1855], 'moving': [1856], 'forward!': 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4363, 4431, 4465, 4555, 4570, 4690, 4713], 'Bioanalysis,': [1953, 2055, 2166, 2271, 2446, 2482, 2636, 2790, 2972, 3149, 3309, 3462, 3577, 3685, 3781, 3902, 4004, 4091, 4193, 4364, 4432, 4466, 4556, 4571, 4691, 4714], 'Vol.': [1954, 2056, 2167, 2272, 2295, 2447, 2483, 2637, 2791, 2973, 3150, 3310, 3463, 3578, 3686, 3708, 3782, 3903, 4005, 4092, 4194, 4365, 4433, 4467, 4557, 4572, 4692, 4715, 4719], '14,': [1955, 2057, 2168], '16Recommendations': [1957], 'qPCR/ddPCR': [1959], 'assay': [1960, 2062], 'GCCMark': [1963], 'Wissel,': [1964, 2109], 'Martin': [1965, 2070], 'Poirier,': [1966, 2071], 'Christina': [1967, 2094, 2213, 2320, 2474, 2555, 2691, 2887, 2941, 3063, 3106, 3230], 'Satterwhite,': [1968, 2095, 2214, 2321, 2556, 2692, 2888, 3064, 3231], 'Lin,': [1970, 2000, 2105, 2113, 2220, 2357, 2566, 2702, 2898, 3068, 3081, 3240, 3261, 3379, 3395, 3546, 3648, 3851, 3859, 4135, 4151, 4170, 4273, 4301, 4326, 4627], 'Rafiq': [1971, 2257, 2318, 2509, 3004, 3188, 3746, 3815, 4131, 4267], 'Islam,': [1972, 2067, 2258, 2319, 2473, 2510, 2657, 2822, 3005, 3189, 3371, 3747, 3816, 4132, 4268], 'Jennifer': [1973, 1977, 2027, 2068, 2072, 2078, 2189, 2201, 2332, 2336, 2539, 2670, 2864, 2877, 3043, 3204, 3210, 3345, 3353, 3508, 3600, 3831], 'Zimmer,': [1974, 2073, 2190, 2337, 2540, 2671, 2865, 3044, 3211, 3354, 3509, 3601, 3832, 4059, 4279], 'Ardeshir': [1975, 2074, 2340, 2545, 2679, 2871, 3049, 3215], 'Khadang,': [1976, 2075, 2341, 2546, 2680, 2872, 3050, 3216], 'Zemo,': [1978, 2079, 2878], 'Todd': [1979, 2080, 2209], 'Lester,': [1980, 2081, 2210], 'Marianne': [1981, 2082], 'Fjording,': [1982, 2083], 'Amanda': [1983, 2084, 2253, 2606, 2662], 'Hays,': [1984, 2085, 2254, 2607, 2663], 'Nicola': [1985, 2086, 2505, 2687, 2879, 3053, 3219], 'Hughes,': [1986, 2087, 2506, 2688, 2880, 3054, 3220], 'Rudolf': [1989, 2092], 'Guilbaud,': [1990, 2093], 'Elizabeth': [1991, 2098, 2215, 3137, 3200, 3450], 'Groeber,': [1992, 2099, 2216, 3138, 3201, 3451], 'Heidi': [1993, 2100, 2217], 'Renfrew,': [1994, 2101, 2218], 'Kelly': [1995, 2096, 2156, 2263, 2889], 'Colletti,': [1996, 2097, 2890], 'Mathilde': [1997, 2102, 2559, 2695, 2893, 3065, 3232, 3372], 'Yu,': [1998, 2103, 2560, 2696, 2894, 3066, 3233, 3373], 'Jenny': [1999, 2104, 2219, 2356, 2565, 2701, 2897, 3067, 3260, 3394, 3545, 3647, 3858, 4150, 4300], 'Santosh': [2003, 2114], 'Shah,': [2004, 2115], 'Wei': [2005, 2116, 2229, 2368, 2580, 2716, 2909, 3082, 3241, 3424, 3535, 3631, 3748, 3852, 4054, 4136, 4276, 4403], 'Sumit': [2007, 2197, 2658], 'Kar,': [2008, 2198, 2659], 'Roger': [2009, 2120, 2233, 2324, 2477, 2507, 2736, 2831, 3108, 3337, 3498, 3651, 3754, 3866, 3956, 4129, 4257, 4614], 'Hayes,': [2010, 2121, 