Pharmacokinetic and pharmacodynamic modeling of erythropoietin administration
First Claim
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1. 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.
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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.
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Citations
203 Claims
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1. A method for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising the steps of:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising the steps of:
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(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. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A system for selecting an optimal EPO dosage regimens for a patient using a pharmacokinetic/pharmacodynamic model comprising:
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(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. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. A computer program for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising:
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(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. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. A computer program for obtaining optimized EPO dosage regimens for a desired pharmacodynamic response in a patient comprising:
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(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. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65)
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66. A method for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising the steps of:
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(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. - View Dependent Claims (67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78)
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79. A method for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising the steps of:
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(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. - View Dependent Claims (80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91)
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92. A computer program for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising:
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(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. - View Dependent Claims (93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104)
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105. A computer program for obtaining optimized EPO dosage regimens for a desired pharmacokinetic response in a patient comprising:
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(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. - View Dependent Claims (106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117)
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118. A method for creating a pharmacokinetic model for subcutaneous EPO administration in patients comprising the steps of:
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(a) obtaining pharmacokinetic data from patients;
(b) choosing an equation based on said data; and
(c) fitting said pharmacokinetic data to said equation. - View Dependent Claims (120, 121, 122, 123, 124, 125)
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119. A method for creating a pharmacodynamic model for subcutaneous EPO administration in patients comprising the steps of:
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(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. - View Dependent Claims (127, 128, 129, 130, 131, 132, 133, 134)
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126. A method for calculating the bioavailability of EPO following subcutaneous administration comprises the steps of:
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(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.
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135. A method for predicting a pharmacodynamic response in a patient to subcutaneous EPO administration comprising the steps of:
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(a) selecting EPO dose and dosage regimens; and
(b) determining said pharmacodynamic response based on said dose and dosage regimens. - View Dependent Claims (136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147)
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148. A method for administering EPO comprising the steps of:
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choosing one or more EPO dosage regimens using a 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. - View Dependent Claims (149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161)
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162. A method of administering EPO comprising the steps of:
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selecting one or more desired pharmacodynamic responses;
using a pharmacokinetic/pharmacodynamic model to determine EPO dosage regimen 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. - View Dependent Claims (163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176)
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177. A method for administering EPO to a patient comprising the step of:
administering said EPO on a once-weekly basis. - View Dependent Claims (178)
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179. A method for administering EPO to a patient comprising the step of:
administering said EPO on a once every two week basis. - View Dependent Claims (180)
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181. 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.
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182. 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. - View Dependent Claims (183, 184, 185)
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186. A business method comprising the step of:
providing to a consumer 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. - View Dependent Claims (187, 188, 189, 190)
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191. 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. - View Dependent Claims (192, 193, 194, 195)
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196. A business method comprising the step of:
providing a dosing regimen of EPO to a user or patient. - View Dependent Claims (197, 198, 199, 200, 201, 202, 203)
Specification