Search Results - "Kowalski, Kenneth G."

Characterization of exposure–Clinical Dementia Rating–Sum of Boxes relationship in subjects with early Alzheimer’s disease from the aducanumab Phase 3 trials by Muralidharan, Kumar Kandadi, Kowalski, Kenneth G., Tong, Xiao, Haeberlein, Samantha Budd, Rajagovindan, Rajasimhan, Nestorov, Ivan

“…Clinical Dementia Rating–Sum of Boxes (CDR–SB) assessments from two Phase 3 studies (ENGAGE and EMERGE) of aducanumab in subjects with early Alzheimer’s…”
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Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease by Kandadi Muralidharan, Kumar, Tong, Xiao, Kowalski, Kenneth G., Rajagovindan, Raj, Lin, Lin, Budd Haberlain, Samantha, Nestorov, Ivan

“…Aducanumab is a human immunoglobulin G1 anti‐amyloid beta (Aβ) antibody currently being evaluated for potential treatment of patients with early Alzheimer’s…”
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Covariate modeling in pharmacometrics: General points for consideration by Sanghavi, Kinjal, Ribbing, Jakob, Rogers, James A., Ahmed, Mariam A., Karlsson, Mats O., Holford, Nick, Chasseloup, Estelle, Ahamadi, Malidi, Kowalski, Kenneth G., Cole, Susan, Kerwash, Essam, Wade, Janet R., Liu, Chao, Wang, Yaning, Trame, Mirjam N., Zhu, Hao, Wilkins, Justin J.

“…Modeling the relationships between covariates and pharmacometric model parameters is a central feature of pharmacometric analyses. The information obtained…”
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Model-Based Approach for Optimization of Atazanavir Dose Recommendations for HIV-Infected Pediatric Patients by Hong, Ying, Kowalski, Kenneth G, Zhang, Jenny, Zhu, Li, Horga, Mariaarantxa, Bertz, Richard, Pfister, Marc, Roy, Amit

“…Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit…”
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Covariate selection in pharmacometric analyses: a review of methods by Hutmacher, Matthew M., Kowalski, Kenneth G.

“…Covariate selection is an activity routinely performed during pharmacometric analysis. Many are familiar with the stepwise procedures, but perhaps not as many…”
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A Time‐to‐Event Exposure‐Response Model for Amyloid‐Related Imaging Abnormalities Following Administration of Aducanumab to Subjects With Early Alzheimer Disease by Muralidharan, Kumar Kandadi, Karumanchi, Sravan, Kowalski, Kenneth G., Burkett, Patrick, Chapel, Sunny, Rajagovindan, Raj, Nestorov, Ivan

“…Amyloid‐related imaging abnormalities with edema (ARIA‐E) have been reported in patients with early Alzheimer disease treated with aducanumab. ARIA‐E incidence…”
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Correction to: Characterization of exposure–Clinical Dementia Rating–Sum of Boxes relationship in subjects with early Alzheimer’s disease from the aducanumab Phase 3 trials by Muralidharan, Kumar Kandadi, Kowalski, Kenneth G., Tong, Xiao, Haeberlein, Samantha Budd, Rajagovindan, Rajasimhan, Nestoro, Ivan

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Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study by Kowalski, Kenneth G., Hutmacher, Matthew M.

“…Clinical trial simulations were conducted to assess power and sample size requirements for a population pharmacokinetic (PK) substudy of a phase III clinical…”
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Population Pharmacokinetics Analysis of Vigabatrin in Adults and Children with Epilepsy and Children with Infantile Spasms by Nielsen, Jace C., Kowalski, Kenneth G., Karim, Aziz, Patel, Mahlaqa, Wesche, David L., Tolbert, Dwain

“…Background and objectives Vigabatrin is an inhibitor of γ-aminobutyric acid transaminase. The purpose of these analyses was to develop a population…”
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Population dose-response analysis of daily seizure count following vigabatrin therapy in adult and pediatric patients with refractory complex partial seizures by Nielsen, Jace C., Hutmacher, Matthew M., Wesche, David L., Tolbert, Dwain, Patel, Mahlaqa, Kowalski, Kenneth G.

