Search Results - "Dimick‐Santos, Lara"

Nonalcoholic Steatohepatitis: Current Thinking From the Division of Hepatology and Nutrition at the Food and Drug Administration by Anania, Frank A., Dimick‐Santos, Lara, Mehta, Ruby, Toerner, Joseph, Beitz, Julie

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Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: Findings and recommendations from an American Association for the Study of Liver Diseases–U.S. Food and Drug Administration Joint Workshop by Sanyal, Arun J., Friedman, Scott L., McCullough, Arthur J., Dimick‐Santos, Lara

“…Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease (CLD) in North America. It is a growing contributor to the burden of…”
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Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis by Ponsioen, Cyriel Y., Lindor, Keith D., Mehta, Ruby, Dimick‐Santos, Lara

“…Primary sclerosing cholangitis (PSC) is a rare and chronic liver disease for which there is no effective therapy. Interest has grown in developing treatments…”
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Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science by Siddiqui, Mohammad Shadab, Harrison, Stephen A., Abdelmalek, Manal F., Anstee, Quentin M., Bedossa, Pierre, Castera, Laurent, Dimick‐Santos, Lara, Friedman, Scott L., Greene, Katherine, Kleiner, David E., Megnien, Sophie, Neuschwander‐Tetri, Brent A., Ratziu, Vlad, Schabel, Elmer, Miller, Veronica, Sanyal, Arun J.

“…Nonalcoholic steatohepatitis (NASH) is an important cause of liver‐related morbidity and mortality. There are no approved therapies, and the results of…”
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Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug‐induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis by Regev, Arie, Palmer, Melissa, Avigan, Mark I., Dimick‐Santos, Lara, Treem, William R., Marcinak, John F., Seekins, Daniel, Krishna, Gopal, Anania, Frank A., Freston, James W., Lewis, James H., Sanyal, Arun J., Chalasani, Naga

“…Summary Background The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and…”
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Consensus guidelines: best practices for detection, assessment and management of suspected acute drug‐induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease by Palmer, Melissa, Regev, Arie, Lindor, Keith, Avigan, Mark I., Dimick‐Santos, Lara, Treem, William, Marcinak, John F., Lewis, James H., Anania, Frank A., Seekins, Daniel, Shneider, Benjamin L., Chalasani, Naga, Dash, Ajit, Krishna, Gopal, Lonjon‐Domanec, Isabelle, Maller, Eric, Marcinak, John F., Palmer, Melissa, Patel, Niti, Patwardhan, Meenal, Raheja, Ritu, Regev, Arie, Lilly, Eli, Seekins, Daniel, Treem, William R., Wuchter‐Czerwony, Christian, Zhang, Hui‐Talia

“…Summary Background Improved knowledge of the molecular pathophysiology and immunopathogenesis of cholestatic liver diseases in recent years has led to an…”
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Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic by Filozof, Claudia, Chow, Shein‐Chung, Dimick‐Santos, Lara, Chen, Yeh‐Fong, Williams, Richard N., Goldstein, Barry J., Sanyal, Arun

“…Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic…”
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Baseline Parameters in Clinical Trials for Nonalcoholic Steatohepatitis: Recommendations From the Liver Forum by Patel, Yuval A., Imperial, Joanne C., Muir, Andrew J., Anstee, Quentin M., DeBrota, David, Dimick-Santos, Lara, Filozof, Claudia, Mehta, Ruby, Sanyal, Arun J., Schabel, Elmer, Neuschwander-Tetri, Brent A., Miller, Veronica, Anstee, Quentin M., Bangma, Sander, Baxter, Melanie, Boulos, Sherif, Burgess, Gary, Chakravarthy, Manu, Christian, Rose, Coombs, Anthony, DeBrota, David, Dimick-Santos, Lara, Filozof, Claudia, Gannedahl, Goran, Herrmann, Richard, Hum, Dean, Imperial, Joanne, Kendrick, Stuart, MacConell, Leigh, Megnien, Sophie, Mehta, Ruby, Miller, Veronica, Muir, Andrew, Neuschwander-Tetri, Brent A., Patel, Yuval, Peres, Dan, Rossi, Stephen, Sanyal, Arun, Schabel, Elmer, Shapiro, David, St Pierre, Tim, Zemel, Michael

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An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids by Kang, Sarah, Brinker, Allen, Jones, S. Christopher, Dimick-Santos, Lara, Avigan, Mark I.

