Publication Information

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'problematic': [533], 'inactive,': [537], 'because': [538, 836, 1120], 'further': [540, 872, 948, 1036], 'needed.': [543], 'So': [544, 1138], 'decision': [546, 1034], 'develop': [548], 'fully': [550, 1087, 1209], 'hinges': [557], 'on': [558, 780, 913, 1130, 1144], '(although,': [564], 'could': [566], 'argue': [567], 'contribute': [573, 992], 'understanding': [576, 772], 'metabolism': [579], 'fate': [582], 'parent': [585, 644], 'molecule).': [586], 'trigger': [588], 'appearance': [591], 'Although': [602], 'useful': [606], 'rule,': [607, 652], 'care': [608], 'should': [609, 1207, 1278, 2165], 'paid': [611], 'molecule.': [617], 'For': [618], 'example,': [619], 'SN-38': [620, 653, 1391], 'irinotecan.': [625], 'Overall,': [626], 'accounts': [628], 'Yet': [636], '1000-times': [640], '[2].': [645], 'If': [646], 'one': [647], 'simply': [648], 'followed': [649], 'measured,': [658], 'although': [659], 'contributes': [661], 'significantly': [662, 993], '(efficacy': [666], 'drug.The': [671], 'second': [672], 'overall': [677, 998], 'purpose': [678, 915], 'study.': [681], 'studies,': [684, 1119], 'extent': [686, 1007], 'unexpected': [695], 'can': [697, 784, 838, 870, 1019, 1171, 1234], 'relatively': [699], 'low.': [700], 'impact': [703, 775], '(e.g.,': [708], 'Phase': [709, 853, 929, 1048], 'I)': [710], 'generally': [712, 718, 1124], 'limited.': [713], 'Later': [714], 'developmental': [715, 1118], 'important': [720, 965, 1127], 'determining': [722, 1055], 'effectiveness': [726, 807], 'drug': [730, 804, 938, 985, 1616, 1809, 2043, 2084], 'biologic,': [732], 'well': [734, 895], 'providing': [736], 'basis': [738, 1053], 'dosing': [740], 'patient': [742, 1195], 'treatment.': [743], 'It': [744], 'setting': [748], 'reliability': [751, 1058], 'importance': [755], 'full': [757], 'required': [761], 'active': [764, 1429], 'moieties': [765], 'drug.': [768], 'Therefore,': [769], 'clear': [771], 'any': [777, 1294, 2181], 'given': [778], 'study': [779, 918, 962], 'submission': [783], 'help': [785], 'choose': [787], 'level': [790, 1022], 'validation.In': [792], 'separate,': [794], 'yet': [795], 'related': [796], 'area,': [797], 'and/or': [806, 1188], 'increased': [809, 820], 'years.': [812], 'Efforts': [813], 'quantify': [815], 'also': [819], 'commensurately.': [821], 'But': [822], 'arena': [824], 'even': [826], 'complicated': [828, 873], "'Metabolites": [831], "Testing'": [834], 'situation,': [835], 'used': [840, 926, 1045], 'wide': [842], 'variety': [843], 'ways,': [845], 'range': [847], 'candidate': [850, 1226], 'selection,': [851, 858, 1227], 'I': [854, 932], 'proof-of-concept': [855], 'dose': [857], 'efficacy': [863, 1001], 'pivotal': [866], 'trial.': [867], 'situation': [869], 'different': [881, 884, 1164], 'purposes': [882], 'at': [883], 'points': [885], 'drug-development.The': [887], 'same': [888], 'question': [889], 'cases:': [893], 'does': [897, 2038], 'various': [905], 'biomarker': [906, 924, 1043, 1806, 2070], 'applications?': [907], 'Here': [908], 'again,': [909], 'answer': [911, 1982], 'depends': [912], 'being': [919], 'developed.For': [920], 'instance,': [921], '0': [930], 'whether': [936], 