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sex differences, pharmacokinetics

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https://www.readbyqxmd.com/read/29119932/relevance-of-cyp2c9-function-in-valproate-therapy
#1
Katalin Monostory, Andrea Nagy, Katalin Toth, Tamas Budi, Adam Kiss, Mate Deri, Gabor Csukly
Genetic polymorphisms of drug metabolizing enzymes can substantially modify the pharmacokinetics of a drug and eventually its efficacy or toxicity; however, inferring a patient's drug metabolizing capacity merely from his or her genotype can lead to false prediction. Non-genetic host factors (age, sex, disease states) and environmental factors (nutrition, co-medication) can transiently alter the enzyme expression and activities resulting in genotype-phenotype mismatch. Although valproic acid is a well-tolerated anticonvulsant, pediatric patients are particularly vulnerable to valproate injury that can be partly attributed to the age-related differences in metabolic pathways...
November 9, 2017: Current Neuropharmacology
https://www.readbyqxmd.com/read/29118712/comparative-long-term-effect-of-three-anti-p2y12-drugs-after-percutaneous-angioplasty-an-observational-study-based-on-electronic-drug-adherence-monitoring
#2
Valentina Forni Ogna, Isabelle Bassi, Isabelle Menetrey, Olivier Muller, Eric Tousset, Pierre Fontana, Eric Eeckhout, Chin B Eap, Bernard Vrijens, Michel Burnier, Grégoire Wuerzner
Aims: Dual platelet inhibition using anti-P2Y12 drugs and aspirin is the standard of care in patients after percutaneous coronary interventions (PCI). Prasugrel and ticagrelor have been shown to be more potent than clopidogrel with less high on-treatment platelet reactivity. Whether differences in long-term adherence to these drugs can partly explain different antiplatelet efficacy has not been studied so far. The objective was to compare the long-term P2Y12 receptor inhibition and drug adherence to different anti-P2Y12 drugs, and to assess the impact of adherence on the pharmacodynamic effect...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29106053/population-pharmacokinetics-of-fosdagrocorat-pf-04171327-a-dissociated-glucocorticoid-receptor-agonist-in-patients-with-rheumatoid-arthritis
#3
Barry Weatherley, Lynn McFadyen, Brinda Tammara
Dissociated agonists of the glucocorticoid receptor (DAGRs) show similar antiinflammatory effects but improved tolerability compared with standard glucocorticoid receptor (GR) agonists. The prodrug fosdagrocorat (PF-04171327), with active DAGR metabolite PF-00251802 (Metabolite-1), is postulated to show superior efficacy over placebo and prednisone in patients with moderate to severe rheumatoid arthritis (RA). We investigated the population pharmacokinetics of active Metabolite-1 and its active metabolite PF-04015475 (Metabolite-2) in patients with moderate to severe RA enrolled in a 12-week, phase II, randomized, double-blind study (NCT01393639)...
November 4, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29046147/neonatal-pain-still-searching-for-the-optimal-approach
#4
Elizabeth Walter-Nicolet, Laurent Calvel, Geraldine Gazzo, Pierrick Poisbeau, Pierre Kuhn
BACKGROUND: although neonatal pain management has seen huge improvements in the past years, many gaps between knowledge and practice still exist. OBJECTIVE: to give the reader the state of the art of actual pain management and treatment. METHODS: a literature review was done on the physiopathology of pain, sex differences in the perception of pain, epidemiology, non-pharmacological treatment and developmental care approach, pharmacological treatment with pharmacokinetics and pharmacodynamics approaches...
October 17, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29040230/serum-concentrations-of-paliperidone-after-administration-of-the-long-acting-injectable-formulation
#5
Arne Helland, Olav Spigset
BACKGROUND: The pharmacokinetics of long-acting intramuscular paliperidone in a naturalistic setting is not well documented. The objective of this study was to investigate the relationship between dose and serum concentrations of paliperidone using data from a routine therapeutic drug monitoring service. METHODS: Serum concentration measurements in 310 samples from 110 male and 75 female patients receiving depot injections of paliperidone were retrospectively retrieved from the therapeutic drug monitoring database...
