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https://www.readbyqxmd.com/read/28304215/use-of-statistical-and-pharmacokinetic-pharmacodynamic-modeling-and-simulation-to-improve-decision-making-a-section-summary-report-of-the-trends-and-innovations-in-clinical-trial-statistics-conference
#1
Holly Kimko, Seth Berry, Michael O'Kelly, Nitin Mehrotra, Matthew Hutmacher, Venkat Sethuraman
The application of modeling and simulation (M&S) methods to improve decision-making was discussed during the Trends & Innovations in Clinical Trial Statistics Conference held in Durham, North Carolina, USA on May 1-4, 2016. Uses of both pharmacometric and statistical M&S were presented during the conference, highlighting the diversity of the methods employed by pharmacometricians and statisticians to address a broad range of quantitative issues in drug development. Five presentations are summarized herein, which cover the development strategy of employing M&S to drive decision-making; European initiatives on best practice in M&S; case studies of pharmacokinetic/pharmacodynamics modeling in regulatory decisions; estimation of exposure-response relationships in the presence of confounding; and the utility of estimating the probability of a correct decision for dose selection when prior information is limited...
February 7, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28276649/precision-medicine-in-pharmacometrics-and-systems-pharmacology
#2
EDITORIAL
L Li
No abstract text is available yet for this article.
March 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28254068/phxnlme-an-r-package-that-facilitates-pharmacometric-workflow-of-phoenix-nlme-analyses
#3
Chay Ngee Lim, Shuang Liang, Kevin Feng, Jason Chittenden, Ana Henry, Samer Mouksassi, Angela K Birnbaum
BACKGROUND AND OBJECTIVE: Pharmacometric analyses are integral components of the drug development process, and Phoenix NLME is one of the popular software used to conduct such analyses. To address current limitations with model diagnostic graphics and efficiency of the workflow for this software, we developed an R package, Phxnlme, to facilitate its workflow and provide improved graphical diagnostics. METHODS: Phxnlme was designed to provide functionality for the major tasks that are usually performed in pharmacometric analyses (i...
March 2017: Computer Methods and Programs in Biomedicine
https://www.readbyqxmd.com/read/28211134/effect-of-age-on-the-performance-of-bispectral-and-entropy-indices-during-sevoflurane-pediatric-anesthesia-a-pharmacometric-study
#4
Alberto Sciusco, Joseph F Standing, Yucheng Sheng, Pasquale Raimondo, Gilda Cinnella, Michele Dambrosio
BACKGROUND: Bispectral index (BIS) and entropy monitors have been proposed for use in children, but research has not supported their validity for infants. However, effective monitoring of young children may be even more important than for adults, to aid appropriate anesthetic dosing and reduce the chance of adverse consequences. This prospective study aimed to investigate the relationships between age and the predictive performance of BIS and entropy monitors in measuring the anesthetic drug effects within a pediatric surgery setting...
February 17, 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28205374/developmental-pharmacokinetics-of-sirolimus-implications-for-precision-dosing-in-neonates-and-infants-with-complicated-vascular-anomalies
#5
Tomoyuki Mizuno, Tsuyoshi Fukuda, Chie Emoto, Paula S Mobberley-Schuman, Adrienne M Hammill, Denise M Adams, Alexander A Vinks
BACKGROUND: Sirolimus has recently been shown to be efficacious and tolerable in pediatric patients with complicated vascular anomalies. Nevertheless, dosing information remains very limited especially for neonates and infants. The purpose of this study was to develop an age-appropriate sirolimus starting dosing regimen based on the developmental changes in drug elimination capacity using data collected in neonates and infants. PROCEDURE: A recently developed sirolimus maturation model [Emoto et al...
February 16, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28205038/clinical-trial-simulations-and-pharmacometric-analysis-in-pediatrics-application-to-inhaled-loxapine-in-children-and-adolescents
#6
Min Dong, Tsuyoshi Fukuda, Sally Selim, Mark A Smith, Laura Rabinovich-Guilatt, James V Cassella, Alexander A Vinks
BACKGROUND AND OBJECTIVES: Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetic study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to the predicted likelihood of achieving the target exposure associated with therapeutic effect in adults...
February 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28205025/the-multistate-tuberculosis-pharmacometric-model-a-semi-mechanistic-pharmacokinetic-pharmacodynamic-model-for-studying-drug-effects-in-an-acute-tuberculosis-mouse-model
#7
Chunli Chen, Fatima Ortega, Joaquin Rullas, Laura Alameda, Iñigo Angulo-Barturen, Santiago Ferrer, Ulrika Sh Simonsson
The Multistate Tuberculosis Pharmacometric (MTP) model, a pharmacokinetic-pharmacodynamic disease model, has been used to describe the effects of rifampicin on Mycobacterium tuberculosis (M. tuberculosis) in vitro. The aim of this work was to investigate if the MTP model could be used to describe the rifampicin treatment response in an acute tuberculosis mouse model. Sixty C57BL/6 mice were intratracheally infected with M. tuberculosis H37Rv strain on Day 0. Fifteen mice received no treatment and were sacrificed on Days 1, 9 and 18 (5 each day)...
