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Population pharmacokinetics

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https://www.readbyqxmd.com/read/28651055/pharmacokinetic-characterization-of-18-f-ucb-h-pet-radiopharmaceutical-in-the-rat-brain
#1
Guillaume Becker, Corentin Warnier, Maria Elisa Serrano, Mohamed Ali Bahri, Joël Mercier, Christian Lemaire, Eric Salmon, André Luxen, Alain Plenevaux
The synaptic vesicle glycoprotein 2A (SV2A), a protein essential to the proper nervous system function, is found in presynaptic vesicles. Thus, SV2A targeting, using dedicated radiotracers combined with positron emission tomography (PET), allows the assessment of synaptic density in the living brain. The first-in-class fluorinated SV2A specific radioligand, [(18)F]UCB-H, is now available at high-activity through an efficient radiosynthesis compliant with the current good manufacturing practices (cGMP). We report here a non-invasive method to quantify [(18)F]UCB-H binding in rat brain with microPET...
June 26, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28650363/population-pharmacokinetics-and-pharmacodynamic-target-attainment-of-vancomycin-in-neonates-on-extracorporeal-life-support
#2
Jeffrey J Cies, Wayne S Moore, Kristen Nichols, Chad A Knoderer, Dominick M Carella, Arun Chopra
OBJECTIVES: To evaluate the population pharmacokinetics and pharmacodynamic target attainment of vancomycin in neonates with a contemporary ¼-inch extracorporeal life support circuit with a Quadrox-iD Pediatric oxygenator (Maquet Cardiovascular, LLC, Wayne, NJ). DESIGN: Retrospective medical record review. SETTING: Two free-standing tertiary/quaternary pediatric children's hospitals. PATIENTS: Neonates receiving either veno-arterial or veno-venous extracorporeal life support and vancomycin for empiric or definitive therapy with resulting serum concentrations...
June 22, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28649438/translational-learning-from-clinical-studies-predicts-drug-pharmacokinetics-across-patient-populations
#3
Markus Krauss, Ute Hofmann, Clemens Schafmayer, Svitlana Igel, Jan Schlender, Christian Mueller, Mario Brosch, Witigo von Schoenfels, Wiebke Erhart, Andreas Schuppert, Michael Block, Elke Schaeffeler, Gabriele Boehmer, Linus Goerlitz, Jan Hoecker, Joerg Lippert, Reinhold Kerb, Jochen Hampe, Lars Kuepfer, Matthias Schwab
Early indication of late-stage failure of novel candidate drugs could be facilitated by continuous integration, assessment, and transfer of knowledge acquired along pharmaceutical development programs. We here present a translational systems pharmacology workflow that combines drug cocktail probing in a specifically designed clinical study, physiologically based pharmacokinetic modeling, and Bayesian statistics to identify and transfer (patho-)physiological and drug-specific knowledge across distinct patient populations...
2017: NPJ Systems Biology and Applications
https://www.readbyqxmd.com/read/28647460/a-prospective-study-evaluating-tobramycin-pharmacokinetics-and-optimal-once-daily-dosing-in-burn-patients
#4
Colin Lee, Sandra A N Walker, Scott E Walker, Winnie Seto, Andrew Simor, Marc Jeschke
BACKGROUND: Once-daily aminoglycoside dosing (ODA) is used in most patient populations to optimize antibacterial activity and reduce toxicity. Unfortunately, burn patients are excluded from ODA due to concerns over altered pharmacokinetics resulting in a shortened half-life and low peak aminoglycoside concentrations. Retrospective studies suggest that ODA may be appropriate if higher milligram/kilogram doses are used. However, no prospective clinical trials in burn patients exist to confirm these findings...
June 21, 2017: Burns: Journal of the International Society for Burn Injuries
https://www.readbyqxmd.com/read/28646274/population-pharmacokinetic-modeling-of-diltiazem-in-chinese-renal-transplant-recipients
#5
Xiao-Feng Guan, Dai-Yang Li, Wen-Jun Yin, Jun-Jie Ding, Ling-Yun Zhou, Jiang-Lin Wang, Rong-Rong Ma, Xiao-Cong Zuo
BACKGROUND AND OBJECTIVES: Diltiazem is a benzothiazepine calcium blocker and widely used in renal transplant patients since it improves the level of tacrolimus or cyclosporine A concentration. Several population pharmacokinetic (PopPK) models had been established for cyclosporine A and tacrolimus but no specific PopPK model was established for diltiazem. The aim of the study is to develop a PopPK model for diltiazem in renal transplant recipients and provide relevant pharmacokinetic parameters of diltiazem for further pharmacokinetic interaction study...
