Claims for Patent: 6,942,614

Summary for Patent: 6,942,614

Title:	Method and system for use in treating a patient with an anticoagulant to optimize therapy and prevent an adverse drug response
Abstract:	A method and system for use in treating a patient receiving an anticoagulant or a substance containing warfarin to optimize therapy and prevent an adverse drug response. This system employs surrogate markers or indicators including blood levels of the anticoagulant to determine the next required dose for a patient. Since the surrogate markers are employed as a percent change in status, virtually any indicator can be used. Surrogate markers could include any measure of the effectiveness of the anticoagulant\'s action. Given the effectiveness of the anticoagulant\'s action relative to the surrogate markers, a change in anticoagulant dose is calculated by the system. Conversely, by employing this system, one could determine the expected result of the anticoagulant dose change on the surrogate markers.
Inventor(s):	Kutzko; John D. (Nokomis, FL), Singer; Michaeal G. (Harrisville, MI), McMichael; John (Wexford, PA)
Assignee:	Dimensional Dosing Systems, Inc. (Wexford, PA)
Application Number:	09/644,503
Patent Claims:	1. A method for calculating a revised dose of an anticoagulant for a patient using said anticoagulant, comprising the steps of: accepting as a first input the patient's current anticoagulant dose; accepting as a second input a maximum dose of the anticoagulant; accepting as a third input a percent response of the patient based on one or more surrogate markers for said patient; and determining a revised dose, wherein said revised dose is a function of said current dose minus a ratio of the percent response of the patient and a ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 2. The method of claim 1, wherein: said determining step includes determining said revised dose based on the equation where: LV={(RESPONSE.times.CAD).times.[(100-RES).times.0.01]}/1.3^(CAD/HIGH) and wherein: RAD=Revised Anticoagulant Dose CAD=Current Anticoagulant Dose PAR=Percent response of patient to surrogate marker RES=Percent response of patient to last dosing based on surrogate marker HIGH=The input parameter that is the high dose range for said anticoagulant RESPONSE=Percent of total dose available for individualizing patient dose 1.3^(CAD/HIGH)=1.3 raised to an exponent of (CAD/HIGH). 3. The method of claim 1, wherein: said anticoagulant is selected from a group comprising warfarin, Coumadin.RTM., heparin, warfarin sodium salt, coumarin derivatives, indandione derivatives, dicumarol, anisindione, phenindione, ethyl bicoumacetate, bishydroxycoumarin, abcimixab, Reopro.RTM., actilyse, alteplase, Activase.RTM., anagrelide, Agrylin.RTM., anistreplase, Eminase.RTM., antithrombin III, Thrombate III.RTM., ardeparin, Normiflo.RTM., argatroban, clopidrogel, Plavix.RTM., dalteparin, Fragmin.RTM., danaparoid, Orgaran.RTM., dipyridamole, Persantine.RTM., dipyridamole/aspirin, Aggrenox.RTM., duteplase, enoxaparin, Lovenox.RTM., eptifibatide, Integrilin.RTM., lepirudin, Refludan.RTM., nadroparin, Fraxiparine.RTM., oprelvekin, Neumega.RTM., pentosan polysulfate sodium, Elmiron.RTM., reteplase, Retavase.RTM., reviparin, Clivarine.RTM., saruplase, streptokinase, Kabikinase.RTM., Streptase.RTM., tinzaparin, Innohep.RTM., tirofiban, Aggrastat.RTM., unfractionated heparin, low molecular weight heparin, all antithrombotic agents, all vitamin K antagonists, and all substances derived from and/or related to the foregoing substances. 4. A method for calculating a revised dose of a anticoagulant for a patient using said anticoagulant comprising the steps of: accepting as a first input the patient's current anticoagulant dose; accepting as a second input a maximum dose of the anticoagulant; accepting as a third input one or more numerical markers indicating a response of the patient; and calculating said revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 5. The method of claim 4, wherein: said calculating step includes calculating said revised dose based on the equation where: LV={(RESPONSE.times.CAD).times.[(1+D)-(1+E)]/abs (1+D)}/1.3^(CAD/HIGH) E=CANM-PANM D=DANM-PANM and wherein: RAD=Revised Anticoagulant Dose CAD=Current Anticoagulant Dose CANM=Current Anticoagulant Numerical Marker DANM=Desired Anticoagulant Numerical Marker PANM=Previous Anticoagulant Numerical Marker HIGH=The input parameter that is the high dose range for said anticoagulant RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CAD/HIGH)=1.3 raised to an exponent of (CAD/HIGH). 