公开(公告)号：US11670409B2

公开(公告)日：2023-06-06

申请号：US16092396

申请日：2017-04-13

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Kameswara Rao Kuchimanchi ,  Alexandra Loew-Baselli ,  Gerald Spotts ,  Myungshin Oh ,  Michael Don Hale ,  Martin Wolfsegger

IPC: G16H20/17 ,  G16H50/70 ,  G16H50/20 ,  G16C20/30 ,  G16H50/50 ,  G16C20/50 ,  G16C20/70 ,  A61P7/04 ,  A61K49/00 ,  G06N7/01

CPC classification number: G16H20/17 ,  G16C20/30 ,  G16H50/20 ,  G16H50/50 ,  G16H50/70 ,  A61K49/0004 ,  A61P7/04 ,  G06N7/01 ,  G16C20/50 ,  G16C20/70

Abstract: 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.

公开(公告)号：US20210343375A1

公开(公告)日：2021-11-04

申请号：US17374315

申请日：2021-07-13

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Kameswara Rao Kuchimanchi ,  Alexandra Loew-Baselli ,  Gerald Spotts ,  Myungshin Oh ,  Michael Don Hale ,  Martin Wolfsegger

IPC: G16C20/30 ,  G16H20/17 ,  G16H50/70 ,  G16H50/20

Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.

公开(公告)号：US11783931B2

公开(公告)日：2023-10-10

申请号：US17119011

申请日：2020-12-11

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Gerald Spotts ,  Roman Pichler ,  Michael Nelson

IPC: G16H20/10 ,  G16C20/30 ,  G09C5/00 ,  G16H50/30 ,  G16H50/50 ,  G06N7/01 ,  G16H10/60 ,  H04L9/06 ,  G16B50/00 ,  G16B40/00 ,  G16C20/90

CPC classification number: G16H20/10 ,  G06N7/01 ,  G09C5/00 ,  G16C20/30 ,  G16H10/60 ,  G16H50/30 ,  G16H50/50 ,  H04L9/0637 ,  G16B40/00 ,  G16B50/00 ,  G16C20/90

Abstract: A drug monitoring tool comprises a data receiver and an interactive user interface. The data receiver is configured to receive a pharmacokinetic (PK) profile of a patient. The interactive user interface is configured to display, to the patient, a time-varying therapeutic plasma protein level of the patient and delineate a plurality of zones within the interactive user interface associated with the time-varying therapeutic plasma protein level. The plurality of zones includes a safe zone indicating to the patient that the time-varying therapeutic plasma protein level is within a first concentration range considered safe for physical activity and a danger zone indicating to the patient that the time-varying therapeutic plasma protein level is within a second concentration range and physical activity should be limited.

公开(公告)号：US11749394B2

公开(公告)日：2023-09-05

申请号：US17374315

申请日：2021-07-13

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Kameswara Rao Kuchimanchi ,  Alexandra Loew-Baselli ,  Gerald Spotts ,  Myungshin Oh ,  Michael Don Hale ,  Martin Wolfsegger

IPC: G16H20/17 ,  G16H50/70 ,  G16H50/50 ,  G16H50/20 ,  G16C20/30 ,  G16C20/50 ,  G16C20/70 ,  A61P7/04 ,  A61K49/00 ,  G06N7/01

CPC classification number: G16H20/17 ,  G16C20/30 ,  G16H50/20 ,  G16H50/50 ,  G16H50/70 ,  A61K49/0004 ,  A61P7/04 ,  G06N7/01 ,  G16C20/50 ,  G16C20/70

Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.