'interacts': [939], 'target': [942], 'sufficiently': [943], 'merit': [947], 'development,': [949, 1231], 'risk': [951], 'entirely': [953], 'assumed': [954], 'sponsor.': [957], 'Generally,': [958], 'type': [960], 'quite': [964], 'sponsor': [968, 1018, 1216, 1233], 'deciding': [970, 1129, 1143], 'move': [972], 'forward': [973], 'not,': [975], 'determine': [978], 'allocate': [982], 'candidate.': [986], 'typically': [990, 1114], "don't": [991], 'decisions': [995, 1224], 'product.': [1004], 'Consequently,': [1005], 'importance.': [1016, 1066], 'decide': [1020], 'uncertainty': [1025], 'acceptable': [1027], 'respect': [1029], 'making': [1031], 'own': [1033], 'product.However,': [1040], 'III': [1049], 'efficacy,': [1056, 1189], 'data': [1061, 1077, 1122, 1178, 1199, 1220], 'case,': [1069], 'degree': [1072], 'confidence': [1074], 'bioanalytical': [1082, 1472], 'needs': [1084, 1149], 'provide': [1090, 1980], 'assurance.Both': [1092], 'scenarios': [1095], 'similar': [1097], 'traditionally': [1101], 'pharmacokinetic': [1105, 1481, 1602], 'assays': [1106, 1206, 1695, 1979], 'small': [1108], 'molecules.': [1109], 'later': [1117], 'approvability,': [1131], 'but': [1132], 'so': [1134], 'latitude': [1142], 'extensive': [1146], 'be.': [1151], 'approach': [1153, 1364, 1470, 1688, 1886, 2005], "'fit-for-purpose'.In": [1155], 'summary,': [1156], 'fit-for-purpose': [1158, 1985], 'applicable': [1161], 'questions.': [1166], 'general': [1168], 'rule': [1169], 'applied': [1173], 'generated': [1179], 'will': [1180, 1217], 'support': [1181], 'action,': [1183], 'assessing': [1186], 'supporting': [1191], 'labeled-dosing': [1192], 'instructions': [1193], 'treatment,': [1196], 'then': [1197], 'must': [1200], 'reliable': [1202], 'validated.': [1210], 'other': [1212], 'cases,': [1213], 'internally': [1221], 'make': [1223, 1246], 'product': [1230], 'deems': [1243], 'decisions.DisclaimerThe': [1248], 'views': [1249, 1368, 2136], 'expressed': [1250, 2137], 'article': [1253, 2140], 'those': [1255, 2142], 'author': [1258, 1285, 2145, 2172], 'reflect': [1262, 2149], 'official': [1263, 1270, 2150, 2157], 'policy': [1264, 2151], 'FDA.': [1268, 2155], 'No': [1269, 1335, 2156, 2222], 'endorsement': [1271, 2158], 'intended': [1276, 2163], 'inferred.Financial': [1280, 2167], 'competing': [1282, 2169], 'interests': [1283, 2170], 'disclosureThe': [1284, 2171], 'relevant': [1288, 2175], 'affiliations': [1289, 2176], 'financial': [1291, 1300, 1304, 2178, 2187, 2191], 'involvement': [1292, 2179], 'organization': [1295, 2182], 'entity': [1297, 2184], 'interest': [1301, 2188], 'conflict': [1305, 2192], 'subject': [1308, 2195], 'matter': [1309, 2196], 'materials': [1311, 2198], 'discussed': [1312, 2199], 'manuscript.': [1315, 2202], 'includes': [1317, 2204], 'employment,': [1318, 2205], 'consultancies,': [1319, 2206], 'honoraria,': [1320, 2207], 'stock': [1321, 2208], 'ownership': [1322, 2209], 'options,': [1324, 2211], 'expert': [1325, 2212], 'testimony,': [1326, 2213], 'grants': [1327, 2214], 'patents': [1329, 2216], 'received': [1330, 2217], 'pending,': [1332, 2219], 'royalties.': [1334, 2221], 'writing': [1336, 2223], 'assistance': [1337, 2224], 'was': [1338, 2225], 'utilized': [1339, 2226], 