首页> 美国卫生研究院文献>Springer Open Choice >Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II

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Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II

机译：使用间接应答模型预测低密度脂蛋白胆固醇降低的健康志愿者或高胆固醇血症受试者中Alirocumab的群体药代动力学/药效学分析：支持生物制品许可申请提交：第二部分

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BackgroundAlirocumab, a human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly lowers low-density lipoprotein cholesterol levels.

机译：背景Alirocumab是一种针对原蛋白转化酶枯草杆菌蛋白酶/ kexin 9型（PCSK9）的人类单克隆抗体，可显着降低低密度脂蛋白胆固醇水平。

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期刊名称 Springer Open Choice
作者
Xavier Nicolas; Nassim Djebli; Clémence Rauch; Aurélie Brunet; Fabrice Hurbin; Jean-Marie Martinez; David Fabre;
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作者单位

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年(卷),期 -1(58),1
年度 -1
页码 115–130
总页数 16
原文格式 PDF
正文语种
中图分类外科学;
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1. Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II [J] . Nicolas Xavier, Djebli Nassim, Rauch Clemence, Clinical pharmacokinetics . 2019,第1期

机译：使用间接响应模型预测低密度脂蛋白胆固醇降低的人口志愿者或高胆固醇受试者的人口药代动力学/药效学分析：对生物制剂申请提交的支持：第二部分
2. Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis-Menten Approximation of a Target-Mediated Drug Disposition ModelSupport for a Biologics License Application Submission: Part I [J] . Martinez Jean-Marie, Brunet Aurelie, Hurbin Fabrice, Clinical pharmacokinetics . 2019,第1期

机译：使用MICHAELIS-MENTEN近似对生物制剂许可申请提交的靶介导的药物处理模型的迈克莱斯 - 霉菌近似的人群药代动力学分析
3. Effects of AMG 145 on low-density lipoprotein cholesterol levels: Results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins [J] . DiasC.S., ShaywitzA.J., WassermanS.M., Journal of the American College of Cardiology . 2012,第19期

机译：AMG 145对低密度脂蛋白胆固醇水平的影响：在健康志愿者和高胆固醇血症受试者中对他汀类药物进行的2项随机，双盲，安慰剂对照，递增剂量1期研究的结果
4. Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model—Support for a Biologics License Application Submission: Part I [O] . Jean-Marie Martinez, Aurélie Brunet, Fabrice Hurbin, -1

机译：使用目标介导的药物处置模型的Michaelis-Menten近似值对健康志愿者或高胆固醇血症受试者中的Alirocumab进行人口药代动力学分析-支持生物制剂许可证申请的提交：第一部分
5. Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model—Support for a Biologics License Application Submission: Part I [O] . Jean-Marie Martinez, Aurélie Brunet, Fabrice Hurbin, 2018

机译：使用MICHAELIS-MENTEN逼近的靶介导的药物处置模型支持的人群体育志法或高胆固醇受试者的人口药代动力学分析 - 用于生物制剂申请提交的靶介导的药物置入模型：第I部分

Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II

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