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https://www.readbyqxmd.com/read/28297816/-population-pharmacokinetics-of-vancomycin-from-severe-in-patients-with-lower-respiratory-tract-infection
#1
W Yang, B He, C H Deng
Objective: To develop a population pharmacokinetic (PPK) model of vancomycin in Chinese inpatients with severe lower respiratory tract infection. Methods: We gathered serum concentrations of vancomycin from inpatients who received vancomycin during Nov 2011 to Nov 2012.Vancomycin serum concentrations was measured by high performance liquid chromatography. Vancomycin PPK analysis was performed using nonlinear mixed effects model (NONMEM) program. Results: We gathered the data of 70 inpatients with lower respiratory tract infection at respiratory ward or respiratory intensive care unit(RICU) between Nov 2011 to Nov 2012 [58 males, 12 females; 78(23-91) years old; the mean of APACHⅡ score was 16...
March 12, 2017: Chinese Journal of Tuberculosis and Respiratory Diseases
https://www.readbyqxmd.com/read/28294376/influence-of-the-pharmacokinetic-profile-on-the-plasma-glucose-lowering-effect-of-ppar%C3%AE-agonist-pioglitazone-in-wistar-fatty-rats
#2
Akihiko Goto, Yoshihiko Tagawa, Yoshiaki Kimura, Akifumi Kogame, Yuu Moriya, Nobuyuki Amano
Although the mechanism of action for peroxisome proliferator-activated receptor gamma (PPARγ) agonists has been extensively explored, the impact of the pharmacokinetic (PK) profile on the pharmacodynamic (PD) effects of PPARγ agonists has not been elucidated in detail. We evaluated the importance of the PK profile of PPARγ agonist for its PD effect based on population PK/PD analysis. Pioglitazone hydrochloride, the PPARγ agonist, was administered orally to Wistar fatty rats once a day (qd) or once every other day (q2d) as double the amount for the qd treatment...
March 11, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28290121/population-pharmacokinetic-analysis-of-ixazomib-an-oral-proteasome-inhibitor-including-data-from-the-phase-iii-tourmaline-mm1-study-to-inform-labelling
#3
Neeraj Gupta, Paul M Diderichsen, Michael J Hanley, Deborah Berg, Helgi van de Velde, R Donald Harvey, Karthik Venkatakrishnan
Ixazomib is an oral proteasome inhibitor, approved in USA, Canada, Australia and Europe in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. We report a population pharmacokinetic model-based analysis for ixazomib that was pivotal in describing the clinical pharmacokinetics of ixazomib, to inform product labelling. Plasma concentration-time data were collected from 755 patients who received oral or intravenous ixazomib in once- or twice-weekly schedules in ten trials, including the global phase III TOURMALINE-MM1 study...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28289434/experience-and-pharmacokinetics-of-levetiracetam-in-korean-neonates-with-neonatal-seizures
#4
Jae Won Shin, Yun Seob Jung, Kyungsoo Park, Soon Min Lee, Ho Seon Eun, Min Soo Park, Kook In Park, Ran Namgung
PURPOSE: The aims of this study were to evaluate the safety and pharmacokinetics of levetiracetam (LEV) in neonates with seizures and to establish a population pharmacokinetics (PPK) model by using the software NONMEM. METHODS: A retrospective analysis of 18 neonatal patients with seizures, who were treated with LEV, including 151 serum samples, was performed. The mean loading dose was 20 mg/kg, followed by a mean maintenance dose of 29 mg/kg/day. RESULTS: Seventeen neonates (94%) had seizure cessation within 1 week and 16 (84%) remained seizure-free at 30 days under the LEV therapy...