2234, 2325, 2508, 2737, 2832, 3109, 3179, 3338, 3499, 3652, 3755, 3867, 3957, 4130, 4258, 4615], 'Pirro,': [2012, 2123, 2435], 'Cheikh': [2013, 2124, 2247, 2390], 'Kane,': [2014, 2125, 2248, 2391], 'Marsha': [2015, 2126, 2243, 2380], 'Luna,': [2016, 2127, 2244, 2381], 'Allan': [2017, 2128, 2245, 2526, 2732, 2933, 3269, 3402, 3547, 3649, 3864], 'Xu,': [2018, 2129, 2246, 2527, 2587, 2727, 2733, 2934, 3270, 3403, 3548, 3650, 3865], 'Stephanie': [2019, 2130, 2221, 2316, 2470, 2515, 2703, 2827, 3035, 3192, 3527, 3533, 3621, 3629], 'Cape,': [2020, 2131, 2222, 2317, 2471, 2516, 2704, 2828, 3003, 3193, 3528, 3622], 'Mark': [2021, 2108, 2132, 2223, 2543, 2677, 2829, 2833, 3555, 3661, 3756, 3876, 3936, 3973, 4033, 4426, 4458], "O'Dell,": [2022, 2133, 2224], 'Wheller,': [2024, 2135], 'Hanna': [2025, 2136, 2386, 2592, 2660, 3104, 3277], 'Ritzen,': [2026, 2137, 3105], 'Vance,': [2028, 2069, 2202, 2333], 'Esme': [2029, 2138, 2249, 2400], 'Farley,': [2030, 2139, 2250, 2401], 'Katie': [2031], 'Matys,': [2032], 'Edward': [2033, 2144, 2193, 2404, 2432, 2604, 2626, 2758, 2780, 2952, 2967, 3102, 3117, 3279], 'Tabler,': [2034, 2145, 2194, 2405, 2605, 2759, 2953, 3118, 3280], 'William': [2035, 2142, 3454, 3776, 3894, 4173, 4336], 'Mylott,': [2036, 2143], 'Moucun': [2037, 2146], 'Yuan,': [2038, 2147], 'Troy': [2041, 2150], 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'Kierstead,': [2141], 'Dong,': [2157], 'Yamashita9': [2162], 'February': [2163, 3306], '4Recommendations': [2170, 3711], 'management': [2175], 'Certificates': [2177], 'Analysis': [2179], 'reference': [2181, 3797], 'bioanalysisJoseph': [2187], 'Bower,': [2188, 2409, 2826, 3330, 3522, 3616], 'Stacie': [2191, 2406], 'McCown,': [2192, 2407], 'Kurt': [2199, 2328], 'Sales,': [2200, 2329], 'Colin': [2203, 2535, 2666, 2858, 3190, 3448, 3744, 4048, 4261], 'Barry,': [2204, 2536, 2667, 2859], 'Anahita': [2205, 2537, 2668, 2862, 3037, 3228], 'Keyhani,': [2206, 2538, 2669, 2863, 3038, 3229], 'Ashley': [2227, 2854], 'Brant,': [2228, 2855], 'Sarah': [2235, 2342, 3250], 'Simchik,': [2236], 'Rachel': [2237, 2935, 3724, 4075, 4334, 4415], 'Sun,': [2238], 'Orlando': [2239, 2344], 'Bravo,': [2240, 2345, 3205, 3346], 'Dawn': [2241, 2378], 'Dufield,': [2242, 2379], 'Mitesh': [2251], 'Sanghvi,': [2252], 'Steve': [2255, 2612, 3025, 3339, 3484, 3728, 3806, 3971, 4224, 4493, 4536, 4623], 'Brian': [2259, 2420, 3944, 4508], 'Hoffpauir,': [2260, 2421], 'Chris': [2261, 2519, 2770, 2921, 3016, 4066, 4304], 'Beaver,': [2262, 2520, 2771, 2922, 3017], 'Dong': [2264], 'Daksha': [2266], 'Desai-Krieger13': [2267], '2021': [2269], '13,': [2273], '8Bioanalytical': [2275], 'How': [2278], 'much': [2279], 'should': [2280, 2285], 'we': [2281, 2286], 'do': [2282], 'document?14': [2287], '2019': [2289, 