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https://www.readbyqxmd.com/read/29319495/investigation-of-the-age-dependency-of-vancomycin-clearance-by-population-pharmacokinetic-modeling
#1
Muhammad Usman, Manfred Fobker, Georg Hempel
PURPOSE: The aim of this study was to evaluate the influence of age and other possible covariates on vancomycin clearance in order to define a possible cut off value of age for dose optimization in elderly patients from data obtained during therapeutic drug monitoring. MATERIALS AND METHODS: Population pharmacokinetic analysis of 256 samples obtained from 144 patients was performed by using NONMEM®. A one-compartment model was applied as the base model with first-order conditional estimation method with interaction (FOCE-I)...
January 10, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29305823/semi-mechanistic-population-pharmacokinetic-modeling-of-l-histidine-disposition-and-brain-uptake-in-wildtype-and-pht1-null-mice
#2
Xiao-Xing Wang, Yang-Bing Li, Meihua R Feng, David E Smith
PURPOSE: To develop a semi-mechanistic population pharmacokinetic (PK) model to quantitate the disposition kinetics of L-histidine, a peptide-histidine transporter 1 (PHT1) substrate, in the plasma, cerebrospinal fluid and brain parenchyma of wildtype (WT) and Pht1 knockout (KO) mice. METHODS: L-[14C]Hisidine (L-His) was administrated to WT and KO mice via tail vein injection, after which plasma, cerebrospinal fluid (CSF) and brain parenchyma samples were collected...
January 5, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29305813/a-simultaneous-mixed-effects-pharmacokinetic-model-for-nefopam-n-desmethylnefopam-and-nefopam-n-oxide-in-human-plasma-and-urine
#3
Aravind Mittur
BACKGROUND AND OBJECTIVE: Nefopam is a non-opioid, non-steroidal, central analgesic thought to act via multiple mechanisms including potent inhibition of serotonin-norepinephrine reuptake and modulation of voltage-sensitive calcium and sodium channels. There has been a resurgence in its use for postoperative pain and neuropathic pain. Dosing route-dependent metabolism and clinical effects have been described following intravenous and oral nefopam. N-desmethylnefopam and nefopam N-oxide are metabolites of clinical interest...
January 5, 2018: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/29282567/demonstration-of-direct-nose-to-brain-transport-of-unbound-hiv-1-replication-inhibitor-db213-via-intranasal-administration-by-pharmacokinetic-modeling
#4
Qianwen Wang, Yufeng Zhang, Chun-Ho Wong, H Y Edwin Chan, Zhong Zuo
Intranasal administration could be an attractive alternative route of administration for the delivery of drugs to the central nervous system (CNS). However, there are always doubts about the direct transport of therapeutics from nasal cavity to the CNS since there are only limited studies on the understanding of direct nose-to-brain transport. Therefore, this study aimed to (1) investigate the existence of nose-to-brain transport of intranasally administered HIV-1 replication inhibitor DB213 and (2) assess the direct nose-to-brain transport of unbound HIV-1 replication inhibitor DB213 quantitatively by a pharmacokinetic approach...
December 27, 2017: AAPS Journal
https://www.readbyqxmd.com/read/29278046/pregnancy-affects-the-pharmacokinetics-of-sildenafil-and-its-metabolite-in-the-rabbit
#5
Francesca M Russo, Paola Mian, Elke Hj Krekels, Kristel Van Calsteren, Dick Tibboel, Jan Deprest, Karel Allegaert
There is growing interest in the use of sildenafil during pregnancy for various maternal and fetal conditions. This study aims to investigate the effect of pregnancy on the maternal pharmacokinetics (PK) of sildenafil and its main metabolite desmethylsildenafil in rabbits. Using NONMEM, population PK-modelling was performed based on plasma samples from 31 rabbits of whom 15 were pregnant and 16 were not. All received a single subcutaneous sildenafil dose of 10mg/kg. One sample was obtained per rabbit at either 30, 60, 120, 360, 720 or 1320 minutes after sildenafil administration...
