{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T19:56:43Z","timestamp":1792612603371,"version":"4.5.0"},"reference-count":105,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,6,15]],"date-time":"2021-06-15T00:00:00Z","timestamp":1623715200000},"content-version":"am","delay-in-days":365,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#am"},{"start":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T00:00:00Z","timestamp":1592179200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000001","name":"National Science Foundation","doi-asserted-by":"publisher","award":["T32 GM066691"],"award-info":[{"award-number":["T32 GM066691"]}],"id":[{"id":"10.13039\/100000001","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A treatment gap exists for pediatric patients with renal impairment. Alterations in renal clearance and metabolism of drugs render standard dosage regimens inappropriate and may lead to drug toxicity, but these studies are not routinely conducted during drug development. The objective of this study was to examine the clinical evidence behind current renal impairment dosage recommendations for pediatric patients in a standard pediatric dosing handbook. The sources of recommendations and comparisons included the pediatric dosing handbook (Lexicomp), the U.S. Food and Drug Administration\u2010approved manufacturer\u2019s labels, and published studies in the literature. One hundred twenty\u2010six drugs in Lexicomp had pediatric renal dosing recommendations. Only 14% (18 of 126) of Lexicomp pediatric renal dosing recommendations referenced a pediatric clinical study, and 15% of manufacturer's labels (19 of 126) described specific dosing regimens for renally impaired pediatric patients. Forty\u2010two products had published information on pediatric renal dosing, but 19 (45%) were case studies. When pediatric clinical studies were not referenced in Lexicomp, the renal dosing recommendations followed the adult and pediatric dosing recommendations on the manufacturer's label. Clinical evidence in pediatric patients does not exist for most renal dosing recommendations in a widely used pediatric dosing handbook, and the adult renal dosing recommendations from the manufacturer's label are currently the primary source of pediatric renal dosing information.<\/jats:p>","DOI":"10.1002\/jcph.1676","type":"journal-article","created":{"date-parts":[[2020,6,16]],"date-time":"2020-06-16T06:33:28Z","timestamp":1592289208000},"page":"1551-1560","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Dosing Recommendations for Pediatric Patients With Renal Impairment"],"prefix":"10.1002","volume":"60","author":[{"given":"Amer","family":"Al\u2010Khouja","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology Johns Hopkins University School of Medicine  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyunghun","family":"Park","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daijha J.C.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Eshelman School of Pharmacy University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlyn","family":"Young","sequence":"additional","affiliation":[{"name":"University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Wang","sequence":"additional","affiliation":[{"name":"Office of Drug Evaluation IV, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiew Mei","family":"Huang","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mona","family":"Khurana","sequence":"additional","affiliation":[{"name":"Office of New Drugs, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2005-9301","authenticated-orcid":false,"given":"Gilbert J.","family":"Burckart","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,6,15]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"US Food and Drug Administration: New Pediatric Labeling Information Database.2019.https:\/\/www.accessdata.fda.gov\/scripts\/sda\/sdNavigation.cfm?sd=labelingdatabase. Accessed May 14 2020."},{"issue":"281","key":"e_1_2_11_3_1","first-page":"1","article-title":"Persistent pharmacokinetic challenges to pediatric drug development","volume":"5","author":"Sage DP","year":"2014","journal-title":"Front Genet"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(68)80414-7"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2018.12.001"},{"issue":"1","key":"e_1_2_11_6_1","first-page":"1","article-title":"KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease","volume":"3","author":"Group KKDIGOCW","year":"2013","journal-title":"Kidney Int Suppl"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ckj\/sfw047"},{"issue":"3","key":"e_1_2_11_8_1","doi-asserted-by":"crossref","first-page":"S125","DOI":"10.1053\/j.ajkd.2018.12.006","article-title":"Chapter 6: CKD among children and adolescents","volume":"73","author":"Miscellaneous","year":"2019","journal-title":"Am J Kidney Dis"},{"issue":"54","key":"e_1_2_11_9_1","first-page":"13562","article-title":"Revised draft guidance for industry on pharmacokinetics in patients with impaired renal function\u2013study design, data analysis, and impact on dosing and labeling; availability","volume":"75","author":"U.S. Department of Health and Human Services","year":"2010","journal-title":"Federal