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Population pharmacokinetics

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https://www.readbyqxmd.com/read/27917261/anti-hepatitis-c-virus-drugs-and-kidney
#1
REVIEW
Paul Carrier, Marie Essig, Marilyne Debette-Gratien, Denis Sautereau, Annick Rousseau, Pierre Marquet, Jérémie Jacques, Véronique Loustaud-Ratti
Hepatitis C virus (HCV) mainly targets the liver but can also induce extrahepatic manifestations. The kidney may be impacted via an immune mediated mechanism or a cytopathic effect. HCV patients are clearly at a greater risk of chronic kidney disease (CKD) than uninfected patients are, and the presence of CKD increases mortality. Interferon-based therapies and ribavirin are difficult to manage and are poorly effective in end-stage renal disease and hemodialysis. These patients should be given priority treatment with new direct anti-viral agents (DAAs) while avoiding peginterferon and ribavirin...
November 18, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/27913319/assessing-the-benefits-of-targeted-drug-delivery-by-nanocarriers-a-partico-pharmacokinetic-framework
#2
Ronald A Siegel, Ameya R Kirtane, Jayanth Panyam
OBJECTIVE: An in vivo kinetic framework is introduced to analyze and predict the quantitative advantage of using nanocarriers to deliver drugs, especially anticancer agents, compared to administering the same drugs in their free form. METHODS: This framework recognizes three levels of kinetics. First is the particokinetics associated with deposition of nanocarriers into tissues associated with drug effect and toxicity, their residence inside those tissues, and elimination of the nanocarriers from the body...
November 29, 2016: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/27911112/treatment-of-alpha-and-beta-herpesvirus-infections-in-solid-organ-transplant-recipients
#3
C L Abad, R R Razonable
Human herpesviruses frequently cause infections in solid organ transplant (SOT) recipients. Areas covered: We provide an overview of the clinical impact of alpha and beta herpesviruses and highlight the mechanisms of action, pharmacokinetics, clinical indications, and adverse effects of antiviral drugs for the management of herpes simplex virus, varicella zoster virus and cytomegalovirus. We comprehensively evaluated key clinical trials that led to drug approval, and served as the foundation for management guidelines...
December 2, 2016: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/27909995/solithromycin-a-novel-fluoroketolide-for-the-treatment-of-community-acquired-bacterial-pneumonia
#4
REVIEW
George G Zhanel, Erika Hartel, Heather Adam, Sheryl Zelenitsky, Michael A Zhanel, Alyssa Golden, Frank Schweizer, Bala Gorityala, Philippe R S Lagacé-Wiens, Andrew J Walkty, Alfred S Gin, Daryl J Hoban, Joseph P Lynch, James A Karlowsky
Solithromycin is a novel fluoroketolide developed in both oral and intravenous formulations to address increasing macrolide resistance in pathogens causing community-acquired bacterial pneumonia (CABP). When compared with its macrolide and ketolide predecessors, solithromycin has several structural modifications which increase its ribosomal binding and reduce its propensity to known macrolide resistance mechanisms. Solithromycin, like telithromycin, affects 50S ribosomal subunit formation and function, as well as causing frame-shift errors during translation...
December 1, 2016: Drugs
https://www.readbyqxmd.com/read/27909942/experiment-design-for-nonparametric-models-based-on-minimizing-bayes-risk-application-to-voriconazole-formula-see-text
#5
David S Bayard, Michael Neely
An experimental design approach is presented for individualized therapy in the special case where the prior information is specified by a nonparametric (NP) population model. Here, a NP model refers to a discrete probability model characterized by a finite set of support points and their associated weights. An important question arises as to how to best design experiments for this type of model. Many experimental design methods are based on Fisher information or other approaches originally developed for parametric models...
December 1, 2016: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/27909740/clinical-pharmacokinetics-of-magnesium-sulfate-in-the-treatment-of-children-with-severe-acute-asthma
#6
Joseph E Rower, Xiaoxi Liu, Tian Yu, Michael Mundorff, Catherine M T Sherwin, Michael D Johnson
PURPOSE: Intravenous (IV) magnesium sulfate (MgSO4) is used as adjunct therapy to treat acute asthma exacerbations. Despite its clinical use, there is a limited understanding of the disposition of magnesium in children. METHODS: To explore the pharmacokinetics (PK) of IV MgSO4 in this population, we collected retrospective data from 54 children who received IV MgSO4 for treatment of an acute asthma exacerbation at Primary Children's Hospital in Salt Lake City, UT...
