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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/28918602/population-pharmacokinetics-and-optimal-sampling-strategy-for-model-based-precision-dosing-of-melphalan-in-patients-undergoing-hematopoietic-stem-cell-transplantation
#1
Kana Mizuno, Min Dong, Tsuyoshi Fukuda, Sharat Chandra, Parinda A Mehta, Scott McConnell, Elias J Anaissie, Alexander A Vinks
BACKGROUND: High-dose melphalan is an important component of conditioning regimens for patients undergoing hematopoietic stem cell transplantation. The current dosing strategy based on body surface area results in a high incidence of oral mucositis and gastrointestinal and liver toxicity. Pharmacokinetically guided dosing will individualize exposure and help minimize overexposure-related toxicity. OBJECTIVE: The purpose of this study was to develop a population pharmacokinetic model and optimal sampling strategy...
September 16, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28905331/antibiotic-distribution-into-cerebrospinal-fluid-can-dosing-safely-account-for-drug-and-disease-factors-in-the-treatment-of-ventriculostomy-associated-infections
#2
Nilesh Kumta, Jason A Roberts, Jeffrey Lipman, Menino Osbert Cotta
Ventriculostomy-associated infections, or ventriculitis, in critically ill patients are associated with considerable morbidity. Efficacious antibiotic dosing for the treatment of these infections may be complicated by altered antibiotic concentrations in the cerebrospinal fluid due to variable meningeal inflammation and antibiotic properties. Therefore, doses used to treat infections with a higher degree of meningeal inflammation (such as meningitis) may often fail to achieve equivalent exposures in patients with ventriculostomy-associated infections such as ventriculitis...
September 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28889370/semi-mechanistic-model-for-predicting-the-dosing-rate-in-children-and-neonates-for-drugs-mainly-eliminated-by-cytochrome-metabolism
#3
Lena Cerruti, Nathalie Bleyzac, Michel Tod
BACKGROUND AND OBJECTIVE: A simple approach is proposed to predict drug clearance in children when no paediatric data are available for drugs metabolised by cytochromes. METHODS: The maturation functions of cytochrome activity and binding proteins in plasma were combined with several measures of body size to describe drug clearance increase with age. The complete model and different reduced models were evaluated on a large panel of drug clearance data in children...
September 9, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28887801/population-pharmacokinetic-and-pharmacodynamic-analysis-of-belimumab-administered-subcutaneously-in-healthy-volunteers-and-patients-with-systemic-lupus-erythematosus
#4
Herbert Struemper, Mita Thapar, David Roth
BACKGROUND: Intravenous belimumab 10 mg/kg every 4 weeks is indicated in patients with active, autoantibody-positive systemic lupus erythematosus receiving standard systemic lupus erythematosus care. Subcutaneous 200-mg weekly administration, which may prove more convenient for patients and improve adherence, is currently under investigation. OBJECTIVE: The objective of this study was to characterize the population pharmacokinetics and exposure-efficacy response of subcutaneous belimumab in a pooled analysis of pharmacokinetic data [phase I: BEL114448 (NCT01583530) and BEL116119 (NCT01516450) in healthy subjects (n = 134); phase III: BEL112341 (NCT01484496) in adults with systemic lupus erythematosus (n = 554)] and pharmacodynamic data [BEL112341 in adults with systemic lupus erythematosus (n = 833)]...
September 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28884437/extrapolation-of-a-brivaracetam-exposure-response-model-from-adults-to-children-with-focal-seizures
#5
Rik Schoemaker, Janet R Wade, Armel Stockis
INTRODUCTION: Prediction of brivaracetam effects in children was obtained by scaling an existing adult pharmacokinetic/pharmacodynamic (PK/PD) model for brivaracetam to children, using an existing population PK model for brivaracetam in children. The scaling was supported by estimating the change from adults to children in the concentration-effect relationship parameters for levetiracetam, a compound interacting with the same target protein (synaptic vesicle protein SV2A). METHODS: The existing adult PK/PD model for brivaracetam was applied to a combined adult-pediatric dataset of levetiracetam...
