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sex differences, pharmacokinetics

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https://www.readbyqxmd.com/read/28066880/population-pharmacokinetic-analysis-of-daclatasvir-in-subjects-with-chronic-hepatitis-c-virus-infection
#1
Phyllis Chan, Hanbin Li, Li Zhu, Marc Bifano, Timothy Eley, Mayu Osawa, Takayo Ueno, Eric Hughes, Richard Bertz, Tushar Garimella, Malaz AbuTarif
BACKGROUND AND OBJECTIVE: Daclatasvir is a potent, pangenotypic once-daily hepatitis C virus (HCV) NS5A inhibitor that is approved for the treatment of chronic HCV infection. The objective of this analysis was to characterize the pharmacokinetics of daclatasvir in subjects with chronic HCV infection. METHODS: A population pharmacokinetic (PPK) model was developed to evaluate effects of covariates on daclatasvir pharmacokinetics in subjects with chronic HCV infection (n = 2149 from 11 studies)...
January 9, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28031395/blood-brain-barrier-leakage-is-more-widespread-in-patients-with-cerebral-small-vessel-disease
#2
C Eleana Zhang, Sau May Wong, Harm J van de Haar, Julie Staals, Jacobus F A Jansen, Cécile R L P N Jeukens, Paul A M Hofman, Robert J van Oostenbrugge, Walter H Backes
OBJECTIVE: As blood-brain barrier (BBB) dysfunction may occur in normal aging but may also play a pivotal role in the pathophysiology of cerebral small vessel disease (cSVD), we used dynamic contrast-enhanced (DCE)-MRI to quantify the rate and the spatial extent of BBB leakage in patients with cSVD and age- and sex-matched controls to discern cSVD-related BBB leakage from aging-related leakage. METHODS: We performed structural brain MRI and DCE-MRI in 80 patients with clinically overt cSVD and 40 age- and sex-matched controls...
December 28, 2016: Neurology
https://www.readbyqxmd.com/read/28003052/population-pharmacokinetic-pharmacodynamic-analysis-to-compare-the-effect-of-moxifloxacin-on-qt-interval-prolongation-between-healthy-korean-and-japanese-subjects
#3
Hyang-Ki Choi, Jin Ah Jung, Tomoe Fujita, Hideki Amano, Jong-Lyul Ghim, Dong-Hwan Lee, Kenichi Tabata, Il-Dae Song, Mika Maeda, Yuji Kumagai, Boaz Mendzelevski, Jae-Gook Shin
PURPOSE: The goal of this study was to evaluate the moxifloxacin-induced QT interval prolongation in healthy male and female Korean and Japanese volunteers to investigate interethnic differences. METHODS: This multicenter, randomized, double-blind, placebo-controlled, 2-way crossover study was conducted in healthy male and female Korean and Japanese volunteers. In each period, a single dose of moxifloxacin or placebo 400 mg was administered orally under fasting conditions...
December 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/28000102/translational-modeling-and-simulation-in-supporting-early-phase-clinical-development-of-new-drug-a-learn-research-confirm-process
#4
Dongyang Liu, Yi Zhang, Ji Jiang, John Choi, Xuening Li, Dalong Zhu, Dawei Xiao, Yanhua Ding, Hongwei Fan, Li Chen, Pei Hu
BACKGROUND AND OBJECTIVE: Pharmacokinetic/pharmacodynamic modeling and simulation can aid clinical drug development by dynamically integrating key system- and drug-specific information into predictive profiles. In this study, we propose a methodology to predict pharmacokinetic/pharmacodynamic profiles of sinogliatin (HMS-5552, RO-5305552), a novel glucokinase activator to treat diabetes mellitus, for first-in-patient (FIP) studies. METHODS AND RESULTS: Initially, pharmacokinetic/pharmacodynamic profiles of sinogliatin and another glucokinase activator (US2) previously acquired from healthy subjects were fitted using Model A incorporating an indirect response mechanism...
December 20, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27915987/sex-differences-in-alcohol-use-disorder
#5
Roberta Agabio, Claudia Pisanu, Gian Luigi Gessa, Flavia Franconi
BACKGROUND: Alcohol use disorder (AUD) is a common and disabling mental disorder associated with a significant burden of medical consequences and high socioeconomic costs. Although a growing number of studies support the existence of sex differences in several aspects of alcohol consumption and AUD, the majority of investigations have been conducted in men. OBJECTIVE: This article was aimed at reviewing sex differences in AUD, focusing on epidemiology, neurobiology, pharmacokinetics, susceptibility to medical consequences, and treatment...
