Drug monitoring tool
AssigneeShire Human Genetic Therapies, Inc.
InventorsGerald Spotts, Roman Pichler, Michael Nelson
Life of this patent
Estimating the term…
Abstract
Embodiments of the present disclosure relate to a drug monitoring tool. The 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. The time-varying therapeutic plasma protein level is based on an administered dose of a clotting factor VIII and the PK profile of the patient.
Claims20
A drug monitoring tool, the tool comprising:
- a data receiver configured to receive, from a secured server, a patient pharmacokinetic (PK) profile of a patient, wherein the secured server comprises:
- (I) a Bayesian model of pharmacokinetic (PK) profiles of sampled patients, the Bayesian model including (i) a therapeutic plasma protein clearance and (ii) a volume of distribution relationship for a therapeutic plasma protein based upon at least one of patient age or body weight, and (II) a PK server configured to determine the patient PK profile based upon the Bayesian model, and at least one of a bodyweight, von Willebrand factor level, and an age of the patient;
- and
- an interactive user interface configured to:
- display to the patient a graphical representation predictive of a time-varying therapeutic plasma protein level of the patient, the time-varying therapeutic plasma protein level determined by the drug monitoring tool based on the timing and amount of an administered dose of a clotting factor VIII to the patient and the patient PK profile;
- and
- delineate a plurality of zones within the graphical representation associated with the time-varying therapeutic plasma protein level, the plurality of zones comprising at least:
- 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.
A drug monitoring system, the system comprising:
- a remote server system comprising:
- a Bayesian model of pharmacokinetic (PK) profiles of sampled patients, the Bayesian model including (i) a therapeutic plasma protein clearance and (ii) a volume of distribution relationship for a therapeutic plasma protein based upon at least one of patient age or body weight,
- a PK server that determines a patient PK profile based upon the Bayesian model and at least one of a bodyweight, von Willebrand factor level, and an age of a patient, and a quick response (QR) code generator that generates a QR code storing the patient PK profile;
- and
- a drug monitoring tool comprising:
- a camera that reads the QR code,
- a code processor that extracts the patient PK profile from the QR code, and
- an interactive user interface that displays a graphical representation of a time-varying therapeutic plasma protein level of the patient determined by the drug monitoring system based on the timing and amount of an administered dose of a clotting factor VIII to the patient and the patient PK profile, the graphical representation delineating a plurality of zones within the graphical representation associated with the time-varying therapeutic plasma protein level, the plurality of zones comprising at least:
- 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.
A method of using a patient pharmacokinetic (PK) profile to predict drug levels, the method comprising:
- receiving, at a user device, a patient PK profile for a clotting factor from a server system that determines the patient PK profile based on a Bayesian model of sampled patients and at least one of a bodyweight, a von Willebrand factor level, and an age of a patient;
- determining, by the user device, time-varying levels of the clotting factor predicted using the patient PK profile to result in the patient from the timing and amount of an administered dose of the clotting factor;
- and
- displaying, via an interactive user interface of the user device, the time-varying levels of the clotting factor predicted in the patient within a plurality of zones, the time-varying levels of the clotting factor being positioned within either:
- a safe zone indicating to the patient that the time-varying levels of the clotting factor is within a first concentration considered safe for physical activity;
- or
- a danger zone indicating to the patient that the time-varying levels of the clotting factor is within a second concentration and physical activity should be limited.
Dependencies are inferred from the claim text.