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CPT: Pharmacometrics & Systems Pharmacology

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https://www.readbyqxmd.com/read/28194906/response-to-time-of-the-day-and-magnitude-of-the-effect-of-a-drug-on-the-qtc-interval
#1
LETTER
L Kervezee, J Burggraaf
No abstract text is available yet for this article.
February 14, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28188701/response-to-letter-quantitative-prediction-of-drug-drug-interactions-involving-inhibitory-metabolites-by-physiologically-based-pharmacokinetic-models-is-it-worth
#2
LETTER
I E Templeton, Y Chen, J Mao, J Lin, H Yu, S Peters, M Shebley, M V Varma
No abstract text is available yet for this article.
February 11, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28181418/mathematical-modeling-of-the-effects-of-ck2-3-on-mineralization-in-osteoporotic-bone
#3
A Lisberg, R Ellis, K Nicholson, P Moku, A Swarup, P Dhurjati, A Nohe
Osteoporosis is caused by decreased bone mineral density (BMD) and new treatments for this disease are desperately needed. Bone morphogenetic protein 2 (BMP2) is crucial for bone formation. The mimetic peptide CK2.3 acts downstream of BMP2 and increases BMD when injected systemically into the tail vein of mice. However, the most effective dosage needed to induce BMD in humans is unknown. We developed a mathematical model for CK2.3-dependent bone mineralization. We used a physiologically based pharmacokinetic (PBPK) model to derive the CK2...
February 9, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28145085/prediction-of-in-vivo-and-in-vitro-infection-model-results-using-a-semimechanistic-model-of-avibactam-and-aztreonam-combination-against-multidrug-resistant-organisms
#4
Skb Sy, L Zhuang, H Xia, M-E Beaudoin, V J Schuck, H Derendorf
The combination of aztreonam-avibactam is active against multidrug-resistant Enterobacteriaceae that express metallo-β-lactamases. A complex synergistic interaction exists between aztreonam and avibactam bactericidal activities that have not been quantitatively explored. A two-state semimechanistic pharmacokinetic/pharmacodynamic (PK/PD) logistic growth model was developed to account for antimicrobial activities in the combination of bacteria-mediated degradation of aztreonam and the inhibition of aztreonam degradation by avibactam...
February 1, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28142221/time-of-the-day-and-magnitude-of-the-effect-of-a-drug-on-the-qtc-interval
#5
LETTER
J Täubel, S Fernandes, G Ferber
No abstract text is available yet for this article.
January 31, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28130915/multiscale-modeling-reveals-inhibitory-and-stimulatory-effects-of-caffeine-on-acetaminophen-induced-toxicity-in-humans
#6
C Thiel, H Cordes, V Baier, L M Blank, L Kuepfer
Acetaminophen (APAP) is a widely used analgesic drug that is frequently co-administered with caffeine (CAF) in the treatment of pain. It is well known that APAP may cause severe liver injury after an acute overdose. However, the understanding of whether and to what extent CAF inhibits or stimulates APAP-induced hepatotoxicity in humans is still lacking. Here, a multiscale analysis is presented that quantitatively models the pharmacodynamic (PD) response of APAP during co-medication with CAF. Therefore, drug-drug interaction (DDI) processes were integrated into physiologically based pharmacokinetic (PBPK) models at the organism level, whereas drug-specific PD response data were contextualized at the cellular level...
January 28, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28109128/population-pharmacokinetics-and-pharmacodynamics-of-benralizumab-in-healthy-volunteers-and-patients-with-asthma
#7
B Wang, L Yan, Z Yao, L K Roskos
Benralizumab is a humanized, afucosylated, anti-interleukin-5 receptor α, immunoglobulin G (IgG) 1 κ monoclonal antibody. We developed a population pharmacokinetic (PK)/pharmacodynamic (PD) model for benralizumab by analyzing PK and blood eosinophil count data from two healthy volunteer studies (N = 48) and four studies in patients with asthma (N = 152). Benralizumab PK was dose-proportional and adequately described by a two-compartment model with first-order elimination from the central compartment and first-order absorption from the subcutaneous dosing site...
