An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs) von Avila, Amy M., Bebenek, Ilona, Bonzo, Jessica A., Bourcier, Todd, Davis Bruno, Karen L., Carlson, David B., Dubinion, John, Elayan, Ikram, Harrouk, Wafa, Lee, Shwu-Luan, Mendrick, Donna L., Merrill, Jill C., Peretz, Jackye, Place, Emily, Saulnier, Muriel, Wange, Ronald L., Yao, Jia, Zhao, Dong, Brown, Paul C.

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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test von Heflich, Robert H., Bishop, Michelle E., Mittelstaedt, Roberta A., Yan, Jian, Guerrero, Sharon K., Sims, Audrey M., Mitchell, Kamela, Moore, Nyosha, Li, Xilin, Mei, Nan, Elespuru, Rosalie K., King, Sruthi T., Keire, David A., Kruhlak, Naomi L., Dorsam, Robert T., Raw, Andre S., Davis Bruno, Karen L., McGovern, Timothy J., Atrakchi, Aisar H.

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Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future von Wange, Ronald L., Brown, Paul C., Davis-Bruno, Karen L.

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Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models von Seo, Ji-Eun, Yu, Joshua Z., Xu, Hannah, Li, Xilin, Atrakchi, Aisar H., McGovern, Timothy J., Bruno, Karen L. Davis, Mei, Nan, Heflich, Robert H., Guo, Xiaoqing

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Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s von Li, Xilin, He, Xiaobo, Le, Yuan, Guo, Xiaoqing, Bryant, Matthew S., Atrakchi, Aisar H., McGovern, Timothy J., Davis-Bruno, Karen L., Keire, David A., Heflich, Robert H., Mei, Nan

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Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells von Li, Xilin, Le, Yuan, Guo, Xiaoqing, King, Sruthi T., Dorsam, Robert T., Atrakchi, Aisar H., McGovern, Timothy J., Davis-Bruno, Karen L., Keire, David A., Heflich, Robert H., Mei, Nan

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Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays von Li, Xilin, Le, Yuan, Seo, Ji-Eun, Guo, Xiaoqing, Li, Yuxi, Chen, Si, Mittelstaedt, Roberta A., Moore, Nyosha, Guerrero, Sharon, Sims, Audrey, King, Sruthi T., Atrakchi, Aisar H., McGovern, Timothy J., Davis-Bruno, Karen L., Keire, David A., Elespuru, Rosalie K., Heflich, Robert H., Mei, Nan

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A Regulatory Perspective on Issues and Approaches in Characterizing Human Metabolites von Davis-Bruno, Karen L., Atrakchi, Aisar

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Expression and characterization of CD4-IgG2, a novel heterotetramer that neutralizes primary HIV type 1 isolates von ALLAWAY, G. P, DAVIS-BRUNO, K. L, MADDON, P. J, BEAUDRY, G. A, GARCIA, E. B, WONG, E. L, RYDER, A. M, HASEL, K. W, GAUDUIN, M.-C, KOUP, R. A, MCDOUGAL, J. S

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Thromboxane A2 receptors von Halushka, P V, Allan, C J, Davis-Bruno, K L

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Thromboxane A 2 receptors von Halushka, Perry V., Allan, Claire J., Davis-Bruno, Karen L.

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Expression and Characterization of CD4-IgG 2 , a Novel Heterotetramer That Neutralizes Primary HIV Type 1 Isolates von ALLAWAY, GRAHAM P., DAVIS-BRUNO, KAREN L., BEAUDRY, GARY A., GARCIA, ELISA B., WONG, EMILY L., RYDER, ANDREW M., HASEL, KARL W., GAUDUIN, MARIE-CLAIRE, KOUP, RICHARD A., McDOUGAL, J. STEVEN, MADDON, PAUL J.