'production': [1342, 2229], 'manuscript.References1': [1345], 'Timmerman': [1346], 'P,': [1347], 'Anders': [1348, 1897], 'Kall': [1349], 'M,': [1350], 'Gordon': [1351], 'B,': [1352, 2075], 'Laakso': [1353], 'S,': [1354], 'Freisleben': [1355], 'A,': [1356], 'Hucker': [1357], 'R.': [1358], 'Best': [1359, 1857], 'practices': [1360, 1611], 'tiered': [1363, 1469, 1735, 1885, 1971], 'quantification:': [1367], 'recommendations': [1370], 'Bioanalysis': [1374, 1623, 1705, 1864, 1881, 2054], 'Forum.': [1375], 'Bioanalysis2(7),1185–1194': [1376], '(2010).Link,': [1377], 'Google': [1378, 1410], 'Scholar2': [1379], 'Ramchandani': [1380], 'RP,': [1381], 'Wang': [1382], 'Y,': [1383], 'Booth': [1384], 'BP': [1385], 'et': [1386], 'al.': [1387], 'role': [1389], 'exposure,': [1392], 'UGT1A*28': [1393], 'polymorphyism': [1394], 'baseline': [1396], 'bilirubin': [1397], 'levels': [1398], 'predicting': [1400], 'severe': [1401], 'irinotecan': [1402], 'toxicity.': [1403], 'J.': [1404], 'Clin.': [1405], 'Pharmacol.47(1),78–86': [1406], '(2007).Crossref,': [1407], 'Medline,': [1408], 'CAS,': [1409], 'Scholar101': [1411], 'Industry:': [1414], '(2008).': [1420], 'www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079266.pdfGoogle': [1421], 'ScholarFiguresReferencesRelatedDetailsCited': [1422], 'ByHighly': [1423], 'selective': [1424], 'sensitive': [1426], 'forms': [1430], 'FGF21': [1432], 'using': [1433, 1662, 1785, 2071], 'immunocapture': [1435], 'enrichment': [1436], 'LC–MS/MSYue': [1438], 'Zhao,': [1439], 'Guowen': [1440], 'Liu,': [1441, 1448], 'Suk': [1442], 'Kwok,': [1443], 'Barry': [1444], 'R': [1445, 1814], 'Jones,': [1446], 'Jane': [1447], 'David': [1449, 1995], 'Marchisin,': [1450], 'Philip': [1451], 'E': [1452, 1955], 'Joyce,': [1453], 'Jon': [1454], 'Peterson': [1455], 'Jim': [1457, 1936, 1944], 'X': [1458, 1937], 'Shen14': [1459], 'December': [1460, 2105, 2124, 2129], '2017': [1461, 1502], '|': [1462, 1503, 1577, 1647, 1682, 1725, 1766, 1789, 1842, 1870, 1909, 1959, 1999, 2016, 2030, 2091, 2107], 'Bioanalysis,': [1463, 1504, 1578, 1648, 1683, 1726, 1767, 1843, 1910, 1960, 2000, 2017, 2031, 2092, 2108], 'Vol.': [1464, 1505, 1579, 1609, 1649, 1684, 1727, 1768, 1794, 1844, 1874, 1911, 1961, 2001, 2018, 2032, 2076, 2093, 2109, 2113], '10,': [1465], '1Implementing': [1467], 'large-molecule': [1476], 'ligand-binding': [1477], 'assessmentsRebecca': [1482], 'G': [1483], 'Watson,': [1484, 1989], 'Adrienne': [1485], 'Clements-Egan,': [1486], 'Allen': [1487], 'Schantz,': [1488], 'Mark': [1489, 1816, 1954], 'Ware,': [1490], 'Bonnie': [1491], 'Wu,': [1492, 1833], 'Tong-Yuan': [1493], 'Yang,': [1494], 'Gopi': [1495], 'Shankar': [1496], 'Joseph': [1498], 'C': [1499], 'Marini18': [1500], 'September': [1501, 1723], '9,': [1506], '18Overview': [1508], 'Targeted': [1510], 'Quantitation': [1511, 1551], 'Biomarkers': [1513], 'Its': [1515], 'Applications14': [1516], 'July': [1517, 1533, 1544, 1554], '2017Current': [1518], 'Pertaining': [1521], 'Biomarker': [1522, 1542, 1550], 'Assay': [1523, 1539], 'Establishment': [1524], 'Industrial': [1526], 'Practice': [1527], 'Fit-for-Purpose': [1529], 'Tiered': [1531], 'Approach14': [1532], '2017Comparison': [1534], 'Between': [1535], 'LC-MS': [1536], 