Assessing Liver Effects of Cannabidiol and Valproate Alone and in Combination Using Quantitative Systems Toxicology

Authors: Lakhani, Vinal V., Generaux, Grant, Howell, Brett A., Longo, Diane M., Watkins, Paul B.

Source: Clinical pharmacology & therapeutics. 114(5):1006-1014

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Identification of Reduced ERAP2 Expression and a Novel HLA Allele as Components of a Risk Score for Susceptibility to Liver Injury Due to Amoxicillin-Clavulanate

Authors: Nicoletti, Paola, Dellinger, Andrew, Li, Yi Ju, Barnhart, Huiman X., Chalasani, Naga, Fontana, Robert J., Odin, Joseph A., Serrano, Jose, Stolz, Andrew, Etheridge, Amy S., Innocenti, Federico, Govaere, Olivier, Grove, Jane I., Stephens, Camilla, Aithal, Guruprasad P., Andrade, Raul J., Bjornsson, Einar S., Daly, Ann K., Lucena, M. Isabel, Watkins, Paul B.

Source: Gastroenterology. 164(3):454-466

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Comparing the Liver Safety Profiles of 4 Next-Generation CGRP Receptor Antagonists to the Hepatotoxic CGRP Inhibitor Telcagepant Using Quantitative Systems Toxicology Modeling

Authors: Woodhead, Jeffrey L, Siler, Scott Q, Howell, Brett A, Watkins, Paul B, Conway, Charles

Source: Toxicological sciences. 188(1):108-116

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Quantitative Systems Toxicology and Drug Development: The DILIsym Experience

Authors: Watkins, Paul B.

Source: Methods in molecular biology. 2486:181-196

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Biolink Model: A universal schema for knowledge graphs in clinical, biomedical, and translational science

