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sex differences, pharmacokinetics

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https://www.readbyqxmd.com/read/28179816/sex-differences-in-the-psychopharmacological-treatment-of-depression
#1
John J Sramek, Michael F Murphy, Neal R Cutler
Although a number of studies have observed that females respond better to serotonergic antidepressants than males and that postmenopausal females have a diminished response to antidepressants compared with younger females, there are also studies that conflict with both of these findings, making any generalizations regarding sex differences difficult to make. Sex variance in antidepressant efficacy and pharmacokinetics profiles have been attributed to sex-based physiological differences, behavioral differences, related disorders, and sex-specific conditions, including pregnancy and menopause...
December 2016: Dialogues in Clinical Neuroscience
https://www.readbyqxmd.com/read/28167552/pharmacokinetic-of-benznidazole-in-healthy-volunteers-implications-in-future-clinical-trials
#2
I Molina, F Salvador, A Sánchez-Montalvá, M A Artaza, R Moreno, L Perin, A Esquisabel, L Pinto, J L Pedraz
BACKGROUND: Despite its toxicity and low efficacy in the chronic phase, benznidazole is the drug of choice in Chagas disease. Scarce information about pharmacokinetics and pharmacodynamics of benznidazole has been published. METHODS: We performed a phase I, open-label, non-randomized pharmacokinetic study of benznidazole (Abarax®) conducted in 8 healthy adult volunteers at the Infectious Diseases Department of the Vall d'Hebron University Hospital (Barcelona, Spain)...
February 6, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28159880/en-route-to-precision-medicine-through-the-integration-of-biological-sex-into-pharmacogenomics
#3
REVIEW
Lea Gaignebet, Georgios Kararigas
Frequently, pharmacomechanisms are not fully elucidated. Therefore, drug use is linked to an elevated interindividual diversity of effects, whether therapeutic or adverse, and the role of biological sex has as yet unrecognized and underestimated consequences. A pharmacogenomic approach could contribute towards the development of an adapted therapy for each male and female patient, considering also other fundamental features, such as age and ethnicity. This would represent a crucial step towards precision medicine and could be translated into clinical routine...
February 1, 2017: Clinical Science (1979-)
https://www.readbyqxmd.com/read/28159657/dose-optimisation-of-voriconazole-with-therapeutic-drug-monitoring-in-children-a-single-centre-experience-in-china
#4
Liang Liu, Xing Zhou, Tingting Wu, Hongliang Jiang, Sitao Yang, Yang Zhang
The pharmacokinetic profile of voriconazole is highly variable, rendering inconsistent and/or inadequate dosing, especially in children <2 years old. A retrospective analysis was performed in children receiving voriconazole with at least one plasma trough level (Ctrough) monitored. Statistical analyses were performed to examine the dose-exposure relationship as well as other factors potentially affecting voriconazole Ctrough in children of different ages. A total of 107 paediatric patients were included, of whom 75 were <2 years old...
January 31, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28139972/population-pharmacokinetics-of-ticagrelor-and-ar-c124910xx-in-patients-with-prior-myocardial-infarction%C3%A2
#5
Daniel Röshammar, Martin Bergstrand, Tomas Andersson, Robert F Storey, Bengt Hamrén
OBJECTIVE: The population pharmacokinetics of ticagrelor and its active metabolite AR-C124910XX were characterized following ticagrelor 60 mg or 90 mg twice daily oral long-term treatment in 4,426 patients with a history of myocardial infarction. METHODS: The ticagrelor and AR-C124910XX plasma concentration-time data were described by one-compartment models with first-order absorption or metabolite formation and elimination. RESULTS: Systemic exposure to ticagrelor and AR-C124910XX were stable over time...
January 30, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28137817/pharmacokinetics-of-the-novel-echinocandin-cd101-in-multiple-animal-species
#6
Voon Ong, Kenneth D James, Steven Smith, B Radha Krishnan
CD101 is a novel semi-synthetic echinocandin with antifungal activity against Candida and Aspergillus spp. The PK of CD101 administered intravenously to mice, rats, dogs, cynomolgus monkeys, and chimpanzees are presented. CD101 consistently exhibited very low clearance, modest volume of distribution, and long half-life across all species tested. In mouse, rat, dog, cynomolgus monkey, and chimpanzee, CD101 clearance [mL/min/kg] was 0.10, 0.47, 0.30, 0.41, and 0.06; Vss [mL/kg] was 206, 1390, not determined, 597, and 400; and t1/2 [h] was 25, 39, 53, 40, and 81, respectively...
January 30, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28133772/pharmacokinetics-safety-tolerability-and-immunogenicity-of-fkb327-a-new-biosimilar-medicine-of-adalimumab-humira-in-healthy-subjects
#7
Adeep Puri, Andrew Niewiarowski, Yasumasa Arai, Hideaki Nomura, Mark Baird, Isobel Dalrymple, Steve Warrington, Malcolm Boyce
AIMS: to compare the pharmacokinetics, safety, tolerability, and immunogenicity of FKB327, a biosimilar of adalimumab, with European Union (EU)-approved Humira and United States (US)-licensed Humira after single subcutaneous doses in healthy subjects. METHODS: in a randomised, double-blind, parallel-group study, 180 healthy subjects received by subcutaneous injection 40 mg of EU-Humira, or US-Humira, or FKB327, in a 1:1:1 ratio, stratified by bodyweight. Pharmacokinetics, local tolerability, immunogenicity, adverse events, vital signs, ECG, and laboratory safety tests were assessed before and up to 1536 h after treatment...
January 30, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28127624/oxycodone-self-administration-in-male-and-female-rats
#8
Maria Mavrikaki, Marco Pravetoni, Sarah Page, David Potter, Elena Chartoff
RATIONALE: Oxycodone is one of the most widely prescribed painkillers in the USA. However, its use is complicated by high abuse potential. As sex differences have been described in drug addiction, the present study tested for sex differences in intravenous oxycodone self-administration in rats. METHODS: Male and female Sprague-Dawley rats were implanted with jugular vein catheters and trained to self-administer oxycodone (0.03 mg/kg/infusion) under fixed ratio 1 (FR1), FR2, and FR5 schedules of reinforcement followed by a dose-response study to assess sensitivity to the reinforcing effects of oxycodone...
January 27, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28066880/population-pharmacokinetic-analysis-of-daclatasvir-in-subjects-with-chronic-hepatitis-c-virus-infection
#9
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
#10
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...
January 31, 2017: 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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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