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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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9. Contributors

Author

Aggarwal, Manoj, primary, Akingbasote, James, additional, Anadón, Arturo, additional, Anger, Gregory J., additional, Archibong, Anthony E., additional, Ares, Irma, additional, Aschner, Michael, additional, Avila, Daiana S., additional, Bailey, Denise C., additional, Barlow, Norman J., additional, Beedanagari, Sudheer, additional, Beltyukov, P.P., additional, Bischoff, Karyn, additional, Boeck, Carina Rodrigues, additional, Bracken, William M., additional, Brehm, Emily, additional, Breyer, Richard M., additional, Bright-Ponte, Susan, additional, Brockett, Mirjana Milosevic, additional, Campagnolo, Luisa, additional, Carney, Edward W., additional, Charrette, Andrew, additional, Chebekoue, Sandrine Fleur, additional, Chiang, Catheryne, additional, Chou, Wei-Chun, additional, Cleal, Jane K., additional, Cole, Toby B., additional, Cook, Daniel, additional, Coppock, Robert W., additional, Costa, Lucio G., additional, Curras-Collazo, Margarita, additional, Dai, Wanying, additional, Dao, Khoi, additional, Da Silva, Rosane Souza, additional, Davis, T. Zane, additional, Dominguez, Francisco, additional, Doss, Robin B., additional, Dziwenka, Margitta M., additional, Enright, Brian, additional, Estevan, Carmen, additional, Evans, Timothy J., additional, Fan, Anna M., additional, Farina, Marcelo, additional, Fenton, Suzanne E., additional, Filazi, Ayhan, additional, Fitsanakis, Vanessa A., additional, FitzGerald, Rex, additional, Flaskos, John, additional, Flaws, Jodi A., additional, Flora, S.J.S., additional, Ganjam, Vekataseshu K., additional, Gardner, Dale R., additional, Garg, Ramesh C., additional, Garrick, Jacqueline M., additional, Garry, Vincent F., additional, Gelineau-van Waes, Janee, additional, Godfrey, Keith M., additional, Golubentseva, Yu V., additional, González-Martín, Roberto, additional, Green, Benedict T., additional, Guerri, Consuelo, additional, Gulati, Kavita, additional, Gupta, P.K., additional, Gupta, Ramesh C., additional, Gupta, Rekha K., additional, Guthrie, Najla, additional, Hall, Jeffery O., additional, Hargreaves, Alan J., additional, Harris, Kenneth J., additional, Hill, Bridgett N., additional, Hilmas, Corey J., additional, Hoberman, Alan M., additional, Hougaard, Karin S., additional, Ince, Sinan, additional, Iyer, Poorni R., additional, Jacobsen, Nicklas R., additional, Kalpana, Starling, additional, Kandimalla, Ramesh, additional, Kanthasamy, Arthi, additional, Kanthasamy, Anumantha, additional, Khlebnikova, N.S., additional, Klüver, Nils, additional, Kodavanti, Prasada Rao S., additional, Krishnan, Kannan, additional, Kulkarni, Shaila, additional, Kuzukiran, Ozgur, additional, Lall, Rajiv, additional, Legradi, Jessica, additional, Lewis, Rohan M., additional, Lewis, Elise M., additional, Li, Xin, additional, Lin, Pinpin, additional, Loganathan, Bommanna G., additional, Machado, Ivo F., additional, Mahadevan, Brinda, additional, Makris, Susan L., additional, Malik, Jitendra K., additional, Marreilha dos Santos, Ana Paula, additional, Marsillach, Judit, additional, Martínez-Larrañaga, María Rosa, additional, Martínez, María Aránzazu, additional, Matouskova, Klara, additional, McClellan, Roger O., additional, Milatovic, Dejan, additional, Mohammed, Ali Mustafa, additional, Montine, Thomas J., additional, Møller, Peter, additional, Multani, Pushpinder Kaur, additional, Ni, Mingwei, additional, Nikolaidis, Efstathios, additional, Novilla, Meliton N., additional, Padilla, Stephanie, additional, Palmeira, Carlos M., additional, Pamies, David, additional, Panner Selvam, Manesh Kumar, additional, Pascual, María, additional, Patwa, Jayant, additional, Phillips, Ashley, additional, Piquette-Miller, Micheline, additional, Popov, V.B., additional, Pratt, M. Margaret, additional, Protasova, G.A., additional, Rai, Nishant, additional, Ramalho-Santos, João, additional, Ramesh, Aramandla, additional, Ray, Kausik, additional, Ray, Arunabha, additional, Ren, Aiguo, additional, Renaud, Stephen J., additional, Roberts, Drucilla J., additional, Rongzhu, Lu, additional, Sachana, Magdalini, additional, Sahlman, Heidi, additional, Saini, Nitin, additional, Saini, Vandna, additional, Shabasheva, L.V., additional, Sharma, Abha, additional, Sikka, Suresh C., additional, Silva, Marilyn Helen, additional, Simsek, Ilker, additional, Singh Kalra, Rajkumar, additional, Sinha, Anita, additional, Sogorb, Miguel A., additional, Soldin, Offie P., additional, Song, Chunjuan, additional, Srivastava, Ajay, additional, Stice, Szabina A., additional, Stoker, Tammy E., additional, Stonecipher, Clinton A., additional, Szlapinski, Sandra, additional, Tanabe, Shihori, additional, Tatiparthi, Arun, additional, Teixeira da Rocha, João Batista, additional, Thokchom, Suresh Kumar, additional, Tornesi, Belen, additional, Torous, Vanda, additional, Truran, Peter, additional, Valdez, Matthew C., additional, Vandenberg, Laura N., additional, Vargesson, Neil, additional, Vilanova, Eugenio, additional, Vähäkangas, Kirsi H., additional, Vulimiri, Suryanarayana V., additional, Warner, Genoa R., additional, Welch, Kevin D., additional, Williams, Daniel C., additional, Woldemeskel, Moges, additional, Yang, Jae-Ho, additional, Yin, Zhaobao, additional, Ying, Xiaoyou, additional, Yurdakok-Dikmen, Begum, additional, Zaja-Milatovic, Snjezana, additional, and Zhou, Changqing, additional

