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Therapeutic Drug Monitoring

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https://www.readbyqxmd.com/read/28230619/population-pharmacokinetics-of-topiramate-in-japanese-pediatric-and-adult-patients-with-epilepsy-using-routinely-monitored-data
#1
Masato Takeuchi, Ikuko Yano, Satoko Ito, Mitsuhiro Sugimoto, Shota Yamamoto, Atsushi Yonezawa, Akio Ikeda, Kazuo Matsubara
BACKGROUND: Topiramate is a second-generation antiepileptic drug used as monotherapy and adjunctive therapy in adults and children with partial seizures. A population pharmacokinetic analysis was performed to improve the topiramate dosage adjustment for individualized treatment. METHODS: Patients whose steady-state serum concentration of topiramate was routinely monitored at Kyoto University Hospital from April 2012 to March 2013 were included in the model-building data...
February 20, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28230618/biopharmaceuticals-reference-products-and-biosimilars-to-treat-inflammatory-diseases
#2
Ann Gils, Antonio Bertolotto, Denis Mulleman, Theodora Bejan-Angoulvant, Paul J Declerck
Biopharmaceuticals are primarily therapeutic proteins developed to perform specific functions by acting on the disease pathophysiology. Compared to low molecular chemically synthesized drugs, production of biopharmaceuticals is much more complex and routes of administration and pharmacokinetics differ. Biopharmaceuticals are blockbusters in the treatment of inflammatory diseases such as psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases, and the introduction of these drugs has revolutionized treatment...
February 20, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28230617/acute-kidney-injury-following-efavirenz-tenofovir-disoproxil-fumarate-emtricitabine-atripla%C3%A2-overdose
#3
Thomas Havenith, David Burger, Maarten Visschers, Jolanda Schippers, Astrid Oude Lashof
We describe a patient with acute renal failure and irreversible kidney damage after an overdose with the fixed dose combination of efavirenz/tenofovir disoproxil fumarate/emtricitabine (Atripla). The acute kidney injury was most probably caused by tenofovir. Efavirenz and emtricitabine seemed relatively safe in overdose. The pharmacokinetics in overdose of all three drugs and the effect of hemodialysis on the tenofovir clearance were studied by measuring the plasma concentrations and by the use of clinical pharmacokinetic software...
February 20, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28207572/cross-reactivity-of-chloroquine-and-hydroxychloroquine-with-dri-amphetamine-immunoassay
#4
Isabel Gomila, Loreto Quesada, Victoria López-Corominas, Julia Fernández, Miguel Ángel Servera, Laura Sahuquillo, Macarena Dastis, Albert Torrents, Bernardino Barceló
BACKGROUND: Chloroquine and hydroxychloroquine are medical drugs used to treat the chemoprophylaxis of malaria as well as a second-line anti-inflammatory drug. METHODS: We performed a study of cross-reactivity of chloroquine and hydroxychloroquine in the DRI Amphetamine Assay inspired by a case report of a self-ingestion of chloroquine following a family dispute, that involved the following: (a) an in vitro study with control samples of healthy subjects, (b) an in vivo study with samples of patients with rheumatoid arthritis, and (c) an evaluation of the cross-reactivity of chloroquine and hydroxychloroquine in three additional immunoassays...
February 14, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28196047/a-time-dependent-model-describes-methotrexate-elimination-and-supports-dynamic-modification-of-mrp2-abcc2-activity
#5
Jean-Baptiste Woillard, Jean Debord, Isabelle Benz-de-Bretagne, Franck Saint-Marcoux, Pascal Turlure, Stéphane Girault, Julie Abraham, Sylvain Choquet, Pierre Marquet, Chantal Barin-Le Guellec
BACKGROUND: MRP2/ABCC2, an efflux transporter expressed at the proximal renal tubule, is rate limiting for urine excretion of coproporphyrin (UCP) isomers I and III, translating in high UCP (I/(I+III)) ratio in MRP2-deficient patients presenting with the Dubin-Johnson Syndrome. MRP2 is also a major contributor to methotrexate (MTX) clearance. As MTX is both a substrate and an inhibitor of MRP2, time course of the concentrations of MTX in blood could induce functional modification of MRP2 over time, which in turn can modify its own elimination rate...
