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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/29333561/pharmacokinetics-of-the-b-cell-lymphoma-2-bcl-2-inhibitor-venetoclax-in-female-subjects-with-systemic-lupus-erythematosus
#1
Mukul Minocha, Jiewei Zeng, Jeroen K Medema, Ahmed A Othman
BACKGROUND AND OBJECTIVE: Venetoclax is an oral selective Bcl-2 inhibitor approved for the treatment of patients with chronic lymphocytic leukemia with 17p deletion. Mechanistic and preclinical evidence warranted evaluation of venetoclax for the treatment of systemic lupus erythematosus (SLE). This work characterized the pharmacokinetics of venetoclax in female subjects with SLE. METHODS: Single (10-500 mg) and multiple (30-600 mg) escalating doses of venetoclax or matching placebo were evaluated using randomized, double-blind, placebo-controlled designs (6 active and 2 placebo per dose with 73 unique SLE patients enrolled, 25 of whom enrolled twice)...
January 15, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29332251/clinical-pharmacokinetics-and-pharmacodynamics-of-telavancin-compared-with-the-other-glycopeptides
#2
REVIEW
Valentin Al Jalali, Markus Zeitlinger
Telavancin was discovered by modifying the chemical structure of vancomycin and belongs to the group of lipoglycopeptides. It employs its antimicrobial potential through two distinct mechanisms of action: inhibition of bacterial cell wall synthesis and induction of bacterial membrane depolarization and permeabilization. In this article we review the clinically relevant pharmacokinetic and pharmacodynamic data of telavancin. For comparison, the pharmacokinetic and pharmacodynamic data of the other glycopeptides are presented...
January 13, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29330784/tacrolimus-concentration-in-saliva-of-kidney-transplant-recipients-factors-influencing-the-relationship-with-whole-blood-concentrations
#3
Mwlod Ghareeb, Reginald Y Gohh, Fatemeh Akhlaghi
OBJECTIVE: The objective of this study was to examine the association between tacrolimus concentration in oral fluids and in whole blood and to investigate the various factors that influence this relationship. PATIENTS AND METHODS: Forty-six adult kidney transplant recipients were included in the study. Study A (ten patients) included the collection of several paired oral fluid samples by passive drool over a 12-h post-dose period. Study B (36 patients) included the collection of oral fluids pre-dose and at 2 h after the tacrolimus dose under three conditions: un-stimulated, after stimulation with a tart candy, and after mouth rinsing...
January 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29330783/clinical-pharmacokinetics-and-pharmacodynamics-of-infliximab-in-the-treatment-of-inflammatory-bowel-disease
#4
REVIEW
Amy Hemperly, Niels Vande Casteele
Infliximab was the first monoclonal antibody to be approved for the treatment of pediatric and adult patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC). It has been shown to induce and maintain both clinical remission and mucosal healing in pediatric and adult patients with inflammatory bowel disease (IBD) who are unresponsive or refractory to conventional therapies. The administration of infliximab is weight-based and the drug is administered intravenously. The volume of distribution of infliximab is low and at steady state ranges from 4...
January 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29330782/characterization-of-the-pharmacokinetics-of-vilaprisan-bioavailability-excretion-biotransformation-and-drug-drug-interaction-potential
#5
Marcus-Hillert Schultze-Mosgau, Joachim Höchel, Olaf Prien, Torsten Zimmermann, Ashley Brooks, Jim Bush, Antje Rottmann
BACKGROUND AND OBJECTIVES: In-vitro data suggest that clearance of vilaprisan is mediated by cytochrome P450 3A4 (oxidation) and aldoketoreductases (reduction). To fully understand the elimination and biotransformation pathways of vilaprisan, a selective progesterone receptor modulator, and to quantify the impact of cytochrome P450 3A4 inhibition on the pharmacokinetics of vilaprisan, two clinical studies in healthy postmenopausal women were conducted. METHODS: In study 1, pharmacokinetics, mass balance, and metabolite patterns were determined after single oral administration of 5 mg of [14C]-labeled vilaprisan in six subjects...
January 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29330781/a-review-of-the-methods-and-associated-mathematical-models-used-in-the-measurement-of-fat-free-mass
#6
REVIEW
Jaydeep Sinha, Stephen B Duffull, Hesham S Al-Sallami
Fat-free mass (FFM) represents the lean component of the body devoid of fat. It has been shown to be a useful predictor of drug dose requirements, particularly in obesity where the excess fat mass does not contribute to drug clearance. However, measuring FFM involves complex and/or expensive experimental methodologies that preclude their use in routine clinical practice. Thus, models to predict FFM from readily measurable variables, such as body weight and height, have been developed and are used in both population pharmacokinetic modelling and clinical practice...
January 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29280062/correction-to-pharmacokinetic-and-pharmacodynamic-analyses-of-5-fluorouracil-in-east-asian-patients-with-nasopharyngeal-carcinoma
#7
Yuxiang Ma, Yuehao Lin, Benyan Zou, Wanli Liu, Yang Zhang, Liping Zhao, Yan Huang, Yunpeng Yang, Wenfeng Fang, Yuanyuan Zhao, Jin Sheng, Tao Qin, Zhihuang Hu, Salavatore J Salamone, Yunying Li, Li Zhang, Hongyun Zhao
Page 1205, the author names and affiliations which previously read.