September 7, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28875477/effects-of-pon1-gene-promoter-dna-methylation-and-genetic-variations-on-the-clinical-outcomes-of-dual-antiplatelet-therapy-for-patients%C3%A2-undergoing-percutaneous-coronary-intervention
#6
He-Ping Lei, Xi-Yong Yu, Hong Wu, Yan-Hong Kang, Wan-Ping Zhong, Li-Yun Cai, Meng-Zhen Zhang, Ji-Yan Chen, Li-Ping Mai, Qing-Shan Ding, Min Yang, Shi-Long Zhong
INTRODUCTION AND OBJECTIVE: The relationship between either paraoxonase 1 (PON1) gene promoter DNA methylation or genetic variations and bleeding or major adverse cardiac events after dual antiplatelet therapy has been incompletely characterized. We aimed to systematically investigate the role of genetic variations and DNA methylation of the PON1 CpG island promoter on the clinical outcomes of dual antiplatelet therapy for patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI)...
September 5, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28866861/effects-of-the-proton-pump-inhibitors-omeprazole-and-pantoprazole-on-the-cytochrome-p450-mediated-metabolism-of-venlafaxine
#7
Maxim Kuzin, Georgios Schoretsanitis, Ekkehard Haen, Benedikt Stegmann, Christoph Hiemke, Gerhard Gründer, Michael Paulzen
BACKGROUND AND OBJECTIVE: An increasing trend in prescribing proton pump inhibitors (PPIs) inevitably increases the risk of unwanted drug-drug interactions (DDIs). The aim of this study was to uncover pharmacokinetic interactions between two PPIs-omeprazole and pantoprazole-and venlafaxine. METHODS: A therapeutic drug monitoring database contained plasma concentrations of venlafaxine and its active metabolite O-desmethylvenlafaxine. We considered three groups: a group of patients who received venlafaxine without confounding medications (non-PPI group, n = 906); a group of patients who were comedicated with omeprazole (n = 40); and a group of patients comedicated with pantoprazole (n = 40)...
September 2, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28861847/population-pharmacokinetics-of-mycophenolic-acid-an-update
#8
REVIEW
Tony K L Kiang, Mary H H Ensom
The most recent comprehensive reviews on the population pharmacokinetics of mycophenolic acid (MPA) were published in 2014. Since then, several population pharmacokinetic studies on MPA have been published. The majority of literature is still focused on the kidney transplant population, although studies have also been conducted in liver and lung transplantation, autoimmune diseases, and hematopoietic stem cell transplant. While the majority of the model building is still based on parametric non-linear mixed-effects modeling, recent studies suggest the suitability of other methodologies...
August 31, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28853050/clinical-pharmacokinetics-and-pharmacodynamics-of-the-epidermal-growth-factor-receptor-inhibitor-panitumumab-in-the-treatment-of-colorectal-cancer
#9
REVIEW
Sander Ketzer, Kirsten Schimmel, Miriam Koopman, Henk-Jan Guchelaar
Despite progress in the treatment of metastatic colorectal cancer (mCRC) in the last 15 years, it is still a condition with a relatively low 5-year survival rate. Panitumumab, a fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFR), is able to prolong survival in patients with mCRC. Panitumumab is used in different lines of therapy in combination with chemotherapy, and as monotherapy for the treatment of wild-type (WT) RAS mCRC. It is administered as an intravenous infusion of 6 mg/kg every 2 weeks and has a t ½ of approximately 7...
August 29, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28849402/pharmacokinetics-and-pharmacodynamics-of-temocillin
#10
REVIEW
Kevin Alexandre, Bruno Fantin
Temocillin, a 6-α-methoxy derivative of ticarcillin, is a forgotten antibiotic that has recently been rediscovered, and issues about clinical breakpoints and optimal therapeutic regimens are still ongoing. Temocillin spectrum is almost restricted to Enterobacteriaceae. The addition of the α-methoxy moiety on ticarcillin confers resistance to hydrolysis by Ambler classes A and C β-lactamases (extended spectrum β-lactamases, Klebsiella pneumoniae carbapenemase and AmpC hyperproduced enzymes). Temocillin is bactericidal, and the effect of inoculum size on its activity is relatively mild...
