KUCHIMANCHI, Kameswara, Rao,LOEW-BASELLI, Alexandra,SPOTTS, Gerald,OH, Myungshin,HALE, Michael, Don,WOLFSEGGER, Martin
申请号:
PH12018502178
公开号:
PH12018502178A1
申请日:
2018.10.10
申请国别(地区):
PH
年份:
2019
代理人:
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.