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https://www.readbyqxmd.com/read/29788329/pharmacokinetic-and-pharmacodynamic-properties-of-metronidazole-in-pediatric-patients-with-acute-appendicitis-a-prospective-study
#1
Jason Child, Xinhui Chen, Rakesh D Mistry, Stig Somme, Christine MacBrayne, Peter L Anderson, Ronald N Jones, Sarah K Parker
Background: Metronidazole is traditionally dosed every 6-8 hours even though in adults it has a long half-life, concentration-dependent killing, and 3-hour postantibiotic effect. Based on this logic, some pediatric hospitals adopted once-daily dosing for appendicitis, despite limited pharmacokinetics-pharmacodynamics (PK/PD) in children. We studied pediatric patients with appendicitis given metronidazole once daily to determine whether this dosing would meet target area under the curve (AUC)/minimum inhibitory concentration (MIC) ratio of ≥70 for Bacteroides fragilis...
May 16, 2018: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/29786422/mechanisms-regulating-the-association-of-protein-phosphatase-1-with-spinophilin-and-neurabin
#2
Michael C Edler, Asma B Salek, Darryl S Watkins, Harjot Kaur, Cameron W Morris, Bryan K Yamamoto, Anthony J Baucum
Protein phosphorylation is a key mediator of signal transduction, allowing for dynamic regulation of substrate activity. Whereas protein kinases obtain substrate specificity by targeting specific amino acid sequences, serine/threonine phosphatase catalytic subunits are much more promiscuous in their ability to dephosphorylate substrates. To obtain substrate specificity, serine/threonine phosphatases utilize targeting proteins to regulate phosphatase subcellular localization and catalytic activity. Spinophilin and its homolog neurabin are two of the most abundant dendritic spine-localized protein phosphatase 1 (PP1) targeting proteins...
May 22, 2018: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/29782406/population-pharmacokinetics-and-pharmacodynamics-of-dexmedetomidine-in-children-undergoing-ambulatory-surgery
#3
María-Gabriela Pérez-Guillé, Alejandra Toledo-López, Liliana Rivera-Espinosa, Radames Alemon-Medina, Chiharu Murata, Ismael Lares-Asseff, Juan Luis Chávez-Pacheco, Josefina Gómez-Garduño, Ana-Lilia Zamora Gutiérrez, Claudia Orozco-Galicia, Karina Ramírez-Morales, Gustavo Lugo-Goytia
BACKGROUND: Dexmedetomidine (DEX) is an α-2 adrenergic agonist with sedative and analgesic properties. Although not approved for pediatric use by the Food and Drug Administration, DEX is increasingly used in pediatric anesthesia and critical care. However, very limited information is available regarding the pharmacokinetics of DEX in children. The aim of this study was to investigate DEX pharmacokinetics and pharmacodynamics (PK-PD) in Mexican children 2-18 years of age who were undergoing outpatient surgical procedures...
May 17, 2018: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29778180/pharmacokinetic-pharmacodynamic-assessment-of-cefquinome-against-actinobacillus-pleuropneumoniae-in-a-piglet-tissue-cage-infection-model
#4
Longfei Zhang, Xun Wu, Zilong Huang, Nan Zhang, Yuzhi Wu, Qinren Cai, Xiangguang Shen, Huanzhong Ding
To evaluate the relationship between the pharmacokinetic/pharmacodynamic (PK/PD) parameters and the antibacterial effect of cefquinome against Actinobacillus pleuropneumoniae, a tissue cage infection model was established in piglets. In this model, an initial count of A. pleuropneumoniae of approximately 106 CFU/mL was exposed to different concentrations of cefquinome after multiple administration at dosages of 0.2, 0.4, 0.8, 1, 2, 4 mg/kg body weight once a day for 3 days. Concentration of cefquinome and bacterial numbers of A...
June 2018: Veterinary Microbiology
https://www.readbyqxmd.com/read/29777529/pharmacokinetics-of-ads-5102-amantadine-extended-release-capsules-administered-once-daily-at-bedtime-for-the-treatment-of-dyskinesia
#5
Robert A Hauser, Rajesh Pahwa, William A Wargin, Cindy J Souza-Prien, Natalie McClure, Reed Johnson, Jack T Nguyen, Rajiv Patni, Gregory T Went
BACKGROUND: Preclinical and clinical studies suggest amantadine immediate-release (IR) may reduce dyskinesia in Parkinson's disease (PD), although higher doses are associated with increased CNS adverse events (AEs). ADS-5102 is an extended release amantadine capsule formulation, designed for once-daily dosing at bedtime (qhs) to provide high concentrations upon waking and throughout the day, with lower concentrations in the evening. The pharmacokinetics (PK) of ADS-5102 were assessed in two phase I studies in healthy subjects, and a blinded, randomized phase II/III dose-finding study in PD patients...