January 21, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28109060/morphine-pharmacodynamics-in-mechanically-ventilated-preterm-neonates-undergoing-endotracheal-suctioning
#8
P A Välitalo, Ehj Krekels, M van Dijk, Shp Simons, D Tibboel, Caj Knibbe
To date, morphine pharmacokinetics (PKs) are well quantified in neonates, but results about its efficacy are ambiguous. This work presents an analysis of a previously published study on pain measurements in mechanically ventilated preterm neonates who received either morphine or placebo to improve comfort during invasive ventilation. The research question was whether morphine reduces the pain associated with endotracheal or nasal suctioning before, during, and after suctioning. Because these neonates cannot verbalize their pain levels, pain was assessed on the basis of several validated pain measurement instruments (i...
January 21, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28109071/implementing-genomic-clinical-decision-support-for-drug-based-precision-medicine
#9
EDITORIAL
Robert R Freimuth, Christine M Formea, James M Hoffman, Eric Matey, Josh F Peterson, Richard D Boyce
No abstract text is available yet for this article.
January 20, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28074615/a-database-of-optimized-proteomic-quantitative-methods-for-284-human-drug-disposition-related-proteins-for-applications-in-pbpk-modeling
#10
Marc Vrana, Dale Whittington, Vivek Nautiyal, Bhagwat Prasad
The aim of this study was to create an open access repository of validated LC-MS/MS (MRM) methods for quantifying 284 important proteins associated with drug absorption, distribution, metabolism and excretion (ADME). Various in silico and experimental approaches were used to select surrogate peptides and optimize instrument parameters for LC-MS/MS quantification of the selected proteins. The final methods were uploaded to an online public database (ADME QPrOmics(TM); www.qpromics.uw.edu/qpromics/assay/) which provides essential information for facile method development in triple quadrupole MS instruments...
January 11, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28063254/the-impact-of-mathematical-modeling-in-understanding-the-mechanisms-underlying-neurodegeneration-evolving-dimensions-and-future-directions
#11
REVIEW
A Lloret-Villas, T M Varusai, N Juty, C Laibe, N Le NovÈre, H Hermjakob, V Chelliah
Neurodegenerative diseases are a heterogeneous group of disorders that are characterized by the progressive dysfunction and loss of neurons. Here, we distil and discuss the current state of modeling in the area of neurodegeneration, and objectively compare the gaps between existing clinical knowledge and the mechanistic understanding of the major pathological processes implicated in neurodegenerative disorders. We also discuss new directions in the field of neurodegeneration that hold potential for furthering therapeutic interventions and strategies...
January 7, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28035755/report-from-the-ema-workshop-on-qualification-and-reporting-of-physiologically-based-pharmacokinetic-pbpk-modeling-and-simulation
#12
EDITORIAL
P Zhao
On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis.(1) Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.
December 30, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28032946/population-pharmacokinetics-modeling-of-unbound-efavirenz-atazanavir-and-ritonavir-in-hiv-infected-subjects-with-aging-biomarkers
#13
J B Dumond, J Chen, M Cottrell, C R Trezza, Hma Prince, C Sykes, C Torrice, N White, S Malone, R Wang, K B Patterson, N E Sharpless, A Forrest
Unbound drug is the pharmacodynamically relevant concentration. This study aimed to determine if chronologic age or markers of biologic aging, such as the frailty phenotype and p16(INK4a) gene expression, altered unbound pharmacokinetics (PKs) of efavirenz (EFV) and atazanavir/ritonavir (ATV/RTV). Sixty human immunodeficiency virus (HIV)-infected participants receiving EFV and 31 receiving ATV/RTV provided 1 to 11 samples to quantify total and unbound plasma concentrations. Population PK models with total and unbound concentrations simultaneously described are developed for each drug...
