ru-66647 and Drug-Related-Side-Effects-and-Adverse-Reactions

ru-66647 has been researched along with Drug-Related-Side-Effects-and-Adverse-Reactions* in 2 studies

Other Studies

2 other study(ies) available for ru-66647 and Drug-Related-Side-Effects-and-Adverse-Reactions

Article	Year
Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. PloS one, 2015, Volume: 10, Issue:12 We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release. Topics: Adverse Drug Reaction Reporting Systems; Aripiprazole; Chemical and Drug Induced Liver Injury; Data Mining; Databases, Factual; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Exenatide; Humans; Hypercalcemia; Ketolides; Pancreatitis; Peptides; Rhabdomyolysis; Rosuvastatin Calcium; Suicide; Teriparatide; Time Factors; United States; United States Food and Drug Administration; Varenicline; Venoms	2015
Discovery of azetidinyl ketolides for the treatment of susceptible and multidrug resistant community-acquired respiratory tract infections. Journal of medicinal chemistry, 2009, Dec-10, Volume: 52, Issue:23 Respiratory tract bacterial strains are becoming increasingly resistant to currently marketed macrolide antibiotics. The current alternative telithromycin (1) from the newer ketolide class of macrolides addresses resistance but is hampered by serious safety concerns, hepatotoxicity in particular. We have discovered a novel series of azetidinyl ketolides that focus on mitigation of hepatotoxicity by minimizing hepatic turnover and time-dependent inactivation of CYP3A isoforms in the liver without compromising the potency and efficacy of 1. Topics: Animals; Azetidines; Bacteria; Community-Acquired Infections; Disease Susceptibility; Drug Discovery; Drug Resistance, Multiple; Drug-Related Side Effects and Adverse Reactions; Humans; Ketolides; Mice; Microbial Sensitivity Tests; Respiratory Tract Infections	2009

Article

Year

Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions.

PloS one, 2015, Volume: 10, Issue:12

We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release.

Topics: Adverse Drug Reaction Reporting Systems; Aripiprazole; Chemical and Drug Induced Liver Injury; Data Mining; Databases, Factual; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Exenatide; Humans; Hypercalcemia; Ketolides; Pancreatitis; Peptides; Rhabdomyolysis; Rosuvastatin Calcium; Suicide; Teriparatide; Time Factors; United States; United States Food and Drug Administration; Varenicline; Venoms

2015

Discovery of azetidinyl ketolides for the treatment of susceptible and multidrug resistant community-acquired respiratory tract infections.

Journal of medicinal chemistry, 2009, Dec-10, Volume: 52, Issue:23

Respiratory tract bacterial strains are becoming increasingly resistant to currently marketed macrolide antibiotics. The current alternative telithromycin (1) from the newer ketolide class of macrolides addresses resistance but is hampered by serious safety concerns, hepatotoxicity in particular. We have discovered a novel series of azetidinyl ketolides that focus on mitigation of hepatotoxicity by minimizing hepatic turnover and time-dependent inactivation of CYP3A isoforms in the liver without compromising the potency and efficacy of 1.

Topics: Animals; Azetidines; Bacteria; Community-Acquired Infections; Disease Susceptibility; Drug Discovery; Drug Resistance, Multiple; Drug-Related Side Effects and Adverse Reactions; Humans; Ketolides; Mice; Microbial Sensitivity Tests; Respiratory Tract Infections

2009