December 26, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/29247451/pharmacokinetics-of-dexmedetomidine-administered-to-patients-with-end-stage-renal-failure-and-secondary-hyperparathyroidism-undergoing-general-anaesthesia
#6
W Zhong, Y Zhang, M-Z Zhang, X-H Huang, Y Li, R Li, Q-W Liu
WHAT IS KNOWN AND OBJECTIVE: The primary objective of this study was to compare the pharmacokinetics of dexmedetomidine in patients with end-stage renal failure and secondary hyperparathyroidism with those in normal individuals. METHOD: Fifteen patients with end-stage renal failure and secondary hyperparathyroidism (Renal-failure Group) and 8 patients with normal renal and parathyroid gland function (Control Group) received intravenous 0.6 μg/kg dexmedetomidine for 10 minutes before anaesthesia induction...
December 16, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/29227461/population-pharmacokinetics-of-lopinavir-in-severely-malnourished-hiv-infected-children-and-the-effect-on-treatment-outcomes
#7
Moherndran Archary, Helen Mcllleron, Raziya Bobat, Phillip La Russa, Thobekile Sibaya, Lubbe Wiesner, Stefanie Hennig
BACKGROUND: In developing countries, malnutrition remains a common clinical syndrome at antiretroviral treatment (ART) initiation. Physiological changes due to malnutrition and during nutritional recovery could affect the pharmacokinetics of antiretroviral drugs. METHODS: HIV-infected children admitted with severe acute malnutrition were randomised to early or delayed initiation of lopinavir/ritonavir, abacavir and lamivudine using WHO weight-band dosage charts...
December 8, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/29204823/balancing-antibacterial-efficacy-and-reduction-in-renal-function-to-optimise-initial-gentamicin-dosing-in-paediatric-oncology-patients
#8
Carolina Consuelo Llanos-Paez, Christine Staatz, Stefanie Hennig
This study aimed to determine the optimal starting dose of gentamicin in paediatric oncology patients. A population pharmacokinetic model describing drug exposure, a semi-mechanistic model describing bacterial killing and an Emax model describing renal cortex accumulation were linked in a utility function using NONMEM®. The optimal gentamicin starting dose was estimated in patients aged from 0.1 to 18.2 years, by balancing the probability of efficacy on day 1 against relative renal function reduction on day 7 with continued dosing...
December 4, 2017: AAPS Journal
https://www.readbyqxmd.com/read/29204688/pharmacokinetics-of-recombinant-asparaginase-in-children-with-acute-lymphoblastic-leukemia
#9
Swantje Völler, Uwe Pichlmeier, Anke Zens, Georg Hempel
PURPOSE: The objective of this study was to assess the pharmacokinetics of recombinant asparaginase (rASNase, Spectrila®) in children with acute lymphoblastic leukemia using a population pharmacokinetic approach in order to explore potential dosing recommendations. METHODS: Data on serum asparaginase activities of 124 children from three clinical studies were included in the analysis, covering an age range from 3 days to 17 years. Most patients received 5000 U/m2 rASNase intravenously every 3 days...
December 5, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29194662/quantitative-predictive-models-for-the-degree-of-disability-after-acute-ischemic-stroke
#10
Hyeong-Seok Lim, Seung Min Kim, Dong-Wha Kang
Although stroke is a leading cause of disability, the quantitative relationship between baseline clinical and imaging characteristics and long-term disability outcomes has rarely been studied. Prospectively collected clinical data from 405 patients with acute ischemic stroke including brain magnetic resonance images (MRIs) and disability outcomes assessed using the modified Rankin Scale (mRS) 3 month after the onset of disease were analyzed using a proportional odds cumulative logit model implemented in NONMEM...
November 30, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29191177/performance-comparison-of-first-order-conditional-estimation-with-interaction-and-bayesian-estimation-methods-for-estimating-the-population-parameters-and-its-distribution-from-data-sets-with-a-low-number-of-subjects
#11
Sudeep Pradhan, Byungjeong Song, Jaeyeon Lee, Jung-Woo Chae, Kyung Im Kim, Hyun-Moon Back, Nayoung Han, Kwang-Il Kwon, Hwi-Yeol Yun
BACKGROUND: Exploratory preclinical, as well as clinical trials, may involve a small number of patients, making it difficult to calculate and analyze the pharmacokinetic (PK) parameters, especially if the PK parameters show very high inter-individual variability (IIV). In this study, the performance of a classical first-order conditional estimation with interaction (FOCE-I) and expectation maximization (EM)-based Markov chain Monte Carlo Bayesian (BAYES) estimation methods were compared for estimating the population parameters and its distribution from data sets having a low number of subjects...
