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https://www.readbyqxmd.com/read/28432468/population-pharmacokinetics-of-intravenous-acetaminophen-in-japanese-patients-undergoing-elective-surgery
#1
Tsuyoshi Imaizumi, Shinju Obara, Midori Mogami, Yuzo Iseki, Makiko Hasegawa, Masahiro Murakawa
INTRODUCTION: Intravenous (i.v.) acetaminophen is administered during surgery for postoperative analgesia. However, little information is available on the pharmacokinetics of i.v. acetaminophen in Japanese patients undergoing surgery under general anesthesia. METHODS: The study was approved by the Institutional Review Board and registered at UMIN-CTR (UMIN000013418). Patients scheduled to undergo elective surgery under general anesthesia were enrolled after obtaining written informed consent...
April 21, 2017: Journal of Anesthesia
https://www.readbyqxmd.com/read/28417561/population-pharmacokinetics-of-morphine-in-patients-with-nonalcoholic-steatohepatitis-nash-and-healthy-adults
#2
V Pierre, C K Johnston, B C Ferslew, Klr Brouwer, D Gonzalez
Altered expression and function of transporters in nonalcoholic steatohepatitis (NASH) patients may affect the pharmacokinetics (PK), efficacy, and safety of substrate drugs. A population pharmacokinetic (PopPK) analysis was performed to assess differences in morphine and morphine-3-glucuronide (M3G) disposition in NASH and healthy subjects. A total of 315 serum and 42 urine samples from 21 subjects (14 healthy; 7 NASH) were analyzed using NONMEM. Morphine and M3G PK were described by three- and one-compartment models, respectively...
April 18, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28409488/a-joint-model-for-vitamin-k-dependent-clotting-factors-and-anticoagulation-proteins
#3
Qing Xi Ooi, Daniel F B Wright, R Campbell Tait, Geoffrey K Isbister, Stephen B Duffull
BACKGROUND: Warfarin acts by inhibiting the reduction of vitamin K (VK) to its active form, thereby decreasing the production of VK-dependent coagulation proteins. The aim of this research is to develop a joint model for the VK-dependent clotting factors II, VII, IX and X, and the anticoagulation proteins, proteins C and S, during warfarin initiation. METHODS: Data from 18 patients with atrial fibrillation who had warfarin therapy initiated were available for analysis...
April 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28408267/population-pharmacokinetics-of-moxifloxacin-cycloserine-p-aminosalicylic-acid-and-kanamycin-for-the-treatment-of-multi-drug-resistant-tuberculosis
#4
Min Jung Chang, Byunghak Jin, Jung-Woo Chae, Hwi-Yeol Yun, Eun Sun Kim, Yeon Joo Lee, Young-Jae Cho, Ho Il Yoon, Choon-Taek Lee, Kyoung Un Park, Junghan Song, Jae-Ho Lee, Jong Sun Park
Control of multi-drug-resistant tuberculosis (MDR-TB) requires extensive, supervised chemotherapy because second-line anti-TB drugs have a narrower therapeutic range than first-line drugs. This study aimed to develop population pharmacokinetic (PK) models for second-line drugs in patients with MDR-TB, evaluate the recommended dosage regimens and, if necessary, suggest new dosage regimens. A prospective, single-centre PK study was performed on second-line anti-TB drugs in patients with MDR-TB. Moxifloxacin, cycloserine, p-aminosalicylic acid (PAS), kanamycin and other second-line drugs were administered to the patients...
April 10, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28407406/phenobarbital-in-intensive-care-unit-pediatric-population-predictive-performances-of-population-pharmacokinetic-model
#5
Amélie Marsot, Fabrice Michel, Estelle Chasseloup, Olivier Paut, Romain Guilhaumou, Olivier Blin
An external evaluation of phenobarbital population pharmacokinetic model described by Marsot et al. was performed in pediatric intensive care unit. Model evaluation is an important issue for dose adjustment. This external evaluation should allow confirming the proposed dosage adaptation and extending these recommendations to the entire intensive care pediatric population. External evaluation of phenobarbital published population pharmacokinetic model of Marsot et al. was realized in a new retrospective dataset of 35 patients hospitalized in a pediatric intensive care unit...
April 13, 2017: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/28396159/a-time-to-event-model-for-acute-kidney-injury-after-reduced-intensity-conditioning-stem-cell-transplantation-using-a-tacrolimus-and-sirolimus-based-graft-versus-host-disease-prophylaxis
#6
Jose Luis Piñana, Alejandro Perez-Pitarch, Irene Garcia-Cadenas, Pere Barba, Juan Carlos Hernandez-Boluda, Albert Esquirol, María Laura Fox, María José Terol, Josep M Queraltó, Jaume Vima, David Valcarcel, Rafael Ferriols-Lisart, Jorge Sierra, Carlos Solano, Rodrigo Martino
There is a paucity of data evaluating acute kidney injury (AKI) incidence and its relationship with the tacrolimus-sirolimus (Tac-Sir) concentrations in the setting of reduced intensity conditioning after allogeneic stem cell transplantation (RIC-allo-HSCT). This multicenter retrospective study evaluated risk factors of AKI defined by two classification systems (KDIGO score and "Grade 0-3 staging") in 186 consecutive RIC-allo-HSCT recipients with Tac-Sir as graft-versus-host disease prophylaxis. Conditioning regimens consisted of fludarabine and busulfan (n=53), or melphalan (n=83), or a combination of thiotepa, fludarabine and busulfan (n=50)...