December 26, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29264787/fetal-physiologically-based-pharmacokinetic-models-systems-information-on-fetal-biometry-and-gross-composition
#8
Khaled Abduljalil, Trevor N Johnson, Amin Rostami-Hodjegan
BACKGROUND: Postulating fetal exposure to xenobiotics has been based on animal studies; however, inter-species differences can make this problematic. Physiologically-based pharmacokinetic models may capture the rapid changes in anatomical, biochemical, and physiological parameters during fetal growth over the duration of pregnancy and help with interpreting laboratory animal data. However, these models require robust information on the longitudinal variations of system parameter values and their covariates...
December 20, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29236229/model-based-therapeutic-drug-monitoring-of-infliximab-using-a-single-serum-trough-concentration
#9
David Ternant, Christophe Passot, Alexandre Aubourg, Philippe Goupille, Céline Desvignes, Laurence Picon, Thierry Lecomte, Denis Mulleman, Gilles Paintaud
BACKGROUND AND OBJECTIVES: The pharmacokinetics of infliximab are highly variable and influence clinical response in chronic inflammatory diseases. The goal of this study was to build a Bayesian model allowing predictions of upcoming infliximab concentrations and dosing regimen adjustment, using only one concentration measurement and information regarding the last infliximab infusion. METHODS: This retrospective study was based on data from 218 patients treated with infliximab in Tours University Hospital who were randomly assigned to learning (two-thirds) or validation (one-third) data subsets...
December 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29236228/population-pharmacokinetic-pharmacodynamic-modeling-of-ropivacaine-in-spinal-anesthesia
#10
Zoubir Djerada, Catherine Feliu, Yoann Cazaubon, Faouzi Smati, Philippe Gomis, Dominique Guerrot, Beny Charbit, Olivier Fernandes, Jean-Marc Malinovsky
BACKGROUND: Ropivacaine is frequently used in spinal anesthesia but the relationship between plasma concentrations and sensory block level remains unknown. OBJECTIVE: The aim of this study was to assess the relationship between plasma ropivacaine concentrations and effects during spinal anesthesia. METHODS: Sixty patients aged between 18 and 82 years were included in this study after providing written informed consent. Patients were randomly assigned to receive intrathecal administration of ropivacaine 15, 20 or 25 mg...
December 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29214439/a-pharmacometric-approach-to-substitute-for-a-conventional-dose-finding-study-in-rare-diseases-example-of-phase-iii-dose-selection-for-emicizumab-in-hemophilia-a
#11
Koichiro Yoneyama, Christophe Schmitt, Naoki Kotani, Gallia G Levy, Ryu Kasai, Satofumi Iida, Midori Shima, Takehiko Kawanishi
BACKGROUND: Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I-I/II studies, emicizumab reduced the bleeding frequency in patients with severe hemophilia A, regardless of the presence of factor VIII inhibitors, at once-weekly subcutaneous doses of 0.3, 1, and 3 mg/kg. METHODS: Using the phase I-I/II study data, population pharmacokinetic and repeated time-to-event (RTTE) modeling were performed to quantitatively characterize the relationship between the pharmacokinetics of emicizumab and reduction in bleeding frequency...
December 6, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29189941/vortioxetine-clinical-pharmacokinetics-and-drug-interactions
#12
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/29188435/antibody-drug-conjugates-pharmacokinetic-pharmacodynamic-modeling-preclinical-characterization-clinical-studies-and-lessons-learned
#13
REVIEW
William D Hedrich, Tamer E Fandy, Hossam M Ashour, Hongbing Wang, Hazem E Hassan
Antibody-drug conjugates are an emerging class of biopharmaceuticals changing the landscape of targeted chemotherapy. These conjugates combine the target specificity of monoclonal antibodies with the anti-cancer activity of small-molecule therapeutics. Several antibody-drug conjugates have received approval for the treatment of various types of cancer including gemtuzumab ozogamicin (Mylotarg®), brentuximab vedotin (Adcetris®), trastuzumab emtansine (Kadcyla®), and inotuzumab ozogamicin, which recently received approval (Besponsa®)...
November 29, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29178007/correction-to-pharmacokinetics-of-fentanyl-and-its-derivatives-in-children-a-comprehensive-review
#14
Victoria C Ziesenitz, Janelle D Vaughns, Gilbert Koch, Gerd Mikus, Johannes N van den Anker
Fentanyl and its derivatives sufentanil, alfentanil, and remifentanil are potent opioids. A comprehensive review of the use of fentanyl and its derivatives in the pediatric population was performed using the National Library of Medicine PubMed. Studies were included if they contained original pharmacokinetic parameters or models using established routes of administration in patients younger than 18 years of age. Of 372 retrieved articles, 44 eligible pharmacokinetic studies contained data of 821 patients younger than 18 years of age, including more than 46 preterm infants, 64 full-term neonates, 115 infants/toddlers, 188 children, and 28 adolescents...