December 1, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29177199/predicting-tacrolimus-concentrations-in-children-receiving-a-heart-transplant-using-a-population-pharmacokinetic-model
#12
Joseph E Rower, Chris Stockmann, Matthew W Linakis, Shaun S Kumar, Xiaoxi Liu, E Kent Korgenski, Catherine M T Sherwin, Kimberly M Molina
Objective: Immunosuppressant therapy plays a pivotal role in transplant success and longevity. Tacrolimus, a primary immunosuppressive agent, is well known to exhibit significant pharmacological interpatient and intrapatient variability. This variability necessitates the collection of serial trough concentrations to ensure that the drug remains within therapeutic range. The objective of this study was to build a population pharmacokinetic (PK) model and use it to determine the minimum number of trough samples needed to guide the prediction of an individual's future concentrations...
2017: BMJ Paediatrics Open
https://www.readbyqxmd.com/read/29176598/population-pharmacokinetics-of-remifentanil-in-critically-ill-patients-receiving-extracorporeal-membrane-oxygenation
#13
Seungwon Yang, Hayeon Noh, Jongsung Hahn, Byung Hak Jin, Kyoung Lok Min, Soo Kyung Bae, Jiseon Kim, Min Soo Park, Taegon Hong, Jin Wi, Min Jung Chang
Extracorporeal membrane oxygenation (ECMO) is associated with pharmacokinetic (PK) changes of drugs. It presents considerable challenges to providing optimal dosing regimens for patients receiving ECMO. We aimed to describe the population PK of remifentanil in critically ill adult patients receiving venoartrial extracorporeal membrane oxygenation (VA-ECMO) and to identify determinants associated with altered remifentanil concentrations. The population PK model of remifentanil was developed using nonlinear mixed effects modelling (NONMEM)...
November 24, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29159710/prediction-of-free-from-total-mycophenolic-acid-concentrations-in-stable-renal-transplant-patients-a-population-based-approach
#14
Helena Colom, Franc Andreu, Teun van Gelder, Dennis A Hesselink, Brenda C M de Winter, Oriol Bestard, Joan Torras, Josep M Cruzado, Josep M Grinyó, Núria Lloberas
BACKGROUND: A population pharmacokinetic (PK) protein-binding model was developed to (1) predict free mycophenolic acid (fMPA) based on total MPA (tMPA) concentrations in renal transplant patients, to establish the therapeutic range of fMPA through pharmacokinetic-pharmacodynamic studies; and (2) provide a guideline for dosing mycophenolate mofetil (MMF). METHODS: Full PK profiles of 56 patients (from five different occasions) during the first year after transplantation who were treated with oral MMF and cyclosporine, or macrolides (either tacrolimus or sirolimus), were analysed...
November 20, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29150770/population-in-vitro-in-vivo-pharmacokinetic-model-of-first-pass-metabolism-itraconazole-and-hydroxy-itraconazole
#15
Ahmad Y Abuhelwa, Stuart Mudge, Richard N Upton, David J R Foster
The aim of this study was to develop a population in vitro-in vivo pharmacokinetic model that simultaneously describe the absorption and accumulation kinetics of itraconazole (ICZ) and hydroxy-itraconazole (HICZ) in healthy subjects. The model integrated meta-models of gastrointestinal pH and gastrointestinal transit time and in vitro dissolution models of ICZ with the absorption and disposition kinetics of ICZ and HICZ. Mean concentration intravenous data, and single- and multi-dose oral data were used for model development...
