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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/30022367/population-pharmacokinetics-of-gemtuzumab-ozogamicin-in-pediatric-patients-with-relapsed-or-refractory-acute-myeloid-leukemia
#1
Joanna C Masters, Elly Barry, Beverly Knight
BACKGROUND AND OBJECTIVE: To date, the population pharmacokinetics (popPK) of gemtuzumab ozogamicin (GO), a CD33-directed antibody-drug conjugate consisting of hP67.6 antibody linked to N-acetyl gamma calicheamicin used in the treatment of acute myeloid leukemia (AML), has not been characterized in pediatric patients. This report describes the popPK of GO following intravenous administration in 29 pediatric patients aged ≤ 17 years with relapsed or refractory AML who were enrolled in the 0903A1-102-US phase I/II study...
July 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/30019172/clinical-pharmacokinetics-and-pharmacodynamics-of-propofol
#2
REVIEW
Marko M Sahinovic, Michel M R F Struys, Anthony R Absalom
Propofol is an intravenous hypnotic drug that is used for induction and maintenance of sedation and general anaesthesia. It exerts its effects through potentiation of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) at the GABAA receptor, and has gained widespread use due to its favourable drug effect profile. The main adverse effects are disturbances in cardiopulmonary physiology. Due to its narrow therapeutic margin, propofol should only be administered by practitioners trained and experienced in providing general anaesthesia...
July 18, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29992396/effects-of-postponing-treatment-in-the-second-year-of-cladribine-administration-clinical-trial-simulation-analysis-of-absolute-lymphocyte-counts-and-relapse-rate-in-patients-with-relapsing-remitting-multiple-sclerosis
#3
Nadia Terranova, Christine Hicking, Fernando Dangond, Alain Munafo
INTRODUCTION: Cladribine Tablets (MAVENCLAD® ) selectively reduce absolute lymphocyte counts (ALCs) in patients with multiple sclerosis. The recommended cumulative dose of Cladribine Tablets is 3.5 mg/kg over 4-5 days in months 1 and 2 of treatment years 1 and 2, followed by prolonged efficacy with no additional treatment. After the cladribine-induced reduction, ALCs recover to normal within each treatment year in most patients. Those patients with slow ALC recovery can develop Grade 3-4 lymphopenia, especially those patients with Grade ≥  2 lymphopenia at the start of year 2...
July 11, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29987837/the-clinical-pharmacology-of-cladribine-tablets-for-the-treatment-of-relapsing-multiple-sclerosis
#4
REVIEW
Robert Hermann, Mats O Karlsson, Ana M Novakovic, Nadia Terranova, Markus Fluck, Alain Munafo
Cladribine Tablets (MAVENCLAD® ) are used to treat relapsing multiple sclerosis (MS). The recommended dose is 3.5 mg/kg, consisting of 2 annual courses, each comprising 2 treatment weeks 1 month apart. We reviewed the clinical pharmacology of Cladribine Tablets in patients with MS, including pharmacokinetic and pharmacometric data. Cladribine Tablets are rapidly absorbed, with a median time to reach maximum concentration (Tmax ) of 0.5 h (range 0.5-1.5 h) in fasted patients. When administered with food, absorption is delayed (median Tmax 1...
July 10, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29987449/fetal-physiologically-based-pharmacokinetic-models-systems-information-on-the-growth-and-composition-of-fetal-organs
#5
Khaled Abduljalil, Masoud Jamei, Trevor N Johnson
BACKGROUND: The growth of fetal organs is a dynamic process involving considerable changes in the anatomical and physiological parameters that can alter fetal exposure to xenobiotics in utero. Physiologically based pharmacokinetic models can be used to predict the fetal exposure as time-varying parameters can easily be incorporated. OBJECTIVE: The objective of this study was to collate, analyse and integrate the available time-varying parameters needed for the physiologically based pharmacokinetic modelling of xenobiotic kinetics in a fetal population...
July 10, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29978361/faster-insulin-aspart-a-new-bolus-option-for-diabetes-mellitus
#6
REVIEW
Abigayle Davis, Jolly Kuriakose, Jennifer N Clements
Since the approval of bolus insulin, it has been used frequently in clinical practice for the management of type 1 and 2 diabetes mellitus for postprandial control. Another new product is faster insulin aspart (Fiasp, Novo Nordisk), a fast-acting insulin with 100 units/mL. Several studies have been conducted evaluating the pharmacokinetics and pharmacodynamics of faster insulin aspart, compared with insulin aspart. This new bolus insulin provides greater glucose-lowering effect at 20 min, following subcutaneous administration...
