Zobrazeno 1 - 10
of 84
pro vyhledávání: '"Murali K. Matta"'
Autor:
Kimberly Chiu, Rebecca Racz, Keith Burkhart, Jeffry Florian, Kevin Ford, M. Iveth Garcia, Robert M. Geiger, Kristina E. Howard, Paula L. Hyland, Omnia A. Ismaiel, Naomi L. Kruhlak, Zhihua Li, Murali K. Matta, Kristin W. Prentice, Aanchal Shah, Lidiya Stavitskaya, Donna A. Volpe, James L. Weaver, Wendy W. Wu, Rodney Rouse, David G. Strauss
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
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
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
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
Autor:
Ryan De Palma, Vikram Patel, Jeffry Florian, David Keire, Daniela Selaya, David G. Strauss, Rodney Rouse, Murali K. Matta
Publikováno v:
Journal of Pharmaceutical Sciences. 112:1315-1323
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3c3496fadd67e747e2092c9f429406ff
https://doi.org/10.1016/j.xphs.2023.01.026
https://doi.org/10.1016/j.xphs.2023.01.026
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
https://pubmed.ncbi.nlm.nih.gov/36308070
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
https://pubmed.ncbi.nlm.nih.gov/36184697
Autor:
Morasa Sheikhy, Sarah J. Schrieber, Qin Sun, Victoria Gershuny, Murali K. Matta, Jane P.F. Bai, Xiulian Du, Giri Vegesna, Aanchal Shah, Kristin Prentice, Colleen Nalepinski, Issam Zineh, Yow‐Ming Wang, David G. Strauss, Jeffry Florian
Publikováno v:
Clinical pharmacology and therapeutics.
US Food and Drug Administration (FDA) guidance outlines how biosimilars can be developed based on pharmacokinetic (PK) and pharmacodynamic (PD) similarity study data in lieu of a comparative clinical efficacy study. There is a paucity of PD comparabi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::069501031fba7ad31cf5af63c13873fa
https://pubmed.ncbi.nlm.nih.gov/36282186
https://pubmed.ncbi.nlm.nih.gov/36282186
Autor:
Jeffry Florian, Victoria Gershuny, Qin Sun, Sarah J. Schrieber, Murali K. Matta, Anthony Hazel, Morasa Sheikhy, James L. Weaver, Paula L. Hyland, Cheng‐Hui Hsiao, Giri Vegesna, Ryan DePalma, Aanchal Shah, Kristin Prentice, Carlos Sanabria, Yow‐Ming Wang, David G. Strauss
Publikováno v:
Clinical pharmacology and therapeutics.
The US Food and Drug Administration (FDA) has taken steps to bring efficiency to the development of biosimilars, including establishing guidance for the use of pharmacokinetic and pharmacodynamic (PD) similarity study data without a comparative clini
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e49b06d5f24aa542efdd8ede4c9fa202
https://pubmed.ncbi.nlm.nih.gov/36324229
https://pubmed.ncbi.nlm.nih.gov/36324229
Autor:
Hao Zhu, David G. Strauss, Murali K. Matta, Marc Stone, Ashok Krishna, Vikram Patel, Michael C. Davis, Donna A. Volpe, Jeffry Florian, Rebecca Racz, Nageswara Rao Pilli, Katherine Shea, James L. Weaver, Rodney Rouse, Suresh Narayanasamy, Lin Xu, Sharron Stewart
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 6, Pp 2208-2219 (2021)
Clinical and Translational Science
Clinical and Translational Science
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 drugs may
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24a36d655b673a8768f6cd64be6c5ec1
https://doi.org/10.1111/cts.13080
https://doi.org/10.1111/cts.13080