December 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29037750/environmental-toxicology-and-omics-a-question-of-sex
#6
Xuefang Liang, April Feswick, Denina Simmons, Christopher J Martyniuk
Molecular initiating events and downstream transcriptional/proteomic responses provide valuable information for adverse outcome pathways, which can be used predict the effects of chemicals on physiological systems. There has been a paucity of research that addresses sex-specific expression profiling in toxicology and due to cost, time, and logistical considerations, sex as a variable has not been widely considered. In response to this deficiency, federal agencies in the United States, Canada, and Europe have highlighted the importance of including sex as a variable in scientific investigations...
October 13, 2017: Journal of Proteomics
https://www.readbyqxmd.com/read/28990173/optimization-of-rituximab-for-the-treatment-of-dlbcl-increasing-the-dose-for-elderly-male-patients
#7
RANDOMIZED CONTROLLED TRIAL
Michael Pfreundschuh, Niels Murawski, Samira Zeynalova, Marita Ziepert, M Loeffler, Matthias Hänel, Judith Dierlamm, Ulrich Keller, Martin Dreyling, Lorenz Truemper, Norbert Frickhofen, Ali-Nuri Hünerlitürkoglu, Norbert Schmitz, Viola Pöschel, Tanja Rixecker, Christian Berdel, Christian Rübe, Gerhard Held, Carsten Zwick
Male sex is associated with unfavourable pharmacokinetics and prognosis in elderly patients with diffuse large B-cell lymphoma (DLBCL). We investigated higher rituximab doses for elderly male DLBCL patients. Elderly patients (61-80 years) received 6 cycles CHOP-14 (cyclophosphamide, doxorubicin, vincristine and prednisone at 14-day intervals) and were randomized to 8 cycles rituximab (males 500 mg/m(2) , females 375 mg/m(2) ) every 2 weeks or according to an upfront dose-dense schedule. In 268 (120 females, 148 males) no difference between the standard and the upfront dose-dense rituximab schedule was found (3-year PFS 72% vs...
November 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28985032/organ-on-a-chip-systems-for-women-s-health-applications
#8
REVIEW
Janna Nawroth, Julia Rogal, Martin Weiss, Sara Y Brucker, Peter Loskill
Biomedical research, for a long time, has paid little attention to the influence of sex in many areas of study, ranging from molecular and cellular biology to animal models and clinical studies on human subjects. Many studies solely rely on male cells/tissues/animals/humans, although there are profound differences in male and female physiology, which can significantly impact disease mechanisms, toxicity of compounds, and efficacy of pharmaceuticals. In vitro systems have been traditionally very limited in their capacity to recapitulate female-specific physiology and anatomy such as dynamic sex-hormone levels and the complex interdependencies of female reproductive tract organs...
October 6, 2017: Advanced Healthcare Materials
https://www.readbyqxmd.com/read/28979299/physicochemical-stress-degradation-evaluation-and-pharmacokinetic-study-of-azgh102-a-new-synthesized-cox2-inhibitors-after-i-v-and-oral-administration-in-male-and-female-rats
#9
Hoda Bahmanof, Simin Dadashzadeh, Afshin Zarghi, Alireza Shafaati, Seyed Mohsen Foroutan
Coxibs such as celecoxib, rofecoxib, and valdecoxib are introduced as selective COX-2 inhibitors to the market. It has been reported that inhibition of COX-2 beside traditional effects of NSAIDs, reduces the risk of colorectal, breast and lung cancers and also slow the progress of Alzheimer's disease. Zarghi et al. reported 8-benzoyl-2-(4-(methylsulfonyl)phenyl)quinoline-4-carboxylic acid (AZGH 102) as a novel compound with similar IC50 to celecoxib besides improved selectivity index (COX-1/COX-2 inhibitory potency) in comparison with celecoxib...
