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118 results on '"Nicolette, John"'

1. Contributors

Author

Ajithdoss, D.K., primary, Al-Humadi, Nabil, additional, Amuzie, C.J., additional, Attar, Mayssa, additional, Aulbach, Adam D., additional, Boersen, Nathan, additional, Bolger, Gordon, additional, Brown, Jennifer G., additional, Chang, T.T.A., additional, Chanut, Franck Jacques-Antoine, additional, Cheng, Z., additional, Colagiovanni, Dorothy B., additional, Colerangle, John B., additional, Collins, Roger, additional, Cristofori, Patrizia, additional, Denny, Kevin H., additional, Dill-Okubo, J., additional, Ennulat, Daniela, additional, Faqi, Ali S., additional, Farmer, John T., additional, Frantz, Stephen, additional, Freshwater, Les, additional, Gauvin, David V., additional, Goud, N.S., additional, Green, M.D., additional, Henry, Scott P., additional, Hoberman, Alan, additional, Hui, Ho-Wah, additional, Hui, Julia Y., additional, Ji, A.Y., additional, Johnson, Colleen, additional, Kile, J.W., additional, Kim, Tae-Won, additional, Koch, Elisabeth, additional, Kornbrust, Douglas, additional, Kulshreshtha, V., additional, Learn, D.B., additional, LeBaron, Mathew J., additional, Levin, Arthur A., additional, Lewis, Elise, additional, Licollari, Albert, additional, Li, X.P., additional, Loo, Deryk, additional, Luhrs, Keith A., additional, Martini, Austin, additional, McCormick, D.L., additional, Meyer-Tamaki, K.B., additional, Nicolette, John, additional, O'Carroll, Andrew, additional, Oh, Hyesun Helena, additional, Oyejide, L., additional, Peraza, Marjorie A., additional, Plassmann, Stephanie, additional, Qiao, H.W., additional, Ramos, Meg Ferrell, additional, Rehagen, D., additional, Resendez, J.C., additional, Schultze, A. Eric, additional, Seals, Jennifer R., additional, Settivari, Raja S., additional, Slauter, Ric, additional, Stahl, Kurt, additional, Stump, Donald, additional, Surapaneni, Sekhar, additional, Templin, Michael, additional, Toltin, Abigail, additional, Vidmar, Tom, additional, Vrbanac, Jim, additional, Wang, Z.J., additional, Whiteley, Laurence O., additional, Wijeyesakere, Sanjeeva, additional, Wrzesinski, Claudia, additional, Xu, Jie, additional, Yang, Ping, additional, Yoder, Lisa, additional, Younis, Husam S., additional, Zhang, Y.M., additional, and Zimmermann, Zachary J., additional

Published
2024
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8. A comparison of transgenic rodent mutation and in vivo comet assay responses for 91 chemicals

Author

Kirkland, David, Levy, Dan D., LeBaron, Matthew J., Aardema, Marilyn J., Beevers, Carol, Bhalli, Javed, Douglas, George R., Escobar, Patricia A., Farabaugh, Christopher S., Guerard, Melanie, Johnson, George E., Kulkarni, Rohan, Le Curieux, Frank, Long, Alexandra S., Lott, Jasmin, Lovell, David P., Luijten, Mirjam, Marchetti, Francesco, Nicolette, John J., Pfuhler, Stefan, Roberts, Daniel J., Stankowski, Leon F., Jr., Thybaud, Veronique, Weiner, Sandy K., Williams, Andrew, Witt, Kristine L., and Young, Robert

Published
2019
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9. Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses

Author

Amberg, Alexander, Andaya, Roxanne V., Anger, Lennart T., Barber, Chris, Beilke, Lisa, Bercu, Joel, Bower, Dave, Brigo, Alessandro, Cammerer, Zoryanna, Cross, Kevin P., Custer, Laura, Dobo, Krista, Gerets, Helga, Gervais, Véronique, Glowienke, Susanne, Gomez, Stephen, Van Gompel, Jacky, Harvey, James, Hasselgren, Catrin, Honma, Masamitsu, Johnson, Candice, Jolly, Robert, Kemper, Raymond, Kenyon, Michelle, Kruhlak, Naomi, Leavitt, Penny, Miller, Scott, Muster, Wolfgang, Naven, Russell, Nicolette, John, Parenty, Alexis, Powley, Mark, Quigley, Donald P., Reddy, M. Vijayaraj, Sasaki, Jennifer C., Stavitskaya, Lidiya, Teasdale, Andrew, Trejo-Martin, Alejandra, Weiner, Sandy, Welch, Dennie S., White, Angela, Wichard, Joerg, Woolley, David, and Myatt, Glenn J.