December 2, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27904098/relationship-between-pk-pd-of-cefepime-and-clinical-outcome-in-febrile-neutropenic-patients-with-normal-renal-function
#7
Yoshiko Yamashita, Hidekazu Kamiyama, Asuka Yamamoto, Hiroki Kanoh, Yoshimitsu Yuhki, Akira Ueda, Yukari Kawamoto, Yoshikazu Gotoh, Satoshi Yamamoto
 The efficacy of cefepime (CFPM) is known to depend on the ratio of the time that the serum levels exceed the minimum inhibitory concentration (MIC) to the dosing interval (%T>MIC). The objective of this study was to clarify the relation between %T>MIC and clinical outcome of CFPM, and to identify the optimal dosage regimen. We investigated the outcome of CFPM treatment for febrile neutropenia (FN) patients with normal renal function. Treatment success was defined as the completion of FN therapy with CFPM only...
2016: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/27903281/improving-the-clinical-management-of-traumatic-brain-injury-through-the-pharmacokinetic-modeling-of-peripheral-blood-biomarkers
#8
Aaron Dadas, Jolewis Washington, Nicola Marchi, Damir Janigro
BACKGROUND: Blood biomarkers of neurovascular damage are used clinically to diagnose the presence severity or absence of neurological diseases, but data interpretation is confounded by a limited understanding of their dependence on variables other than the disease condition itself. These include half-life in blood, molecular weight, and marker-specific biophysical properties, as well as the effects of glomerular filtration, age, gender, and ethnicity. To study these factors, and to provide a method for markers' analyses, we developed a kinetic model that allows the integrated interpretation of these properties...
November 30, 2016: Fluids and Barriers of the CNS
https://www.readbyqxmd.com/read/27901389/population-pharmacokinetics-of-a-single-dose-of-meloxicam-after-oral-and-intramuscular-administration-to-captive-lesser-flamingos-phoeniconaias-minor
#9
Martín A Zordan, Mark G Papich, Ashley A Pich, Katy M Unger, Carlos R Sánchez
OBJECTIVE To determine the pharmacokinetics of a single dose of meloxicam after IM and oral administration to healthy lesser flamingos (Phoeniconaias minor) by use of a population approach. ANIMALS 16 healthy captive lesser flamingos between 1 and 4 years of age. PROCEDURES A single dose of meloxicam (0.5 mg/kg) was administered IM to each bird, and blood samples were collected from birds at 3 (n = 13 birds), 2 (2), or 1 (1) selected point between 0 and 13 hours after administration, with samples collected from birds at each point...
December 2016: American Journal of Veterinary Research
https://www.readbyqxmd.com/read/27898598/pharmacokinetics-of-mycophenolic-acid-and-dose-optimization-in-children-after-intestinal-transplantation
#10
Caroline Barau, Antonio Mellos, Stéphanie Chhun, Florence Lacaille, Valérie Furlan
BACKGROUND: Mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (MPS) are now commonly used in pediatric intestinal transplantation (Tx), but to date, no clear recommendations regarding the dosing regimen have been made in this population. The aim of this study was to determine the MMF/MPS dosage required to achieve an area under the plasma concentration-time curve from 0 to 12 hours (AUC0-12) for mycophenolic acid (MPA) greater than 30 mg.h/L in children after intestinal transplantation...
November 28, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27898515/cost-effectiveness-analysis-of-pharmacokinetic-driven-prophylaxis-vs-standard-prophylaxis-in-patients-with-severe-haemophilia-a
#11
Sergio Iannazzo, Paolo A Cortesi, Roberto Crea, Katharina Steinitz, Lorenzo G Mantovani, Alessandro Gringeri
The objective of this study was to assess the cost-effectiveness of pharmacokinetic-driven prophylaxis in severe haemophilia A patients. A microsimulation model was developed to evaluate the cost-effectiveness of pharmacokinetic-driven prophylaxis vs. standard prophylaxis and estimate cost, annual joint bleed rate (AJBR), and incremental cost-effectiveness ratio over a 1-year time horizon for a hypothetical population of 10 000 severe haemophilia A patients. A dose of 30 IU/kg per 48 h was assumed for standard prophylaxis...
