DK2533768T3 - Fremgangsmåder til normalisering af målte oxycodonkoncentrationer og afprøvning for uoverensstemmelse med en behandlingsplan - Google Patents

Fremgangsmåder til normalisering af målte oxycodonkoncentrationer og afprøvning for uoverensstemmelse med en behandlingsplan Download PDF

Info

Publication number
DK2533768T3
DK2533768T3 DK11742895.3T DK11742895T DK2533768T3 DK 2533768 T3 DK2533768 T3 DK 2533768T3 DK 11742895 T DK11742895 T DK 11742895T DK 2533768 T3 DK2533768 T3 DK 2533768T3
Authority
DK
Denmark
Prior art keywords
drug
normalized
subject
subjects
concentration
Prior art date
Application number
DK11742895.3T
Other languages
English (en)
Inventor
Harry Leider
Ariel Linden
Original Assignee
Ameritox Ltd Partnership
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ameritox Ltd Partnership filed Critical Ameritox Ltd Partnership
Application granted granted Critical
Publication of DK2533768T3 publication Critical patent/DK2533768T3/da

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • G01N33/9486—Analgesics, e.g. opiates, aspirine

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Pathology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)

Claims (3)

1. Fremgangsmåde til formindskelse af en risiko for lægemiddelmisbrug hos en person, omfattende: bestemmelse af en ordineret daglig dosis af et lægemiddel hos personen, hvor lægemidlet omfatter oxycodon, oxycodon med kontrolleret frigivelse eller en metabolit af oxycodon; måling afen koncentration af lægemidlet i urin hos personen; måling af parametre associeret med personen, bestående af urinmassefylde, pH-værdi af urin og personens muskelmasse; beregning af en normaliseret værdi (N) som en funktion af (i) lægemiddelkoncentrationen og (ii) parametrene under anvendelse af den følgende ligning: [N] = [C] x ((SGN-1,00)/(SG-1,00) x (LBW/122) x (pH/8,50)0·56, hvor [C] er den rå lægemiddelkoncentration i ng/ml, SGN er den normaliserede urinmassefylde, SG er urinens massefylde, LBW er personens muskelmasse, og pH er urinens pH-værdi; sammenligning af den normaliserede værdi med en normaliseret middelværdi eller et normaliseret medianestimat svarende til den ordinerede daglige dosis af lægemidlet; identifikation af personen ved høj risiko for lægemiddelmisbrug, såfremt den normaliserede lægemiddelkoncentration falder udenfor den normaliserede middelværdi eller det normaliserede medianestimat svarende til den ordinerede daglige dosis af lægemidlet; og derefter ændring af den daglige dosis af lægemidlet ordineret til personen.
2. Fremgangsmåde ifølge krav 1, ved hvilken koncentrationen af lægemidlet måles under anvendelse af LC-MS-MS eller GC-MS-MS.
3. Fremgangsmåde ifølge krav 1, ved hvilken det normaliserede medianestimat og associerede øvre og nedre konfidensniveauer svarende til den ordinerede daglige dosis af lægemidlet bestemmes ved: måling af en stationær lægemiddelkoncentration i urin hos hvert af et stort antal medlemmer af en befolkning; måling af én eller flere parametre hos hvert medlem; normalisering af lægemiddelkoncentrationen for hvert medlem som en funktion af parameteren eller parametrene; bestemmelse af det normaliserede medianestimat svarende til den ordinerede daglige dosis af lægemidlet ud fra de normaliserede lægemiddelkoncentrationer hos befolkningen; og bestemmelse af øvre og nedre konfidensintervaller for det normaliserede medianestimat.
DK11742895.3T 2010-02-11 2011-02-11 Fremgangsmåder til normalisering af målte oxycodonkoncentrationer og afprøvning for uoverensstemmelse med en behandlingsplan DK2533768T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US30346710P 2010-02-11 2010-02-11
PCT/US2011/024591 WO2011100588A1 (en) 2010-02-11 2011-02-11 Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen

Publications (1)

Publication Number Publication Date
DK2533768T3 true DK2533768T3 (da) 2015-10-19

Family

ID=44368162

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11742895.3T DK2533768T3 (da) 2010-02-11 2011-02-11 Fremgangsmåder til normalisering af målte oxycodonkoncentrationer og afprøvning for uoverensstemmelse med en behandlingsplan