February 15, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28176362/interdisciplinary-pharmacometrics-linking-oseltamivir-pharmacology-influenza-epidemiology-and-health-economics-to-inform-antiviral-use-in-pandemics
#8
Mohamed A Kamal, Patrick F Smith, Nathorn Chaiyakunapruk, David B C Wu, Chayanin Pratoomsoot, Kenneth K C Lee, Huey Yi Chong, Richard E Nelson, Keith Nieforth, Georgina Dall, Stephen Toovey, David C M Kong, Aaron Kamauu, Carl M Kirkpatrick, Craig R Rayner
AIMS: A modular interdisciplinary platform was developed to investigate the economic impact of oseltamivir treatment by dosage regimen under simulated influenza pandemic scenarios. METHODS: The pharmacology module consisted of a pharmacokinetic distribution of oseltamivir carboxylate daily area under the concentration-time curve at steady state (simulated for 75 mg and 150 mg twice daily regimens for 5 days) and a pharmacodynamic distribution of viral shedding duration obtained from phase II influenza inoculation data...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28154789/cyp2b6-genotype-guided-dosing-of-propofol-anesthesia-in-the-elderly-based-on-nonparametric-population-pharmacokinetic-modeling-and-simulations
#9
Andy R Eugene
OBJECTIVE: The primary aim of this article is to test the hypothesis that nonparametric pharmacometric modeling will accurately identify CYP2B6 genotype subgroups based on data from a study that reported results based on parametric pharmacokinetics (PK). METHODS: Propofol concentration-time data were originally reported in the Kansaku et al. 2011 publication. Nonparametric Nonlinear Mixed Effects Modeling (NLME) was conducted using the PMETRICS R package while population pharmacokinetic model parameters were estimated using a FORTRAN compiler...
2017: International Journal of Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/27997736/commentary-on-pharmacometrics-for-immunotherapy
#10
M J Garrido, P Berraondo, I F Trocóniz
This commentary provides an overview of recent examples of pharmacometrics applied during the clinical development of two antagonists of the programmed death-1 (PD-1) cell surface receptor, pembrolizumab and nivolumab. Despite the remarkable achievements obtained in predicting the correct dosing schedule from different quantitative approaches, data indicated a great degree of heterogeneity in tumor response. To achieve therapeutic goals the search for predictive biomarkers associated with a lack of response and mechanism-based combination studies are warranted...
January 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27987629/translating-pharmacometrics-to-a-pharmacoeconomic-model-of-copd
#11
Julia F Slejko, Richard J Willke, Jakob Ribbing, Peter Milligan
BACKGROUND: A model-based meta-analysis (MBMA) is a type of meta-regression that uses nonlinear mixed-effects models estimated on trial-level data to relate patient and trial characteristics, dosing, biomarkers, and outcomes of treatment. OBJECTIVES: To use a pharmacometric MBMA within a pharmacoeconomic model of chronic obstructive pulmonary disease (COPD). METHODS: A Markov microsimulation model was developed to estimate monthly changes in the key disease severity metrics of COPD (forced expiratory volume in 1 second [FEV1] and exacerbations) to compare a hypothetical drug that increases FEV1 to usual care...
December 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27884052/model-evaluation-of-continuous-data-pharmacometric-models-metrics-and-graphics
#12
Tht Nguyen, M-S Mouksassi, N Holford, N Al-Huniti, I Freedman, A C Hooker, J John, M O Karlsson, D R Mould, J J Pérez Ruixo, E L Plan, R Savic, Jgc van Hasselt, B Weber, C Zhou, E Comets, F Mentré
This article represents the first in a series of tutorials on model evaluation in nonlinear mixed effect models (NLMEMs), from the International Society of Pharmacometrics (ISoP) Model Evaluation Group. Numerous tools are available for evaluation of NLMEM, with a particular emphasis on visual assessment. This first basic tutorial focuses on presenting graphical evaluation tools of NLMEM for continuous data. It illustrates graphs for correct or misspecified models, discusses their pros and cons, and recalls the definition of metrics used...
February 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27874325/mixed-beam-murine-harderian-gland-tumorigenesis-predicted-dose-effect-relationships-if-neither-synergism-nor-antagonism-occurs
#13
Nopphon Siranart, Eleanor A Blakely, Alden Cheng, Naval Handa, Rainer K Sachs
Complex mixed radiation fields exist in interplanetary space, and little is known about their late effects on space travelers. In silico synergy analysis default predictions are useful when planning relevant mixed-ion-beam experiments and interpreting their results. These predictions are based on individual dose-effect relationships (IDER) for each component of the mixed-ion beam, assuming no synergy or antagonism. For example, a default hypothesis of simple effect additivity has often been used throughout the study of biology...