November 24, 2016: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
https://www.readbyqxmd.com/read/27897041/novel-antifungal-agents-a-patent-review-2013-present
#12
María Victoria Castelli, Marcos Gabriel Derita, Silvia Noelí López
Superficial infections involving the skin and mucosa are the most common fungal disease in humans. Fungi can also produce invasive infections (IFI), which are increasing in incidence among the growing population of immunocompromised patients, and are characterized by a high mortality rate. Amphotericin B, new triazoles and echinocandins have improved treatment options in IFI. However, the frequency of less common and more resistant fungi, the limited activity of available antifungal drugs and their undesirable side effects reflect the urgent need for the development of new therapeutic strategies...
November 29, 2016: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/27896938/population-pharmacokinetic-pharmacodynamic-modeling-of-tumor-size-dynamics-in-pembrolizumab-treated-advanced-melanoma
#13
M S Chatterjee, J Elassaiss-Schaap, A Lindauer, D C Turner, A Sostelly, T Freshwater, K Mayawala, M Ahamadi, J A Stone, R de Greef, A G Kondic, D P de Alwis
Pembrolizumab is a potent immune-modulating antibody active in advanced melanoma, as demonstrated in the KEYNOTE-001, -002, and -006 studies. Longitudinal tumor size modeling was pursued to quantify exposure-response relationships for efficacy. A mixture model was first developed based on an initial dataset from KEYNOTE-001 to describe four patterns of tumor growth and shrinkage. For subsequent analyses, tumor size measurements were adequately described by a single consolidated model structure that captured continuous tumor size with a combination of growth and regression terms, as well as a fraction of tumor responsive to therapy...
November 29, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27896690/elucidating-the-plasma-and-liver-pharmacokinetics-of-simeprevir-in-special-populations-using-physiologically-based-pharmacokinetic-modelling
#14
Jan Snoeys, Maria Beumont, Mario Monshouwer, Sivi Ouwerkerk-Mahadevan
The disposition of simeprevir (SMV) in humans is characterised by cytochrome P450 3A4 metabolism and hepatic uptake by organic anion transporting polypeptide 1B1/3 (OATP1B1/3). This study was designed to investigate SMV plasma and liver exposure upon oral administration in subjects infected with hepatitis C virus (HCV), in subjects of Japanese or Chinese origin, subjects with organ impairment and subjects with OATP genetic polymorphisms, using physiologically based pharmacokinetic modelling. Simulations showed that compared with healthy Caucasian subjects, SMV plasma exposure was 2...
November 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27896683/population-pharmacokinetics-of-an-extended-release-formulation-of-exenatide-following-single-and-multiple-dose-administration
#15
Brenda Cirincione, Jeffrey Edwards, Donald E Mager
Exenatide is a glucagon-like peptide-1 receptor agonist with both immediate- and extended-release (ER) formulations that are approved for the treatment of type 2 diabetes mellitus. Long-term exposure from the ER formulation is achieved through slow peptide release from a degradable microsphere formulation. The goal of this analysis was to develop a pharmacokinetic model for the ER formulation following single and once-weekly multiple-dose administration. Pharmacokinetic data were collected from two clinical trials-one that evaluated single-dose administration of 2...
November 28, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27896568/how-can-a-good-idea-fail-basal-insulin-peglispro-ly2605541-for-the-treatment-of-type-2-diabetes
#16
REVIEW
Araceli Muñoz-Garach, María Molina-Vega, Francisco J Tinahones
INTRODUCTION: Lack of control in diabetic patients has stimulated the development of new insulin analogues. One of these was basal insulin peglispro (BIL) or LY2605541; it had a large hydrodynamic size, flat pharmacokinetic profile, half life of 2-3 days and acted preferably in the liver. METHODS: We reviewed the recent literature examining the pharmacokinetics, pharmacodynamics, efficacy and safety of BIL treatment in type 2 diabetes patients. RESULTS: The pharmacodynamic and pharmacokinetic outline of BIL seemed to have an advantage over neutral protamine Hagedorn and glargine insulins...
