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https://www.readbyqxmd.com/read/29024493/pharmacokinetics-and-pharmacodynamics-of-meloxicam-in-east-asian-populations-the-role-of-ethnicity-on-drug-response
#1
T Aoyama, Y Ishida, M Kaneko, A Miyamoto, Y Saito, M Tohkin, S Kawai, Y Matsumoto
We aimed to reanalyze the differences in the pharmacokinetics (PKs) of meloxicam in East Asian populations based on a population approach using previously published data and to investigate the factors found in population pharmacokinetic (PK) analysis that affect the pharmacodynamics (PDs) of meloxicam. Population PK analysis was performed in 119 healthy male subjects (30 Japanese, 30 Chinese, 29 Korean, and 30 Caucasian) under strictly controlled trial conditions with regulated meals and a single lot of the drug...
October 12, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28993331/evaluation-of-pk-pd-model-based-optimized-combination-regimens-against-multidrug-resistant-pseudomonas-aeruginosa-in-a-murine-thigh-infection-model-using-humanized-dosing-schemes
#2
Rajbharan Yadav, Jürgen B Bulitta, Jiping Wang, Roger L Nation, Cornelia B Landersdorfer
We previously optimized imipenem and tobramycin combination regimens against a double-resistant clinical P. aeruginosa isolate using in vitro infection models, mechanism-based PK/PD modeling (MBM) and Monte Carlo simulations. The current study aimed to evaluate these regimens in a neutropenic murine thigh infection model and to characterize the time-course of bacterial killing and regrowth via MBM. We studied monotherapies and combinations of imipenem with tobramycin in vivo against the double-resistant clinical P...
October 9, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28993326/a-dynamic-stress-model-explains-the-delayed-drug-effect-in-artemisinin-treatment-of-plasmodium-falciparum
#3
Pengxing Cao, Nectarios Klonis, Sophie Zaloumis, Con Dogovski, Stanley C Xie, Sompob Saralamba, Lisa J White, Freya J I Fowkes, Leann Tilley, Julie A Simpson, James M McCaw
Artemisinin resistance constitutes a major threat to the continued success of control programs for malaria, particularly in light of developing resistance to partner drugs. Improving our understanding of how artemisinin-based drugs act and how resistance manifests is essential for the optimisation of dosing regimens and the development of strategies to prolong the lifespan of current first-line treatment options. Recent short drug-pulse in vitro experiments have shown that the parasite killing rate depends not only on drug concentration but also the exposure time, challenging the standard pharmacokinetic-pharmacodynamic(PK-PD) paradigm in which the killing rate depends only on drug concentration...
October 9, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28988505/clinical-and-pharmacokinetic-drug-evaluation-of-delafloxacin-for-the-treatment-of-acute-bacterial-skin-and-skin-structure-infections
#4
Matteo Bassetti, Davide Pecori, Piergiorgio Cojutti, Federico Pea
In the era of multi-drug resistant pathogens, the adequate treatment of skin and skin structure infections remains a challenge for clinicians. Delafloxacin, with its broad spectrum against Gram-positive, Gram-negative and anaerobic organisms, represents a new therapeutic option in this setting, especially when coverage of methicillin-resistant Staphylococcus aureus is required in the empirical or targeted approach. Areas covered: In this drug evaluation, the Authors have reviewed the pharmacokinetic and pharmacodynamic characteristics of delafloxacin...
October 9, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28982394/leishmania-and-other-intracellular-pathogens-selectivity-drug-distribution-and-pk-pd
#5
Simon L Croft
New drugs and treatments for diseases caused by intracellular pathogens, such as leishmaniasis and the Leishmania species, have proved to be some of the most difficult to discover and develop. The focus of discovery research has been on the identification of potent and selective compounds that inhibit target enzymes (or other essential molecules) or are active against the causative pathogen in phenotypic in vitro assays. Although these discovery paradigms remain an essential part of the early stages of the drug R & D pathway, over the past two decades additional emphasis has been given to the challenges needed to ensure that the potential anti-infective drugs distribute to infected tissues, reach the target pathogen within the host cell and exert the appropriate pharmacodynamic effect at these sites...
