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16 results on '"Narayanasamy, Suresh"'

4. Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

Author

Le Merdy, Maxime, Fan, Jianghong, Bolger, Michael B., Lukacova, Viera, Spires, Jessica, Tsakalozou, Eleftheria, Patel, Vikram, Xu, Lin, Stewart, Sharron, Chockalingam, Ashok, Narayanasamy, Suresh, Rouse, Rodney, Matta, Murali, Babiskin, Andrew, Kozak, Darby, Choi, Stephanie, Zhang, Lei, Lionberger, Robert, and Zhao, Liang

Published
2019
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5. Effects of sedative psychotropic drugs combined with oxycodone on respiratory depression in the rat

Author

Xu, Lin, primary, Krishna, Ashok, additional, Stewart, Sharron, additional, Shea, Katherine, additional, Racz, Rebecca, additional, Weaver, James L., additional, Volpe, Donna A., additional, Pilli, Nageswara R., additional, Narayanasamy, Suresh, additional, Florian, Jeffry, additional, Patel, Vikram, additional, Matta, Murali K., additional, Stone, Marc B., additional, Zhu, Hao, additional, Davis, Michael C., additional, Strauss, David G., additional, and Rouse, Rodney, additional

Published
2021
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7. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Author

Li, Junyi, primary, Florian, Jeffry, additional, Campbell, Elizabeth, additional, Schrieber, Sarah J., additional, Bai, Jane P.F., additional, Weaver, James L., additional, Hyland, Paula L., additional, Thway, Theingi M., additional, Matta, Murali K., additional, Lankapalli, Rachana H., additional, Narayanasamy, Suresh, additional, Dancy, Jimena, additional, Zusterzeel, Robbert, additional, Tyson, Jessica Y., additional, Prentice, Kristin W., additional, Jackson, Kathryn C., additional, Patel, Vikram, additional, Rouse, Rodney L., additional, Wang, Yow‐Ming C., additional, and Strauss, David G., additional

Published
2019
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9. Novel High-Throughput Quantitation of Potent hERG Blocker Dofetilide in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application in a Phase 1 ECG Biomarker Validation Study.

Author

Matta, Murali K, Narayanasamy, Suresh, Vicente, Jose, Zusterzeel, Robbert, Patel, Vikram, and Strauss, David G

Subjects
*TANDEM mass spectrometry, *ION mobility spectroscopy, *LIQUID chromatography-mass spectrometry, *LIQUID chromatography, *MATRIX effect, *FORMIC acid, *PROARRHYTHMIA
Abstract

The authors developed a novel, sensitive high-throughput ultra-performance liquid chromatography-tandem mass spectrometric method for the determination of dofetilide in human plasma. To compensate for the matrix effect, a deuterated internal standard was used. The method employed a very low sample volume (50 μL) of plasma for sample processing by using simple protein precipitation extraction in a 96-well plate. The extracted samples were chromatographed on an Acquity BEH C18 column (2.1 × 100 mm, 1.7 μm) and eluted in a gradient manner at a flow rate of 0.5 mL/min for 2 min using 5 mM ammonium formate (0.1% formic acid) and methanol. The calibration curve was linear from 25 to 2,500 pg/mL with a correlation coefficient (r2)  ≥ 0.99 (0.9969–0.9980; n  = 3). The developed method was validated as per the current United States Food and Drug Administration's guidance for industry on 'Bioanalytical Method Validation'. The multiple reaction–monitoring mode was employed for quantitation of dofetilide with m/z 442.2/198.2 and dofetilide d4 with m/z 446.2/198.2. The validated method was used for evaluation of dofetilide concentration in the Comprehensive in vitro Proarrhythmia Assay phase 1 electrocardiogramic biomarker validation study. [ABSTRACT FROM AUTHOR]

Published
2020
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10. Determination of Non-Transferrin Bound Iron, Transferrin Bound Iron, Drug Bound Iron and Total Iron in Serum in a Rats after IV Administration of Sodium Ferric Gluconate Complex by Simple Ultrafiltration Inductively Coupled Plasma Mass Spectrometric Detection

Author

Matta, Murali, primary, Beekman, Christopher, additional, Gandhi, Adarsh, additional, Narayanasamy, Suresh, additional, Thomas, Christopher, additional, Mohammad, Adil, additional, Stewart, Sharron, additional, Xu, Lin, additional, Chockalingam, Ashok, additional, Shea, Katherine, additional, Patel, Vikram, additional, and Rouse, Rodney, additional

Published
2018
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14. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.

Author

Li, Junyi, Florian, Jeffry, Campbell, Elizabeth, Schrieber, Sarah J., Bai, Jane P.F., Weaver, James L., Hyland, Paula L., Thway, Theingi M., Matta, Murali K., Lankapalli, Rachana H., Narayanasamy, Suresh, Dancy, Jimena, Zusterzeel, Robbert, Tyson, Jessica Y., Prentice, Kristin W., Jackson, Kathryn C., Patel, Vikram, Rouse, Rodney L., Wang, Yow‐Ming C., and Strauss, David G.

Subjects
THERAPEUTIC equivalency in drugs, CLINICAL pharmacology, BIOMARKERS, BIOLOGICAL tags
Abstract

To ensure US patients realize the public health benefit of a robust, competitive market for biosimilar products, the US Food and Drug Administration (FDA) is focused on improving the efficiency of biosimilar development and approvals. As noted above and outlined in FDA guidance documents, biosimilars may be approved based on PK and PD biomarker data without a comparative clinical study with efficacy end point(s).[2] Reliance on PK and PD biomarker data allows for shorter and less costly clinical studies than can often be conducted in healthy participants. Under circumstances where an established and sensitive PD biomarker does not exist, there is an opportunity to explore and identify new PD biomarkers to facilitate the use of PD biomarker data in clinical pharmacology studies. [Extracted from the article]

Published
2020
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