Development of a dried blood spot sampling method towards therapeutic monitoring of radotinib in the treatment of chronic myeloid leukaemia.

What is known and objective: Dried blood spot (DBS) sampling is a minimally invasive method of blood sampling that enables monitoring of drug concentrations to be more convenient. This study aimed at developing a DBS sampling method for an accurate and precise prediction of radotinib plasma concentr...

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Publicado en:Journal of Clinical Pharmacy & Therapeutics Vol. 45; no. 5; pp. 1006 - 1014
Autores principales: Lee, Jihyun, Jung, Su Young, Choi, Mi‐Yeon, Park, Ji‐su, Park, Su‐kyoung, Lim, Seon‐Ah, Cho, Kyung Hee, Oh, Soo Yeon, Ha, Jungeun, Kim, Dong‐Wook, Lee, Jangik
Formato: equations & formulas research tables/charts Journal Article
Publicado: Wiley-Blackwell Oct2020
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Oct2020
      vid: 45
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/jcpt.13124
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        atl: Development of a dried blood spot sampling method towards therapeutic monitoring of radotinib in the treatment of chronic myeloid leukaemia.
      aug:
        au:
          Lee, Jihyun
          Jung, Su Young
          Choi, Mi‐Yeon
          Park, Ji‐su
          Park, Su‐kyoung
          Lim, Seon‐Ah
          Cho, Kyung Hee
          Oh, Soo Yeon
          Ha, Jungeun
          Kim, Dong‐Wook
          Lee, Jangik
        affil: Department of Pharmacy, College of Pharmacy, Seoul National University, Seoul, Korea
      sug:
        subj:
          Blood Chemical Analysis
          Blood Specimen Collection Methods
          Drug Monitoring Methods
          Leukemia, Myeloid, Chronic Drug Therapy
          Antineoplastic Agents Therapeutic Use
          Tyrosine Kinase Inhibitors Therapeutic Use
          Tyrosine Kinase Inhibitors Blood
          Human
          Cancer Patients
          Chromatography, High Pressure Liquid Methods
          Mass Spectrometry Methods
          Regression
          Descriptive Statistics
      ab: What is known and objective: Dried blood spot (DBS) sampling is a minimally invasive method of blood sampling that enables monitoring of drug concentrations to be more convenient. This study aimed at developing a DBS sampling method for an accurate and precise prediction of radotinib plasma concentrations (Cp) in patients with chronic myeloid leukaemia (CML). Methods: Dried blood spot and venous blood samples were simultaneously collected from fifty CML patients who had been receiving radotinib for at least a week. Radotinib concentrations were measured using a high‐performance liquid chromatographic method with tandem mass spectrometric detection. Unmeasured Cp was predicted directly based on a Deming regression between DBS concentrations (CDBS) and Cp. Unmeasured Cp was also predicted from CDBS corrected by each patient's haematocrit (Hct). Both prediction methods were evaluated for their accuracy and precision using Deming regression and Bland‐Altman analysis. Results and discussion: The Deming regression equation between CDBS and Cp was obtained as follows: Cp = 1.34∙CDBS + 4.26 (r2 =.97). Cp was directly predictable using Cp,pred1 = 1.34∙CDBS + 4.26. With Hct correction, Cp was alternatively predictable using Cp,pred2 = CDBS/ (1–Hct + Hct2). The slopes of Deming regression line between predicted and measured Cp were 0.99 and 1.02 for the direct and Hct‐corrected method, respectively. The mean biases (accuracy) were −0.44% and 1.6% with the 95% limits of agreement (precision) of −22.4% to 21.5% and −20.5% to 23.7%, respectively. More than 93% of predicted and measured Cp pairs had their differences within 20% of the mean of each pair in both methods. What is new and conclusions: Radotinib CDBS are highly correlated with radotinib Cp. Radotinib Cp can be accurately and precisely predicted from CDBS using direct or Hct‐corrected prediction methods. Both appear to be appropriate for the therapeutic monitoring of radotinib in patients with CML.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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