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Population pharmacokinetics

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https://www.readbyqxmd.com/read/28534544/-factors-predicting-failure-in-empirical-antibiotic-treatment
#1
REVIEW
E J García-Lamberechts, J González-Del Castillo, A I Hormigo Sánchez, M J Núñez-Orantos, F J Candel, F J Martín-Sánchez
Infections are one of the main causes of morbidity and mortality in the population. The choice of empirical treatment is one of the most common decisions facing the physician. This first decision has consequences in the prognosis of the patient and the costs associated with the process. This review attempts to summarize the aspects that can lead to failure of antibiotic treatment by considering microbiological and pharmacological aspects, patient profile and infectious focus control. In addition, a series of recommendations are established to minimize this risk, from the point of view of diagnostic accuracy, adequate severity stratification of the patient, knowledge of the pharmacokinetic and pharmacodynamic aspects of antibiotics and control of the infectious focus...
April 30, 2017: Anales del Sistema Sanitario de Navarra
https://www.readbyqxmd.com/read/28533244/a-population-pharmacokinetic-model-of-gentamicin-in-paediatric-oncology-patients-to-facilitate-personalised-dosing
#2
C C Llanos-Paez, C E Staatz, R Lawson, S Hennig
To ensure safe and effective dosing of gentamicin in children therapeutic drug monitoring (TDM) is recommended. TDM utilising Bayesian forecasting software is recommended, but is unavailable as no population model exists that describes the pharmacokinetics of gentamicin in paediatric oncology patients. This study aimed to develop and externally evaluate a population pharmacokinetic model of gentamicin to support personalised dosing in paediatric oncology patients. A non-linear mixed effect population pharmacokinetic model was developed from retrospective data...
May 22, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28530311/-adjustments-in-the-oral-drug-treatment-of-bariatric-patients
#3
Ilanit Mahler, Danny Roder
Bariatric surgery continues to be a durable therapeutic option for a growing number of obese patients. The patients that are admitted to our hospital for elective bariatric procedures often suffer from multiple co-morbidities and are therefore treated with a significant number of chronic medications. These operations lead to drastic modifications of the anatomy and physiology of the gastro-intestinal tract that may change the pharmacokinetics of drugs. In addition, the natural post-operative course of a bariatric procedure may lead to amelioration or even resolution of some of the obesity-related chronic diseases, consequently eliminating the need for drug therapy...
January 2017: Harefuah
https://www.readbyqxmd.com/read/28528287/population-pharmacokinetics-of-oxcarbazepine-and-its-metabolite-10-hydroxycarbazepine-in-healthy-subjects
#4
Natalicia de Jesus Antunes, Sven C van Dijkman, Vera Lucia Lanchote, Lauro Wichert-Ana, Eduardo Barbosa Coelho, Veriano Alexandre Junior, Osvaldo Massaiti Takayanagui, Eduardo Tozatto, Johan G C van Hasselt, Oscar Della Pasqua
Oxcarbazepine is indicated for the treatment of partial or generalized tonic-clonic seizures. The majority of the oxcarbazepine is converted into its active metabolite, 10-hydroxycarbazepine (MHD), which can exist as R-(-)- and S-(+)-MHD enantiomers. Here we describe the influence of the P-glycoprotein (P-gp) inhibitor verapamil, on the disposition of oxcarbazepine and MHD enantiomers, both of which are P-gp substrates. Healthy subjects (n=12) were randomized to oxcarbazepine or oxcarbazepine combined with verapamil at doses of 300mg b...
May 17, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28526162/pharmacologic-considerations-of-anesthetic-agents-in-pediatric-patients-a-comprehensive-review
#5
REVIEW
Alan D Kaye, Charles J Fox, Ira W Padnos, Ken P Ehrhardt, James H Diaz, Elyse M Cornett, Debbie Chandler, Sudipta Sen, Shilpadevi Patil
Acute pain in the pediatric population has important differences in terms of biology, intrapopulation variation, and epidemiology. Discussion as to the pharmacologic considerations of anesthetic agents, such as induction agents, neuromuscular blockers, opioids, local anesthetics, and adjuvant agents, is presented in this article. Special considerations and concerns, such as risk for propofol infusion syndrome and adverse potential side effects of anesthesia agents, are discussed. Anesthesiologists managing pediatric patients need to have a firm understanding of physiologic and pharmacologic differences compared with the adult population...