'Ligand-Binding': [1538], 'Approaches': [1540, 1848], 'Quantification14': [1543], '2017Overcome': [1545], 'Endogenous': [1547, 2056], 'Levels': [1548], 'Using': [1552], 'LC-MS14': [1553], '2017Liquid': [1555], 'Chromatography–Mass': [1556], 'Spectrometry': [1557], 'Assays': [1558], 'Regulated': [1561], 'Laboratory26': [1563], 'April': [1564], '2017Biomarkers:': [1565], 'challenge': [1569], 'bioanalysis': [1571], 'expectedPatrick': [1573], 'Bennett5': [1574], 'October': [1575, 1868, 1957, 2046, 2052], '2016': [1576, 1646, 1681], '8,': [1580, 1650, 1685], '22Simultaneous': [1582], 'quantification': [1583, 1614, 1807], 'tenofovir,': [1585], 'emtricitabine,': [1586], 'rilpivirine,': [1587], 'elvitegravir': [1588], 'dolutegravir': [1590], 'mouse': [1592], 'biological': [1593, 1783], 'matrices': [1594], 'LC–MS/MS': [1596], 'application': [1599, 1927], 'studyJournal': [1603], 'Pharmaceutical': [1605], 'Biomedical': [1607], 'Analysis,': [1608], '129Best': [1610], 'development:': [1617], 'updated': [1618], 'recommendation': [1619, 1701], 'ForumPhilip': [1624, 1706], 'Timmerman,': [1625, 1707, 1744, 1891], 'Stefan': [1626], 'Blech,': [1627], 'Stephen': [1628, 1640, 1708], 'White,': [1629, 1709, 1756, 1893], 'Martha': [1630], 'Green,': [1631], 'Claude': [1632], 'Delatour,': [1633], 'Stuart': [1634, 1710, 1747, 1905], 'McDougall,': [1635, 1669, 1711, 1748], 'Geert': [1636], 'Mannens,': [1637], 'John': [1638, 1715, 1902], 'Smeraglia,': [1639, 1716], 'Williams': [1641], 'Graeme': [1643], 'Young24': [1644], 'May': [1645], '12Analysis': [1652], 'aluminium': [1654, 1664], 'rat': [1656], 'following': [1657], 'administration': [1658], 'allergen': [1660], 'immunotherapy': [1661], 'either': [1663], 'microcrystalline-tyrosine-based': [1666], 'adjuvantsStuart': [1667], 'A': [1668, 1678, 1713], 'Matthew': [1670], 'D': [1671, 1837], 'Heath,': [1672], 'Matthias': [1673], 'F': [1674], 'Kramer': [1675], 'Murray': [1677], 'Skinner26': [1679], 'February': [1680], '6Tiered': [1687], 'into': [1689, 2025, 2041], 'practice:': [1690], 'chromatography-based': [1694], '–': [1699, 2079], 'Morten': [1712, 1896], 'Kall,': [1714, 1898], 'Marianne': [1717, 1899], 'Scheel': [1718, 1900], 'Fjording': [1719], 'Magnus': [1721, 1894], 'Knutsson10': [1722], '2015': [1724, 1765, 1788, 1841], '7,': [1728, 1769, 1845], '18Scientific': [1730], 'regulated': [1732], 'validation:': [1733], 'approach?': [1736], 'Meeting': [1737], 'report': [1738], 'joint': [1741], 'EBF/DVDMDG': [1742], 'workshopPhilip': [1743], 'Steve': [1745, 1755, 1820, 1892], 'Lowes,': [1746], 'Irina': [1749], 'Colligon,': [1750], 'Joy': [1751], 'Miksic,': [1752], 'Swapan': [1753], 'Chowdhury,': [1754], 'Anne-Françoise': [1757], 'Aubry,': [1758], 'Rand': [1759], 'Jenkins': [1760], 'Christopher': [1762], 'Kemper13': [1763], 'August': [1764, 2060], '14Strategies': [1771], 'improving': [1773], 'sensitivity': [1774], 'selectivity': [1776], 'quantitation': [1779], 'biotherapeutics': [1781], 'matrix': [1784], 'LC-MS/MS16': [1786], 'March': [1787, 1997, 2014, 2028], 'Expert': [1790], 'Review': [1791], 'Proteomics,': [1793], '12,': [1795], '2Recommendations': [1797], 'adaptation': [1799], 'commercial': [1803], 'kits': [1804], 