2305, 2444, 2480, 2634, 2788], 'Analytical': [2291], 'Chemistry,': [2294], '412,': [2296], '3GCC': [2298], 'Consolidated': [2299, 3315], 'Feedback': [2300], 'ICH': [2302, 2306, 2463], 'M10': [2307], 'Draft': [2311, 3323], 'GuidelineCorey': [2312], 'Nehls,': [2313, 2467, 2603, 2755, 2951, 3007, 3554, 3660, 4539, 4657], 'Andrew': [2326, 2571, 2709, 2901, 3428, 3847], 'Dinan,': [2327, 2572, 2710, 2902, 3848], 'Shelby': [2330], 'Anderson,': [2331], 'Lindsay,': [2335, 2619, 2769, 2963], 'Philippe': [2338, 2541, 2675, 2869, 3047, 3184, 3513, 3605, 3734, 4044, 4121, 4241, 4389], 'Couerbe,': [2339, 2542, 2676, 2870, 3048, 3185, 3514, 3606, 3735, 4045, 4122, 4242, 4390], 'Maasjo,': [2343], 'Kathie': [2346, 2549, 2683], 'Lindley,': [2347, 2550, 2684], 'Liam': [2348], 'Moran,': [2349], 'Sangster,': [2351, 3743, 4026, 4260, 4398], 'Jenifer': [2352, 2557, 2693, 2891, 3139, 3888, 4681], 'Vija,': [2353, 2558, 2694, 2892, 3140, 3889, 4682], 'Scott': [2358, 2885, 3444, 3561, 3669, 3767, 3882, 3946], 'Reuschel,': [2359, 3445, 3562, 3670, 3768, 3883], 'Angie': [2360], 'Underberg,': [2361], 'MacNeill,': [2363, 2574, 2712], 'Luca': [2364, 2578], 'Matassa,': [2365, 2579], 'Adriane': [2366], 'Spytko,': [2367], 'Paul': [2372, 2517, 2722, 3127, 3422], 'Rhyne,': [2373, 2518, 2723, 3128, 3423], 'Jason': [2374], 'Ambrosius,': [2375], 'Valentine': [2376], 'Barra,': [2377, 4505], 'Franklin': [2382, 2531, 2730, 2856], 'Spriggs,': [2383, 2532, 2731, 2857], 'Evgueni': [2384], 'Fedorov,': [2385], 'Ritzén,': [2387, 2593, 2661, 3278], 'Chantal': [2394, 2596, 2743, 3406], 'DiMarco,': [2395, 2744, 2746, 3407], 'Adriana': [2396, 2958, 3027], 'Iordachescu,': [2397, 2959, 3028], 'Ariana': [2398, 2850], 'Tudoroniu,': [2399, 2851], 'Bruce': [2402, 2513, 2756, 2837, 3115], 'Stouffer,': [2403, 2514, 2757, 2838, 3116], 'Joseph': [2408, 2825, 3521, 3615], 'Travis': [2410], 'Harrison,': [2411], 'Brown,': [2415, 2611, 2721, 2914], 'Philip': [2416, 2956], 'Joyce,': [2417, 2957], 'Nadine': [2422, 2923, 3088, 3258, 3541, 3643], 'Boudreau,': [2423, 2924, 3089, 3259, 3542, 3644], 'Jerome': [2424], 'Bergeron,': [2425], 'Hao': [2426, 2428, 2622, 2774, 2776], 'Wang,': [2427, 2623, 2775, 3995], 'Feng,': [2429, 2777], 'Shaolian': [2430], 'Zhou,': [2431], 'Wells,': [2433, 2627, 2781], 'Changming': [2441], 'Yang30': [2442], '11,': [2448, 2484, 2638, 2792], '18sContract': [2450], 'commentary': [2453], 'M10Chad': [2464], 'Corey': [2466, 2602, 2754, 2950, 3006, 3553, 3659, 4538, 4656], 'Rafiqul': [2472, 3370], 'Satterwhite': [2475], 'Hayes26': [2478], '1812th': [2486], 'Closed': [2488, 2796, 2979], 'Forum:': [2489, 2797, 2980], 'reagents;': [2491], 'oligonucleotides;': [2492], 'CoA;': [2493], 'transfer;': [2495], 'HRMS;': [2496], 'flow': [2497], 'cytometry;': [2498], 