December 1, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27825374/low-heritability-in-pharmacokinetics-of-talinolol-a-pharmacogenetic-twin-study-on-the-heritability-of-the-pharmacokinetics-of-talinolol-a-putative-probe-drug-of-mdr1-and-other-membrane-transporters
#6
Johannes Matthaei, Mladen V Tzvetkov, Valerie Gal, Cordula Sachse-Seeboth, Daniel Sehrt, Jakob B Hjelmborg, Ute Hofmann, Matthias Schwab, Reinhold Kerb, Jürgen Brockmöller
BACKGROUND: Efflux transporters like MDR1 and MRP2 may modulate the pharmacokinetics of about 50 % of all drugs. It is currently unknown how much of the variation in the activities of important drug membrane transporters like MDR1 or MRP2 is determined by genetic or by environmental factors. In this study we assessed the heritability of the pharmacokinetics of talinolol as a putative probe drug for MDR1 and possibly other membrane transporters. METHODS: Talinolol pharmacokinetics were investigated in a repeated dose study in 42 monozygotic and 13 same-sex dizygotic twin pairs...
November 8, 2016: Genome Medicine
https://www.readbyqxmd.com/read/27804874/a-focused-review-of-gender-differences-in-antithrombotic-therapy
#7
Andrea Salzano, Pablo Demelo-Rodriguez, Alberto Maria Marra, Marco Proietti
BACKGROUND: The biological differences among male and female, based on distinctive expression of sex chromosomes, on varied gene-expression and on peculiar sexual hormones, lead to important differences in physiology and pathophysiology. OBJECTIVE: The aim of this work was to briefly review the relationships among gender-related differences and clinical implications in antithrombotic therapy, that could be related to sex-differences in platelet biology and coagulation reactions...
October 29, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27785404/the-influence-of-cyp2c8-3-on-carbamazepine-serum-concentration-in-epileptic-pediatric-patients
#8
D D Milovanovic, J R Milovanovic, M Radovanovic, I Radosavljevic, S Obradovic, S Jankovic, D Milovanovic, N Djordjevic
The aim of the present study was to investigate the distribution of CYP2C8 variants *3 and *5, as well as their effect on carbamazepine pharmacokinetic properties, in 40 epileptic pediatric patients on carbamazepine treatment. Genotyping was conducted using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), and allele-specific (AS)-PCR methods, and steady-state carbamazepine plasma concentrations were determined by high performance liquid chromatography (HPLC). The CYP2C8 *3 and *5 polymorphisms were found at frequencies of 17...
July 1, 2016: Balkan Journal of Medical Genetics: BJMG
https://www.readbyqxmd.com/read/27774892/atazanavir-plus-cobicistat-week-48-and-week-144-subgroup-analyses-of-a-phase-3-randomized-double-blind-active-controlled-trial
#9
Joel E Gallant, Graeme Moyle, Juan Berenguer, Peter Shalit, Huyen Cao, Ya-Pei Liu, Joel Myers, Lisa Rosenblatt, Lingfeng Yang, Javier Szwarcberg
OBJECTIVES: Cobicistat (COBI) enhances atazanavir (ATV) pharmacokinetic parameters similarly to ritonavir (RTV) in both healthy volunteers and HIV-infected adults. Primary efficacy and safety outcomes of this Phase 3, international, randomized, double-blind, double-dummy, active-controlled trial in HIV-1-infected treatment-naïve adults (GS-US-216-0114/NCT01108510) demonstrated that ATV+COBI was non-inferior to ATV+RTV, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), at Weeks 48 and 144, with high rates of virologic success for both regimens (85...
October 21, 2016: Current HIV Research
https://www.readbyqxmd.com/read/27743205/population-pharmacokinetics-of-a-novel-once-every-3-months-intramuscular-formulation-of-paliperidone-palmitate-in-patients-with-schizophrenia
#10
Mats O Magnusson, Mahesh N Samtani, Elodie L Plan, E Niclas Jonsson, Stefaan Rossenu, An Vermeulen, Alberto Russu
OBJECTIVES: Our objective was to characterize the population pharmacokinetics of paliperidone after intramuscular administration of its long-acting 3-month formulation palmitate ester at various doses and at different injection sites (deltoid and gluteal muscles). METHODS: This retrospective analysis included pooled data from 651 subjects from one phase I study (single injection of the 3-month formulation) and one phase III study (multiple injections of both 1- and 3-month formulations)...