Published
2022
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17. HESI workshop summary: Interpretation of developmental and reproductive toxicity endpoints and the impact on data interpretation of adverse events.

Author

Green, M. L., Kluever, A., Chen, Connie, Dobreniecki, S., Halpern, Wendy, Hannas, Bethany, Hoberman, Alan, McNerney, M. E., Mitchell‐Ryan, S., Shafer, T. J., Van Cruchten, Steven, and White, Tacey

Abstract

The Health and Environmental Sciences Institute Developmental and Reproductive Toxicology (HESI‐DART) group held a hybrid in‐person and virtual workshop in Washington, DC, in 2022. The workshop was entitled, "Interpretation of DART in Regulatory Contexts and Frameworks." There were 154 participants (37 in person and 117 virtual) across 9 countries. The purpose of the workshop was to capture key consensus approaches used to assess DART risks associated with chemical product exposure when a nonclinical finding is identified. The decision‐making process for determining whether a DART endpoint is considered adverse is critical because the outcome may have downstream implications (e.g., increased animal usage, modifications to reproductive classification and pregnancy labeling, impact on enrollment in clinical trials and value chains). The workshop included a series of webinar modules to train and engage in discussions with federal and international regulators, clinicians, academic investigators, nongovernmental organizations, contract research organization scientists, and private sector scientists on the best practices and principles of interpreting DART and new approach methodologies in the context of regulatory requirements and processes. Despite the differences in regulatory frameworks between the chemical and pharmaceutical sectors, the same foundational principles for data interpretation should be applied. The discussions led to the categorization of principles, which offer guidance for the systematic interpretation of data. Step 1 entails identifying any hazard by closely analyzing the data at the study endpoint level, while Step 2 involves assessing risk using weight of evidence. These guiding principles were derived from the collective outcomes of the workshop deliberations. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Evaluation of gadolinium‐based contrast agents in pregnant CD‐1 mice and subsequent in utero exposure of the developing offspring, including behavioral evaluations.

