{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T23:47:43Z","timestamp":1793231263287,"version":"4.5.0"},"reference-count":42,"publisher":"Elsevier BV","issue":"10","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004328","name":"Genentech Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.fr","clinicalkey.jp","clinicaltherapeutics.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Clinical Therapeutics"],"published-print":{"date-parts":[[2024,10]]},"DOI":"10.1016\/j.clinthera.2024.09.008","type":"journal-article","created":{"date-parts":[[2024,10,5]],"date-time":"2024-10-05T04:21:40Z","timestamp":1728102100000},"page":"759-767","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":10,"title":["Dosing of Venetoclax in Pediatric Patients with Relapsed Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships"],"prefix":"10.1016","volume":"46","author":[{"given":"Mohamed","family":"Badawi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sathej","family":"Gopalakrishnan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Engelhardt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tammy","family":"Palenski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth E.","family":"Karol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey E.","family":"Rubnitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajeev","family":"Menon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed Hamed","family":"Salem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"3","key":"10.1016\/j.clinthera.2024.09.008_bib0001","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1542\/peds.2007-1529","article-title":"Improving pediatric dosing through pediatric initiatives: what we have learned","volume":"121","author":"Rodriguez","year":"2008","journal-title":"Pediatrics"},{"issue":"6","key":"10.1016\/j.clinthera.2024.09.008_bib0002","doi-asserted-by":"crossref","first-page":"662","DOI":"10.1038\/clpt.2008.202","article-title":"Hormonal regulation of hepatic drug-metabolizing enzyme activity during adolescence","volume":"84","author":"Kennedy","year":"2008","journal-title":"Clin Pharmacol Therapeut"},{"issue":"1","key":"10.1016\/j.clinthera.2024.09.008_bib0003","doi-asserted-by":"crossref","first-page":"53","DOI":"10.3390\/pharmaceutics3010053","article-title":"Factors and mechanisms for pharmacokinetic differences between pediatric population and adults","volume":"3","author":"Fernandez","year":"2011","journal-title":"Pharmaceutics"},{"issue":"4","key":"10.1016\/j.clinthera.2024.09.008_bib0004","first-page":"220","article-title":"A retrospective evaluation of allometry, population pharmacokinetics, and physiologically-based pharmacokinetics for pediatric dosing using clearance as a surrogate","volume":"8","author":"Wu","year":"2019","journal-title":"CPT: Pharmacometr Syst Pharmacol"},{"issue":"Suppl 1","key":"10.1016\/j.clinthera.2024.09.008_bib0005","first-page":"S193","article-title":"Pediatric dose selection for therapeutic proteins","volume":"61","author":"Malik","year":"2021","journal-title":"J Clin Pharmacol"},{"issue":"4","key":"10.1016\/j.clinthera.2024.09.008_bib0006","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1038\/clpt.2014.134","article-title":"Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents","volume":"96","author":"Gonzalez","year":"2014","journal-title":"Clin Pharmacol Therapeut"},{"key":"10.1016\/j.clinthera.2024.09.008_bib0007","unstructured":"AbbVie Inc. Venclexta (venetoclax) [package insert]. U.S. Food and Drug Adminstration website. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/208573s023lbl.pdf. Revised November 2020. Accessed July 2024."},{"issue":"15","key":"10.1016\/j.clinthera.2024.09.008_bib0008","doi-asserted-by":"crossref","first-page":"1277","DOI":"10.1200\/JCO.18.01600","article-title":"Venetoclax combined with low-dose cytarabine for previously untreated patients with acute myeloid leukemia: results from a phase Ib\/II study","volume":"37","author":"Wei","year":"2019","journal-title":"J Clin Oncol"},{"issue":"18","key":"10.1016\/j.clinthera.2024.09.008_bib0009","doi-asserted-by":"crossref","first-page":"1964","DOI":"10.1182\/blood-2018-11-880526","article-title":"Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial","volume":"133","author":"Zelenetz","year":"2019","journal-title":"Blood"},{"issue":"8","key":"10.1016\/j.clinthera.2024.09.008_bib0010","doi-asserted-by":"crossref","first-page":"826","DOI":"10.1200\/JCO.2016.70.4320","article-title":"Phase