Search Results - "KOWALSKI, K. G"

Model-based Drug Development by Lalonde, R L, Kowalski, K G, Hutmacher, M M, Ewy, W, Nichols, D J, Milligan, P A, Corrigan, B W, Lockwood, P A, Marshall, S A, Benincosa, L J, Tensfeldt, T G, Parivar, K, Amantea, M, Glue, P, Koide, H, Miller, R

“…The low productivity and escalating costs of drug development have been well documented over the past several years. Less than 10% of new compounds that enter…”
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Modeling and Simulation to Support Dose Selection and Clinical Development of SC-75416, a Selective COX-2 Inhibitor for the Treatment of Acute and Chronic Pain by Kowalski, KG, Olson, S, Remmers, AE, Hutmacher, MM

“…Pharmacokinetic/pharmacodynamic (PK/PD) models were developed and clinical trial simulations were conducted to recommend a study design to test the hypothesis…”
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Matthew Hutmacher, MS (1969–2017) by Chapel, S, Kowalski, KG

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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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Effects of food and antacid on oral absorption of misoprostol, a synthetic prostaglandin E1 analog by Karim, A, Rozek, L F, Smith, M E, Kowalski, K G

“…Misoprostol, a synthetic PGE1 analog with mucosal protective and antisecretory properties, is rapidly and essentially completely metabolized to its active…”
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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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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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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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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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A semicompartmental modeling approach for pharmacodynamic data assessment by Kowalski, K G, Karim, A

“…A new method is proposed for modeling the temporal aspects of the pharmacodynamic-pharmacokinetic relationship of drugs. A semicompartmental solution to the…”
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WAM (Wald's Approximation Method): a user-friendly software program for efficient covariate model building by Kowalski, K. G., Wang, W., Hermann, D.

“…A new software utility (WAM) based on the efficient covariate model building algorithm proposed by Kowalski and Hutmacher (2001) is presented and will be made…”
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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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Population exposure response analysis of pregabalin in patients with generalized anxiety disorder (GAD) by Lockwood, P. A., Kowalski, K. G., Corrigan, B. W.

“…Purpose To describe the exposure‐response relationship of pregabalin in patients with generalized anxiety disorder (GAD). Methods A subject‐specific random…”
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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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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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The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3 by Fischl, M A, Resnick, L, Coombs, R, Kremer, A B, Pottage, Jr, J C, Fass, R J, Fife, K H, Powderly, W G, Collier, A C, Aspinall, R L

“…We conducted a double-blind, randomized phase II study to evaluate the safety and activity of combination therapy with N-butyl-deoxynojirimycin (SC-48334) (an…”
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