Authors: Unni, Deepak R., Moxon, Sierra A. T., Bada, Michael, Brush, Matthew, Bruskiewich, Richard, Caufield, J. Harry, Clemons, Paul A., Dancik, Vlado, Dumontier, Michel, Fecho, Karamarie, Glusman, Gustavo, Hadlock, Jennifer J., Harris, Nomi L., Joshi, Arpita, Putman, Tim, Qin, Guangrong, Ramsey, Stephen A., Shefchek, Kent A., Solbrig, Harold, Soman, Karthik, Thessen, Anne E., Haendel, Melissa A., Bizon, Chris, Mungall, Christopher J., Acevedo, Liliana, Ahalt, Stanley C., Alden, John, Alkanaq, Ahmed, Amin, Nada, Avila, Ricardo, Balhoff, Jim, Baranzini, Sergio E., Baumgartner, Andrew, Baumgartner, William, Belhu, Basazin, Brandes, MacKenzie, Brandon, Namdi, Burtt, Noel, Byrd, William, Callaghan, Jackson, Cano, Marco Alvarado, Carrell, Steven, Celebi, Remzi, Champion, James, Chen, Zhehuan, Chen, Mei‐Jan, Chung, Lawrence, Cohen, Kevin, Conlin, Tom, Corkill, Dan, Costanzo, Maria, Cox, Steven, Crouse, Andrew, Crowder, Camerron, Crumbley, Mary E., Dai, Cheng, Dančík, Vlado, De Miranda Azevedo, Ricardo, Deutsch, Eric, Dougherty, Jennifer, Duby, Marc P., Duvvuri, Venkata, Edwards, Stephen, Emonet, Vincent, Fehrmann, Nathaniel, Flannick, Jason, Foksinska, Aleksandra M., Gardner, Vicki, Gatica, Edgar, Glen, Amy, Goel, Prateek, Gormley, Joseph, Greyber, Alon, Haaland, Perry, Hanspers, Kristina, He, Kaiwen, Henrickson, Jeff, Hinderer, Eugene W., Hoatlin, Maureen, Hoffman, Andrew, Huang, Sui, Huang, Conrad, Hubal, Robert, Huellas‐Bruskiewicz, Kenneth, Huls, Forest B., Hunter, Lawrence, Hyde, Greg, Issabekova, Tursynay, Jarrell, Matthew, Jenkins, Lindsay, Johs, Adam, Kang, Jimin, Kanwar, Richa, Kebede, Yaphet, Kim, Keum Joo, Kluge, Alexandria, Knowles, Michael, Koesterer, Ryan, Korn, Daniel, Koslicki, David, Krishnamurthy, Ashok, Kvarfordt, Lindsey, Lee, Jay, Leigh, Margaret, Lin, Jason, Liu, Zheng, Liu, Shaopeng, Ma, Chunyu, Magis, Andrew, Mamidi, Tarun, Mandal, Meisha, Mantilla, Michelle, Massung, Jeffrey, Mauldin, Denise, McClelland, Jason, McMurry, Julie, Mease, Philip, Mendoza, Luis, Mersmann, Marian, Mesbah, Abrar, Might, Matthew, Morton, Kenny, Muller, Sandrine, Muluka, Arun Teja, Osborne, John, Owen, Phil, Patton, Michael, Peden, David B., Peene, R. Carter, Persaud, Bria, Pfaff, Emily, Pico, Alexander, Pollard, Elizabeth, Price, Guthrie, Raj, Shruti, Reilly, Jason, Riutta, Anders, Roach, Jared, Roper, Ryan T., Rosenblatt, Greg, Rubin, Irit, Rucka, Sienna, Rudavsky‐Brody, Nathaniel, Sakaguchi, Rayn, Santos, Eugene, Schaper, Kevin, Schmitt, Charles P., Schurman, Shepherd, Scott, Erik, Seitanakis, Sarah, Sharma, Priya, Shmulevich, Ilya, Shrestha, Manil, Shrivastava, Shalki, Sinha, Meghamala, Smith, Brett, Southall, Noel, Southern, Nicholas, Stillwell, Lisa, Strasser, Michael " Michi", Su, Andrew I., Ta, Casey, Tinglin, Jillian, Tonstad, Lucas, Tran‐Nguyen, Thi, Tropsha, Alexander, Vaidya, Gaurav, Veenhuis, Luke, Viola, Adam, Grotthuss, Marcin, Wang, Max, Wang, Patrick, Watkins, Paul B., Weber, Rosina, Wei, Qi, Weng, Chunhua, Whitlock, Jordan, Williams, Mark D., Williams, Andrew, Womack, Finn, Wood, Erica, Wu, Chunlei, Xin, Jiwen Kevin, Xu, Hao, Xu, Colleen, Yakaboski, Chase, Yao, Yao, Yi, Hong, Yilmaz, Arif, Zheng, Marissa, Zhou, Xinghua, Zhou, Eric, Zhu, Qian, Zisk, Tom

Source: Clinical and translational science. 15(8):1848-1855

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Progress toward a universal biomedical data translator