Author

Lewis, Elise M., Bussi, Simona, Fretellier, Nathalie, Clemens, Guenther, Jones, Paul, Tedoldi, Fabio, Bourrinet, Phillipe, Czupalla, Oliver, Hirani, Ella, and Hoberman, Alan M.

Abstract

Introduction: The offspring of CD‐1 mice exposed during pregnancy to one of seven gadolinium‐based contrast agents (GBCAs) were evaluated for potential effects on postnatal development and behavior. The GBCAs, comprising four linear (gadopentetate dimeglumine, gadodiamide, gadobenate dimeglumine, and gadoxetate disodium) and three macrocyclic (gadoterate meglumine, gadoteridol, and gadobutrol), were administered via intravenous injection once daily from Gestation Day 6 through 17 following confirmed mating (Day 0) at doses of at least twice the human equivalent recommended clinical dose (i.e., 0.63 mmol Gd/kg for gadoxetate disodium and 2.5 mmol Gd/kg for the other GBCAs). All dams were allowed to deliver naturally. F0 generation females were monitored for maternal toxicity and gadolinium (Gd) levels in blood and brain. Offspring were evaluated for Gd levels in blood and brain at birth and on Day 70 postpartum. F1 generation mice were evaluated for survival and growth preweaning. Selected pups/litter were evaluated postweaning for sexual maturation, growth, and behavior. Gd was quantifiable in the brain of the F1 offspring on PND 1, with levels declining over time. There was no long‐term effect of any GBCA on the growth and development of any offspring. There was no impact on neurodevelopment, as assessed by brain histology and validated neurobehavioral tests, including a battery of functional observational tests, motor activity, and learning and memory as evaluated in the Morris water maze. Conclusion: At the end of the postweaning period, the highest dose tested was considered the no‐observable‐adverse‐effect level (NOAEL) in the F0 and F1 offspring for all tested GBCAs. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Evaluation of gadolinium‐based contrast agents in juvenile CD‐1 mice including behavioral evaluations.

Author

Lewis, Elise M., Jones, Paul, Clemens, Guenther, Fretellier, Nathalie, Bussi, Simona, Hirani, Ella, Czupalla, Oliver, Tedoldi, Fabio, Bourrinet, Phillipe, and Hoberman, Alan M.

Abstract

Introduction: Seven gadolinium‐based contrast agents (GBCAs), four linear and three macrocyclic, were evaluated for potential effects on development, including behavior of juvenile CD‐1 mice. Methods: The GBCAs were administered via intravenous injection once daily on postnatal day (PND) 9, 12, 15, 18, and 21 (PND 1 was the day of delivery) at doses up to twice the human equivalent clinical dose (i.e., 0.63 mmol Gd/kg for gadoxetate disodium and 2.5 mmol Gd/kg for the other GBCAs). Mice were bled for evaluation of exposure (plasma) to gadolinium (Gd) on PND 9, 12, and 70. At scheduled euthanasia, the liver, spleen, brain, skin (dorsal surface), bone (left femur), and kidneys were excised from up to six mice/sex/group on PND 10, 22, or 70 for the determination of Gd levels and histopathological analysis. All mice were monitored for toxicity, growth and survival, sexual maturation, and behavior. Conclusion: Gd was quantifiable in the brain tissues with levels declining over time. There was no long‐term effect on the growth and development for mice exposed to any of the GBCAs. There was no impact on neurodevelopment as assessed by brain histology and validated neurobehavioral tests, including a functional observational battery, motor activity, and learning and memory as evaluated in the Morris water maze. For all GBCAs, the highest dose tested represented the no‐observable‐adverse‐effect level in juvenile mice. [ABSTRACT FROM AUTHOR]

Published
2024
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23. List of Contributors

