From guideline to practice: three years of ICH S11 insights and recommendations

Juvenile Animal Studies (JAS) may be warranted to ensure the safe clinical use of medicines for children. The ICH S11 guideline was developed to guide the need for and design of JAS, and proposes a weight-of-evidence (WoE) approach. We evaluated how the introduction of the guideline shaped the non-c...

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Bibliographic Details
Main Authors: Diana Tavares, Hsiao-Tzu Chien, Maria Elzbieta Sheean, Peter Theunissen, Peter van Meer, Karen Van Malderen
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-02-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1537001/full
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