Search Results - "Jarugula, V"

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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Evaluation of pharmacokinetic and pharmacodynamic interaction between the dipeptidyl peptidase IV inhibitor vildagliptin, glyburide and pioglitazone in patients with Type 2 diabetes by Serra, D, He, Y-L, Bullock, J, Riviere, G-J, Balez, S, Schwartz, S, Wang, Y, Ligueros-Saylan, M, Jarugula, V, Dole, W P

“…Vildagliptin is a selective inhibitor of dipeptidyl peptidase IV (DPP-4) that improves glycemic control and pancreatic b-cell function in patients with Type 2…”
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Bioequivalence of vildagliptin/metformin fixed-dose combination tablets and a free combination of vildagliptin and metformin in healthy subjects by He, Y-L, Paladini, S, Sabia, H, Campestrini, J, Zhang, Y, Leon, S, Ligueros-Saylan, M, Jarugula, V

“…To assess the bioequivalence of vildagliptin/metformin fixed-dose combination tablets (at doses of 50/500, 50/850 and 50/1,000 mg) with free combination of the…”
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Labeling of drugs that interact with oral contraceptives by Kim, M., Castillo, E., Jarugula, V. R., Parekh, A., Furlong, L. A., Hunt, J. P., Malinowski, H. J.

“…Background Labeling should clearly describe drug‐drug interactions (DDI) between oral contraceptives (OCs) and other drugs. The purpose of this study was to…”
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Nonlinear pharmacokinetics of 5-fluorouracil in rats by Jarugula, V R, Lam, S S, Boudinot, F D

“…The effects of dose on the pharmacokinetics of 5-fluorouracil (5-FU) were investigated following intravenous administration of 5-FU at 10, 50, and 100 mg/kg to…”
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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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Pharmacokinetics of 5-carboranyl-2'-deoxyuridine in rats by Jarugula, V R, Schinazi, R F, Fulcrand, G, el Kattan, Y, Liotta, D C, Boudinot, F D

“…The pharmacokinetics of 5-carboranyl-2'-deoxyuridine (CDU) after intravenous administration of 25 mg/kg was investigated in rats. The uptake of CDU into brain…”
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PIII-49Comparison of ethinyl estradiol exposure among approved contraceptive products in the U.S by KIM, M, PARK, J, ORTIZ, S, JARUGULA, V, PAREKH, A

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PIII-49 by Kim, M., Park, J., Ortiz, S., Jarugula, V. R., Parekh, A.

“…BACKGROUND The risk of thromboembolic events in women using hormonal contraceptive products is a concern. Doses of ethinyl estradiol (EE) have been…”
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Experience evaluating QT prolongation data by Kenna, L. A., Parekh, A., Jarugula, V., Chatterjee, D. J., Sun, H., Kim, M. J., Ortiz, S., Hunt, J. P., Malinowski, H.

“…A preliminary concept paper (http://cdernet.cder.fda.gov/QTWG/QT%20Workshop/qt4jam.pdf) advises on the design of effective QT assessment studies. We aimed to…”
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High-performance liquid chromatographic determination of 5-fluorouracil and its prodrugs, tegafur and 4-deoxy-5-fluorouracil, in rat plasma by Jarugula, Venkateswar R., Douglas Boudinot, F.

“…A rapid, sensitive and reproducible ion-pair, reversed-phase high-performance liquid chromatographic (HPLC) method was developed to simultaneously quantitate…”
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