Výsledky vyhledávání - "Sheila M. Galloway"

Predictions of genotoxic potential, mode of action, molecular targets, and potencyviaa tiered multiflow® assay data analysis strategy

Autor: Sheila M. Galloway, Steven M. Bryce, Nikki E. Hall, Derek T. Bernacki, Jeffrey C. Bemis, Andrew R. Kraynak, Ryan P Wheeldon, Patricia A. Escobar, Stephen D. Dertinger, George E. Johnson

Publikováno v: Environmental and Molecular Mutagenesis. 60:513-533

The in vitro MultiFlow® DNA Damage Assay multiplexes γH2AX, p53, phospho-histone H3, and polyploidization biomarkers into a single flow cytometric analysis. The current report describes a tiered sequential data analysis strategy based on data gener

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::11c8687327a0ad6504c7bc03223d67ad
https://doi.org/10.1002/em.22274

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Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

Autor: Michelle O. Kenyon, Melisa Masuda-Herrera, Angela White, Véronique Thybaud, John Nicolette, Robert A. Jolly, Susanne Glowienke, Sheila M. Galloway, P. Parris, P. Heard, Elizabeth A. Martin, Esther Vock, Krista L. Dobo, Laura Custer, James Harvey, W. Ku, Joel P. Bercu, Andrew Teasdale

Publikováno v: Regulatory Toxicology and Pharmacology. 94:172-182

This paper provides compound-specific toxicology limits for 20 widely used synthetic reagents and common by-products that are potential impurities in drug substances. In addition, a 15 μg/day class-specific limit was developed for monofunctional alk

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b57c35386b7c9abf27d6c22b94a88b02
https://doi.org/10.1016/j.yrtph.2018.02.001

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International regulatory requirements for genotoxicity testing for pharmaceuticals used in human medicine, and their impurities and metabolites

Autor: Sheila M. Galloway

Publikováno v: Environmental and Molecular Mutagenesis. 58:296-324

The process of developing international (ICH) guidelines is described, and the main guidelines reviewed are the ICH S2(R1) guideline that includes the genotoxicity test battery for human pharmaceuticals, and the ICH M7 guideline for assessing and lim

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e46cf9aeb1232e75be6d307a055d66c4
https://doi.org/10.1002/em.22077

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In Vivo Mutagenicity Testing of Arylboronic Acids and Esters

Autor: Michelle O. Kenyon, Patricia A. Escobar, Rohan Kulkarni, Melisa Masuda-Herrera, Aparajita Dutta, Megan Young, M. Vijayaraj Reddy, Joel P. Bercu, Robert A. Jolly, Caren Brown, Shannon W. Bruce, Julia Kenny, Kamala Pant, Krista L. Dobo, Marie McKeon, Alejandra Trejo-Martin, Sheila M. Galloway

Publikováno v: Environmental and molecular mutagenesisREFERENCES. 60(9)

Arylboronic acids and esters (referred to collectively as arylboronic compounds) are commonly used intermediates in the synthesis of pharmaceuticals but pose a challenge for chemical syntheses because they are often positive for bacterial mutagenicit

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::37d7de54f6e8c31bf7e6ada6ce58bab7
https://pubmed.ncbi.nlm.nih.gov/32057133

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Standardized cell sources and recommendations for good cell culture practices in genotoxicity testing

Autor: Jennifer Y. Tanir, Elisabeth Lorge, Mick D. Fellows, Véronique Thybaud, Masamitsu Honma, M.R. O'Donovan, B. Bhaskar Gollapudi, Marilyn J. Aardema, A. Kohara, Michael J. Armstrong, Sheila M. Galloway, Julie Clements, Martha M. Moore

Publikováno v: Mutation Research/Genetic Toxicology and Environmental Mutagenesis. 809:1-15

Good cell culture practice and characterization of the cell lines used are of critical importance in in vitro genotoxicity testing. The objective of this initiative was to make continuously available stocks of the characterized isolates of the most f

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::328b3e383eae89ba4eae171365f9567f

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OSWG Recommendations for Genotoxicity Testing of Novel Oligonucleotide-Based Therapeutics

Autor: Zhanna Sobol, Catherine C. Priestley, Michael J. Schlosser, Kevin S. Sweder, Scott A Barros, Frederick B. Oleson, Cindy L Berman, Peter Kasper, Sheila M. Galloway

Publikováno v: Nucleic Acid Therapeutics. 26:73-85

The Oligonucleotide Safety Working Group subcommittee on genotoxicity testing considers therapeutic oligonucleotides (ONs) unlikely to be genotoxic based on their properties and on the negative results for ONs tested to date. Nonetheless, the subcomm

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48fbf645174a2c636efca15f218b9228
https://doi.org/10.1089/nat.2015.0534

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International regulatory requirements for genotoxicity testing for pharmaceuticals used in human medicine, and their impurities and metabolites

Autor: Sheila M, Galloway

Publikováno v: Environmental and molecular mutagenesis. 58(5)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::1835d7119f9f202e8b92d6fae631d937
https://pubmed.ncbi.nlm.nih.gov/28299826

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Propagation of Adenoviral Vectors

Publisher Summary This chapter discusses the production systems of adenoviral vectors. Particular attention is paid to the generation and use of complementation cell lines that carry the El genes and emphasizes on the PER.C6 cell line, which was deve

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::480bd08f5a5545ff92561820c41823ba
https://doi.org/10.1016/b978-0-12-800276-6.00007-3

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