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Population pharmacokinetics

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https://www.readbyqxmd.com/read/29453627/a-phase-i-and-pharmacokinetic-study-of-taladegib-a-smoothened-inhibitor-in-japanese-patients-with-advanced-solid-tumors
#1
Hideki Ueno, Shunsuke Kondo, Shusuke Yoshikawa, Koichi Inoue, Valérie Andre, Masaomi Tajimi, Haruyasu Murakami
Background This phase I dose-escalation study investigated the safety of the Smoothened inhibitor taladegib in Japanese patients with advanced solid tumors. Methods Patients received taladegib orally once daily for 28-day cycles, using a 3 + 3 dose-escalation method. The primary objective was the safety and tolerability of taladegib at doses up to the global recommended dose (400 mg). Secondary objectives included pharmacokinetics, changes in skin glioma-associated oncogene homolog 1 (Gli1) transcript levels, and antitumor activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29452291/pharmacokinetic-models-to-assist-the-prescriber-in-choosing-the-best-tacrolimus-dose
#2
REVIEW
Jean-Baptiste Woillard, Franck Saint-Marcoux, Jean Debord, Anders Åsberg
Due to a high inter-individual variability in its pharmacokinetics, tacrolimus dose individualization is mandatory. Even though the expert opinion has defined the area under the curve (AUC) as the best marker to use when performing dose adjustment of tacrolimus, most centres only use trough levels. Multiple targets have been proposed for this parameter and physicians rely largely on their personal experience when making a decision about dose adjustment. Several population pharmacokinetics models (POPPK) allowing AUC determination have been developed, but only a few are actually used in routine practice for dose individualization...
February 13, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29451394/clinical-application-of-microsampling-versus-conventional-sampling-techniques-in-the-quantitative-bioanalysis-of-antibiotics-a-systematic-review
#3
Yarmarly C Guerra Valero, Steven C Wallis, Jeffrey Lipman, Christophe Stove, Jason A Roberts, Suzanne L Parker
Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. These may not account for alterations to a patient's pathophysiology and can lead to suboptimal treatment. Microsampling offers an important opportunity for clinical pharmacokinetic studies in vulnerable patient populations, where smaller sample volumes can be collected...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451018/incorporating-dried-blood-spot-lc-ms-ms-analysis-for-clinical-development-of-a-novel-oncolytic-agent
#4
Enaksha R Wickremsinhe, Sophie Callies, Chris A Schmalz, Lisa B Lee, Elizabeth S LaBell, Darlene K Satonin
AIM: Design and execution of a dried blood spot (DBS-LC-MS/MS) assay for pharmacokinetic analyses in oncology patients. RESULTS & DISCUSSION: The methodology was validated to collect and store DBS samples from multiple clinical sites, and analyze blood with diverse hematocrit ranges (25-55) to match the potential patient population. Bridging data comparing DBS and plasma showed high degree of concordance with DBS:plasma ratios of 0.81, demonstrating no preferential uptake or association with cellular components of the blood...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29446998/considerations-for-clinical-review-of-cellular-therapy-products-perspectives-of-the-china-food-and-drug-administration-center-for-drug-evaluation
#5
Yantong Liu, Chenyang Zhao, Liucun Gao, Huan Yang, Ruyi He, Chenyan Gao
With increasing numbers of technical developments and clinical studies, pioneering cellular/gene therapies are now available that could cure life-threatening disease. Cellular/gene therapy products are broad-ranging and complicated, and thereby bring challenges for clinical review by regulatory agencies. This review discusses principles for the clinical review of cellular therapy products, including protection of clinical trial populations, pharmacodynamics, pharmacokinetics, dose evaluation, clinical efficacy, clinical safety, and risk-management plans...
