Steve Riley

TL;DR: There is evidence that robust QT assessment in early‐phase clinical studies can replace the thorough QT study, and exposure–response analysis can detect QT effects in a small study with healthy subjects.

TL;DR: Recommendations are provided on how to plan and conduct a definitive QTc assessment of a drug using C-QTc modeling in early phase clinical pharmacology and thorough QT studies and topics include important study design features in a phase 1 study.

TL;DR: Tafamidis meglumine is a rationally designed, non-NSAID benzoxazole derivative that binds with high affinity and selectivity to TTR and kinetically stabilizes the tetramer, slowing monomer formation, misfolding, and amyloidogenesis.

TL;DR: A clinical study in healthy subjects demonstrating that the thorough QT (TQT) study can be replaced by robust ECG monitoring and exposure–response analysis of data generated from First‐in‐Man single ascending dose (SAD) studies is designed.

TL;DR: A group of experts convened to discuss how to improve the confidence in QT data from early clinical studies, for example, the First-Time-in-Human trial, through collection of serial electrocardiograms and pharmacokinetic samples and the use of exposure response analysis.