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Therapeutic Drug Monitoring

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https://www.readbyqxmd.com/read/28723731/the-combined-effect-of-cyp2b6-genotype-and-other-candidate-genes-on-a-steady-state-serum-concentration-of-methadone-in-opioid-maintenance-treatment
#1
Marianne K Kringen, Fatemeh Chalabianloo, Jean-Paul Bernard, Jørgen G Bramness, Espen Molden, Gudrun Høiseth
BACKGROUND: A considerable inter-individual variability in methadone pharmacokinetics is seen in patients on methadone maintenance treatment. The aim of this study was to clarify the impact of the reduced function CYP2B6*6 variant allele together with variants in other candidate genes on a steady-state methadone concentration in a naturalistic setting. METHODS: Information of methadone serum concentration, dose, age, gender and CYP2C9, CYP2C19, and CYP2D6 genotypes were collected from a routine therapeutic drug monitoring (TDM) database while variant alleles in CYP2B6 and CYP3A5 were retrospectively genotyped...
July 18, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700449/development-of-a-simple-and-rapid-method-to-measure-free-fraction-of-valproic-acid-in-plasma-using-ultrafiltration-and-uhplc-ms-application-to-therapeutic-drug-monitoring
#2
Shansen Xu, Yanan Chen, Mingming Zhao, Limei Zhao
BACKGROUND: Valproic acid (VPA) is widely used as an antiepileptic drug in children, and it is usually co-administered with other antiepileptic drugs. Due to its narrow therapeutic range and large variations in pharmacokinetic/pharmacodynamic behavior in different individuals, therapeutic drug monitoring (TDM) of the trough total VPA concentration is commonly used to guide dosing. However, as only the free fraction of VPA that exerts pharmacological and toxic effects, it may be more meaningful to determine the unbound VPA concentration in plasma...
July 8, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28682926/evaluation-of-the-novel-methotrexate-architect-chemiluminescent-inmunoassay-clinical-impact-on-pharmacokinetic-monitoring
#3
María Dolores Aumente, Julia López-Santamaría, Concepción Donoso-Rengifo, Inmaculada Reyes-Torres, Pablo Montejano Hervás
BACKGROUND: Fluorescence polarization immunoassay (FPIA) has been probably the most widely used technique for the determination of methotrexate (MTX) concentrations in clinical laboratories. After its replacement by a novel Architect chemiluminescent microparticle immunoassay (CMIA), it is essential to verify that there are no differences between the methods that can induce an error in leucovorin rescue with dire consequences for the patient. The objective of our study was to compare plasma/serum MTX measurements between CMIA and FPIA, reference method in this study, in the work conditions of a clinical pharmacokinetics unit to determine whether any difference would affect clinical decisions on the management of this drug...
July 3, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28682925/therapeutic-drug-monitoring-of-gentamicin-peak-concentrations-in-critically-ill-patients
#4
C J Hodiamont, J M Janssen, M D de Jong, R A Mathôt, N P Juffermans, R M van Hest
BACKGROUND: Adequate gentamicin peak concentrations (Cmax) are important for optimal clinical efficacy. Within a critically ill patient, substantial variability in Cmax can occur over time, hampering the usefulness of therapeutic drug monitoring (TDM). The aim of this study was to evaluate the effect of gentamicin dosing based on Cmax after the 1st dose on gentamicin target attainment in critically ill patients. METHODS: From gentamicin-treated critically ill patients, dosing information, clinical parameters, and serum concentrations were collected prospectively...
July 3, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28682924/lamotrigine-drug-interactions-in-combination-therapy-and-the-influence-of-therapeutic-drug-monitoring-on-clinical-outcomes-of-adult-patients
#5
Milan Grundmann, Blanka Koristkova, Hana Brozmanova, Ivana Kacirova
BACKGROUND: The aim was to study the impact of therapeutic drug monitoring (TDM) on patients on lamotrigine (LTG) therapy and the evaluation of possible drug interactions, especially in triple antiepileptic drug combinations. METHODS: During the period of 2001-2014, 3118 pre-dose samples were taken from 1137 patients >15 years of age as part of their routine TDM. Drug interactions were evaluated using calculation of LTG clearance. RESULTS: Valproic acid (VPA) decreased LTG clearance by 66% in bitherapy, and by 35% and 31% in triple therapy with carbamazepine (CBZ) and phenytoin (PHT) respectively...