February 11, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28196046/bioequivalence-of-a-new-oral-levosulpiride-formulation-compared-with-a-standard-one-in-healthy-volunteers
#6
Simona De Gregori, Laura Cipollina, Annalisa De Silvestri, Marianna Ventura, Roberta Michelini, Monica Morosini, Michela Montagna, Carmine Tinelli, Mario Regazzi, Mariadelfina Molinaro, Roberto Imberti
BACKGROUND: A monocentric, single-dose, open-label, two-way, crossover randomized study was conducted by the San Matteo Phase I Clinical Trial Unit and Experimental Therapy (Pavia, Italy) to assess the bioequivalence and the systemic tolerability of a new oral formulation of levosulpiride (tablet 25 mg: test) versus a commercially available formulation on the Italian market (tablet 25 mg: reference). METHODS: Thirty-five healthy adult volunteers, males (n = 19) and females (n = 16), aged between 18 and 55 years were screened and 32 of them were enrolled in the study...
February 11, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28169862/quantification-of-acetaminophen-and-its-metabolites-in-plasma-using-uplc-ms-doors-open-to-therapeutic-drug-monitoring-in-special-patient-populations
#7
Robert B Flint, Paola Mian, Bart van der Nagel, Nuria Slijkhuis, Birgit C P Koch
BACKGROUND: Acetaminophen (APAP, paracetamol) is the most commonly used drug for pain and fever in both the United States and Europe and considered safe when used at registered dosages. Nevertheless, differences between specific populations lead to remarkable changes in exposure to potentially toxic metabolites. Furthermore, extended knowledge is required on metabolite formation following intoxication, to optimize antidote treatment. Therefore, the authors aimed to develop and validate a quick and easy analytical method for simultaneous quantification of APAP, APAP-glucuronide, APAP-sulfate, APAP-cysteine, APAP-glutathione, APAP-mercapturate, and protein-derived APAP-cysteine in human plasma by ultra-performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UPLC-MS/MS)...
February 6, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28141745/deferasirox-iron-complex-formation-ratio-as-an-indicator-of-long-term-chelation-efficacy-in-%C3%AE-thalassemia-major
#8
Meng-Yao Lu, Ting-Hao Lin, Po-Hung Chiang, Pei-Hsin Kuo, Ning Wang, Wen-Hsin Wu, Kai-Hsin Lin, Tzu-Hua Wu
BACKGROUND: β-Thalassemia major patients with higher total drug levels (deferasirox [DEFR] plus its iron complex) do not yield better serum ferritin (SF) control. This study aimed to determine the concentrations of DEFR and its iron complex (Fe-[DEFR]2) in thalassemia patients to predict the chelation efficacy in terms of SF and cardiac T2* values. METHODS: Patients' steady-state drug levels at trough (Ctrough) and 2 hours post-dose (C2h) were determined. Since iron deposition may cause changes in the hepatic metabolism of amino acids, the concentrations of 40 amino acids in plasma were also assayed at 2 hours post-dose...
January 30, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28125504/therapeutic-drug-monitoring-of-everolimus-comparability-of-concentrations-determined-by-two-immunoassays-and-a-lc-ms-ms-method
#9
Maria Shipkova, Sonja Rapp, Raül Rigo-Bonnin, Eberhard Wieland, Andreas Peter
BACKGROUND: Therapeutic drug monitoring (TDM) is recommended to guide therapy with the immunosuppressant Everolimus (EVL) in solid organ transplantation to prevent rejections and to limit toxicity. For TDM, pre-dose EVL concentrations are measured in whole blood mainly by liquid chromatography tandem mass spectrometry (LC-MS/MS). In addition, two immunoassays (QMS® Everolimus and Elecsys® Everolimus) are commercially available. The aim of this study was to evaluate the comparability of EVL results determined with the two immunoassays and a validated LC-MS/MS test using samples from kidney (KT)-liver (LT)- and heart (HT) transplant recipients...
January 24, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28125503/measurement-of-clozapine-norclozapine-and-amisulpride-in-plasma-and-in-oral-fluid-obtained-using-two-different-sampling-systems
#10
Danielle S Fisher, Chad Beyer, Gerrit van Schalkwyk, Soraya Seedat, Robert J Flanagan
BACKGROUND: There is a poor correlation between total concentrations of proton-accepting compounds (most basic drugs) in unstimulated oral fluid and in plasma. The aim of this study was to compare clozapine, norclozapine, and amisulpride concentrations in plasma and in oral fluid collected using commercially available collection devices [ThermoFisher Scientific Oral-Eze and Greiner Bio-One (GBO)]. METHODS: Oral-Eze and GBO samples and plasma were collected in that order from patients prescribed clozapine...