6. The method of claim 4, wherein: said anticoagulant is selected from a group comprising warfarin, Coumadin.RTM., heparin, warfarin sodium salt, coumarin derivatives, indandione derivatives, dicumarol, anisindione, phenindione, ethyl bicoumacetate, bishydroxycoumarin, abcimixab, Reopro.RTM., actilyse, alteplase, Activase.RTM., anagrelide, Agrylin.RTM., anistreplase, Eminase.RTM., antithrombin III, Thrombate III.RTM., ardeparin, Normiflo.RTM., argatroban, clopidrogel, Plavix.RTM., dalteparin, Fragmin.RTM., danaparoid, Orgaran.RTM., dipyridamole, Persantine.RTM., dipyridamole/aspirin, Aggrenox.RTM., duteplase, enoxaparin, Lovenox.RTM., eptifibatide, Integrilin.RTM., lepirudin, Refludan.RTM., nadroparin, Fraxiparine.RTM., oprelvekin, Neumega.RTM., pentosan polysulfate sodium, Elmiron.RTM., reteplase, Retavase.RTM., reviparin, Clivarine.RTM., saruplase, streptokinase, Kabikinase.RTM., Streptase.RTM., tinzaparin, Innohep.RTM., tirofiban, Aggrastat.RTM., unfractionated heparin, low molecular weight heparin, all antithrombotic agents, all vitamin K antagonists, and all substances derived from and/or related to the foregoing substances. 7. A method for determnining a dose of a anticoagulant for a patient, comprising the steps of: administering an initial dose of said anticoagulant to the patient; evaluating the patient to monitor and characterize one or more numerical surrogate markers; determining, based on said numerical surrogate markers, if a dose change for said anticoagulant is necessary; and calculating a revised dose as a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to a maximum dose plus the percent of individual patient response multiplied by a response factor. 8. The method of claim 7, wherein: said anticoagulant is selected from a group comprising warfarin, Coumadin.RTM., heparin, warfarin sodium salt, coumarin derivatives, indandione derivatives, dicumarol, anisindione, phenindione, ethyl bicoumacetate, bishydroxycoumarin, abcimixab, Reopro.RTM., actilyse, alteplase, Activase.RTM., anagrelide, Agrylin.RTM., anistreplase, Eminase.RTM., antithrombin III, Thrombate III.RTM., ardeparin, Normiflo.RTM., argatroban, clopidrogel, Plavix.RTM., dalteparin, Fragmin.RTM., danaparoid, Orgaran.RTM., dipyridamole, Persantine.RTM., dipyridamole/aspirin, Aggrenox.RTM., duteplase, enoxaparin, Lovenox.RTM., eptifibatide, Integrilin.RTM., lepirudin, Refludan.RTM., nadroparin, Fraxiparine.RTM., oprelvekin, Neumega.RTM., pentosan polysulfate sodium, Elmiron.RTM., reteplase, Retavase.RTM., reviparin, Clivarine.RTM., saruplase, streptokinase, Kabikinase.RTM., Streptase.RTM., tinzaparin, Innohep.RTM., tirofiban, Aggrastat.RTM., unfractionated heparin, low molecular weight heparin, all antithrombotic agents, all vitamin K antagonists, and all substances derived from and/or related to the foregoing substances. 9. A method for determining a dose of an anticoagulant for a patient, comprising the steps of: administering an initial dose of said anticoagulant to the patient; examining the patient to monitor and characterize one or more numerical surrogate markers; determining if a dose change is necessary; and calculating a revised dose as a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to the maximum dose plus the percent of individual patient response multiplied by a response factor. 10. A method for calculating a revised dose of an anticoagulant for a patient, comprising the steps of: accepting as input the patient's current anticoagulant dose; accepting as input a maximum dose of the anticoagulant; accepting as input the percent response of the patient based on surrogate markers; and calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said percent response of the patient based on said surrogate markers. 11. A method for calculating a revised dose of an anticoagulant for a patient, comprising the steps of: accepting as input a patient's current anticoagulant dose; accepting as input a maximum dose of the anticoagulant; accepting as input the previous, current and desired values of one or more numerical markers indicating the response of the patient; and calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said previous, current and desired values of said numerical markers. 12. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a method comprising the steps of: accepting as input a patient's current anticoagulant dose; accepting as input a maximum dose of the anticoagulant; accepting as input a percent response of a patient based on surrogate markers; and calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 13. The storage device of claim 12, wherein: said anticoagulant is selected from a group comprising warfarin, Coumadin.RTM., heparin, warfarin sodium salt, coumarin derivatives, indandione derivatives, dicumarol, anisindione, phenindione, ethyl bicoumacetate, bishydroxycoumarin, abcimixab, Reopro.RTM., actilyse, alteplase, Activase.RTM., anagrelide, Agrylin.RTM., anistreplase, Eminase.RTM., antithrombin III, Thrombate III.RTM., ardeparin, Normiflo.RTM., argatroban, clopidrogel, Plavix.RTM., dalteparin, Fragmin.RTM., danaparoid, Orgaran.RTM., dipyridamole, Persantine.RTM., dipyridamnole/aspirin, Aggrenox.RTM., duteplase, enoxaparin, Lovenox.RTM., eptifibatide, Integrilin.RTM., lepirudin, Refludan.RTM., nadroparin, Fraxiparine.RTM., oprelvekin, Neumega.RTM., pentosan polysulfate sodium, Elmiron.RTM., reteplase, Retavase.RTM., reviparin, Clivarine.RTM., saruplase, streptokinase, Kabilinase.RTM., Streptase.RTM., tinzaparin, Innohep.RTM., tirofiban, Aggrastat.RTM., unfractionated heparin, low molecular weight heparin, all antithrombotic agents, all vitamin K antagonists, and all substances derived from and/or related to the foregoing substances. 14. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a method comprising the steps of: accepting as input the patient's current anticoagulant dose; accepting as input a maximum dose of the anticoagulant; accepting as input one or more numerical markers indicating the response of the patient; and calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 15. An apparatus for calculating a revised dose of an anticoagulant for a patient comprising: means for accepting as input one or more markers which indicate a patient's response to a dose of said anticoagulant; means for accepting as input the patient's current anticoagulant dose; means for accepting as input the maximum dose of the anticoagulant; and means for calculating a revised dose of the anticoagulant as a function of said markers, said current anticoagulant dose, and said maximum anticoagulant dose. 16. The apparatus of claim 15, wherein: said markers are actual numerical markers. 17. The apparatus of claim 15, wherein: said markers are surrogate markers representing a percent response of the patient to the anticoagulant. 18. The apparatus of claim 15, wherein: said revised dose is calculated by the equation: where: LV={(RESPONSE.times.CAD).times.[(1+D)-(1+E)]/abs (1+D)}/1.3^(CAD/HIGH) E=CANM-PANM D=DANM-PANM and wherein: RAD=Revised Anticoagulant Dose CAD=Current Anticoagulant Dose CANM=Current Anticoagulant Numerical Marker DANM=Desired Anticoagulant Numerical Marker PANM=Previous Anticoagulant Numerical Marker HIGH=The input parameter that is the high dose range for said anticoagulant RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CAD/HIGH)=1.3 raised to an exponent of (CAD/HIGH). 19. The apparatus of claim 15, wherein: said revised dose is calculated by the equation: where: LV={(RESPONSE.times.CAD).times.[(100-RES).times.0.01]}/1.3^(CAD/HIGH) and wherein: RAD=Revised Anticoagulant Dose CAD=Current Anticoagulant Dose PAR=Percent response of patient to surrogate marker RES=Percent response of patient to last dosing based on surrogate marker HIGH=The input parameter that is the high dose range for said anticoagulant RESPONSE=Percent of total dose available for individualizing patient dose 1.3^(CAD/HIGH)=1.3 raised to an exponent of (CAD/HIGH). 20. The apparatus of claim 15, wherein: said anticoagulant is selected from a group comprising warfarin, Coumadin.RTM., heparin, warfarin sodium salt, coumarin derivatives, indandione derivatives, dicumarol, anisindione, phenindione, ethyl bicoumacetate, bishydroxycoumarin, abcimixab, Reopro.RTM., actilyse, alteplase, Activase.RTM., anagrelide, Agrylin.RTM., anistreplase, Eminase.RTM., antithrombin III, Thrombate III.RTM., ardeparin, Normiflo.RTM., argatroban, clopidrogel, Plavix.RTM., dalteparin, Fragmin.RTM., danaparoid, Orgaran.RTM., dipyridamole, Persantine.RTM., dipyridamole/aspirin, Aggrenox.RTM., duteplase, enoxaparin, Lovenox.RTM., eptifibatide, Integrilin.RTM., lepirudin, Refludan.RTM., nadroparin, Fraxiparine.RTM., oprelvekin, Neumega.RTM., pentosan polysulfate sodium, Elmiron.RTM., reteplase, Retavase.RTM., reviparin, Clivarine.RTM., saruplase, streptokinase, Kabikinase.RTM., Streptase.RTM., tinzaparin, Innohep.RTM., tirofiban, Aggrastat.RTM., unfractionated heparin, low molecular weight heparin, all antithrombotic agents, all vitamin K antagonists, and all substances derived from and/or related to the foregoing substances. 21. A method for calculating a revised dose of Coumadin.RTM. for a patient using Coumadin.RTM., comprising the steps of: accepting as a first input the patient's current Coumadin.RTM. dose; accepting as a second input a maximum dose of Coumadin.RTM.; accepting as a third input a percent response of the patient based on one or more surrogate markers for said patient; and determining a revised dose, wherein said revised dose is a function of said current dose minus a ratio of the percent response of the patient and a ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 22. The method of claim 21, wherein: said determining step includes determining said revised dose based on the equation where: LV={(RESPONSE.times.CCD).times.