'developmentMasood': [1810], 'U': [1811], 'Khan,': [1812], 'Ronald': [1813], 'Bowsher,': [1815], 'Cameron,': [1817], 'Viswanath': [1818], 'Devanarayan,': [1819], 'Keller,': [1821], 'Lindsay': [1822], 'King,': [1823], 'Jean': [1824], 'Lee,': [1825], 'Alyssa': [1826], 'Morimoto,': [1827], 'Paul': [1828], 'Rhyne,': [1829], 'Laurie': [1830], 'Stephen,': [1831], 'Yuling': [1832], 'Timothy': [1834], 'Wyant': [1835], 'Richard': [1838], 'Lachno14': [1839], 'January': [1840], '2Tiered': [1847], 'Chromatographic': [1850], 'Method': [1852], 'Performance': [1853], 'Evaluation:': [1854], 'Recommendation': [1855], 'Practices': [1858], 'Harmonization': [1860, 1866], 'Global': [1863], 'Consortium': [1865], 'Team23': [1867], '2014': [1869, 1908, 1958, 1998, 2015, 2029], 'AAPS': [1872], 'Journal,': [1873], '17,': [1875], '1Feedback': [1877], 'Workshop:': [1883], 'taking': [1884], 'next': [1889], 'levelPhilip': [1890], 'Knutsson,': [1895], 'Fjording,': [1901], 'Smeraglia': [1903], 'McDougall20': [1906], 'November': [1907, 2089], '6,': [1912, 1962, 2002, 2019, 2033], '19LC–MS/MS': [1914], 'apixaban': [1917], '(BMS-562247)': [1918], 'major': [1921], 'plasma:': [1925], 'polarity': [1929], 'switching': [1930], 'monolithic': [1932], 'HPLC': [1933], 'columnJanice': [1934], 'Pursley,': [1935], 'Shen,': [1938], 'Alan': [1939], 'Schuster,': [1940], 'Oanh': [1941], 'T': [1942], 'Dang,': [1943], 'Lehman,': [1945], 'Michael': [1946], 'H': [1947], 'Buonarati,': [1948], 'Yan': [1949], 'Song,': [1950], 'Anne-Francoise': [1951], 'Aubry': [1952], 'Arnold17': [1956], '15Measuring': [1964], 'soluble': [1965], 'trials:': [1969], 'approaches': [1972], 'analysis': [1975, 2078], 'challenge?Richard': [1986], 'Hucker,': [1987], 'Carl': [1988], 'Ian': [1990], 'James,': [1991], 'Scott': [1992], 'Vincent': [1993], 'Muirhead12': [1996], '5Tiered': [2004, 2021], 'revisited:': [2006], 'introducing': [2007], 'stage-appropriate': [2008], 'assay-appropriate': [2010], 'validationPhilip': [2012], 'Timmerman12': [2013, 2027], 'approach:': [2022], 'plan': [2024], 'practicePhilip': [2026], '5Bioanalysis': [2035], 'fit': [2040], 'process?30': [2045], '2013Method': [2047], 'qualification': [2048], 'tissue': [2050], 'bioanalysis11': [2051], '2013LC-MS': [2053], 'Compounds': [2057], 'Biomarkers30': [2059], '2013Quantitation': [2061], 'leukotriene': [2063], 'B4': [2064], 'sputum': [2067], 'UPLC–MS/MSJournal': [2072], 'Chromatography': [2074], '932Tissue': [2077], 'powerful': [2081], 'discovery': [2085], 'developmentStacy': [2087], 'Ho23': [2088], '2012': [2090], '4,': [2094], '21Conference': [2096], 'Report:': [2097], '19th': [2099], 'International': [2100], 'Reid': [2101], 'ForumHoward': [2103], 'Hill20': [2104], '2011': [2106, 2125, 2130], 'STAY': [2117], 'CONNECTED': [2118], 'Metrics': [2119], 'History': [2120], 'online': [2122], '20': [2123], 'print': [2128], 'Information©': [2131], 'Future': [2132], 'Science': [2133], 'LtdKeywordsbioanalysisregulatoryvalidatedvalidationUS': [2134], 'FDADisclaimerThe': [2135], 'manuscript.PDF': [2232], 'download': [2233]}, 'cited_by_api_url': 'https://api.openalex.org/works?filter=cites:W2039177908', 'counts_by_year': [{'year': 2024, 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