2.1 Objectives of S7B Studies The objectives of studies are to: 1) identify the potential of a test substance and its metabolites to delay ventricular repolarization, and 2) relate the extent of delayed

In August 2020 the International Conference for Har-monization (ICH) Implementation Working Group (IWG) developed a draft guideline document titled “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential: Questions and Answers.”

There were 4 major topics covered in the S7B document pertaining to the role of preclinical assays in assessing ventricular repolarization, requisite elements to standardize the in vitro and in vivo tests, proper formatting of results, and how best to integrate this information with clinical data into a proarrhythmic risk prediction model ...

New S7B Q&As on best practice considerations for the core S7B assays (hERG and in vivo QTc) and additional ion channel assays that can be used as follow-up studies. New S7B Q&As on …

Q&As for ICH E14 and S7B were finalized recently (February 2022) and describe non-clinical and clinical integrated risk assessment strategies to inform the potential risk for proarrhythmia of a test substance.

The CiPA Steering Team is pleased to share the most recent ICH E14/S7B Implementation Working Group (IWG) update. As we have shared in the past, a concept paper was developed in November 2018 which led to the formation of a combined E14/S7B IWG to develop Questions & Answers (Q&As) to both documents. The ICH E14/S7B IWG most

Oct 22, 2024 · The S7B/E14 Q&A document now defines these exposures and describes how the required twofold margin can be reduced if supported by negative nonclinical assays, performed according to the “best practices” (Anon. 2022).

May 6, 2020 · This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. The guidance includes information concerning...

Sep 1, 2023 · The ICH E14/S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers (Q&A) guidance document was issued in 2022 and introduces the concept of a ‘double negative’ nonclinical scenario comprised of a negative hERG assay finding and a negative in vivo QTc study finding.

2.1 Objectives of S7B Studies The objectives of studies are to: 1) identify the of a test substance and its potential metabolites to delay ventricular repolarization, and 2) relate the extent of delayed ventricular repolarization to the concentrations of a test substance and its metabolites.