Published
2019
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11. Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses

Author

Amberg, Alexander, Beilke, Lisa, Bercu, Joel, Bower, Dave, Brigo, Alessandro, Cross, Kevin P., Custer, Laura, Dobo, Krista, Dowdy, Eric, Ford, Kevin A., Glowienke, Susanne, Van Gompel, Jacky, Harvey, James, Hasselgren, Catrin, Honma, Masamitsu, Jolly, Robert, Kemper, Raymond, Kenyon, Michelle, Kruhlak, Naomi, Leavitt, Penny, Miller, Scott, Muster, Wolfgang, Nicolette, John, Plaper, Andreja, Powley, Mark, Quigley, Donald P., Reddy, M. Vijayaraj, Spirkl, Hans-Peter, Stavitskaya, Lidiya, Teasdale, Andrew, Weiner, Sandy, Welch, Dennie S., White, Angela, Wichard, Joerg, and Myatt, Glenn J.

Published
2016
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15. An Evaluation of the Occupational Health Hazards of Peptide Couplers

Author

Graham, Jessica C., primary, Trejo-Martin, Alejandra, additional, Chilton, Martyn L., additional, Kostal, Jakub, additional, Bercu, Joel, additional, Beutner, Gregory L., additional, Bruen, Uma S., additional, Dolan, David G., additional, Gomez, Stephen, additional, Hillegass, Jedd, additional, Nicolette, John, additional, and Schmitz, Matthew, additional

Published
2022
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17. Utility of a Next Generation Framework for Assessment of Genomic Damage: A Case Study Using the Pharmaceutical Drug Candidate Etoposide

Author

Nicolette, John, primary, Luijten, Mirjam, additional, Sasaki, Jennifer C., additional, Custer, Laura, additional, Embry, Michelle, additional, Froetschl, Roland, additional, Johnson, George, additional, Ouedraogo, Gladys, additional, Powley, Mark, additional, Settivari, Raja, additional, Thybaud, Veronique, additional, and Dearfield, Kerry L., additional

Published
2021
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18. Permitted daily exposure limits for noteworthy N‐nitrosamines

Author

Johnson, George E., primary, Dobo, Krista, additional, Gollapudi, Bhaskar, additional, Harvey, Jim, additional, Kenny, Julia, additional, Kenyon, Michelle, additional, Lynch, Anthony, additional, Minocherhomji, Sheroy, additional, Nicolette, John, additional, Thybaud, Veronique, additional, Wheeldon, Ryan, additional, and Zeller, Andreas, additional

Published
2021
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20. Contributors

Author

Abdi, Mohamoud M., primary, Al-Humadi, Nabil Hussain, additional, Attar, Mayssa, additional, Baird, Theodore J., additional, Behrens, Jeff, additional, Boersen, Nathan, additional, Brassard, Jacqueline A., additional, Beck, Melissa J., additional, Brown, Jennifer G., additional, Carney, Edward W., additional, Chang, Ting-Tung A., additional, Chen, Mingli, additional, Colagiovanni, Dorothy B., additional, Colerangle, John B., additional, Collins, Roger, additional, Dabora, Rebecca, additional, Dalton, Jill A., additional, Denny, Kevin H., additional, Dietert, Rodney R., additional, Donald, Forbes P., additional, Duncan, J. Neil, additional, Farmer, John T., additional, Faqi, Ali S., additional, Frantz, Stephen, additional, Freshwater, Les, additional, Fuchs, Tobias C., additional, Gauvin, David V., additional, Green, Martin David, additional, Guo, Lining, additional, Henry, Scott P., additional, Hewitt, Philip G., additional, Hoberman, Alan, additional, Hui, Ho-Wah, additional, Hui, Julia Y., additional, Johnson, Colleen, additional, Kille, John W., additional, Kim, Andrea S., additional, Kim, Tae-Won, additional, Kirby, Neil, additional, Kornbrust, Douglas, additional, Learn, Douglas B., additional, Lee, Thomas, additional, Lewis, Elise, additional, Matsumoto, Steven, additional, McCormick, David L., additional, Meyer-Tamaki, Kathleen B., additional, Mendes, Odete R., additional, Milburn, Michael V., additional, Mikaelian, Igor, additional, Morford, LaRonda L., additional, Nicolette, John, additional, Nugent, Paul, additional, Oh, Hyesun H., additional, Oyejide, Lekan, additional, Ramos, Meg, additional, Regal, Kelly A., additional, Rehagen, David, additional, Resendez, John Cody, additional, Ryals, John A., additional, Sambuco, Christopher P., additional, Schrag, Michael, additional, Serota, David G., additional, Settivari, Raja, additional, Slauter, Richard, additional, Stewart, Christopher W., additional, Stump, Donald, additional, Surapaneni, Sekhar, additional, Templin, Michael, additional, Thorsrud, Bjorn A., additional, Truisi, Germaine L., additional, Vangyi, Chang, additional, Vidmar, Tom, additional, Vrbanac, Jim, additional, Wang, Qingli, additional, Wang, Zheng J., additional, Whitely, Lawrence O., additional, Yan, James S., additional, York, Malcolm J., additional, and Younis, Husam S., additional

