Optimization and individualization of medication selection and dosing

Abstract

Described are methods for treating a patient with a therapeutic drug using a combination of genetic and non-genetic information to tailor the dose of the drug to the patient.

1 . A computerized method and/or computer-assisted method of selecting a dosing regimen for a patient the method comprising the steps of:
 (a) integrating patient data with patient associated genotype information;   (b) generating a drug concentration profile for the patient;   (c) integrating the drug concentration profile and the target drug concentration profile; and   (d) providing a dosing regimen for a first compound likely to result in the target drug concentration profile in the subject.   
     
     
         2 .- 11 . (canceled) 
     
     
         12 . A computerized method and/or computer-assisted method of selecting a dosing regimen for a patient the method comprising the steps of:
 (a) generating statistical population models of drug interactions for a plurality of genotypes;   (b) obtaining patient associated genotype information;   (c) establishing a dosing regimen by applying the genotype information against the population models.   
     
     
         13 - 14 . (canceled) 
     
     
         15 . A computerized method and/or computer-assisted method for selecting one or more drugs for a patient comprising the steps of:
 identifying the phenotype;   providing a first plurality of possible medications based upon the identified phenotype;   calculating a ranked list or a predictive index of medications from the first plurality of medications based upon, at least in part, patient specific genetic factors, non-heritable patient factors and drug specific factors.   
     
     
         16 .- 26 . (canceled) 
     
     
         27 . A computerized method and/or computer-assisted method for selecting a starting dose of a medication for a patient comprising the steps of:
 for a given medication, determining if the patient is an extensive metabolizer for the medication, an intermediate metabolizer for the medication, or a poor metabolizer for the medication;   calculating the starting dose based upon, at least in part, a usual drug dose for a given population (D pop ), the frequency of extensive metabolizers in the given population (f E   u ), the frequency of intermediate metabolizers in the given population (fi M ) and/or the frequency of poor metabolizers in the general population (fp M ); and   determining a minimal dose adjustment unit for the medication based, at least in part, upon the patient's genetic information.   
     
     
         28 .- 39 . (canceled) 
     
     
         40 . A method of selecting a medication for a patient suffering from a neuropsychiatric disease or disorder comprising:
 obtaining an individualized medication report for the patient, the report comprising at least one group of medications, wherein the report is generated by:
 (a) providing a first set of possible medications for the patient comprising at least one medication selected from propranolol, diazepam, alprazolam and risperidone, selection of the first set of medications determined based on the patient's phenotype; 
 (b) calculating a score based on the patient's genotype for each of the possible medications, the patient's genotype having been determined by a genotyping assay for CYP genes comprising 1A2, 2B6, 2C9, 2C19, 2D6 and 3A4 using a biological sample obtained from the patient; and 
 (c) providing at least one group of possible medications based on the score of each medication; and 
   selecting, from the individualized medication report, a medication based on the report.   
     
     
         41 . The method of  claim 40 , wherein a score is calculated for each of propranolol, diazepam, alprazolam and risperidone. 
     
     
         42 . The method of  claim 40 , wherein the patient's genotype is determined by genotyping one or more further genes selected from DAT1, SLC6A3, DRD1, DRD2, DRD3, DRD4, DRD5, TPH, 5-HTTR, HTR1A, HTR1B, HTR1D, HTR2A, HTR2C and COMT. 
     
     
         43 . The method of  claim 40 , wherein the group of possible medications includes medications selected from one or more of the classes of medications consisting of antidepressants, antipsychotics, and mood elevating or stabilizing agents. 
     
     
         44 . The method of  claim 40 , wherein the report is generated by a method comprising calculating the score based on the patient's genotype and a non-heritable patient factor. 
     
     
         45 . The method of  claim 44 , wherein the non-heritable patient factor comprises toxic exposure. 
     
     
         46 . The method of  claim 45 , wherein the toxic exposure is smoke. 
     
     
         47 . The method of  claim 45 , wherein the toxic exposure is alcohol. 
     
     
         48 . The method of  claim 44 , wherein the report is generated by a method further comprising obtaining or having obtained patient information from the patient regarding the non-heritable patient factor, and calculating the score based on the patient's genotype and the patient information regarding the non-heritable patient factor. 
     
     
         49 . The method of  claim 40 , additionally comprising administering the selected medication to the patient. 
     
     
         50 . The method of  claim 40 , additionally comprising determining a starting dose of the selected medication for administration to the patient. 
     
     
         51 . The method of  claim 50 , additionally comprising administering the starting dose of the selected medication to the patient. 
     
     
         52 . The method of  claim 40 , wherein the genotyping assay for CYP genes indicates catalytic activity of proteins encoded by 1A2, 2B6, 2C9, 2C19, 2D6 and 3A4. 
     
     
         53 . The method of  claim 52 , wherein the calculated score for each of the possible medications indicates the patient's ability to metabolize each of the possible medications. 
     
     
         54 . The method of  claim 53 , wherein selecting the medication based on the report or determining a starting dose of the selected medication for administration to the patient is based on the calculated score for each of the possible medications.