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Therapeutic Drug Monitoring

M Oellerich, E Schütz, J Beck, P D Walson
Genomic analyses in oncologic care allow for the development of more precise clinical laboratory tests that will be critical for personalized pharmacotherapy. Traditional biopsy-based approaches are limited by the availability of sequential tissue specimens to detect resistance. Blood-based genomic profiling ("liquid biopsy") is useful for longitudinal monitoring of tumor genomes and can complement biopsies. Tumor-associated mutations can be identified in cell-free tumor DNA (ctDNA) from patient blood samples and used for monitoring disease activity...
October 16, 2018: Therapeutic Drug Monitoring
Xiaoxi Liu, Anne Smits, Yuhuan Wang, Marleen Renard, Stephanie Wead, Richard J Kagan, Daniel P Healy, Pieter De Cock, Karel Allegaert, Catherine Sherwin
BACKGROUND: Amikacin is widely used to treat severe Gram-negative bacterial infections. Its peak concentration in plasma is associated with treatment efficacy. Amikacin pharmacokinetics (PK) is influenced by disease conditions, in addition to other patient characteristics. In this retrospective study, we evaluated the impact of clinical characteristics and disease condition on amikacin PK in children with burn injuries and those with cancer. METHODS: Amikacin PK data from 66 children with burn injuries and 112 children with cancer were analyzed...
October 15, 2018: Therapeutic Drug Monitoring
Sophie Neugebauer, Christina Wichmann, Sibylle Bremer-Streck, Stefan Hagel, Michael Kiehntopf
BACKGROUND: Adequate antibiotic treatment is a prerequisite for the successful treatment of systemic infections. Based on accumulating scientific evidence, a fixed dosage regimen can lead to insufficient and ineffective antibiotic therapy. Thus, the aim of this study was to develop and validate a simplified, but sensitive method for the simultaneous quantification of antimicrobials by using liquid chromatography with tandem mass spectrometry (LC-MS/MS) for the development of personalized therapy regimens using therapeutic drug monitoring (TDM)...
October 12, 2018: Therapeutic Drug Monitoring
Eun Jung Kim, Jaeseong Oh, Kyounghoon Lee, Kyung-Sang Yu, Jae-Yong Chung, Joo-Hee Hwang, Eun Young Nam, Hyoung Sook Kim, Moonsuk Kim, Jeong Su Park, Kyoung-Ho Song, Eu Suk Kim, Junghan Song, Hong Bin Kim
BACKGROUND: Colistin is increasingly used as the last therapeutic option for the treatment of multidrug-resistant, Gram-negative bacterial infections. To ensure safe and efficacious use of colistin, therapeutic drug monitoring (TDM) is needed due to its narrow therapeutic window. This study aimed to evaluate the pharmacokinetic (PK) characteristics of colistin and to guide TDM in colistin-treated patients in Korea. METHODS: In a prospective study, we analysed PK characteristics in 15 patients who intravenously received colistin methanesulfonate (CMS) twice per day...
October 3, 2018: Therapeutic Drug Monitoring
Sotheara Moeung, Christine Chevreau, Vianney Poinsignon, Jérôme Guitton, Bénédicte Lelièvre, Joseph Ciccolini, Laurence Gladieff, Christophe Massart, Aude Fléchon, Rémy Delva, Gwenaëlle Gravis, Jean-Pierre Lotz, Jacques-Olivier Bay, Marine Gross-Goupil, Julia Delahousse, Thomas Filleron, Isabelle Lochon, Etienne Chatelut, Fabienne Thomas
BACKGROUND: Therapeutic drug monitoring of carboplatin is based on its unbound clearance (CLU) determined by Bayesian analysis on unbound (U) concentrations. However, the ultrafiltration of plasma samples presents technical and time constraints. Therefore, the present study aims to estimate CLU using total plasma (P) concentrations. METHODS: U and P concentration data of 407 patients were obtained from two clinical studies in which actual CLU had been determined for each patient...
October 3, 2018: Therapeutic Drug Monitoring
Erwin Dreesen, Ann Gils
BACKGROUND: Psoriasis, psoriatic arthritis, spondyloarthritis, rheumatoid arthritis, ulcerative colitis and Crohn's disease share similar underlying pathophysiological processes, providing the opportunity to treat the patients using similar biological therapies. Failure of biological treatments due to underexposure can be managed by therapeutic drug monitoring. Adjusting the treatment based on pharmacokinetic monitoring can be further improved by taking pharmacodynamic parameters such as clinical and molecular markers into account...