February 2018: Human Gene Therapy
https://www.readbyqxmd.com/read/29446256/using-a-vancomycin-pbpk-model-in-special-populations-to-elucidate-case-based-clinical-pk-observations
#6
Chie Emoto, Trevor N Johnson, Brooks T McPhail, Alexander A Vinks, Tsuyoshi Fukuda
Simultaneous changes in several physiological factors may contribute to the large pharmacokinetic (PK) variability of vancomycin. This study was designed to systematically characterize the effects of multiple physiological factors to the altered PK of vancomycin observed in special populations. A vancomycin physiologically based pharmacokinetic (PBPK) model was developed as a PK simulation platform to quantitatively assess the effects of changes in physiologies to the PK profiles. The developed model predicted the concentration-time profiles in healthy adults and diseased patients...
February 15, 2018: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29445339/population-pharmacokinetic-modeling-of-a-desmopressin-oral-lyophilisate-in-growing-piglets-as-a-model-for-the-pediatric-population
#7
Elke Gasthuys, An Vermeulen, Siska Croubels, Joske Millecam, Stijn Schauvliege, Thomas van Bergen, Pauline De Bruyne, Johan Vande Walle, Mathias Devreese
Desmopressin is used to treat primary nocturnal enuresis in children. Over the years, various formulations of desmopressin were commercialized of which the sublingual melt tablet is preferred in the pediatric population, despite the lack of full PK studies in this population. A full PK study was performed in growing conventional piglets to evaluate if this juvenile animal model can provide supplementary information to complement the information gap in the pediatric population. A desmopressin sublingual melt tablet (120 μg) was administered to 32 male piglets aged 8 days, 4 weeks, 7 weeks, and 6 months (each group n = 8)...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29443789/polymorphisms-of-drug-metabolizing-enzyme-cyp2e1-in-chinese-uygur-population
#8
Linhao Zhu, Yongjun He, Fanglin Niu, Mengdan Yan, Jing Li, Dongya Yuan, Tianbo Jin
Pharmacogenetics is the genetic basis of pharmacokinetics, genetic testing, and clinical management in diseases. Evaluation about genetic alterations of drug metabolizing enzymes in human genome contributes toward understanding the interindividual and interethnic variability for clinical response to potential toxicants. CYP2E1 gene encodes a drug-metabolizing enzyme that metabolizes mostly small, polar molecules, including toxic laboratory chemicals. The aim of this study was to investigate CYP2E1 polymorphisms and gene profile in a Chinese Uygur population...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29442148/population-pharmacokinetics-and-pharmacodynamics-of-ticagrelor-and-ar-c124910xx-in-chinese-healthy-male-subjects
#9
Shuaibing Liu, Ling Xue, Xiangfen Shi, Zhiyong Sun, Zhenfeng Zhu, Xiaojian Zhang, Xin Tian
BACKGROUND: Ticagrelor, the first reversible P2Y 12 receptor antagonist, exhibits faster onset and offset of antiplatelet effects and more consistent platelet inhibition than clopidogrel in both healthy subjects and patients with stable coronary artery disease. OBJECTIVE: The objectives of this study were to establish a population pharmacokinetics (PK) and pharmacodynamics (PD) model of ticagrelor and to provide a theoretical basis for the optimization of ticagrelor treatment in clinic...
February 13, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29442139/safety-profile-of-nivolumab-administered-as-30-min-infusion-analysis-of-data-from-checkmate-153
#10
David Waterhouse, Leora Horn, Craig Reynolds, David Spigel, Jason Chandler, Tarek Mekhail, Mohamed Mohamed, Ben Creelan, Kenneth B Blankstein, Petros Nikolinakos, Michael J McCleod, Ang Li, Abderrahim Oukessou, Shruti Agrawal, Nivedita Aanur
PURPOSE: Nivolumab has been administered using a 60-min infusion time. Reducing this time to 30 min would benefit both patients and infusion facilities. This analysis compared the safety of 30- and 60-min infusions of nivolumab in patients with previously treated advanced non-small cell lung cancer. METHODS: CheckMate 153 is an open-label, phase 3b/4, predominantly community-based study ongoing in the United States and Canada. Patients with stage IIIB/IV disease with progression/recurrence after at least one prior systemic therapy received nivolumab 3 mg/kg every 2 weeks over 30 or 60 min for 1 year or until disease progression...
