Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As - Rossman, Eric I.; Wisialowski, Todd A.; Vargas, Hugo M.; Valentin, Jean-Pierre; Rolf, Michael G.; Roche, Brian M.; Riley, Steve; Pugsley, Michael K.; Nichols, Jill; Li, Dingzhou; Leishman, Derek J.; Kleiman, Robert B.; et al. (Journal of pharmacological and toxicological methods, 2023)
Keywords: Cardiovascular safety; drug development; drugs; guidelines; hERG; ICH E14; ICH E14/S7B Q&as; ICH S7B; In vivo cardiovascular telemetry; industry; Integrated risk assessment; pharmacokinetics; QT prolongation; species; telemetry; Ventricular repolarization; RR; CRO; TdP; FDA; CNS; LOEL; HR; MDD; NOEL; ICH S7B; Integrated risk assessment; AUC; In vivo cardiovascular telemetry; IKs; ANCOVA; IKr; 3Rs; Ventricular repolarization; ANOVA; IACF; LSD; Cmax; QTc; hERG; Q&As; QT; Cardiovascular safety; FIH; NME; ICH E14/S7B Q&as; ECG; RMSE; IV; SEND; ICH; NCE; C-QT; QT prolongation; CV; PC; PD; TQT; ICH E14; msec; Tmax; PK; MTD