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Procedures and devices for providing drug dosage regimes.

机译:提供药物剂量方案的程序和设备。

摘要

Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first weight is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than the predetermined threshold, and a second weight, less than the first weight, is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is less than the predetermined threshold. A dosing regimen is determined for the patient based on the PK profile.
机译:提供凝血因子VIII(CFVIII)给药方案的系统和方法包括:在输注CFVIII之后从患者收集两个血液样品,并基于这两个血液样品确定CFVIII清除率,并确定患者的半衰期是否更长超过预定阈值。使用具有相似患者体重或年龄的被采样患者的药物代谢动力学曲线的贝叶斯模型确定患者的药物代谢动力学(PK)曲线。如果患者的半衰期大于预定阈值,则将第一权重应用于样本患者的药代动力学特征曲线的贝叶斯模型,将低于第一权重的第二权重应用于药物动力学特征的贝叶斯模型。如果患者的半衰期小于预定阈值,则对样本患者进行抽样。基于PK曲线确定患者的给药方案。

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