'findings;': [2500], 'immunogenicityChad': [2503], 'Patrick': [2511, 2750, 3012, 3283], 'Bennett,': [2512, 2751, 3013, 3284], 'Jessica': [2521, 2738, 2945], 'St': [2522, 2739, 2946], 'Charles,': [2523, 2740, 2947], 'Vellalore': [2524, 2752], 'Kakkanaiah,': [2525, 2753], 'Cruz': [2529, 2673, 2867, 3023, 3213, 3358, 3511, 3603, 3809, 4042, 4239, 4387, 4608], 'Rabab': [2533, 2664, 2852, 3031], 'Tayyem,': [2534, 2665, 2853, 3032], 'Warren,': [2544, 2678, 2834, 3556, 3662, 3877], 'Bourdage,': [2548, 2682, 2874, 3052, 3218], 'Iohann': [2561, 2697], 'Boulay,': [2562, 2698], 'Sian': [2567, 2705], 'Estdale,': [2568, 2706], 'Eric': [2569, 2707, 3073, 3982, 3996, 3999, 4495, 4542], 'Thomas,': [2570, 2708, 3074], 'Yi': [2575, 2713, 2839, 3245], 'Qun': [2576, 2714, 2840, 3246], 'Xiao,': [2577, 2715, 2841, 3247], 'George': [2584, 2724, 2919], 'Hristopoulos,': [2585, 2725, 2920], 'Arron': [2586, 2726], 'Lawrence': [2588, 2728], 'Goodwin,': [2589, 2729, 4051, 4266], 'Kayode': [2590, 2734, 3055, 3515, 3607, 3837], 'Awaiye,': [2591, 2735, 3056, 3516, 3608, 3838], 'Marco,': [2598], 'Simona': [2599, 2747, 3112], 'Rizea': [2600, 2748, 3113], 'Savu,': [2601, 2749, 3114], 'Nadia': [2616, 2766], 'Kulagina,': [2617, 2767], 'Fang': [2629, 2783], 'Moussallie19': [2632], 'July': [2633], 'classification': [2642], 'commercial': [2644], 'LBA': [2645], 'kits': [2646], 'biomarkers': [2648], 'drug': [2650], 'bioanalysisRafiq': [2656], 'Luigi': [2745, 3029, 3202], 'Moussallie17': [2786], '711th': [2794], 'cumulative': [2798], 'stability;': [2799, 2801], 'matrix': [2800, 2992, 3481], 'immunogenicity': [2802], 'assays;': [2803, 2811], 'laboratory': [2804, 3177, 3477], 'manuals;': [2805], 'biosimilars;': [2806], 'chiral': [2807], 'methods;': [2808], 'hybrid': [2809], 'LBA/LCMS': [2810], 'fit-for-purpose': [2812, 3472], 'validation;': [2813], 'Food': [2815], 'Administration': [2818], 'validationRafiq': [2821], 'Arnold,': [2830, 3937], 'Barry': [2842, 3123, 3414], 'der': [2844, 3125, 3416], 'Strate,': [2845, 3126, 3417], 'Sikkema,': [2847], 'Masood': [2860, 3018, 3262, 3400, 3821, 4125, 4249], 'Khan,': [2861, 3019, 3264, 3401, 3822], 'Datin,': [2876, 3361], 'Fountain,': [2886], 'Wilfahrt,': [2900], 'Susan': [2903], 'Ohorodnik,': [2904], 'Hulse,': [2906, 3015, 3237, 3375, 3530, 3624], 'Vimal': [2907], 'Patel,': [2908], 'Damon': [2915], 'Papac,': [2916], 'Yansheng': [2927, 3092, 3267, 3862], 'Liu,': [2928, 3093, 3268, 3399, 3863], 'Gene': [2929, 3265, 3396], 'Ray,': [2930, 3266, 3397], 'Dominic': [2931, 3094], 'Warrino,': [2932, 3095], 'Green,': [2936, 3725, 4076, 4335, 4416], 'Joanne': [2937], 'Hayward-Sewell,': [2938], 'Marcelletti,': [2940, 3566, 3674], 'Sanchez,': [2942, 3107], 'Kennedy,': [2944], 'Tu,': [2955, 3120], 'Yamashita': [2965], 