S11 Nonclinical Paediatric Safety
S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines
The S11 Guideline provides direction on the nonclinical safety studies important to support a paediatric development programme. It recommends standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provides guidance on the design of the studies.
A streamlined drug development and higher scientific rigor while minimizing the unnecessary use of animals will be achieved with the implementation of this new harmonised ICH Guideline.
Date of Step 4: 14 April 2020
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations/Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
