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https://www.readbyqxmd.com/read/29777329/population-pharmacokinetics-of-theophylline-in-adult-chinese-patients-with-asthma-and-chronic-obstructive-pulmonary-disease
#1
Yanjiao Ma, Ling Xue, Xin Chen, Yingbo Kang, Yong Wang, Liqing Wang
Background Theophylline has a narrow therapeutic range and large interindividual variability in blood levels, so a thorough understanding of its pharmacokinetic characteristics is essential. Population pharmacokinetic (PPK) approaches could achieve it and many PPK studies of theophylline have been reported in infants. However, none was conducted in Chinese adults and none has explored the effect of CYP1A2 genotypes on the PPK characteristics of theophylline in adults. Objective To evaluate the PPK characteristics of theophylline and to assess the possible influence of covariates, including CYP1A2 genotypes, on theophylline clearance in Chinese adult patients...
May 18, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29775201/tacrolimus-population-pharmacokinetics-and-multiple-cyp3a5-genotypes-in-black-and-white-renal-transplant-recipients
#2
Olivia Campagne, Donald E Mager, Daniel Brazeau, Rocco C Venuto, Kathleen M Tornatore
Tacrolimus exhibits inter-patient pharmacokinetic variability attributed to CYP3A5 isoenzymes and the efflux transporter, P-glycoprotein. Most black renal transplant recipients require higher tacrolimus doses compared to whites to achieve similar troughs when race-adjusted recommendations are used. An established guideline provides tacrolimus genotype dosing recommendations based on CYP3A5*1(W/T) and loss of protein function variants: CYP3A5*3 (rs776746), CYP3A5*6 (rs10264272), CYP3A5*7 (rs41303343) and may provide more comprehensive race-adjusted dosing recommendations...
May 18, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29766530/population-pharmacokinetics-of-tacrolimus-in-paediatric-systemic-lupus-erythematosus-based-on-real-world-study
#3
D-D Wang, J-M Lu, Q Li, Z-P Li
WHAT IS KNOWN AND OBJECTIVES: Different population pharmacokinetics (PPK) models of tacrolimus have been established in various populations. However, the tacrolimus PPK model in paediatric systemic lupus erythematosus (PSLE) is still undefined. This study aimed to establish the tacrolimus PPK model in Chinese PSLE. METHODS: A total of nineteen Chinese patients with PSLE from real-world study were characterized with nonlinear mixed-effects modelling (NONMEM). The impact of demographic features, biological characteristics, and concomitant medications was evaluated...
May 15, 2018: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/29757380/simultaneous-population-pharmacokinetic-modelling-of-plasma-and-intracellular-pbmc-miltefosine-concentrations-in-new-world-cutaneous-leishmaniasis-and-exploration-of-exposure-response-relationships
#4
Anke E Kip, María Del Mar Castro, Maria Adelaida Gomez, Alexandra Cossio, Jan H M Schellens, Jos H Beijnen, Nancy Gore Saravia, Thomas P C Dorlo
Objectives: Leishmania parasites reside within macrophages and the direct target of antileishmanial drugs is therefore intracellular. We aimed to characterize the intracellular PBMC miltefosine kinetics by developing a population pharmacokinetic (PK) model simultaneously describing plasma and intracellular PBMC pharmacokinetics. Furthermore, we explored exposure-response relationships and simulated alternative dosing regimens. Patients and methods: A population PK model was developed with NONMEM, based on 339 plasma and 194 PBMC miltefosine concentrations from Colombian cutaneous leishmaniasis patients [29 children (2-12 years old) and 22 adults] receiving 1...
May 10, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29748932/increased-metformin-clearance-in-overweight-and-obese-adolescents-a-pharmacokinetic-substudy-of-a-randomized-controlled-trial
#5
Anne van Rongen, Marloes P van der Aa, Maja Matic, Ron H N van Schaik, Vera H M Deneer, Marja M van der Vorst, Catherijne A J Knibbe
BACKGROUND: In view of the increased use of metformin in obese adolescents, the aim of this study was to determine the pharmacokinetics of metformin in overweight and obese adolescents. METHODS: In overweight and obese adolescents receiving metformin 500 or 1000 mg twice daily for 37 weeks during a clinical trial, blood samples were collected over 8 h during an oral glucose tolerance test. Population pharmacokinetic modeling was performed using NONMEM. RESULTS: Data for 22 overweight and obese adolescents with a mean total body weight (TBW) of 79...