October 6, 2017: Parasitology
https://www.readbyqxmd.com/read/28980026/-bacterial-sepsis-diagnostics-and-calculated-antibiotic-therapy
#6
REVIEW
D C Richter, A Heininger, T Brenner, M Hochreiter, M Bernhard, J Briegel, S Dubler, B Grabein, A Hecker, W A Krüger, K Mayer, M W Pletz, D Störzinger, N Pinder, T Hoppe-Tichy, S Weiterer, S Zimmermann, A Brinkmann, M A Weigand, Christoph Lichtenstern
The mortality of patients with sepsis and septic shock is still unacceptably high. An effective antibiotic treatment within 1 h of recognition of sepsis is an important target of sepsis treatment. Delays lead to an increase in mortality; therefore, structured treatment concepts form a rational foundation, taking relevant diagnostic and treatment steps into consideration. In addition to the assumed focus and individual risks of each patient, local resistance patterns and specific problem pathogens must be taken into account for selection of anti-infection treatment...
October 4, 2017: Der Anaesthesist
https://www.readbyqxmd.com/read/28975652/pharmacological-versus-classical-approaches-in-the-design-of-first-in-man-clinical-drug-trials
#7
Cornelis A van den Bogert, Adam F Cohen, Hubert G M Leufkens, Joop M A van Gerven
AIMS: To investigate the role of pharmacology in the design of first in man (FIM) trials in the Netherlands, and to evaluate the change in design approaches between 2007 and 2015. METHODS: All FIM drug trials approved by all Dutch Institutional Review Boards (IRBs) in 2007 and in 2015 were selected. The original trial protocols, investigator's brochures and investigational medicinal product dossiers were the data sources. The design elements preclinical information, dose calculation, endpoints and dose escalation were assessed on the justification of the chosen approaches...
October 4, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28974368/correlation-of-pharmacokinetics-and-brain-penetration-data-of-adult-zebrafish-with-higher-mammals-including-humans
#8
Pushkar Kulkarni, Raghavender Medishetti, Nagaraju Nune, Swapna Yellanki, Vijaykumar Sripuram, Pallavi Rao, Dharmarajan Sriram, Uday Saxena, Srinivas Oruganti, Perumal Yogeeswari
INTRODUCTION: Adult zebrafish pharmacology is evolving rapidly for creating efficacy and safety models for drug discovery. However, there is very limited research in understanding pharmacokinetics (PK) in adult zebrafish. Methods for understanding PK will help in conducting pharmacokinetic - pharmacodynamic (PK-PD) correlations and improving the quality and applicability of data obtained using zebrafish. METHODS: We conducted adult zebrafish PK and brain penetration studies on two known compounds (irinotecan and lorcaserin) with distinct PK and brain penetration properties using validated LCMS/MS method...
September 30, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28971281/model-informed-pediatric-development-applied-to-bilastine-ontogenic-pk-model-development-dose-selection-for-first-time-in-children-and-pk-study-design
#9
Valvanera Vozmediano, Ander Sologuren, John C Lukas, Nerea Leal, Mónica Rodriguez
PURPOSE: Bilastine is an H1 antagonist whose pharmacokinetics (PK) and pharmacodynamics (PD) have been resolved in adults with a therapeutic oral dose of 20 mg/day. Bilastine has favorable characteristics for use in pediatrics but the PK/PD and the optimal dose in children had yet to be clinically explored. The purpose is to: (1) Develop an ontogenic predictive model of bilastine PK linked to the PD in adults by integrating current knowledge; (2) Use the model to design a PK study in children; (3) Confirm the selected dose and the study design through the evaluation of model predictability in the first recruited children; (4) Consider for inclusion the group of younger children (< 6 years)...
October 2, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28968675/pharmacodynamics-of-the-novel-antifungal-agent-f901318-for-acute-sinopulmonary-aspergillosis-caused-by-aspergillus-flavus
#10
Clara E Negri, Adam Johnson, Laura McEntee, Helen Box, Sarah Whalley, Julie A Schwartz, V Ramos-Martín, Joanne Livermore, Ruwanthi Kolamunnage-Dona, Arnaldo L Colombo, William W Hope
Background: Aspergillus flavus is one of the most common agents of invasive aspergillosis and is associated with high mortality. The orotomides are a new class of antifungal agents with a novel mechanism of action. An understanding of the pharmacodynamics of the lead compound F901318 is required to plan safe and effective regimens for clinical use. Methods: The pharmacokinetics (PK) and pharmacodynamics (PD) of F901318 were evaluated by developing new in vitro and in vivo models of invasive fungal sinusitis...