May 18, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29776710/pharmacokinetics-pharmacodynamics-computer-decision-support-technologies-and-antimicrobial-stewardship-the-compass-and-rudder
#6
REVIEW
Robert C Owens, Catharine C Bulik, David R Andes
The first guidelines for conducting antimicrobial stewardship in the hospitalized setting were published in 2007. These guidelines recommend that stewardship programs employ the science of pharmacokinetics-pharmacodynamics (PK-PD) as well as adopting computerized decision support technologies when possible. The United States Food and Drug Administration have adopted PK-PD as a cornerstone in the evaluation of antimicrobial agents during clinical development. The core principles of PK-PD center around describing the relationship between drug exposure indexed to the susceptibility of the infecting bacterial pathogen and patient response...
April 13, 2018: Diagnostic Microbiology and Infectious Disease
https://www.readbyqxmd.com/read/29776017/pharmacokinetics-and-c-reactive-protein-modelling-of-anti-il-6-antibody-pf-04236921-in-healthy-volunteers-and-patients-with-autoimmune-disease
#7
Cheryl Li, Satoshi Shoji, Jean Beebe
AIMS: The purpose of this study was to characterize pharmacokinetics (PK) of PF-04236921, a novel anti-IL-6 monoclonal antibody, and its pharmacokinetics/pharmacodynamics (PK/PD) relationship on serum C-Reactive Protein (CRP) in healthy volunteers and patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Crohn's disease (CD) METHODS: Population modelling analyses were conducted using nonlinear mixed effects modelling. Data from 2 phase 1 healthy volunteer studies, a phase 1 RA study, a Phase 2 CD study, and a Phase 2 SLE study were included...
May 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29773891/assessing-the-feasibility-of-neutralizing-osteopontin-with-various-therapeutic-antibody-modalities
#8
Vahid Farrokhi, Jeffrey R Chabot, Hendrik Neubert, Zhiyong Yang
Osteopontin is a secreted glycophosphoprotein that is highly implicated in many physiological and pathological processes such as biomineralization, cell-mediated immunity, inflammation, fibrosis, cell survival, tumorigenesis and metastasis. Antibodies against osteopontin have been actively pursued as potential therapeutics for various diseases by pharmaceutical companies and academic laboratories. Many studies have demonstrated the efficacy of osteopontin inhibition in a variety of preclinical models of diseases such as rheumatoid arthritis, cancer, nonalcoholic steatohepatitis, but clinical utility has not yet been demonstrated...
May 17, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29773888/antitumor-effect-of-axitinib-combined-with-dopamine-and-pk-pd-modeling-in-the-treatment-of-human-breast-cancer-xenograft
#9
Yuan-Heng Ma, Si-Yuan Wang, Yu-Peng Ren, Jian Li, Ting-Jie Guo, Wei Lu, Tian-Yan Zhou
Rising evidence has shown the development of resistance to vascular endothelial growth factor receptor (VEGFR) inhibitors in the practices of cancer therapy. It is reported that the efficacy of axitinib (AX), a VEGFR inhibitor, is limited in the treatment of breast cancer as a single agent or in combination with other chemotherapeutic drugs due to the probability of rising population of cancer stem-like cells (CSCs) caused by AX. The present study evaluated the effect of dopamine (DA) improving AX's efficacy on MCF-7/ADR breast cancer in vitro and in vivo, and developed a pharmacokinetic-pharmacodynamic (PK-PD) model describing the in vivo experimental data and characterizing the interaction of effect between AX and DA...
May 17, 2018: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/29773068/pharmacokinetic-and-pharmacodynamic-relationship-of-blinatumomab-in-patients-with-non-hodgkin-lymphoma
#10
Youssef Hijazi, Matthias Klinger, Andrea Kratzer, Benjamin Wu, Patrick A Baeuerle, Peter Kufer, Andreas Wolf, Dirk Nagorsen, Min Zhu
OBJECTIVE: We describe the relationship between pharmacokinetics (PK) of blinatumomab and pharmacodynamic (PD) changes in peripheral lymphocytes, serum cytokines, and tumor size in patients with non-Hodgkin lymphoma (NHL). METHODS: In a phase 1 study, 76 patients with relapsed/refractory NHL received blinatumomab by continuous intravenous infusion at various doses (0.5 to 90 µg/m2/day). PD changes were analyzed with respect to dose, blinatumomab concentration at steady state (Css), and cumulative area under the concentration-versus-time curve (AUCcum)...
