Methods and devices for determining optimal agent dosages

Abstract

The present invention is generally directed to methods and devices for determining dosing for a medical agent. In some embodiments, a mathematical algorithm is employed for computing erythropoiesis-stimulating agents dosing for treating anemia in a subject, e.g., a human subject. Any suitable dosing may be used, e.g., intravenous, subcutaneous, or oral dosing. In some cases, dosing for a wide range of subject types and health conditions can be achieved using the devices and methods disclosed herein.

What is claimed is: 
     
         1 - 46 . (canceled) 
     
     
         47 . A method for treating anemia in a subject, comprising:
 (a) determining a concentration of at least one biochemical property in the subject;   (b) using a feedback controller to calculate a dosage of an erythropoiesis-stimulating agent based on the concentration of the at least one biochemical property, wherein the controller comprises an algorithm including an integrator or an approximated discrete-time integrator;   (c) administering the dosage of the erythropoiesis-stimulating agent to the subject; and   (d) repeating steps (a) through (c) a plurality times.   
     
     
         48 . The method of  claim 47 , wherein the subject is human. 
     
     
         49 . The method of  claim 47 , wherein the subject has renal failure. 
     
     
         50 . The method of  claim 47 , wherein said biochemical property is hemoglobin concentration. 
     
     
         51 . The method of  claim 47 , wherein said biochemical property is iron concentration. 
     
     
         52 . The method of  claim 47 , wherein the erythropoiesis-stimulating agent comprises erythropoietin (EPO) and/or recombinant human erythropoietin (rHuEPO) and/or novel erythropoiesis stimulating protein (NESP) and/or HIF stabilizing agent. 
     
     
         53 . The method of  claim 47 , wherein said integrator is described by the equation 
       
         
           
             
               
                 z 
                 
                   z 
                   - 
                   1 
                 
               
               , 
             
           
         
         and said approximated discrete-time integrator is described by 
       
       
         
           
             
               
                 z 
                 
                   z 
                   - 
                   a 
                 
               
               , 
             
           
         
         wherein the value of a is near 1. 
       
     
     
         54 . The method of  claim 53 , wherein said discrete-time integrator is selected from the following: Forward Euler, Backward Euler, Trapezoidal method, second-order accurate method, or third order accurate method. 
     
     
         55 . The method of  claim 47 , wherein the feedback controller encodes Equations 1-5. 
     
     
         56 . A device for treating anemia in a subject, comprising:
 a receiver for determining a concentration of at least one biochemical property in the subject;   a feedback controller configured and arranged to calculate a dosage of an erythropoiesis-stimulating agent based on the concentration of the at least one biochemical property, wherein the controller comprises an algorithm including an integrator or an approximated discrete-time integrator; and   an applicator for administering the dosage of the erythropoiesis-stimulating agent to the subject.   
     
     
         57 . The device of  claim 56 , wherein the device further comprises a needle for withdrawing blood from the subject. 
     
     
         58 . The device of  claim 56 , wherein the device further comprises a reservoir containing the erythropoiesis-stimulating agent. 
     
     
         59 . The device of  claim 56 , wherein the receiver further comprises a hemoglobin sensor. 
     
     
         60 . The device of  claim 56 , wherein the receiver further comprises an iron sensor. 
     
     
         61 . The device of  claim 56 , wherein the erythropoiesis-stimulating agent comprises erythropoietin (EPO). 
     
     
         62 . The device of  claim 56 , wherein the erythropoiesis-stimulating agent comprises novel erythropoiesis stimulating protein (NESP). 
     
     
         63 . The device of  claim 56 , wherein the erythropoiesis-stimulating agent comprises HIF stabilizing agent. 
     
     
         64 . The device of  claim 56 , wherein said integrator is described by the equation 
       
         
           
             
               
                 z 
                 
                   z 
                   - 
                   1 
                 
               
               , 
             
           
         
         and said approximated discrete-time integrator is described by 
       
       
         
           
             
               
                 z 
                 
                   z 
                   - 
                   a 
                 
               
               , 
             
           
         
         wherein the value of a is near 1. 
       
     
     
         65 . The device of  claim 64 , wherein said discrete-time integrator is selected from the following: Forward Euler, Backward Euler, Trapezoidal device, second-order accurate device, or third order accurate device. 
     
     
         66 . The device of  claim 56 , wherein the feedback controller encodes Equations 1-5.