Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the “Double‐Negative” Scenario

For nearly 2 decades, regulators have adopted a harmonized approach to drug development, which has succeeded in bringing new pharmaceuticals to market without significant cardiac liability. Ushered in by technological advancements and better understanding of cellular electrophysiology, the initial p...

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Bibliographic Details
Published inClinical pharmacology in drug development Vol. 10; no. 9; pp. 964 - 973
Main Author Lester, Robert M.
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.09.2021
John Wiley and Sons Inc
Subjects
Animals
cardiac liability
Cardiotoxicity - prevention & control
concentration response analysis
Drug development
Drug Development - legislation & jurisprudence
Drug Development - methods
Drug Evaluation, Preclinical - methods
Drug Labeling - legislation & jurisprudence
Heart Diseases - chemically induced
Heart Diseases - prevention & control
hERG
Humans
Liability
Pharmaceutical industry
Pharmaceuticals
proarrhythmia risk
Review
thorough QT study (TQT)
United States
United States Food and Drug Administration
United States
proarrhythmia risk
concentration response analysis
hERG
thorough QT study (TQT)
cardiac liability
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Summary:For nearly 2 decades, regulators have adopted a harmonized approach to drug development, which has succeeded in bringing new pharmaceuticals to market without significant cardiac liability. Ushered in by technological advancements and better understanding of cellular electrophysiology, the initial paradigm detailed in the 2005 International Conference for Harmonization E14 and S7B documents has undergone evolutionary changes designed to streamline drug development and improve regulatory decision‐making and product labeling. The intent of this review is to summarize the new US Food and Drug Administration (FDA) Question and Answer update from August 2020 and key messaging from a subsequent FDA webinar describing best practices for preclinical and clinical data integration into a QT risk prediction model.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
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ObjectType-Review-1
ISSN:2160-763X
2160-7648
DOI:10.1002/cpdd.1003