Author

Aggarwal, Manoj, primary, Agrawal, Shruti, additional, Anadón, Arturo, additional, Anger, Gregory J., additional, Archibong, Anthony E., additional, Ares, Irma, additional, Aschner, Michael, additional, Avila, Daiana S., additional, Bailey, Denise C., additional, Baker, Nancy C., additional, Barlow, Norman J., additional, Beedanagari, Sudheer, additional, Bischoff, Karyn, additional, Bracken, William M., additional, Brehm, Emily, additional, Breyer, Richard M., additional, Bright-Ponte, Susan, additional, Campagnolo, Luisa, additional, Carney, Edward W., additional, Castellano, Victor, additional, Chebekoue, Sandrine Fleur, additional, Chiang, Catheryne, additional, Chou, Wei-Chun, additional, Choudhuri, Supratim, additional, Cleal, Jane K., additional, Coppock, Robert W., additional, Costa, Lucio G., additional, Curras-Collazo, Margarita, additional, da Rocha, João Batista Teixeira, additional, Da Silva, Rosane S., additional, Davis, T. Zane, additional, Doss, Robin B., additional, Dziwenka, Margitta M., additional, Enright, Brian, additional, Eriksson, Per, additional, Estevan, Carmen, additional, Evans, Timothy J., additional, Fadeel, Bengt, additional, Fan, Anna M., additional, Faqi, Ali S., additional, Farina, Marcelo, additional, Fenton, Suzanne E., additional, Feuston, Maureen H., additional, Filazi, Ayhan, additional, Fitsanakis, Vanessa A., additional, Flaskos, John, additional, Flaws, Jodi A., additional, Flora, Swaran J.S., additional, Ganjam, Vekataseshu K., additional, Gardner, Dale R., additional, Gardner, Nicole M., additional, Garg, Ramesh C., additional, Garry, Vincent F., additional, Gelineau-van Waes, Janee, additional, Godfrey, Keith M., additional, Guerri, Consuelo, additional, Guizzetti, Marina, additional, Gulati, Kavita, additional, Gulumian, Mary, additional, Gupta, Pawan K., additional, Gupta, Ramesh C., additional, Gupta, Rekha K., additional, Gwaltney-Brant, Sharon M., additional, Hall, Jeffrey O., additional, Hansen, Deborah K., additional, Hargreaves, Alan J., additional, Harris, Kenneth J., additional, Hoberman, Alan M., additional, Hougaard, Karin S., additional, Ince, Sinan, additional, Inselman, Amy L., additional, Iyer, Poorni, additional, Jacobsen, Nicklas R., additional, Kagan, Valerian E., additional, Kalpana, Starling, additional, Kaneko, Kotaro, additional, Kanthasamy, Anumantha, additional, Kanthasamy, Arthi, additional, Karttunen, Vesa, additional, Kim, Hyung Sik, additional, Knudsen, Thomas B., additional, Kodavanti, Prasada Rao S., additional, Krishnan, Kannan, additional, Kulkarni, Shaila, additional, Lall, Rajiv, additional, Lasher, Michelle A., additional, Laudert, Scott B., additional, Lee, Byung-Mu, additional, Legradi, Jessica, additional, Leung, Maxwell C.K., additional, Lewis, Elise M., additional, Lewis, Rohan M., additional, Li, Xin, additional, Lin, Pinpin, additional, Loganathan, Bommanna G., additional, Lyche, Jan Ludvig, additional, MacPhail, Robert C., additional, Mahadevan, Brinda, additional, Malik, Jitendra K., additional, Marreilha dos Santos, Ana Paula, additional, Martínez, Maria Aranzazu, additional, Martínez-Larrañaga, Maria Rosa, additional, McClary, David, additional, Menezes, Fabiano P., additional, Meyer, Jerrold S., additional, Milatovic, Dejan, additional, Miller Mukherjee, Ida R., additional, Mohammed, Ali Mustafa, additional, Møller, Peter, additional, Montine, Thomas J., additional, Ni, Mingwei, additional, Nikolaidis, Efstathios, additional, Novilla, Meliton N., additional, Padilla, Stephanie, additional, Palmeira, Carlos M., additional, Pamies, David, additional, Panter, Kip E., additional, Pascual, María, additional, Pellacani, Claudia, additional, Piper, Brian J., additional, Piquette-Miller, Micheline, additional, Popov, Vadim B., additional, Pratt, M. Margaret, additional, Protasova, Galina A., additional, Rai, Nishant, additional, Ramalho-Santos, João, additional, Ramesh, Aramandla, additional, Ray, Arunabha, additional, Ray, Kausik, additional, Ren, Aiguo, additional, Renaud, Stephen J., additional, Riley, Ronald T., additional, Roberts, Drucilla J., additional, Rongzhu, Lu, additional, Sachana, Magdalini, additional, Savolainen, Kai M., additional, Shabasheva, Lilia V., additional, Shiverick, Kathleen T., additional, Sikka, Suresh C., additional, Sogorb, Miguel A., additional, Soldin, Offie P., additional, Song, Chunjuan, additional, Srivastava, Ajay, additional, Stice, Szabina A., additional, Stoker, Tammy E., additional, Toor, Jaideep S., additional, Tornesi, Belen, additional, Truran, Peter, additional, Vähäkangas, Kirsi, additional, Valdez, Joseph, additional, Vargesson, Neil, additional, Viberg, Henrik, additional, Vilanova, Eugenio, additional, Voss, Kenneth A., additional, Vulimiri, Suryanarayana V., additional, Welch, Kevin D., additional, Williams, Daniel C., additional, Woldemeskel, Moges, additional, Yang, Jae-Ho, additional, Yin, Zhaobao, additional, Ying, Xiaoyou, additional, Yurdakok-Dikmen, Begum, additional, Zaja-Milatovic, Snjezana, additional, and Zhou, Changqing, additional