December 2016: Radiation Research
https://www.readbyqxmd.com/read/27872070/estimation-of-the-in-vivo-mic-of-cipargamin-in-uncomplicated-plasmodium-falciparum-malaria
#14
Tran Tinh Hien, Nicholas J White, Nguyen Thanh Thuy-Nhien, Nhu Thi Hoa, Phung Duc Thuan, Joel Tarning, François Nosten, Baldur Magnusson, Jay Prakash Jain, Kamal Hamed
The MIC of an antimalarial drug for a particular infection is the drug level associated with a net parasite multiplication rate of one per asexual cycle. To ensure the cure of malaria, the MIC must be exceeded until all parasites have been eliminated. The development of highly sensitive and accurate PCR quantitation of low-density malaria parasitemia enables the prospective pharmacokinetic-pharmacodynamic (PK-PD) characterization of antimalarial drug effects and now allows identification of the in vivo MIC...
February 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27863137/a-philosophical-framework-for-integrating-systems-pharmacology-models-into-pharmacometrics
#15
REVIEW
S B Duffull
The framework for systems pharmacology style models does not naturally sit with the usual scientific dogma of parsimony and falsifiability based on deductive reasoning. This does not invalidate the importance or need for overarching models based on pharmacology to describe and understand complicated biological systems. However, it does require some consideration on how systems pharmacology fits into the overall scientific approach.
December 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27813436/pharmacometrics-based-decision-tools-facilitate-mhealth-implementation
#16
REVIEW
Fahima Nekka, Chantal Csajka, Mélanie Wilbaux, Sachin Sanduja, Jun Li, Marc Pfister
The healthcare system is experiencing a paradigm shift in delivering its services, evolving from a reactive 'one size-fits-all' structure to a patient-centric model focusing on individualized medicine. This change is driven by scientific progress, including quantitative evaluation and optimization of treatment strategies through pharmacometric approaches, harnessing the power of the digital revolution. Areas covered: This review describes four main steps to apply pharmacometrics-based decision support tools, consisting of validated scientific components, available technical options, consideration of regulatory aspects, and achievement of efficient commercialization...
January 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/27799204/population-pharmacokinetic-modeling-to-estimate-the-contributions-of-genetic-and-nongenetic-factors-to-efavirenz-disposition
#17
Jason D Robarge, Ingrid F Metzger, Jessica Lu, Nancy Thong, Todd C Skaar, Zeruesenay Desta, Robert R Bies
Efavirenz pharmacokinetics is characterized by large between-subject variability, which determines both therapeutic response and adverse effects. Some of the variability in efavirenz pharmacokinetics has been attributed to genetic variability in cytochrome P450 genes that alter efavirenz metabolism, such as CYP2B6 and CYP2A6 While the effects of additional patient factors have been studied, such as sex, weight, and body mass index, the extent to which they contribute to variability in efavirenz exposure is inconsistently reported...
January 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27761201/the-promises-of-quantitative-systems-pharmacology-modelling-for-drug%C3%A2-development
#18
REVIEW
V R Knight-Schrijver, V Chelliah, L Cucurull-Sanchez, N Le Novère
Recent growth in annual new therapeutic entity (NTE) approvals by the U.S. Food and Drug Administration (FDA) suggests a positive trend in current research and development (R&D) output. Prior to this, the cost of each NTE was considered to be rising exponentially, with compound failure occurring mainly in clinical phases. Quantitative systems pharmacology (QSP) modelling, as an additional tool in the drug discovery arsenal, aims to further reduce NTE costs and improve drug development success. Through in silico mathematical modelling, QSP can simulate drug activity as perturbations in biological systems and thus understand the fundamental interactions which drive disease pathology, compound pharmacology and patient response...
2016: Computational and Structural Biotechnology Journal
https://www.readbyqxmd.com/read/27744580/lack-of-clinical-pharmacokinetic-studies-to-optimize-the-treatment-of-neglected-tropical-diseases-a-systematic-review
#19
Luka Verrest, Thomas P C Dorlo
INTRODUCTION: Neglected tropical diseases (NTDs) affect more than one billion people, mainly living in developing countries. For most of these NTDs, treatment is suboptimal. To optimize treatment regimens, clinical pharmacokinetic studies are required where they have not been previously conducted to enable the use of pharmacometric modeling and simulation techniques in their application, which can provide substantial advantages. OBJECTIVES: Our aim was to provide a systematic overview and summary of all clinical pharmacokinetic studies in NTDs and to assess the use of pharmacometrics in these studies, as well as to identify which of the NTDs or which treatments have not been sufficiently studied...
October 15, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27699614/abstracts-accepted-for-american-conference-on-pharmacometrics-2016-acop7
#20
(no author information available yet)
No abstract text is available yet for this article.
October 2016: Journal of Pharmacokinetics and Pharmacodynamics
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