February 2017: Korean Journal of Pediatrics
https://www.readbyqxmd.com/read/28279893/population-pharmacokinetics-and-dose-response-relationship-of-levetiracetam-in-adult-patients-with-epilepsy
#5
Su-Jin Rhee, Jung-Won Shin, SeungHwan Lee, Jangsup Moon, Tae-Joon Kim, Ki-Young Jung, Kyung-Il Park, Soon-Tae Lee, Keun-Hwa Jung, Kyung-Sang Yu, In-Jin Jang, Kon Chu, Sang Kun Lee
Levetiracetam (LEV) is commonly used as a mono- or adjunctive therapy for treating patients with partial and generalized epilepsy. This study aimed to develop a population pharmacokinetic (PK) model of LEV, based on sparse data, and to explore LEV efficacy relative to its PK properties in patients with epilepsy. We included 483 LEV concentrations from 425 patients with epilepsy that received multiple oral LEV doses. We performed a population PK analysis, implemented in NONMEM (version 7.2). In addition, we explored the relationships between seizure control and PK variables (i...
February 27, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28274497/development-and-validation-of-a-quantification-method-for-cucurbitacins-e-and-i-in-rat-plasma-application-to-population-pharmacokinetic-studies
#6
Giovana Maria Lanchoti Fiori, Salvatore D'Agate, Adriana Rocha, Ana Maria Soares Pereira, Oscar Della Pasqua, Norberto Peporine Lopes
Cucurbitacin E is a potential drug candidate due to its anticancer activity, recognition of its molecular targets, and synergism with other drugs used for cancer treatment. However, the use of cucurbitacin E in clinical practice is not possible because of important knowledge gaps in its preclinical and clinical pharmacokinetic characteristics. Cucurbitacin E is hydrolyzed to cucurbitacin I in plasma and in human liver microsomes. The aim of this study was to evaluate the population pharmacokinetics of cucurbitacin E and of its metabolite cucurbitacin I in rats...
February 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28257285/population-pharmacokinetics-of-vancomycin-in-chinese-pediatric-patients%C3%A2
#7
Taotao Liu, Chen Deng, Daohai Cheng, Tianyan Zhou, Hua Lu, Wenxing Wei, Wei Lu
OBJECTIVE: This study was conducted to develop a population pharmacokinetic (PopPK) model for vancomycin and to detect the significant covariates that influence the PopPKs to facilitate individualized therapy for Chinese pediatric patients. METHODS: Patients ≤ 10 years old who received vancomycin for ≥ 72 hours between 2007 and 2010 were analyzed using a nonlinear mixed-effects modeling approach (-NONMEM). A one-compartment model with first-order elimination was chosen to depict the data...
March 3, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28250007/population-pharmacokinetics-of-intravenous-erwinia-asparaginase-in-pediatric-acute-lymphoblastic-leukemia-patients
#8
Sebastiaan D T Sassen, Ron A A Mathôt, Rob Pieters, Robin Q H Kloos, Valérie de Haas, Gertjan J L Kaspers, Cor van den Bos, Wim J E Tissing, Maroeska Te Loo, Marc B Bierings, Wouter J W Kollen, Christian M Zwaan, Inge M van der Sluis
Erwinia asparaginase is an important component in the treatment of pediatric acute lymphoblastic leukemia. A large variability in serum concentrations has been observed after intravenous Erwinia asparaginase. Currently, Dutch Childhood Oncology Group protocols dose alterations are based on trough concentrations to ensure adequate asparaginase activity (≥100 IU/L). The aim of this study was to describe the population pharmacokinetics of intravenous Erwinia asparaginase to quantify and gather insight into inter-individual and inter-occasion variability...
March 2017: Haematologica
https://www.readbyqxmd.com/read/28230619/population-pharmacokinetics-of-topiramate-in-japanese-pediatric-and-adult-patients-with-epilepsy-using-routinely-monitored-data
#9
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 (PPK) 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...
April 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28229374/effect-of-short-term-fasting-on-systemic-cytochrome-p450-mediated-drug-metabolism-in-healthy-subjects-a-randomized-controlled-crossover-study-using-a-cocktail-approach
#10
Laureen A Lammers, Roos Achterbergh, Ron H N van Schaik, Johannes A Romijn, Ron A A Mathôt
BACKGROUND AND OBJECTIVE: Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic clearance of different drugs. METHODS: In a randomized, controlled, crossover trial, 12 healthy subjects received a single administration of a cytochrome P450 (CYP) probe cocktail, consisting of caffeine (CYP1A2), metoprolol (CYP2D6), midazolam (CYP3A4), omeprazole (CYP2C19) and warfarin (CYP2C9), on four occasions: an oral (1) and intravenous (2) administration after an overnight fast (control) and an oral (3) and intravenous (4) administration after 36 h of fasting...