Register"},{"issue":"3","key":"e_1_2_11_10_1","doi-asserted-by":"crossref","first-page":"S383","DOI":"10.1053\/j.ajkd.2018.01.020","article-title":"Chapter7: ESRD among children, adolescents, and young adults","volume":"71","author":"Miscellaneous","year":"2018","journal-title":"Am J Kidney Dis"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.00340118"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011415410"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2014.09.001"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-005-1922-9"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-540-76341-3_69"},{"issue":"1","key":"e_1_2_11_16_1","first-page":"S9","article-title":"Pediatric renal ontogeny and applications in drug development","volume":"59","author":"Zhang Y","year":"2019","journal-title":"J Clin Pharmacol"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-008-0997-5"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.01640309"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2008030287"},{"key":"e_1_2_11_20_1","volume-title":"Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children","author":"Aronoff GR","year":"2007"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2015.01.023"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.1981.112"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.30.2.310"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.3109\/10641968609046603"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-018-3976-5"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.1993.163"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02006-18"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0000000000000487"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.tp.0000209195.95115.8e"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.04348-14"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.4103\/1319-2442.215142"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.29271\/jcpsp.2018.06.436"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0000000000000962"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00609754"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-017-3763-8"},{"issue":"20","key":"e_1_2_11_36_1","first-page":"4881","article-title":"Etoposide pharmacokinetics in children: the development and prospective validation of a dosing equation","volume":"53","author":"Lowis SP","year":"1993","journal-title":"Cancer Res"},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/1053-0770(94)90197-X"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(97)80056-2"},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2006.07.013"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0920-1211(01)00311-4"},{"key":"e_1_2_11_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(80)80841-9"},{"key":"e_1_2_11_42_1","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.2002.34521"},{"key":"e_1_2_11_43_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01149-05"},{"key":"e_1_2_11_44_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.127"},{"key":"e_1_2_11_45_1","doi-asserted-by":"publisher","DOI":"10.1007\/s004670100015"},{"key":"e_1_2_11_46_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2009-05-224840"},{"key":"e_1_2_11_47_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.10.9298"},{"key":"e_1_2_11_48_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2008.02528.x"},{"key":"e_1_2_11_49_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(80)80347-7"},{"issue":"4","key":"e_1_2_11_50_1","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1542\/peds.52.4.561","article-title":"Serum digoxin studies in infants and children","volume":"52","author":"Hayes CJ","year":"1973","journal-title":"Pediatrics"},{"key":"e_1_2_11_51_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/132.6.637"},{"key":"e_1_2_11_52_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/156.6.885"},{"key":"e_1_2_11_53_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.10.8456"},{"key":"e_1_2_11_54_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cir001"},{"key":"e_1_2_11_55_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2010.187"},{"key":"e_1_2_11_56_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinids\/4.2.566"},{"key":"e_1_2_11_57_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e31819f1f50"},{"key":"e_1_2_11_58_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbmt.2017.06.021"},{"key":"e_1_2_11_59_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0715-9"},{"key":"e_1_2_11_60_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00318-07"},{"key":"e_1_2_11_61_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12363"},{"key":"e_1_2_11_62_1","doi-asserted-by":"publisher","DOI":"10.1177\/009127000104100901"},{"key":"e_1_2_11_63_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00067-19"},{"key":"e_1_2_11_64_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.inf.0000250687.05055.67"},{"key":"e_1_2_11_65_1","doi-asserted-by":"publisher","DOI":"10.12659\/AJCR.889290"},{"key":"e_1_2_11_66_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-003-1069-5"},{"key":"e_1_2_11_67_1","first-page":"706107","article-title":"Diagnosis and treatment of status epilepticus in a pediatric renal recipient","volume":"2011","author":"Hongjun G","year":"2011","journal-title":"Case Rep