ICH S7A - S7B Pharmacology Studies Guidelines


S7A - S7B Pharmacology Studies

S7A  Safety Pharmacology Studies for Human Pharmaceuticals

The ICH Harmonised Guideline was adopted under Step 4 in November 2000. This document provides a definition, general principles and recommendations for safety pharmacology studies. This Guideline generally applies to new chemical entities and biotechnology-derived products for human use. It can be applied to marketed pharmaceuticals when appropriate (e.g., when adverse clinical events, a new patient population, or a new route of administration raises concerns not previously addressed).

Date of Step 4: 8 November 2000

Status: Step 5

Guidelines (Click the links below for complete guidelines)

S7A Guidelines

WG Presentations / Trainings (Click the links below for complete guidelines)

S7A Step 4 Presentation

S7B  The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

The ICH Harmonised Guideline was adopted under Step 4 in May 2005. This Guideline describes a non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. This Guideline includes information concerning non-clinical assays and integrated risk assessments.

Date of Step 4: 12 May 2005

Status: Step 5

Guidelines (Click the links below for complete guidelines)

S7B Guidelines

Endorsed Document (Click the links below for complete guidelines)

S7B Concept Paper

E14/S7B IWG  Questions & Answers: Clinical and nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

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 nonclinical 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 nonclinical 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 nonclinical assays in order for these assays to influence nonclinical 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 nonclinical strategy that is more informative for clinical development.

On 15 and 16 October 2020, a public webinar (ICH WG Presentations and Live Q&A) will be held to provide an overview of the high-level principles and rationale behind the new interconnected Q&As to ICH E14 and S7B and to answer questions received during the webinar. The agenda is available for download and more information, including the link for registration, will be published shortly.

Date of Step 2b: 27 August 2020

Status: Step 3

Q&As (Click the links below for complete guidelines)

E14/S7B Draft Q&As

Endorsed Documents (Click the links below for complete guidelines)

E14/S7B Concept Paper

E14/S7B Work Plan

WG Presentations/Trainings (Click the links below for complete guidelines)

E14/S7B Initial Training Material PDF

E14/S7B Initial Training Material - Example Supplemental File PDF

*These Guidelines Belongs to ICH website.

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