October 3, 2018: Therapeutic Drug Monitoring
Alexandre Jentzer, Anne -Emmanuelle Berger, Rémi Labetoulle, Alice Haccourt, Xavier Roblin, Stephane Paul
BACKGROUND: SB2, an infliximab (IFX) biosimilar to the reference infliximab (R.I.) product (Remicade), received approval in EU for all IFX indications. Many decision algorithms based on the measurement of IFX trough levels and antibodies to infliximab (ATI) are being increasingly used to optimize IFX treatment. The aim of our study was to evaluate if the biosimilar SB2 could be efficiently monitored using the LISA-TRACKER IFX and anti-IFX assays developed by Theradiag (Croissy Beaubourg, France)...
September 21, 2018: Therapeutic Drug Monitoring
Ken Chen, Xianglin Zhang, Xiaoyan Ke, Guanhua Du, Kehu Yang, Suodi Zhai
BACKGROUND: Voriconazole (VRZ) is a second-generation triazole antifungal agent with broad-spectrum activity. It is available in both intravenous and oral formulations, and is primarily indicated for treating invasive aspergillus. The most commonly used dose for adults is 4 mg/kg or 200 mg twice daily. VRZ presents nonlinear pharmacokinetics (PK) in adults, while drug-drug interactions and cytochrome P450 2C19 (CYP2C19) polymorphism are of great concern for VRZ. Since liquid chromatography method has been widely used for measuring VRZ blood concentration, and target VRZ blood concentration has been recommended in some guidelines regarding efficacy and safety, therapeutic drug monitoring (TDM) is considered as a useful tool for VRZ individualized medication...
September 4, 2018: Therapeutic Drug Monitoring
Peter G M Zweipfenning
No abstract text is available yet for this article.
August 29, 2018: Therapeutic Drug Monitoring
Yanan Chen, Shansen Xu, Zhanyou Wang, Mingming Zhao, Huanxin Wang, Tong Lu, Limei Zhao
BACKGROUND: The pharmacokinetics of lamotrigine (LTG) is complex and varies significantly among individuals, especially among children. Therefore, this study aimed to establish a population pharmacokinetic (PPK) model of LTG in Chinese children with epilepsy and to comprehensively evaluate the effects of genetic variations in drug metabolizing enzymes, transporters, and a transcriptional regulator on LTG pharmacokinetics METHODS:: 385 steady-state plasma concentrations were obtained from 179 children (age 10...
August 27, 2018: Therapeutic Drug Monitoring
Marianne Skov-Skov Bergh, Inger Lise Bogen, Steven Ray Wilson, Åse Marit Leere Øiestad
BACKGROUND: Fentanyl and fentanyl analogues (fentanyls) are very potent opioids posing a serious threat to the public health. Thousands of overdose deaths across the world are caused by fentanyls and the numbers are increasing. Rapid mapping of current trends in opioid abuse is necessary to accelerate preventive measures. To ensure this, there is a need for sensitive targeted multiplex MS/MS methods to pinpoint drugs of abuse. We present a fully validated UHPLC-MS/MS method for the determination of 26 fentanyls, including several structural isomers, and the opioid antagonist naloxone in human whole blood...
August 27, 2018: Therapeutic Drug Monitoring
Hidetoshi Ishii, Keita Hirai, Kyohei Sugiyama, Eiji Nakatani, Midori Kimura, Kunihiko Itoh
BACKGROUND: Adjustment of initial vancomycin (VCM) dosage has been recommended on the basis of the renal function nomogram in therapeutic drug monitoring guidelines in Japan. However, this nomogram has not been clinically validated, and few studies have focused on its usefulness in patients with risk of augmented renal function. Therefore, this study aimed to evaluate the validity of the VCM nomogram and the association between patient conditions related to augmented renal function and its accuracy...
August 27, 2018: Therapeutic Drug Monitoring
Thomas Plecko, Kevin Berbalk, Eberhard Wieland, Maria Shipkova
BACKGROUND: Oral fluid (OF) is increasingly used as an alternative sample matrix in drug of abuse screening. Screening is commonly performed by immunoassays and results confirmed using laborious gas chromatography-mass spectrometry (GC-MS)-based methods. Therefore, an easy to operate ion trap mass spectrometric (IT-MS) commercial screening method (Toxtyper; Bruker Daltronik, Bremen, Germany) combined with a laboratory-developed sample preparation procedure has been evaluated for their application to OF...
October 2018: Therapeutic Drug Monitoring
Theodor W May, Renate Helmer, Christian G Bien, Christian Brandt
BACKGROUND: Lacosamide (LCM) is a new antiepileptic drug (AED). The purpose of the study was to investigate the effects of LCM dose, body weight, height, sex, age, and concomitant AEDs on LCM trough serum concentrations (at a steady state) in patients with epilepsy. METHODS: A total number of 3154 blood samples of 973 consecutive patients of the Mara Hospital (Bethel Epilepsy Centre) were evaluated. Generalized estimating equation (GEE) models were used for statistical analyses...