2017: Iranian Journal of Pharmaceutical Research: IJPR
https://www.readbyqxmd.com/read/28955238/food-and-sex-related-impacts-on-the-pharmacokinetics-of-a-single-dose-of-ginsenoside-compound-k-in-healthy-subjects
#10
Lulu Chen, Luping Zhou, Yaqin Wang, Guoping Yang, Jie Huang, Zhirong Tan, Yicheng Wang, Gan Zhou, Jianwei Liao, Dongsheng Ouyang
Background and Objectives: Ginsenoside compound K (CK) is a candidate drug for rheumatoid arthritis therapy. This clinical trial was designed to evaluate the effects of food and sex on the pharmacokinetics of CK and its metabolite 20(S)-protopanaxadiol (PPD). Methods: An open-label, single-center, two-period crossover trial was performed in healthy Chinese subjects (n = 24; male = 12, female = 12), randomized to either the fasting overnight or the high-fat meal group before a single 200 mg dose of monomer CK was administered...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28945481/long-term-influence-of-cyp3a5-cyp3a4-abcb1-and-nr1i2-polymorphisms-on-tacrolimus-concentration-in-chinese-renal-transplant-recipients
#11
Fei Liu, Yang-Meng Ou, Ai-Rong Yu, Lei Xiong, Hua-Wen Xin
BACKGROUND: The highly pharmacokinetic variability of tacrolimus makes it difficult to adjust the dose. In the current study, we investigated the influence of gene polymorphisms and other clinical factors on long-term tacrolimus dosing in Chinese renal transplant recipients. METHODS: A total of 276 renal transplant recipients were enrolled. The tacrolimus trough concentration and other clinical variables were recorded for 5 years following transplantation. Eight single nucleotide polymorphisms in four genes (CYP3A5, CYP3A4, ABCB1, and NR1I2) were genotyped using polymerase chain reaction-restriction fragment length polymorphism analysis and sequencing...
September 25, 2017: Genetic Testing and Molecular Biomarkers
https://www.readbyqxmd.com/read/28941196/pharmacokinetics-safety-and-tolerability-of-vortioxetine-following-single-and-multiple-dose-administration-in-healthy-japanese-adults
#12
Kumi Matsuno, Koki Nakamura, Yutaka Aritomi, Akira Nishimura
Three phase 1 randomized single-center studies assessed the pharmacokinetics, safety, and tolerability of vortioxetine after single- and multiple-dose administration in healthy Japanese adults. Study 1 assessed the pharmacokinetics of vortioxetine after administration of single rising doses to men and multiple doses to men and women; study 2 evaluated vortioxetine pharmacokinetics in elderly adults; and study 3 assessed food effects on vortioxetine pharmacokinetics in healthy men. The primary end points included pharmacokinetic parameters of vortioxetine and incidence of adverse events (AEs)...
September 21, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28872908/pharmacokinetic-profile-of-edaravone-a-comparison-between-japanese-and-caucasian-populations
#13
Yoshinobu Nakamaru, Shuji Kinoshita, Atsuhiro Kawaguchi, Koji Takei, Joseph Palumbo, Masayuki Suzuki
BACKGROUND: Amyotrophic lateral sclerosis (ALS) affects persons of all races, and there continues to be a need for effective therapies to treat the disease. OBJECTIVE: To compare the pharmacokinetics (PK) of edaravone between Japanese and Caucasian populations. METHODS: Data from five PK studies among Japanese and Caucasian healthy volunteers were pooled and evaluated. In population PK (PPK) modelling, compartment models and other models with linear elimination were evaluated for appropriateness...
October 2017: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
https://www.readbyqxmd.com/read/28844011/the-pharmacokinetics-of-racemic-mdpv-and-its-r-and-s-enantiomers-in-female-and-male-rats
#14
Michael D Hambuchen, Howard P Hendrickson, Melinda G Gunnell, Samantha J McClenahan, Laura E Ewing, Dillon M Gibson, Michael D Berquist, S Michael Owens
BACKGROUND: These studies investigated the serum pharmacokinetic (PK) profile of racemic (3,4)-methylenedioxypyrovalerone [(R,S)-MDPV)] and its (R)- and (S)-enantiomers in female and male Sprague Dawley rats. METHODS: Intravenous (R,S)-MDPV (3 and 5.6mg/kg) and single enantiomer of (R)- and (S)-MDPV (1.5mg/kg) were administered to both sexes for PK studies. Intraperitoneal (ip) bioavailability was determined at 3mg/kg (R,S)-MDPV. Locomotor activity studies were conducted after ip treatment with saline and 0...