July 3, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28650902/itpa-activity-in-adults-and-children-treated-with-or-without-azathioprine-relationship-between-tpmt-activity-thiopurine-metabolites-and-co-medications
#6
Boulieu Roselyne, Antony Citterio-Quentin, Mustapha Moulsma, Marie-Paule Gustin
BACKGROUND: The implication of inosine triphosphate pyrophosphatase (ITPA) on thiopurine drug response variability has been investigated but little data is available on its role on thiopurine metabolites. ITPA' ability to modify the thiopurine metabolite levels currently used to optimize azathioprine (AZA) therapy in relation to TPMT activity, the aim of this study is to investigate ITPA phenotype in a large population and to evaluate the relation between ITPA and TPMT activities and thiopurine metabolites...
June 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28650901/application-of-quality-by-design-approach-to-bioanalysis-development-of-a-method-for-elvitegravir-quantification-in-human-plasma
#7
Sara Baldelli, Giorgio Marrubini, Dario Cattaneo, Emilio Clementi, Matteo Cerea
BACKGROUND: The application of Quality by Design (QbD) principles in clinical laboratories can help to develop an analytical method through a systematic approach, providing a significant advance over the traditional heuristic and empirical methodology. In the present work, we applied for the first time the QbD concept in the development of a method for drug quantification in human plasma using elvitegravir as the test molecule. METHODS: The goal of the study was to develop a fast and inexpensive quantification method, with precision and accuracy as requested by the EMA guidelines on bioanalytical method validation...
June 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28650900/a-high-throughput-hplc-ms-ms-assay-for-the-detection-quantification-and-simultaneous-structural-confirmation-of-136-drugs-and-metabolites-in-human-urine
#8
Jacek Klepacki, Baharak Davari, Marion Boulet, Ryan Lizarraga, Uwe Christians
BACKGROUND: Due to its superior sensitivity and specificity, multi-analyte high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) has become the gold standard in clinical toxicology. Although several qualitative and quantitative LC-MS/MS assays on various mass spectrometry platforms have been described in the literature, the majority of these methods either analyze only a limited number of compounds, and/or require tedious and time-consuming sample preparation...
June 22, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28640063/pharmacodynamic-monitoring-of-tacrolimus-based-immunosuppression-in-cd14-monocytes-after-kidney-transplantation
#9
Nynke M Kannegieter, Dennis A Hesselink, Marjolein Dieterich, Gretchen N De Graav, Rens Kraaijeveld, Ajda T Rowshani, Pieter Jm Leenen, Carla C Baan
BACKGROUND: Monocytes significantly contribute to ischemia reperfusion injury and allograft rejection after kidney transplantation. However, the knowledge about the effects of immunosuppressive drugs on monocyte activation is limited. Conventional pharmacokinetic methods for immunosuppressive drug monitoring are not cell type-specific. In this study, phosphorylation of three signaling proteins was measured to determine the pharmacodynamic effects of immunosuppression on monocyte activation in kidney transplant patients...
June 19, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28640062/an-atmospheric-pressure-ionization-ms-ms-assay-using-online-extraction-for-the-analysis-of-11-cannabinoids-and-metabolites-in-human-plasma-and-urine
#10
Jelena Klawitter, Cristina Sempio, Sophie Mörlein, Erik De Bloois, Jacek Klepacki, Thomas Henthorn, Maureen A Leehey, Edward J Hoffenberg, Kelly Knupp, George S Wang, Christian Hopfer, Greg Kinney, Russell Bowler, Nicholas Foreman, Jeffrey Galinkin, Uwe Christians, Jost Klawitter
BACKGROUND: Although, especially in the United States, there has been a recent surge of legalized cannabis for either recreational or medicinal purposes, surprisingly little is known about clinical dose-response relationships, pharmaco- and toxicodynamic effects of cannabinoids such as Δ9-tetrahydrocannabinol (THC). Even less is known about other active cannabinoids. METHODS: To address this knowledge gap, an online extraction, high-performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) method for simultaneous quantification of 11 cannabinoids and metabolites including THC, 11-hydroxy-Δ9-tetrahydrocannabinol (11OH-THC), 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid (THC-COOH), 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid glucuronide (THC-C-gluc), cannabinol (CBN), cannabidiol (CBD), cannabigerol (CBG), cannabidivarin (CBDV), Δ9-tetrahydrocannabivarin (THCV), and 11-nor-9-carboxy-Δ9-tetrahydrocannabivarin (THCV-COOH) was developed and validated in human urine and plasma...