Transplant"},{"key":"e_1_2_11_68_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccr3.1217"},{"key":"e_1_2_11_69_1","doi-asserted-by":"publisher","DOI":"10.1177\/106002809202600307"},{"key":"e_1_2_11_70_1","doi-asserted-by":"publisher","DOI":"10.1097\/00043426-200211000-00016"},{"key":"e_1_2_11_71_1","first-page":"153","article-title":"Granulomatosis with polyangiitis: rapidly progressive necrotizing glomerulonephritis in a pediatric patient","volume":"7","author":"Luna M","year":"2014","journal-title":"Int J Nephrol Renovasc Dis"},{"issue":"4","key":"e_1_2_11_72_1","first-page":"300","article-title":"The use of Daptomycin to treat methicillin\u2010resistant Staphylococcus Epidermidis bacteremia in a critically ill child with renal failure","volume":"22","author":"Morris S","year":"2017","journal-title":"J Pediatr Pharmacol Ther"},{"key":"e_1_2_11_73_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002800050720"},{"key":"e_1_2_11_74_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0272-6386(05)80022-8"},{"key":"e_1_2_11_75_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-002-0946-7"},{"key":"e_1_2_11_76_1","doi-asserted-by":"publisher","DOI":"10.5863\/1551-6776-22.1.60"},{"key":"e_1_2_11_77_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1875-9114.1997.tb03766.x"},{"key":"e_1_2_11_78_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000000046"},{"key":"e_1_2_11_79_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(97)70246-4"},{"key":"e_1_2_11_80_1","doi-asserted-by":"publisher","DOI":"10.1177\/106002809302700219"},{"key":"e_1_2_11_81_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mph.0000137368.27242.ca"},{"key":"e_1_2_11_82_1","doi-asserted-by":"publisher","DOI":"10.1111\/pde.13607"},{"key":"e_1_2_11_83_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1G214"},{"key":"e_1_2_11_84_1","doi-asserted-by":"publisher","DOI":"10.1007\/s004670100016"},{"key":"e_1_2_11_85_1","doi-asserted-by":"publisher","DOI":"10.1007\/s004670050697"},{"key":"e_1_2_11_86_1","doi-asserted-by":"publisher","DOI":"10.1007\/s004670050633"},{"key":"e_1_2_11_87_1","doi-asserted-by":"publisher","DOI":"10.1007\/s004670000317"},{"key":"e_1_2_11_88_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-3487"},{"key":"e_1_2_11_89_1","first-page":"1","article-title":"Extrapolation of efficacy in pediatric drug development and evidence\u2010based medicine: progress and lessons learned","volume":"2017","author":"Sun H","year":"2017","journal-title":"Ther Innov Regul Sci"},{"key":"e_1_2_11_90_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.744"},{"key":"e_1_2_11_91_1","doi-asserted-by":"publisher","DOI":"10.5863\/1551-6776-19.4.262"},{"key":"e_1_2_11_92_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.176"},{"key":"e_1_2_11_93_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200645110-00003"},{"key":"e_1_2_11_94_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.112.2.431"},{"key":"e_1_2_11_95_1","volume-title":"Pediatric Dosage Handbook: A Discussion of Dosage, Particularly as Applied to Infants and Children, Complete with a Table of Pediatric Doses Related to Body Weight and to Body Surface Area","author":"Shirkey HC","year":"1973"},{"key":"e_1_2_11_96_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6947-7-7"},{"issue":"2","key":"e_1_2_11_97_1","first-page":"130","article-title":"Quality and usability of common drug information databases","volume":"63","author":"Mountford CM","year":"2010","journal-title":"Can J Hosp Pharm"},{"key":"e_1_2_11_98_1","doi-asserted-by":"publisher","DOI":"10.1136\/amiajnl-2013-001725"},{"key":"e_1_2_11_99_1","doi-asserted-by":"publisher","DOI":"10.5863\/1551-6776-23.6.424"},{"key":"e_1_2_11_100_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ackd.2017.09.011"},{"key":"e_1_2_11_101_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2015.09.014"},{"key":"e_1_2_11_102_1","unstructured":"US Food and Drug Administration: Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function \u2014 Study Design Data Analysis and Impact on Dosing and Labeling.2010.https:\/\/www.fda.gov\/media\/78573\/download. Accessed December 16 2019."},{"key":"e_1_2_11_103_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2005010034"},{"key":"e_1_2_11_104_1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.16.176123"},{"key":"e_1_2_11_105_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1332"},{"key":"e_1_2_11_106_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1390"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.1676","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1676","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.1676","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/am-pdf\/10.1002\/jcph.1676","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1676","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T11:04:08Z","timestamp":1693566248000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.1676"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,15]]},"references-count":105,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["10.1002\/jcph.1676"],"URL":"https:\/\/doi.org\/10.1002\/jcph.1676","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6,15]]},"assertion":[{"value":"2020-03-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}