'Wells27': [2968], '2018': [2970], '10,': [2974], '7The': [2976], '10th': [2977], 'rejected': [2981], 'data,': [2982], 'GCP': [2983, 4018], 'bioanalysis,': [2985], 'extract': [2986], 'stability,': [2987, 2993, 3171, 3475, 4105, 4580], 'BAV,': [2988], 'processed': [2989], 'batch': [2990], 'acceptance,': [2991], 'reagents,': [2995, 3793], 'ELN': [2996], 'data': [2998], 'integrity': [2999], 'counteracting': [3001], 'fraudStephanie': [3002], 'Allinson,': [3009, 3495, 3638, 3723, 3818], 'Afshin': [3010, 3186, 3811], 'Safavi,': [3011, 3187, 3812], 'Silvestro,': [3030, 3203], 'Ron': [3033, 3206], 'Shoup,': [3034, 3207, 3348, 3487, 3593, 3826, 4116, 4229, 4598], 'Mowery,': [3036], 'Andrea': [3039, 3446, 3572, 3680], 'Wakefield,': [3040], 'Yinghe': [3041], 'Li,': [3042, 4535], 'Javier': [3045], 'Torres,': [3046], 'Brent': [3057], 'Matthews,': [3058], 'Rhonda': [3061], 'Johnson,': [3062], 'Laura': [3069, 3198, 3440, 3563, 3671, 3769, 3856, 3880, 4177, 4344, 4671], 'Cojocaru,': [3070, 3199, 3441, 3564, 3672, 3770, 3881, 4178, 4345, 4672], 'Fiscella,': [3072, 3235, 3524, 3618], 'Kai': [3075, 3248, 3382], 'Kurylak,': [3076, 3249, 3383], 'Kamerud,': [3078, 3377, 3532, 3626, 3846, 4622], 'Zhongping': [3079, 3238, 3849, 4133, 4271, 4625], '(John)': [3080, 3239, 3850, 4134, 4272, 4626], 'Prashant': [3096], 'Kale,': [3097], 'Neil': [3098, 4652], 'Adcock,': [3099], 'Radha': [3100], 'Shekar,': [3101], "O'Connor,": [3103], 'Phyllis': [3129, 3434], 'Conliffe,': [3130, 3435], 'Yamashita,': [3134, 3861], 'Malone': [3142, 3302, 3774, 4186, 4684], 'Mohamed': [3144], 'Osman24': [3145], 'March': [3146, 4361, 4711], '2017': [3147], '9,': [3151], '79th': [3153], 'forum:': [3156], 'CAPA': [3157], 'bioanalysis;': [3160], 'robustness,': [3162], 'biosimilars,': [3163], 'preclinical': [3164], 'validation,': [3166, 3473], 'endogenous': [3167, 3801], 'biomarkers,': [3168], 'whole': [3169], 'audit': [3173], 'experiences': [3174], 'notebooksRoger': [3178], 'Pattison,': [3191, 3745, 4049, 4262], 'Manon': [3208], 'Verville,': [3209], 'Harris,': [3251], 'Manju': [3252], 'Saxena,': [3253], 'Ann': [3256, 3390, 3870, 4160, 4316], 'Lévesque,': [3257], 'U': [3263], 'Gunjan': [3271], 'Soni,': [3272], 'Ian': [3273, 3569, 3677], 'Ward,': [3274], 'Clare': [3275], 'Kingsley,': [3276], 'Nico': [3285], 'de': [3287, 4073, 4141, 4289, 4633, 4665], 'Merbel,': [3288], 'Mulvana,': [3296], 'Benno': [3297], 'Ingelse,': [3298], 'Allen,': [3300, 3443, 4180, 4347, 4674], 'Fang26': [3305], '2016': [3307], '8,': [3311], '68th': [3313], 'feedback': [3316], 'US': [3318], '2013': [3322], 'ValidationJoseph': [3329], 'Ronald': [3347, 3486, 3592, 3825, 3942, 4115, 4228, 4506, 4597], 'Mary': [3351, 3551, 3655], 'Carbone,': [3352], 'Jordi': [3355], 'Ortuno,': [3356], 'Tim': [3362, 4123, 4247, 4616], 