Authors: Fecho, Karamarie, Thessen, Anne E., Baranzini, Sergio E., Bizon, Chris, Hadlock, Jennifer J., Huang, Sui, Roper, Ryan T., Southall, Noel, Ta, Casey, Watkins, Paul B., Williams, Mark D., Xu, Hao, Byrd, William, Dančík, Vlado, Duby, Marc P., Dumontier, Michel, Glusman, Gustavo, Harris, Nomi L., Hinderer, Eugene W., Hyde, Greg, Johs, Adam, Su, Andrew I., Qin, Guangrong, Zhu, Qian, Acevedo, Liliana, Ahalt, Stanley C., Alden, John, Alkanaq, Ahmed, Amin, Nada, Avila, Ricardo, Bada, Michael, Balhoff, Jim, Baumgartner, Andrew, Baumgartner, William, Belhu, Basazin, Brandes, Mac Kenzie, Brandon, Namdi, Brush, Matthew, Bruskiewich, Richard, Burtt, Noel, Callaghan, Jackson, Cano, Marco Alvarado, Carrell, Steven, Caufield, J. Harry, Celebi, Remzi, Champion, James, Chen, Zhehuan, Chen, Mei‐Jan, Chung, Lawrence, Clemons, Paul A., Cohen, Kevin, Conlin, Tom, Corkill, Dan, Costanzo, Maria, Cox, Steven, Crouse, Andrew, Crowder, Camerron, Crumbley, Mary E., Dai, Cheng, Azevedo, Ricardo De Miranda, Deutsch, Eric, Dougherty, Jennifer, Duvvuri, Venkata, Edwards, Stephen, Emonet, Vincent, Fehrmann, Nathaniel, Flannick, Jason, Foksinska, Aleksandra M., Gardner, Vicki, Gatica, Edgar, Glen, Amy, Goel, Prateek, Gormley, Joseph, Greyber, Alon, Haaland, Perry, Haendel, Melissa A., Hanspers, Kristina, He, Kaiwen, Henrickson, Jeff, Hoatlin, Maureen, Hoffman, Andrew, Huang, Conrad, Hubal, Robert, Huellas‐Bruskiewicz, Kenneth, Huls, Forest B., Hunter, Lawrence, Issabekova, Tursynay, Jarrell, Matthew, Jenkins, Lindsay, Joshi, Arpita, Kang, Jimin, Kanwar, Richa, Kebede, Yaphet, Kim, Keum Joo, Kluge, Alexandria, Knowles, Michael, Koesterer, Ryan, Korn, Daniel, Koslicki, David, Krishnamurthy, Ashok, Kvarfordt, Lindsey, Lee, Jay, Leigh, Margaret, Lin, Jason, Liu, Zheng, Liu, Shaopeng, Ma, Chunyu, Magis, Andrew, Mamidi, Tarun, Mandal, Meisha, Mantilla, Michelle, Massung, Jeffrey, Mauldin, Denise, McClelland, Jason, McMurry, Julie, Mease, Philip, Mendoza, Luis, Mersmann, Marian, Mesbah, Abrar, Might, Matthew, Morton, Kenny, Moxon, Sierra A. T., Muller, Sandrine, Muluka, Arun Teja, Mungall, Christopher J., Osborne, John, Owen, Phil, Patton, Michael, Peden, David B., Peene, R. Carter, Persaud, Bria, Pfaff, Emily, Pico, Alexander, Pollard, Elizabeth, Price, Guthrie, Putman, Tim, Raj, Shruti, Ramsey, Stephen A., Reilly, Jason, Riutta, Anders, Roach, Jared, Rosenblatt, Greg, Rubin, Irit, Rucka, Sienna, Rudavsky‐Brody, Nathaniel, Sakaguchi, Rayn, Santos, Eugene, Schaper, Kevin, Schmitt, Charles P., Schurman, Shepherd, Scott, Erik, Seitanakis, Sarah, Sharma, Priya, Shefchek, Kent A., Shmulevich, Ilya, Shrestha, Manil, Shrivastava, Shalki, Sinha, Meghamala, Smith, Brett, Solbrig, Harold, Soman, Karthik, Southern, Nicholas, Stillwell, Lisa, Strasser, Michael " Michi", Tinglin, Jillian, Tonstad, Lucas, Tran‐Nguyen, Thi, Tropsha, Alexander, Unni, Deepak R., Vaidya, Gaurav, Veenhuis, Luke, Viola, Adam, Grotthuss, Marcin, Wang, Max, Wang, Patrick, Weber, Rosina, Wei, Qi, Weng, Chunhua, Whitlock, Jordan, Williams, Andrew, Womack, Finn, Wood, Erica, Wu, Chunlei, Xin, Jiwen Kevin, Xu, Colleen, Yakaboski, Chase, Yao, Yao, Yi, Hong, Yilmaz, Arif, Zheng, Marissa, Zhou, Xinghua, Zhou, Eric, Zisk, Tom

Source: Clinical and translational science. 15(8):1838-1847

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Tolvaptan safety in autosomal-dominant polycystic kidney disease; a focus on idiosyncratic drug-induced liver injury liabilities.