November 24, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29159710/prediction-of-free-from-total-mycophenolic-acid-concentrations-in-stable-renal-transplant-patients-a-population-based-approach
#15
Helena Colom, Franc Andreu, Teun van Gelder, Dennis A Hesselink, Brenda C M de Winter, Oriol Bestard, Joan Torras, Josep M Cruzado, Josep M Grinyó, Núria Lloberas
BACKGROUND: A population pharmacokinetic (PK) protein-binding model was developed to (1) predict free mycophenolic acid (fMPA) based on total MPA (tMPA) concentrations in renal transplant patients, to establish the therapeutic range of fMPA through pharmacokinetic-pharmacodynamic studies; and (2) provide a guideline for dosing mycophenolate mofetil (MMF). METHODS: Full PK profiles of 56 patients (from five different occasions) during the first year after transplantation who were treated with oral MMF and cyclosporine, or macrolides (either tacrolimus or sirolimus), were analysed...
November 20, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29139042/obesity-and-altered-aspirin-pharmacology
#16
REVIEW
Nicholas B Norgard
Obesity is an independent risk factor for cardiovascular morbidity and mortality due to atherothrombotic events and represents a group of patients who are in need of optimized antithrombotic therapy. Central to the obesity-related risk of atherothrombosis is a pro-thrombotic state characterized by increased levels of coagulation factors, impaired fibrinolysis, and platelet hyper-reactivity, which results from the interaction among the features clustering in obesity: insulin resistance, inflammation, oxidative stress, and endothelial dysfunction...
November 14, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29134570/evaluation-of-tobramycin-exposure-predictions-in-three-bayesian-forecasting-programmes-compared-with-current-clinical-practice-in-children-and-adults-with-cystic-fibrosis
#17
Marc Burgard, Indy Sandaradura, Sebastiaan J van Hal, Sonya Stacey, Stefanie Hennig
BACKGROUND AND OBJECTIVES: Bayesian forecasting (BF) methods for tobramycin dose individualisation has not seen widespread clinical adoption, despite being endorsed by clinical practice guidelines. Several freeware and commercial programmes using BF methods are available to support personalised dosing. This study evaluated exposure estimates, dose recommendations, and predictive performance compared with current clinical practice. METHODS: Data from 105 patients (50 adults and 55 children) with cystic fibrosis who received intravenous tobramycin treatment and had paired concentration-time measurements were analysed using (1) log-linear regression analysis, and (2) three BF programmes: TDMx, InsightRX, and DoseMe...
November 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29086344/clinical-pharmacokinetic-and-pharmacodynamic-profile-of-riociguat
#18
REVIEW
Reiner Frey, Corina Becker, Soundos Saleh, Sigrun Unger, Dorina van der Mey, Wolfgang Mück
Oral riociguat is a soluble guanylate cyclase (sGC) stimulator that targets the nitric oxide (NO)-sGC-cyclic guanosine monophosphate pathway with a dual mode of action: directly by stimulating sGC, and indirectly by increasing the sensitivity of sGC to NO. It is rapidly absorbed, displays almost complete bioavailability (94.3%), and can be taken with or without food and as crushed or whole tablets. Riociguat exposure shows pronounced interindividual (60%) and low intraindividual (30%) variability in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH), and is therefore administered using an individual dose-adjustment scheme at treatment initiation...
October 30, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29080937/population-pharmacokinetics-and-dosing-considerations-for-the-use-of-linezolid-in-overweight-and-obese-adult-patients
#19
Piergiorgio Cojutti, Manjunath P Pai, Federico Pea
BACKGROUND: Linezolid is an anti-Gram-positive antimicrobial agent used at a fixed dose of 600 mg every 12 h. OBJECTIVES: The objective of this study was to assess the population pharmacokinetics and pharmacodynamics of linezolid in a retrospective cohort of overweight and obese hospitalized patients. PATIENTS AND METHODS: Population pharmacokinetic and Monte Carlo simulations were conducted to assess the probability of target attainment (PTA) of an area under the concentration-time curve from time zero to 24 h (AUC24)/minimum inhibitory concentration (MIC) ratio > 100, defined as the pharmacodynamic target of efficacy, with incremental candidate dosages...
October 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29076110/population-pharmacokinetics-of-upadacitinib-in-healthy-subjects-and-subjects-with-rheumatoid-arthritis-analyses-of-phase-i-and-ii-clinical-trials
#20
Ben Klünder, Mohamed-Eslam F Mohamed, Ahmed A Othman
BACKGROUND AND OBJECTIVES: Upadacitinib is a janus kinase (JAK) 1 inhibitor being developed for the treatment of rheumatoid arthritis (RA) and other inflammatory diseases. This work characterized upadacitinib population pharmacokinetics in healthy subjects and RA patients and the effects of covariates on upadacitinib exposure. METHODS: Upadacitinib plasma concentrations (n = 6399) from 107 healthy subjects and 466 RA patients from three phase I and two 12-week RA phase IIb trials (1-48 mg immediate-release doses across studies) were analyzed using non-linear mixed-effects modeling...
October 26, 2017: Clinical Pharmacokinetics
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