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Population pharmacokinetics

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https://www.readbyqxmd.com/read/28213941/population-pharmacokinetic-and-exposure-simulation-analysis-for-cediranib-azd2171-in-pooled-phase-i-ii-studies-in-patients-with-cancer
#1
Jianguo Li, Nidal Al-Huniti, Anja Henningsson, Weifeng Tang, Eric Masson
AIMS: A population pharmacokinetic (PPK) model was developed for cediranib to simulate cediranib exposure for different doses, including co-medication with strong UGT/Pgp inducers such as rifampicin, in cancer patients. METHODS: Plasma concentrations and covariates from 625 cancer patients after single or multiple oral cediranib administrations ranging from 0.5 to 90 mg in 19 Phase I and II studies were included in the analysis. Stepwise covariate modelling was used to develop the PPK model...
February 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28208135/abcb1-and-slco1b3-gene-polymorphisms-and-their-impact-on-digoxin-pharmacokinetics-in-atrial-fibrillation-patients-among-the-tunisian-population
#2
Nejia Tounsi, Imen Trabelsi, Emna Kerkeni, Mohamed Habib Grissa, Nizar Fredj, Adel Sekma, Malek Mzali, Ilhem Hellara, Kamel Monastiri, Wahiba Douki, Semir Nouira
BACKGROUND: Digoxin is a substrate of P-glycoprotein (P-gp) and organic anion transporting polypeptide transporters that are encoded by ABCB1 and SLCO1B3 genes. Genetic polymorphisms in both genes may explain inter-individual variability of serum digoxin concentration (SDC). This study evaluates the possible effect of the most common ABCB1 and SLCO1B3 polymorphisms on SDC after a single oral dose of digoxin in Tunisian atrial fibrillation (AF) patients. METHODS: ABCB1 and SLCO1B3 genotypes were analyzed in 102 patients with AF who received digoxin (0...
February 17, 2017: Pharmacology
https://www.readbyqxmd.com/read/28205038/clinical-trial-simulations-and-pharmacometric-analysis-in-pediatrics-application-to-inhaled-loxapine-in-children-and-adolescents
#3
Min Dong, Tsuyoshi Fukuda, Sally Selim, Mark A Smith, Laura Rabinovich-Guilatt, James V Cassella, Alexander A Vinks
BACKGROUND AND OBJECTIVES: Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetic study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to the predicted likelihood of achieving the target exposure associated with therapeutic effect in adults...
February 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28205025/the-multistate-tuberculosis-pharmacometric-model-a-semi-mechanistic-pharmacokinetic-pharmacodynamic-model-for-studying-drug-effects-in-an-acute-tuberculosis-mouse-model
#4
Chunli Chen, Fatima Ortega, Joaquin Rullas, Laura Alameda, Iñigo Angulo-Barturen, Santiago Ferrer, Ulrika Sh Simonsson
The Multistate Tuberculosis Pharmacometric (MTP) model, a pharmacokinetic-pharmacodynamic disease model, has been used to describe the effects of rifampicin on Mycobacterium tuberculosis (M. tuberculosis) in vitro. The aim of this work was to investigate if the MTP model could be used to describe the rifampicin treatment response in an acute tuberculosis mouse model. Sixty C57BL/6 mice were intratracheally infected with M. tuberculosis H37Rv strain on Day 0. Fifteen mice received no treatment and were sacrificed on Days 1, 9 and 18 (5 each day)...
February 15, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28205004/maturation-of-oxycodone-pharmacokinetics-in-neonates-and-infants-a-population-pharmacokinetic-model-of-three-clinical-trials
#5
Pyry Välitalo, Merja Kokki, Veli-Pekka Ranta, Klaus T Olkkola, Andrew C Hooker, Hannu Kokki
PURPOSE: The aim of the current population pharmacokinetic study was to quantify oxycodone pharmacokinetics in children ranging from preterm neonates to children up to 7 years of age. METHODS: Data on intravenous or intramuscular oxycodone administration were obtained from three previously published studies (n = 119). The median [range] postmenstrual age of the subjects was 299 days [170 days-7.8 years]. A population pharmacokinetic model was built using 781 measurements of oxycodone plasma concentration...
