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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/28791666/clinical-pharmacokinetics-and-pharmacodynamics-of-micafungin
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/28744796/pharmacokinetics-of-abt-122-a-tnf-%C3%AE-and-il-17a-targeted-dual-variable-domain-immunoglobulin-in-healthy-subjects-and-patients-with-rheumatoid-arthritis-results-from-three-phase-i-trials
#10
Amit Khatri, Sandra Goss, Ping Jiang, Heikki Mansikka, Ahmed A Othman
BACKGROUND AND OBJECTIVE: ABT-122 is a dual-variable domain immunoglobulin that neutralizes both tumor necrosis factor-α and interleukin-17A, with the goal of achieving greater clinical efficacy than can be achieved by blocking either cytokine alone. This work characterized the pharmacokinetics of ABT-122 in healthy subjects and in patients with rheumatoid arthritis. METHODS: ABT-122 pharmacokinetics was evaluated in three phase I studies. In Study 1, single intravenous (0...
July 25, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28744795/prediction-of-fetal-darunavir-exposure-by-integrating-human-ex-vivo-placental-transfer-and-physiologically-based-pharmacokinetic-modeling
#11
Stein Schalkwijk, Aaron O Buaben, Jolien J M Freriksen, Angela P Colbers, David M Burger, Rick Greupink, Frans G M Russel
BACKGROUND: Fetal antiretroviral exposure is usually derived from the cord-to-maternal concentration ratio. This static parameter does not provide information on the pharmacokinetics in utero, limiting the assessment of a fetal exposure-effect relationship. OBJECTIVE: The aim of this study was to incorporate placental transfer into a pregnancy physiologically based pharmacokinetic model to simulate and evaluate fetal darunavir exposure at term. METHODS: An existing and validated pregnancy physiologically based pharmacokinetic model of maternal darunavir/ritonavir exposure was extended with a feto-placental unit...
July 25, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28688027/pharmacokinetics-of-fentanyl-and-its-derivatives-in-children-a-comprehensive-review
#12
REVIEW
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...
July 7, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28681225/a-population-pharmacokinetic-model-to-predict-the-individual-starting-dose-of-tacrolimus-following-pediatric-renal-transplantation
#13
Louise M Andrews, Dennis A Hesselink, Teun van Gelder, Birgit C P Koch, Elisabeth A M Cornelissen, Roger J M Brüggemann, Ron H N van Schaik, Saskia N de Wildt, Karlien Cransberg, Brenda C M de Winter
BACKGROUND: Multiple clinical, demographic, and genetic factors affect the pharmacokinetics of tacrolimus in children, yet in daily practice, a uniform body-weight based starting dose is used. It can take weeks to reach the target tacrolimus pre-dose concentration. OBJECTIVES: The objectives of this study were to determine the pharmacokinetics of tacrolimus immediately after kidney transplantation and to find relevant parameters for dose individualization using a population pharmacokinetic analysis...
July 5, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28669130/review-of-the-clinical-pharmacokinetics-and-pharmacodynamics-of-alemtuzumab-and-its-use-in-kidney-transplantation
#14
REVIEW
Marieke van der Zwan, Carla C Baan, Teun van Gelder, Dennis A Hesselink
Alemtuzumab is a humanized monoclonal antibody against CD52 and causes depletion of T and B lymphocytes, monocytes, and NK cells. Alemtuzumab is registered for the treatment of multiple sclerosis (MS) and is also used in chronic lymphocytic leukemia (CLL). Alemtuzumab is used off-label in kidney transplantation as induction and anti-rejection therapy. The objective of this review is to present a review of the pharmacokinetics, pharmacodynamics, and use of alemtuzumab in kidney transplantation. A systematic literature search was conducted using Ovid Medline, Embase, and Cochrane Central Register of controlled trials...
July 1, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28667460/prediction-of-the-effect-of-renal-impairment-on-the-pharmacokinetics-of-new-drugs
#15
Elisa Borella, Italo Poggesi, Paolo Magni
INTRODUCTION: Renal impairment may have a significant impact on the pharmacokinetics of drugs. Ad hoc studies in subjects with renal impairment are required by the regulatory authorities to propose dose adjustments in these subjects, to find a dosing regimen able to provide a systemic exposure similar to those in subjects with a normal renal function given the relevant clinical dose. METHODS: To evaluate the main descriptors and establish a predictive model of the effect of renal impairment on the exposure of new drugs, we considered 73 marketed drugs, for which studies in subjects with different degrees of renal impairment were available in the literature...