February 13, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29442027/the-effect-of-slco1b1-polymorphism-on-the-pharmacokinetics-of-atorvastatin-and-2-hydroxyatorvastatin-in-healthy-chinese-people
#11
Yaqin Wang, Yingying Tian, Peiyu Lv, Lulu Chen, Wei Luo, Xian Jing, Hui Li, Zhirong Tan, Yicheng Wang, Honghao Zhou, Dong-Sheng Ouyang
The pharmacokinetics of statins show substantial inter-subject variability. Increasing systemic exposure of statins may lead to adverse drug reactions such as myopathy. The variation in statin pharmacokinetics is partly explained by genetic factors. OATP1B1, coded by SLCO1B1 transports a large number of therapeutic drugs, such as atorvastatin. Here we investigated the effect of SLCO1B1 polymorphism on the pharmacokinetics of atorvastatin and its metabolites. Two pharmacokinetic studies were conducted in Chinese Han volunteers and 132 volunteers were enrolled in our study as 72 in trial 1 and 60 in trial 2...
June 1, 2017: Die Pharmazie
https://www.readbyqxmd.com/read/29441439/pediatric-dose-selection-and-utility-of-pbpk-in-determining-dose
#12
Ian E Templeton, Nicholas S Jones, Luna Musib
Interest in determining safe and efficacious doses for drug administration in pediatric patients has increased dramatically in recent years. However, published pediatric clinical studies have failed to increase proportionally with adult clinical study publications. In order to assess the current state of pediatric dose determination and the supporting role of physiologically based pharmacokinetic modeling and simulation in determining pediatric dose, the pediatric clinical literature (2006-2016) and case examples of pediatric PBPK modeling efforts were reviewed...
February 13, 2018: AAPS Journal
https://www.readbyqxmd.com/read/29439603/semaglutide-in-type-2-diabetes-is-it-the-best-glucagon-like-peptide-1-receptor-agonist-glp-1r-agonist
#13
Sheila A Doggrell
Glucagon-like peptide-1 (GLP-1) is produced by the gut, and in a glucose-dependent manner stimulates insulin secretion while inhibiting glucagon secretion, reduces appetite and energy intake, and delays gastric emptying. The GLP-1R agonist semaglutide has recently been registered for use in the treatment of type 2 diabetes. Area covered: This review is of semaglutide in type 2 diabetes, and considers which properties of this GLP-1R agonist, may be responsible for its clinical outcome benefits in this condition...
February 13, 2018: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/29439084/evaluating-the-impact-of-type-2-diabetes-mellitus-on-cyp450-metabolic-activities-protocol-for-a-case-control-pharmacokinetic-study
#14
Sophie Gravel, Jean-Louis Chiasson, Suzanne Dallaire, Jacques Turgeon, Veronique Michaud
INTRODUCTION: Diabetes affects more than 9% of the adult population worldwide. Patients with type 2 diabetes mellitus (T2DM) show variable responses to some drugs which may be due, in part, to variability in the functional activity of drug-metabolising enzymes including cytochromes P450 (CYP450s). CYP450 is a superfamily of enzymes responsible for xenobiotic metabolism. Knowledge must be gained on the impact of T2DM and related inflammatory processes on drug metabolism and its consequences on drug response...
February 8, 2018: BMJ Open
https://www.readbyqxmd.com/read/29438998/hydroxychloroquine-a-physiologically-based-pharmacokinetic-model-in-the-context-of-cancer-related-autophagy-modulation
#15
Keagan P Collins, Kristen M Jackson, Daniel L Gustafson
Hydroxychloroquine (HCQ) is a lysosomotropic autophagy inhibitor being used in over 50 clinical trials either alone or in combination with chemotherapy. Pharmacokinetic (PK) and pharmacodynamic (PD) studies with HCQ have shown that drug exposure in the blood does not correlate with autophagy inhibition in either peripheral blood mononuclear cells (PBMCs) or tumor tissue. To better explain this PK/PD disconnect a physiologically-based pharmacokinetic model (PBPK) was developed for HCQ describing the tissue-specific absorption, distribution, metabolism, and excretion as well as lysosome-specific sequestration...