Published
2017
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29. Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies – A workshop report

Author

Solomon, Howard M., Makris, Susan L., Alsaid, Hasan, Bermudez, Oscar, Beyer, Bruce K., Chen, Antong, Chen, Connie L., Chen, Zhou, Chmielewski, Gary, DeLise, Anthony M., de Schaepdrijver, Luc, Dogdas, Belma, French, Julian, Harrouk, Wafa, Helfgott, Jonathan, Henkelman, Mark R., Hesterman, Jacob, Hew, Kok-Wah, Hoberman, Alan, Lo, Cecilia W., McDougal, Andrew, Minck, Daniel R., Scott, Lelia, Stewart, Jane, Sutherland, Vicki, Tatiparthi, Arun K., Winkelmann, Christopher T., Wise, David L., Wood, Sandra L., and Ying, Xiaoyou

Published
2016
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31. Supplemental Material, sj-docx-1-tpx-10.1177_01926233211046869 - Regulatory Perspectives on Juvenile Animal Toxicologic Pathology

Author

Rao, Deepa B., Hoberman, Alan M., Brown, Paul C., Varela, Aurore, and Bolon, Brad

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-1-tpx-10.1177_01926233211046869 for Regulatory Perspectives on Juvenile Animal Toxicologic Pathology by Deepa B. Rao, Alan M. Hoberman, Paul C. Brown, Aurore Varela and Brad Bolon in Toxicologic Pathology

Published
2021
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34. 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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35. Rethinking developmental toxicity testing: Evolution or revolution?

Author

Scialli, Anthony R, Daston, George, Chen, Connie, Coder, Prägati S, Euling, Susan Y, Foreman, Jennifer, Hoberman, Alan M, Hui, Julia, Knudsen, Thomas, Makris, Susan L, Morford, LaRonda, Piersma, Aldert H, Stanislaus, Dinesh, Thompson, Kary E, Sub RIVM, dIRAS RA-1, Sub RIVM, and dIRAS RA-1