“…Vigabatrin is an irreversible inhibitor of γ‐aminobutyric acid transaminase (GABA‐T) and is used as an adjunctive therapy for adult patients with refractory…”
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Vigabatrin pediatric dosing information for refractory complex partial seizures: Results from a population dose–response analysis by Nielsen, Jace C., Tolbert, Dwain, Patel, Mahlaqa, Kowalski, Kenneth G., Wesche, David L.

“…Summary We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures (rCPS) that would produce…”
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Exposure-response modeling using latent variables for the efficacy of a JAK3 inhibitor administered to rheumatoid arthritis patients by Hutmacher, Matthew M., Krishnaswami, Sriram, Kowalski, Kenneth G.

“…Currently, no general methods have been developed to relate pharmacologically based models, such as indirect response models, to discrete or ordered…”
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Population pharmacokinetics of pegaptanib sodium (Macugen(®)) in patients with diabetic macular edema by Basile, Anthony S, Hutmacher, Matthew M, Kowalski, Kenneth G, Gandelman, Kuan Y, Nickens, Dana J

“…Population pharmacokinetic modeling of pegaptanib was undertaken to determine influence of renal function on apparent clearance. In a randomized, double-masked…”
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How modeling and simulation have enhanced decision making in new drug development by MILLER, Raymond, EWY, Wayne, LI, Cheryl S. W, WERTH, John L, FELTNER, Douglas E, LALONDE, Richard L, CORRIGAN, Brian W, OUELLET, Daniele, HERMANN, David, KOWALSKI, Kenneth G, LOCKWOOD, Peter, KOUP, Jeffrey R, DONEVAN, Sean, EL-KATTAN, Ayman

“…The idea of model-based drug development championed by Lewis Sheiner, in which pharmacostatistical models of drug efficacy and safety are developed from…”
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A two-part mixture model for longitudinal adverse event severity data by KOWALSKI, Kenneth G, MCFADYEN, Lynn, HUTMACHER, Matthew M, FRAME, Bill, MILLER, Raymond

“…We fit a mixed effects logistic regression model to longitudinal adverse event (AE) severity data (four-point ordered categorical response) to describe the…”
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Collapsing mechanistic models : An application to dose selection for proof of concept of a selective irreversible antagonist by HUTMACHER, Matthew M, MUKHERJEE, Debu, KOWALSKI, Kenneth G, JORDAN, David C

“…When data fail to support fully mechanistic models, alternative modeling strategies must be pursued. Simpler, more empirical models or the fixing of various…”
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An algorithm for estimating the terminal half-life in pharmacokinetic studies by Kowalski, K G

“…An algorithm is developed for automating the process of identifying the terminal phase in plasma concentration-time curves for non-compartmental estimation of…”
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Bidisomide (SC-40230), a new antiarrhythmic agent: initial study of tolerability and pharmacokinetics by Page, R L, Wharton, J M, Wilkinson, W E, Friedman, I M, Claypool, W D, Karim, A, Kowalski, K G, McDonald, S J, Gardiner, P, Pritchett, E L

“…Forty-nine healthy male volunteers received the test article for bidisomide (SC-40230) in a double-blind, placebo-controlled, dose-ranging study. Intravenous…”
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Efficient screening of covariates in population models using Wald's approximation to the likelihood ratio test by KOWALSKI, Kenneth G, HUTMACHER, Matthew M

“…We propose an efficient algorithm for screening covariates in population model building using Wald's approximation to the likelihood ratio test (LRT) statistic…”
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Absorption and disposition of a new antiarrhythmic agent bidisomide in man by COOK, C. S, AMES, G. B, SMITH, M. E, KOWALSKI, K. G, KARIM, A

“…Absorption and disposition of bidisomide were studied in 12 healthy male subjects after a 20-min iv (1 mg/kg; N = 6) infusion and oral (2 mg/kg; N = 6)…”
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