January 24, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28107255/high-methotrexate-triglutamate-level-is-an-independent-predictor-of-adverse-effects-in-asian-indian-rheumatoid-arthritis-patients-a-preliminary-study
#11
Amit Sandhu, Varun Dhir, Archana Bhatnagar, Veena Dhawan, Jasbinder Kaur, Ankita Sood, Shankar Naidu, Shabeer Ahmad, Neelam Varma, Aman Sharma, Shefali Sharma
BACKGROUND: It is unclear whether erythrocyte methotrexate polyglutamate levels (MTX-glun) are associated with response or adverse effects to methotrexate in rheumatoid arthritis. This preliminary study evaluated their utility in Asian-Indian patients over 24 weeks. METHODS: Rheumatoid arthritis patients were started on oral methotrexate at a dose of 15 mg per week, which was escalated to 25 mg by 12 weeks and continued till 24 weeks. Erythrocyte (RBC) MTX-glu1 to MTX-glu5 levels (nmol/L RBC) were determined at 4, 8, 16, and 24 weeks by using reverse-phase high-performance liquid chromatography...
January 19, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28045783/quantitative-method-for-simultaneous-analysis-of-acetaminophen-and-six-metabolites
#12
Laureen A Lammers, Roos Achterbergh, Marcel C M Pistorius, Johannes A Romijn, Ron A A Mathôt
BACKGROUND: Hepatotoxicity after ingestion of high-dose acetaminophen (N-acetyl-para-aminophenol, APAP) is caused by the metabolites of the drug. To gain more insight in factors influencing susceptibility to APAP hepatotoxicity, quantification of APAP and metabolites is important. A few methods have been developed to simultaneously quantify APAP and its most important metabolites. However, these methods require a comprehensive sample preparation and long run times. The aim of this study was to develop and validate a simplified, but sensitive, method for the simultaneous quantification of acetaminophen, the main metabolites acetaminophen-glucuronide and acetaminophen-sulfate, and four Cytochrome P450-mediated metabolites by using liquid chromatography with mass spectrometric detection (LC-MS/MS)...
December 30, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28045782/fast-and-adequate-liquid-chromatography-tandem-mass-spectrometric-determination-of-z-endoxifen-serum-levels-for-therapeutic-drug-monitoring
#13
S de Krou, H Rosing, B Nuijen, J H M Schellens, J H Beijnen
BACKGROUND: Z-endoxifen (further referred to as endoxifen, unless stated otherwise) is proposed as the most important metabolite of tamoxifen. Patients receiving adjuvant tamoxifen treatment with endoxifen levels below the threshold of 5.9 ng/mL may have an increased risk of breast cancer recurrence. Several factors, such as genetic polymorphisms, drug interactions, and (non-)adherence, lead to large inter-patient variability in endoxifen exposure, resulting in a substantial number of patients showing sub therapeutic levels...
December 30, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28045781/improved-open-well-stability-of-acmia-reagent-for-determining-blood-tacrolimus
#14
Yoshiharu Suzuki, Keisuke Kohno, Kosuke Doki, Nobuhiro Ohkohchi, Masato Homma
No abstract text is available yet for this article.
December 30, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28045862/comparing-azole-plasma-trough-levels-in-lung-transplant-recipients-percentage-of-therapeutic-levels-and-intra-patient-variability
#15
Daniela Stelzer, Alexandra Weber, Franziska Ihle, Sandhya Matthes, Felix Ceelen, Gregor Zimmermann, Nikolaus Kneidinger, Rene Schramm, Hauke Winter, Michael Zoller, Michael Vogeser, Juergen Behr, Claus Neurohr
BACKGROUND: This study compared therapeutic azole plasma trough levels (APL) of the azole antimycotics itraconazole (ITR), voriconazole (VOR), and posaconazole (POS) in lung transplant recipients and analyzed the influencing factors. In addition, intra-patient variability for each azole was determined. METHODS: From July 2012 to July 2015, 806 APL of ITR, VOR, POS liquid (POS-Liq), and POS tablets (POS-Tab) were measured in 173 patients of the Munich Lung Transplantation (LTx) Program...
