Cardiac safety integrated risk assessments

Subsequently, either additional ion channel studies or more sophisticated voltage-clamp methods may be used in conjunction with in vitro APD studies to assess proarrhythmia liability. In vivo models may be used before selection of the candidate drug, but use is limited due to their low-throughput nature. Prior to first in human (FIH) studies in vitro APD and in vivo APD and QT interval assessments are usually undertaken to complement the early cardiac screening data, thus establishing a dataset used to inform an integrated risk assessment as described in the ICH S7A and ICH S7B guidelines (Anon. 2001, 2005). Almost no non-clinical safety work is conducted after FIH. 

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