May 17, 2018: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/29770901/factors-impacting-unbound-vancomycin-concentrations-in-neonates-and-young-infants
#11
Anne Smits, Steven Pauwels, Matthijs Oyaert, Nele Peersman, Isabel Spriet, Veroniek Saegeman, Karel Allegaert
Vancomycin pharmacokinetic (PK) and pharmacodynamic (PD) data in neonates are based on total concentrations. However, only unbound vancomycin is pharmacologically active. The objective was to determine vancomycin protein binding and the covariates impacting unbound vancomycin concentration in neonates and young infants. In neonates and young infants to whom vancomycin was administered intermittently for medical indications, total and unbound vancomycin plasma concentrations were determined using LC-MS/MS. Sampling occurred randomly during vancomycin exposure, covering a broad range of concentrations...
May 16, 2018: European Journal of Clinical Microbiology & Infectious Diseases
https://www.readbyqxmd.com/read/29770552/variability-of-insulin-degludec-and-glargine-u300-a-matter-of-methodology-or-just-marketing
#12
Tim Heise, Sascha Heckermann, J Hans DeVries
The variability in the time-action profiles of insulin preparations, in particular basal insulins, has been a matter of debate ever since the publication of a glucose clamp study comparing the day-to-day variability of three different basal insulins (glargine U100, detemir and NPH) in 2004 [1]. While critics did not contest the findings of a lower variability of some basal insulins in this and a later [2] glucose clamp study, they did question the relevance of a lower pharmacokinetic (PK) and pharmacodynamic (PD) variability for clinical endpoints [3, 4]...
May 17, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29768083/sebo-pharmacokinetics-a-proposed-percutaneous-sebum-egression-method
#13
Rasika Reddy, John Havens Cary, Akram Elmahdy, Howard Maibach
BACKGROUND/AIMS: The sebaceous gland is widely believed a critical factor in the pathogenesis of acne vulgaris. Although extensive studies document the ability of oral and topical treatments to improve acne, little is known about the quantification and mechanism of drug delivery via the sebaceous gland. A percutaneous egression method presents a way to study how drugs reaching the bloodstream can enter the skin. METHODS: A literature search was performed across databases (PubMed, Embase, and Google Scholar) and the University of California, San Francisco (UCSF) textbook library with relevant search terms...
May 16, 2018: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/29768060/seek-and-destroy-improving-pk-pd-profiles-of-anticancer-agents-with-nanoparticles
#14
Anne Rodallec, Raphaelle Fanciullino, Bruno Lacarelle, Joseph Ciccolini
The Pharmacokinetics/pharmacodynamics (PK/PD) relationships with cytotoxics are usually based on a steepening concentration-effect relationship; the greater the drug amount, the greater the effect. The Maximum Tolerated Dose paradigm, finding the balance between efficacy while keeping toxicities at their manageable level, has been the rule of thumb over the last 50-years. Developing nanodrugs is an appealing strategy to help broaden this therapeutic window. The fact that efficacy and toxicity with cytotoxics are intricately linked is primarily due to the complete lack of specificity towards the tumor tissue during their distribution phase...
May 16, 2018: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/29766633/empagliflozin-as-adjunct-to-insulin-in-japanese-participants-with-type-1-diabetes-results-of-a-4-week-double-blind-randomized-placebo-controlled-phase-2-trial
#15
Akira Shimada, Toshiaki Hanafusa, Atsutaka Yasui, Ganghyuck Lee, Yusuke Taneda, Akiko Sarashina, Kosuke Shiki, Jyothis George, Nima Soleymanlou, Jan Marquard
AIMS: This phase 2, double-blind, randomized, placebo-controlled trial (4 sites in Japan) investigated the pharmacodynamics (PD), pharmacokinetics (PK), and safety profile of empagliflozin in Japanese participants with type 1 diabetes mellitus (T1DM) as adjunctive therapy to insulin. MATERIALS AND METHODS: Participants on multiple daily injections of insulin for ≥12 months with an HbA1c of 7.5%-10.0%, entered a 2-week, open-label, placebo run-in period followed by a 4-week, double-blind period where participants were randomized 1:1:1:1 to receive empagliflozin 2...