December 29, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28045861/pharmacokinetics-and-pharmacogenetics-of-ssris-during-pregnancy-an-observational-study
#16
Laura Pogliani, Felicia Stefania Falvella, Dario Cattaneo, Paola Pileri, Anna Flora Moscatiello, Stefania Cheli, Sara Baldelli, Valentina Fabiano, Irene Cetin, Emilio Clementi, Gianvincenzo Zuccotti
BACKGROUND: An involvement of selective serotonin reuptake inhibitors (SSRIs) in increasing the risk of malformations, neonatal withdrawal syndrome, has been suggested recently. Here, we aimed to investigate the contribution of individual pharmacogenetics of SSRI on infants' outcome. We also estimated the umbilical/maternal plasma SSRI concentration ratio in the pregnant women still on SSRI therapy at the time of delivery. METHODS: Thirty-four pregnant women, referred to our hospital from January 2011 to July 2015, who were given SSRIs in the third trimester, and related children, were considered...
December 29, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28033162/an-ex-vivo-model-to-decipher-the-impact-of-extracorporeal-membrane-oxygenation-on-beta-lactam-degradation-kinetics
#17
Cyril Leven, Pierre Fillâtre, Antoine Petitcollin, Marie-Clémence Verdier, Jérôme Laurent, Nicolas Nesseler, Yoann Launey, Pierre Tattevin, Eric Bellissant, Erwan Flécher, Florian Lemaitre
BACKGROUND: As a consequence of drug sequestration, increase in volume of distribution or alteration of elimination, extracorporeal membrane oxygenation (ECMO) might lead to inadequate plasma concentrations of vital drugs. The aim of this experimental study was to develop an ex vivo model to better characterize the impact of ECMO procedure on beta-lactam antibiotics pharmacokinetics. METHODS: Plasma concentrations of cefotaxime, ceftazidime, cefepime, piperacillin, oxacillin, amoxicillin, and ceftriaxone were measured in an ex vivo ECMO circuit primed with whole human blood and compared to controls stored in glass tubes and polyvinyl chloride (PVC) tubing...
December 23, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28030535/development-of-a-limited-sampling-strategy-for-the-estimation-of-exposure-to-high-dose-etoposide-after-intravenous-infusion-in-pediatric-patients
#18
Dorota Danielak, Joanna Sobiak, Jacek Wachowiak, Franciszek Główka, Maria Chrzanowska
BACKGROUND: Etoposide (VP-16), a podophylotoxin derivative, is used in conditioning regimens prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in children with acute lymphoblastic leukemia (ALL). The aim of this study was to develop a limited sampling strategy (LSS) suitable for the prediction of exposure to VP-16 defined as area-under-time-concentration curve (AUC). METHODS: The study included 28 pediatric patients with ALL, who were administered a 4h infusion of 60 mg/kg VP-16...
December 20, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27941536/lc-ms-ms-analysis-of-erythrocyte-thiopurine-nucleotides-and-their-association-with-genetic-variants-in-patients-with-neuromyelitis-optica-spectrum-disorders-taking-azathioprine
#19
Shenghui Mei, Xindi Li, Xiaoqing Gong, Xingang Li, Li Yang, Heng Zhou, Yonghong Liu, Anna Zhou, Leting Zhu, Xinghu Zhang, Zhigang Zhao
BACKGROUND: Azathioprine (AZA) is a first-line drug in treating neuromyelitis optica spectrum disorders (NMOSD). To exhibit its bioactivity, AZA needs to be converted to thiopurine nucleotides (TPNs) including 6-thioguanine nucleotides (6-TGNs) and 6-methylmercaptopurine nucleotides (6-MMPNs) that are affected by genetic polymorphisms. This study aims to develop an LC-MS/MS method for the analysis of erythrocyte concentrations of TPNs and to evaluate their associations with variants of various genes (MTHFR, TPMT, HLA, SLC29A1, SLC28A2, SLC28A3, ABCB1 and ABCC4) in patients with NMOSD...
November 29, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28081042/detection-of-hydrocodone-and-morphine-as-metabolites-in-oral-fluid-by-lc-ms-ms-in-patients-prescribed-codeine
#20
Robert E West, Maria G Guevara, Charles Mikel, Ruben Gamez
A retrospective analysis of oral fluid drug testing results using LC-MS/MS was performed to determine the prevalence rates in oral fluid for codeine (COD) and 3 COD metabolites-morphine (MOR), norhydrocodone (NHC), and hydrocodone (HCOD). Oral fluid samples were collected using Quantisal oral fluid collection device (Immunalysis Inc.) and submitted to Millennium Health, LLC for the routine drug analysis by LC-MS/MS. Consistent with previously published literature, COD was the primary analyte detected in oral fluid after the use of COD...
February 2017: Therapeutic Drug Monitoring
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