Výsledky vyhledávání - "Murali K. Matta"

Akademický článek

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Publikováno v: Frontiers in Medicine, Vol 9 (2023)

The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams,

Externí odkaz: https://doaj.org/article/9d617856bbe343189c0a88673db07198

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Akademický článek

Effects of sedative psychotropic drugs combined with oxycodone on respiratory depression in the rat

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

Publikováno v: Clinical and Translational Science, Vol 14, Iss 6, Pp 2208-2219 (2021)

Abstract Following a decision to require label warnings for concurrent use of opioids and benzodiazepines and increased risk of respiratory depression and death, the US Food and Drug Administratioin (FDA) recognized that other sedative psychotropic d

Externí odkaz: https://doaj.org/article/47f7303872624d87ada0be77ae52f79d

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Akademický článek

Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism, and accumulation

Autor: Andrés Rubiano, Amruta Indapurkar, Ryosuke Yokosawa, Alina Miedzik, Barry Rosenzweig, Ayesha Arefin, Chloe M. Moulin, Keri Dame, Neil Hartman, Donna A. Volpe, Murali K. Matta, David J. Hughes, David G. Strauss, Tomasz Kostrzewski, Alexandre J. S. Ribeiro

Publikováno v: Clinical and Translational Science, Vol 14, Iss 3, Pp 1049-1061 (2021)

Abstract Liver microphysiological systems (MPSs) are promising models for predicting hepatic drug effects. Yet, after a decade since their introduction, MPSs are not routinely used in drug development due to lack of criteria for ensuring reproducibil

Externí odkaz: https://doaj.org/article/4e035e2bdd70479abbd93eb9dd228abf

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Akademický článek

Developing an animal model to detect drug–drug interactions impacting drug-induced respiratory depression

Autor: Lin Xu, Ashok Chockalingam, Sharron Stewart, Katherine Shea, Murali K. Matta, Suresh Narayanasamy, Nageswara R. Pilli, Donna A. Volpe, James Weaver, Hao Zhu, Michael C. Davis, David G. Strauss, Rodney Rouse

Publikováno v: Toxicology Reports, Vol 7, Iss , Pp 188-197 (2020)

Opioids and benzodiazepines were frequently co-prescribed to patients with pain and psychiatric or neurological disorders; however, co-prescription of these drugs increased the risk for severe respiratory depression and death. Consequently, the U.S.

Externí odkaz: https://doaj.org/article/b52b833fe4214e969df8c6926f6d031f

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Akademický článek

Evaluation of Immunocompetent Urinary Tract Infected Balb/C Mouse Model For the Study of Antibiotic Resistance Development Using Escherichia Coli CFT073 Infection

Autor: Ashok Chockalingam, Sharron Stewart, Lin Xu, Adarsh Gandhi, Murali K. Matta, Vikram Patel, Leonard Sacks, Rodney Rouse

Publikováno v: Antibiotics, Vol 8, Iss 4, p 170 (2019)

Urinary tract infections (UTI) are common worldwide and are becoming increasingly difficult to treat because of the development of antibiotic resistance. Immunocompetent murine models of human UTI have been used to study pathogenesis and treatment bu

Externí odkaz: https://doaj.org/article/68327b14a189434488b4cc50cf37d704

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Akademický článek

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

Autor: Murali K. Matta, Christopher R. Beekman, Adarsh Gandhi, Suresh Narayanasamy, Christopher D. Thomas, Adil Mohammad, Sharron Stewart, Lin Xu, Ashok Chockalingam, Katherine Shea, Vikram Patel, Rodney Rouse

Publikováno v: Nanomaterials, Vol 8, Iss 2, p 101 (2018)

A rapid, sensitive and specific ultrafiltration inductively-coupled plasma mass spectrometry method was developed and validated for the quantification of non-transferrin bound iron (NTBI), transferrin bound iron (TBI), drug bound iron (DI) and total

Externí odkaz: https://doaj.org/article/cda4dda269d14c9c9bf3e42fd2ccee5b

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Akademický článek

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats

Autor: Christopher R. Beekman, Murali K. Matta, Christopher D. Thomas, Adil Mohammad, Sharron Stewart, Lin Xu, Ashok Chockalingam, Katherine Shea, Dajun Sun, Wenlei Jiang, Vikram Patel, Rodney Rouse

Publikováno v: Nanomaterials, Vol 8, Iss 1, p 10 (2017)

Relative biodistribution of FDA-approved innovator and generic sodium ferric gluconate (SFG) drug products was investigated to identify differences in tissue distribution of iron after intravenous dosing to rats. Three equal cohorts of 42 male Spragu

Externí odkaz: https://doaj.org/article/f1fa474e3306409daee18855b2720ab3

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Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics

Autor: Paula L. Hyland, Lakshmi Manasa S. Chekka, Deepti P. Samarth, Barry A. Rosenzweig, Erica Decker, Esraa G. Mohamed, Yan Guo, Murali K. Matta, Qin Sun, William Wheeler, Carlos Sanabria, James L. Weaver, Sarah J. Schrieber, Jeffry Florian, Yow‐Ming Wang, David G. Strauss

Publikováno v: Clinical pharmacology and therapeutics. 113(1)

Proteomics has the potential to identify pharmacodynamic (PD) biomarkers for similarity assessment of proposed biosimilars without relying on clinical efficacy end points. In this study, with 36 healthy participants randomized to therapeutic doses of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d8bb25b241af8db4472cc6b8cbeb1d81
https://pubmed.ncbi.nlm.nih.gov/36308070

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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists

Autor: Victoria Gershuny, Qin Sun, Sarah J. Schrieber, Murali K. Matta, James L. Weaver, Ping Ji, Morasa Sheikhy, Cheng‐Hui Hsiao, Giri Vegesna, Aanchal Shah, Kristin Prentice, Jennifer Deering, Yow‐Ming Wang, David G. Strauss, Jeffry Florian

Publikováno v: Clinical pharmacology and therapeutics. 113(1)

The US Food and Drug Administration (FDA) guidance describes how pharmacodynamic (PD) biomarkers can be used to address residual uncertainty and demonstrate no clinically meaningful differences between a proposed biosimilar and its reference product

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::57d2cea26f8ff0c188b2642eff1230ae
https://pubmed.ncbi.nlm.nih.gov/36184697

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