Search Results - "Sarapa, N"

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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Ritonavir 100 mg Does Not Cause QTc Prolongation in Healthy Subjects: A Possible Role as CYP3A Inhibitor in Thorough QTc Studies by Sarapa, N, Nickens, D J, Raber, S R, Reynolds, R R, Amantea, M A

“…To assess the QTc prolongation by ritonavir (RTV) 100 mg and explore its potential use as CYP3A inhibitor in thorough QTc (TQT) studies. Randomized, crossover…”
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A phase I, randomized, open-label study of the multiple-dose pharmacokinetics of vemurafenib in patients with BRAF V600E mutation-positive metastatic melanoma by Grippo, J F, Zhang, W, Heinzmann, D, Yang, K H, Wong, J, Joe, A K, Munster, P, Sarapa, N, Daud, A

“…This study characterized the multiple-dose pharmacokinetics of vemurafenib 240-960 mg twice daily (bid) in BRAF(V600E) mutation-positive metastatic melanoma…”
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A phase I, randomized, open-label study of the multiple-dose pharmacokinetics of vemurafenib in patients with BRAFV600E mutation-positive metastatic melanoma by Grippo, J. F., Zhang, W., Heinzmann, D., Yang, K. H., Wong, J., Joe, A. K., Munster, P., Sarapa, N., Daud, A.

“…Purpose This study characterized the multiple-dose pharmacokinetics of vemurafenib 240–960 mg twice daily (bid) in BRAF V600E mutation-positive metastatic…”
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Electrocardiographic Identification of Drug-Induced QT Prolongation: Assessment by Different Recording and Measurement Methods by Sarapa, Nenad, Morganroth, Joel, Couderc, Jean-Philippe, Francom, Steven F., Darpo, Borje, Fleishaker, Joseph C., McEnroe, Janet D., Chen, William T., Zareba, Wojciech, Moss, Arthur J.

“…Background: Careful assessment of QT interval prolongation is required before novel drugs are approved by regulatory authorities. The choice of the most…”
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Exploratory IND: a new regulatory strategy for early clinical drug development in the United States by Sarapa, N

“…Optimizing exploratory drug development by means of doing first-in-human studies earlier is an attractive option for pharmaceutical sponsors to select more…”
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461P - First in human phase I/IIa study of PEN-866, a heat shock protein 90 (HSP90) ligand – SN38 conjugate for patients with advanced solid tumours: Phase I results by Bendell, J.C., Falchook, G., Sen, S., Johnson, M.L., Jerkovic, G., Sarapa, N., Vilimas, R., Kriksciukaite, K., Mei, L., Wooster, R., Bloss, J., Thomas, A.

“…HSP90 is a molecular chaperone that plays a key role in regulating the maturation and functional stability of a wide repertoire of cellular proteins, many of…”
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First in human phase I/IIa study of PEN-866, a heat shock protein 90 (HSP90) ligand – SN38 conjugate for patients with advanced solid tumours: Phase I results by Bendell, J.C., Falchook, G., Sen, S., Johnson, M.L., Jerkovic, G., Sarapa, N., Vilimas, R., Kriksciukaite, K., Mei, L., Wooster, R., Bloss, J., Thomas, A.

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461PFirst in human phase I/IIa study of PEN-866, a heat shock protein 90 (HSP90) ligand – SN38 conjugate for patients with advanced solid tumours: Phase I results by Bendell, J C, Falchook, G, Sen, S, Johnson, M L, Jerkovic, G, Sarapa, N, Vilimas, R, Kriksciukaite, K, Mei, L, Wooster, R, Bloss, J, Thomas, A

“…Abstract Background HSP90 is a molecular chaperone that plays a key role in regulating the maturation and functional stability of a wide repertoire of cellular…”
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Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward by Darpo, Borje, MD, PhD, Garnett, Christine, PharmD, Benson, Charles T., MD, PhD, Keirns, James, PhD, Leishman, Derek, PhD, Malik, Marek, MD, PhD, Mehrotra, Nitin, PhD, Prasad, Krishna, MD, FRCP, Riley, Steve, PharmD, PhD, Rodriguez, Ignacio, MD, Sager, Philip, MD, Sarapa, Nenad, MD, Wallis, Robert, PhD

