Top-down, bottom-up and middle-out strategies for drug cardiac safety assessment via modeling and simulations

Z Tylutki, S Polak, B Wiśniowska - Current Pharmacology Reports, 2016 - Springer
Cardiac safety is an issue causing early terminations at various stages of drug development.
Efforts are put into the elimination of false negatives as well as false positives resulting from …

Moxifloxacin pharmacokinetics, cardiac safety, and dosing for the treatment of rifampicin-resistant tuberculosis in children

KK Radtke, AC Hesseling, JL Winckler… - Clinical Infectious …, 2022 - academic.oup.com
Background Moxifloxacin is a recommended drug for rifampin-resistant tuberculosis (RR-TB)
treatment, but there is limited pediatric pharmacokinetic and safety data, especially in young …

A thorough QT study to evaluate the QTc prolongation potential of two neuropsychiatric drugs, quetiapine and escitalopram, in healthy volunteers

A Kim, KS Lim, H Lee, H Chung, SH Yoon… - International clinical …, 2016 - journals.lww.com
Prolongation of the QT interval on an ECG is a surrogate marker for predicting the
proarrhythmic potential of a drug under development. The aim of this study was to evaluate …

Limited sampling strategies using linear regression and the Bayesian approach for therapeutic drug monitoring of moxifloxacin in tuberculosis patients

SHJ van den Elsen, MGG Sturkenboom… - Antimicrobial Agents …, 2019 - Am Soc Microbiol
Therapeutic drug monitoring (TDM) of moxifloxacin is recommended to improve the
response to tuberculosis treatment and reduce acquired drug resistance. Limited sampling …

Evaluating cardiac risk: exposure response analysis in early clinical drug development

J Grenier, S Paglialunga, BH Morimoto… - Drug, Healthcare and …, 2018 - Taylor & Francis
The assessment of a drug's cardiac liability has undergone considerable metamorphosis by
regulators since International Council for Harmonization of Technical Requirement for …

[HTML][HTML] Moxifloxacin concentration correlate with QTc interval in rifampicin-resistant tuberculosis patients on shorter treatment regimens

T Kusmiati, NM Mertaniasih, JNE Putranto… - Journal of Clinical …, 2022 - Elsevier
Background Drug-resistant tuberculosis (DR-TB) continues to be a global threat.
Moxifloxacin is one of the components of the shorter treatment regimen which is suspected …

Diurnal profile of the QTc interval following moxifloxacin administration

J Täubel, G Ferber, S Fernandes… - The Journal of Clinical …, 2019 - Wiley Online Library
Understanding the physiological fluctuations in the corrected QT (QTc) interval is important
to accurately interpret the variations in drug‐induced prolongation. The present study aimed …

[HTML][HTML] The role of C-Reactive protein as an inflammatory marker to predict prolonged QTc interval in rifampicin-resistant tuberculosis patients: A case-control study

T Kusmiati, NM Mertaniasih, JNE Putranto… - Annals of Medicine and …, 2021 - Elsevier
Background long-term use of anti-tuberculosis drugs (ATD) increases the risk of QTc
prolongation, while C-reactive protein (CRP) can be used as an inflammatory marker of …

QTc Interval Prolongation in Drug Resistant-Tuberculosis Patients Treated with Shorter Treatment Regimen.

T Kusmiati, YD Suci, KP Dewi - Medico-Legal Update, 2021 - search.ebscohost.com
Abstract Background: Shorter Treatment Regimen (STR) is a combination of treatments with
a shortened period from 20-24 months to 9-11 months. Shortened treatment requires a …

Lack of ethnic differences of moxifloxacin and metabolite pharmacokinetics in East Asian men

M Kaneko, T Aoyama, Y Ishida, A Miyamoto… - … of Pharmacokinetics and …, 2018 - Springer
This study was designed to investigate ethnic differences in the pharmacokinetics (PKs) of
moxifloxacin and its metabolites, M1 (sulfo conjugate) and M2 (acyl-glucuronate), among …