Search Results - "Ene, Ette"

The New Big Is Small: Leveraging Knowledge from Small Trials for Rare Disease Drug Development - Blarcamesine for Rett Syndrome by Ette, Ene I, Fadiran, Emmanuel O, Missling, Christopher, Hammond, Edward

“…Big data in drug development may not satisfactorily address the demands of precision medicine in a rare disease population, making the use of smaller clinical…”
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Pharmacometrics of clobazam in pediatrics: Prediction of effective clobazam doses for Dravet syndrome by Tolbert, Dwain, Chu, Hui-May, Ette, Ene I.

“…•An efficacious pediatric clobazam (CLB) dosing regimen identified by PopPK modeling.•Evaluation/validation showed the model adequately described CLB and N-CLB…”
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Plasma concentration and eGFR in preterm and term neonates receiving gentamicin or successive amikacin therapy by Singu, Bonifasius Siyuka, Ndeunyema, Milka Ndapandula, Ette, Ene I, Pieper, Clarissa Hildegard, Verbeeck, Roger Karel

“…Gentamicin and amikacin are aminoglycoside antibiotics which are renally excreted and known to be nephrotoxic. Estimate of glomerular filtration rate (eGFR)…”
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Predictors of gentamicin therapy failure in neonates with sepsis by Singu, Bonifasius Siyuka, Pieper, Clarissa Hildegard, Verbeeck, Roger Karel, Ette, Ene I.

“…Sepsis is a common disease with high morbidity and mortality among newborns in intensive care units world‐wide. Gram‐negative bacillary bacteria are the major…”
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Confirming the Suitability of a Gentamicin Dosing Strategy in Neonates Using the Population Pharmacokinetic Approach with Truncated Sampling Duration by Singu, Bonifasius Siyuka, Verbeeck, Roger Karel, Pieper, Clarissa Hildegard, Ette, Ene I

“…(1) Background: Gentamicin is known to be nephrotoxic and ototoxic. Although gentamicin dosage guidelines have been established for preterm and term neonates,…”
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Population‐Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease by Fadiran, Emmanuel O., Hammond, Edward, Tran, James, Missling, Christopher U., Ette, Ene

“…Pharmacokinetic (PK) data from 28 subjects who received 5‐200‐mg single ascending doses of ANAVEX3‐71, formerly AF710B, were analyzed to characterize the PK of…”
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Maximizing Knowledge Extraction From Patient‐Reported Outcome Data Using Exposure‐Outcome Item Response Modeling Approach: Understanding Efavirenz‐Induced Central Nervous System Toxicity by Bisaso, Karungi S., Bisaso, Kuteesa R., Mukonzo, Jackson K., Ette, Ene I.

“…This investigation was undertaken to maximally extract hidden knowledge from an efavirenz‐based trial data set using an item response theory‐based approach to…”
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A mechanistic assessment of the nature of pharmacodynamic drug-drug interaction in vivo and in vitro by Bisaso, Kuteesa R., Mukonzo, Jackson K., Ette, Ene I.

“…Combination pharmacotherapy is becoming increasingly necessary because most diseases are pathophysiologically controlled at the subcellular level by target…”
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Drug-metabolism mechanism: Knowledge-based population pharmacokinetic approach for characterizing clobazam drug-drug interactions by Tolbert, Dwain, Bekersky, Ihor, Chu, Hui-May, Ette, Ene I.

“…A metabolic mechanism‐based characterization of antiepileptic drug‐drug interactions (DDIs) with clobazam in patients with Lennox‐Gastaut syndrome (LGS) was…”
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Population Pharmacokinetics I: Background, Concepts, and Models by Ette, Ene I, Williams, Paul J

“…OBJECTIVE To present and emphasize the background, foundations, utility, and conceptual underlying theory of the population pharmacokinetic (PPK) approach with…”
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Markov model for characterizing neuropsychologic impairment and Monte Carlo simulation for optimizing efavirenz therapy by Bisaso, Kuteesa R., Mukonzo, Jackson K., Ette, Ene I.

“…The study was undertaken to develop a pharmacokinetic‐pharmacodynamic model to characterize efavirenz‐induced neuropsychologic impairment, given preexistent…”
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An integrative population pharmacokinetics approach to the characterization of the effect of hepatic impairment on clobazam pharmacokinetics by Tolbert, Dwain, Bekersky, Ihor, Chu, Hui-May, Ette, Ene I.

“…An integrative population pharmacokinetics (PPK)–based approach was used to characterize the effect of hepatic impairment on clobazam PK and its major…”
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Transition modeling of neuropsychiatric impairment in HIV by Bisaso, Kuteesa R, Mukonzo, Jackson K, Ette, Ene I

“…Abstract Few studies have reported analyses of neuropsychiatric impairment (NPI) data from HIV patients, in a real world clinical setting with the aim of…”
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Population Pharmacokinetics II: Estimation Methods by Ette, Ene I, Williams, Paul J

“…OBJECTIVE To present, compare, and contrast the various approaches to estimating population pharmacokinetic (PPK) models with respect to the mathematical…”
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Model Appropriateness and Population Pharmacokinetic Modeling by Ette, Ene I., Williams, Paul J., Kim, Yong Ho, Lane, James R., Liu, Mei-Jen, Capparelli, Edmund V.

“…The purpose of this study was to define model appropriateness, identifying the individual elements thereof, and to set out a framework within which model…”
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Stimulus – Response mechanistic modeling of pharmacodynamic drug-drug interaction: Extension of the operational receptor model of agonism by Bisaso, Kuteesa Ronald, Mukonzo, Jackson K., Ette, Ene I.

“…Combination therapy is becoming the cornerstone of pharmacotherapy. The choice of combination therapy is premised on pharmacodynamic drug – drug interactions…”
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Population Pharmacokinetics III: Design, Analysis, and Application of Population Pharmacokinetic Studies by Ette, Ene I, Williams, Paul J, Lane, James R

“…OBJECTIVE To present a framework within which population pharmacokinetic (PPK) studies should be designed and analyzed and discuss the application of developed…”
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A pragmatic approach to the design of population pharmacokinetic studies by Roy, Amit, Ette, Ene I

“…The publication of a seminal article on nonlinear mixed-effect modeling led to a revolution in pharmacokinetics (PKs) with the introduction of the population…”
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Stability and Performance of a Population Pharmacokinetic Model by Ette, Ene I.

“…This study aimed to determine the stability (in terms of covariate selection) of a population pharmacokinetic model and evaluate its performance in the absence…”
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Safety and Efficacy of the Multidrug Resistance Inhibitor Incel (Biricodar; VX-710) in Combination with Paclitaxel for Advanced Breast Cancer Refractory to Paclitaxel by TOPPMEYER, Deborah, SEIDMAN, Andrew D, DEMETRI, George D, POLLAK, Michael, RUSSELL, Christy, TKACZUK, Katherine, VERMA, Shailendra, OVERMOYER, Beth, GARG, Varun, ETTE, Ene, HARDING, Matthew W

“…Purpose: VX-710 (biricodar, Incel) restores drug sensitivity to P-glycoprotein ( MDR 1) and multidrug resistance-associated protein (MRP1)-expressing cells…”
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