February 15, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28202365/optimising-the-use-of-medicines-to-reduce-acute-kidney-injury-in-children-and-babies
#6
REVIEW
L Oni, D B Hawcutt, M A Turner, M W Beresford, S McWilliam, C Barton, B K Park, P Murray, B Wilm, I Copple, R Floyd, M Peak, A Sharma, D J Antoine
The majority of medications in children are administered in an unlicensed or off-label manner. Paediatricians are obliged to prescribe using the limited evidence available. The 2007 EU regulation on the use of paediatric drugs means pharmaceutical companies are now obliged to (and receive incentives for) contributing to paediatric drug data and carrying out paediatric clinical trials. This is important, as the efficacy and adverse effect profiles of medicines vary across childhood. Additionally, there are significant age-related changes in the pharmacodynamic and pharmacokinetic activity of many drugs...
February 12, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28202004/a-phase-ii-study-to-evaluate-ly2603618-in-combination-with-gemcitabine-in-pancreatic-cancer-patients
#7
Berta Laquente, Jose Lopez-Martin, Donald Richards, Gerald Illerhaus, David Z Chang, George Kim, Philip Stella, Dirk Richel, Cezary Szcylik, Stefano Cascinu, G L Frassineti, Tudor Ciuleanu, Karla Hurt, Scott Hynes, Ji Lin, Aimee Bence Lin, Daniel Von Hoff, Emiliano Calvo
BACKGROUND: The aim of this study was to determine whether checkpoint kinase 1 inihibitor (CHK1), LY2603618, and gemcitabine prolong overall survival (OS) compared to gemcitabine alone in patients with unresectable pancreatic cancer. METHODS: Patients with Stage II-IV locally advanced or metastatic pancreatic cancer were randomized (2:1) to either 230 mg of LY2603618/1000 mg/m(2) gemcitabine combined or 1000 mg/m(2) gemcitabine alone. OS was assessed using both a Bayesian augment control model and traditional frequentist analysis for inference...
February 15, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28196047/a-time-dependent-model-describes-methotrexate-elimination-and-supports-dynamic-modification-of-mrp2-abcc2-activity
#8
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: 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...
February 11, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28195852/a-real-life-population-pharmacokinetic-study-reveals-factors-associated-with-clearance-and-immunogenicity-of-infliximab-in-inflammatory-bowel-disease
#9
Johannan F Brandse, Diane Mould, Oscar Smeekes, Yaël Ashruf, Sabine Kuin, Anne Strik, Gijs R van den Brink, Geert R DʼHaens
BACKGROUND: Several factors influencing the pharmacokinetics of infliximab (IFX) in inflammatory bowel disease (IBD) have been identified. We studied the impact of patient, disease, and treatment characteristics on clearance and immunogenicity of IFX in a real-world patient-with-IBD cohort. METHODS: Serum concentrations of IFX and antibodies to IFX (ATIs) were measured in patients with IBD at a single center using an enzyme-linked immunosorbent assay and radioimmunoassay...