November 28, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/27895016/are-prophylactic-and-therapeutic-target-concentrations-different-the-case-of-lopinavir-ritonavir-or-lamivudine-administered-to-infants-for-the-prevention-of-mother-to-child-hiv-1-transmission-during-breastfeeding
#17
Frantz Foissac, Jörn Blume, Jean-Marc Tréluyer, Thorkild Tylleskär, Chipepo Kankasa, Nicolas Meda, James K Tumwine, Mandisa Singata-Madliki, Kim Harper, Silvia M Illamola, Naïm Bouazza, Nicolas Nagot, Philippe Van de Perre, Stéphane Blanche, Déborah Hirt
The ANRS 12174 trial assessed the efficacy and tolerance of LPV/r versus 3TC prophylaxis administered to breastfed infants, whose HIV-infected mothers were not on ART. In this sub-study, we assessed LPV/r and 3TC pharmacokinetics to evaluate the percentage of infants with therapeutic plasma concentrations and to discuss these data in the context of a prophylactic treatment. Infants from the South African trial site underwent blood sampling for pharmacokinetic study at week 6, 26 and 38 of life. We applied a Bayesian approach to derive the 3TC and LPV pharmacokinetic parameters based on previously published pharmacokinetic models for HIV-infected children...
November 28, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27891230/development-of-a-population-pharmacokinetic-model-of-prucalopride-in-children-with-functional-constipation
#18
Erno van Schaick, Marc A Benninga, Amy Levine, Mats Magnusson, Steven Troy
A recent phase 3 trial of prucalopride in children with functional constipation (SPD555-303 ClinicalTrials.gov Identifier: NCT01330381) reported negative efficacy results. Here, we developed a population pharmacokinetic (PK) model of prucalopride in children to assess prucalopride exposure in SPD555-303. An initial population PK model in children was developed based on sampled single-dose data from a phase 1 study (PRU-USA-12). This model was subsequently updated with sampled data from SPD555-303 and used to simulate plasma concentration-time profiles for children aged 6 months to 18 years who were treated once daily with prucalopride 0...
August 2016: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/27890817/sec-butylpropylacetamide-spd-a-new-amide-derivative-of-valproic-acid-for-the-treatment-of-neuropathic-and-inflammatory-pain
#19
Dan Kaufmann, Peter J West, Misty D Smith, Boris Yagen, Meir Bialer, Marshall Devor, H Steve White, K C Brennan
Chronic pain is a multifactorial disease comprised of both inflammatory and neuropathic components that affect ∼20% of the world's population. sec-Butylpropylacetamide (SPD) is a novel amide analogue of valproic acid (VPA) previously shown to possess a broad spectrum of anticonvulsant activity. In this study we defined the pharmacokinetic parameters of SPD in rat and mouse, and then evaluated its antinociceptive potential in neuropathic and acute inflammatory pain models. In the sciatic nerve ligation (SNL) model of neuropathic pain, SPD was equipotent to gabapentin and more potent than its parent compound VPA...
November 24, 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/27889876/population-pharmacokinetic-pharmacodynamic-modeling-of-5-fluorouracil-for-toxicities-in-rats
#20
Shinji Kobuchi, Yukako Ito, Toshiyuki Sakaeda
BACKGROUND AND OBJECTIVES: Myelosuppression is a dose-limiting toxicity of 5-fluorouracil (5-FU). Predicting the inter- and intra-patient variability in pharmacokinetics and toxicities of 5-FU may contribute to the individualized medicine. This study aimed to establish a population pharmacokinetic-pharmacodynamic model that could evaluate the inter- and intra-individual variability in the plasma 5-FU concentration, 5-FU-induced body weight loss and myelosuppression in rats. METHOD: Plasma 5-FU concentrations, body weight loss, and blood cell counts in rats following the intravenous administration of various doses of 5-FU for 4 days were used to develop the population pharmacokinetic-pharmacodynamic model...
November 26, 2016: European Journal of Drug Metabolism and Pharmacokinetics
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