May 10, 2018: Paediatric Drugs
https://www.readbyqxmd.com/read/29744900/pharmacokinetics-and-safety-of-fluconazole-and-micafungin-in-neonates-with-systemic-candidiasis-a-randomized-open-label-clinical-trial
#6
S Leroux, E Jacqz Aigrain, V Elie, F Legrand, C Barin-Le Guellec, B Aurich, V Biran, B Dusang, S Goudjil, S Coopman, R Garcia Sanchez, W Zhao, P Manzoni
AIMS: Pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children and adults. Dosing instructions in product labels appear inconsistent with the emerging scientific evidence. Limited information is available on their safety profile in neonates. Our objective was to study population PK and safety of both drugs, randomly administered in neonates with suspected or confirmed systemic candidiasis. METHODS: Neonates were randomized 1:1 to fluconazole (loading dose 25mg/kg; maintenance dose 12 or 20mg/kg/day for infants <30 or ≥ 30 weeks corrected gestational age) or micafungin (loading dose 15mg/kg/day; maintenance dose 10mg/kg/day)...
May 10, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29736878/vancomycin-in-pediatric-patients-with-solid-or-hematological-malignant-disease-predictive-performance-of-a-population-pharmacokinetic-model-and-new-optimized-dosing-regimens
#7
Amélie Marsot, F Gallais, C Galambrun, C Coze, O Blin, N Andre, R Guilhaumou
BACKGROUND: The application of population pharmacokinetic models and Bayesian methods offers the potential to develop individualized therapeutic approaches. OBJECTIVES: The current study presents an external evaluation of a vancomycin pharmacokinetic model in a pediatric cancer population and proposes an easy-to-use chart for clinicians for a priori vancomycin schedule adaptation to achieve target concentration. METHODS: External evaluation of a population pharmacokinetic model of vancomycin administered via continuous infusion was realized in a new retrospective dataset of pediatric patients with cancer...
May 8, 2018: Paediatric Drugs
https://www.readbyqxmd.com/read/29736841/evaluation-of-the-interaction-of-amino-acid-infusion-on-177-lu-dotatate-pharmacokinetics-in-patients-with-gastroenteropancreatic-neuroendocrine-tumors
#8
Alicja Puszkiel, Mathilde Bauriaud-Mallet, Roxane Bourgeois, Lawrence Dierickx, Frédéric Courbon, Etienne Chatelut
BACKGROUND AND OBJECTIVE: 177 Lu-Dotatate is a radio-labeled analog of somatostatin used in the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. In order to prevent nephrotoxic effects of 177 Lu-Dotatate a co-infusion of amino acids (AA) is administered, resulting in a decrease in tubular renal reabsorption of 177 Lu-Dotatate. This study aimed to quantify the impact of AA co-infusion on the pharmacokinetics of 177 Lu-Dotatate in cancer patients and to evaluate its relationship with toxicity during the first treatment cycle (C1)...
May 8, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29729414/semi-mechanistic-pharmacokinetic-pharmacodynamic-model-of-three-pegylated-rhuepo-and-ior%C3%A2-epocim-in-new-zealand-rabbits
#9
G Reynaldo-Fernández, J Solozábal, D Amaro, E M Fernández-Sánchez, L Rodríguez-Vera, M Bermejo, V Mangas-Sanjuan, I F Troconiz
Marketed formulations of erythropoietin (EPO) ior®EPOCIM, MIRCERA® and two newly developed pegylated-EPO analogues (PEG-EPO 32 and 40 kDa) formulations were intravenously administered to New Zealand rabbits. A semi-mechanistic Pharmacokinetic/Pharmacodynamic (PK/PD) model describing in a simultaneous and integrated form the time course of reticulocytes, red blood cells and hemoglobin was built to account for the time course of hematopoiesis stimulation after erythropoietin administration. Data analysis was performed based on the population approach with the software NONMEM version 7...