February 22, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28196047/a-time-dependent-model-describes-methotrexate-elimination-and-supports-dynamic-modification-of-mrp2-abcc2-activity
#11
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: Multidrug resistance protein-2 encoded by the ABCC2 gene (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...
April 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28194623/comparison-of-non-compartmental-and-mixed-effect-modelling-methods-for-establishing-bioequivalence-for-the-case-of-two-compartment-kinetics-and-censored-concentrations
#12
Jim H Hughes, Richard N Upton, David J R Foster
Non-compartmental analysis (NCA) is regarded as the standard for establishing bioequivalence, despite its limitations and the existence of alternative methods such as non-linear mixed effects modelling (NLMEM). Comparisons of NCA and NLMEM in bioequivalence testing have been limited to drugs with one-compartment kinetics and have included a large number of different approaches. A simulation tool was developed with the ability to rapidly compare NCA and NLMEM methods in determining bioequivalence using both R and NONMEM and applied to a drug with two-compartment pharmacokinetics...
February 13, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28177137/hypoalbuminemia-and-decreased-midazolam-clearance-in-terminally-ill-adult-patients-an-inflammatory-effect
#13
L G Franken, A D Masman, B C M de Winter, F P M Baar, D Tibboel, T van Gelder, B C P Koch, R A A Mathot
BACKGROUND AND OBJECTIVE: Midazolam is the drug of choice for palliative sedation and is titrated to achieve the desired level of sedation. Because of large inter-individual variability (IIV), however, the time it takes to achieve adequate sedation varies widely. It would therefore greatly improve clinical care if an individualised dose could be determined beforehand. To find clinically relevant parameters for dose individualisation we performed a pharmacokinetic study on midazolam, 1OH-midazolam (1-OH-M) and 1OH-midazolam-glucuronide (1-OH-MG) in terminally ill patients...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28177130/a-population-pharmacokinetic-model-of-at9283-in-adults-and-children-to-predict-the-maximum-tolerated-dose-in-children-with-leukaemia
#14
Janna K Duong, Melanie J Griffin, Darren Hargrave, Josef Vormoor, David Edwards, Alan V Boddy
AIMS: AT9283 is used to treat patients with solid tumors and patients with leukaemia. However, the maximum tolerated dose (MTD) for children with leukaemia remains unknown due to early termination of the Phase I trial. The aim of this study was to develop a population model of AT9283 to describe the pharmacokinetics in adults and children and to estimate the MTD in children with leukaemia. METHODS: Data from Phase I dose-escalation studies in adults and children were used to build a population pharmacokinetic model (NONMEM v7...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28168884/population-pharmacokinetics-and-pharmacodynamics-of-doripenem-in-obese-hospitalized-patients
#15
Eun Kyoung Chung, Megan R Fleming, S Christian Cheatham, Michael B Kays
BACKGROUND: Doripenem population pharmacokinetics and dosing recommendations are limited in obesity. OBJECTIVE: To evaluate the population pharmacokinetics and pharmacodynamics of doripenem in obese patients. METHODS: Hospitalized adults with a body mass index (BMI) ≥ 40 kg/m(2) or total body weight (TBW) ≥45.5 kg over their ideal body weight received doripenem 500 mg every 8 hours, infused over 1 hour. Population pharmacokinetic analyses were performed using NONMEM, and Monte Carlo simulations were performed for 5 intermittent and prolonged infusion dosing regimens to calculate probability of target attainment (PTA) at 40% and 100% fT>MIC (free drug concentrations above the minimum inhibitory concentration)...