[(100-RES).times.0.01]}1.3^(CCD/HIGH) and wherein: RCD=Revised Coumadin.RTM. Dose CCD=Current Coumadin.RTM. Dose PCR=Percent response of patient to surrogate marker RES=Percent response of patient to last dosing based on surrogate marker HIGH=The input parameter that is the high dose range for Coumadin.RTM. RESPONSE=Percent of total dose available for individualizing patient dose 1.3^(CCD/HIGH)=1.3 raised to an exponent (CCD/HIGH). 23. A method for calculating a revised dose of Coumadin.RTM. for a patient using Coumadin.RTM., comprising the steps of: accepting as a first input the patient's current Coumadin.RTM. dose; accepting as a second input the maximum dose of Coumadin.RTM.; accepting as a third input one or more numerical markers indicating a response of the patient; and calculating said revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 24. The method of claim 23, wherein: said calculating step includes calculating said revised dose based on the equation where: LV={(RESPONSE.times.CCD).times.[(1+D)-(1+E)]/abs (1+D)}/1.3^(CCD/HIGH) E=CCNM-PCNM D=DCNM-PCNM and wherein: RCD=Revised Coumadin.RTM. Dose CCD=Current Coumadin.RTM. Dose CCNM=Current Coumadin.RTM. Numerical Marker DCNM=Desired Coumadin.RTM. Numerical Marker PCNM=Previous Coumadin.RTM. Numerical Marker HIGH=The input parameter that is the high dose range for Coumadin.RTM. RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CCD/HIGH)=1.3 raised to an exponent of (CCD/HIGH). 25. A method for determining a dose of Coumadin.RTM. for a patient, comprising the steps of: administering an initial dose of Coumadin.RTM. to the patient; evaluating the patient to monitor and characterize one or more numerical surrogate markers; determining, based on said numerical surrogate markers, if a dose change for Coumadin.RTM. is necessary; and calculating a revised dose as a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to the maximum dose plus the percent of individual patient response multiplied by a response factor. 26. A method for determining a dose of Coumadin.RTM. for a patient, comprising the steps of: administering an initial dose of Coumadin.RTM. to the patient; examining the patient to monitor and characterize one or more numerical surrogate markers; determining if a dose change is necessary; and calculating a revised dose as a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to the maximum dose plus the percent of individual patient response multiplied by a response factor. 27. A method for calculating a revised dose of Coumadin.RTM. for a patient, comprising the steps of: accepting as input the patient's current Coumadin.RTM. dose; accepting as input the maximum dose of Coumadin.RTM.; accepting as input the percent response of the patient based on surrogate markers; and calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said percent response of the patient based on said surrogate markers. 28. A method for calculating a revised dose of Coumadin.RTM. for a patient, comprising the steps of: accepting as input a patient's current Coumadin.RTM. dose; accepting as input a maximum dose of Coumadin.RTM.; accepting as input the previous, current and desired values of one or more numerical markers indicating the response of the patient; and calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said previous, current and desired values of said numerical markers. 29. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a method comprising the steps of: accepting as input a patient's current Coumadin.RTM. dose; accepting as input a maximum dose of Coumadin.RTM.; accepting as input a percent response of a patient based on surrogate markers; and calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 30. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a method comprising the steps of: accepting as input the patient's current Coumadin.RTM. dose; accepting as input the maximum dose of Coumadin.RTM.; accepting as input one or more numerical markers indicating the response of the patient; and calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 31. An apparatus for calculating a revised dose of Coumadin.RTM. for a patient comprising: means for accepting as input one or more markers which indicate a patient's response to a dose of Coumadin.RTM.; means for accepting as input the patient's current Coumadin.RTM. dose; means for accepting as input the maximum dose of Coumadin.RTM.; and means for calculating a revised dose of Coumadin.RTM. as a function of said markers, said current Coumadin.RTM. dose, and said maximum Coumadin.RTM. doses. 32. The apparatus of claim 31, wherein: said markers are actual numerical markers. 33. The apparatus of claim 31, wherein: said markers are surrogate markers representing a percent response of the patient to Coumadin.RTM.. 34. The apparatus of claim 31, wherein: said revised dose is calculated by the equation: where: LV={(RESPONSE.times.CCD).times.