September 12, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28967873/assessment-of-skin-permeability-to-topically-applied-drugs-by-skin-impedance-and-admittance
#11
Simon Schwingenschuh, Hermann Scharfetter, Orjan Grottem Martinsen, Beate Boulgaropoulos, Thomas Augustin, Katrin Tiffner, Christian Dragatin, Reingard Raml, Christian Hoefferer, Eva-Christina Prandl, Frank Sinner, Martin Hajnsek
<b>Objective </b> Pharmacokinetic and pharmacodynamic studies of topically applied drugs are commonly performed by sampling of interstitial fluid with dermal open flow microperfusion and subsequent analysis of the samples. However, the reliability of results from the measured concentration-time profile of the penetrating drug suffers from highly variable skin permeability to topically applied drugs that is mainly caused by inter- and intra-subject variations of the stratum corneum. Thus, statistically significant results can only be achieved by performing high numbers of experiments...
October 2, 2017: Physiological Measurement
https://www.readbyqxmd.com/read/28964956/in-vivo-infection-models-in-the-pre-clinical-pharmacokinetic-pharmacodynamic-evaluation-of-antimicrobial-agents
#12
REVIEW
David R Andes, Alex J Lepak
Animal infection models serve a critical role in the pre-clinical development of antimicrobials. Thoughtful use of these tools can be useful to design and de-risk subsequent clinical trials. Specifically, pharmacokinetic/pharmacodynamic (PK/PD) evaluation of antimicrobials can define the PK/PD driver and target magnitude. In doing so they provide guidance for dosing regimen design and forecast the likelihood of success against target pathogens at the infection site of interest. This review outlines the key design features to consider for successful assessment of experimental output...
September 28, 2017: Current Opinion in Pharmacology
https://www.readbyqxmd.com/read/28962026/pharmacodynamics-of-teicoplanin-against-mrsa
#13
V Ramos-Martín, A Johnson, L McEntee, N Farrington, K Padmore, P Cojutti, F Pea, M N Neely, W W Hope
Objectives: The overall study aim was to identify the relevant preclinical teicoplanin pharmacokinetic (PK)/pharmacodynamic (PD) indices to predict efficacy and suppression of resistance in MRSA infection. Methods: A hollow-fibre infection model and a neutropenic murine thigh infection model were developed. The PK/PD data generated were modelled using a non-parametric population modelling approach with Pmetrics. The posterior Bayesian estimates derived were used to study the exposure-effect relationships...
September 11, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28950814/optimising-%C3%AE-lactam-dosing-in-neonates-a-review-of-pharmacokinetics-drug-exposure-and-pathogens
#14
Aline Fuchs, Grace Li, Johannes Van Den Anker, Julia Bielicki
BACKGROUND: β-lactams are among the most frequently prescribed antibiotics for the treatment of neonatal sepsis. Survival of extremely preterm neonates necessitates an improved understanding of how β-lactams should be used in this vulnerable population. Appropriate dosing regimens for neonates remain unclear. We reviewed available data on the pharmacokinetics (PK) of β-lactam drugs in neonates. Pharmacokinetic/pharmacodynamic (PK/PD) efficacy index surrogates and minimum inhibitory concentrations (MICs) used to support dosing regimens recommendation in the studies were also investigated...
September 25, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28948652/pharmacokinetic-changes-of-antibiotic-antiviral-antituberculosis-and-antifungal-agents-during-extracorporeal-membrane-oxygenation-in-critically-ill-adult-patients
#15
REVIEW
J Hahn, J H Choi, M J Chang
WHAT IS KNOWN AND OBJECTIVE: Extracorporeal membrane oxygenation (ECMO) is a life-saving system used for critically ill patients with cardiac and/or respiratory failure. The pharmacokinetics (PK) of drugs can change in patients undergoing ECMO, which can result in therapeutic failure or drug toxicity requiring further management of drug complications. In this review, we discussed changes in the PK of antibiotic, antiviral, antituberculosis and antifungal agents administered to adult patients on ECMO...
September 25, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28947475/pharmacokinetics-pharmacodynamics-of-tazobactam-in-combination-with-cefepime-in-an-in-vitro-infection-model
#16
Brian D VanScoy, David Tenero, Simon Turner, David M Livermore, Jennifer McCauley, Haley Conde, Sujata M Bhavnani, Christopher M Rubino, Paul G Ambrose
We previously demonstrated that for tazobactam administered in combination with ceftolozane, the pharmacokinetic-pharmacodynamic (PK-PD) index that best described tazobactam efficacy was the percentage of the dosing interval that tazobactam concentrations were above a threshold (%T>threshold). Using data from studies of Enterobacteriaceae-producing ESBL, a relationship between tazobactam %T>threshold and reduction in log10 CFU from baseline, for which tazobactam threshold concentration was the product of the isolate's ceftolozane-tazobactam MIC value and 0...