June 19, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700524/challenges-for-detecting-valproic-acid-in-a-nontargeted-urine-drug-screening-method
#11
Jeffrey D Pope, Marion J Black, Olaf H Drummer, Hans G Schneider
BACKGROUND: Valproic acid (VPA) is a widely prescribed medicine, and acute toxicity is possible. As such, it should be included in any nontargeted urine drug screening method. In many published liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS/MS) methods, VPA is usually measured using a pseudo-multiple reaction monitoring (MRM) transition. We investigate a simple ultra-high-performance liquid chromatography-quadrupole time-of-flight (QTof) approach to detect the presence of VPA with more confidence...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700523/dried-blood-spots-combined-with-ultra-high-performance-liquid-chromatography-mass-spectrometry-for-the-quantification-of-the-antipsychotics-risperidone-aripiprazole-pipamperone-and-their-major-metabolites
#12
Camille Tron, Sanne M Kloosterboer, Bart C H van der Nagel, Rixt A Wijma, Bram Dierckx, Gwen C Dieleman, Teun van Gelder, Birgit C P Koch
BACKGROUND: Risperidone, aripiprazole, and pipamperone are antipsychotic drugs frequently prescribed for the treatment of comorbid behavioral problems in children with autism spectrum disorders. Therapeutic drug monitoring (TDM) could be useful to decrease side effects and to improve patient outcome. Dried blood spot (DBS) sample collection seems to be an attractive technique to develop TDM of these drugs in a pediatric population. The aim of this work was to develop and validate a DBS assay suitable for TDM and home sampling...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700522/dried-blood-spot-sampling-for-tacrolimus-and-mycophenolic-acid-in-children-analytical-and-clinical-validation
#13
Lisa C Martial, Karin E J Hoogtanders, Michiel F Schreuder, Elisabeth A Cornelissen, Jac van der Heijden, Manuela A Joore, Erik M Van Maarseveen, David M Burger, Sander Croes, Roger J M Brüggemann, Rob E Aarnoutse
BACKGROUND: Tacrolimus and mycophenolic acid (MPA) are the backbone of immunosuppressive therapy after pediatric kidney transplantation. Dosing of these drugs is individualized by therapeutic drug monitoring. Dried blood spot (DBS) sampling may prove beneficial over conventional venous sampling. We aimed to develop and clinically validate a DBS method for tacrolimus and MPA in children. METHODS: A joint DBS liquid chromatography-mass spectrometry assay for tacrolimus and MPA was developed...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700521/effect-of-cyp3a4-and-cyp3a5-genetic-polymorphisms-on-the-pharmacokinetics-of-sirolimus-in-healthy-chinese-volunteers
#14
Jing Zhang, Ying Dai, Zhihong Liu, Minxin Zhang, Chen Li, Dingxiong Chen, Hongtao Song
BACKGROUND: Sirolimus is a promising immunosuppressive drug for preventing the rejection of organ transplants. However, inter-individual variability in sirolimus pharmacokinetics causes adverse drug reactions, compromising therapeutic efficacy. Sirolimus is primarily metabolized by cytochrome CYP3A4 and CYP3A5. This study aimed to clarify the effect of CYP3A genetic polymorphisms, including the CYP3A4*1G and CYP3A5*3 polymorphisms, on the pharmacokinetics of sirolimus. METHODS: Thirty-one healthy Chinese volunteers were included in this study...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700520/current-practice-for-therapeutic-drug-monitoring-of-biopharmaceuticals-in-rheumatoid-arthritis
#15
Frédéric Medina, Chamaida Plasencia, Philippe Goupille, David Ternant, Alejandro Balsa, Denis Mulleman
The treatment of rheumatoid arthritis (RA) has largely improved in the biopharmaceutical era. These compounds, primarily tumor necrosis factor (TNF) inhibitors, are effective, but some patients may show poor response, sometimes because of the presence of antidrug antibodies (ADAs). In some instances, clinicians may increase or taper the dose depending on the clinical response. Besides the current clinical-based practice, a tailored strategy based on drug monitoring has emerged as a way to improve the use of these drugs...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28700519/managing-drug-drug-interaction-between-ombitasvir-paritaprevir-ritonavir-dasabuvir-and-mycophenolate-mofetil
