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  1. Article: Sub-therapeutic trimethoprim and sulfamethoxazole plasma concentrations during continuous venovenous hemofiltration in a patient with COVID-19 and pulmonary

    le Noble, Jos L M L / Foudraine, Norbert / van der Elst, Kim C M / Bouwman, Sander

    International journal of clinical pharmacology and therapeutics

    2023  Volume 61, Issue 11, Page(s) 525–530

    Abstract: Objective: To investigate drug concentration of trimethoprim-sulfamethoxazole (TMP-SMX) using therapeutic drug monitoring (TDM) for severe : Materials and methods: A 72-year-old man with hypoxemic respiratory failure due to COVID-19 infection was ... ...

    Abstract Objective: To investigate drug concentration of trimethoprim-sulfamethoxazole (TMP-SMX) using therapeutic drug monitoring (TDM) for severe
    Materials and methods: A 72-year-old man with hypoxemic respiratory failure due to COVID-19 infection was admitted to the intensive care unit for invasive mechanical ventilation. The patient developed acute renal failure that required RCA-CVVH. Pulmonary co-infection with PJP was diagnosed, and a high TMP-SMX dose was initiated according to (inter)national guidelines with dose reduction after 3 days because of renal failure. Population pharmacokinetics were assessed for TMP and SMX as well as clearance by RCA-CVVH, volume of distribution, and time above threshold levels for measured plasma concentrations.
    Results: During renal failure requiring RCA-CVVH, a corresponding dose reduction of TMP-SMX to 320/1,600 mg twice a day, according to current Dutch SWAB and Dutch Association of Hospital Pharmacists guidelines, resulted in unintended under-dosing with sub-therapeutic TMP-SMX concentrations. Pharmacokinetic modeling and dose adjustment of TMP-SMX to 640/3,200 mg 3 times daily resulted in steady-state TMP-SMX peak concentrations associated with efficacy against PJP. Hence, the patient was successfully weaned from the ventilator and discharged.
    Conclusion: We hypothesize that our new dose recommendation of 640/3,200 mg TMP-SMX 3 times daily is associated with an increased probability of critical patients being successfully liberated from mechanical weaning following PJP pneumonia and COVID-19 infection.
    MeSH term(s) Male ; Humans ; Aged ; Trimethoprim, Sulfamethoxazole Drug Combination ; Pneumocystis carinii ; Pneumonia, Pneumocystis/complications ; Pneumonia, Pneumocystis/diagnosis ; Pneumonia, Pneumocystis/drug therapy ; Continuous Renal Replacement Therapy ; Coinfection/drug therapy ; COVID-19/complications ; COVID-19/therapy ; Renal Insufficiency ; Retrospective Studies
    Chemical Substances Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2)
    Language English
    Publishing date 2023-07-24
    Publishing country Germany
    Document type Case Reports ; Journal Article
    ZDB-ID 124384-6
    ISSN 0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
    ISSN 0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
    DOI 10.5414/CP204407
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  2. Article ; Online: Association of Lamotrigine Plasma Concentrations with Efficacy and Toxicity in Patients with Epilepsy: A Retrospective Study.

    Lee, Ze-Ning / van Nuland, Merel / Bognàr, Tim / Leijten, Frans S S / van der Elst, Kim C M

    Therapeutic drug monitoring

    2024  

    Abstract: Background: There is limited evidence to support the currently suggested lamotrigine (LTG) therapeutic reference range of 2.5-15 mg/L for the treatment of seizures. The objective of this study was to evaluate the association of LTG plasma concentrations ...