October 2018: Therapeutic Drug Monitoring
Robert L Smith, Tore Haslemo, Hilde F Chan, Helge Refsum, Espen Molden
BACKGROUND: Previous studies have reported inconsistent findings regarding the impact of the UGT1A4*3 variant allele on lamotrigine (LTG) exposure. As no studies have controlled for nongenetic factors, the aim of this study was to compare serum concentrations of LTG in carriers versus noncarriers of UGT1A4*3 adjusting for differences in age, sex, and valproic acid (VPA) comedication. METHODS: Matched data on serum concentration of LTG and UGT1A4 genotype patients with known information about VPA comedication were included retrospectively from a therapeutic drug monitoring service...
October 2018: Therapeutic Drug Monitoring
Rolf Anton Klaasen, Stein Bergan, Sara Bremer, Lina Daleq, Anders Mikal Andersen, Karsten Midtvedt, Morten Heier Skauby, Nils Tore Vethe
INTRODUCTION: Tacrolimus (TAC) is an immunosuppressive drug used after organ transplantation. Dosing is adjusted using whole blood (WB-TAC) measurements. Patients within the therapeutic WB-TAC window still experience rejections and adverse effects. Alternative monitoring methods are therefore warranted. The authors developed a method for measuring TAC in peripheral blood mononuclear cell (PBMC) isolates (PBMC-TAC) and performed a pharmacokinetic study in a cohort of kidney transplant patients during the first year after transplantation...
October 2018: Therapeutic Drug Monitoring
Million A Tegenge, Iftekhar Mahmood
BACKGROUND: In population pharmacokinetic modeling, bodyweight is often incorporated as an important covariate using fixed (0.75) or single-exponent model. In recent years, several variations of allometric models have been suggested for the prediction of drug clearance across a wide age range. The objective of this study is to develop and evaluate single-exponent, bodyweight-dependent allometric exponent (BDE), age-dependent exponent (ADE), and segmented regression models for predicting clearance and maintenance dose of theophylline...
October 2018: Therapeutic Drug Monitoring
Zohra Chadli, Emna Kerkeni, Ibtissem Hannachi, Saoussen Chouchene, Nadia Ben Fredj, Naceur A Boughattas, Karim Aouam, Amel Chaabane
Thiopurine-S-methyltransferase (TPMT) and inosine triphosphate pyrophosphatase (ITPA) are crucial enzymes involved in the metabolism of thiopurine drugs. Significant interethnic variation in the expression of TPMT and ITPA is caused by single nucleotide polymorphisms of genes encoding these proteins. The aim of this study was to describe the distribution of TPMT and ITPA polymorphisms in healthy Tunisian subjects and to establish the metabolizer status of thiopurine drugs in this population. A total of 309 healthy Tunisian subjects were recruited among blood donors of Fattouma Bourguiba Hospital of Monastir...
October 2018: Therapeutic Drug Monitoring
Yukari Miyadera, Takafumi Naito, Takahiro Yamada, Junichi Kawakami
BACKGROUND: Daptomycin, a cyclic lipopeptide antibiotic, displays high plasma protein binding. This study developed the simple method of liquid chromatographic separation using a core-shell octadecylsilyl microparticulate coupled to tandem mass spectrometry for the quantitation of total and free daptomycin in human plasma. METHODS: Free daptomycin in plasma was obtained by centrifugal ultrafiltration. Deproteinized plasma specimens were directly separated using a core-shell octadecylsilyl microparticulate with isocratic elution...
October 2018: Therapeutic Drug Monitoring
Sarah Allegra, Antonello Di Paolo, Jessica Cusato, Giovanna Fatiguso, Elena Arrigoni, Romano Danesi, Silvia Corcione, Antonio DʼAvolio
BACKGROUND: Several factors contribute to the high variability of linezolid plasma exposure in patients. Very recently, it has been suggested that linezolid could be an ABCB1 substrate. Therefore, the present clinical study was aimed at investigating whether ABCB1 polymorphisms could predict linezolid pharmacokinetics in 27 critically ill patients. METHODS: Genotypes were assessed through a real-time polymerase chain reaction allelic discrimination system, and linezolid plasma concentrations, considering trough concentration (Ctrough) and area under the time-concentration curve (AUC), were analyzed through a nonlinear mixed-effects modeling approach...
October 2018: Therapeutic Drug Monitoring
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