I first-in-human study of venetoclax in patients with relapsed or refractory non-Hodgkin lymphoma","volume":"35","author":"Davids","year":"2017","journal-title":"J Clin Oncol"},{"issue":"6","key":"10.1016\/j.clinthera.2024.09.008_bib0011","doi-asserted-by":"crossref","first-page":"1440","DOI":"10.1158\/2159-8290.CD-20-1465","article-title":"Venetoclax and navitoclax in combination with chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia and lymphoblastic lymphoma","volume":"11","author":"Pullarkat","year":"2021","journal-title":"Cancer Discov"},{"issue":"4","key":"10.1016\/j.clinthera.2024.09.008_bib0012","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1016\/S1470-2045(20)30060-7","article-title":"Venetoclax in combination with cytarabine with or without idarubicin in children with relapsed or refractory acute myeloid leukaemia: a phase 1, dose-escalation study","volume":"21","author":"Karol","year":"2020","journal-title":"Lancet Oncol"},{"issue":"21","key":"10.1016\/j.clinthera.2024.09.008_bib0013","doi-asserted-by":"crossref","first-page":"2115","DOI":"10.2217\/fon-2018-0121","article-title":"Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed\/refractory malignancies","volume":"14","author":"Place","year":"2018","journal-title":"Future Oncol"},{"issue":"9","key":"10.1016\/j.clinthera.2024.09.008_bib0014","doi-asserted-by":"crossref","first-page":"2253","DOI":"10.1002\/1878-0261.12899","article-title":"Insights into the molecular profiles of adult and paediatric acute myeloid leukaemia","volume":"15","author":"Aung","year":"2021","journal-title":"Mol Oncol"},{"issue":"7","key":"10.1016\/j.clinthera.2024.09.008_bib0015","doi-asserted-by":"crossref","DOI":"10.3390\/cancers15071983","article-title":"Venetoclax for acute myeloid leukemia in pediatric patients: a texas medical center experience","volume":"15","author":"Trabal","year":"2023","journal-title":"Cancers (Basel)"},{"key":"10.1016\/j.clinthera.2024.09.008_bib0016","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1182\/blood-2020-136999","article-title":"Venetoclax alone or in combination with chemotherapy: responses in pediatric patients with relapsed\/refractory acute myeloid leukemia with heterogeneous genomic profiles","volume":"136","author":"Karol","year":"2020","journal-title":"Blood"},{"issue":"3","key":"10.1016\/j.clinthera.2024.09.008_bib0017","doi-asserted-by":"crossref","first-page":"294","DOI":"10.1124\/dmd.116.071613","article-title":"Metabolism and disposition of a novel B-cell lymphoma-2 inhibitor venetoclax in humans and characterization of its unusual metabolites","volume":"45","author":"Liu","year":"2017","journal-title":"Drug Metabol Disposit Biologic Fate Chem"},{"issue":"5","key":"10.1016\/j.clinthera.2024.09.008_bib0018","doi-asserted-by":"crossref","first-page":"1192","DOI":"10.1208\/s12248-016-9927-9","article-title":"Clinical predictors of venetoclax pharmacokinetics in chronic lymphocytic leukemia and non-Hodgkin's lymphoma patients: a pooled population pharmacokinetic analysis","volume":"18","author":"Jones","year":"2016","journal-title":"AAPS J"},{"key":"10.1016\/j.clinthera.2024.09.008_tboref0001","unstructured":"U. S. Food and Drug Administration. Center for Drug Evaluation and Research. Drug development and drug interactions: table of substrates, inhibitors and inducers. 2023. Accessed September 16, 2024"},{"issue":"7","key":"10.1016\/j.clinthera.2024.09.008_bib0020","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1007\/s40262-014-0140-7","article-title":"A re-evaluation and validation of ontogeny functions for cytochrome P450 1A2 and 3A4 based on in vivo data","volume":"53","author":"Salem","year":"2014","journal-title":"Clin Pharmacokinet"},{"issue":"12","key":"10.1016\/j.clinthera.2024.09.008_bib0021","doi-asserted-by":"crossref","first-page":"1621","DOI":"10.1007\/s40262-019-00788-8","article-title":"Bayesian population model of the pharmacokinetics of venetoclax in combination with rituximab in patients with relapsed\/refractory chronic lymphocytic leukemia: results from the phase III MURANO