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Strategies for clinical development of monoclonal antibodies beyond first-in-human trials: tested doses and rationale for dose selection

机译：超出首次人类试验的单克隆抗体临床开发策略：测试剂量和剂量选择依据

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Background: Our previous survey on first-in-human trials (FIHT) of monoclonal antibodies (mAbs) showed that, due to their limited toxicity, the recommended phase II dose (RP2D) was only tentatively defined.

机译：背景：我们先前对单克隆抗体（mAb）的首次人体试验（FIHT）的调查显示，由于毒性有限，建议性的II期推荐剂量（RP2D）只是初步确定。

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期刊名称 British Journal of Cancer
作者
Marie Viala; Marie Vinches; Marie Alexandre; Caroline Mollevi; Anna Durigova; Nadia Hayaoui; Krisztian Homicsko; Alice Cuenant; Céline Gongora; Luca Gianni; Diego Tosi;
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作者单位

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年(卷),期 2018(118),5
年度 2018
页码 679–697
总页数 19
原文格式 PDF
正文语种
中图分类肿瘤学;
关键词
mAbs first-in-human trials non first-in-human trials recommended dose maximum administered dose;

机译：单克隆抗体;首次人类试验;非首次人类试验;推荐剂量;最大给药剂量;

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专利

1. Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. [J] . Muller PY, Brennan FR Clinical Pharmacology and Therapeutics . 2009,第3期

机译：使用免疫调节单克隆抗体进行首次人类临床试验的安全性评估和剂量选择。
2. Non-Clinical Pharmacokinetics, Prediction of Human Pharmacokinetics and First-in-Human Dose Selection for CNTO 5825, an Anti-Interleukin-13 Monoclonal Antibody [J] . Nnane Ivo P., Xu Zhenhua, Zhou Honghui, Basic & clinical pharmacology & toxicology. . 2015,第4期

机译：抗白细胞介素13单克隆抗体CNTO 5825的非临床药代动力学，人类药代动力学预测和人选剂量选择。
3. Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013 [J] . Hoon Young Suh, Carl C Peck, Kyung-Sang Yu, Drug Design, Development and Therapy . 2016,第5期

机译：单克隆抗体在人类首次临床试验中的起始剂量确定：1990年至2013年发表论文的系统综述
4. Pharmacokinetic Modeling For Evaluating Dosing Strategies Of Anti P 185/supHER2/ Monoclonal Antibodies [C] . Schoenhoff, M., Maneval, . 2001

机译：评估抗P 185 / supHER2 /单克隆抗体给药策略的药代动力学模型
5. Dose selection study designs in early phase II clinical trials. [D] . Hamlett, Anthony Cleophas. 1999

机译：早期II期临床试验中的剂量选择研究设计。
6. Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013 [O] . Hoon Young Suh, Carl C Peck, Kyung-Sang Yu, 2016

机译：用单克隆抗体在人类首次临床试验中确定起始剂量：对1990年至2013年发表的论文的系统评价
7. Non-Clinical Pharmacokinetics, Prediction of Human Pharmacokinetics and First-in-Human Dose Selection for CNTO 5825, an Anti-Interleukin-13 Monoclonal Antibody [O] . Ivo P. Nnane, Zhenhua Xu, Honghui Zhou, 2015

机译：非临床药代动力学，预测人类药代动力学和CNTO 5825的第一对人剂量选择，抗白细胞介素-13单克隆抗体
8. Humanized Monoclonal Antibody Specific to the Extracellular Domain of PSMA: Dose Escalation Trial in Patients with Prostate Cancer [R] . Vallabhajosula, S. 2003

机译：psma细胞外区特异性人源化单克隆抗体：前列腺癌患者的剂量递增试验

Strategies for clinical development of monoclonal antibodies beyond first-in-human trials: tested doses and rationale for dose selection

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