From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver

The transition from animal-based experimentation toward New Approach Methodologies (NAMs) requires not only technological innovation but also regulatory frameworks that enable evidence-based decision-making. We discuss how the European Medicines Agency’s evolving strategy for regulatory acceptance o...

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Bibliografische gegevens

Hoofdauteurs:	Jean-Michel Dogné, Médéa Locquet, Flora Musuamba, Sonja Beken
Formaat:	Artigo
Taal:	Inglês
Gepubliceerd in:	Frontiers Media S.A. 2026-07-01
Reeks:	Frontiers in Pharmacology
Onderwerpen:	new approach methodologies model-informed drug development regulatory science pharmacokinetic/pharmacodynamic modeling artificial intelligence
Online toegang:	https://www.frontiersin.org/articles/10.3389/fphar.2026.1877947/full
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