#16
Florian Lemaitre, Zeineb Ben Ali, Camille Tron, Caroline Jezequel, Christelle Boglione-Kerrien, Marie-Clémence Verdier, Dominique Guyader, Eric Bellissant
No drug-drug interaction study has been conducted to date for the combination of ombitasvir, paritaprevir/ritonavir, dasabuvir (3D), and mycophenolic acid (MPA). We here report the case of a hepatitis C virus-infected patient treated with 3D and MPA for vasculitis. In light of the threat of drug-drug interaction, the concentration of MPA was measured before, during, and 15 days after the end of the 3D treatment. Similar values were found at all 3 time points, thus indicating that there is probably no need to adapt MPA dosage to 3D...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28691952/intrapatient-variability-in-the-pharmacokinetics-of-etanercept-maintenance-treatment
#17
Ji S van Bezooijen, Marco W J Schreurs, Birgit C P Koch, Henk Te Velthuis, Martijn B A van Doorn, Errol P Prens, Teun van Gelder
AIM: Etanercept has shown to mediate a favorable effect on immune-mediated inflammatory diseases (IMID), including plaque psoriasis. Therapeutic drug monitoring (TDM) of etanercept could improve clinical outcome and cost-effectiveness. A high intrapatient variability (IPV) of etanercept trough concentrations at standard dosing would reduce the feasibility of therapeutic drug monitoring. Studies have focused on the interpatient differences associated with the exposure to biologics. The aim of this study was to determine IPV of etanercept and correlate etanercept trough concentrations and IPV with treatment response...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28604475/analysis-of-the-variables-influencing-valproic-acid-concentration-in-the-serum-and-cerebrospinal-fluid-of-chinese-patients-after-craniotomy
#18
Zhihong Li, Weiqi Gao, Guifen Liu, Weihong Chen
BACKGROUND: Valproic acid (VPA) has been widely used in Chinese patients after craniotomy. Many studies have focused on the influencing factors of VPA serum concentration, but conclusions are sometimes paradoxical. Furthermore, the concentration of VPA in the cerebrospinal fluid (CSF) has been rarely reported. In the present study, VPA CSF concentrations were measured, and the potential factors influencing serum concentration and CSF distribution of VPA were investigated. In addition, the functional relationship between serum and CSF concentration was explored...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28604474/impact-of-cyp2c19-genotype-and-liver-function-on-voriconazole-pharmacokinetics-in-renal-transplant-recipients
#19
Zi-Wei Li, Feng-Hua Peng, Miao Yan, Wu Liang, Xiao-Lei Liu, Yan-Qin Wu, Xiao-Bin Lin, Sheng-Lan Tan, Feng Wang, Ping Xu, Ping-Fei Fang, Yi-Ping Liu, Da-Xiong Xiang, Bi-Kui Zhang
BACKGROUND: Invasive fungal infection (IFI) is one of the leading causes of early death after renal transplantation. Voriconazole (VRC) is the first-line drug of IFI. Because of the large inter- and intraindividual variability in VRC plasma concentrations and the narrow therapeutic window for treating patients with IFIs, it is crucial to study the factors which could influence pharmacokinetic variability. We performed a population pharmacokinetics (PPK) study of VRC for personalized medicine...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28570371/prolongation-of-biologic-dosing-intervals-in-patients-with-stable-psoriasis-a-feasibility-study
#20
Ji S van Bezooijen, Martijn B A van Doorn, Marco W J Schreurs, Birgit C P Koch, Henk Te Velthuis, Errol P Prens, Teun van Gelder
BACKGROUND: Biologics are usually licensed according to the "one dose fits all" principle. It is therefore suspected that a significant number of patients with psoriasis are overtreated. However, evidence for successful dose reduction of biologics in psoriasis is scarce. The aim of this study was to investigate whether the dosing interval of 3 biologics, adalimumab, etanercept, or ustekinumab could be prolonged successfully in patients with plaque psoriasis. METHODS: In a prospective exploratory cohort study, 59 patients with psoriasis on maintenance treatment with adalimumab, etanercept, or ustekinumab were included...
August 2017: Therapeutic Drug Monitoring
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