Genotoxicity and Carcinogenicity Testing of Pharmaceuticals von Graziano, Michael J, Jacobson-Kram, David

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Cancer Risk Assessment Approaches at the FDA/CDER: Is the Era of the 2-Year Bioassay Drawing to a Close? von Jacobson-Kram, David

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Transgenic animal models in toxicology: historical perspectives and future outlook von Boverhof, Darrell R, Chamberlain, Mark P, Elcombe, Clifford R, Gonzalez, Frank J, Heflich, Robert H, Hernández, Lya G, Jacobs, Abigail C, Jacobson-Kram, David, Luijten, Mirjam, Maggi, Adriana, Manjanatha, Mugimane G, Benthem, Jan van, Gollapudi, B Bhaskar

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Development and Evaluation of a Genomic Signature for the Prediction and Mechanistic Assessment of Nongenotoxic Hepatocarcinogens in the Rat von Fielden, Mark R., Adai, Alex, Dunn, Robert T., Olaharski, Andrew, Searfoss, George, Sina, Joe, Aubrecht, Jiri, Boitier, Eric, Nioi, Paul, Auerbach, Scott, Jacobson-Kram, David, Raghavan, Nandini, Yang, Yi, Kincaid, Andrew, Sherlock, Jon, Chen, Shen-Jue, Car, Bruce

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Leveraging Exploratory Investigational New Drug Studies to Accelerate Drug Development von Jacobson-Kram, David, Mills, George

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New and emerging technologies for genetic toxicity testing von Lynch, Anthony M, Sasaki, Jennifer C, Elespuru, Rosalie, Jacobson-Kram, David, Thybaud, Véronique, De Boeck, Marlies, Aardema, Marilyn J, Aubrecht, Jiri, Benz, R. Daniel, Dertinger, Stephen D, Douglas, George R, White, Paul A, Escobar, Patricia A, Fornace, Albert Jr, Honma, Masamitsu, Naven, Russell T, Rusling, James F, Schiestl, Robert H, Walmsley, Richard M, Yamamura, Eiji, van Benthem, Jan, Kim, James H

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Interlaboratory Evaluation of Genomic Signatures for Predicting Carcinogenicity in the Rat von Fielden, Mark R., Nie, Alex, McMillian, Michael, Elangbam, Chandi S., Trela, Bruce A., Yang, Yi, Dunn, Robert T., Dragan, Yvonne, Fransson-Stehen, Ronny, Bogdanffy, Matthew, Adams, Stephen P., Foster, William R., Chen, Shen-Jue, Rossi, Phil, Kasper, Peter, Jacobson-Kram, David, Tatsuoka, Kay S., Wier, Patrick J., Gollub, Jeremy, Halbert, Donald N., Roter, Alan, Young, Jamie K., Sina, Joseph F., Marlowe, Jennifer, Martus, Hans-Joerg, Aubrecht, Jiri, Olaharski, Andrew J., Roome, Nigel, Nioi, Paul, Pardo, Ingrid, Snyder, Ron, Perry, Richard, Lord, Peter, Mattes, William, Car, Bruce D.

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Distribution and toxicity resulting from adenoviral vector administration to a single salivary gland in adult rats von O'Connell, Brian C., Zheng, Changyu, Jacobson-Kram, David, Baum, Bruce J.

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Use of Transgenic Mice in Carcinogenicity Hazard Assessment von Jacobson-Kram, David, Sistare, Frank D., Jacobs, Abigail C.

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Use of Genotoxicity Data to Support Clinical Trials or Positive Genetox Findings on a Candidate Pharmaceutical or Impurity …. Now What? von Jacobson-Kram, David, Jacobs, Abigail

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Review Article: Use of Transgenic Animals for Carcinogenicity Testing: Considerations and Implications for Risk Assessment von Gulezian, Donna, Jacobson-Kram, David, Mccullough, C. Bruce, Olson, Harry, Recio, Leslie, Robinson, Denise, Storer, Richard, Tennant, Raymond, Ward, Jerrold M., Neumann, David A.

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Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation Part I: Early Screening for Potential Human Mutagens von Jacobson-Kram, David, Contrera, Joseph F.

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Regulation of genotoxic and carcinogenic impurities in drug substances and products von McGovern, Timothy, Jacobson-Kram, David

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Use of Animals in the Development of Medicines and Devices for Humans and Animals von Jacobson-Kram, David

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Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation von Ball, Douglas, Blanchard, James, Jacobson-Kram, David, McClellan, Roger O, McGovern, Timothy, Norwood, Daniel L, Vogel, WMark, Wolff, Ron, Nagao, Lee

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Human Carcinogenic Risk Evaluation, Part III: Assessing Cancer Hazard and Risk in Human Drug Development von Jacobs, Abigail, Jacobson-Kram, David

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Toxicological overview of impurities in pharmaceutical products von Jacobson-Kram, David, McGovern, Timothy

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Review of the mutagenicity of ethylene oxide von Dellarco, Vicki L., Generoso, Walderico M., Sega, Gary A., Fowle III, John R., Jacobson-Kram, David, Brockman, H. E.

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Scientific and Regulatory Policy Committee (SRPC) Review: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment von Wood, Charles E., Hukkanen, Renee R., Sura, Radhakrishna, Jacobson-Kram, David, Nolte, Thomas, Odin, Marielle, Cohen, Samuel M.

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Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium von Dieterle, Frank, Sistare, Frank, Goodsaid, Federico, Papaluca, Marisa, Ozer, Josef S, Webb, Craig P, Baer, William, Senagore, Anthony, Schipper, Matthew J, Vonderscher, Jacky, Sultana, Stefan, Gerhold, David L, Phillips, Jonathan A, Maurer, Gérard, Carl, Kevin, Laurie, David, Harpur, Ernie, Sonee, Manisha, Ennulat, Daniela, Holder, Dan, Andrews-Cleavenger, Dina, Gu, Yi-Zhong, Thompson, Karol L, Goering, Peter L, Vidal, Jean-Marc, Abadie, Eric, Maciulaitis, Romaldas, Jacobson-Kram, David, Defelice, Albert F, Hausner, Elizabeth A, Blank, Melanie, Thompson, Aliza, Harlow, Patricia, Throckmorton, Douglas, Xiao, Shen, Xu, Nancy, Taylor, William, Vamvakas, Spiros, Flamion, Bruno, Lima, Beatriz Silva, Kasper, Peter, Pasanen, Markku, Prasad, Krishna, Troth, Sean, Bounous, Denise, Robinson-Gravatt, Denise, Betton, Graham, Davis, Myrtle A, Akunda, Jackie, McDuffie, James Eric, Suter, Laura, Obert, Leslie, Guffroy, Magalie, Pinches, Mark, Jayadev, Supriya, Blomme, Eric A, Beushausen, Sven A, Barlow, Valérie G, Collins, Nathaniel, Waring, Jeff, Honor, David, Snook, Sandra, Lee, Jinhe, Rossi, Phil, Walker, Elizabeth, Mattes, William

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