    Abstract Background: There is limited evidence to support the currently suggested lamotrigine (LTG) therapeutic reference range of 2.5-15 mg/L for the treatment of seizures. The objective of this study was to evaluate the association of LTG plasma concentrations with the efficacy and toxicity of the treatment in patients with epilepsy.
    Methods: Patients whose LTG plasma concentration was measured between January 2013 and February 2022 were included. Efficacy was defined as seizure freedom for at least 6 months around the time of measured LTG concentration. Toxicity was defined as any LTG-related adverse drug effect documented in each patient's health record or when the reason for measuring the LTG concentration was toxicity. In addition, the dose-concentration relationship of LTG was assessed.
    Results: In total, 549 concentrations from 259 patients with epilepsy were included. The most common reasons for therapeutic drug monitoring were suspected inefficacy (39%) and pregnancy (21%). The LTG plasma concentration was not associated with efficacy (adjusted odds ratio = 0.94; 95% confidence interval, 0.85-1.04). The LTG plasma concentration was positively associated with the incidence of toxicity after adjusting for age, sex, and number of antiepileptic drugs (odds ratio = 1.11; 95% confidence interval, 1.04-1.19). The daily dose had a significant linear correlation with the LTG plasma concentration (P < 0.001).
    Conclusions: The LTG plasma concentration was associated with toxicity, whereas no association with efficacy was found. A reference range of 2.5-10 mg/L may be considered to decrease the risk of toxicity while maintaining similar efficacy. Therapeutic drug monitoring may be useful when LTG-related toxicity is suspected and in cases of pharmacokinetic changes (eg, pregnancy and concomitant use of interacting drugs) that can influence the LTG plasma concentration.
    Language English
    Publishing date 2024-04-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 424443-6
    ISSN 1536-3694 ; 0163-4356
    ISSN (online) 1536-3694
    ISSN 0163-4356
    DOI 10.1097/FTD.0000000000001205
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  3. Article ; Online: Ion suppression, reduced long-term robustness and leakage current of the spray voltage during the ionization of trichloroacetic acid; a case study with a methylmalonic acid assay.

    Punt, Arjen M / van der Elst, Kim C M / Huitema, Alwin D R / Lentjes, Eef G W M

    Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

    2023  Volume 1224, Page(s) 123727

    Abstract: Sample clean-up with the protein precipitation solvent trichloroacetic acid (TCA), combined with a stable isotope labeled internal standard, is widely used for the analysis of endogenous and exogenous compounds in serum and plasma with liquid ... ...

    Abstract Sample clean-up with the protein precipitation solvent trichloroacetic acid (TCA), combined with a stable isotope labeled internal standard, is widely used for the analysis of endogenous and exogenous compounds in serum and plasma with liquid chromatography-tandem mass spectrometry (LC-MS/MS). During the application of an assay for methylmalonic acid (MMA), used for routine analysis in patient care, negative long-term side effects of TCA on assay performance were observed. Step-by-step extensive troubleshooting disclosed the limitations of using TCA in MS. After running over 2000 samples with the MMA assay over a course of one year, a black coating formed between the probe and the heater that was traced to the use of TCA. The MMA assay used a C18 column with an isocratic eluent of 95% water (0.1% formic acid) as starting condition, on which TCA was more retained than MMA. Next, concentrations of 2.2% TCA in the prepared serum or plasma sample caused a drop in spray voltage during ionization into the MS. This was caused by the strong acid properties of TCA, resulting in current loss of the spray voltage between the heated electrospray ionization (HESI) needle and the union holder, which had also a grounding function. Replacing the original metal HESI needle with a custom made fussed silica HESI needle or detaching the union from the union holder, eliminated the effect of the drop in spray voltage. In conclusion, TCA can seriously affect the long-term robustness by affecting the source of the MS. We recommend the use of a very low sample injection volume, and/or shifting the mobile phase to waste when TCA is eluting, when using TCA in LC-MS/MS analysis.
    MeSH term(s) Humans ; Chromatography, Liquid/methods ; Tandem Mass Spectrometry/methods ; Methylmalonic Acid ; Trichloroacetic Acid ; Plasma ; Spectrometry, Mass, Electrospray Ionization/methods
    Chemical Substances Methylmalonic Acid (8LL8S712J7) ; Trichloroacetic Acid (5V2JDO056X)
    Language English
    Publishing date 2023-05-01
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1180823-8
    ISSN 1873-376X ; 0378-4347 ; 1570-0232 ; 1387-2273
    ISSN (online) 1873-376X
    ISSN 0378-4347 ; 1570-0232 ; 1387-2273
    DOI 10.1016/j.jchromb.2023.123727
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  4. Article ; Online: Middle-up quantification of therapeutic monoclonal antibodies in human plasma with two dimensional liquid chromatography high resolution mass spectrometry: Adalimumab as a proof of principle.

    Amrani, Mohsin El / van der Elst, Kim C M / Huitema, Alwin D R / van Luin, Matthijs

    Journal of chromatography. A

    2022  Volume 1665, Page(s) 462840

    Abstract: Next generation human therapeutic monoclonal antibodies (t-mAbs) are harder to quantify with the widely used bottom-up tryptic digestion method. Due to their homology with endogenous immunoglobulins, there is a lack of unique and stable 'signature' ... ...

