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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
Yoshiaki Yamamoto, Yukitoshi Takahashi, Asako Horino, Naotaka Usui, Takuji Nishida, Katsumi Imai, Yoshiyuki Kagawa, Yushi Inoue
BACKGROUND: It is well-known that the pharmacokinetics of various drugs are influenced by inflammation. This study evaluated the relationship between C-reactive protein (CRP; an inflammation marker) and the pharmacokinetics of perampanel. METHODS: Among 111 patients who underwent measurement of both CRP and perampanel, 23 patients had a serum CRP level exceeding 1.5 mg/dL (CRP-positive). We compared the concentration/dose ratio (CD ratio) of perampanel in these 23 patients between the times when they were CRP-positive and CRP-negative...
August 1, 2018: Therapeutic Drug Monitoring
Kei Irie, Akira Okada, Yuta Yamasaki, Chiyuki Kokan, Akito Hata, Reiko Kaji, Keizo Fukushima, Nobuyuki Sugioka, Yutaka Okada, Nobuyuki Katakami, Shoji Fukushima
BACKGROUND: Nivolumab is a fully humanized IgG4 monoclonal antibody that targets the programmed death-1 (PD-1) receptor, disrupting PD-1-mediated signaling and restoring antitumor immunity. The objective of this study was to develop a nivolumab quantification method using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to evaluate its application in clinical therapeutic drug monitoring. METHODS: Nivolumab was purified from human plasma using rProtein A resin and then digested with trypsin...
July 25, 2018: Therapeutic Drug Monitoring
Alice Ameline, Nadia Arbouche, Jean-Sébastien Raul, Pascal Kintz
No abstract text is available yet for this article.
July 25, 2018: Therapeutic Drug Monitoring
Swan Lin, Mina Nikanjam, Edmund V Capparelli, Alessandro Allegrini, Daniele Pavone, Dong-Seok Yim, Muhammad M Hammami, Joseph S Bertino, Anne N Nafziger, Yoo-Sin Park, Ophelia Q Yin, Joseph D Ma
PURPOSE: Limited sampling strategy (LSS) is a validated method to estimate pharmacokinetic (PK) parameters from a reduced number of samples. Omeprazole is used to phenotype in vivo cytochrome P450 (CYP) 2C19 activity. This study examined a LSS using two estimation methods to determine apparent oral clearance (CL/F) and thus CYP2C19 activity. METHODS: Data from 7 previously published studies included healthy subjects receiving a single, oral dose of omeprazole with intensive PK sampling...
July 24, 2018: Therapeutic Drug Monitoring
Mei Zhang, Grant A Moore, Paul Kl Chin, Richard Everts, Evan J Begg
BACKGROUND: Pharmacokinetic studies and therapeutic drug monitoring (TDM) of antibiotics require a simple, rapid and reliable analytical method for monitoring the concentrations in plasma, including unbound concentrations for highly protein-bound drugs. The aim of the current work was to develop and validate a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous determination of total and unbound concentrations of three widely used β-lactam antibiotics (cefalexin, cefazolin and flucloxacillin) and the often co-administered drug probenecid in human plasma, suitable for pharmacokinetic studies and for routine use in ordinary, busy hospital laboratories...
July 10, 2018: Therapeutic Drug Monitoring
Masahiro Ohgami, Takayuki Kaburagi, Atsuhiko Kurosawa, Kosuke Doki, Toshihiro Shiozawa, Nobuyuki Hizawa, Masato Homma
BACKGROUND: Erlotinib is used for treating non-small cell lung cancer (NSCLC). Intestinal absorption of erlotinib is impaired under gastric pH elevation, therefore, co-administration of gastric acid suppressants may provide lower blood concentration of erlotinib. We investigated the effects of erlotinib co-administration with proton pump inhibitors (PPI) and histamine H2 receptor blockers (H2RB) on the plasma concentration of erlotinib and erlotinib-induced adverse reaction in NSCLC patients...
July 9, 2018: Therapeutic Drug Monitoring
Mami Iwasaki, Ikuko Yano, Sachio Fukatsu, Sachiyo Hashi, Yuki Yamamoto, Mitsuhiro Sugimoto, Masahide Fukudo, Satohiro Masuda, Shunsaku Nakagawa, Atsushi Yonezawa, Toshimi Kaido, Shinji Uemoto, Kazuo Matsubara
BACKGROUND: This study investigates the pharmacokinetics and pharmacodynamics of tacrolimus using the once-daily (OD) formulation in the early stage after living donor liver transplantation (LDLT) in comparison with those using the twice-daily (TD) formulation. METHODS: Nine patients undergoing primary LDLT and treated with the OD tacrolimus formulation were included. The trough blood concentration (C0) of tacrolimus was monitored every day for three weeks after LDLT...
June 29, 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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