June 30, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28667459/clinical-pharmacokinetics-and-pharmacodynamics-of-panobinostat
#16
REVIEW
Mathilde Van Veggel, Elsbeth Westerman, Paul Hamberg
Histone deacetylase (HDAC) inhibitors cause an increase in acetylation that leads to an increase in DNA transcription and accumulation of different proteins, reducing cell proliferation and inducing cell death. Panobinostat is a first-in-line HDAC inhibitor approved for treating multiple myeloma in combination with bortezomib and dexamethasone. It is a pan-deacetylase inhibitor and therefore inhibits not only HDAC but also other deacetylases. The main mechanism of action of panobinostat is to inhibit HDAC, which causes cell cycle arrest and apoptosis, leading to it being an antineoplastic drug...
June 30, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28653144/explaining-ethnic-variability-of-transporter-substrate-pharmacokinetics-in-healthy-asian-and-caucasian-subjects-with-allele-frequencies-of-oatp1b1-and-bcrp-a-mechanistic-modeling-analysis
#17
Rui Li, Hugh A Barton
BACKGROUND: Ethnic variability in the pharmacokinetics of organic anion transporting polypeptide (OATP) 1B1 substrates has been observed, but its basis is unclear. A previous study hypothesizes that, without applying an intrinsic ethnic variability in transporter activity, allele frequencies of transporters cannot explain observed ethnic variability in pharmacokinetics. However, this hypothesis contradicts the data collected from compounds that are OATP1B1 substrates but not breast cancer resistance protein (BCRP) substrates...
June 26, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28639230/intracellular-pharmacokinetics-of-antibacterials-and-their-clinical-implications
#18
REVIEW
Federico Pea
The intracellular pharmacokinetics of the different classes of antimicrobials into surrogate markers of tissue accumulation (alveolar macrophages and/or total alveolar cells collected by means of bronchoalveolar lavage or peripheral white blood cells) was reviewed. The aim of this review was to discuss the clinical implications of the intracellular pharmacokinetics of antibacterials, either from the therapeutic or toxicological perspective. The different pharmacokinetic behaviour of antimicrobials within cells is mainly related to their physicochemical properties (hydrophilicity and lipophilicity), and may have several clinical implications...
June 21, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28639229/pharmacokinetics-of-mhaa4549a-an-anti-influenza-a-monoclonal-antibody-in-healthy-subjects-challenged-with-influenza%C3%A2-a-virus-in-a-phase-iia-randomized-trial
#19
Rong Deng, Ai Ping Lee, Mauricio Maia, Jeremy J Lim, Tracy Burgess, Priscilla Horn, Michael A Derby, Elizabeth Newton, Jorge A Tavel, William D Hanley
BACKGROUND AND OBJECTIVES: MHAA4549A, a human anti-influenza immunoglobulin (Ig) G1 monoclonal antibody, is being developed to treat patients hospitalized for influenza A infection. This study examined the pharmacokinetics (PKs) of MHAA4549A in a phase IIa, randomized, double-blind, dose-ranging trial in healthy volunteers challenged with influenza A virus. METHODS: Serum PK data were collected from 60 subjects in three single-dose groups (400, 1200, or 3600 mg) who received MHAA4549A intravenously 24-36 h after inoculation with the influenza A virus...
June 21, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28634655/effect-of-adherence-on-pharmacokinetic-pharmacodynamic-relationships-of-oral-targeted-anticancer-drugs
#20
Evelina Cardoso, Chantal Csajka, Marie P Schneider, Nicolas Widmer
The emergence of oral targeted anticancer agents transformed several cancers into chronic conditions with a need for long-term oral treatment. Although cancer is a life-threatening condition, oncology medication adherence-the extent to which a patient follows the drug regimen that is intended by the prescriber-can be suboptimal in the long term, as in any other chronic disease. Poor adherence can impact negatively on clinical outcomes, notably because most of these drugs are given as a standard non-individualized dosage despite marked inter-individual variabilities that can lead to toxic or inefficacious drug concentrations...
June 20, 2017: Clinical Pharmacokinetics
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