METHODS OF NORMALIZING MEASURED DRUG CONCENTRATIONS AND TESTING FOR NON-COMPLIANCE WITH A DRUG TREATMENT REGIMEN

摘要

Methods for monitoring subject compliance with a prescribed treatment regimen are disclosed. In one embodiment, the method comprises measuring a drug level in fluid of a subject and normalizing said measured drug level as a function of one or more parameters associated with the subject. The normalized drug level is compared to a reference value and associated confidence intervals or to a concentration range. The reference value and associated confidence intervals and/or the concentration range may be normalized based on one or more parameters associated with subjects in a reference population.

主权项

1. A method of creating confidence intervals for a prescribed opioid regimen by:
(a) administering to a plurality of members of a population the opioid regimen for a time sufficient to achieve steady state; (b) measuring a raw urine opioid level in a plurality of members of the population, wherein said raw opioid level is measured by a least one of GC-MS or LC-MS-MS; (c) normalizing the raw urine opioid levels as a function of at least one of urine pH, urine specific gravity, urine creatinine concentration, subject height, subject weight, subject age, subject body mass index, subject gender, subject lean body mass, and subject body surface area; (d) determining a mean or median estimate of the normalized opioid levels for the prescribed opioid regimen; and (e) determining upper and lower confidence intervals for the normalized mean or median estimate.