August 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28819726/population-pharmacokinetics-of-stiripentol-in-paediatric-patients-with-dravet-syndrome-treated-with-stiripentol-valproate-and-clobazam-combination-therapy
#11
Sophie Peigné, Stéphanie Chhun, Michel Tod, Elisabeth Rey, Christelle Rodrigues, Catherine Chiron, Gérard Pons, Vincent Jullien
AIM: The aim of this study was to describe the pharmacokinetics of stiripentol in children with Dravet syndrome and to determine the concentrations of stiripentol achieved in this population for the usual 25 mg/kg twice-daily dose. METHODS: Thirty-five children with epilepsy were included in a prospective population pharmacokinetic study (using MONOLIX software). Four blood samples were drawn per patient. Stiripentol area under the plasma concentration-time curve (AUC) values and trough concentrations were simulated for 7000 theoretical children weighing between 10 and 70 kg for the 25 mg/kg twice-daily dose...
August 17, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28791666/clinical-pharmacokinetics-and-pharmacodynamics-of-micafungin
#12
REVIEW
Roeland E Wasmann, Eline W Muilwijk, David M Burger, Paul E Verweij, Catherijne A Knibbe, Roger J Brüggemann
Micafungin is a selective inhibitor of the synthesis of fungal 1,3-β-D-glucan, an essential component of the fungal cell wall. It is available as a powder for infusion only and is registered for the treatment of invasive and esophageal candidiasis in addition to prophylaxis of Candida infections in both adults and children. Average exposure after a single intravenous 100 mg dose in healthy adults is 133 mg h/L. Both exposure and maximum plasma concentration show linear dose proportional pharmacokinetics (PK) over a 0...
August 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28791593/key-pharmacokinetic-essentials-of-fixed-dosed-combination-products-case-studies-and-perspectives
#13
Ranjeet Prasad Dash, Rana Rais, Nuggehally R Srinivas
Fixed-dose combinations are gaining popularity because they provide convenience while enhancing patient compliance. Literature examples suggest that many fixed-dose combinations are being rationalized and investigated for their potential utility in therapy. This article provides an introspection into the pharmacokinetic essentials that need to be considered prior to implementing a fixed-dose combination strategy. While the drug-drug interaction potential is an important question for the two drugs in a fixed-dose combination, the occurrence of a drug-drug interaction in itself is not a negative outcome for the proposed fixed-dose combination...
August 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28785981/higher-midazolam-clearance-in-obese-adolescents-compared-with-morbidly-obese-adults
#14
Anne van Rongen, Margreke J E Brill, Janelle D Vaughns, Pyry A J Välitalo, Eric P A van Dongen, Bert van Ramshorst, Jeffrey S Barrett, Johannes N van den Anker, Catherijne A J Knibbe
BACKGROUND: The clearance of cytochrome P450 (CYP) 3A substrates is reported to be reduced with lower age, inflammation and obesity. As it is unknown what the overall influence is of these factors in the case of obese adolescents vs. morbidly obese adults, we studied covariates influencing the clearance of the CYP3A substrate midazolam in a combined analysis of data from obese adolescents and morbidly obese adults. METHODS: Data from 19 obese adolescents [102.7 kg (62-149...
August 7, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28779464/evidence-based-design-of-fixed-dose-combinations-principles-and-application-to-pediatric-anti-tuberculosis-therapy
#15
Elin M Svensson, Gunnar Yngman, Paolo Denti, Helen McIlleron, Maria C Kjellsson, Mats O Karlsson
BACKGROUND AND OBJECTIVES: Fixed-dose combination formulations where several drugs are included in one tablet are important for the implementation of many long-term multidrug therapies. The selection of optimal dose ratios and tablet content of a fixed-dose combination and the design of individualized dosing regimens is a complex task, requiring multiple simultaneous considerations. METHODS: In this work, a methodology for the rational design of a fixed-dose combination was developed and applied to the case of a three-drug pediatric anti-tuberculosis formulation individualized on body weight...