June 23, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28645995/mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma
#6
REVIEW
Mara N Poulakos, Shawna M Cargill, Melissa F Waineo, Allen L Wolford
PURPOSE: Published data on the pharmacology, pharmacokinetics and pharmacodynamics, and clinical efficacy and safety of the interleukin-5 antagonist mepolizumab are reviewed. SUMMARY: Asthma of the eosinophilic phenotype is characterized by persistent eosinophilic airway inflammation promoted primarily by T-helper type 2 cytokines, the key regulator of eosinophils. Patients with severe eosinophilic asthma are burdened by the need to administer high doses of corticosteroids to help manage their symptoms...
July 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28645525/placenta-as-alternative-specimen-to-detect-in-utero-cannabis-exposure-a-systematic-review-of-the-literature
#7
REVIEW
Daniela Marchetti, Gerardo Di Masi, Francesca Cittadini, Giuseppe La Monaca, Nadia De Giovanni
The use of cannabis during pregnancy and lactation is widely recognized as a health concern. The placenta is one of the several biological matrices that can be used to detect in utero drug exposure with the distinct advantage of easy and noninvasive collection. We conducted a PubMed search of selected literature published to June 30, 2016 to investigate the pharmacokinetics of cannabinoids, the active constituent of cannabis, in the placenta. The majority of the selected twelve papers was before 1990 and concerned animals at term gestation with great variability of experimental conditions...
June 20, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28645013/per-and-polyfluoroalkyl-substances-in-human-serum-and-urine-samples-from-a-residentially-exposed-community
#8
Rachel Rogers Worley, Susan McAfee Moore, Bruce C Tierney, Xiaoyun Ye, Antonia M Calafat, Sean Campbell, Million B Woudneh, Jeffrey Fisher
BACKGROUND: Per- and polyfluoroalkyl substances (PFAS) are considered chemicals of emerging concern, in part due to their environmental and biological persistence and the potential for widespread human exposure. In 2007, a PFAS manufacturer near Decatur, Alabama notified the United States Environmental Protection Agency (EPA) it had discharged PFAS into a wastewater treatment plant, resulting in environmental contamination and potential exposures to the local community. OBJECTIVES: To characterize PFAS exposure over time, the Agency for Toxic Substances and Disease Registry (ATSDR) collected blood and urine samples from local residents...
June 20, 2017: Environment International
https://www.readbyqxmd.com/read/28644049/the-standard-treatment-protocol-for-paracetamol-poisoning-may-be-inadequate-following-overdose-with-modified-release-formulation-a-pharmacokinetic-and-clinical-analysis-of-53-cases
#9
Heléne Salmonson, Gunilla Sjöberg, Jacob Brogren
OBJECTIVE: The use of the standard procedure for managing overdoses with immediate release (IR) paracetamol is questionable when applied to overdoses with modified release (MR) formulations. This study describes the pharmacokinetics of paracetamol and the clinical outcomes following overdoses with a MR formulation. METHODS: Medical records including laboratory analyses concerning overdoses of MR paracetamol from 2009 to 2015 were collected retrospectively. Inclusion criteria were ingestion of a toxic dose, known time of intake and documented measurements of serum paracetamol and liver function tests...
June 23, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28643852/therapeutic-d2-3-receptor-occupancies-and-response-with-low-amisulpride-blood-concentrations-in-very-late-onset-schizophrenia-like-psychosis-vloslp
#10
Suzanne Reeves, Kate Eggleston, Elizabeth Cort, Emma McLachlan, Stuart Brownings, Akshay Nair, Suki Greaves, Alan Smith, Joel Dunn, Paul Marsden, Robert Kessler, David Taylor, Julie Bertrand, Robert Howard
OBJECTIVE: Antipsychotic drug sensitivity in very late-onset schizophrenia-like psychosis (VLOSLP) is well documented, but poorly understood. This study aimed to investigate blood drug concentration, D2/3 receptor occupancy and outcome in VLOSLP during open amisulpride prescribing, and compare this with Alzheimer's disease (AD). METHODS: Blood drug concentration, prolactin, symptoms and extrapyramidal side-effects (EPS) were serially assessed during dose titration...
