Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers and Subjects with Multiple Sclerosis: Analysis of Phase I-III Clinical Trials

Diao Lei; Hang Yaming; Othman Ahmed A.; Nestorov Ivan; Tran Jonathan Q.

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Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers and Subjects with Multiple Sclerosis: Analysis of Phase I-III Clinical Trials

机译：达克珠单抗高产工艺在健康志愿者和多发性硬化症患者中的群体药代动力学：I-III期临床试验分析

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Daclizumab high-yield process (HYP) is a humanized IgG1 monoclonal antibody that binds to the alpha-subunit (CD25) of the interleukin-2 receptor. The present work characterized the population pharmacokinetics of daclizumab HYP in healthy volunteers (HVs) and subjects with relapsing-remitting multiple sclerosis (RRMS) and evaluated the effects of covariates on daclizumab HYP exposure.

机译：达克珠单抗高产过程（HYP）是一种人源化IgG1单克隆抗体，可与白介素2受体的α亚基（CD25）结合。本工作表征了健康志愿者（HVs）和患有复发缓解型多发性硬化症（RRMS）的受试者中daclizumab HYP的群体药代动力学，并评估了协变量对daclizumab HYP暴露的影响。

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《Clinical pharmacokinetics》 |2016年第8期|共13页
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Diao Lei; Hang Yaming; Othman Ahmed A.; Nestorov Ivan; Tran Jonathan Q.;
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正文语种 eng
中图分类药理学;
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1. Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers and Subjects with Multiple Sclerosis: Analysis of Phase I-III Clinical Trials [J] . Diao Lei, Hang Yaming, Othman Ahmed A., Clinical pharmacokinetics . 2016,第8期

机译：达克珠单抗高产工艺在健康志愿者和多发性硬化症患者中的群体药代动力学：I-III期临床试验分析
2. Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers: Integrated Analysis of Intravenous and Subcutaneous, Single- and Multiple-Dose Administration [J] . Othman Ahmed A., Tran Jonathan Q., Tang Meina T., Clinical pharmacokinetics . 2014,第10期

机译：Daclizumab的人口药代动力学在健康志愿者中的高产过程：静脉内和皮下，单剂量和多剂量施用的综合分析
3. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials [J] . Suleiman Ahmed A., Minocha Mukul, Khatri Amit, Clinical pharmacokinetics . 2019,第10期

机译：Risankizumab的人口药代动力学在健康志愿者和中度至重度斑块牛皮癣的受试者：II-III期临床试验的综合分析
4. Pharmacokinetics and Tolerability of Sublingual Fentanyl in Healthy Japanese and Caucasian Volunteers: Phase I, Open-Label Single-Dose Study [C] . U. Lorch, F. Farrell, J. Kilborn, International Pain Clinic Congress . 2008

机译：健康日本和白种人志愿者舌下芬太尼的药代动力学和耐受性：I期，开放标签单剂量研究
5. Phase I clinical trial of a chlorhexidine diacetate intraoral delivery system in medically healthy gingivitis subjects. [D] . Van Scoyoc, Steven M. 2008

机译：在医学上健康的牙龈炎患者中，双乙酸洗必泰口服系统的I期临床试验。
6. Pharmacokinetics of daclizumab high-yield process with repeated administration of the clinical subcutaneous regimen in patients with relapsing-remitting multiple sclerosis [O] . Jonathan Q Tran, Ahmed A Othman, Alvydas Mikulskis, 2016

机译：达克珠单抗高产过程与反复给药临床皮下疗法在复发缓解型多发性硬化症患者中的药代动力学
7. Pharmacokinetics of daclizumab high-yield process with repeated administration of the clinical subcutaneous regimen in patients with relapsing-remitting multiple sclerosis [O] . Jonathan Tran, Ahmed Othman, Alvydas Mikulskis, 2016

机译：Daclizumab高产过程的药代动力学，重复施用患者患者复发式多发性硬化症的临床皮下方案

Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers and Subjects with Multiple Sclerosis: Analysis of Phase I-III Clinical Trials

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