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sex differences, pharmacokinetics

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https://www.readbyqxmd.com/read/29340623/pharmacokinetics-of-rituximab-and-clinical-outcomes-in-patients-with-anti-neutrophil-cytoplasmic-antibody-associated-vasculitis
#1
Divi Cornec, Brian F Kabat, John R Mills, Melissa Cheu, Amber M Hummel, Darrell R Schroeder, Matthew D Cascino, Paul Brunetta, David L Murray, Melissa R Snyder, Fernando Fervenza, Gary S Hoffman, Cees G M Kallenberg, Carol A Langford, Peter A Merkel, Paul A Monach, Philip Seo, Robert F Spiera, E William St Clair, John H Stone, David R Barnidge, Ulrich Specks
Objectives: To study the determinants of the pharmacokinetics (PK) of rituximab (RTX) in patients with ANCA-associated vasculitis (AAV) and its association with clinical outcomes. Methods: This study included data from 89 patients from the RTX in AAV trial who received the full dose of RTX (four weekly infusions of 375 mg/m2). RTX was quantified at weeks 2, 4, 8, 16 and 24, and summarized by computing the trapezoidal area under the curve. We explored potential determinants of the PK-RTX, and analysed its association with clinical outcomes: achievement of remission at 6 months, duration of B-cell depletion and time to relapse in patients who achieved complete remission...
January 10, 2018: Rheumatology
https://www.readbyqxmd.com/read/29275265/anesthetic-and-pharmacologic-considerations-in-perioperative-care-of-obese-children
#2
REVIEW
Vidya Chidambaran, Anurag Tewari, Mohamed Mahmoud
PURPOSE: Anesthetic management of obese pediatric patients is challenging. With increasing prevalence of childhood obesity, more severely obese children with comorbidities present for surgery every day. The purpose of this review is to provide an up-to-date comprehensive narrative review on the impact of pathophysiological changes imposed by pediatric obesity on the perioperative management of obese children, especially drug dosing. This knowledge is necessary to provide safe delivery of anesthesia for severely obese children...
December 21, 2017: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/29247451/pharmacokinetics-of-dexmedetomidine-administered-to-patients-with-end-stage-renal-failure-and-secondary-hyperparathyroidism-undergoing-general-anaesthesia
#3
W Zhong, Y Zhang, M-Z Zhang, X-H Huang, Y Li, R Li, Q-W Liu
WHAT IS KNOWN AND OBJECTIVE: The primary objective of this study was to compare the pharmacokinetics of dexmedetomidine in patients with end-stage renal failure and secondary hyperparathyroidism with those in normal individuals. METHOD: Fifteen patients with end-stage renal failure and secondary hyperparathyroidism (Renal-failure Group) and 8 patients with normal renal and parathyroid gland function (Control Group) received intravenous 0.6 μg/kg dexmedetomidine for 10 minutes before anaesthesia induction...
December 16, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/29226975/mathematical-modeling-and-simulation-in-animal-health-part-iii-using-nonlinear-mixed-effects-to-characterize-and-quantify-variability-in-drug-pharmacokinetics
#4
REVIEW
C Bon, P L Toutain, D Concordet, R Gehring, T Martin-Jimenez, J Smith, L Pelligand, M Martinez, T Whittem, J E Riviere, J P Mochel
A common feature of human and veterinary pharmacokinetics is the importance of identifying and quantifying the key determinants of between-patient variability in drug disposition and effects. Some of these attributes are already well known to the field of human pharmacology such as bodyweight, age, or sex, while others are more specific to veterinary medicine, such as species, breed, and social behavior. Identification of these attributes has the potential to allow a better and more tailored use of therapeutic drugs both in companion and food-producing animals...
December 11, 2017: Journal of Veterinary Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29217733/sex-as-a-biological-variable-in-preclinical-imaging-research-initial-observations-with-18f-fluorothymidine
#5
Szeman Ruby Chan, Kelley Salem, Justin Jeffery, Ginny L Powers, Yongjun Yan, Kooresh I Shoghi, Aparna M Mahajan, Amy M Fowler
The study objective was to investigate whether sex influences 3'-deoxy-3'-[18F]fluorothymidine (18F-FLT) uptake and tissue distribution in mouse models of cancer. Methods:18F-FLT biodistribution was measured in three strains of male and female mice (129S6/SvEv, athymic nude, and BALB/c). 18F-Fluoro-2-deoxy-2-D-glucose (18F-FDG) biodistribution was performed for comparison. 18F-FLT uptake was also measured in female 129S6/SvEv mice bearing estrogen-dependent SSM3 mouse mammary tumors, male athymic nude mice bearing androgen-dependent CWR22 prostate cancer xenografts, and male and female athymic nude mice bearing estrogen-independent MDA-MB-231 human breast cancer xenografts...
December 7, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29215040/sex-related-pharmacokinetic-differences-and-mechanisms-of-metapristone-ru486-metabolite
#6
Wenge Chen, Yingying Xiao, Jianzhong Chen, Jian Liu, Jingwei Shao, Tao Li, Yewei Zhu, Ji Ma, Yu Gao, Jichuang Wang, Jianguo Xu, Yusheng Lu, Lee Jia
Metapristone is the primary metabolite of the abortifacient mifepristone (RU486), and is being developed as a safe and effective cancer metastatic chemopreventive agent for both sexes. Here, we systematically investigated the sex-related pharmacokinetics of metapristone in both rats and dogs, and explored the related mechanisms of actions. Administration of metapristone to rats and dogs showed that plasma concentrations of metapristone (AUC, C max ) were significantly higher in female dogs and rats than in males...
December 7, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29212434/stable-isotope-pharmacokinetic-studies-provide-insight-into-effects-of-age-sex-and-weight-on-levothyroxine-metabolism
#7
Islam Younis, Mariam A Ahmed, Kenneth D Burman, Offie P Soldin, Jacqueline Jonklaas
Background We wished to determine whether levothyroxine pharmacokinetics (PKs) are affected by age, weight, and sex. Methods A pharmacokinetic study was performed after administration of a tracer dose of carbon-13- labeled LT4 (13C-LT4). The study was conducted at an academic medical center. Adults of any age being treated with levothyroxine for hypothyroidism were enrolled in the study. A single dose of 13C- LT4 was administered. Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the majority of the remaining samples were collected over the 120-hour period post-dosing...
December 6, 2017: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/29189941/vortioxetine-clinical-pharmacokinetics-and-drug-interactions
#8
REVIEW
Grace Chen, Astrid-Maria Højer, Johan Areberg, George Nomikos
Vortioxetine is a novel antidepressant with multimodal activity currently approved for the treatment of major depressive disorder. Vortioxetine is orally administered once daily at 5- to 20-mg doses. The pharmacokinetics of vortioxetine are linear and dose proportional, with a mean terminal half-life of approximately 66 h and steady-state plasma concentrations generally achieved within 2 weeks of dosing. The mean absolute oral bioavailability of vortioxetine is 75%. No food effect on pharmacokinetics was observed...
November 30, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29119932/relevance-of-cyp2c9-function-in-valproate-therapy
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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/m2 , females 375 mg/m2 ) 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
#16
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
#17
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
#18
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
#19
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
#20
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
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