July 6, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29946870/comment-on-van-rongen-et-al-higher-midazolam-clearance-in-obese-adolescents-compared-with-morbidly-obese-adults
#7
LETTER
David M Reith, Hesham Saleh Al-Sallami
No abstract text is available yet for this article.
June 23, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29936679/author-s-reply-to-reith-higher-midazolam-clearance-in-obese-adolescents-compared-with-morbidly-obese-adults
#8
LETTER
Anne van Rongen, Johannes N van den Anker, Catherijne A J Knibbe
No abstract text is available yet for this article.
June 23, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29936678/four-decades-of-%C3%AE-lactam-antibiotic-pharmacokinetics-in-cystic-fibrosis
#9
REVIEW
Jürgen B Bulitta, Yuanyuan Jiao, Stefanie K Drescher, Antonio Oliver, Arnold Louie, Bartolome Moya, Xun Tao, Mathias Wittau, Brian T Tsuji, Alexandre P Zavascki, Beom Soo Shin, George L Drusano, Fritz Sörgel, Cornelia B Landersdorfer
The pharmacokinetics (PK) of β-lactam antibiotics in cystic fibrosis (CF) patients has been compared with that in healthy volunteers for over four decades; however, no quantitative models exist that explain the PK differences between CF patients and healthy volunteers in older and newer studies. Our aims were to critically evaluate these studies and explain the PK differences between CF patients and healthy volunteers. We reviewed all 16 studies that compared the PK of β-lactams between CF patients and healthy volunteers within the same study...
June 23, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29923172/author-s-reply-to-woillard-et-al-population-pharmacokinetics-of-mycophenolic-acid-an-update
#10
LETTER
Tony K L Kiang, Mary H H Ensom
No abstract text is available yet for this article.
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29923171/comment-on-population-pharmacokinetics-of-mycophenolic-acid-an-update
#11
LETTER
Jean-Baptiste Woillard, Jean Debord, Pierre Marquet
No abstract text is available yet for this article.
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29915924/clinical-pharmacokinetics-of-anaplastic-lymphoma-kinase-inhibitors-in-non-small-cell-lung-cancer
#12
REVIEW
Takeshi Hirota, Shota Muraki, Ichiro Ieiri
The identification of anaplastic lymphoma kinase rearrangements in 2-5% of patients with non-small-cell lung cancer led to rapid advances in the clinical development of oral tyrosine kinase inhibitors. Anaplastic lymphoma kinase inhibitors are an effective treatment in preclinical models and patients with anaplastic lymphoma kinase-translocated cancers. Four anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, and brigatinib) have recently been approved. Post-marketing studies provided additional pharmacokinetic information on their pharmacokinetic parameters...
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29915923/pharmacokinetics-and-clinical-implications-of-semaglutide-a-new-glucagon-like-peptide-glp-1-receptor-agonist
#13
REVIEW
Sylvie Hall, Diana Isaacs, Jennifer N Clements
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) came to market in the year 2005, as a new therapeutic classification, for clinical use in the management of type 2 diabetes mellitus (T2DM). Since 2005, there have been six approved products on the market, with the newest product being semaglutide (Novo Nordisk). Several studies have been conducted and completed evaluating its pharmacokinetics as a once-weekly subcutaneous injection. As a dose of 0.5 or 1 mg, semaglutide has a half-life of 7 days; therefore, it would reach steady state in 4-5 weeks...
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29915922/clinical-pharmacokinetics-of-atypical-antipsychotics-an-update
#14
REVIEW
Massimo Carlo Mauri, Silvia Paletta, Chiara Di Pace, Alessandra Reggiori, Giovanna Cirnigliaro, Isabel Valli, Alfredo Carlo Altamura
Therapeutic drug monitoring studies have generally concentrated on controlling compliance and avoiding side effects by maintaining long-term exposure to minimally effective blood concentrations. The rationale for using therapeutic drug monitoring in relation to second-generation antipsychotics is still being discussed at least with regard to the real clinical utility, but there is evidence that it can improve efficacy, especially when patients do not respond or develop side effects using therapeutic doses. Furthermore, drug plasma concentration determinations can be of some utility in medico-legal problems...
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29915921/pharmacokinetics-of-hiv-integrase-inhibitors-during-pregnancy-mechanisms-clinical-implications-and-knowledge-gaps
#15
REVIEW
Ruben van der Galiën, Rob Ter Heine, Rick Greupink, Stein J Schalkwijk, Antonius E van Herwaarden, Angela Colbers, David M Burger
Prevention of mother-to-child transmission of HIV and optimal maternal treatment are the most important goals of antiretroviral therapy in pregnant women with HIV. These goals may be at risk due to possible reduced exposure during pregnancy caused by physiological changes. Limited information is available on the impact of these physiological changes. This is especially true for HIV-integrase inhibitors, a relatively new class of drugs, recommended first-line agents and hence used by a large proportion of HIV-infected patients...
