• S7A - S7B Pharmacology Studies

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    • Description :

      In November 2018, the Assembly endorsed the establishment of the E14/S7B Implementation Working Group (IWG) for the development of Q&As for the ICH E14 and ICH S7B Guidelines. ICH S7B and ICH E14 describe non-clinical and clinical risk assessment strategies to inform the potential risk for proarrhythmia of a test substance and contribute to the design of clinical investigations. Emergent data over the past several years demonstrate that different experimental results can arise for the same compound as a function of the study conditions used in non-clinical assays. The E14/S7B IWG will build on work done by the former E14/S7B Discussion Group (DG) which discussed the advances in science and methods related to the clinical assessment of QT prolongation and worked on the Comprehensive in vitro Proarrhythmia Assessment (CiPA) initiative.


      The E14/S7B IWG will provide guidance regarding best practices for the design, conduct, analysis, interpretation and reporting of in vitro, in silico and in vivo non-clinical assays in order for these assays to influence non-clinical and clinical evaluations. The Q&As will be developed in two stages to allow for more rapid impact of novel approaches on S7B and subsequently E14 for evolving drug candidates, enabling a more efficient, comprehensive and mechanism-driven process. The objective of the first stage of the proposed harmonisation work is to provide clarity on how to standardise assays such as multi-ion channel assays, in silico models, in vitro human primary and induced pluripotent cardiomyocyte assays and in vivo evaluation, and apply these learnings to guide predictions and subsequent clinical assessment. These efforts will provide a customisable non-clinical strategy that is more informative for clinical development.


      For more information on the progress of the work, see the E14/S7B accordeon.