study","volume":"58","author":"Deng","year":"2019","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.clinthera.2024.09.008_bib0022","series-title":"Population pharmacokinetic models for lamivudine and nevirapine for measuring adherence using therapeutic drug monitoring","author":"Van der Walt","year":"2008"},{"issue":"2","key":"10.1016\/j.clinthera.2024.09.008_bib0023","doi-asserted-by":"crossref","first-page":"269","DOI":"10.1002\/hon.2964","article-title":"Venetoclax exposure-efficacy and exposure-safety relationships in patients with treatment-naive acute myeloid leukemia who are ineligible for intensive chemotherapy","volume":"40","author":"Brackman","year":"2022","journal-title":"Hematologic Oncol"},{"issue":"8","key":"10.1016\/j.clinthera.2024.09.008_bib0024","doi-asserted-by":"crossref","first-page":"950","DOI":"10.1002\/jcph.2248","article-title":"Pooled population pharmacokinetic analyses of venetoclax in patients across indications and healthy subjects from phase 1, 2, and 3 clinical trials","volume":"63","author":"Gong","year":"2023","journal-title":"J Clin Pharmacol"},{"issue":"6","key":"10.1016\/j.clinthera.2024.09.008_bib0025","doi-asserted-by":"crossref","first-page":"612","DOI":"10.1177\/00912700122010492","article-title":"Montelukast dose selection in children ages 2 to 5 years: comparison of population pharmacokinetics between children and adults","volume":"41","author":"Knorr","year":"2001","journal-title":"J Clin Pharmacol"},{"key":"10.1016\/j.clinthera.2024.09.008_bib0026","unstructured":"Capparelli, E.V. et al. Use of pediatric and adult midazolam population pharmacokinetics to assess IM dosing and early drug exposure for status epilepticus. https:\/\/www.pediatrictrials.org\/wp-content\/uploads\/2014\/11\/Capparelli_MDZ_PAS-2016v2.pdf. Accessed September 16, 2024."},{"issue":"3","key":"10.1016\/j.clinthera.2024.09.008_bib0027","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1007\/s40262-016-0436-x","article-title":"Allometric scaling of clearance in paediatric patients: when does the magic of 0.75 fade?","volume":"56","author":"Calvier","year":"2017","journal-title":"Clin Pharmacokinet"},{"issue":"2","key":"10.1016\/j.clinthera.2024.09.008_bib0028","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1080\/17425255.2021.2027907","article-title":"An update on the use of allometric and other scaling methods to scale drug clearance in children: towards decision tables","volume":"18","author":"van Rongen","year":"2022","journal-title":"Exp Opin Drug Metabol Toxicol"},{"issue":"1","key":"10.1016\/j.clinthera.2024.09.008_bib0029","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1007\/s12325-021-01919-z","article-title":"Population pharmacokinetics and exposure-response analyses for venetoclax in combination with R-CHOP in relapsed\/refractory and previously untreated patients with diffuse large B cell lymphoma","volume":"39","author":"Samineni","year":"2022","journal-title":"Adv Ther"},{"issue":"1","key":"10.1016\/j.clinthera.2024.09.008_bib0030","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1128\/AAC.01738-13","article-title":"Pharmacometric characterization of efavirenz developmental pharmacokinetics and pharmacogenetics in HIV-infected children","volume":"58","author":"Salem","year":"2014","journal-title":"Antimicrob Agents Chemother"},{"issue":"3","key":"10.1016\/j.clinthera.2024.09.008_bib0031","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1002\/jcph.585","article-title":"Meta-analysis of hepatic cytochrome P450 ontogeny to underwrite the prediction of pediatric pharmacokinetics using physiologically based pharmacokinetic modeling","volume":"56","author":"Upreti","year":"2016","journal-title":"J Clin Pharmacol"},{"issue":"7","key":"10.1016\/j.clinthera.2024.09.008_bib0032","doi-asserted-by":"crossref","first-page":"683","DOI":"10.2165\/00003088-200645070-00004","article-title":"A mechanistic approach for the scaling of clearance in children","volume":"45","author":"Edginton","year":"2006","journal-title":"Clin Pharmacokinet"},{"issue":"9","key":"10.1016\/j.clinthera.2024.09.008_bib0033","doi-asserted-by":"crossref","first-page":"931","DOI":"10.2165\/00003088-200645090-00005","article-title":"Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children","volume":"45","author":"Johnson","year":"2006","journal-title":"Clin