Search Results - "Stockbridge, N"

Differentiating Drug-Induced Multichannel Block on the Electrocardiogram: Randomized Study of Dofetilide, Quinidine, Ranolazine, and Verapamil by Johannesen, L, Vicente, J, Mason, J W, Sanabria, C, Waite-Labott, K, Hong, M, Guo, P, Lin, J, Sørensen, J S, Galeotti, L, Florian, J, Ugander, M, Stockbridge, N, Strauss, D G

“…Block of the hERG potassium channel and prolongation of the QT interval are predictors of drug‐induced torsade de pointes. However, drugs that block the hERG…”
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Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial by Johannesen, L, Vicente, J, Mason, JW, Erato, C, Sanabria, C, Waite-Labott, K, Hong, M, Lin, J, Guo, P, Mutlib, A, Wang, J, Crumb, WJ, Blinova, K, Chan, D, Stohlman, J, Florian, J, Ugander, M, Stockbridge, N, Strauss, DG

“…Drug‐induced long QT syndrome has resulted in many drugs being withdrawn from the market. At the same time, the current regulatory paradigm for screening new…”
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Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase by Darpo, B, Benson, C, Dota, C, Ferber, G, Garnett, C, Green, CL, Jarugula, V, Johannesen, L, Keirns, J, Krudys, K, Liu, J, Ortemann-Renon, C, Riley, S, Sarapa, N, Smith, B, Stoltz, RR, Zhou, M, Stockbridge, N

“…The QT effects of five “QT‐positive” and one negative drug were tested to evaluate whether exposure–response analysis can detect QT effects in a small study…”
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Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science by Johannesen, L, Vicente, J, Gray, R A, Galeotti, L, Loring, Z, Garnett, C E, Florian, J, Ugander, M, Stockbridge, N, Strauss, D G

“…Fourteen drugs have been removed from the market worldwide because they cause torsade de pointes. Most drugs that cause torsade can be identified by assessing…”
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A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials by Selker, H P, Oye, K A, Eichler, H-G, Stockbridge, N L, Mehta, C R, Kaitin, K I, McElwee, N E, Honig, P K, Erban, J K, D'Agostino, R B

“…We propose an “efficacy‐to‐effectiveness” (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the…”
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Evaluating the Renal Safety of Investigational New Drugs: Where Should We Be Going? by Stockbridge, N, Blank, M, Hausner, EA, Thompson, A

“…We the authors work in the US Food and Drug Administration (FDA) review division responsible for the therapeutic agents for primary renal disease. We also…”
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Reliable and developmentally appropriate study end points are needed to achieve drug development for treatment of pediatric pulmonary arterial hypertension by Sun, H, Stockbridge, N, Ariagno, R L, Murphy, D, Nelson, R M, Rodriguez, W

“…Objective: To identify suitable end points and surrogates for pediatric pulmonary arterial hypertension (PAH) as the lack of developmentally appropriate end…”
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Essential Pharmacokinetic Information for Drug Dosage Decisions: A Concise Visual Presentation in the Drug Label by Menon‐Andersen, D, Yu, B, Madabushi, R, Bhattaram, V, Hao, W, Uppoor, R S, Mehta, M, Lesko, L, Temple, R, Stockbridge, N, Laughren, T, Gobburu, J V

“…A critical issue in labeling is to succinctly communicate, in a manner that is readily understandable and actionable, changes in systemic exposure that affect…”
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Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14 by Darpo, Borje, Garnett, Christine, Keirns, James, Stockbridge, Norman

“…Exposure-response (ER) analysis has evolved as an important tool to evaluate the effect of a drug on cardiac repolarization, as reflected in the QTc interval…”
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Development of a QT database with analytic tools: Preliminary results by Kenna, L., Sun, H., Ahwah, C., Li, M., Lee, S., Choi, J., Stockbridge, N., Parekh, A., Malinowski, H.

“…Background Development of tools for centralized QT data storage and analysis should facilitate the regulatory review process. Methods We initiated projects to…”
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Free radicals mediate actions of oxyhemoglobin on cerebrovascular smooth muscle cells by STEELE, J. A, STOCKBRIDGE, N, MALJKOVIC, G, WEIR, B

“…Single smooth muscle cells were isolated from the basilar artery of the rat by enzymatic dispersion. The membrane properties of the cells were assessed using…”
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Universal Correction for QT/RR Hysteresis by Malik, Marek, Johannesen, Lars, Hnatkova, Katerina, Stockbridge, Norman

“…Introduction Clinical pharmacology QT/QTc studies can be smaller if they more efficiently use the data generated. Objective The aim was to use large sets of…”
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Differential conduction at axonal bifurcations. II. Theoretical basis by Stockbridge, N

“…1. Numerical methods are employed to describe unbranched and branched axons like those employed in the previous paper (13). The model axon consists of a set of…”
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EGTA by Stockbridge, N

“…A method is described to compute the free calcium concentration in a solution buffered by EGTA. The effects of solution pH and [Mg] are fully taken into…”
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Etiology of the supernormal period by Stockbridge, N.

“…In many excitable cells, there is a time after the action potential when the threshold for eliciting a second action potential is lower than it is in the…”
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Theoretical response to trains of action potentials of a bifurcating axon with one short daughter branch by Stockbridge, N.

“…It has been shown both experimentally (Stockbridge, N., and L. L. Stockbridge. 1988. J. Neurophysiol. 59:1277–1285) and theoretically (Stockbridge, N. 1988. J…”
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Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamil by Vicente, Jose, Johannesen, Lars, Mason, Jay W, Crumb, William J, Pueyo, Esther, Stockbridge, Norman, Strauss, David G

“…Congenital long QT syndrome type 2 (abnormal hERG potassium channel) patients can develop flat, asymmetric, and notched T waves. Similar observations have been…”
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Theoretical response of a bifurcating axon with a locally altered axial resistivity by Stockbridge, N

“…A short region of high axial resistivity at one daughter branch of an axonal bifurcation can produce frequency dependent differential conduction of action…”
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Effects of K+ channel agonists cromakalim and pinacidil on rat basilar artery smooth muscle cells are mediated by Ca(++)-activated K+ channels by Stockbridge, N, Zhang, H, Weir, B

“…Whole-cell and cell-free inside-out patch-clamp recording techniques were used to examine the actions of potassium channel openers pinacidil and cromakalim in…”
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Solution of the Hodgkin-Huxley and cable equations of an array processor by STOCKBRIDGE, N

“…This paper presents a method for the solution of equations for membrane ionic currents and the cable equation which describes the interaction of various…”
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