June 2017: Anesthesiology Clinics
https://www.readbyqxmd.com/read/28526146/perioperative-pharmacologic-considerations-in-obesity
#6
REVIEW
Simon Willis, Gregory J Bordelon, Maunak V Rana
Obesity has increased in incidence worldwide. Along with the increased number of obese patients, comorbid conditions are also more prevalent in this population. Obesity leads to changes in the physiology of patients along with an altered response to pharmacologic therapy. Vigilant perioperative physicians must be aware of the unique characteristics of administered agents in order to appropriately provide anesthetic care for obese patients. Because of the variability in tissue content in obese patients and changes in pharmacokinetic modeling, a one-size-fits-all approach is not justified and a more sophisticated and prudent approach is indicated...
June 2017: Anesthesiology Clinics
https://www.readbyqxmd.com/read/28523596/pharmacokinetics-and-safety-of-vismodegib-in-patients-with-advanced-solid-malignancies-and-hepatic-impairment
#7
Ghassan K Abou-Alfa, Lionel D Lewis, Patricia LoRusso, Michael Maitland, Priya Chandra, Sravanthi Cheeti, Dawn Colburn, Sarah Williams, Brian Simmons, Richard A Graham
PURPOSE: Vismodegib is a Hedgehog pathway inhibitor approved for the treatment of advanced basal cell carcinoma. Currently, the pharmacokinetics (PK) and safety of vismodegib in patients with hepatic dysfunction are unknown and are the objective of this study. METHODS: Patients with advanced solid malignancies and hepatic impairment were enrolled into one of four cohorts: normal [bilirubin (bili) < upper limit of normal (ULN)], mild (ULN < bili ≤ 1...
May 18, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28523450/a-review-of-the-clinical-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-vedolizumab
#8
REVIEW
Maria Rosario, Nathanael L Dirks, Catherine Milch, Asit Parikh, Michael Bargfrede, Tim Wyant, Eric Fedyk, Irving Fox
Vedolizumab is a humanized anti-α4β7 integrin monoclonal antibody that selectively blocks trafficking of memory T cells to inflamed gut tissue by inhibiting the α4β7-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) interaction. Approved for treating patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD), vedolizumab is administered as a 300 mg intravenous infusion. Vedolizumab undergoes a rapid, saturable, non-linear, target-mediated elimination process at low concentrations and a slower, linear, non-specific elimination process at higher concentrations...
May 18, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28522374/population-pharmacokinetics-of-nnz-2566-in-healthy-subjects
#9
Sean P Oosterholt, Joseph Horrigan, Nancy Jones, Larry Glass, Oscar Della Pasqua
NNZ-2566 is a novel, small molecule being developed as a treatment for cognitive impairment in different CNS conditions, including Rett and Fragile-X syndrome, both of which are associated with moderate to severe neurodevelopmental disorder. In current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects. A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age 23years, range 19 to 38) were treated with NNZ-2566...
May 15, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28522373/population-pharmacokinetics-of-carvedilol-enantiomers-and-their-metabolites-in-type-2-diabetes-and-healthy-subjects
#10
Glauco H B Nardotto, Vera L Lanchote, Eduardo B Coelho, Oscar Della Pasqua
Carvedilol, a drug available as a racemic mixture, is eliminated as hydroxyphenylcarvedilol (OHC) by CYP2D6 and O-desmethylcarvedilol (DMC) by CYP2C9 followed by conjugation to glucuronides. In contrast to other β-adrenergic receptor antagonists, carvedilol does not induce insulin resistance or worsen glycaemic control in the diabetic hypertensive patients. This study aims to investigate the implications of type 2 diabetes (T2DM) on the pharmacokinetics of carvedilol enantiomers using an integrated population pharmacokinetic modelling approach...