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Oral Anticoagulants in the Oldest Old with Recent Stroke and Atrial Fibrillation von Wilson, Duncan, Koga, Masatoshi, Seiffge, David J., De Marchis, Gian Marco, Wang, Ruihao, Alberti, Andrea, Yoshimura, Sohei, Brown, Martin M., Tanaka, Kanta, Takagi, Masahito, Toyoda, Kazunori, Werring, David J., Kallmünzer, Bernd, Polymeris, Alexandros A, Peters, Nils, Thilemann, Sebastian, Hert, Lisa, Fladt, Joachim, Dittrich, Tolga, Stoll, Svenja, Kallmünzer, Bernd, Bonetti, Bruno, Tomelleri, Giampaolo, Micheletti, Nicola, Zivelonghi, Cecilia, Emiliani, Andrea, Parry‐Jones, Adrian, Patterson, Chris, Nallasivam, Arumug, Nor, Azlisham Mohd, Esis, Bernard, Holmes, Clare, Cohen, David, Anwar, Ijaz, Scott, Jon, Birns, Jonathan, Pasco, Kath, Choy, Lillian, Iveson, Liz, Smyth, Nigel, O’Mahony, Paul, Aghoram, Prasanna, Luder, Robert, Subramonian, Santhosh, Andole, Sreeman, Manoj, Aravindakshan, Harkness, Kirsty, McCormich, Michael, Sprigg, Nikola, Krishnamurthy, Vinodh, Acciarresi, Monica, Agnelli, Giancarlo, D’Amore, Cataldo, Cimini, Ludovica Anna, Paciaroni, Maurizio, Chondrogianni, Maria, Zedde, Marialuisa, Bovi, Paolo, Carletti, Monica, Cappellari, Manuel, Pezzini, Alessandro, Sohn, Sung‐Il, Lorenzini, Gianni, Karagkiozi, Efstathia, Galati, Franco, Sacco, Simona, Colombo, Giovanna, Maccarrone, Miriam, Ulivi, Leonardo, Orlandi, Giovanni, Tassinari, Tiziana, Letteri, Federica, Monaco, Serena, Szabó, Lilla, Giorli, Elisa, Del Sette, Massimo, Imberti, Davide, Doronin, Boris, Volodina, Vera, Michel, Patrik, Barlinn, Jessica, Deleu, Dirk, Akhtar, Naveed, Gourbali, Vanessa, Shibazaki, Kensaku, Hirano, Teruyuki, Homma, Kazunari, Okuda, Satoshi, Hasegawa, Yasuhiro, Ito, Yasuhiro, Matsuoka, Hideki, Takamatsu, Kazuhiro, Nishiyama, Kazutoshi, Tanaka, Kanta, Sakamoto, Yuki, Tokunaga, Keisuke, Ide, Toshihiro, Yoshimoto, Takeshi, Ando, Daisuke, Mizoguchi, Tadataka

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Growth Outcomes of Preterm Infants Exposed to Different Oxygen Saturation Target Ranges from Birth von Navarrete, Cristina T., MD, Wrage, Lisa A., MPH, Carlo, Waldemar A., MD, Walsh, Michele C., MD, MS, Rich, Wade, RRT, Gantz, Marie G., PhD, Das, Abhik, PhD, Schibler, Kurt, MD, Newman, Nancy S., RN, Piazza, Anthony J., MD, Poindexter, Brenda B., MD, MS, Shankaran, Seetha, MD, Sánchez, Pablo J., MD, Morris, Brenda H., MD, Frantz, Ivan D., MD, Van Meurs, Krisa P., MD, Cotten, C. Michael, MD, MHS, Ehrenkranz, Richard A., MD, Bell, Edward F., MD, Watterberg, Kristi L., MD, Higgins, Rosemary D., MD, Duara, Shahnaz, MD

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Interim Estimates of 2023-24 Seasonal Influenza Vaccine Effectiveness - United States von Frutos, Aaron M, Price, Ashley M, Harker, Elizabeth, Reeves, Emily L, Ahmad, Haris M, Murugan, Vel, Martin, Emily T, House, Stacey, Saade, Elie A, Zimmerman, Richard K, Gaglani, Manjusha, Wernli, Karen J, Walter, Emmanuel B, Michaels, Marian G, Staat, Mary A, Weinberg, Geoffrey A, Selvarangan, Rangaraj, Boom, Julie A, Klein, Eileen J, Halasa, Natasha B, Ginde, Adit A, Gibbs, Kevin W, Zhu, Yuwei, Self, Wesley H, Tartof, Sara Y, Klein, Nicola P, Dascomb, Kristin, DeSilva, Malini B, Weber, Zachary A, Yang, Duck-Hye, Ball, Sarah W, Surie, Diya, DeCuir, Jennifer, Dawood, Fatimah S, Moline, Heidi L, Toepfer, Ariana P, Clopper, Benjamin R, Link-Gelles, Ruth, Payne, Amanda B, Chung, Jessie R, Flannery, Brendan, Lewis, Nathaniel M, Olson, Samantha M, Adams, Katherine, Tenforde, Mark W, Garg, Shikha, Grohskopf, Lisa A, Reed, Carrie, Ellington, Sascha

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