October 14, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27727157/brief-report-pharmacokinetic-pharmacodynamic-investigation-of-single-dose-oral-maraviroc-in-the-context-of-hiv-1-pre-exposure-prophylaxis
#11
Julie Fox, Juan M Tiraboschi, Carolina Herrera, Laura Else, Deirdre Egan, Laura Dickinson, Akil Jackson, Natalia Olejniczak, David Back, Saye Khoo, Robin Shattock, Marta Boffito
To investigate the pharmacokinetics/pharmacodynamics of single-dose maraviroc 300 mg in HIV-1 exposure compartments. Maraviroc concentrations in blood, secretions (vaginal, urethral, oral, and rectal), and tissue (vaginal and rectal) were measured, and ex vivo challenge was performed in 54 healthy volunteers to study protection from HIV infection. Maraviroc Cmax occurred within 4 hours in most compartments. Concentrations from 4 to 72 hours were above intracellular (IC) IC90 in all compartments, range 15-8095 ng/mL...
November 1, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/27697075/sex-impact-on-biomarkers-pharmacokinetics-and-pharmacodynamics
#12
Flavia Franconi, Ilaria Campesi
Sex is one of several factors influencing pharmacological responses, but research on its effects on pharmacokinetics and pharmacodynamics, although emerging remarkably, remains poor and contains many methodological issues. In this review, the current state of knowledge about sex differences in pharmacokinetics and some hints to pharmacogenomics were evaluated. Moreover, considering that many pharmacological responses are monitored through biomarkers, the influence of sex on some biomarkers has been reported...
October 3, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27684290/evaluation-of-the-relationship-between-pharmacokinetics-and-the-safety-of-aripiprazole-and-its-cardiovascular-effects-in-healthy-volunteers
#13
Carmen Belmonte, Dolores Ochoa, Manuel Román, Teresa Cabaleiro, Maria Talegón, Sergio Daniel Sánchez-Rojas, Francisco Abad-Santos
AIMS: The aim of this study was the evaluation of the possible relationship between pharmacokinetics and the safety of aripiprazole as well as its influence on blood pressure (BP), heart rate (HR), and corrected QT (QTc) interval. METHODS: The study population comprised 157 healthy volunteers from 6 bioequivalence clinical trials. Subjects were administered a single 10-mg oral dose of each formulation separated by a 28-day washout period. Plasma concentrations were measured using high-performance liquid chromatography coupled to mass spectrometry...
December 2016: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/27647273/physiologically-based-pharmacokinetic-models-approaches-for-enabling-personalized-medicine
#14
REVIEW
Clara Hartmanshenn, Megerle Scherholz, Ioannis P Androulakis
Personalized medicine strives to deliver the 'right drug at the right dose' by considering inter-person variability, one of the causes for therapeutic failure in specialized populations of patients. Physiologically-based pharmacokinetic (PBPK) modeling is a key tool in the advancement of personalized medicine to evaluate complex clinical scenarios, making use of physiological information as well as physicochemical data to simulate various physiological states to predict the distribution of pharmacokinetic responses...
October 2016: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/27627193/effects-of-age-sex-and-obesity-on-the-single-dose-pharmacokinetics-of-omarigliptin-in-healthy-subjects
#15
Carol Addy, Daniel A Tatosian, Xiaoli S Glasgow, Isaias Noel Gendrano Iii, Christine McCrary Sisk, Eunkyung A Kauh, S Aubrey Stoch, John A Wagner
Omarigliptin is being developed as a potent, once-weekly, oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. This double-blind, randomized, placebo-controlled study evaluated the effects of age, sex, and obesity on the pharmacokinetics of omarigliptin in healthy subjects. A single oral dose of omarigliptin 10 mg (n = 6/panel) or placebo (n = 2/panel) was administered in the fasted state to elderly nonobese men and women, young obese (30 ≤ body mass index [BMI] ≤ 35 kg/m(2) ) men and women, and young nonobese women of nonchildbearing potential...