Country Status (9)

Country Link
US (1) US20110224910A1 (da)
EP (2) EP2942055A1 (da)
JP (1) JP5795006B2 (da)
AU (1) AU2011215707A1 (da)
CA (1) CA2789335A1 (da)
DK (1) DK2533768T3 (da)
ES (1) ES2544873T3 (da)
PL (1) PL2533768T3 (da)
WO (1) WO2011100588A1 (da)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013123236A1 (en) * 2012-02-14 2013-08-22 Purdue Pharma L.P. Systems and methods to quantify analytes in keratinized samples
AU2014232758A1 (en) * 2013-03-15 2015-10-08 Ameritox, Ltd. Methods of normalizing measured drug concentrations and testing for potential non-compliance with a drug treatment regimen
CN111489822A (zh) * 2020-04-02 2020-08-04 首都医科大学附属北京安定医院 一种治疗药物监测结果解释系统

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE245814T1 (de) * 1993-11-02 2003-08-15 U D Testing Inc Verffahren zum überwachen der befolgung einer vorgeschriebenen medikation durch einen patienten
EP1339879A4 (en) * 2001-06-05 2004-12-29 Genaissance Pharmaceuticals METHOD OF IDENTIFYING POLYMORPHISM IN CYP2D6
US7585680B2 (en) * 2003-08-28 2009-09-08 Marshfield Medical Research And Education Foundation Method and device for monitoring medication usage
US8073633B2 (en) * 2008-12-30 2011-12-06 The Invention Science Fund I, Llc Computational methods and systems for suggesting modulators of CYP450 as treatment options

Also Published As

Publication number Publication date
EP2533768A1 (en) 2012-12-19
AU2011215707A1 (en) 2012-09-20
EP2533768B1 (en) 2015-07-22
EP2533768A4 (en) 2013-07-10
EP2942055A1 (en) 2015-11-11
WO2011100588A1 (en) 2011-08-18
PL2533768T3 (pl) 2015-12-31
CA2789335A1 (en) 2011-08-18
JP5795006B2 (ja) 2015-10-14
US20110224910A1 (en) 2011-09-15
JP2013519883A (ja) 2013-05-30
AU2011215707A2 (en) 2012-09-27
ES2544873T3 (es) 2015-09-04

Similar Documents

Publication Publication Date Title
US20110195520A1 (en) Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen
Christo et al. Urine drug testing in chronic pain
Butler et al. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R)
US20140287529A1 (en) Methods of normalizing measured drug concentrations and testing for potential non-compliance with a drug treatment regimen
DK2533768T3 (da) Fremgangsmåder til normalisering af målte oxycodonkoncentrationer og afprøvning for uoverensstemmelse med en behandlingsplan
US20160041146A1 (en) Methods of normalizing the ratio of measured parent and metabolite drug concentrations in fluids and testing for non-compliance
O'Malley et al. Effects of the opioid system modulator, samidorphan, on measures of alcohol consumption and patient‐reported outcomes in adults with alcohol dependence
CN117423427A (zh) 一种临床决策模型的重抽样检测方法
Dunn et al. Individual differences in human opioid abuse potential as observed in a human laboratory study
US20160252483A1 (en) Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen
JP5796873B2 (ja) 測定された薬物濃度の正規化方法、及び薬物治療レジメンのノンコンプライアンスを検査するための方法
Shelton et al. Measuring adherence in a community-based elderly population
US20180045744A1 (en) Normalizing measured drug concentrations in oral fluids and testing for potential non-compliance with drug treatment regimen
US20160300038A1 (en) Methods of normalizing measured drug concentrations in urine using patient specific data and testing for potential non-compliance with a chronic drug treatment regimen
Hernández et al. Potentially inappropriate medication in elderly
Khine et al. Screening of nyaope use by rapid urine testing
DHAWAN et al. Comparison of accuracy of self-report and urinanalysis results in opiate dependent patients
Alshehri Best practices for monitoring opioid compliance—making the case for usingblood and liquid chromatography–tandem mass spectrometry for screen analysis.