Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Paul Sonders"'
Autor:
Alejandra Trejo-Martin, Joel P. Bercu, Andrew Thresher, Rachael E. Tennant, Robert F. Thomas, Kevin Cross, Andreas Czich, Kerstin Waese, John J. Nicolette, Joel Murray, Paul Sonders, Alison Kondratiuk, Jennifer R. Cheung, Dean Thomas, Anthony Lynch, James Harvey, Susanne Glowienke, Laura Custer, Patricia A. Escobar
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 135
Under ICH M7, impurities are assessed using the bacterial reverse mutation assay (i.e., Ames test) when predicted positive using in silico methodologies followed by expert review. N-Nitrosamines (NAs) have been of recent concern as impurities in phar
Publikováno v:
Environmental and Molecular Mutagenesis. 62:4-17
Hydrazine has been described as a mutagenic, probable human carcinogen. It is mutagenic in in vitro systems such as bacterial reverse mutation (Ames) tests and some yeast systems, as well as in in vivo systems with drosophila. It was shown to cause c
Publikováno v:
Environmental and Molecular Mutagenesis. 59:91-95
The in vivo rodent Pig-a mutation assay is a sensitive test to identify exposure to mutagenic substances, and has been proposed as an assay for the identification of impurities for pharmaceuticals. Red blood cells (RBCs) and reticulocytes (RETs) are
Autor:
John Nicolette, Alison Kondratiuk, G. Jayakumar, Paul Sonders, Meredith Crosby, A. Patel, Emily Dakoulas, Joel Murray, Kamala Pant, R. Vicente, K. Datta, M. Mathur, Rohan Kulkarni, Kyle L. Kolaja
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 100
The bacterial reverse mutation assay (Ames) is a fundamental genetic toxicology test, and efforts to miniaturize the regulatory GLP version are essential in assessing genotoxic liabilities earlier in the drug development pipeline. Two versions of the
Publikováno v:
Environmental and molecular mutagenesis. 59(1)
The in vivo rodent Pig-a mutation assay is a sensitive test to identify exposure to mutagenic substances, and has been proposed as an assay for the identification of impurities for pharmaceuticals. Red blood cells (RBCs) and reticulocytes (RETs) are
Autor:
William C. Gunther, Ann Schuermans, John Nicolette, Fabrice Nesslany, Ronald D. Fiedler, Stephen D. Dertinger, Céline Defrain, Laura Custer, Thomas J. Shutsky, Catherine J. Thiffeault, Robert H. Heflich, Paul Sonders, Amanda Giddings, Ljubica Krsmanovic, Javed A. Bhalli, Eleanor C. Wilde, Anthony M. Lynch, James T. MacGregor, Kevin Sweder, Osamu Tajima, Takafumi Kimoto, Andrew Henwood, Jing Shi, Terry Van Doninck, Souk Phonethepswath, Carol Gleason, Bas-jan M. van der Leede, Hans-Werner Vohr, Daniel J. Roberts, Pamela Weller, Azeddine Elhajouji, Yoshie Hiwata, Leon F. Stankowski, Joel Murray, Julia Kenny, Kentaro Tanaka
Publikováno v:
Environmental and Molecular Mutagenesis. 52:690-698
A collaborative international trial was conducted to evaluate the reproducibility and transferability of an in vivo mutation assay based on the enumeration of CD59-negative rat erythrocytes, a phenotype that is indicative of Pig-a gene mutation. Four
Publikováno v:
Environmental and Molecular Mutagenesis. 52:355-362
We previously reported a high concordance of in vitro micronucleus (MNvit) results obtained by flow cytometry to the known cytogenetic activity of ten commercially available compounds mentioned as validation compounds in an early draft of the OECD MN
Autor:
Marilyn S. Diehl, Svetlana L. Avlasevich, Stephen D. Dertinger, Sarojini Raja, Jeffrey C. Bemis, Paul Sonders, John Nicolette, Steven M. Bryce, Jing Shi
Publikováno v:
Environmental and molecular mutagenesis. 51(3)
A flow cytometric method for analyzing suspension cell cultures for micronucleus content has been previously reported (Avlasevich et al. [2006]: Environ Mol Mutagen 47: 56-66). The experiments described herein were undertaken to evaluate the compatib