scholarly journals Comparison of Liver Safety of Favipiravir and Hydroxychloroquine in COVID-19 Treatment

2020 ◽  
Vol 33 (3) ◽  
pp. 235-240
Author(s):  
Feyza Izci Cetinkaya ◽  
◽  
Hatice Karagoz ◽  
Orhan Yildiz ◽  
◽  
...  
Keyword(s):  
Liver Safety

Preclinical safety evaluation of nafithromycin (WCK 4873) with emphasis on liver safety in rat and dog

2021 ◽  
Vol 122 ◽  
pp. 104889
Author(s):  
Manohar Nandanwar ◽  
Rajesh Chavan ◽  
Atul Kansagara ◽  
Muftedar Ahmed Patel ◽  
Anasuya Patel ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Liver Safety ◽  
Preclinical Safety

scholarly journals Statin liver safety in non‐alcoholic fatty liver disease. A systematic review and metanalysis

2021 ◽  
Author(s):  
Daniele Pastori ◽  
Arianna Pani ◽  
Arianna Di Rocco ◽  
Danilo Menichelli ◽  
Gianluca Gazzaniga ◽  
...  
Keyword(s):  
Systematic Review ◽  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Alcoholic Fatty Liver ◽  
Liver Safety ◽  
Alcoholic Fatty Liver Disease

scholarly journals Mechanistic Investigations Support Liver Safety of Ubrogepant

2020 ◽  
Vol 177 (1) ◽  
pp. 84-93 ◽  
Author(s):  
Brenda Smith ◽  
Josh Rowe ◽  
Paul B Watkins ◽  
Messoud Ashina ◽  
Jeffrey L Woodhead ◽  
...  
Keyword(s):  
Drug Exposure ◽  
Liver Toxicity ◽  
Cgrp Receptor ◽  
Receptor Antagonists ◽  
Drug Induced ◽  
Clinical Dose ◽  
Liver Safety ◽  
Trial Experience ◽  
Dosing Regimens ◽  
Cgrp Receptor Antagonists

Abstract Small-molecule calcitonin gene-related peptide (CGRP) receptor antagonists have demonstrated therapeutic efficacy for the treatment of migraine. However, previously investigated CGRP receptor antagonists, telcagepant and MK-3207, were discontinued during clinical development because of concerns about drug-induced liver injury. A subsequent effort to identify novel CGRP receptor antagonists less likely to cause hepatotoxicity led to the development of ubrogepant. The selection of ubrogepant, following a series of mechanistic studies conducted with MK-3207 and telcagepant, was focused on key structural modifications suggesting that ubrogepant was less prone to forming reactive metabolites than previous compounds. The potential for each drug to cause liver toxicity was subsequently assessed using a quantitative systems toxicology approach (DILIsym) that incorporates quantitative assessments of mitochondrial dysfunction, disruption of bile acid homeostasis, and oxidative stress, along with estimates of dose-dependent drug exposure to and within liver cells. DILIsym successfully modeled liver toxicity for telcagepant and MK-3207 at the dosing regimens used in clinical trials. In contrast, DILIsym predicted no hepatotoxicity during treatment with ubrogepant, even at daily doses up to 1000 mg (10-fold higher than the approved clinical dose of 100 mg). These predictions are consistent with clinical trial experience showing that ubrogepant has lower potential to cause hepatotoxicity than has been observed with telcagepant and MK-3207.

A pre-marketing ALT signal predicts post-marketing liver safety

2012 ◽  
Vol 63 (3) ◽  
pp. 433-439 ◽  
Author(s):  
Cynthia A. Moylan ◽  
Ayako Suzuki ◽  
Julie I. Papay ◽  
Nancy A. Yuen ◽  
Michael Ames ◽  
...  
Keyword(s):  
Liver Safety ◽  
Post Marketing

scholarly journals Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

Drug Safety ◽  
2018 ◽  
Vol 41 (12) ◽  
pp. 1431-1437 ◽  
Author(s):  
John F. Marcinak ◽  
Melvin S. Munsaka ◽  
Paul B. Watkins ◽  
Takashi Ohira ◽  
Neila Smith
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Liver Safety ◽  
Trial Experience ◽  
Global Clinical Trial ◽  
Clinical Trial Experience
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