Published
2013
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23. International Pig-a gene mutation assay trial: Evaluation of transferability across 14 laboratories

Author

Dertinger, Stephen D., Phonethepswath, Souk, Weller, Pamela, Nicolette, John, Murray, Joel, Sonders, Paul, Vohr, Hans-Werner, Shi, Jing, Krsmanovic, Ljubica, Gleason, Carol, Custer, Laura, Henwood, Andrew, Sweder, Kevin, Stankowski, Leon F., Jr., Roberts, Daniel J., Giddings, Amanda, Kenny, Julia, Lynch, Anthony M., Defrain, Céline, Nesslany, Fabrice, van der Leede, Bas-jan M., Van Doninck, Terry, Schuermans, Ann, Tanaka, Kentaro, Hiwata, Yoshie, Tajima, Osamu, Wilde, Eleanor, Elhajouji, Azeddine, Gunther, William C., Thiffeault, Catherine J., Shutsky, Thomas J., Fiedler, Ronald D., Kimoto, Takafumi, Bhalli, Javed A., Heflich, Robert H., and MacGregor, James T.

Published
2011
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28. Selective inhibition of the BD2 bromodomain of BET proteins in prostate cancer

Author

Faivre, Emily J., primary, McDaniel, Keith F., additional, Albert, Daniel H., additional, Mantena, Srinivasa R., additional, Plotnik, Joshua P., additional, Wilcox, Denise, additional, Zhang, Lu, additional, Bui, Mai H., additional, Sheppard, George S., additional, Wang, Le, additional, Sehgal, Vasudha, additional, Lin, Xiaoyu, additional, Huang, Xiaoli, additional, Lu, Xin, additional, Uziel, Tamar, additional, Hessler, Paul, additional, Lam, Lloyd T., additional, Bellin, Richard J., additional, Mehta, Gaurav, additional, Fidanze, Steve, additional, Pratt, John K., additional, Liu, Dachun, additional, Hasvold, Lisa A., additional, Sun, Chaohong, additional, Panchal, Sanjay C., additional, Nicolette, John J., additional, Fossey, Stacey L., additional, Park, Chang H., additional, Longenecker, Kenton, additional, Bigelow, Lance, additional, Torrent, Maricel, additional, Rosenberg, Saul H., additional, Kati, Warren M., additional, and Shen, Yu, additional

Published
2020
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29. In vitro and in vivo mammalian mutation assays support a nonmutagenic mechanism of carcinogenicity for hydrazine.

Author

Nicolette, John, Murray, Joel, Sonders, Paul, Kondratiuk, Alison, and Crosby, Meredith

Subjects
HYDRAZINE, CARCINOGENICITY, AMES test, BIOTRANSFORMATION (Metabolism), BACTERIAL mutation, MUTAGENS
Abstract