Subjects
0301 basic medicine, Embryology, Reproductive toxicology, Health, Toxicology and Mutagenesis, hypothesis-based testing, Developmental toxicity, Embryonic Development, Toxicology, Risk Assessment, Article, Fetal Development, 03 medical and health sciences, Testing protocols, Pregnancy, Toxicity Tests, Adverse Outcome Pathway, Animals, Humans, virtual embryo, Technical committee, Segment II, adverse outcome pathways, Test (assessment), 030104 developmental biology, Risk analysis (engineering), Background current, embryo-fetal toxicity testing, Pediatrics, Perinatology and Child Health, Female, developmental toxicity testing, Developmental Biology, Dose selection
Abstract

Background Current developmental toxicity testing adheres largely to protocols suggested in 1966 involving the administration of test compound to pregnant laboratory animals. After more than 50 years of embryo-fetal development testing, are we ready to consider a different approach to human developmental toxicity testing? Methods A workshop was held under the auspices of the Developmental and Reproductive Toxicology Technical Committee of the ILSI Health and Environmental Sciences Institute to consider how we might design developmental toxicity testing if we started over with 21st century knowledge and techniques (revolution). We first consider what changes to the current protocols might be recommended to make them more predictive for human risk (evolution). Results The evolutionary approach includes modifications of existing protocols and can include humanized models, disease models, more accurate assessment and testing of metabolites, and informed approaches to dose selection. The revolution could start with hypothesis-driven testing where we take what we know about a compound or close analog and answer specific questions using targeted experimental techniques rather than a one-protocol-fits-all approach. Central to the idea of hypothesis-driven testing is the concept that testing can be done at the level of mode of action. It might be feasible to identify a small number of key events at a molecular or cellular level that predict an adverse outcome and for which testing could be performed in vitro or in silico or, rarely, using limited in vivo models. Techniques for evaluating these key events exist today or are in development. Discussion Opportunities exist for refining and then replacing current developmental toxicity testing protocols using techniques that have already been developed or are within reach.