May 2, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29713143/population-pharmacokinetics-and-dosing-optimization-of-cefathiamidine-in-children-with-hematologic-infection
#10
Li-Juan Zhi, Li Wang, Xing-Kai Chen, Xiao-Ying Zhai, Li Wen, Lei Dong, Evelyne Jacqz-Aigrain, Zhong-Ren Shi, Wei Zhao
Purpose: Cefathiamidine, a first-generation cephalosporin, has approval from the China Food and Drug Administration for the treatment of infections caused by susceptible bacteria in both adults and children. As pharmacokinetic data are limited in the pediatric population, we aimed to evaluate the population pharmacokinetics of cefathiamidine in children and to define the appropriate dose in order to optimize cefathiamidine treatment. Methods: Blood samples were collected from children treated with cefathiamidine, and concentrations were quantified by high-performance liquid chromatography and tandem mass spectrometry...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29705215/relationship-between-exposure-to-treosulfan-and-its-monoepoxytransformer-an-insight-from-population-pharmacokinetic-study-in-pediatric-patients-before-hematopoietic-stem-cell-transplantation
#11
Dorota Danielak, Anna Kasprzyk, Tomasz Wróbel, Jacek Wachowiak, Krzysztof Kałwak, Franciszek Główka
Treosulfan (TREO), a structural analog of busulfan, is currently studied as a myeloablative agent in conditioning regimens before hematopoietic stem cell transplantation in pediatric patients. High exposure to TREO (>1650 mg∗h/mL) might be related to early toxicity, especially skin toxicity and mucositis. The aim of the present study was to investigate a potential relationship between exposure to TREO and its monoepoxytransformer (S,S-EBDM), as well as variability of the pharmacokinetics of these entities by means of a population pharmacokinetic approach with a non-linear mixed-effects analysis...
April 26, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29704547/predictive-performance-of-a-gentamicin-population-pharmacokinetic-model-in-two-western-populations-of-critically-ill-patients
#12
Laura H Bukkems, Claire Roger, Caspar J Hodiamont, Jean-Yves Lefrant, Nicole P Juffermans, Jason A Roberts, Reinier M van Hest
: Before population pharmacokinetic (PK) models can be clinically applied to aid in dose selection of antibiotics, external validation of the model is warranted. The aim of this study was to assess the predictive performance of a gentamicin population PK model in intensive care unit (ICU) patients in two independent populations of Western critically ill patients. METHODS: Data from the same ICU as used for the earlier model development (Academic Medical Centre, Amsterdam (AMC)) and from the Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) were collected...
April 25, 2018: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/29703559/personalized-weight-change-prediction-in-the-first-week-of-life
#13
Mélanie Wilbaux, Severin Kasser, Julia Gromann, Isabella Mancino, Tania Coscia, Olav Lapaire, Johannes N van den Anker, Marc Pfister, Sven Wellmann
BACKGROUND & AIMS: Almost all neonates show physiological weight loss and consecutive weight gain after birth. The resulting weight change profiles are highly variable as they depend on multiple neonatal and maternal factors. This limits the value of weight nomograms for the early identification of neonates at risk for excessive weight loss and related morbidities. The objective of this study was to characterize weight changes and the effect of supplemental feeding in late preterm and term neonates during the first week of life, to identify and quantify neonatal and maternal influencing factors, and to provide an educational online prediction tool...
April 11, 2018: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/29683874/time-dependent-decline-in-serum-phenytoin-concentration-with-heightened-convulsive-seizure-risk-by-prolonged-administration-of-fosphenytoin-in-japanese-a-retrospective-study
#14
Yuta Ohno, Takashi Niwa, Keita Hirai, Keiko Suzuki, Yuto Yamada, Yuichi Hayashi, Hideki Hayashi, Akio Suzuki, Yoshinori Itoh
BACKGROUND: Because clinical data to confirm the safety and effectiveness of fosphenytoin, a prodrug of phenytoin, are insufficient, the length of administration of fosphenytoin is restricted. Nevertheless, some cases require fosphenytoin administration for more than a few days. The aim of this study was to retrospectively investigate the serum concentration of phenytoin in adult Japanese patients who received intravenous fosphenytoin therapy for more than 3 days. METHODS: Patients injected with intravenous fosphenytoin for more than 3 days at Gifu University Hospital between January 2012 and September 2014 were enrolled...