    Abstract Next generation human therapeutic monoclonal antibodies (t-mAbs) are harder to quantify with the widely used bottom-up tryptic digestion method. Due to their homology with endogenous immunoglobulins, there is a lack of unique and stable 'signature' peptides that can be targeted. Middle-up two dimensional liquid chromatography high resolution mass spectrometry (2D-LC-HRMS), targeting the entire light chain, was examined as an alternative. Adalimumab (ADM) was successfully quantified in human plasma after Melon® Gel sample purification, followed by orthogonal separation on a weak cation exchange (WCX) and reversed phase column. Charge and hydrophobicity were used to separate ADM from the polyclonal immunoglobulin background. HRMS with its high resolution and exact mass was able to isotopically resolve the ADM light chain and to provide another separation dimension on the basis of mass to charge ratio. Using the targeted single ion monitoring (T-SIM) with multiplex (MSX) option, three ADM light chain precursors, 2341.80, 2129.00, and 1951.68 m/z, and one internal standard precursor 2146.39 m/z, were measured simultaneously. The Melon® Gel sample purification was found to be very efficient in removing plasma proteins that would otherwise interfere with chromatographic separation and ionization. The linearity of the method for the analysis of ADM was excellent (R
    Language English
    Publishing date 2022-01-21
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1171488-8
    ISSN 1873-3778 ; 0021-9673
    ISSN (online) 1873-3778
    ISSN 0021-9673
    DOI 10.1016/j.chroma.2022.462840
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  5. Article: Middle-up quantification of therapeutic monoclonal antibodies in human plasma with two dimensional liquid chromatography high resolution mass spectrometry: Adalimumab as a proof of principle

    Amrani, Mohsin El / van der Elst, Kim C.M. / Huitema, Alwin D.R. / van Luin, Matthijs

    Journal of chromatography. 2022 Feb. 22, v. 1665

    2022  

    Abstract: Next generation human therapeutic monoclonal antibodies (t-mAbs) are harder to quantify with the widely used bottom-up tryptic digestion method. Due to their homology with endogenous immunoglobulins, there is a lack of unique and stable ‘signature’ ... ...

    Abstract Next generation human therapeutic monoclonal antibodies (t-mAbs) are harder to quantify with the widely used bottom-up tryptic digestion method. Due to their homology with endogenous immunoglobulins, there is a lack of unique and stable ‘signature’ peptides that can be targeted. Middle-up two dimensional liquid chromatography high resolution mass spectrometry (2D-LC-HRMS), targeting the entire light chain, was examined as an alternative. Adalimumab (ADM) was successfully quantified in human plasma after Melon® Gel sample purification, followed by orthogonal separation on a weak cation exchange (WCX) and reversed phase column. Charge and hydrophobicity were used to separate ADM from the polyclonal immunoglobulin background. HRMS with its high resolution and exact mass was able to isotopically resolve the ADM light chain and to provide another separation dimension on the basis of mass to charge ratio. Using the targeted single ion monitoring (T-SIM) with multiplex (MSX) option, three ADM light chain precursors, 2341.80, 2129.00, and 1951.68 m/z, and one internal standard precursor 2146.39 m/z, were measured simultaneously. The Melon® Gel sample purification was found to be very efficient in removing plasma proteins that would otherwise interfere with chromatographic separation and ionization. The linearity of the method for the analysis of ADM was excellent (R²=0.999) between 1 – 128 mg/L with an LLOQ signal to noise ratio (S/N) of 10. Within-run and between-run precision and accuracy were in concordance with the EMA guideline. Cross-validation of the 2D-LC-HRM method with the standard peptide LC-MS/MS method showed a good agreement (R² = 0.86) between the methods. However, there was a bias present, possibly due to charge variant ADM formation over time. Since the presented 2D-LC-HRMS method is able to measure only the native form of ADM, it is able to provide a measure of the active form of ADM in patients.
    Keywords cation exchange ; digestion ; guidelines ; humans ; hydrophobicity ; immunoglobulins ; ionization ; liquid chromatography ; peptides ; signal-to-noise ratio ; therapeutics
    Language English
    Dates of publication 2022-0222
    Publishing place Elsevier B.V.
    Document type Article
    ZDB-ID 218139-3
    ISSN 0021-9673 ; 0378-4355 ; 0376-737X
    ISSN 0021-9673 ; 0378-4355 ; 0376-737X
    DOI 10.1016/j.chroma.2022.462840
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  6. Article ; Online: Pharmacokinetic investigations of isavuconazole in paediatric cancer patients show reduced exposure of isavuconazole after opening capsules for administration via a nasogastric tube.