Published
2018

39. List of Contributors

Author

Adams, Margaret R., primary, Aggarwal, Manoj, additional, Ahmed, Tausif, additional, Allard, Patrick, additional, Anadón, Arturo, additional, Anger, Gregory J., additional, Archibong, Anthony E., additional, Aschner, Michael, additional, Avila, Daiana S., additional, Bagchi, Debasis, additional, Bagchi, Manashi, additional, Barlow, Norman J., additional, Barr, Dana Boyd, additional, Beedanagari, Sudheer, additional, Bischoff, Karyn, additional, Bracken, William M., additional, Breyer, Rich M., additional, Bright, Susan, additional, Bruner-Tran, Kaylon L., additional, Buch, Shilpa, additional, Buckley, Brian, additional, Bursian, Steven J., additional, Carney, Edward W., additional, Castellano, Victor, additional, Chakraborty, Sudipta, additional, Chen, Jing, additional, Chirwa, Sanika, additional, Choudhuri, Rajani, additional, Choudhuri, Supratim, additional, Cleal, Jane K., additional, Colaiácovo, Monica P., additional, Coppock, Robert W., additional, Costa, Lucio G., additional, Costantine, Maged M., additional, Damodaran, Tirupapuliyur V., additional, Da Silva, Rosane Souza, additional, Davis, T. Zane, additional, Di Carlo, Marta, additional, Doherty, John D., additional, Domingo, José L., additional, Dziwenka, Margitta M., additional, Eriksson, Per, additional, Martínez, Carmen Estevan, additional, Evans, Timothy J., additional, Fadeel, Bengt, additional, Faqi, Ali S., additional, Farina, Marcelo, additional, Fenton, Suzanne E., additional, Feuston, Maureen H., additional, Flaskos, John, additional, Flora, Swaran J.S., additional, Ganjam, Vekataseshu K., additional, Gardner, Dale R., additional, Garg, Ramesh C., additional, Garry, Vincent F., additional, Waes, Janee Gelineau-van, additional, Giordano, Gennaro, additional, Glaberman, Scott, additional, Godfrey, Keith M., additional, Guizzetti, Marina, additional, Gulati, Kavita, additional, Gulumian, Mary, additional, Gupta, P.K., additional, Gupta, Ramesh C., additional, Gwaltney-Brant, Sharon M., additional, Hall, Jeffery O., additional, Han, Xiaodong, additional, Hansen, Deborah K., additional, Hargreaves, Alan J., additional, Hoberman, Alan M., additional, Hood, Darryl B., additional, Hougaard, Karin Sørig, additional, Inselman, Amy L., additional, Irwin, William A., additional, Kagan, Valerian E., additional, Kalpana, Starling, additional, Kanthasamy, Anumantha G., additional, Kanthasamy, Arthi, additional, Karttunen, Vesa, additional, Khoshbouei, Habibeh, additional, Kim, Hyung Sik, additional, Kodavanti, Prasada Rao S., additional, Koprivsek, Katarina, additional, Kozic, Dusko, additional, Krishnan, Kannan, additional, Kulkarni, Shaila, additional, Kummu, Maria, additional, Lee, Byung Mu, additional, Lewis, Rohan M., additional, Li, Dongmei, additional, Li, Xin, additional, Lindbohm, Marja-Liisa, additional, Loikkanen, Jarkko, additional, Lyche, Jan L., additional, MacPhail, Robert, additional, Mahadevan, Brinda, additional, Makris, Susan L., additional, Malik, Jitendra K., additional, Martínez-Larrañaga, Maria Rosa, additional, Meyer, Jerrold S., additional, Milatovic, Dejan, additional, Montine, Thomas J., additional, Mor, Inbal, additional, Mostrom, Michelle, additional, Myllynen, Päivi, additional, Kolla, Jayaprakash Narayana, additional, Nayyar, Tultul, additional, Newsted, John L., additional, Ni, Mingwei, additional, Nikolaidis, Efstathios, additional, Mikic, Aleksandra Novakov, additional, Novilla, Meliton N., additional, Osteen, Kevin G., additional, Pachauri, Vidhu, additional, Padilla, Stephanie, additional, Palmeira, Carlos M., additional, Pamies, David, additional, Panter, Kip E., additional, Partanen, Heidi, additional, Patel, Sangeeta, additional, Piper, Brian J., additional, Piquette-Miller, Micheline, additional, Popov, Vadim, additional, Pratt, M. Margaret, additional, Protasova, Galina, additional, Ramalho-Santos, João, additional, Ramesh, Aramandla, additional, Ramos, Eva, additional, Ray, Arunabha, additional, Ray, Kausik, additional, Renaud, Stephen J., additional, Rezk, Bashir M., additional, Riley, Ronald T., additional, Roberts, Drucilla J., additional, Robles, Noemi, additional, Teixeira da Rocha, João Batista, additional, Rongzhu, Lu, additional, Sabriá, Josefa, additional, Sachana, Magdalini, additional, Sallmén, Markku, additional, Marreilha dos Santos, Ana Paula, additional, Savolainen, Kai M., additional, Saxena, Geetu, additional, Sebastian, Manu, additional, Segner, Helmut, additional, Sengupta, Krishanu, additional, Shiverick, Kathleen T., additional, Sieppi, Elina, additional, Sikka, Suresh, additional, Soares, Michael J., additional, Sogorb, Miguel Angel, additional, Soldin, Offie P., additional, Song, Chunjuan, additional, Soreq, Hermona, additional, Stoker, Tammy E., additional, Sugawara, Teruo, additional, Szabo, David T., additional, Taskinen, Helena, additional, Truran, Peter, additional, Vähäkangas, Kirsi H., additional, Vangala, Subrahmanyam, additional, Vargesson, Neil, additional, Veid, Jenni, additional, Viberg, Henrik, additional, Vilanova, Eugenio, additional, Voss, Kenneth A., additional, Vulimiri, Suryanarayana V., additional, Wada, Etsuko, additional, Wada, Keiji, additional, Wangikar, Pralhad, additional, Welch, Kevin D., additional, Yao, Honghong, additional, Yin, Zhaobao, additional, Ying, Xiaoyou, additional, Zafra-Stone, Shirley, additional, Zaja-Milatovic, Snjezana, additional, and Zwiernik, Matthew J., additional

Published
2011
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