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 chromosome damage both in vitro and in vivo but was negative in some well‐validated mammalian mutation systems such as CHO HPRT assays. Importantly, there is only one in vivo gene mutation test reported, which was negative. Our objective was to determine if hydrazine is mutagenic in mammalian test systems. Thus, we conducted an in vitro gene mutation test in Muta™Mouse lung epithelial cells (FE1 cell assay) and a regulatory‐compliant in vivo Big Blue® mouse test. Consistent with previous reports, an additional six‐well Ames assay showed that hydrazine was mutagenic to bacteria. The FE1 cell assay was negative in conditions with and without metabolic activation when tested to cytotoxicity limits. In the Big Blue® mouse study, female mice received dosages of hydrazine up to 10.9 mg/kg via drinking water for 28 days. This dose is comparable to a dose used in a carcinogenicity study where female mice had significant increases in hepatocellular adenoma at 11.5 mg/kg. There were no increases in mutant frequency in liver and lung, two tissues sensitive to the carcinogenic effects of hydrazine in mice. Our research shows that hydrazine is not mutagenic in mammalian cells either in vitro or in vivo, indicating mutagenicity may not play a role in the carcinogenicity of hydrazine. [ABSTRACT FROM AUTHOR]

Published
2021
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32. A regenerative erythropoietic response does not increase the frequency of <italic>Pig‐a</italic> mutant reticulocytes and erythrocytes in Sprague‐Dawley rats.

Author

Nicolette, John, Murray, Joel, Sonders, Paul, and Leroy, Bruce

Subjects
ERYTHROPOIESIS, RETICULOCYTES, ERYTHROCYTES, GENETIC mutation, LABORATORY rats
Abstract

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 analyzed by flow cytometry after exposure to potentially mutagenic chemicals for cells deficient in the cell surface anchored protein CD59, representing mutation in the X‐linked Pig‐a gene. The full potential of the assay as well as its limitations are currently being explored. The current study investigated the effects of regenerative erythropoietic bone marrow responses on the frequency of Pig‐a mutated reticulocytes (RETCD59‐) and erythrocytes (RBCCD59‐). We hypothesized that a robust regenerative erythropoietic response would not increase the basal frequency of RETCD59‐ or RBCCD59‐ cells. Two groups of six male Sprague‐Dawley rats either had 2 mL of blood sampled each day via an indwelling catheter over a period of 5 days or were minimally sampled for hematology and used as controls. Blood was also then collected and evaluated 5, 18, and 49 days after the initial bleed period for the number of Pig‐a mutant cells in either the RET or RBC population. Despite the expected decrease in hematocrit and the correlative increase in reticulocytes after bleeding, no increase in the number of Pig‐a mutant cells was observed in male Sprague‐Dawley rats that were bled for five consecutive days. These results indicate that changes in erythropoiesis and hematology parameters in rats appear to have no effect on the background levels of Pig‐a mutated RETs and RBCs. Environ. Mol. Mutagen. 59:91–95, 2018. © 2017 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Published
2018
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33. Peptide bond-forming reagents H OAt and H ATU are not mutagenic in the bacterial reverse mutation test.

Author

Nicolette, John, Neft, Robin E., Vanosdol, Jessica, Murray, Joel, and Zeiger, E.

Subjects
PEPTIDE bonds, AMES test, MICROBIOLOGICAL assay, MUTAGENICITY testing, CHEMICAL reagents
Abstract

The peptide bond-forming reagents 1-hydroxy-7-azabenzotriazole (HOAt, CAS 39968-33-7) and O-(7-Azabenzotriazol-1-yl)-N,N,N′,N′-tetramethyluronium hexafluorophosphate (HATU, CAS 148893-10-1) either have structural alerts, unclassified features or are considered out of domain when evaluated for potential mutagenicity with in silico programs DEREK and CaseUltra. Since they are commonly used reagents in pharmaceutical drug syntheses, they may become drug substance or drug product impurities and would need to be either controlled to appropriately safe levels or tested for mutagenicity. Both reagents were tested in the bacterial reverse mutation (Ames) test at Covance, under GLP conditions, following the OECD test guideline and ICH S2(R1) recommendations and found to be negative. Our data show that HOAt and HATU-common pharmaceutical synthesis reagents-are not mutagenic, and can be treated as ordinary drug impurities. Environ. Mol. Mutagen. 57:236-240, 2016. © 2016 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Published
2016
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36. Multi-lab validation of an improved flow cytometric in vitro micronucleus assay using attached cell lines

Author

Young, Robert, primary, Shi, Jing, additional, Bryce, Steven, additional, Nicolette, John, additional, Diehl, Marilyn, additional, Sonder, Paul, additional, Phonethepswath, Souk, additional, Avlasevich, Svetlana, additional, Raja, Sarojini, additional, Bemis, Jeffrey, additional, Dertinger, Stephen, additional, and Nicholette, John, additional

Published
2009
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