Pharmacokinet"},{"issue":"6","key":"10.1016\/j.clinthera.2024.09.008_bib0034","doi-asserted-by":"crossref","first-page":"691","DOI":"10.1111\/j.1365-2125.2004.02225.x","article-title":"Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: theophylline and midazolam as model drugs","volume":"59","author":"Bjorkman","year":"2005","journal-title":"Br J Clin Pharmacol"},{"issue":"1","key":"10.1016\/j.clinthera.2024.09.008_bib0035","doi-asserted-by":"crossref","first-page":"e3222","DOI":"10.1002\/hon.3222","article-title":"Venetoclax in biomarker-selected multiple myeloma patients: Impact of exposure on clinical efficacy and safety","volume":"42","author":"Badawi","year":"2024","journal-title":"Hematrol Oncol"},{"issue":"5","key":"10.1016\/j.clinthera.2024.09.008_bib0036","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1007\/s40262-016-0453-9","article-title":"Impact of venetoclax exposure on clinical efficacy and safety in patients with relapsed or refractory chronic lymphocytic leukemia","volume":"56","author":"Freise","year":"2017","journal-title":"Clin Pharmacokinet"},{"issue":"4","key":"10.1016\/j.clinthera.2024.09.008_bib0037","doi-asserted-by":"crossref","first-page":"871","DOI":"10.1080\/10428194.2017.1361024","article-title":"Exposure-response evaluations of venetoclax efficacy and safety in patients with non-Hodgkin lymphoma","volume":"59","author":"Parikh","year":"2018","journal-title":"Leuk Lymphoma"},{"key":"10.1016\/j.clinthera.2024.09.008_bib0038","doi-asserted-by":"crossref","DOI":"10.1007\/s10637-024-01471-x","article-title":"Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed\/refractory t (11; 14) multiple myeloma patients","author":"Badawi","year":"2024","journal-title":"Invest New Drugs"},{"issue":"4","key":"10.1016\/j.clinthera.2024.09.008_bib0039","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1002\/hon.2646","article-title":"Optimizing venetoclax dose in combination with low intensive therapies in elderly patients with newly diagnosed acute myeloid leukemia: an exposure-response analysis","volume":"37","author":"Agarwal","year":"2019","journal-title":"Hematologic Oncol"},{"issue":"7","key":"10.1016\/j.clinthera.2024.09.008_bib0040","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1056\/NEJMoa2012971","article-title":"Azacitidine and venetoclax in previously untreated acute myeloid leukemia","volume":"383","author":"DiNardo","year":"2020","journal-title":"N Engl J Med"},{"issue":"8","key":"10.1016\/j.clinthera.2024.09.008_bib0041","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1007\/s40261-022-01172-4","article-title":"Bioavailability evaluation of venetoclax lower-strength tablets and oral powder formulations to establish interchangeability with the 100 mg tablet","volume":"42","author":"Badawi","year":"2022","journal-title":"Clin Drug Investigat"},{"key":"10.1016\/j.clinthera.2024.09.008_bib0042","doi-asserted-by":"crossref","DOI":"10.1016\/j.clinthera.2024.03.012","article-title":"Venetoclax clinical pharmacokinetics after administration of crushed, ground or whole tablets","author":"Alaei","year":"2024","journal-title":"Clin Therapeut"}],"container-title":["Clinical Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0149291824002704?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0149291824002704?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,10,31]],"date-time":"2024-10-31T02:50:51Z","timestamp":1730343051000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0149291824002704"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":42,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2024,10]]}},"alternative-id":["S0149291824002704"],"URL":"https:\/\/doi.org\/10.1016\/j.clinthera.2024.09.008","relation":{},"ISSN":["0149-2918"],"issn-type":[{"value":"0149-2918","type":"print"}],"subject":[],"published":{"date-parts":[[2024,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Dosing of Venetoclax in Pediatric Patients with Relapsed Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships","name":"articletitle","label":"Article Title"},{"value":"Clinical Therapeutics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.clinthera.2024.09.008","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 Elsevier Inc.","name":"copyright","label":"Copyright"}]}}