September 2016: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27621672/the-effect-of-weight-body-mass-index-age-sex-and-race-on-plasma-concentrations-of-subcutaneous-sumatriptan-a-pooled-analysis
#16
Sagar Munjal, Anirudh Gautam, Alan M Rapoport, Dennis M Fisher
OBJECTIVE/BACKGROUND: Factors such as body size (weight and body mass index [BMI]), age, sex, and race might influence the clinical response to sumatriptan. We evaluated the impact of these covariates on the plasma concentration (Cp) profile of sumatriptan administered subcutaneously. METHODS: We conducted three pharmacokinetic studies of subcutaneous sumatriptan in 98 healthy adults. Sumatriptan was administered subcutaneously (236 administrations) as either DFN-11 3 mg, a novel 0...
2016: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/27574509/alcohol-and-aldehyde-dehydrogenases-contribute-to-sex-related-differences-in-clearance-of-zolpidem-in-rats
#17
Cody J Peer, Jonathan D Strope, Shaunna Beedie, Ariel M Ley, Alesia Holly, Karim Calis, Ronald Farkas, Jagan Parepally, Angela Men, Emmanuel O Fadiran, Pamela Scott, Marjorie Jenkins, William H Theodore, Tristan M Sissung
OBJECTIVES: The recommended zolpidem starting dose was lowered in females (5 mg vs. 10 mg) since side effects were more frequent and severe than those of males; the mechanism underlying sex differences in pharmacokinetics (PK) is unknown. We hypothesized that such differences were caused by known sex-related variability in alcohol dehydrogenase (ADH) expression. METHODS: Male, female, and castrated male rats were administered 2.6 mg/kg zolpidem, ± disulfiram (ADH/ALDH pathway inhibitor) to compare PK changes induced by sex and gonadal hormones...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27554088/pharmacokinetic-properties-of-intravenous-ibuprofen-in-healthy-chinese-volunteers
#18
RANDOMIZED CONTROLLED TRIAL
Yali Shen, Feng Nan, Mei Li, Maozhi Liang, Ying Wang, Zhihui Chen, Zhu Luo
BACKGROUND AND OBJECTIVES: No pharmacokinetic data of intravenous ibuprofen were available in a Chinese population and the published information remained inadequate. The present study aimed to investigate the pharmacokinetic properties of intravenous ibuprofen in healthy Chinese volunteers after single- and multiple-dose administration. METHODS: Twelve subjects received single doses of 200, 400, and 800 mg intravenous ibuprofen, respectively, and multiple doses of 400 mg intravenous ibuprofen, four times per day (every 6 h) till the morning of the sixth day in each study period...
December 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27503578/population-differences-in-s-warfarin-pharmacokinetics-among-african-americans-asians-and-whites-their-influence-on-pharmacogenetic-dosing-algorithms
#19
K Kubo, M Ohara, M Tachikawa, L H Cavallari, M T M Lee, M S Wen, M G Scordo, E A Nutescu, M A Perera, A Miyajima, N Kaneko, V Pengo, R Padrini, Y T Chen, H Takahashi
Using population pharmacokinetic analysis (PPK), we attempted to identify predictors of S-warfarin clearance (CL(S)) and to clarify population differences in S-warfarin pharmacokinetics among a cohort of 378 African American, Asian and white patients. Significant predictors of CL(S) included clinical (age, body weight and sex) and genotypic (CYP2C9*2,*3 and *8) factors, as well as African American ethnicity, the median CL(S) being 30% lower in the latter than in Asians and whites (170 versus 243 and 250 ml h(-1), P<0...
August 9, 2016: Pharmacogenomics Journal
https://www.readbyqxmd.com/read/27467032/-pharmacokinetic-and-pharmacodynamic-effects-of-psychotropic-medications-differences-between-sexes
#20
J D Bergiannaki, P Kostaras
The gender based or gender sensitive pharmacology is a new research area. Differences among sexes are observed in several parameters of their pharmacokinetic which may relate to alteration of their pharmacodynamic as well. Most psychotropics are given per os, and the greater part of their absorption takes place in the small intestine. Premenopausal women have slower gastric emptying times and lower gastrointestinal blood flow which probably reduces the extent of drug absorption. The distribution of drugs is influenced by the relative lower body mass index, the lower blood volume and flow and the greater percentage of body fat of women...
April 2016: Psychiatrikē, Psychiatriki
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