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Therapeutic Drug Monitoring

Brady S Moffett, Charissa Kam, Marianne Galati, Lindsay Schmees, Gideon A Stitt, Paula A Revell, Debra L Palazzi
BACKGROUND: Obese pediatric patients often require dose reductions when initiating gentamicin therapy. An appropriate method for calculating ideal body weight for dosing gentamicin in pediatric patients has not been validated. METHODS: A retrospective, population pharmacokinetic study was designed and included non-intensive care pediatric patients who received gentamicin and had serum gentamicin concentrations sampled. Actual body weight, adjusted body weight, and fat-free mass were used to describe the pharmacokinetic variables...
March 6, 2018: Therapeutic Drug Monitoring
Pierre Marquet, Anne Bedu, Caroline Monchaud, Franck Saint-Marcoux, Jean-Philippe Rérolle, Isabelle Etienne, Nassim Kamar, Bruno Moulin, Elisabeth Cassuto, Marie Essig, Jean-Baptiste Woillard
BACKGROUND: ISBA is an online expert system, routinely used by approximately 140 transplantation centers in the world for the dose adjustment of immunosuppressive drugs in transplant patients. This system determines the drug area-under-the-curve (AUC) by PK modeling and Bayesian estimation. The purpose of this study was to analyze tacrolimus exposure after administration of its modified-release formulation (Advagraf) in kidney allograft recipients, in order to optimize its therapeutic drug monitoring...
March 2, 2018: Therapeutic Drug Monitoring
Sanne M Kloosterboer, Brenda C M de Winter, Soma Bahmany, Linda Al-Hassany, Annet Dekker, G C Dieleman, Teun van Gelder, Bram Dierckx, Birgit C P Koch
BACKGROUND: Dried Blood Spot (DBS) sampling offers a minimally invasive sampling method for therapeutic drug monitoring of antipsychotics. To facilitate implementation in clinical practice, the aim of this study was to perform a clinical validation study of a DBS method for quantification of risperidone, aripiprazole, pipamperone and its major metabolites 9-OH risperidone and dehydro-aripiprazole in a real-life, clinical setting. METHODS: Paired DBS and venous plasma samples were analyzed (n=35 for risperidone, n=21 for aripiprazole, n=21 for pipamperone)...
March 2, 2018: Therapeutic Drug Monitoring
Ksenija Makar-Aušperger, Kristina Krželj Cand Med, Martina Lovrić Benčić, Matea Radačić Aumiler, Viktorija Erdeljić Turk, Nada Božina
BACKGROUND: Observational studies have indicated potential benefits of CYP2C9 and VKORC1 guided dosing of warfarin but randomized clinical trials have resulted in contradictory findings. One of the reasons for contradiction may be the negligence of possible differences between warfarin indications. This study aims to determine efficacy and safety of genotype- and clinically guided dosing of warfarin in atrial fibrillation (AF), deep-vein thrombosis (DVT), and pulmonary embolism (PE) within the first five days after the introduction of therapy...
February 27, 2018: Therapeutic Drug Monitoring
Hyojin Chae, Jeong Joong Lee, Kyoungho Cha, Su Hyun Her, Hyo-Young Kim, Eunhee Han, Myungshin Kim, Yonggoo Kim, Sung-Yeon Cho, Dong-Gun Lee
BACKGROUND: Teicoplanin is a glycopeptide antibiotic that has become increasingly popular with the spread of methicillin-resistant Staphylococcus aureus. The aim of the study was to develop and validate a UHPLC-MS/MS (ultra-high performance liquid chromatography tandem mass spectrometry) method for teicoplanin, and analyze trough teicoplanin concentrations achieved in patients with hematological diseases. METHODS: The UHPLC-MS/MS method for teicoplanin was developed, validated, and applied in a retrospective analysis of trough plasma teicoplanin concentrations from 305 patients receiving standard dose, and 17 patients receiving TDM-guided individualized dose...
February 27, 2018: Therapeutic Drug Monitoring
Takahiro Kobayashi, Masatomo Miura, Takenori Niioka, Maiko Abumiya, Fumiko Ito, Isuzu Kobayashi, Sho Ikeda, Tomoko Yoshioka, Yoshihiro Kameoka, Naoto Takahashi
BACKGROUND: The authors conducted a phase II clinical trial of lenalidomide and dexamethasone combination therapy in Japanese elderly patients with newly diagnosed multiple myeloma to evaluate its safety and efficacy and to determine whether safety and efficacy correlate with the plasma concentration of lenalidomide. METHODS: Forty patients received oral lenalidomide on days 1-21 of a 28-day cycle in addition to weekly doses of dexamethasone. Plasma concentrations of lenalidomide were measured, and the area under the concentration-time curve from 0 to 24 h (AUC0-24) of lenalidomide was predicted using a formula the authors previously reported in this journal...