March 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28167229/population-pharmacokinetics-model-of-thc-used-by-pulmonary-route-in-occasional-cannabis-smokers
#16
A Marsot, C Audebert, L Attolini, B Lacarelle, J Micallef, O Blin
Cannabis is the most widely used illegal drug in the world. Delta-9-tetrahydrocannabinol (THC) is the main source of the pharmacological effect. Some studies have been carried out and showed significant variability in the described models as the values of the estimated pharmacokinetic parameters. The objective of this study was to develop a population pharmacokinetic model for THC in occasional cannabis smokers. Twelve male volunteers (age: 20-28years, body weight: 62.5-91.0kg), tobacco (3-8 cigarette per day) and cannabis occasional smokers were recruited from the local community...
February 4, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28135768/population-pharmacokinetics-analysis-of-intravenous-busulfan-in-chinese-patients-undergoing-hematopoietic-stem-cell-transplantation
#17
Xuemei Wu, Helin Xie, Weiwei Lin, Ting Yang, Nainong Li, Shanshan Lin, Xiaohong Yuan, Jinhua Ren, Xiaofan Li, Xian Huang
There are several reports describing population pharmacokinetic (popPK) models of busulfan (BU). However, limited information is available in Chinese hematopoietic stem-cell transplantation (HSCT) patients. The present study aimed to establish a popPK model of intravenous BU in Chinese HSCT patients for individualized drug therapy. The popPK model of BU was developed from a total of 284 concentration-time points from 53 patients. The effects of demographic and biochemical covariates were investigated by NONMEM(®) software...
January 30, 2017: Clinical and Experimental Pharmacology & Physiology
https://www.readbyqxmd.com/read/28125552/o-004-application-of-population-pharmacokinetic-modeling-to-develop-individualized-infliximab-dosing-strategies-in-pediatric-crohn-s-disease
#18
Adam Frymoyer, Daniel Hoekman, Tim de Meij, Thalia Hummel, Marc Benninga, Angelika Kindermann, Travis Piester, K T Park
BACKGROUND: Adequate infliximab (IFX) exposure is critical when treating Crohn's disease (CD), and trough concentrations <3 μg/mL are associated with loss of response. However, the pharmacokinetics of IFX are highly variable in children with CD, and this has made IFX dosing challenging in this population. Model-based drug dosing offers the potential for developing individualized dosing strategies. The objective of the current study was to evaluate the predictive performance and clinical utility of a previously published population pharmacokinetic model of IFX when applied to children with CD...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28099756/levofloxacin-effect-on-erlotinib-absorption-evaluation-of-the-interaction-in-undernutrition-situations-through-population-pharmacokinetic-analysis-in-rats
#19
Alejandro Pérez Pitarch, Beatriz Guglieri-López, Amparo Nacher, Virginia Merino, Matilde Merino-Sanjuan
The main objective of this study was to develop a pharmacokinetic model in order to describe the intestinal absorption of erlotinib in rat and to quantify the interaction of levofloxacin on this process in well- and undernourished rats. Absorption studies were performed in male Wistar rats. Concentration-time profiles in proximal and distal intestine were analysed through non-linear mixed effect modelling using the NONMEM software version 7.3. Simulations were performed in order to explore the influence of covariates on apparent absorption rate constant...
January 18, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28079918/dose-evaluation-of-lamivudine-in-hiv-infected-children-aged-5%C3%A2-months-18%C3%A2-years-based-on-a-population-pharmacokinetic-analysis
#20
Esther J H Janssen, Diane E T Bastiaans, Pyry A J Välitalo, Annemarie M C van Rossum, Evelyne Jacqz-Aigrain, Hermione Lyall, Catherijne A J Knibbe, David M Burger
AIM: The objectives of this study were to characterise age-related changes in lamivudine pharmacokinetics in children and evaluate lamivudine exposure, followed by dose recommendations for subgroups in which target steady state AUC0-24h is not reached. METHODS: Population pharmacokinetic modelling was performed in NONMEM using data from two model building datasets and two external datasets (n = 180 (age 0.4-18 years, bodyweight 3.4-60.5 kg); 2,061 samples (median 12 per child); daily oral dose 60-300 mg (3...
January 12, 2017: British Journal of Clinical Pharmacology
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