February 8, 2018: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/29436172/population-pharmacokinetic-pharmacodynamic-pk-pd-modeling-of-depot-testosterone-cypionate-in-healthy-male-subjects
#16
Youwei Bi, Paul J Perry, Michael Ellerby, Daryl J Murry
A randomized, double-blind clinical trial was conducted to investigate long-term abuse effects of testosterone cypionate. Thirty-one healthy males were randomized into a dose group of 100, 250 or 500mg/wk and received 14 weekly injections of TC. A PK-PD model was developed to characterize testosterone concentrations and link exposure to change in luteinizing hormone and spermatogenesis following long-term TC administration. A linear one-compartment model best described the concentration-time profile of total testosterone...
February 13, 2018: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29436076/mrna-expression-of-drug-metabolism-enzymes-and-transporter-genes-at-birth-using-human-umbilical-cord-blood
#17
Virginia Neyro, Valéry Elie, Yves Médard, Evelyne Jacqz-Aigrain
Growth and maturation changes are mainly responsible for differences in drug pharmacokinetics and pharmacodynamics observed between adults and children, especially neonates. Ontogeny of drug metabolizing enzymes and transporters play an important role in drugs inter-individual pharmacokinetic variability but data are limited in both term and preterm neonates. This study aimed to characterize mRNA expression of the main drug metabolizing enzymes and transport proteins involved in drug disposition, using umbilical cord blood (UCB), according to gender, gestational age and genetic background...
February 13, 2018: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29435949/a-pharmacokinetic-model-for-amiodarone-in-infants-developed-from-an-opportunistic-sampling-trial-and-published-literature-data
#18
Samantha H Dallefeld, Andrew M Atz, Ram Yogev, Janice E Sullivan, Amira Al-Uzri, Susan R Mendley, Matthew Laughon, Christoph P Hornik, Chiara Melloni, Barrie Harper, Andrew Lewandowski, Jeff Mitchell, Huali Wu, Thomas P Green, Michael Cohen-Wolkowiez
Amiodarone is a first-line antiarrhythmic for life-threatening ventricular fibrillation or ventricular tachycardia in children, yet little is known about its pharmacokinetics (PK) in this population. We developed a population PK (PopPK) model using samples collected via an opportunistic study design of children receiving amiodarone per standard of care supplemented by amiodarone PK data from the literature. Both study data and literature data were predominantly from infants < 2 years old, so our analysis was restricted to this group...
February 12, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29433307/role-of-hepatic-organic-anion-transporter-2-in-the-pharmacokinetics-of-r-and-s-warfarin-in-vitro-studies-and-mechanistic-evaluation
#19
Yi-An Bi, Jian Lin, Sumathy Mathialagan, Laurie Tylaska, Ernesto Callegari, A David Rodrigues, Manthena V S Varma
Inter-individual variability in warfarin dose requirement demands personalized medicine approaches to balance its therapeutic benefits (anticoagulation) and bleeding risk. Cytochrome P450 2C9 (CYP2C9) genotype-guided warfarin dosing is recommended in the clinic, given the more potent S-warfarin is primarily metabolized by CYP2C9. However, only about 20-30% of inter-patient variability in S-warfarin clearance is associated with CYP2C9 genotype. We evaluated the role of hepatic uptake in the clearance of R- and S-warfarin...
February 12, 2018: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29431542/obesity-and-drug-pharmacology-a-review-of-the-influence-of-obesity-on-pharmacokinetic-and-pharmacodynamic-parameters
#20
Cornelis Smit, Sjoerd De Hoogd, Roger J M Brüggemann, Catherijne A J Knibbe
The rising prevalence of obesity confronts clinicians with dosing problems in the (extreme) overweight population. Obesity has a great impact on key organs that play a role in the pharmacokinetics (PK) and pharmacodynamics (PD) of drugs, however the ultimate impact of these changes on how to adapt the dose may not always be known. Areas covered: In this review, physiological changes associated with obesity are discussed. An overview is provided on the alterations in absorption, distribution, drug metabolism and clearance in (morbid) obesity focusing on general principles that can be extracted from pharmacokinetic studies...
February 12, 2018: Expert Opinion on Drug Metabolism & Toxicology
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