“…The International Conference on Harmonization E14 guidance for the clinical evaluation of QT/QTc interval prolongation requires almost all new drugs to undergo…”
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Are women more susceptible than men to drug‐induced QT prolongation? Concentration–QTc modelling in a phase 1 study with oral rac‐sotalol by Darpo, Borje, Karnad, Dilip R., Badilini, Fabio, Florian, Jeff, Garnett, Christine E, Kothari, Snehal, Panicker, Gopi Krishna, Sarapa, Nenad

“…Aim To study the differences in QTc interval on ECG in response to a single oral dose of rac‐sotalol in men and women. Methods Continuous 12‐lead ECGs were…”
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The IQ-CSRC Prospective Clinical Phase 1 Study: "Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?" by Darpo, Borje, Sarapa, Nenad, Garnett, Christine, Benson, Charles, Dota, Corina, Ferber, Georg, Jarugula, Venkateswar, Johannesen, Lars, Keirns, James, Krudys, Kevin, Ortemann-Renon, Catherine, Riley, Steve, Rogers-Subramaniam, Danise, Stockbridge, Norman

“…A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac Safety Research Consortium has been formed to…”
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Are women more susceptible than men to drug-induced QT prolongation? Concentration-QT c modelling in a phase 1 study with oral rac-sotalol by Darpo, B, Karnad, DR, Badilini, F, Florian, J, Garnett, CE, Kothari, S, Panicker, GK, Sarapa, N

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A phase I, randomized, open-label study of the multiple-dose pharmacokinetics of vemurafenib in patients with BRAF^sup V600E^ mutation-positive metastatic melanoma by Grippo, J F, Zhang, W, Heinzmann, D, Yang, K H, Wong, J, Joe, A K, Munster, P, Sarapa, N, Daud, A

“…This study characterized the multiple-dose pharmacokinetics of vemurafenib 240-960 mg twice daily (bid) in BRAF ^sup V600E^ mutation-positive metastatic…”
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A phase I, randomized, open-label study of the multiple-dose pharmacokinetics of vemurafenib in patients with BRAF super(V600E) mutation-positive metastatic melanoma by Grippo, J F, Zhang, W, Heinzmann, D, Yang, KH, Wong, J, Joe, A K, Munster, P, Sarapa, N, Daud, A

“…Purpose: This study characterized the multiple-dose pharmacokinetics of vemurafenib 240-960 mg twice daily (bid) in BRAF super(V600E) mutation-positive…”
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Digital 12-lead Holter in the assessment of drug effects on cardiac repolarization by Sarapa, Nenad

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Risk management and eligibility criteria for QTc assessment in patients with advanced cancer by Sarapa, N., Huang, X., Varterasian, M., Fingert, H.

“…Abstract only…”
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Quantitative Performance of E-Scribe Warehouse in Detecting Quality Issues With Digital Annotated ECG Data From Healthy Subjects by Sarapa, Nenad, Mortara, Justin L., Brown, Barry D., Isola, Lamberto, Badilini, Fabio

“…The US Food and Drug Administration recommends submission of digital electrocardiograms in the standard HL7 XML format into the electrocardiogram warehouse to…”
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Effect of rifampin on the pharmacokinetics of SU11248 in healthy volunteers by Bello, C., Houk, B., Sherman, L., Misbah, S., Sarapa, N., Smeraglia, J., Haung, X.

“…Abstract only…”
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Assessment of normal and tumor tissue uptake of MAG-CPT, a polymer-bound prodrug of camptothecin, in patients undergoing elective surgery for colorectal carcinoma by SARAPA, Nenad, BRITTO, Margaret R, NYGREN, Peter, SPEED, William, JANNUZZO, Mariagabriella, BREDA, Massimo, JAMES, Christopher A, PORRO, Mariagrazia, ROCCHETTI, Maurizio, WANDERS, Alkvin, MAHTEME, Haile

“…MAG-camptothecin (MAG-CPT) is the lead compound of a novel drug delivery system in which an active cytotoxic moiety, camptothecin (CPT), is covalently linked…”
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