May 15, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28521880/pharmacokinetics-of-oral-hydrocortisone-results-and-implications-from-a-randomized-controlled-trial
#11
Jorien Werumeus Buning, Daan J Touw, Pauline Brummelman, Robin P F Dullaart, Gerrit van den Berg, Melanie M van der Klauw, Jasper Kamp, Bruce H R Wolffenbuttel, André P van Beek
CONTEXT AND OBJECTIVE: This study aimed at comparing pharmacokinetics of two different doses of hydrocortisone (HC) in patients with secondary adrenal insufficiency (SAI). DESIGN, SETTING AND PATIENTS: Forty-six patients with SAI participated in this randomized double-blind crossover study. INTERVENTION: Patients received two different doses of HC (0.2-0.3mg HC/kg body weight/day and 0.4-0.6mg HC/kg body weight/day). MAIN OUTCOME MEASURES: One- and two-compartment population models for plasma free cortisol, plasma total cortisol and salivary cortisol were parameterized...
June 2017: Metabolism: Clinical and Experimental
https://www.readbyqxmd.com/read/28520840/assessment-of-nivolumab-benefit-risk-profile-of-a-240-mg-flat-dose-relative-to-a-3-mg-kg-dosing-regimen-in-patients-with-advanced-tumors
#12
X Zhao, S Suryawanshi, M Hruska, Y Feng, X Wang, J Shen, H E Vezina, M B McHenry, I M Waxman, A Achanta, A Bello, A Roy, S Agrawal
Background: : Nivolumab 3 mg/kg every 2 weeks (Q2W) has shown benefit versus the standard of care in melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). However, flat dosing is expected to shorten preparation time and improve ease of administration. With knowledge of nivolumab safety, efficacy, and pharmacokinetics across a wide dose range in BW dosing, assessment of the benefit-risk profile of a 240-mg flat dose relative to the approved 3-mg/kg dose was approached by quantitative clinical pharmacology...
May 17, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28515943/evaluation-of-dosing-strategy-for-pembrolizumab-for-oncology-indications
#13
Tomoko Freshwater, Anna Kondic, Malidi Ahamadi, Claire H Li, Rik de Greef, Dinesh de Alwis, Julie A Stone
BACKGROUND: Traditionally, most monoclonal antibodies (mAbs) have been dosed based on body weight because of perceived contribution of body size in pharmacokinetic variability. The same approach was used in the initial pembrolizumab studies; however, following availability of PK data, the need for weight-based dosing for pembrolizumab was reassessed. METHODS: A previously established population PK (popPK) model as well as exposure-response results from patients with advanced melanoma or non-small cell lung cancer (NSCLC) were used to evaluate the potential application of a fixed dosing regimen with the aim of maintaining pembrolizumab exposures within the range demonstrated to provide near maximal efficacy and acceptable safety...
2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28513856/the-utility-of-a-population-approach-in-drug-drug-interaction-assessments-a-simulation-evaluation
#14
Diane D Wang, Yanke Yu, Nastya Kassir, Min Zhu, William D Hanley, Justin C Earp, Andrew T Chow, Manish Gupta, Chuanpu Hu
This study aims at evaluating the utility of the population pharmacokinetics approach in therapeutic protein drug-drug-interaction (DDI) assessment. Simulations were conducted for 2 representative victim drugs, methotrexate and trastuzumab, using a parallel-group design with and without the interaction drug. The effect of a perpetrator on the exposure of the victim drug is described as the ratio of clearance/apparent clearance of the victim drug given with or without the perpetrator. The power of DDI assessment was calculated as the percentage of runs with 90% confidence interval of the estimated DDI effect within 80% to 125% for the scenarios of no DDI, benchmarked with the noncompartmental approach with intensive sampling...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513851/population-pharmacokinetics-of-brentuximab-vedotin-in-patients-with-cd30-expressing-hematologic-malignancies
#15
Hong Li, Tae H Han, Naomi N Hunder, Graham Jang, Baiteng Zhao
Brentuximab vedotin, a CD30-directed antibody-drug conjugate (ADC), is approved for treating certain patients with CD30-expressing hematologic malignancies. Its primary mechanism of action is the targeted delivery of a microtubule-disrupting agent, monomethyl auristatin E (MMAE), to CD30-expressing cells. A population pharmacokinetic (PopPK) analysis was conducted to characterize the PK of ADC and unconjugated MMAE in patients with CD30-expressing hematologic malignancies by compartmental analysis and to evaluate the effects of covariates on PK of the ADC...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513427/population-pharmacokinetics-of-lyophilized-recombinant-glucagon-like-peptide-1-receptor-agonist-recombinant-exendin-4-re-4-in-chinese-patients-with-type-2-diabetes-mellitus%C3%A2
#16
Yan-Nan Zang, Min-Jie Zhang, Yi-Tong Wang, Chen Wang, Qian Wang, Qing-Shan Zheng, Li-Nong Ji, Wei Guo, Yi Fang
OBJECTIVE: To investigate the population pharmacokinetics of lyophilized recombinant glucagon-like peptide-1 receptor agonist (rE-4) in Chinese patients with type 2 diabetes mellitus (T2DM) for plasma concentration estimation and individualized treatment. METHODS: Twelve patients with T2DM were enrolled to receive subcutaneous injections of rE-4 at 5 µg twice daily for 84 days. Administration dosage was adjusted from 5 µg to 10 µg twice daily at day 29 in case of glycated albumin (GA) ≥ 17%...