February 10, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28194422/pharmacokinetic-properties-of-adenosine-amine-congener-in-cochlear-perilymph-after-systemic-administration
#10
Hao Chang, Ravindra S Telang, Sreevalsan Sreebhavan, Malcolm Tingle, Peter R Thorne, Srdjan M Vlajkovic
Noise-induced hearing loss (NIHL) is a global health problem affecting over 5% of the population worldwide. We have shown previously that acute noise-induced cochlear injury can be ameliorated by administration of drugs acting on adenosine receptors in the inner ear, and a selective A1 adenosine receptor agonist adenosine amine congener (ADAC) has emerged as a potentially effective treatment for cochlear injury and resulting hearing loss. This study investigated pharmacokinetic properties of ADAC in rat perilymph after systemic (intravenous) administration using a newly developed liquid chromatography-tandem mass spectrometry detection method...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28193647/piperaquine-population-pharmacokinetics-and-cardiac-safety-in-cambodia
#11
Pattaraporn Vanachayangkul, Chanthap Lon, Michele Spring, Sommethy Sok, Winita Ta-Aksorn, Chanikarn Kodchakorn, Sut-Thang Pann, Soklyda Chann, Mali Ittiverakul, Sabaithip Sriwichai, Nillawan Buathong, Worachet Kuntawunginn, Mary So, Theng Youdaline, Erin Milner, Mariusz Wojnarski, Charlotte Lanteri, Jessica Manning, Satharath Prom, Mark Haigney, Louis Cantilena, David Saunders
Despite rising resistance, dihydroartemisinin-piperaquine (DP) remains a first line therapy for uncomplicated malaria in many parts of Cambodia. While generally well-tolerated as a 3-day regimen, compressed 2-day regimens were associated with treatment-limiting cardiac repolarization effects in a recent clinical trial. To better estimate the risks of piperaquine concentration on QT interval prolongation, we pooled data from 3 randomized clinical trials between 2010 and 2014 in northern Cambodia. A population pharmacokinetic model was developed to compare exposure-response relationships between 2-day (2DP) and 3-day (3DP) regimens while accounting for differences in regimen and sample collection times between studies...
February 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28192761/a-comparison-of-bayesian-and-non-linear-regression-methods-for-robust-estimation-of-pharmacokinetics-in-dce-mri-and-how-it-affects-cancer-diagnosis
#12
Nikolaos Dikaios, David Atkinson, Chiara Tudisca, Pierpaolo Purpura, Martin Forster, Hashim Ahmed, Timothy Beale, Mark Emberton, Shonit Punwani
The aim of this work is to compare Bayesian Inference for nonlinear models with commonly used traditional non-linear regression (NR) algorithms for estimating tracer kinetics in Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI). The algorithms are compared in terms of accuracy, and reproducibility under different initialization settings. Further it is investigated how a more robust estimation of tracer kinetics affects cancer diagnosis. The derived tracer kinetics from the Bayesian algorithm were validated against traditional NR algorithms (i...
February 5, 2017: Computerized Medical Imaging and Graphics: the Official Journal of the Computerized Medical Imaging Society
https://www.readbyqxmd.com/read/28191803/population-pharmacokinetics-of-imatinib-and-its-application-to-the-therapeutic-drug-monitoring-middle-east-cml-population
#13
Mehdi Ansari, Behjat Kalantary-Khandani, Abbas Pardakhty, Moein Safavi, Nabi Mosavi, Ehsan Mohajeri
INTRODUCTION: Despite the outstanding results generally obtained with Imatinib in the treatment of chronic myeloid leukemia, some patients show sub-optimal or no response. To evaluate the relationship between steady-state through plasma concentration and clinical response in CML patients. The objectives of this study were to assess the variability in Imatinib pharmacokinetics and to explore the effects of several demographic and biological covariates on the disposition of Imatinib. METHODS: A population pharmacokinetic analysis was performed on 170 plasma samples from 74 adult Iranian chronic myeloid leukemia patients...
September 2016: Gulf Journal of Oncology
https://www.readbyqxmd.com/read/28187395/population-pharmacokinetic-modelling-of-valproic-acid-and-its-selected-metabolites-in-acute-vpa-poisoning
#14
Wojciech Jawień, Jolanta Wilimowska, Małgorzata Kłys, Wojciech Piekoszewski
BACKGROUND: Valproic acid (VPA) is a first-line antiepileptic drug. It is used in the treatment of many different types of partial and generalized epileptic seizures. Though the clinical pharmacokinetics of VPA has been well defined, information about pharmacokinetics after overdoses is rare. The aim of this study was to try to build a population pharmacokinetic model that would describe the time course of VPA and its selected metabolites when the drug is ingested in an overdose situation...
