Design of a Drug-Drug Interaction Study of Vincristine With Azole Antifungals in Pediatric Cancer Patients Using Clinical Trial Simulation

van Hasselt J. G. Coen; van Eijkelenburg Natasha K. A.; Beijnen Jos H.; Schellens Jan H. M.; Huitema Alwin D. R.

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Design of a Drug-Drug Interaction Study of Vincristine With Azole Antifungals in Pediatric Cancer Patients Using Clinical Trial Simulation

机译：长春新碱与儿唑类抗真菌药在儿童癌症患者中的药物相互作用研究的临床试验设计

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BackgroundThe aim of the current work was to perform a clinical trial simulation (CTS) analysis to optimize a drug-drug interaction (DDI) study of vincristine in children who also received azole antifungals, taking into account challenges of conducting clinical trials in this population, and, to provide a motivating example of the application of CTS in the design of pediatric oncology clinical trials.

机译：背景技术目前的目的是进行临床试验模拟（CTS）分析，以优化也接受吡咯类抗真菌药的儿童中长春新碱的药物-药物相互作用（DDI）研究，同时考虑到在该人群中进行临床试验的挑战，并提供一个有启发性的实例，说明CTS在儿科肿瘤临床试验设计中的应用。

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《Pediatric blood & cancer》 |2014年第12期|共7页
作者
van Hasselt J. G. Coen; van Eijkelenburg Natasha K. A.; Beijnen Jos H.; Schellens Jan H. M.; Huitema Alwin D. R.;
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正文语种 eng
中图分类儿科学;
关键词
clinical trial simulation; pediatric oncology; pharmacokinetics; vincristine;

机译：临床试验模拟;儿科肿瘤学;药代动力学;长春新碱;

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1. Design of a Drug-Drug Interaction Study of Vincristine With Azole Antifungals in Pediatric Cancer Patients Using Clinical Trial Simulation [J] . van Hasselt J. G. Coen, van Eijkelenburg Natasha K. A., Beijnen Jos H., Pediatric blood & cancer . 2014,第12期

机译：长春新碱与儿唑类抗真菌药在儿童癌症患者中的药物相互作用研究的临床试验设计
2. Simulation of clinical drug-drug interactions from hepatocyte CYP3A4 induction data and its potential utility in trial designs. [J] . Xu Y, Zhou Y, Hayashi M, Drug Metabolism and Disposition: The Biological Fate of Chemicals . 2011,第7期

机译：从肝细胞CYP3A4诱导数据模拟临床药物相互作用，及其在试验设计中的潜在用途。
3. Breast Cancer Resistance Protein (ABCG2) in Clinical Pharmacokinetics and Drug Interactions: Practical Recommendations for Clinical Victim and Perpetrator Drug-Drug Interaction Study Design [J] . Lee Caroline A., OConnor Meeghan A., Ritchie Tasha K., Drug Metabolism and Disposition: The Biological Fate of Chemicals . 2015,第4期

机译：临床药代动力学和药物相互作用中的乳腺癌抗性蛋白（ABCG2）：临床受害者和作案者药物相互作用研究设计的实用建议
4. DO CANCER CLINICAL TRIAL POPULATIONS TRULY REPRESENT CANCER PATIENTS? A COMPARISON OF OPEN CLINICAL TRIALS TO THE CANCER GENOME ATLAS [C] . NOPHARGEIFMAN, ATUL J.BUTTE Pacific Symposium on Biocomputing . 2016

机译：癌症临床试验群体真正代表癌症患者吗？对癌症基因组阿特拉斯公开临床试验的比较
5. A phase I study of vincristine, escalating doses of irinotecan, temozolomide and bevacizumab (VIT-B) in pediatric and adolescent patients with recurrent or refractory solid tumors of non-hematopoietic origin [D] . Venkatramani, Rajkumar. 2010

机译：长春新碱，伊非替康，替莫唑胺和贝伐单抗（VIT-B）逐步剂量在患有非造血源性复发或难治性实体瘤的儿童和青少年患者中的I期研究
6. Clinical characteristics and outcomes of pediatric oncology patients with aggressive biology enrolled in phase I clinical trials designed for adults: The university of Texas MD Anderson cancer center experience [O] . Fernando F. Corrales-Medina, Cynthia Herzog, Kenneth Hess, 2014

机译：参加针对成人的I期临床试验的具有侵略性生物学的儿科肿瘤患者的临床特征和结果：德克萨斯大学MD安德森癌症中心的经验
7. Breast Cancer Resistance Protein (ABCG2) in Clinical Pharmacokinetics and Drug Interactions: Practical Recommendations for Clinical Victim and Perpetrator Drug-Drug Interaction Study Design [O] . Lee CA, OConnor MA, Ritchie TK, 2015

机译：临床药代动力学和药物相互作用中的乳腺癌耐药蛋白（aBCG2）：临床受害者和犯罪者药物 - 药物相互作用研究设计的实用建议
8. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment [R] . Kaplan, C. P. 2010

机译：将少数患者纳入乳腺癌临床试验：临床试验环境的作用

Design of a Drug-Drug Interaction Study of Vincristine With Azole Antifungals in Pediatric Cancer Patients Using Clinical Trial Simulation

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