[(1+D)-(1+E)]/abs (1+D)}/1.3^(CCD/HIGH) E=CCNM-PCNM D=DCNM-PCNM and wherein: RCD=Revised Coumadin.RTM. Dose CCD=Current Coumadin.RTM. Dose CCNM=Current Coumadin.RTM. Numerical Marker DCNM=Desired Coumadin.RTM. Numerical Marker PCNM=Previous Coumadin.RTM. Numerical Marker HIGH=The input parameter that is the high dose range for Coumadin.RTM. RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CCD/HIGH)=1.3 raised to an exponent of (CCD/HIGH). 35. The apparatus of claim 31, wherein: said revised dose is calculated by the equation: where: LV={(RESPONSE.times.CCD).times.[(100-RES).times.0.01]}/1.3^(CCD/HIGH) and wherein: RCD=Revised Coumadin.RTM. Dose CCD=Current Coumadin.RTM. Dose PCR=Percent response of patient to surrogate marker RES=Percent response of patient to last dosing based on surrogate marker HIGH=The input parameter that is the high dose range for Coumadin.RTM. RESPONSE=Percent of total dose available for individualizing patient dose 1.3^(CDD/HIGH)=1.3 raised to an exponent of (CD/HIGH). 36. A method for calculating a revised dose of warfarin or a substance containing warfarin for a patient using warfarin or said substance containing warfarin, comprising the steps of: accepting as a first input the patient's current warfarin or said substance containing warfarin dose; accepting as a second input a maximum dose of warfarin or said substance containing warfarin; accepting as a third input a percent response of the patient based on one or more surrogate markers for said patient; and determining a revised dose, wherein said revised dose is a function of said current dose minus a ratio of the percent response of the patient and a ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 37. The method of claim 36, wherein: said determining step includes determining said revised dose based on the equation where: LV={(RESPONSE.times.CWD).times.[(100-RES).times.0.01]}/1.3^(CWD/HIGH) and wherein: RWD=Revised Warfarin or said substance containing warfarin Dose CWD=Current Warfarin or a substance containing warfarin Dose PWR=Percent response of patient to surrogate marker RES=Percent response of patient to last dosing based on surrogate marker HIGH=The input parameter that is the high dose range for warfarin or said substance containing warfarin RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CWD/HIGH)=1.3 raised to an exponent of (CWD/HIGH). 38. A method for calculating a revised dose of warfarin or a substance containing warfarin for a patient using warfarin or said substance containing warfarin comprising the steps of: accepting as a first input the patient's current warfarin or said substance containing warfarin dose; accepting as a second input the maximum dose of warfarin or said substance containing warfarin; accepting as a third input one or more numerical markers indicating a response of the patient; and calculating said revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 39. The method of claim 38, wherein: said calculating step includes calculating said revised dose based on the equation where: LV={(RESPONSE.times.CWD).times.[(1+D)-(1+E)]/abs (1+D)}/1.3^(CWD/HIGH) E=CWNM-PWNM D=DWNM-PWNM and wherein: RWD=Revised Warfarin or said substance containing warfarin Dose CWD=Current Warfarin or said substance containing warfarin Dose CWNM=Current Warfarin or said substance containing warfarin Numerical Marker DWNM=Desired Warfarin or said substance containing warfarin Numerical Marker PWNM=Previous Warfarin or said substance containing warfarin Numerical Marker HIGH=The input parameter that is the high dose range for warfarin or said substance containing warfarin RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CWD/HIGH)=1.3 raised to an exponent of (CWD/HIGH). 40. A method for determining a dose of warfarin or a substance containing warfarin for a patient, comprising the steps of: administering an initial dose of warfarin or said substance containing warfarin to the patient; evaluating the patient to monitor and characterize one or more numerical surrogate markers; determining, based on said numerical surrogate markers, if a dose change for warfarin or said substance containing warfarin is necessary; and calculating a revised dose as a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to the maximum dose plus the percent of individual patient response multiplied by a response factor. 41. A method for determining a dose of warfarin or a substance containing warfarin for a patient, comprising the steps of: administering an initial dose of warfarin or said substance containing warfarin to the patient; examining the patient to monitor and characterize one or more numerical surrogate markers; determining if a dose change is necessary; and calculating a revised dose as a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to the maximum dose plus the percent of individual patient response multiplied by a response factor. 