June 23, 2017: International Journal of Geriatric Psychiatry
https://www.readbyqxmd.com/read/28643374/population-pharmacokinetic-and-pharmacodynamic-modeling-of-ly2510924-in-patients-with-advanced-cancer
#11
S Bihorel, E Raddad, J Fiedler-Kelly, J R Stille, J Hing, E Ludwig
The objectives of this study were to characterize the pharmacokinetics (PK) of LY2510924, a potent peptide antagonist of the CXCR4 receptor, after subcutaneous administration in patients with advanced cancer forms and quantify LY2510924 stimulatory effects on the mobilization of cells bearing the cluster of differentiation 34 (CD34) as an indirect reflection of the chemokine C-X-C motif ligand 12/CXCR4 axis inhibition. LY2510924 PK were best characterized by a 2-compartment model with first-order absorption and dose-dependent clearance predicting steady state after three daily doses and little accumulation (accumulation ratio <1...
June 23, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28642710/tacrolimus-updated-guidelines-through-poppk-modeling-how-to-benefit-more-from-cyp3a-pre-emptive-genotyping-prior-to-kidney-transplantation
#12
Jean-Baptiste Woillard, Michel Mourad, Michael Neely, Arnaud Capron, Ron H van Schaik, Teun van Gelder, Nuria Lloberas, Dennis A Hesselink, Pierre Marquet, Vincent Haufroid, Laure Elens
Tacrolimus (Tac) is a profoundly effective immunosuppressant that reduces the risk of rejection after solid organ transplantation. However, its use is hampered by its narrow therapeutic window along with its highly variable pharmacological (pharmacokinetic [PK] and pharmacodynamic [PD]) profile. Part of this variability is explained by genetic polymorphisms affecting the metabolic pathway. The integration of CYP3A4 and CY3A5 genotype in tacrolimus population-based PK (PopPK) modeling approaches has been proven to accurately predict the dose requirement to reach the therapeutic window...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28640606/pharmacokinetics-of-mequindox-and-its-marker-residue-1-4-bisdesoxymequindox-in-swine-following-multiple-oral-gavage-and-intramuscular-administration-an-experimental-study-coupled-with-population-physiologically-based-pharmacokinetic-modeling
#13
Dongping Zeng, Zhoumeng Lin, Binghu Fang, Miao Li, Ronette Gehring, Jim E Riviere, ZhenLing Zeng
Mequindox (MEQ) is a quinoxaline-N,N-dioxide antibiotic used in food-producing animals. MEQ residue in animal-derived foods is a food safety concern. The tissue distribution of MEQ and its marker residue 1,4-bisdesoxymequindox (M1) was determined in swine following oral gavage or intramuscular injection twice daily for 3 days. The experimental data were used to construct a flow-limited physiologically based pharmacokinetic (PBPK) model. The model predictions correlated with available data well. Monte Carlo analysis showed that the times needed for M1 concentrations to fall below limit of detection (5 µg/kg) in liver for the 99th percentile of the population were 27 and 34 days after oral gavage and intramuscular administration twice daily for 3 days, respectively...
June 22, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28640540/the-effects-of-advanced-age-and-serum-%C3%AE-1-acid-glycoprotein-on-docetaxel-unbound-exposure-and-dose-limiting-toxicity-in-cancer-patients
#14
Hirotsugu Kenmotsu, Chiyo K Imamura, Akira Ono, Shota Omori, Kazuhisa Nakashima, Kazushige Wakuda, Tetsuhiko Taira, Tateaki Naito, Haruyasu Murakami, Toshiaki Takahashi, Yusuke Tanigawara
AIM: α1 -Acid glycoprotein (AAG), which is a major binding protein of docetaxel, is considered to be a determinant for docetaxel pharmacokinetics. However, there are no reports about the impact of serum AAG on pharmacokinetics and pharmacodynamics in elderly patients treated with docetaxel. The aim of this prospective study was to elucidate the effects of advanced age and serum AAG on docetaxel unbound exposure and neutropenia, dose-limiting toxicity, in cancer patients. METHODS: Docetaxel was administered at 60 mg/m(2) to 51 patients with non-small cell lung cancer, 17 of whom were ≥ 75 years of age...
June 22, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28640009/augmented-renal-clearance-using-population-based-pharmacokinetic-modeling-in-critically-ill-pediatric-patients
#15
Sean N Avedissian, Erin Bradley, Diana Zhang, John S Bradley, Lama H Nazer, Tri M Tran, Austin Nguyen, Jennifer Le
OBJECTIVES: The objectives of this study were to: 1) evaluate the prevalence of augmented renal clearance in critically ill pediatric patients using vancomycin clearance; 2) derive the pharmacokinetic model that best describes vancomycin clearance in critically ill pediatric patients; and 3) correlate vancomycin clearance with creatinine clearance estimated by modified Schwartz or Cockcroft-Gault. DESIGN: Retrospective, two-center, cohort study from 2003 to 2016...