November 17, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29136160/highly-variable-absorption-of-clavulanic-acid-during-the-day-a-population-pharmacokinetic-analysis
#16
Femke De Velde, Brenda C M De Winter, Birgit C P Koch, Teun Van Gelder, Johan W Mouton
Objectives: To calculate the clavulanic acid exposure of oral amoxicillin/clavulanic acid dosing regimens, to investigate variability using a population pharmacokinetic model and to explore target attainment using Monte Carlo simulations. Methods: Two groups of healthy male volunteers received amoxicillin/clavulanic acid tablets at the start of a standard meal on two separate days 1 week apart. One group (n = 14) received 875/125 mg q12h and 500/125 mg q8h and the other group (n = 15) received 500/125 mg q12h and 250/125 mg q8h...
November 9, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29106979/development-of-a-population-pharmacokinetic-model-to-predict-brain-distribution-and-dopamine-d2-receptor-occupancy-of-raclopride-in-non-anesthetized-rat
#17
Yin Cheong Wong, Trayana Ilkova, Rob C van Wijk, Robin Hartman, Elizabeth C M de Lange
BACKGROUND: Raclopride is a selective antagonist of the dopamine D2 receptor. It is one of the most frequently used in vivo D2 tracers (at low doses) for assessing drug-induced receptor occupancy (RO) in animals and humans. It is also commonly used as a pharmacological blocker (at high doses) to occupy the available D2 receptors and antagonize the action of dopamine or drugs on D2 in preclinical studies. The aims of this study were to comprehensively evaluate its pharmacokinetic (PK) profiles in different brain compartments and to establish a PK-RO model that could predict the brain distribution and RO of raclopride in the freely moving rat using a LC-MS based approach...
November 4, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29077992/population-pharmacokinetics-of-exendin-9-39-and-clinical-dose-selection-in-patients-with-congenital-hyperinsulinism
#18
Chee M Ng, Fei Tang, Steven Seeholzer, Yixuan Zou, Diva D De León
AIMS: Congenital hyperinsulinism (HI) is the most common cause of persistent hypoglycaemia in infants and children. Exendin-(9-39), an inverse glucagon-like peptide 1 (GLP-1) agonist, is a novel therapeutic agent for HI that has demonstrated glucose-raising effect. We reported the first population pharmacokinetic (PopPK) model of the exendin-(9-39) in patients with HI and proposed the optimal dosing regimen for future clinical trials in neonates with HI. METHODS: 182 pharmacokinetic (PK) observations from 26 subjects in three clinical studies were included for constructing the PopPK model using FOCE with interaction method in NONMEM...
October 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29045766/population-pharmacodynamic-analysis-of-uric-acid-lowering-effects-of-febuxostat-based-on-electronic-medical-records-in-two-hospitals
#19
Shota Muraki, Kuniaki Moriki, Saki Shigematsu, Masato Fukae, Makoto Kakara, Daiki Yamashita, Takeshi Hirota, Hiroshi Takane, Miki Shimada, Masaaki Hirakawa, Ichiro Ieiri
The aim of this study was to develop a population pharmacodynamic (PPD) model to describe uric acid (UA)-lowering effects in patients treated with febuxostat based on electronic medical records in 2 independent hospitals (university and city hospitals). Interhospital differences in the PPD model were also evaluated. We conducted the following 2 approaches to build the PPD models. A PPD model was developed separately using individual hospital data, and structural models and covariates between the two hospitals were compared (approach A)...
October 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29032112/dermal-pharmacokinetics-of-pyrazinamide-determined-by-microdialysis-sampling-in-rats
#20
Nivea M F Voelkner, Alexander Voelkner, Juliana Costa, Sherwin K B Sy, Juliane Hermes, Johanna Weitzel, Sebastian Morales, Hartmut Derendorf
Studies have demonstrated pyrazinamide's efficacy against stages of the parasite which causes cutaneous leishmaniasis. Although pyrazinamide is widely distributed to most fluids and tissues, the drug distribution that reaches the skin is unknown. The aim of this study was to investigate pyrazinamide pharmacokinetics in rat dermal tissue by dermal microdialysis. Skin pharmacokinetics were assessed by implanting a linear microdialysis probe in the dermis of ten rats. Additionally, blood samples were collected for assessing plasma pharmacokinetics...
October 12, 2017: International Journal of Antimicrobial Agents
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