April 20, 2018: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29679474/population-pharmacokinetics-of-gliclazide-in-normal-and-diabetic-rabbits
#15
Mastan Shaik, Shabana Shaik, Eswar Kumar Kilari
Gliclazide is a second-generation sulphonylurea drug widely used in the treatment of type 2 diabetes. However, there is no single report to describe the population pharmacokinetics of gliclazide in animal models. This study was aimed to evaluate the population pharmacokinetics (PK) of gliclazide in normal and alloxan-induced diabetic rabbits using nonlinear mixed effects modeling. A total of 90 New Zealand white rabbits were administered with 3 doses (4.13, 8.27 and 16.53 mg/kg b.wt) of gliclazide by an oral route...
April 21, 2018: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/29661414/dexmedetomidine-metabolic-clearance-is-not-affected-by-fat-mass-in-obese-patients
#16
A Rolle, S Paredes, L I Cortínez, B J Anderson, N Quezada, S Solari, F Allende, J Torres, D Cabrera, V Contreras, J Carmona, C Ramírez, A M Oliveros, M Ibacache
BACKGROUND: Obesity has been associated with reduced dexmedetomidine clearance, suggesting impaired hepatic function or reduced hepatic blood flow. The aim of this study was to clarify the effect of obesity in dexmedetomidine metabolic clearance. METHODS: Forty patients, ASA I-III, 18-60 yr old, weighing 47-126 kg, scheduled for abdominal laparoscopic surgery, were enrolled. Anaesthetic agents (propofol, remifentanil, and dexmedetomidine) were dosed based on lean body weight measured by dual X-ray absorptiometry...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29661413/pharmacokinetic-and-pharmacodynamic-study-of-intranasal-and-intravenous-dexmedetomidine
#17
A Li, V M Yuen, S Goulay-Dufaÿ, Y Sheng, J F Standing, P C L Kwok, M K M Leung, A S Leung, I C K Wong, M G Irwin
BACKGROUND: Intranasal dexmedetomidine produces safe, effective sedation in children and adults. It may be administered by drops from a syringe or by nasal mucosal atomisation (MAD NasalTM ). METHODS: This prospective, three-period, crossover, double-blind study compared the pharmacokinetic (PK) and pharmacodynamic (PD) profile of i.v. administration with these two different modes of administration. In each session each subject received 1 μg kg-1 dexmedetomidine, either i...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29661412/pharmacokinetic-pharmacodynamic-model-for-propofol-for-broad-application-in-anaesthesia-and-sedation
#18
D J Eleveld, P Colin, A R Absalom, M M R F Struys
BACKGROUND: Pharmacokinetic (PK) and pharmacodynamic (PD) models are used in target-controlled-infusion (TCI) systems to determine the optimal drug administration to achieve a desired target concentration in a central or effect-site compartment. Our aim was to develop a PK-PD model for propofol that can predict the bispectral index (BIS) for a broad population, suitable for TCI applications. METHODS: Propofol PK data were obtained from 30 previously published studies, five of which also contained BIS observations...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29626594/population-pharmacokinetics-of-oxaliplatin-after-intraperitoneal-administration-with-hyperthermia-in-wistar-rats
#19
M I Mas-Fuster, A Ramon-Lopez, F J Lacueva, A Arroyo, P Más-Serrano, R Nalda-Molina
BACKGROUND: The evaluation of the efficacy and toxicity of hyperthermic intraoperative peritoneal chemotherapy presents some difficulties, due in part to the lack of information about the pharmacokinetic behavior of the drugs administered in this procedure. The aim of this study was to characterize the population pharmacokinetics of hyperthermic intraoperative peritoneal oxaliplatin in Wistar rats and to evaluate the effect of treatment-related covariates dose, instillation time and temperature on the pharmacokinetic parameters...
April 4, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29623653/infliximab-pharmacokinetics-are-influenced-by-intravenous-immunoglobulin-administration-in-patients-with-kawasaki-disease
#20
Niels Vande Casteele, Jun Oyamada, Chisato Shimizu, Brookie M Best, Edmund V Capparelli, Adriana H Tremoulet, Jane C Burns
BACKGROUND: Infliximab, a monoclonal antibody directed against tumor necrosis factor-α, is being evaluated as adjunctive therapy to intravenous immunoglobulin (IVIG) for treatment of young children with acute Kawasaki disease (KD). OBJECTIVE: The aim of this study was to develop a population pharmacokinetic (PopPK) model for infliximab in children with KD, and to evaluate the impact of covariates on infliximab disposition. Specifically, we wanted to investigate the effect of body weight and IVIG administration on PK parameters...
April 5, 2018: Clinical Pharmacokinetics
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