January 6, 2017: Pharmacological Reports: PR
https://www.readbyqxmd.com/read/28186644/population-pharmacokinetics-and-pharmacodynamics-of-linezolid-induced-thrombocytopenia-in-hospitalized-patients
#15
Yasuhiro Tsuji, Nicholas H G Holford, Hidefumi Kasai, Chika Ogami, Young-A Heo, Yoshitsugu Higashi, Akiko Mizoguchi, Hideto To, Yoshihiro Yamamoto
AIMS: Thrombocytopenia is among the most important adverse effects of linezolid treatment. Linezolid-induced thrombocytopenia incidence varies considerably but has been associated with impaired renal function. We investigated the pharmacodynamic mechanism (myelosuppression or enhanced platelet destruction) and the role of impaired renal function in the development of thrombocytopenia. METHODS: The pharmacokinetics of linezolid were described with a two-compartment distribution model with first-order absorption and elimination...
February 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28181240/cytochrome-p450-genetic-variations-can-predict-mrna-expression-cyclophosphamide-4-hydroxylation-and-treatment-outcomes-in-chinese-patients-with-non-hodgkin-s-lymphoma
#16
Wenying Shu, Lingyan Chen, Xiaoye Hu, Meimei Zhang, Wensheng Chen, Lei Ma, Xiaoyan Liu, Jianing Huang, Tingyuan Pang, Jia Li, Yu Zhang
To investigate the impact of cytochrome P450 (CYP) genetic polymorphisms CYP2B6, CYP2C19, and CYP3A5 on mRNA expression, cyclophosphamide/4-hydroxycyclophosphamide pharmacokinetics, and treatment outcomes of the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in Chinese patients with non-Hodgkin's lymphoma, 567 cases were investigated. Plasma concentrations of cyclophosphamide/4-hydroxycyclophosphamide were determined using liquid chromatography-tandem mass spectrometry and pharmacokinetic parameters calculated...
February 9, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28178895/repetitive-urine-and-blood-sampling-in-neonatal-and-weaned-piglets-for-pharmacokinetic-and-pharmacodynamic-modelling-in-drug-discovery-a-pilot-study
#17
Elke Gasthuys, Stijn Schauvliege, Thomas van Bergen, Joske Millecam, Ilaria Cerasoli, Ann Martens, Frank Gasthuys, Tim Vandecasteele, Pieter Cornillie, Wim Van den Broeck, Filip Boyen, Siska Croubels, Mathias Devreese
Piglets are considered to be suitable animal models for predicting the pharmacokinetics and pharmacodynamics (PK/PD) of test drugs for potential use in the paediatric population. Such PK/PD studies require multiple blood and urine samplings. The goal of the present study was to determine a suitable blood collection strategy applicable in the youngest age categories of six days, four weeks and eight weeks of age, as well as a urine collection technique for male piglets in the same age categories. Blood was collected either by a surgically-placed jugular vein catheter (six days old [ n = 4] and four weeks old [ n = 2] piglets) or by direct venepuncture of the jugular vein (four weeks old [ n = 2] and eight weeks old [ n = 4] piglets)...
January 1, 2017: Laboratory Animals
https://www.readbyqxmd.com/read/28177137/hypoalbuminemia-and-decreased-midazolam-clearance-in-terminally-ill-adult-patients-an-inflammatory-effect
#18
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
#19
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/28176362/interdisciplinary-pharmacometrics-linking-oseltamivir-pharmacology-influenza-epidemiology-and-health-economics-to-inform-antiviral-use-in-pandemics
#20
M A Kamal, P F Smith, N Chaiyakunapruk, D B C Wu, C Pratoomsoot, K K C Lee, H Y Chong, R E Nelson, K Nieforth, G Dall, S Toovey, D C M Kong, A Kamauu, C M Kirkpatrick, C R Rayner
AIM: A modular interdisciplinary platform was developed to investigate the economic impact of oseltamivir treatment by dosage regimen under simulated influenza pandemic scenarios. METHODS: The pharmacology module consisted of a pharmacokinetic distribution of oseltamivir carboxylate AUC0-24h at steady state (simulated for 75 mg and 150 mg BID regimens for 5 days) and a pharmacodynamic distribution of viral shedding duration (Tshed ) obtained from phase II influenza inoculation data...
February 8, 2017: British Journal of Clinical Pharmacology
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