    Bury, Didi / Wolfs, Tom F W / Ter Heine, Rob / Muilwijk, Eline W / van der Elst, Kim C M / Tissing, Wim J E / Brüggemann, Roger J M

    The Journal of antimicrobial chemotherapy

    2024  Volume 78, Issue 12, Page(s) 2886–2889

    Abstract: Objectives: To study the isavuconazole pharmacokinetics in a real-life paediatric cohort and confirm whether the isavuconazole exposures are within the adult exposure range. Furthermore, we are the first to describe unbound isavuconazole ... ...

    Abstract Objectives: To study the isavuconazole pharmacokinetics in a real-life paediatric cohort and confirm whether the isavuconazole exposures are within the adult exposure range. Furthermore, we are the first to describe unbound isavuconazole pharmacokinetics.
    Methods: In this prospective, observational study, the isavuconazole dosing regimen was as follows (IV/oral/nasogastric tube): 5.4 mg/kg isavuconazole (maximum 200 mg/dose) three times daily on Days 1 and 2, followed by 5.4 mg/kg isavuconazole (maximum 200 mg/dose) once daily. At least one pharmacokinetic curve was assessed. Non-linear mixed effects modelling was used for analysis. Monte Carlo simulations were performed with the above mentioned maintenance dose for IV administrations and a weight band dosing regimen for oral/nasogastric tube administrations: I) <18 kg (100 mg daily); II) 18-37 kg (150 mg daily); III)>37 kg (200 mg daily).
    Results: Seventeen paediatric patients with a median age of 9 years (range 1-17) and median weight of 26.0 kg (range 8.4-78.5) were evaluated. A two-compartment model describing linear pharmacokinetics of the unbound concentrations and saturable protein binding fitted the isavuconazole concentrations best. The absolute bioavailability of isavuconazole was 41.0% (95% CI: 32.4%-50.8%). The median (IQR) simulated exposures (AUC0-24h, SS) of the total isavuconazole concentrations after IV and oral/nasogastric tube administration were 87.7 mg·h/L (70.5-105.1) and 50.3 mg·h/L (39.0-62.4), respectively. The unbound isavuconazole fraction (unbound/total) ranged from 0.5% to 2.3%.
    Conclusions: This study revealed low bioavailability after nasogastric tube administration with opened capsules. Isavuconazole exposures were in the expected range following IV administration. Total and unbound isavuconazole pharmacokinetics were reported with a 5-fold range in the unbound fraction.
    MeSH term(s) Adult ; Humans ; Child ; Infant ; Child, Preschool ; Adolescent ; Prospective Studies ; Nitriles ; Pyridines ; Neoplasms
    Chemical Substances isavuconazole (60UTO373KE) ; Nitriles ; Pyridines
    Language English
    Publishing date 2024-02-26
    Publishing country England
    Document type Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 191709-2
    ISSN 1460-2091 ; 0305-7453
    ISSN (online) 1460-2091
    ISSN 0305-7453
    DOI 10.1093/jac/dkad324
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  7. Article: Optimization of a Quantitative Anti-Drug Antibodies against Infliximab Assay with the Liquid Chromatography-Tandem Mass Spectrometry: A Method Validation Study and Future Perspectives.

    Smeijsters, Erin H / van der Elst, Kim C M / Visch, Amy / Göbel, Camiel / Loeff, Floris C / Rispens, Theo / Huitema, Alwin D R / van Luin, Matthijs / El Amrani, Mohsin

    Pharmaceutics

    2023  Volume 15, Issue 5

    Abstract: Monoclonal antibodies (mAbs), such as infliximab, are important treatment options for different diseases. Immunogenicity is a major risk, resulting in anti-drug antibodies (ADAs), being associated with adverse events and loss of response, influencing ... ...

    Abstract Monoclonal antibodies (mAbs), such as infliximab, are important treatment options for different diseases. Immunogenicity is a major risk, resulting in anti-drug antibodies (ADAs), being associated with adverse events and loss of response, influencing long-term outcomes. The development of ADAs against infliximab is primarily measured by immunoassays like radioimmunoassay (RIA). Although liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly utilized across different fields, this technique is currently not used for ADAs against infliximab measurements. Therefore, we developed the first LC-MS/MS method. Stable isotopically labeled infliximab antigen-binding fragments (SIL IFX F(ab')
    Language English
    Publishing date 2023-05-12
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2527217-2
    ISSN 1999-4923
    ISSN 1999-4923
    DOI 10.3390/pharmaceutics15051477
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  8. Article ; Online: A generic sample preparation method for the multiplex analysis of seven therapeutic monoclonal antibodies in human plasma or serum with liquid chromatography-tandem mass spectrometry.

