Search Results - "Senior, John R"

Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges by Senior, John R.

“…Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began to show serious and sometimes fatal liver toxicity, we began at the…”
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Drug Hepatotoxicity from a Regulatory Perspective by Senior, John R., MD

“…This article summarizes problems of drug-induced liver injury (DILI), as seen from the perspective of the Food and Drug Administration (FDA). After brief…”
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Recognizing Drug-Induced Liver Injury: Current Problems, Possible Solutions by Lee, William M., Senior, John R.

“…Currently there are three major problems in understanding drug-induced liver injury (DILI): (1) reliably establishing whether the liver disease was caused by…”
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Can rechallenge be done safely after mild or moderate drug‐induced liver injury? by Senior, John R.

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Drug-Related Hepatotoxicity by Navarro, Victor J, Senior, John R

“…Given its rarity, drug-related hepatotoxicity may not be seen during the initial clinical trials of a new medication. After approval, when many more patients…”
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New biomarkers for drug-induced liver injury: are they really better? what do they diagnose? by Senior, John R.

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Why the threshold criteria should not be modified for detection of possibly serious drug-induced hepatotoxicity in special groups of trial subjects by Senior, John R.

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Unintended Hepatic Adverse Events Associated with Cancer Chemotherapy by Senior, John R.

“…Chemotherapy is meant to be toxic, but it is particularly aimed at the tumor cells. Collateral damage may occur to normal cells and tissues, especially if they…”
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What is idiosyncratic hepatotoxicity? What is it not? by Senior, John R.

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Some Recollections of the American Association for the Study of Liver Diseases Transformative Decade 1970‐1979 by Senior, John R.

“…Abbreviations AASLD American Association for the Study of Liver Diseases ALF American Liver Foundation ASLD Association for the Study of Liver Disease CPC…”
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The Clinical Liver Safety Assessment Best Practices Workshop: Rationale, Goals, Accomplishments and the Future by Watkins, Paul B., Merz, Michael, Avigan, Mark I., Kaplowitz, Neil, Regev, Arie, Senior, John R.

“…The pharmaceutical industry has entered challenging economic times, and some analysts have questioned the long-term sustainability of its current business…”
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Using controlled clinical trials to learn more about acute drug‐induced liver injury by Watkins, Paul B., Seligman, Paul J., Pears, John S., Avigan, Mark I., Senior, John R.

“…Drug‐induced liver injury (DILI) is of major interest to hepatologists and clinicians in general, patients, government regulators, and the pharmaceutical…”
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Troglitazone-induced liver failure: a case study by Graham, David J, Green, Lanh, Senior, John R, Nourjah, Parivash

“…Troglitazone was removed from the U.S. market because its use was associated with an increased risk of liver failure. We evaluated the clinical features of all…”
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The Australia antigen and role of the late Philadelphia general hospital in reducing post‐transfusion hepatitis and sequelae by Senior, John R., London, W. Thomas, Sutnick, Alton I.

“…Baruch Blumberg, who received the Nobel Prize for Physiology or Medicine for his discovery of the Australia antigen, died on April 5, 2011. Arguably, that…”
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How can 'Hy's law' help the clinician? by Senior, John R.

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CURRENT CONCEPTS: Drug-Related Hepatotoxicity by Navarro, Victor J, Senior, John R

“…Given its rarity, drug-related hepatotoxicity may not be seen during the initial clinical trials of a new medication. After approval, when many more patients…”
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Black cohosh: considerations of safety and benefit by Betz, Joseph M, Anderson, Linda, Avigan, Mark I, Barnes, Joanne, Farnsworth, Norman R, Gerden, Barbro, Henderson, Leigh, Kennelly, Edward J, Koetter, Uwe, Lessard, Stephanie, Dog, Tieraona Low, McLaughlin, Michelle, Naser, Belal, Osmers, Ruediger G.W, Pellicore, Linda S, Senior, John R

“…Black cohosh, Actaea racemosa L (syn. Cimicifuga racemosa [L] Nutt), has enjoyed a rapid rise in popular use for the amelioration or alleviation of menopausal…”
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Healthy ranges for alanine aminotransferase levels by De Rosa, Francesco G, Bonora, Stefano, Di Perri, Giovanni

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Ursodeoxycholic acid for the treatment of primary sclerosing cholangitis: a 30-month pilot study by O'Brien, C B, Senior, J R, Arora-Mirchandani, R, Batta, A K, Salen, G

“…We investigated the effects of once-daily oral administration of 10 mg/kg ursodeoxycholic acid (generic name, ursodiol) on elevated serum enzyme activities,…”
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Working group session report: chronic renal and gastrointestinal disease by Senior, J R, Maroni, B J

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