August 4, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28779463/the-clinical-pharmacology-of-elotuzumab
#16
REVIEW
Chaitali Passey, Jennifer Sheng, Johanna Mora, Amol Tendolkar, Michael Robbins, Robert Dodge, Amit Roy, Akintunde Bello, Manish Gupta
Novel treatment options are needed to improve long-term outcomes for patients with multiple myeloma (MM). In this article, we comprehensively review the clinical pharmacology of elotuzumab, a first-in-class monoclonal anti-SLAMF7 antibody approved in combination with lenalidomide and dexamethasone (ELd) for the treatment of patients with MM and one to three prior therapies. Elotuzumab has a dual mechanism of action to specifically kill myeloma cells: binding SLAMF7 on myeloma cells facilitates natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC), and direct engagement of SLAMF7 on NK cells further enhances NK cell activity...
August 4, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28779462/improving-pediatric-protein-binding-estimates-an-evaluation-of-%C3%AE-1-acid-glycoprotein-maturation-in-healthy-and-infected-subjects
#17
Anil R Maharaj, Daniel Gonzalez, Michael Cohen-Wolkowiez, Christoph P Hornik, Andrea N Edginton
BACKGROUND: Differences in plasma protein levels observed between children and adults can alter the extent of xenobiotic binding in plasma, resulting in divergent patterns of exposure. OBJECTIVE: This study aims to quantify the ontogeny of α1-acid glycoprotein in both healthy and infected subjects. METHODS: Data pertaining to α1-acid glycoprotein from healthy subjects were compiled over 26 different publications. For subjects diagnosed or suspected of infection, α1-acid glycoprotein levels were obtained from 214 individuals acquired over three clinical investigations...
August 4, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28762136/predicting-cortisol-exposure-from-paediatric-hydrocortisone-formulation-using-a-semi-mechanistic-pharmacokinetic-model-established-in-healthy-adults
#18
Johanna Melin, Zinnia P Parra-Guillen, Niklas Hartung, Wilhelm Huisinga, Richard J Ross, Martin J Whitaker, Charlotte Kloft
BACKGROUND AND OBJECTIVE: Optimisation of hydrocortisone replacement therapy in children is challenging as there is currently no licensed formulation and dose in Europe for children under 6 years of age. In addition, hydrocortisone has non-linear pharmacokinetics caused by saturable plasma protein binding. A paediatric hydrocortisone formulation, Infacort(®) oral hydrocortisone granules with taste masking, has therefore been developed. The objective of this study was to establish a population pharmacokinetic model based on studies in healthy adult volunteers to predict hydrocortisone exposure in paediatric patients with adrenal insufficiency...
July 31, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28762135/pharmacokinetic-optimization-of-everolimus-dosing-in-oncology-a-randomized-crossover-trial
#19
Remy B Verheijen, Florence Atrafi, Jan H M Schellens, Jos H Beijnen, Alwin D R Huitema, Ron H J Mathijssen, Neeltje Steeghs
BACKGROUND: The mammalian target of rapamycin (mTOR) inhibitor everolimus is used in the treatment of breast cancer, neuroendocrine tumors, and renal cancer. The approved 10 mg once-daily dose is associated with considerable adverse effects and it has been suggested that these are associated with the maximum concentration (C max) of everolimus. Twice-daily dosing might be an alternative strategy with improved tolerability; however, a direct pharmacokinetic comparison of 10 mg once-daily with 5 mg twice-daily dosing is lacking...
July 31, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28756612/clinical-pharmacokinetics-of-systemically-administered-antileishmanial-drugs
#20
REVIEW
Anke E Kip, Jan H M Schellens, Jos H Beijnen, Thomas P C Dorlo
This review describes the pharmacokinetic properties of the systemically administered antileishmanial drugs pentavalent antimony, paromomycin, pentamidine, miltefosine and amphotericin B (AMB), including their absorption, distribution, metabolism and excretion and potential drug-drug interactions. This overview provides an understanding of their clinical pharmacokinetics, which could assist in rationalising and optimising treatment regimens, especially in combining multiple antileishmanial drugs in an attempt to increase efficacy and shorten treatment duration...
July 29, 2017: Clinical Pharmacokinetics
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