December 29, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28019088/p16-ink4a-a-senescence-marker-influences-tenofovir-emtricitabine-metabolite-disposition-in-hiv-infected-subjects
#14
J B Dumond, J W Collins, M L Cottrell, C R Trezza, Hma Prince, C Sykes, C Torrice, N White, S Malone, R Wang, K B Patterson, N E Sharpless, A Forrest
The goal of this study was to explore the relationships between tenofovir (TFV) and emtricitabine (FTC) disposition and markers of biologic aging, such as the frailty phenotype and p16(INK4a) gene expression. Chronologic age is often explored in population pharmacokinetic (PK) analyses, and can be uninformative in capturing the impact of aging on physiology, particularly in human immunodeficiency virus (HIV)-infected patients. Ninety-one HIV-infected participants provided samples to quantify plasma concentrations of TFV/FTC, as well as peripheral blood mononuclear cell (PBMC) samples for intracellular metabolite concentrations; 12 participants provided 11 samples, and 79 participants provided 4 samples, over a dosing interval...
December 26, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27997740/model-based-estimates-of-tumor-growth-inhibition-metrics-are-time-independent-a-reply-to-mistry
#15
LETTER
Laurent Claret, Kelong Han, Rene Bruno
No abstract text is available yet for this article.
December 20, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27984676/quantitative-prediction-of-drug-drug-interactions-involving-inhibitory-metabolites-by-physiologically-based-pharmacokinetic-models-is-it-worth
#16
LETTER
M Tod, S Goutelle, L Bourguignon, N Bleyzac
No abstract text is available yet for this article.
December 16, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27935268/characterization-of-contributing-factors-to-variability-in-morphine-clearance-through-pbpk-modeling-implemented-with-oct1-transporter
#17
C Emoto, T Fukuda, T N Johnson, S Neuhoff, S Sadhasivam, A A Vinks
Morphine shows large interindividual variability in its pharmacokinetics; however, the cause of this has not been fully addressed. The variability in morphine disposition is considered to be due to a combination of pharmacogenetic and physiological determinants related to morphine disposition. We previously reported the effect of organic cation transporter (OCT1) genotype on morphine disposition in pediatric patients. To further explore the underlying mechanisms for variability arising from relevant determinants, including OCT1, a physiologically based pharmacokinetic (PBPK) model of morphine was developed...
December 9, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27884052/model-evaluation-of-continuous-data-pharmacometric-models-metrics-and-graphics
#18
Thi-Huyen-Tram Nguyen, Mohamad-Samer Mouksassi, Nick Holford, Nidal Al-Huniti, Immanuel Freedman, Andrew C Hooker, Jyothy John, Mats O Karlsson, Diane R Mould, Juan José Pérez Ruixo, Elodie L Plan, Rada Savic, Johan G C van Hasselt, Benjamin Weber, Chenguang Zhou, Emmanuelle Comets, France Mentré
This article represents the first in a series of tutorials on model evaluation in nonlinear mixed effect models (NLMEM), from the 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. This article is protected by copyright...
November 24, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28019091/model-based-population-pharmacokinetic-analysis-of-nivolumab-in-patients-with-solid-tumors
#19
G Bajaj, X Wang, S Agrawal, M Gupta, A Roy, Y Feng
Nivolumab is a fully human monoclonal antibody that inhibits programmed death-1 activation. The clinical pharmacology profile of nivolumab was analyzed by a population pharmacokinetics model that assessed covariate effects on nivolumab concentrations in 1,895 patients who received 0.3-10.0 mg/kg nivolumab in 11 clinical trials. Nivolumab pharmacokinetics is linear with a time-varying clearance. A full covariate model was developed to assess covariate effects on pharmacokinetic parameters. Nivolumab clearance and volume of distribution increase with body weight...
January 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28019090/quantitative-characterization-of-the-exposure-response-relationship-for-cancer-immunotherapy-a-case-study-of-nivolumab-in-patients-with-advanced-melanoma
#20
X Wang, Y Feng, G Bajaj, M Gupta, S Agrawal, A Yang, J-S Park, B Lestini, A Roy
To inform the benefit-risk assessment of nivolumab in patients with advanced melanoma, analyses of efficacy and safety exposure-response (E-R) relationships were conducted with data from patients with advanced melanoma enrolled in two clinical studies (phase I and phase III) who received nivolumab 0.1-10.0 mg/kg every 2 weeks. E-R efficacy analyses were performed by relating the nivolumab time-averaged concentration after the first dose (Cavg1 ) to two endpoints: RECIST objective response (OR) and overall survival (OS)...
January 2017: CPT: Pharmacometrics & Systems Pharmacology
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