'Lansing,': [3363, 4124, 4248], 'Petra': [3366, 3738, 4029, 4253, 4395], 'Struwe,': [3367, 3739, 4030, 4254, 4396], 'Alexandre': [3388], 'Blanchette,': [3389], 'Levesque,': [3391, 3871, 4161, 4317], 'Sofi': [3392, 3872, 4162, 4318, 4654], 'Gagnon-Carignan,': [3393, 3873, 4163, 4319, 4655], 'Yanseng': [3398], 'Gibran': [3404], 'el-Sulayman,': [3405], 'Dick': [3410, 4070, 4310, 4411], 'Rand': [3412, 4164, 4322], 'Jenkins,': [3413, 4165, 4323], 'Gary': [3426], 'Schultz,': [3427], 'Roberts,': [3429], 'Redrup,': [3431], 'Teri': [3436], 'Pekol,': [3437], 'Jamil': [3438], 'Hantash,': [3439], 'Watson,': [3447], 'Farrell,': [3449], 'Nowatzke': [3455, 3895], 'Fang11': [3458], '2014': [3460, 3575, 3683], '6,': [3464, 3579, 3687, 3709], '227th': [3466], 'Insights:': [3468], 'samples': [3470], 'use;': [3471], 'solution': [3474], 'notebook': [3478], 'hyperlipidemic': [3480], 'testingMario': [3482], 'Raymond': [3490, 3611], 'Farmen,': [3491, 3612], 'Tianyi': [3492, 4648], 'Zhang,': [3493, 3628, 4649], 'Houghton,': [3503, 3666, 4078, 4333, 4418, 4668], 'Michelle': [3523], 'Pasas-Farmer,': [3534, 3630], 'Brigitte': [3543, 3645], 'Pellerin,': [3544, 3646], 'Stipancic,': [3552, 3656], 'Craig': [3559, 3667], 'Stovold,': [3560, 3668], 'Smith': [3570, 3678], 'Watson21': [3573], 'November': [3574, 3682, 3778, 4742], '20Recommendations': [3581], '(ISS)': [3586], 'GCCSteve': [3588], 'Suzanne': [3598, 3827, 3924, 4234, 4399, 4491], 'Martinez,': [3599, 3828, 3925, 4235, 4492], 'Tee': [3627], 'Watson11': [3681], '18Bioanalytical': [3689], 'settingsContract': [3696], 'analysisInternational': [3701], 'Journal': [3702], 'Healthcare': [3706], 'Marketing,': [3707], 'biomarker': [3713], 'GCCRichard': [3718], 'Hougton,': [3719], 'Losauro,': [3727], 'Stéphane': [3736], 'Bronner,': [3737], 'Christine': [3740, 4046, 4251], 'Schiebl,': [3741, 4047, 4252], 'Pawula,': [3751, 4063, 4285, 4408], 'Cameron,': [3757], 'Jake': [3760, 3874], 'Harman,': [3761, 3875], 'Theo': [3764, 4072, 4329, 4664], 'De': [3765, 4330], 'Boer,': [3766, 4074, 4331, 4666], 'Tammy': [3771, 4083, 4348, 4423, 4675], 'Harter,': [3772, 4349, 4676], 'Nowatzke16': [3777], '2012': [3779, 3900, 4002, 4089, 4191, 4362], '4,': [3783, 3904, 4006, 4093, 4195, 4366], '20Conference': [3785], 'Report:': [3786, 4096, 4369, 4437, 4561, 4696], '6th': [3787], 'LBA:': [3791], 'controls': [3795], 'standards;': [3798], 'specificity': [3799], 'compounds;': [3802], 'biomarkers;': [3803], 'biosimilarsRobert': [3804], 'Dan': [3813], 'Mamelak,': [3814], 'Petrilla,': [3836], 'Turk,': [3842], 'Wright,': [3857], 'Yasuhiro': [3860], 'Pilar': [3884], 'Gonzalez,': [3885], 'Marie': [3890], 'Rock,': [3891], 'Fang23': [3898], '192012': [3906], 'Paper': [3908, 4472], 'Recent': [3910, 4474, 4703], 'Issues': [3911, 