Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the "Double-Negative" Scenario.
Clin Pharmacol Drug Dev
; 10(9): 964-973, 2021 09.
Article
em En
| MEDLINE
| ID: mdl-34331518
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cardiotoxicidade
/
Desenvolvimento de Medicamentos
/
Cardiopatias
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Animals
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Clin Pharmacol Drug Dev
Ano de publicação:
2021
Tipo de documento:
Article