Cell-Based Assays for Toxicity Prediction

One example of a cell-based assay that has been successfully incorporated into the safety assessment pathway is the assessment of drug-induced proarrhythmia risk based on block of the cardiac repolarization current IKr and the clinical assessment of the electrocardiographic QT interval, as discussed in the ICH S7B and ICH E14 harmonized 

EMERGING TECHNOLOGIES AND THEIR ROLE IN REGULATORY REVIEW 

Abaci HE and Shuler ML (2015) Human-on-a-chip design strategies and principles for physiologically based pharmacokinetics/phar-macodynamics modeling. IntegrBiol (Camb). 7(4) 383-91. 

Abi-Gerges N, HoMam H, Jones EM, Pollard CE, Valentin JP and Robertson GA (2011) hERG subunit composition determines differential drug sensitivity. Br J Pharmacol. 164(2b) 419-32. 

Alden CL, Lynn A, Bourdeau A, Morton D, Sistare FD, Kadambi VJ and Silverman L (2011) A critical review of the effectiveness of rodent pharmaceutical carcinogenesis testing in predicting for human risk. Vet Pathol. 48(3) 772-84. 

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