June 20, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28636998/physiologically-based-pharmacokinetic-modeling-for-predicting-irinotecan-exposure-in-human-body
#16
Yingfang Fan, Najia Mansoor, Tasneem Ahmad, Rafeeq Alam Khan, Martin Czejka, Syed Sharib, Dong-Hua Yang, Mansoor Ahmed
Colorectal cancer is the third leading cause of cancer-related deaths in the United States. Treatment of colorectal cancer remains a challenge to clinicians as well as drug developers. Irinotecan, a Camptothecin derivative, is successfully used for the treatment of this rapidly progressing malignancy and finds its place in the first line of therapeutic agents. Irinotecan is also effective in treating SCLC, malignant glioma and pancreatic adenocarcinoma. However, its adverse effects limit its clinical application...
June 6, 2017: Oncotarget
https://www.readbyqxmd.com/read/28636538/phase-i-dose-escalation-study-of-the-c-met-tyrosine-kinase-inhibitor-sar125844-in-asian-patients-with-advanced-solid-tumors-including-patients-with-met-amplified-gastric-cancer
#17
Kohei Shitara, Tae Min Kim, Tomoya Yokota, Masahiro Goto, Taroh Satoh, Jin-Hee Ahn, Hyo Song Kim, Sylvie Assadourian, Corinne Gomez, Marzia Harnois, Satoshi Hamauchi, Toshihiro Kudo, Toshihido Doi, Yung-Jue Bang
SAR125844 is a potent and selective inhibitor of the c-Met kinase receptor. This was an open-label, phase I, multicenter, dose-escalation, and dose-expansion trial of SAR125844 in Asian patients with solid tumors, a subgroup of whom had gastric cancer and MET amplification (NCT01657214). SAR125844 was administered by intravenous infusion (260-570 mg/m2) on days 1, 8, 15, and 22 of each 28-day cycle. Objectives were to determine the maximum tolerated dose (MTD) and to evaluate SAR125844 safety and pharmacokinetic profile...
June 16, 2017: Oncotarget
https://www.readbyqxmd.com/read/28636184/pharmacokinetics-pharmacodynamics-of-bococizumab-a-monoclonal-antibody-to-pcsk9-after-single-subcutaneous-injection-at-3-sites-nct-02043301
#18
Ellen Q Wang, Anna Plotka, Joanne Salageanu, Catherine Sattler, Carla Yunis
AIM: To characterize the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) of bococizumab, a monoclonal antibody inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9), administered subcutaneously (s.c.) to the abdomen, thigh, or upper arm (NCT02043301). METHODS: Seventy-five adults with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL and not on background lipid-lowering therapy were randomized (1:1:1) to a single 150-mg s.c. dose of bococizumab administered to the abdomen, thigh, or upper arm...
June 21, 2017: Cardiovascular Therapeutics
https://www.readbyqxmd.com/read/28634902/therapeutic-potential-of-baicalein-in-alzheimer-s-disease-and-parkinson-s-disease
#19
Yanwei Li, Jinying Zhao, Christian Hölscher
Alzheimer's disease and Parkinson's disease are the two most common, progressive central neurodegenerative diseases affecting the population over the age of 60 years. Apart from treatments that temporarily improve symptoms, there is no medicine currently available to inhibit or reverse the progression of Alzheimer's disease and Parkinson's disease. In traditional Chinese medicine, the root of Scutellaria baicalensis Georgi is a classic compatible component in the decoction of herbal medicine used for treating central nervous system diseases...
June 20, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28634748/exposure-response-relationship-of-ramucirumab-in-east-asian-patients-from-rainbow-a-randomized-clinical-trial-in-second-line-treatment-of-gastric-cancer
#20
Tae You Kim, Chia-Jui Yen, Salah-Eddin Al-Batran, David Ferry, Ling Gao, Yanzhi Hsu, Rebecca Cheng, Mauro Orlando, Atsushi Ohtsu
BACKGROUND: Ramucirumab is a recombinant human IgG1 neutralizing monoclonal antibody specific for vascular endothelial growth factor receptor-2. Second-line ramucirumab, in conjunction with paclitaxel (ramucirumab 8 mg/kg or placebo in combination with 80 mg/m(2) paclitaxel), has been shown to be effective and safe in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in RAINBOW, a global phase III randomized clinical trial. We conducted an exploratory exposure-response analysis of efficacy and safety of ramucirumab in East Asian patients from the RAINBOW trial...
June 20, 2017: Gastric Cancer
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