4475, 4704], 'Alignment': [3915], 'Multiple': [3917], 'GuidelinesBinodh': [3918], 'DeSilva,': [3919, 4514], 'France': [3928], 'Landry,': [3929], 'Catherine': [3930], 'Dicaire,': [3931], 'Gabriella': [3932], 'Szekely-Klepser,': [3933], 'Russell': [3934, 4548], 'Weiner,': [3935], 'Surendra': [3938, 4500], 'Bansal,': [3939, 4501], 'Kevin': [3940], 'Bateman,': [3941], 'Bauer,': [3943, 4507], 'Booth,': [3945, 4510], 'Davis,': [3947], 'Sherri': [3948], 'Dudal,': [3949], 'Grundy,': [3953], 'Sam': [3954], 'Haidar,': [3955], 'Jemal,': [3959, 4526], 'Surinder': [3960], 'Kaur,': [3961], 'Marian': [3962], 'Kelley,': [3963], 'Magnus': [3964], 'Knutsson,': [3965], 'Olivier': [3966, 4529], 'Le': [3967, 4530], 'Blaye,': [3968, 4531], 'Jean': [3969, 4532], 'Lee,': [3970, 4533], 'Ma,': [3974], 'Toshinari': [3975], 'Mitsuoka,': [3976], 'João': [3977], 'Tavares': [3978], 'Neto,': [3979], 'Ormsby,': [3983, 4543], 'Jeffrey': [3984], 'Sailstad,': [3985], 'Lauren': [3986], 'Stevenson,': [3987], 'Jan': [3990], 'Welink,': [3991], 'CT': [3992, 4546], 'Viswanathan,': [3993, 4547], 'Laixin': [3994], 'Woolf': [3997], 'Yang9': [4000], '18Recommendations': [4008], 'ISR': [4010], 'multi': [4012], 'analyte': [4013], 'assays,': [4014], 'QA/bioanalytical': [4015], 'consultants': [4016], '(GCC)Timothy': [4025], 'Maltas,': [4028, 4246, 4392], 'Hillier,': [4032, 4275, 4402, 4629], 'Boterman,': [4034, 4219], 'Mira': [4035, 4220], 'Doig,': [4036, 4221], 'Massimo': [4037, 4222], 'Breda,': [4038, 4223, 4383], 'Lee': [4050, 4265], 'Rudi': [4052, 4269], 'Segers,': [4053, 4270], 'Lois': [4056, 4280], 'Folguera,': [4057, 4281], 'Dieter': [4058, 4278], 'Zimmerman,': [4061, 4406], 'Cox,': [4067, 4305], 'Chiara': [4068, 4308], 'Bigogno,': [4069, 4309], 'Schoutsen,': [4071, 4311, 4412], 'Romuald': [4079, 4338], 'Sable,': [4080, 4339], 'Christoff': [4081], 'Siethoff,': [4082, 4343], 'Harter': [4084, 4424], 'Stuart': [4086, 4356], 'Best9': [4087], 'August': [4088], '14Conference': [4095], 'Bioanalysis:': [4102, 4562], 'coadministered': [4103], 'drugs': [4104], 'EMA/US': [4106], 'Guidelines,': [4108], '483s': [4109, 4586], 'CarryoverSteve': [4111], 'Needham,': [4120, 4237, 4606], 'Bhatti,': [4126, 4250], 'Leonardo': [4140, 4288, 4632], 'Souza': [4142, 4290, 4634], 'Teixeira,': [4143, 4291, 4635], 'Thais': [4144, 4292], 'Rocha,': [4145, 4293], 'Paula': [4146, 4296], 'Jardieu,': [4147, 4297], 'Truog,': [4149, 4299, 4641], 'Lundberg,': [4153, 4303, 4645], 'Carmen': [4156, 4312], 'Dilger,': [4157, 4313], 'Ming': [4168, 4324], 'Hung': [4169, 4325], 'DeMaio,': [4174, 4337], 'Fang18': [4189], '7Recommendations': [4197], 'interpretation': [4200], 'new': [4203], 'Medicines': [4205], 'Agency': [4206], 'Guideline': [4207], '(GCC)Mark': [4218], 'Joelle': [4243], 