Search Results - "Viswanathan, C T"

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations by Fast, Douglas M., Kelley, Marian, Viswanathan, C. T., O’Shaughnessy, Jacqueline, King, S. Peter, Chaudhary, Ajai, Weiner, Russell, DeStefano, Anthony J., Tang, Daniel

“…The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in…”
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Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays by Viswanathan, C T, Bansal, Surendra, Booth, Brian, DeStefano, Anthony J, Rose, Mark J, Sailstad, Jeffrey, Shah, Vinod P, Skelly, Jerome P, Swann, Patrick G, Weiner, Russell

“…The Third AAPS/FDA Bioanalytical Workshop, entitled "Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and…”
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2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections by Garofolo, Fabio, Rocci, Jr, Mario L, Dumont, Isabelle, Martinez, Suzanne, Lowes, Steve, Woolf, Eric, van Amsterdam, Peter, Bansal, Surendra, Barra, Ariadna Cristina Gomes, Bauer, Ronald, Booth, Brian P, Carrasco-Triguero, Montserrat, DeSilva, Binodh, Dunn, John, Gallicano, Keith, Gouty, Dominique, Ho, Stacy, Hucker, Richard, Jemal, Mohammed, Katori, Noriko, Le Blaye, Olivier, Lee, Jean, Li, Wenkui, Michael, Steve, Nehls, Corey, Nicholson, Robert, Ormsby, Eric, Tang, Daniel, Viswanathan, C T, Weiner, Russell, Young, Graeme

“…The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for…”
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Perspectives on microsampling: DBS by Viswanathan, C T

“…The concept of microsampling and particularly the dried blood spot methodology has been widely known to the scientific community for considerable time. Yet,…”
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Bringing new technologies into regulatory space by Viswanathan, C T

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Regulatory observations in bioanalytical determinations by Viswanathan, C T

“…The concept of measuring analytes in biological media is a long-established area of the quantitative sciences that is employed in many sectors. While academic…”
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Bioanalytical method validation--a revisit with a decade of progress by Shah, V P, Midha, K K, Findlay, J W, Hill, H M, Hulse, J D, McGilveray, I J, McKay, G, Miller, K J, Patnaik, R N, Powell, M L, Tonelli, A, Viswanathan, C T, Yacobi, A

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2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines by DeSilva, Binodh, Garofolo, Fabio, Rocci, Mario, Martinez, Suzanne, Dumont, Isabelle, Landry, France, Dicaire, Catherine, Szekely-Klepser, Gabriella, Weiner, Russell, Arnold, Mark, Bansal, Surendra, Bateman, Kevin, Bauer, Ronald, Booth, Brian, Davis, Scott, Dudal, Sherri, Gouty, Dominique, Grundy, John, Haidar, Sam, Hayes, Roger, Jemal, Mohammed, Kaur, Surinder, Kelley, Marian, Knutsson, Magnus, Le Blaye, Olivier, Lee, Jean, Lowes, Steve, Ma, Mark, Mitsuoka, Toshinari, Neto, João Tavares, Nicholson, Robert, Ormsby, Eric, Sailstad, Jeffrey, Stevenson, Lauren, Tang, Daniel, Welink, Jan, Viswanathan, C T, Wang, Laixin, Woolf, Eric, Yang, Eric

“…Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in…”
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US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium by Garofolo, Fabio, Michon, Josée, Leclaire, Virginie, Booth, Brian, Lowes, Stephen, Viswanathan, C T, Welink, Jan, Haidar, Sam, Teixeira, Leonardo de Souza, Tang, Daniel, Desilva, Binodh

“…The 2011 annual conference of the American Association of Pharmaceutical Scientists, held in Washington DC, USA, hosted a roundtable entitled: 'Update of the…”
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Effects of humidity and temperature on in vitro dissolution of carbamazepine tablets by Wang, J T, Shiu, G K, Ong-Chen, T, Viswanathan, C T, Skelly, J P

“…The rate and extent of dissolution of various approved marketed carbamazepine (CBZ) tablets exposed to 33, 52, 75, and 97% relative humidities at both room…”
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Pharmacokinetic evaluation of drug interactions with zidovudine. I: Probenecid and zidovudine in monkeys by Qian, M X, Finco, T S, Mehta, M, Viswanathan, C T, Gallo, J M

“…Pharmacokinetic evaluation of a drug interaction between zidovudine (AZT) and probenecid was conducted in monkeys. Six animals received 20 mg/kg of AZT as…”
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Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays by Viswanathan, C. T., Bansal, Surendra, Booth, Brian, DeStefano, Anthony J., Rose, Mark J., Sailstad, Jeffrey, Shah, Vinod P., Skelly, Jerome P., Swann, Patrick G., Weiner, Russell

“…For quantitative bioanalytical method validation procedure and requirements, there was a relatively good agreement between chromatographic assays and…”
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Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development by Peck, C C, Barr, W H, Benet, L Z, Collins, J, Desjardins, R E, Furst, D E, Harter, J G, Levy, G, Ludden, T, Rodman, J H

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Pharmacokinetics of rifampin in children. II. Oral bioavailability by Koup, J R, Williams-Warren, J, Viswanathan, C T, Weber, A, Smith, A L

“…The absolute bioavailability of oral rifampin was determined in 20 pediatric patients. Intravenous doses of rifampin (mean 287 mg/m2) were compared with p.o…”
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Diurnal oscillations of CSF valproate in monkey by Lockard, J S, Viswanathan, C T, Levy, R H

“…Valproate (VPA) was administered to four rhesus monkeys by constant-rate intravenous infusion for two weeks under controlled conditions. Plasma and CSF samples…”
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Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report by Shah, V P, Midha, K K, Dighe, S, McGilveray, I J, Skelly, J P, Yacobi, A, Layloff, T, Viswanathan, C T, Cook, C E, McDowall, R D

“…This is a summary report of the conference on Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. The conference was…”
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Effect of central cholinergic blockade on the hyperthermia evoked by prostaglandin E1 injected into the rostral hypothalamus of the rat by Rudy, T A, Viswanathan, C T

“…The possibility of a cholinergic involvement in the hyperthermic action produced by the injection of prostaglandin E1 (PGE1) into the anterior…”
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Diurnal oscillations in plasma protein binding of valproic acid by Patel, I H, Venkataramanan, R, Levy, R H, Viswanathan, C T, Ojemann, L M

“…In view of the observed variation of valproic acid (VPA) free fraction (fp) during a dosing interval and the competitive binding effect of free fatty acids…”
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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance by Savoie, Natasha, Garofolo, Fabio, van Amsterdam, Peter, Bansal, Surendra, Beaver, Chris, Bedford, Patrick, Booth, Brian P, Evans, Christopher, Jemal, Mohammed, Lefebvre, Marc, Lopes de Silva, Arthur Leonardo, Lowes, Steve, Marini, Joseph C, Massé, Robert, Mawer, Louise, Ormsby, Eric, Rocci, Jr, Mario L, Viswanathan, Ct, Wakelin-Smith, Jason, Welink, Jan, White, Joleen T, Woolf, Eric

“…The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration…”
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Plasma protein binding interaction between valproic and salicylic acids in rhesus monkeys by Viswanathan, C T, Levy, R H

“…The effects of three levels of salicylic acid on the steady-state plasma concentrations of free and total valproic acid were examined in catheterized rhesus…”
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