42. A method for calculating a revised dose of warfarin or a substance containing warfarin for a patient, comprising the steps of: accepting as input the patient's current warfarin or said substance containing warfarin dose; accepting as input the maximum dose of warfarin or said substance containing warfarin; accepting as input the percent response of the patient based on surrogate markers; and calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said percent response of the patient based on said surrogate markers. 43. A method for calculating a revised dose of warfarin or a substance containing warfarin for a patient, comprising the steps of: accepting as input a patient's current warfarin or said substance containing warfarin dose; accepting as input a maximum dose of warfarin or said substance containing warfarin; accepting as input the previous, current and desired values of one or more numerical markers indicating the response of the patient; and calculating a revised dose, wherein said revised dose is a function of said current dose, said maximum dose, and said previous, current and desired values of said numerical markers. 44. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a method comprising the steps of: accepting as input a patient's current warfarin or a substance containing warfarin dose; accepting as input a maximum dose of warfarin or said substance containing warfarin; accepting as input a percent response of a patient based on surrogate markers; and calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of a percent response of the patient and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 45. A storage device having stored thereon an ordered set of instructions which, when executed by a computer, performs a method comprising the steps of: accepting as input the patient's current warfarin or a substance containing warfarin dose; accepting as input the maximum dose of warfarin or said substance containing warfarin; accepting as input one or more numerical markers indicating the response of the patient; and calculating a revised dose, wherein said revised dose is a function of said current dose minus the ratio of the change in numerical markers and the ratio of said current dose to said maximum dose plus the percent of individual patient response multiplied by a response factor. 46. An apparatus for calculating a revised dose of warfarin or a substance containing warfarin for a patient, comprising: means for accepting as input one or more markers which indicate a patient's response to a dose of warfarin or said substance containing warfarin; means for accepting as input the patient's current warfarin or said substance containing warfarin dose; means for accepting as input the maximum dose of warfarin or said substance containing warfarin; and means for calculating a revised dose of warfarin or said substance containing warfarin as a function of said markers, said current warfarin or said substance containing warfarin dose, and said maximum warfarin or said substance containing warfarin dose. 47. The apparatus of claim 46, wherein: said markers are actual numerical markers. 48. The apparatus of claim 46, wherein: said markers are surrogate markers representing a percent response of the patient to warfarin or said substance containing warfarin. 49. The apparatus of claim 46, wherein: said revised dose is calculated by the equation: where: LV={(RESPONSE.times.CWD).times.[(1+D)-(1+E)]/abs (1+D)}/1.3^(CWD/HIGH) E=CWNM-PWNM D=DWNM-PWNM and wherein: RWD=Revised Warfarin or said substance containing warfarin Dose CWD=Current Warfarin or said substance containing warfarin Dose CWNM=Current Warfarin or said substance containing warfarin Numerical Marker DWNM=Desired Warfarin or said substance containing warfarin Numerical Marker PWNM=Previous Warfarin or said substance containing warfarin Numerical Marker HIGH=The input parameter that is the high dose range for warfarin or said substance containing warfarin RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^CWD/HIGH)=1.3 raised to an exponent of (CWD/HIGH). 50. The apparatus of claim 46, wherein: said revised dose is calculated by the equation: where: LV={(RESPONSE.times.CWD).times.[(100-RES).times.0.01]}/1.3^(CWD/HIGH) and wherein: RWD=Revised Warfarin or said substance containing warfarin Dose CWD=Current Warfarin or said substance containing warfarin Dose PWR=Percent response of patient to surrogate marker RES=Percent response of patient to last dosing based on surrogate marker HIGH=The input parameter that is the high dose range for warfarin or said substance containing warfarin RESPONSE=Percent of total dose available for individualizing patient dose abs=The absolute value of 1.3^(CWD/HIGH)=1.3 raised to an exponent of (CWD/HIGH).

Details for Patent 6,942,614

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
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