Pharmacokinetic and pharmacodynamic modeling of erythropoietin administration
AssigneeOrtho-McNeil Pharmaceutical, Inc.
InventorsWing Cheung, David Gibson, Christine Cote, Els Vercammen
Life of this patent
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Abstract
The present invention relates to systems and methods for obtaining optimized EPO dosage regimens for a desired pharmacodynamic/pharmacokinetic response. The system includes choosing one or more EPO dosage regimens, then using a PK/PD model to determine the pharmacodynamic/pharmacokinetic profile of one or more EPO dosage regimens, and finally selecting one of the EPO dosage regimens for administration to achieve the desired pharmacodynamic/pharmacodynamic response based on the EPO profile.
Claims203
A method for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising the steps of:
- (a) choosing one or more EPO dosage regimens;
- (b) using a pharmacokinetic/pharmacodynamic model to determine the pharmacodynamic profile of said one or more EPO dosage regimens;
- and
- (c) selecting said one or more EPO dosage regimens that provide said desired pharmacodynamic response based on said pharmacodynamic profile.
A method for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising the steps of:
- (a) selecting one or more desired pharmacodynamic responses;
- (b) using a pharmacokinetic/pharmacodynamic model to determine EPO dosage regimens that provides said desired one or more pharmacodynamic responses;
- and
- (c) selecting the one or more EPO dosage regimens that provide said desired pharmacodynamic responses.
A system for selecting an optimal EPO dosage regimens for a patient using a pharmacokinetic/pharmacodynamic mode comprising:
- (a) a processor that is controlled in accordance with a set of program instructions that determine the steps implemented by said pharmacokinetic/pharmacodynamic model;
- (b) a memory coupled to said processor, said memory storing the set of program instructions and parameters used by said pharmacokinetic/pharmacodynamic model;
- and
- (c) a user interface, coupled to said processor, said user interface enabling a user to input parameters used by said pharmacokinetic/pharmacodynamic model.
A computer program for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising:
- (a) computer code that describes a pharmacokinetic/pharmacodynamic model for EPO, said code providing for selection of one or more desired pharmacodynamic responses and the use of said pharmacokinetic/pharmacodynamic model to determine one or more EPO dosage regimens that provide said desired one or more pharmacodynamic responses;
- and
- (b) computer readable medium that stores said computer code.
A computer program for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising:
- (a) computer code that describes a pharmacokinetic/pharmacodynamic model for EPO, said code providing for user selection of one or more EPO dosage regimens and the use of said pharmacokinetic/pharmacodynamic model to determine a pharmacodynamic response for said one or more rHuEPO dosage regimens;
- and
- (b) computer readable medium that stores said computer code.
A method for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising the steps of:
- (a) choosing one or more EPO dosage regimens;
- (b) using a pharmacokinetic/pharmacodynamic model to determine the pharmacokinetic profile of said one or more EPO dosage regimens;
- and
- (c) selecting the one or more EPO dosage regimens that provide said desired pharmacokinetic response based on said pharmacokinetic profile.
A method for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising the steps of:
- (a) selecting one or more desired pharmacokinetic responses;
- (b) using a pharmacokinetic/pharmacodynamic model to determine EPO dosage regimens that provide said desired one or more pharmacokinetic responses;
- and
- (c) selecting one or more EPO dosage regimens that provide said desired pharmacokinetic responses.
A computer program for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising:
- (a) computer code that describes a pharmacokinetic/pharmacodynamic model for EPO, said code providing for selection of one or more desired pharmacokinetic responses and the use of said pharmacokinetic/pharmacodynamic model to determine one or more EPO dosage regimens that provide said desired one or more pharmacokinetic responses;
- and
- (b) computer readable medium that stores said computer code.
A computer program for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising:
- (a) computer code that describes a pharmacokinetic/pharmacodynamic model for EPO, said code providing for user selection of one or more EPO dosage regimens and the use of said pharmacokinetic/pharmacodynamic model to determine a pharmacokinetic response for said one or more EPO dosage regimens;
- and
- (b) computer readable medium that stores said computer code.
A method for creating a pharmacokinetic model for subcutaneous EPO administration in patients comprising the steps of:
- (a) obtaining pharmacokinetic data from patients;
- (b) choosing an equation based on said data;
- and
- (c) fitting said pharmacokinetic data to said equation.
A method for creating a pharmacodynamic model for subcutaneous EPO administration in patients comprising the steps of:
- (a) normalizing serum EPO concentrations;
- (b) obtaining pharmacodynamic data;
- (c) choosing a pharmacodynamic model;
- (d) obtaining equation based on said model;
- and
- (e) fitting pharmacodynamic data to said equation.
A method for calculating the bioavailability of EPO following subcutaneous administration comprises the steps of:
- (a) obtaining pharmacokinetic data;
- (b) calculating AUC;
- (c) normalizing AUC to dose;
- and
- (d) deriving an equation to represent said bioavailability of EPO by performing a linear regression of said pharmacokinetic data.
A method for predicting a pharmacodynamic response in a patient to subcutaneous EPO administration comprising the steps of:
- (a) selecting EPO dose and dosage regimens;
- and
- (b) determining said pharmacodynamic response based on said dose and dosage regimens.
A method for administering EPO comprising the steps of:
- choosing one or more EPO dosage regimens
- using pharmacokinetic/pharmacodynamic model to determine the pharmacodynamic profile of said one or more EPO regimens;
- selecting said EPO dosage regimens that provides a desired pharmacodynamic response based on said pharmacodynamic profile;
- and
- administering said EPO dosage regimen to a patient.
A method of administering EPO comprising the steps of:
- selecting one ore more desired pharmacodynamic responses;
- using a pharmacokinetic/pharmacodynamic model to determine EPO dosage regiment that provides said desired one or more pharmacodynamic responses;
- selecting said one ore more EPO dosage regimens that provides said desired pharmacodynamic responses;
- and
- administering said selected EPO dosage regiment to a patient.
A method for administering EPO to a patient comprising the step of:
- administering said EPO on a one weekly basis.
A method for administering EPO to a patient comprising the step of:
- administering said EPO on a once every two week basis.
A method for enhancing the production of mature red blood cells from young red blood cells in a patient comprising the step of:
- administering EPO to said patient so that said young red blood cells are induced to become mature red blood cells.
A method for maintaining an enhanced level of red blood cells in a patient comprising the step of:
- administering a first dose of EPO followed by a second dose of EPO to said patient, wherein said second dose of EPO is administered to said patient at a time after said first dose that coincides with the production of reticulocytes resulting from said first dose of EPO.
A business method comprising the step of:
- providing a consumer an EPO dosing regiment that is a first dose of EPO followed by a second dose of EPO to a patient, wherein said second dose of EPO is administered to said patient at a time after said first dose that coincides with the production of reticulocytes resulting from said first dose of EPO.
A business method comprising the step of:
- providing to a patient an EPO dosing regimen that is a first dose of EPO followed by a second dose of EPO to a patient, wherein said second dose of EPO is administered to said patient at a time after said first dose that coincides with the production of reticulocytes resulting from said first dose of EPO.
A business method comprising the step of:
- providing a dosing regimen of EPO to a user or patient.
Dependencies are inferred from the claim text.