Ayça Kömürlüoğlu, Esra Akaydın Gültürk, Sıddika Songül Yalçın
Turkish Adaptation, Reliability, and Validity Study of the Vaccine Acceptance Instrument
Vaccines
ich e14s7b qas highlighted need best practices concerning design execution analysis interpretation reporting vivo nonrodent qt assay component integrated risk assessment potentially support tqt waiver substitute conducted dog telemetry study assess effects qtc six reference compounds five positive one negative previously evaluated darpo et al 2015 humans sensitivity assay detect qtc increases determined exposureresponse analysis performed done clinical practice bytimepoint analysis showed qtc prolongation induced moxifloxacin dofetilide dolasetron ondansetron quinine within human relevant plasma exposures ranges moreover hysteresis observed quinine expected levocetirizine showed statistically significant effect qtc across range exposure well exceeding therapeutic cmax power analyses confirmed study ability detect statistically significant qtc changes less 10 milliseconds 80 probability even sample size low n 4 animals finally concentrationqtc modeling enabled predict minimal plasma concentration needed detect 10 milliseconds qtc prolongation including quinine comparison clinical available data supported relevance dogs experimental conditions robust translational predictor druginduced qtc prolongation humans key pillar integrated risk assessment