February 27, 2018: Therapeutic Drug Monitoring
Paul Lewis
BACKGROUND: Serum trough concentrations as the sole means of monitoring safety and efficacy of vancomycin are insufficient. The daily area under the curve (AUC24) of serum concentration versus time to minimum inhibitory concentration (MIC) ratio of greater than 400 mg*hr/L has emerged as a more robust dosing target. A simple and practical method to extrapolate AUC24 from troughs is needed. MATERIALS AND METHODS: This mathematical model computes the median and range AUC24 using the dose in mg/kg and the observed serum trough concentration...
February 27, 2018: Therapeutic Drug Monitoring
Claire Pressiat, Huu-Hien Huynh, Alain Plé, Hélène Sauvageon, Isabelle Madelaine, Cécile Chougnet, Christine Le Maignan, Samia Mourah, Lauriane Goldwirt
BACKGROUND: A simple, rapid, and sensitive LC-MS/MS method has been developed and validated for the quantification of ruxolitinib, olaparib, vismodegib, and pazopanib in human plasma. METHODS: After a simple protein precipitation of plasma samples, the chromatographic separation was performed using an UPLC system coupled with MS/MS in a positive ionization mode. The mobile phase consisted of a gradient elution of 10 mmol/L formate ammonium buffer containing 0.1% (v/v) formic acid (phase A) and acetonitrile with 0...
February 22, 2018: Therapeutic Drug Monitoring
Thijs H Oude Munnink, Anna Demmer, Roel H J Slenter, Kris L L Movig
The authors present a case of a 69-year-old man with arrhythmogenic right ventricular cardiomyopathy controlled with amiodarone and an infected orthopedic prosthesis requiring treatment with rifampicin. This combination involves a pharmacokinetic drug-drug interaction leading to subtherapeutic drug concentrations of amiodarone and its active metabolite. The long half-life of amiodarone and its active metabolite in combination with the late onset and offset of cytochrome P4503A (CYP3A4) induction by rifampicin makes this a challenging drug-drug interaction to cope with in clinical practice...
February 20, 2018: Therapeutic Drug Monitoring
V Goti, A Chaturvedula, M J Fossler, S Mok, J T Jacob
BACKGROUND: Despite being in clinical use for about six decades, vancomycin dosing remains perplexing and complex. METHODS: A population pharmacokinetic modeling and simulation approach was used to evaluate the efficiency of the current nomogram-based dosing of vancomycin. Serum vancomycin concentrations were obtained as a part of routine therapeutic drug monitoring (TDM) from two 500-bed academic medical centers. A population pharmacokinetic model was first built using these TDM data...
February 20, 2018: Therapeutic Drug Monitoring
Chi-Ju Yang, Chia-Wei Wu, Chien-Chih Wu
BACKGROUND: The optimal dosing regimen of vancomycin for critically ill patients receiving continuous veno-venous hemofiltration (CVVH) remains controversial, not to mention those with concurrent use of extracorporeal membrane oxygenation (ECMO). We aimed to determine if a new dosing regimen can achieve the target vancomycin trough concentration (Ctrough) of 10-20 μg/mL in patients receiving CVVH with or without ECMO. METHODS: We conducted a retrospective study by enrolling patients who received vancomycin while undergoing CVVH...
February 14, 2018: Therapeutic Drug Monitoring
Emily K Brooks, Christine E Staatz, Susan E Tett, Nicole M Isbel, Brett McWhinney
BACKGROUND: Although multiple linear regression-based limited sampling strategies (LSS) have been published for enteric-coated mycophenolate sodium (EC-MS), none have been evaluated for the prediction of subsequent mycophenolic acid (MPA) exposure. This study aimed to examine the predictive performance of the published LSS for the estimation of future MPA area under the concentration-time curve from 0 to 12 hours (AUC0-12) in renal transplant recipients. METHODS: Total MPA plasma concentrations were measured in twenty adult renal transplant patients on two occasions a week apart...
February 14, 2018: Therapeutic Drug Monitoring
Bart C H van der Nagel, Sophie Wassenaar, Soma Bahmany, Birgit C P Koch
BACKGROUND: Detection of alcohol consumption after a longer period of time can be useful in certain patient groups. To monitor chronic alcohol consumption, a novel analytical method for the quantification of phosphatidylethanols (PEth) was developed and validated using ultra performance convergence chromatography tandem mass spectrometry. METHODS: The main phosphatidylethanols -Palmitoyl-2-oleoyl-sn-glycero-3-phosphoethanol (POPEth), 1-Palmitoyl-2-linoleoyl-sn-glycero-3-phosphoethanol (PLPEth), and 1,2-Dioleoyl-sn-glycero-3-phosphoethanol (DOPEth) were analyzed using a simple and fast sample preparation protocol followed by chromatographic separation using ultra performance convergence chromatography, a novel kind of supercritical fluid chromatography...