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29862468/the-ontogeny-of-udp-glucuronosyltransferase-enzymes-recommendations-for-future-profiling-studies-and-application-through-physiologically-based-pharmacokinetic-modelling
#16
REVIEW
Justine Badée, Stephen Fowler, Saskia N de Wildt, Abby C Collier, Stephan Schmidt, Neil Parrott
Limited understanding of drug pharmacokinetics in children is one of the major challenges in paediatric drug development. This is most critical in neonates and infants owing to rapid changes in physiological functions, especially in the activity of drug-metabolising enzymes. Paediatric physiologically based pharmacokinetic models that integrate ontogeny functions for cytochrome P450 enzymes have aided our understanding of drug exposure in children, including those under the age of 2 years. Paediatric physiologically based pharmacokinetic models have consequently been recognised by the European Medicines Agency and the US Food and Drug Administration as innovative tools in paediatric drug development and regulatory decision making...
June 4, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29862467/therapeutic-drug-monitoring-of-oral-anti-hormonal-drugs-in-oncology
#17
REVIEW
Stefanie L Groenland, Merel van Nuland, Remy B Verheijen, Jan H M Schellens, Jos H Beijnen, Alwin D R Huitema, Neeltje Steeghs
Oral anti-hormonal drugs are essential in the treatment of breast and prostate cancer. It is well known that the interpatient variability in pharmacokinetic exposure is high for these agents and exposure-response relationships exist for many oral anti-hormonal drugs. Yet, they are still administered at fixed doses. This could lead to underdosing and thus suboptimal efficacy in some patients, while other patients could be overdosed resulting in unnecessary side effects. Therapeutic drug monitoring (TDM), individualized dosing based on measured blood concentrations of the drug, could therefore be a valid option to further optimize treatment...
June 4, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29862466/piperacillin-population-pharmacokinetics-and-dosing-regimen-optimization-in-critically-ill-children-with-normal-and-augmented-renal-clearance
#18
Agathe Béranger, Sihem Benaboud, Saïk Urien, Florence Moulin, Emmanuelle Bille, Fabrice Lesage, Yi Zheng, Mathieu Genuini, Inès Gana, Sylvain Renolleau, Déborah Hirt, Jean-Marc Tréluyer, Mehdi Oualha
BACKGROUND: Critically ill children frequently display observed alterations of pharmacokinetic (PK) parameters, leading to a reduction in β-lactam concentrations. This study aimed to develop a PK population model for piperacillin in order to optimize individual dosing regimens. METHODS: All children aged ≤ 18 years, weighing more than 2.5 kg, and receiving piperacillin infusions were included in this study. Piperacillin was quantified by high-performance liquid chromatography, and PK were described using the non-linear mixed-effect modeling software MONOLIX...
June 4, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29802543/clinical-pharmacokinetics-and-pharmacodynamics-of-bortezomib
#19
REVIEW
Carlyn Rose C Tan, Saif Abdul-Majeed, Brittany Cael, Stefan K Barta
Proteasome inhibitors disrupt multiple pathways in cells and the bone marrow microenvironment, resulting in apoptosis and inhibition of cell-cycle progression, angiogenesis, and proliferation. Bortezomib is a first-in-class proteasome inhibitor approved for the treatment of multiple myeloma and mantle cell lymphoma after one prior therapy. It is also effective in other plasma cell disorders and non-Hodgkin lymphomas. The main mechanism of action of bortezomib is to inhibit the chymotrypsin-like site of the 20S proteolytic core within the 26S proteasome, thereby inducing cell-cycle arrest and apoptosis...
May 26, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29802542/influence-of-antigen-mass-on-the-pharmacokinetics-of-therapeutic-antibodies-in-humans
#20
REVIEW
David Ternant, Nicolas Azzopardi, William Raoul, Theodora Bejan-Angoulvant, Gilles Paintaud
Therapeutic antibodies are increasingly used to treat various diseases, including neoplasms and chronic inflammatory diseases. Antibodies exhibit complex pharmacokinetic properties, notably owing to the influence of antigen mass, i.e. the amount of antigenic targets to which the monoclonal antibody binds specifically. This review focuses on the influence of antigen mass on the pharmacokinetics of therapeutic antibodies quantified by pharmacokinetic modelling in humans. Out of 159 pharmacokinetic studies, 85 reported an influence of antigen mass...
May 26, 2018: Clinical Pharmacokinetics
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