Authors: Hammond, Sean, Meng, Xiaoli, Barber, Jane, Mosedale, Merrie, Chadwick, Amy, Watkins, Paul B, Naisbitt, Dean J

Source: Toxicological Sciences; Jan2025, Vol. 203 Issue 1, p11-27, 17p

Subject Terms: POLYCYSTIC kidney disease, DRUG labeling, WARNING labels, LIVER injuries, DRUG side effects

Pregnancy-Related Hormones Increase Nifedipine Metabolism in Human Hepatocytes by Inducing CYP3A4 Expression

Authors: Khatri, Raju, Kulick, Natasha, Rementer, Rebecca J.B., Fallon, John K., Sykes, Craig, Schauer, Amanda P., Malinen, Melina M., Mosedale, Merrie, Watkins, Paul B., Kashuba, Angela D.M., Boggess, Kim A., Smith, Philip C., Brouwer, Kim L.R., Lee, Craig R.

Source: In Journal of Pharmaceutical Sciences January 2021 110(1):412-421

Human Leukocyte Antigen B*14:01 and B*35:01 Are Associated With Trimethoprim‐Sulfamethoxazole Induced Liver Injury

Authors: Li, Yi‐Ju, Phillips, Elizabeth J., Dellinger, Andrew, Nicoletti, Paola, Schutte, Ryan, Li, Danmeng, Ostrov, David A., Fontana, Robert J., Watkins, Paul B., Stolz, Andrew, Daly, Ann K, Aithal, Guruprasad P, Barnhart, Huiman, Chalasani, Naga

Source: Hepatology. 73(1):268-281

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Cannabidiol and Abnormal Liver Chemistries in Healthy Adults: Results of a Phase I Clinical Trial

Authors: Watkins, Paul B., Church, Rachel J., Li, Jie, Knappertz, Volker

Source: Clinical pharmacology & therapeutics. 109(5):1224-1231

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100120013133.0x000001&indx=1&recIds=ETOCvdc_100120013133.0x000001

Genetic Risk Factors in Drug‐Induced Liver Injury Due to Isoniazid‐Containing Antituberculosis Drug Regimens

Authors: Nicoletti, Paola, Devarbhavi, Harshad, Goel, Ashish, Venkatesan, Radha, Eapen, Chundamannil E., Grove, Jane I., Zafer, Samreen, Bjornsson, Einar, Lucena, M. Isabel, Andrade, Raul J., Pirmohamed, Munir, Wadelius, Mia, Larrey, Dominique, Maitland‐van der Zee, Anke‐Hilse, Ibanez, Luisa, Watkins, Paul B, Daly, Ann K., Aithal, Guruprasad P.

Source: Clinical pharmacology & therapeutics. 109(4):1125-1135

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100117506495.0x000001&indx=1&recIds=ETOCvdc_100117506495.0x000001

Quantitative Systems Toxicology Modeling Predicts that Reduced Biliary Efflux Contributes to Tolvaptan Hepatotoxicity

Authors: Beaudoin, James J., Brock, William J., Watkins, Paul B., Brouwer, Kim L. R.

Source: Clinical pharmacology & therapeutics. 109(2):433-442

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100113511551.0x000001&indx=1&recIds=ETOCvdc_100113511551.0x000001

Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development

Authors: Regev, Arie, Avigan, Mark I., Kiazand, Alexandre, Vierling, John M., Lewis, James H., Omokaro, Stephanie O., Di Bisceglie, Adrian M., Fontana, Robert J., Bonkovsky, Herbert L., Freston, James W., Uetrecht, Jack P., Miller, Ethan D., Pehlivanov, Nonko D., Haque, Syed Asif, Harrison, Melanie J., Kullak-Ublick, Gerd A., Li, Hewei, Patel, Niti N., Patwardhan, Meenal, Price, Karen D., Watkins, Paul B., Chalasani, Naga P.