February 8, 2018: Therapeutic Drug Monitoring
Ignacio G Bressán, Mariana L Mendez, María I Gimenez
BACKGROUND: Voriconazole is a broad-spectrum triazole antifungal agent. It is widely used in the treatment of invasive fungal infections in immunocompromised patients. Because the pharmacokinetics of voriconazole demonstrates considerable variability, monitoring its serum levels plays an important role in optimizing therapies against many clinically relevant fungal pathogens. The aim of this study was to validate a simple and rapid U-HPLC-PDA method with minimal sample preparation for routine therapeutic drug monitoring (TDM) of voriconazole...
February 8, 2018: Therapeutic Drug Monitoring
Nobuhiro Ooba, Daisuke Tsutsumi, Naoko Kobayashi, Shinji Hidaka, Hiroyuki Hayashi, Taku Obara, Michihiro Satoh, Kiyoshi Kubota, Noriyasu Fukuoka
BACKGROUND: Therapeutic drug monitoring (TDM) for lithium is recommended in guidelines; however, the prevalence of TDM for lithium is seldom reported. We have therefore investigated the prevalence of TDM for lithium and evaluated the impact of the regulatory warnings requiring routine TDM for lithium. METHODS: Monthly claims data covering around 1.7 million persons aged 20 to 74 years old during the period January 1, 2005 and March 31, 2015 were evaluated. All patients who had at least one prescription for lithium were selected and included to calculate the annual prevalence of TDM for lithium...
February 5, 2018: Therapeutic Drug Monitoring
Guillemette E Benoist, Eric van der Meulen, Inge M van Oort, Jan Hendrik Beumer, Diederik M Somford, Jack A Schalken, David M Burger, Nielka P van Erp
BACKGROUND: Enzalutamide is a potent androgen-signaling receptor inhibitor and is licensed for the treatment of metastatic castration-resistant prostate cancer. N-desmethylenzalutamide is the active metabolite of enzalutamide. A method to quantitate enzalutamide and its active metabolite was developed and validated according to the European Medicine Agency (EMA) guidelines. METHODS: Enzalutamide and N-desmethylenzalutamide were extracted by protein precipitation, separated on a C18 column with gradient elution and analyzed with tandem quadruple mass spectrometry in positive ion mode...
February 5, 2018: Therapeutic Drug Monitoring
Simuli L Wabuyele, Jennifer M Colby, Gwendolyn A McMillin
Maternal substance abuse during pregnancy is a growing problem with major public health and legal concerns. In utero substance exposure may adversely affect neonatal development, pregnancy outcome and the long term behavioral, cognitive and developmental abilities of the child. Also, serious legal implications are associated with substance abuse during pregnancy, including charges of child abuse and neglect which may result in removal of the neonate from parental care and loss of custodial rights. Timely detection of in utero drug exposure is necessary for early identification and effective management of exposed newborns...
February 5, 2018: Therapeutic Drug Monitoring
Makiko Shimizu, Tatsuki Kondo, Tetsuya Fukuoka, Toshihiro Tanaka, Hiroshi Yamazaki
A high activity of cytochrome P450 2D6 (CYP2D6) reportedly leads toxicity of dihydrocodeine/codeine by increasing toxic potential of their metabolite dihydromorphine/morphine, which are further metabolized to highly active dihydromorphine 6-O-glucuronide and the less active morphine 3-O-glucorinide but rapidly excreted into urine as water-soluble forms. A case of acute respiratory depression after administration of prescribed dihydrocodeine phosphate (2.0 mg/day divided TID for 2 days) to a 1-month-old baby boy genotyped as cytochrome CYP2D6*1/*10-*36 is described...
January 30, 2018: Therapeutic Drug Monitoring
Mariana Bustillo, Arantzazu Zabala, Imanol Querejeta, Jaione I Carton, Oiane Mentxaka, Ana González-Pinto, Sainza García, J Javier Meana, J Ignacio Eguiluz, Rafael Segarra
BACKGROUND: Studies on therapeutic drug monitoring (TDM) of second-generation antipsychotics (SGAs) have provided conflicting results regarding the association between dose, plasma concentrations, and drug effect and have focused rather on analyzing how individual drugs work. No study has attempted to process data from different SGAs globally to offer a panoramic view of the utility of TDM in clinical practice, and data on patients with first-episode psychosis (FEP) are lacking. The present study aimed to assess the relationship between dose, plasma concentrations, and drug effect in a sample of FEP patients, regardless of the SGA prescribed...
January 23, 2018: Therapeutic Drug Monitoring
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April 2018: Therapeutic Drug Monitoring
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