May 17, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28512056/combined-proportional-and-additive-residual-error-models-in-population-pharmacokinetic-modelling
#17
Johannes H Proost
INTRODUCTION: In pharmacokinetic modelling, a combined proportional and additive residual error model is often preferred over a proportional or additive residual error model. Different approaches have been proposed, but a comparison between approaches is still lacking. METHODS: The theoretical background of the methods is described. Method VAR assumes that the variance of the residual error is the sum of the statistically independent proportional and additive components; this method can be coded in three ways...
May 13, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28510797/influence-of-morbid-obesity-on-the-pharmacokinetics-of-morphine-morphine-3-glucuronide-and-morphine-6-glucuronide
#18
Sjoerd de Hoogd, Pyry A J Välitalo, Albert Dahan, Simone van Kralingen, Michael M W Coughtrie, Eric P A van Dongen, Bert van Ramshorst, Catherijne A J Knibbe
INTRODUCTION: Obesity is associated with many pathophysiological changes that may result in altered drug metabolism. The aim of this study is to investigate the influence of obesity on the pharmacokinetics of morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) through a combined analysis in morbidly obese patients and non-obese healthy volunteers. METHODS: In this analysis, data from 20 morbidly obese patients [mean body mass index 49.9 kg/m(2) (range 37...
May 16, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28510738/pharmacokinetic-pharmacodynamic-model-for-unfractionated-heparin-dosing-during-cardiopulmonary-bypass
#19
X Delavenne, E Ollier, S Chollet, F Sandri, J Lanoiselée, S Hodin, A Montmartin, J-F Fuzellier, P Mismetti, L Gergelé
Background: High-dose heparin is used during cardiopulmonary bypass (CPB) to prevent thrombosis in the circuits used for extracorporeal circulation. The aim of this study was, initially, to develop a population pharmacokinetic/pharmacodynamic (PK/PD) model to assess the variability of PK/PD parameters and their correlation with the results of the routine haemostatic test activated clotting time (ACT) and thereafter to develop a Bayesian estimator enabling an individualized dosing strategy...
May 1, 2017: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28510304/flip-flop-phenomenon-in-epidural-sufentanil-pharmacokinetics-a-population-study-in-children-and-infants
#20
Agnieszka Borsuk, Bogumiła Wołoszczuk-Gębicka, Alicja Bartkowska-Śniatkowska, Jowita Rosada-Kurasińska, Agnieszka Bienert, Paweł Wiczling
The aims of this study were to develop a population pharmacokinetic model of sufentanil coadministered with 0.2% ropivacaine as an epidural infusion in infants and describe the sufentanil absorption profile from epidural space. Data from 2 previously published studies were merged for analysis-20 infants aged 3-36 months receiving sufentanil as an epidural infusion and 41 children 0-17 years old receiving sufentanil as a long-term intravenous infusion. A population nonlinear mixed-effects model was built in NONMEM...
May 16, 2017: Journal of Clinical Pharmacology
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