October 1, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28838299/peculiarities-of-feline-hyperadrenocorticism-update-on-diagnosis-and-treatment
#15
Lara A Boland, Vanessa R Barrs
Practical relevance: Hyperadrenocorticism (HAC) is a relatively uncommon endocrinopathy of older cats, with a mean age at diagnosis of 10 years. In addition to pituitary-dependent and adrenal-dependent hypercortisolism, clinical signs of HAC can result from adrenal sex steroid-producing tumours. Clinical challenges: While HAC in cats has many similarities to canine HAC, there are key differences in presentation, diagnosis and response to therapy. Most, but not all, cats with HAC have concurrent diabetes mellitus, which is often insulin resistant...
September 2017: Journal of Feline Medicine and Surgery
https://www.readbyqxmd.com/read/28815798/infant-spinal-anesthesia-do-girls-need-a-larger-dose-of-local-anesthetic
#16
Geoff Frawley, Md Hamidul Huque
BACKGROUND: Gender differences in absorption, distribution, and metabolism of a number of anesthetic agents have been identified in adults. Clinically, adult studies suggest women demonstrate slower onset of opioid analgesic effects, lower spinal and epidural dose requirements, and greater sensitivity to neuromuscular blocking agents. Sex-related differences in the pharmacokinetics and pharmacodynamics of local anesthetics in neonates and infants, however, have not been well documented...
October 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28719359/levodopa-in-parkinson-s-disease-a-review-of-population-pharmacokinetics-pharmacodynamics-analysis
#17
Amélie Marsot, Romain Guilhaumou, Jean Philippe Azulay, Olivier Blin
BACKGROUND: Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease. Although levodopa remains the single effective agent in the management of Parkinson's disease, the accurate determination of this optimal dosage is complicated by marked between-subject and between-occasion variability in this population.  This review presents a synthesis of the population pharmacokinetic and pharmacodynamic models of levodopa described in Parkinson's disease...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28644086/single-dose-pharmacokinetics-of-piperacillin-tazobactam-in-hispaniolan-amazon-parrots-amazona-ventralis
#18
James W Carpenter, Thomas N Tully, Ronette Gehring, David Sanchez-Migallon Guzman
To determine the pharmacokinetics of piperacillin/tazobactam in Hispaniolan Amazon parrots ( Amazona ventralis ), 8 healthy adult parrots of both sexes were used in a 2-part study. In a pilot study, piperacillin (87 mg/kg) in combination with tazobactam (11 mg/kg) was administered intramuscularly (IM) to 2 birds, and blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours after administration. Based on the results obtained, a main study was done in which piperacillin/tazobactam was administered at 2 different doses...
June 2017: Journal of Avian Medicine and Surgery
https://www.readbyqxmd.com/read/28561693/age-and-sex-in-non-hodgkin-lymphoma-therapy-it-s-not-all-created-equal-or-is-it
#19
Michael Pfreundschuh
Age is the most prominent factor for survival in all patients diagnosed with lymphoma, and male sex implies an increased and independent risk for a worse progression-free survival (PFS) and overall survival (OS) in most lymphomas, possibly with the exception of mantle cell lymphoma (MCL). The worse outcome for elderly patients is only partially explained by decreased tolerance to treatment regimens associated with the increasing number and severity of comorbidities. Little is known about specific differences in lymphoma biology with respect to age and sex, and this is changing only slowly despite the recent rise in interest about these issues...
2017: American Society of Clinical Oncology Educational Book
https://www.readbyqxmd.com/read/28546090/safety-and-tolerability-of-long-acting-cabotegravir-injections-in-hiv-uninfected-men-eclair-a-multicentre-double-blind-randomised-placebo-controlled-phase-2a-trial
#20
Martin Markowitz, Ian Frank, Robert M Grant, Kenneth H Mayer, Richard Elion, Deborah Goldstein, Chester Fisher, Magdalena E Sobieszczyk, Joel E Gallant, Hong Van Tieu, Winkler Weinberg, David A Margolis, Krischan J Hudson, Britt S Stancil, Susan L Ford, Parul Patel, Elizabeth Gould, Alex R Rinehart, Kimberly Y Smith, William R Spreen
BACKGROUND: Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection. METHODS: We did this multicentre, double-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA...
August 2017: Lancet HIV
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