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Method and device of plant dose pharmaceutical science production

机译:植物剂量药物科学生产的方法和装置

摘要

Systems and Methods for producing a dosage regimen of coagulation factor VIII (cfviii) include collecting two samples of blood from a patient after an infusion of cfviii andDetermine the cfviii clearance on the basis of the two blood samples, and determine whether a patient has a half-life exceeding a Predetermined Threshold.Determining a Profile of the patient pharmacokinetic (PK) Model using a Bayesian pharmacokinetic Profiles of patients sampled with similar body weight and Age of the patient.The Model applies a First weighting Bayesian pharmacokinetic Profiles of patients sampled if the Half Life of the patient is higher than a Predetermined Threshold and applies.NDA weighting less than the first weighting, the Model Bayesian pharmacokinetic Profiles of patients sampled if the Half Life of the patient is less than the Predetermined Threshold.It determines a dosage regimen for the patient based on the PK Profile.
机译:用于产生凝血因子VIII(cfviii)剂量方案的系统和方法包括:在输注cfviii之后收集患者的两个血液样本,并根据这两个血液样本确定cfviii清除率,并确定患者是否有一半寿命超过预定阈值。使用体重和患者年龄相近的患者的贝叶斯药代动力学特征曲线确定患者药代动力学(PK)模型的特征模型。患者的半衰期高于预定阈值并适用NDA权重小于第一权重,如果患者的半衰期小于预定阈值,则对患者的模型贝叶斯药代动力学概况进行抽样,并确定剂量方案基于PK档案的患者。

著录项

  • 公开/公告号AR108212A1

    专利类型

  • 公开/公告日2018-07-25

    原文格式PDF

  • 申请/专利权人 BAXALTA INCORPORATED;BAXALTA GMBH;

    申请/专利号AR2017P100974

  • 发明设计人

    申请日2017-04-17

  • 分类号A61P7/04;G06F19/12;G06N7;

  • 国家 AR

  • 入库时间 2022-08-21 12:54:14

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