    Amrani, Mohsin El / Gerencser, Laszlo / Huitema, Alwin D R / Hack, C Erik / van Luin, Matthijs / van der Elst, Kim C M

    Journal of chromatography. A

    2021  Volume 1655, Page(s) 462489

    Abstract: Due to the increasing number of therapeutic monoclonal antibodies (mAbs) used in the clinic, there is an increasing need for robust analytical methods to quantify total mAb concentrations in human plasma for clinical studies and therapeutic drug ... ...

    Abstract Due to the increasing number of therapeutic monoclonal antibodies (mAbs) used in the clinic, there is an increasing need for robust analytical methods to quantify total mAb concentrations in human plasma for clinical studies and therapeutic drug monitoring. We developed an easy, rapid, and robust sample preparation method for liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. The method was validated for infliximab (IFX), rituximab (RTX), cetuximab (CTX), dupilumab (DPL), dinutuximab (DNX), vedolizumab (VDZ), and emicizumab (EMZ). Saturated ammonium sulfate (AS) was used to precipitate immunoglobulins in human plasma. After centrifugation, supernatant containing albumin was decanted, and the precipitated immunoglobulin fraction was re-dissolved in buffer containing 6M guanidine. This fraction was then completely denatured, reduced, alkylated, and trypsin digested. Finally, signature peptides from the seven mAbs were simultaneously quantified on LC-MS/MS together with their internal standards stable isotopically labeled peptide counterparts. The linear dynamic ranges (1 - 512 mg/L) of IFX, CTX, RTX, and EMZ showed excellent (R2 > 0.999) linearity and those of DPL, DNX, and VDZ showed good (R2 > 0.995) linearity. The method was validated in accordance with the EMA guidelines. EDTA plasma, sodium citrate plasma, heparin plasma, and serum yielded similar results. Prepared samples were stable at room temperature (20°C) and at 5°C for 3 days, and showed no decline in concentration for all tested mAbs. This described method, which has the advantage of an easy, rapid, and robust pre-analytical sample preparation, can be used as a template to quantify other mAbs in human plasma or serum.
    MeSH term(s) Antibodies, Monoclonal ; Chromatography, Liquid ; Humans ; Infliximab ; Plasma ; Tandem Mass Spectrometry
    Chemical Substances Antibodies, Monoclonal ; Infliximab (B72HH48FLU)
    Language English
    Publishing date 2021-08-27
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1171488-8
    ISSN 1873-3778 ; 0021-9673
    ISSN (online) 1873-3778
    ISSN 0021-9673
    DOI 10.1016/j.chroma.2021.462489
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  9. Article: A generic sample preparation method for the multiplex analysis of seven therapeutic monoclonal antibodies in human plasma or serum with liquid chromatography-tandem mass spectrometry

    Amrani, Mohsin El / Gerencser, Laszlo / Huitema, Alwin D.R. / Hack, C. Erik / van Luin, Matthijs / van der Elst, Kim C.M.

    Journal of chromatography. 2021 Oct. 11, v. 1655

    2021  

    Abstract: Due to the increasing number of therapeutic monoclonal antibodies (mAbs) used in the clinic, there is an increasing need for robust analytical methods to quantify total mAb concentrations in human plasma for clinical studies and therapeutic drug ... ...