Source: In Journal of Autoimmunity November 2020 114

DILIsym: Quantitative systems toxicology impacting drug development

Authors: Watkins, Paul B.

Source: In Current Opinion in Toxicology October-December 2020 23-24:67-73

Liver Injury Due to Drugs and Viruses: Mechanistic Similarities and Implications for AAV Gene Therapy

Authors: Watkins, Paul B.

Source: Clinical pharmacology & therapeutics. 112(4):751-753

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Quantitative Systems Toxicology Approaches to Understand and Predict Drug-Induced Liver Injury

Authors: Watkins, Paul B.

Source: In Clinics in Liver Disease February 2020 24(1):49-60

Incidence and Etiology of Drug-Induced Liver Injury in Mainland China

Authors: Shen, Tao, Liu, Yingxia, Shang, Jia, Xie, Qing, Li, Jun, Yan, Ming, Xu, Jianming, Niu, Junqi, Liu, Jiajun, Watkins, Paul B., Aithal, Guruprasad P., Andrade, Raúl J., Dou, Xiaoguang, Yao, Lvfeng, Lv, Fangfang, Wang, Qi, Li, Yongguo, Zhou, Xinmin, Zhang, Yuexin, Zong, Peilan, Wan, Bin, Zou, Zhengsheng, Yang, Dongliang, Nie, Yuqiang, Li, Dongliang, Wang, Yuya, Han, Xi’an, Zhuang, Hui, Mao, Yimin, Chen, Chengwei

Source: In Gastroenterology June 2019 156(8):2230-2241

A Missense Variant in PTPN22 is a Risk Factor for Drug-induced Liver Injury

Authors: Aithal, Guruprasad P., Andrade, Raul J., Bessone, Fernando, Bjornsson, Einar, Cascorbi, Ingolf, Daly, Ann K., Dillon, John F., Day, Christopher P., Hallberg, Par, Hernández, Nelia, Ibanez, Luisa, Kullak-Ublick, Gerd A., Laitinen, Tarja, Larrey, Dominique, Lucena, M. Isabel, Maitland-van der Zee, Anke, Martin, Jennifer H., Menzies, Dick, Molokhia, Mariam, Pirmohamed, Munir, Qin, Shengying, Wadelius, Mia, Cirulli, Elizabeth T., Nicoletti, Paola, Abramson, Karen, Bjornsson, Einar S., Chalasani, Naga, Fontana, Robert J., Hallberg, Pär, Li, Yi Ju, Long, Nanye, Nelson, Matthew R., Odin, Joseph A., Rafnar, Thorunn, Serrano, Jose, Stefánsson, Kári, Stolz, Andrew, Watkins, Paul B.

Source: In Gastroenterology May 2019 156(6):1707-1716

Next‐Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development

Authors: Roth, Sharin E., Avigan, Mark I., Bourdet, David, Brott, David, Church, Rachel, Dash, Ajit, Keller, Douglas, Sherratt, Philip, Watkins, Paul B., Westcott‐Baker, Lucas, Lentini, Silvia, Merz, Michael, Ramaiah, Lila, Ramaiah, Shashi K., Stanley, Ann Marie, Marcinak, John

Source: Clinical pharmacology & therapeutics. 107(2):333-346

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ERAP-1 and ERAP-2 Variants in Liver Injury After COVID-19 mRNA Vaccination: A US Multicenter Study.

Authors: Fontana, Robert J., Yi Ju Li, Vuppalanchi, Raj, Kleiner, David E., Jiezhun Gu, Shroff, Hersh, Van Wagner, Lisa B., Watkins, Paul B.

Source: American Journal of Gastroenterology (Lippincott Williams & Wilkins); Aug2024, Vol. 119 Issue 8, p1496-1505, 10p