Pharmacokinetic and pharmacodynamic modeling of erythropoietin administration

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.

1 - 203 . (canceled)  
   
   
       204 . A method comprising the step of: 
 providing to a consumer an EPO dosing regimen, wherein said regimen maintains at least a serum EPO concentration above a predose level for about 5 to 30 days.    
   
   
       205 . The method of  claim 204 , wherein said consumer is a patient.  
   
   
       206 . The method of  claim 204 , wherein said consumer is a physician.  
   
   
       207 . The method of  claim 204 , wherein said consumer is a healthcare professional.  
   
   
       208 . The method of  claim 204 , wherein said serum EPO concentration is sufficient to increase production of red blood cells.  
   
   
       209 . The method of  claim 208 , wherein said serum EPO concentration is sufficient to maintain increased red blood cell production for at least a week.  
   
   
       210 . The method of  claim 204 , wherein said serum EPO concentration is sufficient to maintain increased red blood cell production for at least two weeks.  
   
   
       211 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering a dose EPO about once a week.  
   
   
       212 . The method of  claim 211 , wherein said once a week EPO dosing regimen comprises administering a dose of EPO in the range of about 300 IU/kg to about 2400 IU/kg.  
   
   
       213 . The method of  claim 211 , wherein said once a week EPO dosing regimen comprises administering a dose of EPO in the range of about 30,000 IU to about 54,000 IU.  
   
   
       214 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering a dose of EPO about once every two weeks.  
   
   
       215 . The method of  claim 214 , wherein said once every two weeks EPO dosing regimen comprises administering a dose of EPO in the range of about 900 IU/kg to about 1200 IU/kg.  
   
   
       216 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering a dose of EPO once every ten days.  
   
   
       217 . The method of  claim 216 , herein said once every ten days EPO dosing regimen comprises administering a dose of EPO of about 900 IU/kg.  
   
   
       218 . The method of  claim 204 ,  209 ,  210 ,  214  or  216  wherein said EPO dosing regimen comprises administering EPO selected from the group consisting of epoietin alpha and darbepoietin alpha.  
   
   
       219 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering EPO selected from the group consisting of novel erythropoiesis stimulating protein (NESP), human erythropoietin analog, and erythropoietin omega.  
   
   
       220 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering proteins having EPO biological activity.  
   
   
       221 . The method of  claim 220 , wherein said proteins having EPO biological activity are selected from the group consisting of erythropoietin analogs, erythropoietin isoforms, and renal erythropoietin.  
   
   
       222 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering EPO derived from the group consisting of naturally occurring EPO, recombinant EPO, and synthetic EPO.  
   
   
       223 . The method of  claim 205 , wherein said patient has anemia.  
   
   
       224 . The method of  claim 223 , wherein said anemia comprises EPO concentration related anemia.  
   
   
       225 . The method of  claim 224 , wherein said anemia is selected from the group consisting of end-stage renal failure, renal failure related anemia, and dialysis related anemia.  
   
   
       226 . The method of  claim 223 , wherein said anemia comprises cancer chemotherapy related anemia.  
   
   
       227 . The method of  claim 223 , wherein said anemia comprises AIDS drug therapy related anemia.  
   
   
       228 . The method of  claim 223 , wherein said anemia comprises drug related anemia.  
   
   
       229 . The method of  claim 228 , wherein said drug is selected from the group consisting of cisplatin and carboplatin.  
   
   
       230 . The method of  claim 228 , wherein the drug is zidovudine.  
   
   
       231 . The method of  claim 205 , wherein said patient is undergoing blood donation.  
   
   
       232 . The method of  claim 205 , wherein said patient has received a bone marrow transplant.  
   
   
       233 . The method of  claim 205 , wherein said patient has rheumatoid arthritis.  
   
   
       234 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering EPO via a route selected fin the group consisting of intravenous administration, subcutaneous administration, and parental administration.  
   
   
       235 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering EPO having a modified glycosylation pattern.  
   
   
       236 . The method of  claim 235 , wherein said EPO having a modified glycosylation pattern comprises darbepoietin alpha.  
   
   
       237 . The method of  claim 204  further comprising the step of: 
 providing EPO in conjunction with said providing to a consumer an EPO dosing regimen.    
   
   
       238 . The method of  claim 204 , wherein said providing step comprises selling.  
   
   
       239 . The method of  claim 237 , wherein said providing step comprises selling.  
   
   
       240 . The method of  claim 204 , wherein said providing step is performed through the use of a computer system.  
   
   
       241 . The method of  claim 237 , wherein said providing step is performed through the use of a computer system.  
   
   
       242 . The method of  claim 204 , wherein said EPO is purified hyperglycosylated erythropoietin.  
   
   
       243 . The method of  claim 242 , wherein said purified hyperglycosylated erythropoietin is hyperglycosylated human erythropoietin.  
   
   
       244 . The method of  claim 204 , wherein said EPO dosing regimen comprises administering EPO about once every four weeks.