“…Introduction Ulipristal acetate (ulipristal) is a selective progesterone receptor modulator that has been marketed for daily use in Europe and Canada to reduce…”
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Defining Improvement in Nonalcoholic Steatohepatitis for Treatment Trial Endpoints: Recommendations From the Liver Forum by Cheung, Amanda, Neuschwander‐Tetri, Brent A., Kleiner, David E., Schabel, Elmer, Rinella, Mary, Harrison, Stephen, Ratziu, Vlad, Sanyal, Arun J., Loomba, Rohit, Jeannin Megnien, Sophie, Torstenson, Richard, Miller, Veronica

“…Identifying effective therapies for nonalcoholic steatohepatitis (NASH) with fibrosis is a pressing challenge, with 1%‐2% of the population in developed…”
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Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials by Hey-Hadavi, Juliana, Seekins, Daniel, Palmer, Melissa, Coffey, Denise, Caminis, John, Abdullaev, Sandzhar, Patwardhan, Meenal, Tyler, Haifa, Raheja, Ritu, Stanley, Ann Marie, Pineda-Salgado, Liliam, Bourdet, David L., Andrade, Raul J., Hayashi, Paul H., Dimick-Santos, Lara, Rockey, Don C., Estilo, Alvin

“…Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality…”
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Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis by Treem, William R., Palmer, Melissa, Lonjon-Domanec, Isabelle, Seekins, Daniel, Dimick-Santos, Lara, Avigan, Mark I., Marcinak, John F., Dash, Ajit, Regev, Arie, Maller, Eric, Patwardhan, Meenal, Lewis, James H., Rockey, Don C., Di Bisceglie, Adrian M., Freston, James W., Andrade, Raul J., Chalasani, Naga

“…With the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more…”
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Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum by Noureddin, Mazen, Noureddin, Mazen, Chan, Jean L., Chan, Jean L., Barradas, Katherine, Barradas, Katherine, Dimick-Santos, Lara, Dimick-Santos, Lara, Schabel, Elmer, Schabel, Elmer, Omokaro, Stephanie O., Omokaro, Stephanie O., Anania, Frank A., Anania, Frank A., Myers, Robert P., Miller, Veronica, Miller, Veronica, Sanyal, Arun J., Chalasani, Naga, Chalasani, Naga, Bajaj, Jasmohan, Berzigotti, Annalisa, Birman, Pascal, Bosch, Jaime, Brower, Ashley, Calboli, Dania, Charlton, William, Dickinson, Klara, Filozof, Claudia, Forsgren, Mikael F., Fuchs, Michael, Garcia-Tsao, Guadalupe, Gonzalez-Abraldes, Juan, Gruss, Hans-Juergen, Hansen, Morten, Hosman, Suneil, Imperial, Joanne, Jones, David, Lalazar, Gadi, Leinhard, Olof Dahlqvist, Lyons, Erica, McColgan, Brian, Mehta, Ruby, Mesenbrink, Peter, Myers, Rob, Pei, Veronica, Ratziu, Vlad, Regev, Arie, Riccio, Robert, Sanyal, Arun, Seo, Suna, Smith, Alastair, Szitanyi, Peter, Traber, Peter

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Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease by Vos, Miriam B., Dimick-Santos, Lara, Mehta, Ruby, Omokaro, Stephanie O., Taminiau, Johannes, Taminiau, Johannes, Schabel, Elmer, Schabel, Elmer, Kleiner, David E., Kleiner, David E., Szitanyi, Peter, Szitanyi, Peter, Socha, Piotr, Socha, Piotr, Schwimmer, Jeffrey B., Schwimmer, Jeffrey B., Noviello, Stephanie, Noviello, Stephanie, Silberg, Debra G., Torstenson, Richard, Torstenson, Richard, Miller, Veronica, Miller, Veronica, Lavine, Joel E., Adda, Nathalie, Baldyga, William, Banerjee, Rajarshi, Behling, Cynthia, Boulos, Sherif, Burgess, Gary, Calboli, Dania, Charles, Edgar, Christian, Rose, Cohen-Bacrie, Claude, Cosma-Roman, Doina, Danzer, Claus-Peter, Delaet, Ingrid, Delegge, Mark, DiProspero, Nicholas, Donohue, Kathleen, Fischer, Laurent, Fitzpatrick, Emer, Fried, Michael, Hagerty, David, Hale, Paula, Hildick, Keri, Hum, Dean, Jamil, Khurram, Jiang, Lijuan, Karpen, Saul, Kelly, Matt, Kohli, Rohit, Kordy, Kattayoun, Krieger, Nancy, Lavine, Joel, Lee, Lois, Lefebvre, Eric, Lopez, Patricia, Lyons, Erica, Malahias, Laura, Megnien, Sophie, Mesenbrink, Peter, Minnick, Pansy, Murray, Christine, Nghiem, Tien, Nicholson, Nikki, Pang, Wenjie, Percival, Lisa, Peres, Dan, Powell, Margaret, Roman, Dragos, Root, Mark, Sampson, Claire, Sanyal, Arun, Schwarz, Kathleen, Seyedkazemi, Star, Shapiro, David, Shringarpure, Reshma, Silberg, Debra, Smith, Edward, Squires, Robert, Treem, William, Vig, Pamela, Vos, Miriam, Yamashita, Mason, Zemel, Michael

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Best Practices in Liver Biopsy Histologic Assessment for Nonalcoholic Steatohepatitis Clinical Trials: Expert Opinion by Filozof, Claudia M., Lackner, Carolin, Romero-Gómez, Manuel, Imperial, Joanne C., McGee, Robert, Dimick-Santos, Lara, Cummings, Oscar, Behling, Cynthia, Johnson, Troy, Sanyal, Arun

“…Background. In most clinical trials focusing on precirrhotic nonalcoholic steatohepatitis (NASH), a liver biopsy is required for confirmation of diagnosis,…”
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