September 25, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28947474/pharmacokinetics-pharmacodynamics-of-cb-618-in-combination-with-cefepime-ceftazidime-ceftolozane-and-meropenem-the-pharmacological-basis-for-a-stand-alone-%C3%AE-lactamase-inhibitor
#17
Paul G Ambrose, Brian D VanScoy, Michael Trang, Jennifer McCauley-Miller, Haley Conde, Sujata M Bhavnani, Dylan C Alexander, Lawrence V Friedrich
A major challenge in treating patients is the selection of the "right" antibiotic regimen. Given that the optimal β-lactam-β-lactamase inhibitor pair is dependent upon the spectrum of β-lactamase enzymes produced and the frequency of resistance to the β-lactamase inhibitor, it might be useful if a stand-alone were available for the clinician to pair with the "right" β-lactam rather than only in a fixed combination. In this communication, we describe a one-compartment in vitro infection model studies conducted to identify the magnitude of the pharmacokinetic-pharmacodynamic (PK-PD) index for a β-lactamase inhibitor, CB-618, that would restore the activity of four β-lactam partner agents (cefepime, ceftazidime, ceftolozane, and meropenem) with varying dose (1 or 2 g) and dosing intervals (8 or 12 h)...
September 25, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28942005/relating-observed-psychoactive-effects-to-the-plasma-concentrations-of-delta-9-tetrahydrocannabinol-thc-and-its-active-metabolite-an-effect-compartment-modeling-approach
#18
Rakesh Awasthi, Guohua An, Maureen D Donovan, Laura L Boles Ponto
The medical use of marijuana is increasing, yet little is known about the exposure-response relationship for its psychoactive effects. It is well known that the plasma concentrations of the principal psychoactive component of marijuana, Δ(9)-tetrahydrocannabinol (THC), do not directly correlate to the observed psychoactive effects. The purpose of this research was to use an effect-compartment modeling approach to predict and relate the concentrations of the psychoactive components (THC and its active metabolite) in the "hypothetical" effect-site compartment to the observed psychoactive effects...
September 20, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28936957/-pk-pd-of-vancomycin-in-patients-with-severe-acute-pancreatitis-combined-with-augmented-renal-clearance
#19
Juan He, Enqiang Mao, Feng Jing, Huiting Jiang, Wenyun Xu, Wanhua Yang, Erzhen Chen
OBJECTIVE: To evaluate the serum trough concentration and the pharmacokinetics/pharmacodynamics (PK/PD) of vancomycin in patients with severe acute pancreatitis (SAP), and analyze the effect of vancomycin continuous infusion for optimizing the characteristics of its PK/PD. METHODS: The inhospital patients with SAP received vancomycin treatment and admitted to emergency intensive care unit (EICU) of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine from January 2011 to December 2016 were enrolled...
September 2017: Zhonghua Wei Zhong Bing Ji Jiu Yi Xue
https://www.readbyqxmd.com/read/28928866/ct-721-a-potent-bcr-abl-inhibitor-exhibits-excellent-in-vitro-and-in-vivo-efficacy-in-the-treatment-of-chronic-myeloid-leukemia
#20
Yinghui Sun, Na Zhao, Huan Wang, Qiong Wu, Yunqi Han, Qichao Liu, Mangang Wu, Yuliang Liu, Fansheng Kong, He Wang, Ying Sun, Deguang Sun, Lutao Jing, Guojing Tang, Yuandong Hu, Dengming Xiao, Hong Luo, Yongxin Han, Yong Peng
Kinase inhibitors that target Bcr-Abl are highly effective in the treatment of chronic myeloid leukemia (CML). However, these inhibitors are often invalidated due to the drug resistance. Therefore, the discovery and development of novel Bcr-Abl inhibitors is required to overwhelm the drug resistance in the treatment of CML resistant to the currently used first-line Bcr-Abl inhibitors. Herein we have described a newly developed Bcr-Abl inhibitor CT-721, which displayed potent inhibitory effects on wild-type and T315I mutant Bcr-Abl...
2017: Journal of Cancer
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