April 7, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28389762/analysis-of-opioid-consumption-in-clinical-trials-a-simulation-based-analysis-of-power-of-four-approaches
#7
Rasmus Vestergaard Juul, Joakim Nyberg, Mads Kreilgaard, Lona Louring Christrup, Ulrika S H Simonsson, Trine Meldgaard Lund
Inconsistent trial design and analysis is a key reason that few advances in postoperative pain management have been made from clinical trials analyzing opioid consumption data. This study aimed to compare four different approaches to analyze opioid consumption data. A repeated time-to-event (RTTE) model in NONMEM was used to simulate clinical trials of morphine consumption with and without a hypothetical adjuvant analgesic in doses equivalent to 15-62% reduction in morphine consumption. Trials were simulated with duration of 24-96 h...
April 7, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28369967/a-simulation-study-to-compare-the-treatment-effect-of-tamoxifen-by-cyp2d6-genotypes-and-third-generation-aromatase-inhibitors
#8
Gwan Cheol Park, Jin-A Jung, Kyun-Seop Bae, Hyeong-Seok Lim
Some prospective, randomized clinical trials, including ATAC and BIG 1-98, demonstrated superior treatment effect of third-generation aromatase inhibitors (AIs) versus tamoxifen in postoperative therapy for patients with breast cancer. In retrospective genotyping analyses of the 2 studies using tumor samples, no difference in the treatment effect of tamoxifen was observed by CYP2D6 genotypes. However, those analyses did not consider loss of heterozygosity that could have occurred when genotyping using tumor tissue...
April 3, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28353056/pharmacokinetics-of-escalating-doses-of-oral-psilocybin-in-healthy-adults
#9
Randall T Brown, Christopher R Nicholas, Nicholas V Cozzi, Michele C Gassman, Karen M Cooper, Daniel Muller, Chantelle D Thomas, Scott J Hetzel, Kelsey M Henriquez, Alexandra S Ribaudo, Paul R Hutson
INTRODUCTION: Psilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. This open-label study of the pharmacokinetics of psilocybin was performed to describe the pharmacokinetics and safety profile of psilocybin in sequential, escalating oral doses of 0.3, 0.45, and 0.6 mg/kg in 12 healthy adults. METHODS: Eligible healthy adults received 6-8 h of preparatory counseling in anticipation of the first dose of psilocybin...
March 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28353055/accounting-for-pharmacokinetic-variability-of-certolizumab-pegol-in-patients-with-crohn-s-disease
#10
Niels Vande Casteele, Diane R Mould, Jason Coarse, Iram Hasan, Ann Gils, Brian Feagan, William J Sandborn
BACKGROUND: Certolizumab pegol is an effective biologic for patients with Crohn's disease (CD). Individual differences in certolizumab pegol apparent clearance (CL/F) affect exposure and possibly efficacy. A previously developed population pharmacokinetic (PK) model did not account for dynamic changes in clinical parameters during therapy. OBJECTIVE: The aim of this study was to refine the existing PK model to capture the time-varying influence of covariates. METHODS: Data collected from 2157 Crohn's disease patients in nine studies were analyzed using nonlinear mixed-effects modeling software (NONMEM)...
March 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28349335/population-pharmacokinetics-to-model-the-time-varying-clearance-of-the-pegylated-asparaginase-oncaspar-%C3%A2-in-children-with-acute-lymphoblastic-leukemia
#11
Gudrun Würthwein, Claudia Lanvers-Kaminsky, Georg Hempel, Silke Gastine, Anja Möricke, Martin Schrappe, Mats O Karlsson, Joachim Boos
BACKGROUND AND OBJECTIVES: The pharmacokinetics of the polyethylene glycol (PEG)-conjugated asparaginase Oncaspar(®) are characterized by an increase in elimination over time. The focus of our analysis is the better understanding of this time-dependency. METHODS: In paediatric acute lymphoblastic leukemia therapy (AIEOP-BFM ALL 2009), two administrations of Oncaspar(®) (2500 U/m(2) intravenously) in induction phase (14-day interval) and one single administration in reinduction were followed by weekly monitoring of asparaginase activity...
March 27, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28297816/-population-pharmacokinetics-of-vancomycin-from-severe-in-patients-with-lower-respiratory-tract-infection
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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