May 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29766540/gaps-in-predicting-clinical-doses-for-cannabinoids-therapy-overview-of-issues-for-pharmacokinetics-and-pharmacodynamics-modelling
#16
REVIEW
Zheng Liu, Jennifer H Martin
AIM: Model-based prediction on clinical doses for cannabinoids therapy is beneficial in the clinical setting, especially for seriously ill patients with both altered pharmacokinetics and pharmacodynamic responses. The objective of this article is to review the currently available PK and/or PD models of Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to highlight the major issues for modelling this complex therapeutic area. METHODS: A systematic search was conducted in the electronic databases PubMed and EMBASE using the key words "cannabis", "cannabinoid", "tetrahydrocannabinol", "THC", "cannabidiol", "CBD", "pharmacokinetic model", "pharmacodynamics model" and their combinations...
May 16, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29766208/-adequate-anti-infective-treatment-importance-of-individual-dosing-and-application
#17
A Brinkmann, A C Röhr, A Köberer, T Fuchs, W A Krüger, C König, D Richter, M A Weigand, O R Frey
Sepsis-induced changes in pharmacokinetic parameters are a well-known problem in intensive care medicine. Dosing of antibiotics in this setting is therefore challenging. Alterations to the substance-specific kinetics of anti-infective substances have an effect on the distribution and excretion processes in the body. Increased clearance and an increased distribution volume (Vd ) and particularly compromized organ function with reduced antibiotic elimination are often encountered in patients with sepsis. Renal replacement treatment, which is frequently used in intensive care medicine, represents a substantial intervention in this system...
May 15, 2018: Der Anaesthesist
https://www.readbyqxmd.com/read/29765318/utility-of-a-novel-three-dimensional-and-dynamic-3dd-cell-culture-system-for-pk-pd-studies-evaluation-of-a-triple-combination-therapy-at-overcoming-anti-her2-treatment-resistance-in-breast-cancer
#18
Anusha Ande, Tanaya R Vaidya, Bao N Tran, Michael Vicchiarelli, Ashley N Brown, Sihem Ait-Oudhia
Background: Emergence of Human epidermal growth factor receptor 2 (HER2) therapy resistance in HER2-positive (HER2+) breast cancer (BC) poses a major clinical challenge. Mechanisms of resistance include the over-activation of the PI3K/mTOR and Src pathways. This work aims to investigate a novel combination therapy that employs paclitaxel (PAC), a mitotic inhibitor, with everolimus (EVE), an mTOR inhibitor, and dasatinib (DAS), an Src kinase inhibitor, as a modality to overcome resistance. Methods: Static (two dimensional, 2D) and three-dimensional dynamic (3DD) cell culture studies were conducted using JIMT-1 cells, a HER2+ BC cell line refractory to HER2 therapies...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29762861/pharmacokinetic-pharmacodynamic-analysis-of-isavuconazole-against-aspergillus-spp-and-candida-spp-in-healthy-subjects-and-patients-with-hepatic-or-renal-impairment-by-monte-carlo-simulation
#19
Xiaowei Zheng, Gaoqi Xu, Liqin Zhu, Luo Fang, Yiwen Zhang, Haiying Ding, Yinghui Tong, Jiao Sun, Ping Huang
The aim of this pharmacokinetic/pharmacodynamic (PK/PD) study is to evaluate the efficacy of various isavuconazole dosing regimens for healthy individuals and patients with hepatic or renal impairment against Aspergillus spp. and Candida spp. Monte Carlo simulations were conducted using pharmacokinetic (PK) parameters and pharmacodynamics (PD) data to determine the probabilities of target attainment and cumulative fractions of response in terms of area under the concentration curve/minimum inhibition concentration (AUC/MIC) targets of isavuconazole...
May 15, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29762386/exposure-response-analysis-of-micafungin-in-neonatal-candidiasis-pooled-analysis-of-two-clinical-trials
#20
Laura L Kovanda, Thomas J Walsh, Daniel K Benjamin, Antonio Arrieta, David A Kaufman, P Brian Smith, Paolo Manzoni, Amit V Desai, Atsunori Kaibara, Peter L Bonate, William W Hope
BACKGROUND: Neonatal candidiasis causes significant morbidity and mortality in high risk infants. The micafungin dosage regimen of 10 mg/kg established for the treatment of neonatal candidiasis is based on a laboratory animal model of neonatal hematogenous Candida meningoencephalitis and pharmacokinetic (PK)-pharmacodynamic (PD) bridging studies. However, little is known about the how these PK-PD data translate clinically. METHODS: Micafungin plasma concentrations from infants were used to construct a population PK model using Pmetrics software...
June 2018: Pediatric Infectious Disease Journal
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