    Abstract Due to the increasing number of therapeutic monoclonal antibodies (mAbs) used in the clinic, there is an increasing need for robust analytical methods to quantify total mAb concentrations in human plasma for clinical studies and therapeutic drug monitoring. We developed an easy, rapid, and robust sample preparation method for liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. The method was validated for infliximab (IFX), rituximab (RTX), cetuximab (CTX), dupilumab (DPL), dinutuximab (DNX), vedolizumab (VDZ), and emicizumab (EMZ). Saturated ammonium sulfate (AS) was used to precipitate immunoglobulins in human plasma. After centrifugation, supernatant containing albumin was decanted, and the precipitated immunoglobulin fraction was re-dissolved in buffer containing 6M guanidine. This fraction was then completely denatured, reduced, alkylated, and trypsin digested. Finally, signature peptides from the seven mAbs were simultaneously quantified on LC-MS/MS together with their internal standards stable isotopically labeled peptide counterparts. The linear dynamic ranges (1 – 512 mg/L) of IFX, CTX, RTX, and EMZ showed excellent (R2 > 0.999) linearity and those of DPL, DNX, and VDZ showed good (R2 > 0.995) linearity. The method was validated in accordance with the EMA guidelines. EDTA plasma, sodium citrate plasma, heparin plasma, and serum yielded similar results. Prepared samples were stable at room temperature (20°C) and at 5°C for 3 days, and showed no decline in concentration for all tested mAbs. This described method, which has the advantage of an easy, rapid, and robust pre-analytical sample preparation, can be used as a template to quantify other mAbs in human plasma or serum.
    Keywords albumins ; ambient temperature ; ammonium sulfate ; blood serum ; centrifugation ; decline ; drugs ; guanidines ; heparin ; humans ; immunoglobulins ; liquid chromatography ; peptides ; sodium citrate ; tandem mass spectrometry ; therapeutics ; trypsin
    Language English
    Dates of publication 2021-1011
    Publishing place Elsevier B.V.
    Document type Article
    ZDB-ID 218139-3
    ISSN 0021-9673 ; 0378-4355 ; 0376-737X
    ISSN 0021-9673 ; 0378-4355 ; 0376-737X
    DOI 10.1016/j.chroma.2021.462489
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  10. Article ; Online: Clinical characteristics do not reliably identify non-adherence in patients with uncontrolled hypertension.

    Groenland, Eline H / Dasgupta, Indranil / Visseren, Frank L J / van der Elst, Kim C M / Lorde, Nathan / Lawson, Alexander J / Bots, Michiel L / Spiering, Wilko

    Blood pressure

    2022  Volume 31, Issue 1, Page(s) 178–186

    Abstract: Purpose: Chemical adherence testing is a reliable method to assess adherence to antihypertensive drugs. However, it is expensive and has limited availability in clinical practice. To reduce the number and costs of chemical adherence tests, we aimed to ... ...

    Abstract Purpose: Chemical adherence testing is a reliable method to assess adherence to antihypertensive drugs. However, it is expensive and has limited availability in clinical practice. To reduce the number and costs of chemical adherence tests, we aimed to develop and validate a clinical screening tool to identify patients with a low probability of non-adherence in patients with uncontrolled hypertension.
    Materials and methods: In 495 patients with uncontrolled hypertension referred to the University Medical Centre Utrecht (UMCU), the Netherlands, a penalised logistic regression model including seven pre-specified easy-to-measure clinical variables was derived to estimate the probability of non-adherence. Non-adherence was defined as not detecting at least one of the prescribed antihypertensive drugs in plasma or urine. Model performance and test characteristics were evaluated in 240 patients with uncontrolled hypertension referred to the Heartlands Hospital, United Kingdom.
    Results: Prevalence of non-adherence to antihypertensive drugs was 19% in the UMCU and 44% in the Heartlands Hospital population. After recalibration of the model's intercept, predicted probabilities agreed well with observed frequencies. The c-statistic of the model was 0.63 (95%CI 0.53-0.72). Predicted probability cut-off values of 15%-22.5% prevented testing in 5%-15% of the patients, carrying sensitivities between 97% (64-100) and 90% (80-95), and negative predictive values between 74% (10-99) and 70% (50-85).
    Conclusion: The combination of seven clinical variables is not sufficient to reliably discriminate adherent from non-adherent individuals to safely reduce the number of chemical adherence tests. This emphasises the complex nature of non-adherence behaviour and thus the need for objective chemical adherence tests in patients with uncontrolled hypertension.
    MeSH term(s) Antihypertensive Agents/therapeutic use ; Humans ; Hypertension/diagnosis ; Medication Adherence ; Predictive Value of Tests
    Chemical Substances Antihypertensive Agents
    Language English
    Publishing date 2022-07-08
    Publishing country England
    Document type Journal Article
    ZDB-ID 1170048-8
    ISSN 1651-1999 ; 1651-2480 ; 0803-7051 ; 0803-8023
    ISSN (online) 1651-1999 ; 1651-2480
    ISSN 0803-7051 ; 0803-8023
    DOI 10.1080/08037051.2022.2104215
    Database MEDical Literature Analysis and Retrieval System OnLINE

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