'Guittard,': [4244], 'Johanne': [4263], 'Bouchard,': [4264], 'Zimmermann,': [4283], 'Christoph': [4342], 'Best': [4357], 'Fang28': [4360], '6Conference': [4368], '3rd': [4371], 'Reid': [4380, 4450], 'ForumMassimo': [4382], 'White,': [4394], 'Riches,': [4400], 'Eileen': [4409], 'Collins,': [4410], 'Jeanbaptiste,': [4420], 'Quinton': [4421], 'Claassen,': [4422], 'Seymour,': [4427], '20': [4428, 4736], '3,': [4434, 4468, 4558, 4573, 4693, 4716], '24Conference': [4436], 'Discussion': [4438], 'globalization': [4442], '19th': [4448], 'ForumFabio': [4452], 'Smeraglia,': [4455], 'Briggs,': [4457], 'Seymour': [4459], 'Howard': [4461], 'Hill20': [4462], '242011': [4470], 'Regulatory': [4479], 'Findings': [4480], 'Audits': [4482], 'InspectionsFabio': [4484], 'L': [4487], 'Woolf,': [4496], 'Amsterdam,': [4499], 'Ariadna': [4502], 'Cristina': [4503], 'Gomes': [4504], 'Montserrat': [4511], 'Carrasco-Triguero,': [4512], 'Binodh': [4513], 'Dunn,': [4516], 'Keith': [4517], 'Gallicano,': [4518], 'Stacy': [4521], 'Ho,': [4522], 'Hucker,': [4524], 'Noriko': [4527], 'Katori,': [4528], 'Wenkui': [4534], 'Michael,': [4537, 4624], 'Weiner': [4549], 'Graeme': [4551], 'Young26': [4552], '18Conference': [4560], 'Challenges': [4563], 'SeminarAndrew': [4566], 'Roberts8': [4567], '17Recommendations': [4575], 'on:': [4576], 'internal': [4577], 'standard': [4578], 'criteria,': [4579], 'reanalysis': [4583], 'BioanalysisSteve': [4593], 'Ejvind': [4603], 'Mortz,': [4604], 'Saleh': [4642], 'Hussain,': [4643], 'Jianine': [4650], 'Jonker,': [4651], 'Berger,': [4653], 'Martijn': [4660], 'Hilhorst,': [4661], 'Dennis': [4686], 'Heller16': [4687], '12Conference': [4695], '1st': [4698], 'Conference': [4699], 'Asia-Pacific': [4701], 'BioanalysisIsabelle': [4706], 'Dumont': [4707], 'Garofolo31': [4710], '7': [4718], 'Follow': [4723], 'us': [4724], 'social': [4726], 'media': [4727], 'latest': [4730], 'Metrics': [4732], 'History': [4733], 'Published': [4734, 4739], 'online': [4735], 'print': [4741], 'Information©': [4744], 'Future': [4745], 'Science': [4746], 'LtdKeywordsbioanalysisbioanalytical': [4747], 'CouncilFinancial': [4755], 'manuscript.PDF': [4820], 'download': [4821]}, 'cited_by_api_url': 'https://api.openalex.org/works?filter=cites:W1992131047', 'counts_by_year': [{'year': 2024, 'cited_by_count': 1}, {'year': 2022, 'cited_by_count': 3}, {'year': 2021, 'cited_by_count': 1}, {'year': 2019, 'cited_by_count': 5}, {'year': 2018, 'cited_by_count': 1}, {'year': 2017, 'cited_by_count': 1}, {'year': 2016, 'cited_by_count': 1}, {'year': 2014, 'cited_by_count': 3}, {'year': 2013, 'cited_by_count': 1}, {'year': 2012, 'cited_by_count': 8}], 'updated_date': '2024-12-11T05:47:43.663073', 'created_date': '2016-06-24'}
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